Doctor Fred L. Pasternack, Appellant,v.Laboratory Corporation of America Holdings,, et al., Respondents.BriefN.Y.June 1, 2016To be Argued by: ROBERT I. STEINER (Time Requested: 30 Minutes) CTQ-2015-00004 United States Court of Appeals for the Second Circuit Case No. 14-4101-cv Court of Appeals of the State of New York DOCTOR FRED L. PASTERNACK, Plaintiff-Appellant, – against – LABORATORY CORPORATION OF AMERICA HOLDINGS a/k/a LabCorp and CHOICEPOINT, INC., Defendants-Respondents. BRIEF FOR DEFENDANT-RESPONDENT LABORATORY CORPORATION OF AMERICA HOLDINGS A/K/A LABCORP KELLEY DRYE & WARREN LLP Attorneys for Defendant-Respondent Laboratory Corporation of America Holdings a/k/a LabCorp 101 Park Avenue New York, New York 10178 Tel.: (212) 808-7800 Fax: (212) 808-7897 April 1, 2016 i COURT OF APPEALS STATE OF NEW YORK DOCTOR FRED L. PASTERNACK, Plaintiff-Appellant, v. LABORATORY CORPORATION OF AMERICA HOLDINGS, Defendant-Respondent. CTQ-2015-00004 DEFENDANT-RESPONDENT’S CORPORATE DISCLOSURE STATEMENT Pursuant to 22 N.Y.C.R.R. § 500.1(f), the undersigned counsel for Defendant-Respondent, Kelley Drye & Warren LLP, certifies that Laboratory Corporation of America Holdings, a publicly-traded company, is the parent and holding company of the following subsidiaries: 2089729 Ontario, Inc.; 2248848 Ontario Inc.; 3065619 Nova Scotia Company; 3257959 Nova Scotia Company; 8165335 Canada Inc.; 8348596 Canada Inc.; 896988 Ontario Inc.; 9279-3280 Quebec Inc.; Accupath Diagnostic Laboratories, Inc.; Beacon Laboratory Benefit Solutions, Inc.; CannAmm GP Inc.; CannAmm Limited Partnership; Cellmark Forensics, Inc.; Centrex Clinical Laboratories, Inc.; Clearstone Central Laboratories (U.S.) Inc.; Clearstone Holdings (International) Ltd.; Clipper Holdings, Inc.; Colorado Coagulation Consultants, Inc.; Correlagen Diagnostics, Inc.; Covance Inc.; Cytometry Associates, Inc.; Czura Thornton (Hong Kong) Limited; DCL Acquisition, Inc.; DCL Medical Laboratories, LLC; DCL Medical ii Laboratories, LLC; DCL Sub LLC; Decision Diagnostics, LLC (aka DaVinici/Medicorp LLC); Diagnostic Services, Inc.; DIANON Systems, Inc.; DL Holdings Limited Partnership; Dynacare - Gamma Laboratory Partnership; Dynacare Company; Dynacare G.P. Inc.; Dynacare Holdco LLC; Dynacare Laboratories Limited Partnership; Dynacare Laboratories Inc.; Dynacare Northwest Inc.; Dynacare Realty Inc.; DynaLifeDX; DynalifeDX Infrastructure Inc.; Endocrine Sciences, Inc.; Esoterix Genetic Counseling, LLC; Esoterix Genetic Laboratories, LLC; Esoterix, Inc.; Execmed Health Services Inc.; FirstSource Laboratory Solutions, Inc.; Gamma Dynacare Central Medical Laboratories GP Inc.; Gamma Dynacare Central Medical Laboratory Limited Partnership; GDML Medical Laboratories Inc.; GeneScreen, Inc.; Glen Ames LLP; HHLA Lab-In-An-Envelope, LLC; Home Healthcare Laboratory of America, LLC; IDX Pathology, Inc.; Impact Genetics, Inc.; Kaleida LabCorp, LLC; Lab Delivery Service of New York City, Inc.; LabCorp BVBA; LabCorp Central Laboratories (Canada) Inc.; LabCorp Central Laboratories (China) Inc.; LabCorp Central Laboratories (Singapore) Pte. Ltd.; LabCorp Development Company; LabCorp Dialysis Services, Inc.; LabCorp Japan, G.K.; LabCorp Limited; LabCorp Neon Ltd.; LabCorp Neon Luxenbourg S.à r.l.; LabCorp Specialty Testing Billing Service, Inc.; LabCorp Specialty Testing Group, Inc.; LabCorp Tennessee, LLC; Laboratoire Bio-Medic Inc.; Laboratory Corporation of America (LCA); Labwest, iii Inc.; Lifecodes Corporation; LipoScience, Inc.; Litholink Corporation; MedAxio Insurance Medical Services GP Inc.; MedAxio Insurance Medical Services LP; Medtox Diagnostics, Inc.; Medtox Laboratories, Inc.; Medtox Scientific, Inc.; Monogram Biosciences, Inc.; National Genetics Institute; New Brighton Business Center LLC; New Imaging Diagnostics, LLC; New Molecular Diagnostics Ventures LLC; NWT Inc.; Orchid Cellmark Ltd.; Orchid Cellmark ULC; Overland Park Reference Laboratory, Inc.; PA Labs, Inc.; Path Lab Incorporated; Persys Technology Inc.; Princeton Diagnostic Laboratories of America, Inc.; Protedyne Corporation; ReliaGene Technologies, Inc.; SW/DL LLC; Tandem Labs Inc.; The Biomarker Factory, LLC; The Bode Technology Group, Inc.; Viro-Med Laboratories, Inc. Covance Inc.’s operating entities are as follows: CJB Inc.; Covance Asia-Pacific Inc.; Covance (Argentina) SA; Covance Austria GmbH; Covance (Asia) Pte. Ltd.; Covance Bioanalytical Services LLC; Covance Brazil Pharmaceutical Services Limitada; Covance (Canada) Inc.; Covance Central Laboratory Services Inc.; Covance Central Laboratory Services Limited Partnership; Covance Central Laboratory Services S.A.; The Covance Charitable Foundation; Covance Chile Services Limitada; Covance Classic Laboratory Services Inc.; Covance Clinical and Periapproval Services AG; Covance Clinical and Periapproval Services GmbH; Covance Clinical and Periapproval Services iv LLC; Covance Clinical and Periapproval Services Limited; Covance Clinical and Periapproval Services Limited; Covance Clinical and Periapproval Services SA; Covance Clinical and Periapproval Services SARL; Covance Clinical Product Developments Ltd.; Covance Clinical Research, L.P.; Covance Clinical Research Unit Inc.; Covance Colombia Services Limitada; Covance CRU Inc.; Covance Clinical Research Unit Limited; Covance Denmark Aps; Covance Development Services (Pty) Ltd.; Covance Hong Kong Holdings Limited; Covance Hong Kong Services Limited; Covance Hungaria Consultancy Limited Liability Company; Covance India Pharmaceutical Services Private Limited; Covance International Holdings B.V.; Covance Luxembourg S.a r.l.; Covance Neon Luxembourg S.a r.l.; Covance Japan Co., Ltd.; Covance Korea Services Limited; Covance Preclinical Services GmbH; Covance Laboratories Korea Company Limited; Covance Laboratories Inc.; Covance Laboratories Limited; Covance Laboratory; Covance Latin America Inc.; Covance Limited; Covance Luxenbourg S.à r.l.; Covance Neon Luxenbourg S.à r.l.; Covance Market Access Services Inc.; Medaxial Limited; Covance Services Malaysia Sdn. Bhd.; Covance Mexico Services, S. DE R. L. De C.V.; Covance New Zealand Limited; Covance Periapproval Services Inc.; Covance Peru Services S.A.; Covance Pharmaceutical Research and Development (Beijing) Co., Ltd.; Covance Pharmaceutical Research and Development (Shanghai) Co., Ltd.; Covance (Polska) Sp.Zo.O; Covance v Preclinical Corporation; Covance Pty. Ltd.; Covance Research Holdings, LLC; Covance Research Products Inc.; Covance Specialty Pharmacy LLC; CRPP Inc.; Covance Services (Thailand) Limited; Covance Taiwan Services Limited; Covance Virtual Central Laboratory B.V.; Fairfax Storage Limited; Texas Covance GP, Inc.; Hazpen Trustees Ltd.; Safe Foods International Holdings, LLC; The National Food Laboratory; International Food Network; IFN Research, LLC; International Food Network Ltd. Laboratory Corporation of America Holdings has no parent. TABLE OF CONTENTS Page vi TABLE OF AUTHORITIES ................................................................................ viii INTRODUCTION .................................................................................................... 1 PRELIMINARY STATEMENT .............................................................................. 1 COUNTER-STATEMENT OF QUESTIONS PRESENTED ................................. 5 COUNTER-STATEMENT OF THE CASE ............................................................ 5 COUNTER-STATEMENT OF FACTS ................................................................... 7 A. Background .......................................................................................... 7 B. The Drug Test ....................................................................................... 8 C. Appellant’s Decision to Leave the LabCorp Facility is Deemed a Refusal to Test by the MRO ............................................................10 D. Appellant Challenges the FAA’s Emergency Order ..........................10 SUMMARY OF ARGUMENT ..............................................................................12 I. THE DOT DRUG TESTING REGULATIONS AND GUIDELINES DO NOT GIVE RISE TO ANY DUTY OF CARE UNDER NEW YORK NEGLIGENCE LAW ......................................................................16 A. Landon Did Not Determine the Issue Presented Here .......................17 B. A New Duty of Care Should Not be Imposed Here Based on the DOT Regulations and Guidelines ......................................................25 1. Appellant is Not Within the Class of Persons Intended to be Protected Nor is His Claim Consistent With the Goal of the DOT Regulations ...........................................................26 2. No Private Right of Action Exists Under the DOT Regulations and Guidelines Nor is this an Area in Which State Common Law Intrudes ...................................................30 C. The DOT Regulations and Guidelines do Not Establish an Industry Standard ...............................................................................37 II. THE RELIANCE ELEMENT OF A FRAUD CLAIM CANNOT BE MET BY RELIANCE ON STATEMENTS MADE TO A THIRD PARTY WHERE THERE IS NO ALLEGATION SUCH STATEMENTS WERE MADE FOR THE PURPOSE OF BEING COMMUNICATED TO PLAINTIFF OR WITH THE INTENT THAT SUCH REPRESENTATIONS WOULD REACH AND INFLUENCE PLAINTIFF ...........................................................................41 vii A. A Plaintiff Cannot Prove Reliance Through a Third Party’s Reliance on Alleged Misrepresentations ............................................43 B. Appellant Does Not Allege any Intent on LabCorp’s Part that the Representations Were Made to Defraud Appellant .....................52 C. Appellant Cannot Show Ms. Montalvo’s Statements Caused His Injury ............................................................................................53 D. It Would Not be in the Public Interest to Permit a Fraud Claim to Proceed Where Reliance is Based on Statements Made by a Witness in a Quasi-Judicial Proceeding .............................................55 CONCLUSION .......................................................................................................56 viii TABLE OF AUTHORITIES Page(s) Cases Admiral Webster v. Psychemedics Corp., No. 2010-01087-COA-R3-CV, 2011 WL 2520157, 2011 Tenn. App. LEXIS 335 (Tenn. Ct. App. June 24, 2011) .............................................. 24 Aymes v. Gateway Demolition Inc., 30 A.D.3d 196 (1st Dep’t 2006) ................................................................... 47, 48 Baker v. Abo, No. Civ. 01-1248 JRTJSM, 2003 WL 21639151, 2003 U.S. Dist. LEXIS 11737 (D. Minn. July 2, 2003) ............................................................... 24 Balistrieri v. Express Drug Screening, LLC, No. 04-C-0989, 2008 WL 906236, 2008 U.S. Dist. LEXIS 26839 (E.D. Wis. Mar. 31, 2008) .................................................................................. 35 Bauer v. Female Acad. of the Sacred Heart, 97 N.Y.2d 445 (2002) ......................................................................................... 40 Bd. of Managers of Beacon Tower Condo. v. 85 Adams St., LLC., 136 A.D.3d 680 (2d Dep’t 2016) ........................................................................ 52 Berry Nat’l Med. Servs., 205 P.3d 745 (Kan. Ct. App. 2009) .................................................................... 23 Braverman v. Bendiner & Schlesinger, Inc., 121 A.D.3d 353 (2d Dep’t 2014) ...................................................... 14, 18, 19, 20 Briarpatch Ltd., L.P. v. Frankfurt, Garbus, Klein & Selz, P.C., 13 A.D.3d 296 (1st Dep’t 2004) ......................................................................... 47 Bruff v. Mali, 36 N.Y. 200 (1867) ....................................................................................... 44, 45 Buxton Mfg. Co. v. Valiant Moving & Stor., 239 A.D.2d 452 (2d Dep’t 1997) .................................................................. 46, 49 ix Bynum v. Keber, 135 A.D.3d 1066 (3d Dep’t 2016) ................................................................ 45, 46 Cement & Concrete Workers Dist. Council v. Lollo, 148 F.3d 194 (2d Cir. 1998) ............................................................................... 41 Chan v. City of New York, 1 F.3d 96 (2d Cir. 1993) ..................................................................................... 37 Chem. Corn Exch. Bank v. Wassung, 7 N.Y.2d 337 (1960) ........................................................................................... 52 City of New York v. Smoker-Spirits, Inc., 541 F.3d 425 (2d Cir. 2008) ............................................................................... 41 Coleman v. Town of Hempstead, 30 F. Supp. 2d 356 (E.D.N.Y. 1999) ...................................................... 23, 34, 35 Compania Importadora Materiales Industriales v. Caldwell & Co., 58 N.Y.S.2d 745 (Sup. Ct. N.Y. County 1945) .................................................. 26 CPC Int’l Inc. v. McKesson Corp., 70 N.Y.2d 268 (1987) ......................................................................................... 53 Cutler v. Quality Terminal Servs., LLC, No. 08-cv-6630, 2009 WL 4674124, 2009 U.S Dist. LEXIS 112742 (N.D. Ill. Dec. 4, 2009) .................................................................... 24, 35 Dance v. Southampton, 95 A.D.2d 442 (2d Dep’t 1983) .................................................................... 29, 39 Darby v. Compagnie Nat’l. Air France, 96 N.Y.2d 343 (2001) ......................................................................................... 16 Desser v. Schatz, 182 A.D.2d 478 (1st Dep’t 1992) ....................................................................... 48 Drake v. Delta Airlines, Inc., 923 F. Supp. 387 (E.D.N.Y. 1996) ..............................................................passim Drake v. Lab. Corp. of Am. Holdings, No. 02-CV-1924 (FB)(RML), 2007 WL 776818, 2007 U.S. Dist. LEXIS 17430 (E.D.N.Y. Mar. 15, 2007) ............................................... 24, 34, 35 x Drake v. Lab. Corp. of Am. Holdings, 290 F. Supp. 2d 352 (E.D.N.Y. 2003) ................................................................ 31 Drake v. Lab. Corp. of Am. Holdings, 458 F.3d 48 (2d Cir. 2006) ................................................................................. 31 Duncan v. Afton, Inc., 991 P.2d 739 (Wyo. 1999) .................................................................................. 23 Eaton Cole & Burnham Co. v. Avery, 83 N.Y. 31 (1880) ......................................................................................... 44, 45 Elliott v. Lab. Specialists, Inc., 588 So. 2d 175 (La. Ct. App. 1991) .................................................................... 23 Ferguson v. Hanson Aggregates New York, Inc., 103 A.D.3d 1174 (4th Dep’t 2013) ..................................................................... 40 First Credit Alliance Corp. v Arthur Andersen & Co., 65 N.Y.2d 536 (1985) ......................................................................................... 52 Friedman v. Anderson, 23 A.D.3d 163 (1st Dep’t 2005) ......................................................................... 52 Garelick v. Carmel, 141 A.D.2d 501 (2d Dep’t 1988) .................................................................. 48, 49 Garlick v. Quest Diagnostics, Inc., No. 06-cv-6244, 2009 WL 5033949, 2009 U.S. Dist. LEXIS 116452 (D.N.J. Dec. 14, 2009) ........................................................................... 24 Gomez-Jimenez v. New York Law Sch., 943 N.Y.S.2d 834 (Sup. Ct. 2012) ...................................................................... 15 Hand v. Gilbank, 300 A.D.2d 1067 (2d Dep’t 2002) ...................................................................... 40 Ishikawa v. Delta Airlines, Inc., 343 F.3d 1129 (9th Cir. 2003) ...................................................................... 22, 36 Kindernay v. Hillsboro Area Hosp., 851 N.E.2d 866 (Ill. App. Ct. 2006) ................................................................... 23 xi King v. Garfield County Pub. Hosp. Dist. No. 1, 17 F. Supp. 3d 1060, 1072 (E.D. Wash. 2014) ................................................... 22 Lacondeguy v. Adapa, No. 2:10-CV-1917-JAM-KJM, 2011 WL 9572, 2010 U.S. Dist. LEXIS 137894 (E.D. Cal. Jan. 3, 2011) ............................................................. 23 Landon v. Kroll Lab. Specialists, Inc., 22 N.Y.3d 1 (2013) ......................................................................................passim Lewis v. Aluminum Co. of Am., 588 So. 2d 167 (La. Ct. App. 1991) .................................................................... 23 Lombard v. Booz‐Allen & Hamilton, Inc., 280 F.3d 209 (2d Cir. 2002) ............................................................................... 16 Lopes v. Rostad, 45 N.Y.2d 617 (1978) ......................................................................................... 36 Lynn v. Mount Sinai Med. Ctr., 692 So. 2d 1002 (Fla. Dist. Ct. App. 1997) .................................................. 23, 36 Manfredonia v. Am. Airlines, Inc., 68 A.D.2d 131 (2d Dep’t 1979) .................................................................... 26, 27 McDowell v. J.B. Hunt Transport, Inc., No. 03-C-6590, 2004 WL 1878334, 2004 U.S. Dist. LEXIS 15728 (N.D. Ill. Aug. 10, 2004)..................................................................................... 27 McSweeney v. Rogan, 209 A.D.2d 386 (2d Dep’t 1994) ........................................................................ 36 Miller v. Paris Cmty. Hosp., No. 07-CV-2195, 2009 WL 2050996, 2009 U.S. Dist. LEXIS 59456 (C.D. Ill. July 13, 2009) ........................................................................... 24 N.Y. Univ. v. Cont’l Ins. Co., 87 N.Y.2d 308 (1995) ......................................................................................... 52 Nichter v. Hartley, 192 A.D.2d 842 (3d Dep’t 1993) ........................................................................ 41 xii Odyssey Re (London) Ltd. v. Stirling Cooke Brown Holdings Ltd., 85 F. Supp. 2d 282 (S.D.N.Y. 2000) .................................................................. 42 Palka v. Servicemaster Mgmt. Servs. Corp., 83 N.Y.2d 579 (1994) ......................................................................................... 17 Parry v. Mohawk Motors of Michigan, Inc., 236 F.3d 299 (6th Cir 2000) ......................................................................... 27, 28 Pasternack v. Huerta, 513 F. App’x 1 (D.C. Cir. 2013) ..................................................................passim Pasternack v. Lab. Corp. of Am., 892 F. Supp. 2d 540 (S.D.N.Y. 2012) ............................................................ 6, 15 Pasternack v. Lab. Corp. of Am. Holdings, 807 F.3d 14 (2d Cir. 2015) ................................................................. 7, 17, 41, 45 Pasternack v. Lab. Corp. of Am., No. 10-CIV-4426 (PGG), 2011 WL 3478732, 2011 U.S. Dist. LEXIS 88311 (S.D.N.Y. Aug. 1, 2011).......................................................... 6, 14 Pasternack v. Lab. Corp. of Am., No. 10-CIV-4426 (PGG), 2014 WL 4832299, 2014 U.S. Dist. LEXIS 137671 (S.D.N.Y. Sept. 29, 2014) ......................................... 7, 14, 32, 34 Pasternack v. Nat’l. Transp. Safety Bd., 596 F.3d 836 (D.C. Cir. 2010) ............................................................................ 11 Piper v. Hoard, 107 N.Y. 73 (1887) ................................................................................. 45, 49, 50 Quisenberry v. Compass Vision, Inc., 618 F. Supp. 2d 1226 (S.D. Cal. 2007)............................................................... 23 Ragsdale v. Mount Sinai Med. Ctr., 770 So. 2d 167 (Fla. Dist. Ct. App. 2000) .......................................................... 23 Rice v. Manley, 66 N.Y. 82 (1876) ......................................................................................... 44, 45 Rodriguez v. Lab. Corp. of Am. Holdings, 13 F. Supp. 3d 121, 131 (D.D.C. 2014) .............................................................. 22 xiii Rosenberg v. Metlife, Inc., 8 N.Y.3d 359 (2007) ........................................................................................... 55 Ruffing v. Union Carbide Corp., 308 A.D.2d 526 (2d Dep’t 2003) ........................................................................ 49 Salomon v. Roche Compuchem Laboratories, Inc., 909 F. Supp. 126 (E.D.N.Y. 1995) ..................................................................... 33 Santiago v. Greyhound Lines, Inc., 956 F. Supp. 144 (N.D.N.Y. 1997) ......................................................... 23, 34, 35 Securities Investor Protection Corp. v. BDO Seidman, LLP, 95 N.Y. 2d 702 (2001) .................................................................................passim Sharpe v. St. Luke’s Hosp., 573 Pa. 90 (2003) ................................................................................................ 23 Silverboys, LLC v. Skordas, No. 653874/2014, 2015 N.Y. Misc. LEXIS 3266, 2015 NY Slip Op 31711(U), (Sup. Ct. N.Y. County Sept. 4, 2015) ......................................... 39 Siotkas v. LabOne, Inc., 594 F. Supp. 2d 259 (E.D.N.Y. 2009) .................................................... 23, 34, 42 Smithkline Beecham Corp. v. Doe, 903 S.W.2d 347 (Tex. 1995) .............................................................................. 28 Spiker v. Sanjivan PLLC, No. CV-13-00334-PHX-GMS, 2013 WL 5200209, 2013 U.S. Dist. LEXIS 131985 (D. Ariz. Sept. 16, 2013) ..................................................... 23, 27 Stinson v. Physicians Immediate Care, 646 N.E.2d 930 (Ill. App. Ct. 1995) ................................................................... 23 Trimarco v. Klein, 56 N.Y.2d 98 (1982) ........................................................................................... 41 Uhr v. East Greenbush Cent. Sch. Dist., 94 N.Y.2d 32 (1999) ........................................................................................... 32 Warren v. Forest Lawn Cemetery & Mausoleum, 635 N.Y.S.2d 874 (1995) .................................................................................... 50 xiv Warshaw v. Concentra Health Servs., 719 F. Supp. 2d 484 (E.D. Pa. 2010) ............................................................ 23, 35 Washington v. Nedd, No. 25395/2008, 31 Misc. 3d 1211(A), 2011 NY Slip Op 50564(U), (Sup. Ct. Queens County Apr. 13, 2011) .......................................... 39 Wildenstein v. 5H & Co, Inc., 97 A.D.3d 488 (1st Dep’t 2012) ................................................................... 47, 48 Williams v. Nat’l R.R. Passenger Corp., 16 F. Supp. 2d 178 (D. Conn. 1998) ................................................................... 23 Statutes and Regulations 49 U.S.C. § 40120(c) ............................................................................................... 33 49 U.S.C. § 45102(a). (App. Br. at 7, 9) ............................................................ 12, 28 49 U.S.C. § 46101(a) ............................................................................................... 33 14 C.F.R. § 120.3 ..................................................................................................... 27 49 C.F.R. § 40.1(b) .................................................................................................. 37 49 C.F.R. § 40.191(a)(2) ................................................................................ 2, 53, 54 49 C.F.R. § 40.191(a)(8) .......................................................................................... 54 49 C.F.R. § 40.193 ................................................................................................... 37 49 C.F.R. § 40.193(b) .............................................................................................. 25 53 Fed. Reg. 47024-01, 47043 (Nov. 21, 1988) ...................................................... 29 54 Fed. Reg. 49854-01 (Dec. 1, 1989) ..................................................................... 30 64 Fed. Reg. 69076-01 (Dec. 9, 1999) ..................................................................... 29 Omnibus Transportation Employee Testing Act of 1991, Pub. L. No. 102-143, § 2(6), 105 Stat. 953 (1991) ................................................................ 29 Other Authorities Fed. R. Civ. P. 12(b)(6) .............................................................................................. 3 xv Department of Transportation, Urine Specimen Collection Guidelines, (July 3, 2014) ...............................................................................................passim 1 INTRODUCTION This case is before the Court to decide two questions certified by the United States Court of Appeals for the Second Circuit. The first question is whether Appellant, a licensed pilot and doctor, can state a claim for negligence based solely on an alleged violation of federal drug-testing regulations and guidelines where it is conceded that the drug test itself was properly performed and it is further conceded that no private right of action exists for a breach of these federal drug-testing regulations and guidelines. The second certified question is whether Appellant can maintain an action for fraud based on alleged third-party reliance by the Federal Aviation Administration (“FAA”) in connection with alleged misstatements made by a witness, defendant LabCorp’s employee, to FAA investigators when Appellant has not alleged he relied on the statements or that the statements were made with intent to reach or influence him, and so deprive him of a benefit for personal gain. Under this Court’s precedents, the answer to both questions is “no.” PRELIMINARY STATEMENT Plaintiff-Appellant, Dr. Fred L. Pasternack (“Appellant”), brought ten causes of action against Defendant-Respondent, Laboratory Corporation of America Holdings (“LabCorp”), arising out of LabCorp’s purported actions in June 2007, during a random drug test Appellant was required to take pursuant to Federal 2 Aviation Administration (“FAA”) regulations (the “Drug Test”). (A-50).1 As a result of his decision to leave the testing facility before his test was complete, the FAA determined that he refused a test under 49 C.F.R. § 40.191(a)(2). (A-173, ¶ 36). The FAA, therefore, suspended Appellant’s airman certificates and his Aviation Medical Examiner (“AME”) designation (the “Emergency Order”). (A- 20, ¶ 25). Appellant appealed the FAA’s Emergency Order to the National Traffic and Safety Board (the “NTSB”) and the decision was upheld. (A-20, ¶ 26). Appellant then brought suit against LabCorp and ChoicePoint Inc. (“ChoicePoint”), the Medical Review Officer (the “MRO”). (A-164). His Second Amended Complaint against LabCorp alleged negligence, gross negligence, negligent misrepresentation, fraud, and injurious falsehood concerning LabCorp’s role in the Drug Test and the FAA’s subsequent determination in issuing the Emergency Order. (A-175). In the meanwhile, the United States Court of Appeals for the D.C. Circuit (the “D.C. Circuit”) reversed the NTSB and FAA’s decisions—not based on any actions of LabCorp—but rather based on its determination that under the circumstances, Appellant’s leaving the testing facility should not have been deemed by the FAA to be a refusal to test under 49 C.F.R. § 1 “A” refers to Plaintiff-Appellant’s Appendix. “ADD” refers to the Addendum attached to Plaintiff-Appellant’s brief. “LC-ADD” refers to the Addendum attached to this brief. 3 40.191(a)(2) of the Department of Transportation (“DOT”) Regulations. Pasternack v. Huerta, 513 F. App’x 1, 2 (D.C. Cir. 2013) (“Huerta”). The United States District Court for the Southern District of New York (the “District Court”) dismissed Appellant’s Second Amended Complaint against LabCorp because Appellant failed to state any claim for which relief can be granted pursuant to Fed. R. Civ. P. 12(b)(6). (A-251). The District Court found that Appellant failed to state causes of action for (i) negligence; (ii) gross negligence; and (iii) negligent misrepresentation because the claims were premised solely on conclusory allegations that one LabCorp employee (Theresa Montalvo), in contravention of the DOT Regulations and Guidelines, failed to explain the “shy bladder” procedures, that she failed to advise him that leaving the testing site could be constituted a “refusal to test,” and that she improperly noted his leaving and return on the Chain of Custody Form (the “CCF”). (A-273). The District Court correctly held that the alleged violations of the DOT Regulations by a drug testing entity did not give rise to a cognizable breach of a recognized duty of care under New York law. (A-273). Critical to this Court’s review of the first certified question is the uncontested fact that Appellant’s claim for negligence does not relate to LabCorp’s duty “to perform [a] drug test in keeping with relevant professional standards.” Landon v. Kroll Lab. Specialists, Inc., 22 N.Y.3d 1, 6–7 (2013) (“Landon”). 4 Indeed, there is no dispute that the test results were accurately reported. Any failure by LabCorp to advise Appellant that leaving the testing facility would be deemed a refusal to test under DOT Guidelines cannot give rise to a duty of care which is independent and apart from a claim for breach of the DOT Regulations and Guidelines. This becomes clear in view of the D.C. Circuit’s finding that Appellant’s leaving the testing facility was not a refusal to test as a matter of law and that the FAA should never have concluded otherwise. Huerta, 513 F. App’x at 2. Thus, had LabCorp advised Appellant that his leaving would be deemed a refusal to test, it would have been wrong under the law. Plaintiff’s argument that LabCorp is liable in negligence for not warning him of possible, erroneous interpretations of federal regulations goes far beyond any duty of care recognized under common law. As to the second certified question, Appellant’s fraud claim is fatally deficient because it is based on statements allegedly made by a witness to FAA investigators, not to Appellant himself, where there is no allegation Appellant knew about the statements or that the statements were intended to reach or influence him. Accordingly, there is no legal causation between LabCorp’s collector, Ms. Montalvo’s statements and Appellant’s injury; nor is there any allegation that Ms. Montalvo had any pecuniary motive for making an alleged 5 fraudulent misrepresentation. Appellant’s theory of alleged third-party reliance is insufficient under New York law. The certified questions should be answered in the negative. COUNTER-STATEMENT OF QUESTIONS PRESENTED 1. Whether the District Court correctly held that a plaintiff cannot state a claim for negligent drug testing if the claim is based solely on an alleged violation of federal regulations and guidelines but, instead, must be based on an independent claim of liability under tort law? 2. Whether the District Court correctly held that, under New York law, a plaintiff cannot establish the reliance element of fraud by showing only that a third party relied on defendant’s allegedly false statement? COUNTER-STATEMENT OF THE CASE On June 2, 2010, Appellant filed a Complaint against LabCorp and ChoicePoint alleging, among other things, claims for negligence, gross negligence, negligent misrepresentation, and fraud. (A-14). Prior to LabCorp or ChoicePoint filing a responsive pleading, Appellant filed an Amended Complaint again alleging claims against LabCorp and ChoicePoint for, among other things, negligence, gross negligence, negligent misrepresentation, and fraud. (A-50). On August 30, 2010, LabCorp filed its Answer to the Amended Complaint denying all of the material allegations in their entirety. (A-5, ECF No. 15). 6 On October 15, 2010, ChoicePoint moved to dismiss the Complaint. (A-5, ECF No. 16). In a Memorandum and Order, dated August 1, 2011, the District Court granted ChoicePoint’s motion to dismiss. Pasternack v. Lab. Corp. of Am., No. 10-CIV-4426 (PGG), 2011 WL 3478732, 2011 U.S. Dist. LEXIS 88311 (S.D.N.Y. Aug. 1, 2011) (“Pasternack I”), (A-89). Thereafter, Appellant sought leave to file a second amended complaint to assert claims against LabCorp and ChoicePoint for, among other things, negligence, gross negligence, negligent misrepresentation, fraud, and injurious falsehood. (A-7, ECF No. 37) ChoicePoint opposed this motion. (A-8, ECF No. 40). LabCorp did not. The District Court, in a Memorandum Opinion and Order, dated September 6, 2012, denied Appellant’s motion to amend the complaint as to ChoicePoint but granted Appellant’s motion as to LabCorp based on its non- opposition. Pasternack v. Lab. Corp. of Am., 892 F. Supp. 2d 540 (S.D.N.Y. 2012) (“Pasternack II”), (A-139). On September 12, 2012, Appellant filed his Second Amended Complaint (the “Second Amended Complaint”) against LabCorp. (A- 164). On June 5, 2013, LabCorp moved to dismiss the Second Amended Complaint. (A-9, ECF No. 56). On October 24, 2013, while LabCorp’s motion to dismiss was pending, Appellant moved for the District Court to reconsider its prior decision as it related to ChoicePoint. (A-10, ECF No. 62). 7 On September 29, 2014, the District Court issued an order denying Appellant’s motion for reconsideration and granting LabCorp’s motion to dismiss. Pasternack v. Lab. Corp. of Am., No. 10-CIV-4426 (PGG), 2014 WL 4832299, 2014 U.S. Dist. LEXIS 137671 (S.D.N.Y. Sept. 29, 2014) (“Pasternack III”) (A- 251). On September 30, 2014, the District Court entered judgment and closed the case. (A-288). Plaintiff filed a Notice of Appeal on October 29, 2014. (A-290).2 On November 17, 2015, the Second Circuit issued its opinion certifying its two questions to this Court. Pasternack v. Lab. Corp. of Am. Holdings, 807 F.3d 14 (2d Cir. 2015) (Pasternack IV), (A-292). In an Order dated December 15, 2015, this Court accepted the certified questions. (A-316). COUNTER-STATEMENT OF FACTS3 A. Background Appellant is a physician. (A-166, ¶ 7). In 1978, he became a Senior Aviation Medical Examiner, which permitted him to conduct medical examinations of pilots as required by the FAA. (A-166, ¶ 9). He was an MRO “from 1990 to 2006, and was thus himself responsible for reviewing and certifying 2 The District Court dismissed Pasternack’s claim for injurious falsehood. (A-287). Pasternack did not submit any argument concerning the District Court’s dismissal of this claim to the Court of Appeals. Pasternack, therefore, has abandoned his claim for injurious falsehood. 3 The Counter-Statement of Facts contained herein are taken from the Second Amended Complaint and are assumed true for the purposes of this appeal. 8 drug test results pursuant to the applicable DOT regulations.” (A-258, n.3). He is also a licensed pilot, who piloted chartered flights for Northeastern Aviation Corporation (“Northeastern”) and Skytypers, an aerial advertising business. (A- 167, ¶ 10). B. The Drug Test On June 1, 2007, Appellant was notified by Northeastern that he was required to take a drug test. (A-168, ¶ 16). Four days later—on June 5, 2007—at approximately 1:10 p.m., Appellant reported to a LabCorp facility at 1317 Third Avenue in Manhattan (the “LabCorp Facility”), with a pre-printed CCF provided to him by Northeastern and to be used in connection with his Drug Test. (A-168, ¶ 17). Upon his arrival, LabCorp employee Theresa Montalvo took Appellant to the restroom, asked him to wash his hands and empty his pockets, and directed him to select a specimen container to provide a urine sample. (A-169, ¶ 18). During the collection, however, Appellant was unable to provide an adequate quantity of urine to conduct the test. (A-169, ¶ 18). Ms. Montalvo instructed Appellant to wait in the LabCorp Facility’s waiting area until he was able to provide a sufficient sample of urine. (A-169, ¶ 20). Notwithstanding Ms. Montalvo’s instructions to remain in the waiting area until he was able to complete the test, Appellant “believed that he was unlikely to produce a sufficient urine sample before needing to depart for his office in time for [an] appointment.” 9 (A-169, ¶ 21). Accordingly, Appellant told Ms. Montalvo that he was going to leave and he would return later to complete the Drug Test. (A-170, ¶ 22). Ms. Montalvo asked Appellant when he planned to return and informed him that if he left she would need to call Northeastern and advise them that he was leaving before completing the Drug Test. (A-170, ¶ 22). Appellant told Ms. Montalvo she was free to notify Northeastern and that he would return the next day—June 6, 2007. (A-170, ¶ 22). Appellant then exited the LabCorp Facility. (A-170, ¶ 25). Approximately three hours later, Appellant returned to the LabCorp Facility to complete his Drug Test. (A-170, ¶ 26). Ms. Montalvo advised Appellant that she would need to obtain approval from Northeastern before she could conduct a second collection. (A-170, ¶ 26). Ms. Montalvo spoke to Northeastern’s General Manager and he approved Ms. Montalvo’s second collection. (A-170, ¶ 26). Accordingly, Ms. Montalvo proceeded with the Drug Test and conducted a second specimen collection in which Appellant “produced a sufficient quantity of urine.” (A-171, ¶ 27). Upon submitting his sample, Appellant signed the CCF which contained the notation that he had left and returned and that Appellant’s employer “Northeastern approved the second collection.” (A-171, ¶¶ 26, 28.) There is no dispute that Ms. Montalvo’s notation on the CCF accurately reflected what had occurred during the Drug Test. 10 C. Appellant’s Decision to Leave the LabCorp Facility is Deemed a Refusal to Test by the MRO LabCorp tested Appellant’s urine sample and the result was negative for prohibited drugs. (A-171, ¶ 29). The MRO, ChoicePoint, an entity unaffiliated with LabCorp and whose responsibility it is, among other things, to review the test results, interpret them, and report its conclusions, reviewed Appellant’s records and determined that his leaving constituted a “refusal to test” under the DOT Regulations. (A-171, ¶ 29, A-172, ¶ 30). After the MRO’s decision, in July 2007, the FAA began an investigation. (A-172, ¶ 32). During this investigation, FAA investigators interviewed Ms. Montalvo. (A-172, ¶ 32). Ms. Montalvo told the investigators that Appellant was on his cell phone during his Drug Test and that Appellant left before she called Northeastern. (A-172, ¶¶ 33-34). There is no allegation that Ms. Montalvo told the FAA that Appellant refused a drug test. On November 20, 2007, the FAA through an emergency order, suspended Appellant’s airman certificates and his AME designation based on his refusal to take a drug test. (A-173, ¶ 36). D. Appellant Challenges the FAA’s Emergency Order On or about November 26, 2007, Appellant challenged the FAA’s Emergency Order revoking his airman certificates. (A-173, ¶ 37). A two-day evidentiary hearing was held before an Administrative Law Judge (“ALJ”) with the NTSB on July 30 and 31, 2008 (the “Hearing”). (A-173, ¶ 37). After obtaining 11 testimony from Appellant, Ms. Montalvo, and others, the ALJ upheld the FAA’s Emergency Order (the “ALJ Decision”). (A-186). Appellant appealed the ALJ Decision to the NTSB. (See A-200). The NTSB, in a decision dated April 29, 2009, affirmed the ALJ’s Decision (the “NTSB Decision”). (A-200). On February 26, 2010, the D.C. Circuit vacated the NTSB Decision, holding, in part, that the decision was not based on any finding of credibility as to any of the witnesses, including Ms. Montalvo. Pasternack v. Nat’l. Transp. Safety Bd., 596 F.3d 836, 838–39 (D.C. Cir. 2010). On September 2, 2010, the NTSB remanded the matter to the ALJ for additional findings of fact and law based on the D.C. Circuit’s decision. (A-214). On April 8, 2011, the ALJ issued a detailed decision affirming the revocation of Appellant’s airman certificates and AME designation (the “April 8 Decision”). (A-229). The ALJ made specific findings of fact and law, crediting Ms. Montalvo’s version of the events on the date of the Drug Test and finding that Appellant’s testimony was not credible. (A-229). Appellant appealed the April 8 Decision to the D.C. Circuit. The D.C. Circuit heard argument and, on March 22, 2013, issued a Judgment reversing the decision of the NTSB and vacating the NTSB’s Order. Huerta, 513 F. App’x at 2. On the appeal, the FAA conceded that “leaving with permission does not constitute a refusal” to test. Id. at 2. Accordingly, the D.C. Circuit found that, “substantial 12 evidence does not support the NTSB’s determination that [Ms. Montalvo] did not impliedly give Dr. Pasternack permission to leave.” Id. Thus, the NTSB Decision to revoke Appellant’s airman certificates and AME designation was overturned. Id. SUMMARY OF ARGUMENT Appellant’s brief is an exhaustive exposition of areas of the law which are not relevant to the issues presented here. Appellant first argues that this Court in Landon held that a specific duty of care exists for drug test administrators to advise test subjects as to the correct meaning of the DOT Regulations and Guidelines, in addition to a duty to perform drug testing properly. (App. Br. at 20). Appellant, having assumed the very issue to be determined by this Court, then briefs at length the law on when regulations may be evidence of some negligence as opposed to statutory negligence per se, all in the context of analyzing the standard of care when a duty of care has been found to exist. (App. Br. at 21-26). Appellant’s argument is a red herring, however, which provides no assistance in deciding the question presented to this Court. Appellant argues alternatively that a duty of care exists because he is in the class of persons envisioned to be protected under the federal drug-testing regime even though his own brief states that Congress directed the FAA to establish a drug testing program for the aviation industry and to adopt regulations for that program “[i]n the interest of aviation safety.” 49 U.S.C. § 45102(a). (App. Br. at 7, 9). Finally, he argues that the fact 13 that there is no private right of action for breach of the DOT Regulations and Guidelines is irrelevant to whether he should be able to obtain damages against LabCorp for negligently breaching what he concedes is a comprehensive federal drug-testing regime. (App. Br. at 8, 43). The lynchpin of Appellant’s argument is this Court’s decision in Landon. According to Appellant, the Landon decision was a “landmark” ruling that expanded a test administrator’s duty to the test subject to include claims for breach of the DOT Regulations and Guidelines even where there is no claim of negligent drug testing or an erroneous result. (App. Br. at 27, 31). Appellant’s reliance on Landon is misplaced. This Court, in finding that a testing laboratory owed a duty of care to the test subject, reaffirmed what has long been the law in New York. Landon, 22 N.Y.3d at 6–7. Appellant utterly ignores that the plaintiff in Landon made negligence allegations against the testing laboratory that were independent of any government regulations or guidelines. Id. at 4–5. Here, Appellant’s claims against LabCorp are not related to negligent testing. Indeed, everyone agrees the test results were accurate. This is not a case, moreover, in which LabCorp mishandled Appellant’s urine sample. Instead, Appellant’s claims solely concern the DOT Regulations and Guidelines and LabCorp’s alleged failure to follow them. Thus, his negligence claims are not based on industry standards or facts that are independent from any alleged 14 violations of the DOT Regulations and Guidelines. The District Court in Pasternack I and Pasternack III was correct in determining that to find LabCorp and ChoicePoint’s actions were a breach of a duty “would represent a significant extension of precedent.” (A-109; see also A-273). In a 2014 case discussed infra at 17-20, the Second Department correctly declined to find that Landon envisioned such an extension in a case where plaintiff sought to impose a duty to label separate and apart from the duty to test. Braverman v. Bendiner & Schlesinger, Inc., 121 A.D.3d 353, 362–63 (2d Dep’t 2014). Similarly, Appellant’s argument that the DOT Regulations and Guidelines were intended to protect him, as opposed to the flying public, is not only wrong but also meaningless in view of the conceded fact that there is no private right of action for breach of these Regulations and Guidelines. Drake v. Delta Airlines, Inc., 923 F. Supp. 387, 392–93 (E.D.N.Y. 1996) (“Drake I”), aff’d in part, Drake v. Delta Air Lines, Inc., 147 F.3d 169, 170–71 (2d Cir. 1998) (“Drake II”). Indeed, the Guidelines themselves state that they do not have the force of law and “should not be used to interpret or be viewed as adding to or modifying the legal requirements of the actual [regulations].” Department of 15 Transportation, Urine Specimen Collection Guidelines, (July 3, 2014)4, (LC-ADD- 3) (emphasis in original). Likewise, Appellant has failed to state a cause of action for fraud. In order to sustain a claim for fraud, Appellant must plead that he reasonably relied on a statement from LabCorp. See Gomez-Jimenez v. New York Law Sch., 943 N.Y.S.2d 834, 853 (Sup. Ct. 2012), aff'd, 103 A.D.3d 13 (1st Dep’t 2012). Appellant has not done so. Instead, Appellant argues that statements made to a third-party are sufficient to plead fraud even though there is no nexus alleged between Appellant’s injury and the statements by a witness to FAA investigators that were not intended by the witness to be communicated to Appellant or to be relied on by him. Indeed, the District Court correctly found that “[t]he injury to Pasternack—the loss of his airman certificates and AME designation and the resulting loss of compensation—was caused by the legal determination of the FAA and the ALJ that Pasternack’s conduct constituted a ‘refusal to test.’” Pasternack II, 892 F. Supp. 2d at 556, (A-162). The D.C. Circuit, in reversing the ALJ, likewise held that the FAA’s determination was erroneous under the circumstances. 4 Previous editions of the Urine Specimen Collection Guidelines are considered “obsolete.” (LC-ADD-2). 16 Huerta, 513 F. App’x at 2. There was no negligence by LabCorp or Ms. Montalvo, and the injury, such as it was, was not caused by them. I. THE DOT DRUG TESTING REGULATIONS AND GUIDELINES DO NOT GIVE RISE TO ANY DUTY OF CARE UNDER NEW YORK NEGLIGENCE LAW The Second Circuit certified the following question to this Court: [W]hether drug testing regulations and guidelines promulgated by the FAA and DOT create a duty of care for drug testing laboratories and test program administrators under New York negligence law[.] Pasternack IV, 907 F.3d at 24. Contrary to the argument of Appellant, the Second Circuit’s certified question is exactly the right one. Appellant’s “reformulated” question assumes that the Second Circuit did not understand the difference between a duty of care and the standard of care, which exists only once a duty is found. The elements of a negligence claim under New York law are: “(i) a duty owed to the plaintiff by the defendant; (ii) breach of that duty; and (iii) injury substantially caused by that breach.” Lombard v. Booz‐Allen & Hamilton, Inc., 280 F.3d 209, 215 (2d Cir. 2002) (citing Merino v. New York City Tr. Auth., 218 A.D.2d 451, 457 (1st Dep’t 1996)). If the defendant owes no duty to the plaintiff, the action must fail. “Although juries determine whether and to what extent a particular duty was breached, it is for the courts first to determine whether any duty exists.” Darby v. Compagnie Nat’l. Air France, 96 N.Y.2d 343, 347 (2001). “[T]he existence and 17 scope of an alleged tortfeasor’s duty is usually a legal, policy‐laden declaration reserved for Judges to make prior to submitting anything to fact‐finding or jury consideration.” Palka v. Servicemaster Mgmt. Servs. Corp., 83 N.Y.2d 579, 585 (1994). A. Landon Did Not Determine the Issue Presented Here Appellant argues that this Court has already found in Landon that the FAA drug test regulations and guidelines create a duty of care under New York negligence law. (App. Br. at 37). That is not so, and the Second Circuit correctly rejected such a claim when it wrote, “[t]he New York Court of Appeals has not addressed the question before us, for Landon did not address the question of whether the federal regulatory scheme creates a duty of care for drug testing companies.” Pasternack IV, 807 F.3d at 22. This is a critical distinction: there is no question that this Court has held that a drug testing company can be liable under the common law for negligent testing, i.e., so-called false positives, where a testing company incorrectly indicates the presence of a prohibited drug in a sample. See Landon, 22 N.Y.3d at 6–7. That is not what is at issue here. It is undisputed that LabCorp performed Appellant’s test accurately. What Appellant now argues for is the imposition of a separate and unrelated duty under the federal regulations, namely to inform a drug test subject as to the possible meanings of the federal regulations and the possible consequences of the subject’s failure to follow the 18 regulations. In fact, Appellant goes so far as to claim LabCorp breached a duty to advise him of a reading of the regulation that the D.C. Circuit expressly rejected under the undisputed facts. See Huerta, 513 F. App’x at 2. The Second Department recently faced and rejected a similar argument. See Braverman, 121 A.D.3d at 355 (cited by Appellant at 38). As the Second Department wrote: In Landon v Kroll Lab. Specialists, Inc. (22 NY3d 1, 6-7, 999 NE2d 1121, 977 NYS2d 676 [2013]), the plaintiff sought to recover damages from a drug testing laboratory, alleging that it negligently reported his drug test as positive. The Court of Appeals, in affirming an opinion and order of this Court (see Landon v Kroll Lab. Specialists, Inc., 91 AD3d 79, 934 NYS2d 183 [2011]), recognized that a drug testing laboratory had a duty to the subject of a drug test to adhere to relevant professional standards in performing such testing. The plaintiffs in this case similarly claim that they suffered adverse consequences when the positive results of drug tests, performed by the defendant Bendiner & Schlesinger, Inc. (hereinafter Bendiner), were reported to drug treatment courts by the defendant drug treatment center, Daytop Village, Inc. (hereinafter Daytop). However, the plaintiffs in this case do not take issue with the manner in which the tests were performed or challenge the accuracy of the results reported. Rather, the plaintiffs assert that the testing met only clinical, not forensic standards, and that, accordingly, the results should not have been admitted as evidence in court. They argue that Bendiner and Daytop had a duty to label the drug test results or provide a disclaimer indicating that the results were only to be used for clinical, not forensic, purposes. We find this to be an unwarranted expansion of the duty set forth in Landon, and, therefore, affirm the judgment in favor of Bendiner and Daytop, dismissing the complaint. 19 Id. at 354–55 (emphasis added). In rejecting the argument that defendants had an obligation to label the drug test results as “clinical” rather than “forensic,” the court noted that Landon’s duty was to perform a drug test in keeping with relevant professional standards: Both the Court of Appeals’ decision and this Court’s decision in Landon focused on the laboratory’s alleged negligent performance of drug testing, which yielded false positive results. Further, the Court of Appeals described the duty imposed on a laboratory as a duty “to perform a drug test in keeping with relevant professional standards (Landon, 22 NY3d at 6-7).” Id. at 359. The Second Department explained why the Landon reasoning could not be extended: Moreover, the reasoning employed in Landon cannot be extended to the present circumstances. The Court of Appeals, in imposing a duty upon the laboratory in favor of a party with whom it had no contractual relationship, relied, in part, upon the exception to the rule against such liability for conduct that constitutes launching a force or instrument of harm (see Landon, 22 NY3d at 6, citing Espinal, 98 NY2d at 141-142). However, in applying that exception in prior cases, the courts have distinguished between situations where a ‘putative wrongdoer has advanced to such a point as to have launched a force or instrument of harm’ and those in which such a party has merely ‘stopped where inaction is at most a refusal to become an instrument for good.’ 20 Id. at 360. (quoting Moch Co. v. Rensselaer Water Co., 247 N.Y. 160, 167, 168 (1928)). This is comparable to LabCorp’s alleged failure to tell Appellant that his leaving the facility was a refusal to test (even though the D.C. Circuit held it was not). Here, there being no claim that the defendants released a false positive drug test, the plaintiffs seek to hold the defendants liable for the mere denial of a benefit—a label or disclaimer as to the clinical nature of the results that would alert attorneys and courts to the inadmissibility of the test results as evidence in court. . . . Imposing liability upon the defendants for the failure to confer this benefit would enlarge the duty imposed in Landon in such a manner as to unduly extend the zone of liability. Id. at 360–61 (citations omitted). The plaintiff’s claims in Landon were independent tort claims, not reliant on any governmental regulations. As Braverman notes, Landon concerned the issue of a laboratory’s conduct in the actual testing of a specimen and whether a test subject could bring an action against a drug testing company for negligence when the drug testing company deviates from the industry standard of care. Braverman, 121 A.D.3d at 359 (citing Landon, 22 N.Y.3d at 6–7). As a result, the plaintiff in Landon was allowed to continue his negligence claims that were based on state common-law tort claims, i.e., those actions based on defendant’s failure to conduct the test in a reasonable manner. Landon, 22 N.Y.3d at 6. 21 In Landon, the plaintiff was convicted of forgery and sentenced to a five-year term of probation. 22 N.Y.3d at 4. The plaintiff, as a condition of his probation, was required to submit to random drug testing. Id. On December 17, 2007, the plaintiff’s probation officer collected an oral fluid sample from plaintiff using a device manufactured by Orasure Technologies, Inc. Id. The specimen was sent to Kroll Laboratory Specialists, Inc. (“Kroll”) for testing. Id. Kroll’s test detected the presence of cannabinoids at a cutoff level of 1 ng/ml. Id. Kroll reported the results and the probation department filed a violation of probation proceeding in which the plaintiff was arraigned and incarcerated. Id. The plaintiff, through independent testing, was able to show that Kroll’s test was incorrect—a so-called “false positive”—and he was released. Id. at 4–5. The plaintiff then sued Kroll based on its negligent testing of his specimen. Id. at 5. The bases of plaintiff’s allegations were not violations of any regulations or guidelines. Instead, the plaintiff’s claims were that Kroll’s test used a cutoff level (1 ng/ml) that was lower than the manufacturer’s recommended cutoff level of 3.0 ng/ml and the level suggested by the United States Department of Health and Human Services Substance Abuse and Mental Health Services Administration’s (“SAMHSA”) cutoff-level of 4.0 ng/ml. Id. at 5. This Court found that the plaintiff could maintain an action for “negligent testing.” Id. at 3. The basis for the Court’s holding was that the testing 22 laboratory deviated from the industry-wide standard by using a lower cut-off level, as recommended by the test’s manufacturer, and thus reported an erroneous result. Id. at 6–7. The SAMHSA Guidelines, while instructive, were not the standard that plaintiff was complaining that Kroll breached. Instead, the plaintiff in Landon complained that Kroll breached industry standards in selecting a lower cut-off level than what was typically used in the industry, i.e., the test manufacturer’s recommended level. Id. Thus, the plaintiff had an independent tort claim that did not implicate any governmental regulations or guidelines at all. The Landon Court, therefore, in affirming a decision by the Appellate Division, 91 A.D.3d 79 (2d Dep’t 2011), merely confirmed what federal and state courts in New York have continuously held: a testing laboratory owes a duty of care to perform a test in a reasonable manner such that it can report accurate results. 22 N.Y.3d at 7. In his brief, all of the cases cited and relied on by Appellant involve allegations of negligent testing leading to false positives or otherwise inaccurate results and as such are not helpful to this Court. See Ishikawa v. Delta Airlines, Inc., 343 F.3d 1129, 113 (9th Cir. 2003) (specimen inaccurately reported as “substituted”); Rodriguez v. Lab. Corp. of Am. Holdings, 13 F. Supp. 3d 121, 131 (D.D.C. 2014) (improper testing); King v. Garfield County Pub. Hosp. Dist. No. 1, 17 F. Supp. 3d 1060, 1072 (E.D. Wash. 2014), rev’d on other grounds, No. 14- 35460, 2015 WL 9459747, 2015 U.S. App. LEXIS 22618 (9th Cir. Dec. 24, 2015) 23 (false positive); Warshaw v. Concentra Health Servs., 719 F. Supp. 2d 484, 505– 06 (E.D. Pa. 2010) (false positive); Siotkas v. LabOne, Inc., 594 F. Supp. 2d 259, 265–66 (E.D.N.Y. 2009) (specimen inaccurately reported as “substituted”); Quisenberry v. Compass Vision, Inc., 618 F. Supp. 2d 1226 (S.D. Cal. 2007) (false positive); Coleman v. Town of Hempstead, 30 F. Supp. 2d 356, 362–63 (E.D.N.Y. 1999) (false positive); Williams v. Nat’l R.R. Passenger Corp., 16 F. Supp. 2d 178, 180 (D. Conn. 1998) (improper testing); Santiago v. Greyhound Lines, Inc., 956 F. Supp. 144, 147, 153 (N.D.N.Y. 1997) (false positive); Sharpe v. St. Luke’s Hosp., 573 Pa. 90, 93 (2003) (false positive); Duncan v. Afton, Inc., 991 P.2d 739, 744–45 (Wyo. 1999) (false positive); Ragsdale v. Mount Sinai Med. Ctr., 770 So. 2d 167, 168 (Fla. Dist. Ct. App. 2000) (false positive); Lynn v. Mount Sinai Med. Ctr., 692 So. 2d 1002, 1003 (Fla. Dist. Ct. App. 1997) (false positive); Kindernay v. Hillsboro Area Hosp., 851 N.E.2d 866, 870 (Ill. App. Ct. 2006) (false positive); Stinson v. Physicians Immediate Care, 646 N.E.2d 930, 931 (Ill. App. Ct. 1995) (false positive); Berry Nat’l. Med. Servs., 205 P.3d 745, 751 (Kan. Ct. App. 2009) (false positive); Elliott v. Lab. Specialists, Inc., 588 So. 2d 175, 176 (La. Ct. App. 1991) (false positive); Lewis v. Aluminum Co. of Am., 588 So. 2d 167, 170 (La. Ct. App. 1991) (false positive); Spiker v. Sanjivan PLLC, No. CV-13-00334-PHX- GMS, 2013 WL 5200209, at *1, 2013 U.S. Dist. LEXIS 131985, at *3–4 (D. Ariz. Sept. 16, 2013) (false positive); Lacondeguy v. Adapa, No. 2:10-CV-1917-JAM- 24 KJM, 2011 WL 9572, at *1, 2010 U.S. Dist. LEXIS 137894, at *2–3 (E.D. Cal. Jan. 3, 2011) (false positive); Miller v. Paris Cmty. Hosp., No. 07-CV-2195, 2009 WL 2050996, at *4, 2009 U.S. Dist. LEXIS 59456, at *11 (C.D. Ill. July 13, 2009) (false positive); Garlick v. Quest Diagnostics, Inc., No. 06-cv-6244, 2009 WL 5033949, at *2, 2009 U.S. Dist. LEXIS 116452, at *5–6 (D.N.J. Dec. 14, 2009) (false positive); Cutler v. Quality Terminal Servs., LLC, No. 08-cv-6630, 2009 WL 4674124, at *1–3, 2009 U.S Dist. LEXIS 112742, at *5–8 (N.D. Ill. Dec. 4, 2009) (false positive); Drake v. Lab. Corp. of Am. Holdings, No. 02-CV-1924 (FB)(RML), 2007 WL 776818, at *7, 2007 U.S. Dist. LEXIS 17430, at *21 (E.D.N.Y. Mar. 15, 2007) (false positive) (“Drake V”); Baker v. Abo, No. Civ. 01- 1248 JRTJSM, 2003 WL 21639151, at *1, 2003 U.S. Dist. LEXIS 11737, at *4 (D. Minn. July 2, 2003) (false positive); Admiral Webster v. Psychemedics Corp., No. 2010-01087-COA-R3-CV, 2011 WL 2520157, at *6, 2011 Tenn. App. LEXIS 335, at *19–20 (Tenn. Ct. App. June 24, 2011) (false positive). This is not a case about negligent testing or inaccurate results. The entire predicate for Appellant’s negligence claim is that LabCorp breached its duty to him by failing “to explain the ‘shy bladder’ procedures,” failing to inform him “that he was required to remain at the collection site,” and failing to inform him that leaving the collection site “would or even could constitute a refusal to test.” (A-175, ¶ 46). According to Appellant, LabCorp’s failure to “take these steps 25 [was] in direct contravention of 49 C.F.R. § 40.193(b) of the DOT Regulations and Sections 8.3 and 8.5 of the DOT Guidelines.” (A-175, ¶ 46). However, Landon does nothing to reverse or modify the rule that there is no private right of action for any alleged failure to follow the DOT Guidelines. Drake II, 147 F.3d at 170–71. Appellant does not—and cannot—allege that LabCorp negligently tested his specimen. Indeed, Appellant concedes LabCorp’s test result was accurate. (A- 171, ¶ 29). Nor does Appellant allege that LabCorp breached any industry-wide standard. All of the cases Appellant relies on for support relate to situations wherein a specimen was mishandled or where there was negligence in the testing of the specimen without regard to the DOT Regulations. Finding that LabCorp breached a duty under the DOT Guidelines for its failure to stop Appellant from leaving the LabCorp Facility before completing his test would be “a significant extension of precedent.” (A-109; see also A-273). B. A New Duty of Care Should Not be Imposed Here Based on the DOT Regulations and Guidelines Appellant also argues that a new duty of care can be imposed because of “negligence duties springing directly from statutes, regulations and ordinances.” (App. Br. at 41). However, in New York, such can only ground a cause of action if: “(1) the regulation was intended to protect a particular class of persons; (2) there was an intention to create or deny a private right; (3) the right would be consistent 26 with the goal of the statute; and (4) the cause of action is one traditionally left to State law.” Manfredonia v. Am. Airlines, Inc., 68 A.D.2d 131, 139 (2d Dep’t 1979). As set forth below, Appellant is unable to meet any of these prongs. 1. Appellant is Not Within the Class of Persons Intended to be Protected Nor is His Claim Consistent With the Goal of the DOT Regulations The DOT Regulations were not created to protect Appellant and should not give rise to a new and unintended duty of care. [S]ometimes the rule is stated as if a violation of a statute never gives a right of action to anyone other than one of a particular class or group for whose special benefit the statute was enacted . . . although whether or not civil liability results from a violation of a statute depends, in great measure, upon whether the duty is imposed for the special benefit of a particular group or class of persons, the ultimate test is whether a consideration, not only of the scope and meaning of the statute, but also of the evil at which it was aimed, or, in other words, its object as well as its purport, fairly leads to the conclusion that such was within the intent of the Legislature. Compania Importadora Materiales Industriales v. Caldwell & Co., 58 N.Y.S.2d 745, 749 (Sup. Ct. N.Y. County 1945) (citations omitted). There is no question that the purpose of the DOT Regulations was to protect the flying public, as even Appellant concedes. (App. Br. at 7). The DOT Regulations specifically state: The purpose of this part is to establish a program designed to help prevent accidents and injuries resulting from the use of prohibited drugs or the misuse of alcohol by 27 employees who perform safety-sensitive functions in aviation. 14 C.F.R. § 120.3. In Manfredonia, the Second Department held that “[t]he [DOT Regulations], it is clear, [are] instinct with a pervasive interest in the safety of passengers.” 68 A.D.2d at 139. The Sixth Circuit has further elaborated that “[t]his regulatory scheme does not evince a concern for the protection of [employees] who believe that they have been aggrieved through the drug testing process.” Parry v. Mohawk Motors of Michigan, Inc., 236 F.3d 299, 309 (6th Cir 2000). See also McDowell v. J.B. Hunt Transport, Inc., No. 03-C-6590, 2004 WL 1878334, at *4, 2004 U.S. Dist. LEXIS 15728, at *11 (N.D. Ill. Aug. 10, 2004) (“[W]hile drivers may indirectly benefit from uniform procedures, and the statute and regulations include protections for employees affected by drug testing requirements, . . . this does not mean commercial drivers are a class of persons for whose benefit FOTETA was enacted.”). While the “regulations aim to achieve a regulatory balance between safety interests and the protection of employees[, t]he purpose of the regulations . . . is to protect the public at large and not to protect employees . . . who are tested according to the requirements set out therein.” Spiker v. Sanjivan PLLC, No. CV-13-00334-PHX-GMS, 2013 WL 5200209, at *13, 2013 U.S. Dist. LEXIS 131985, at *41 (D. Ariz. Sept. 16, 2013) (plaintiff 28 alleged that the MRO negligently reviewed plaintiff’s false positive drug test results causing plaintiff’s termination). Requiring all testing personnel to correctly interpret and adhere to every guideline, rule and regulation is inconsistent with the purpose of the DOT Regulations, promulgated under the Federal Omnibus Transportation Employee Testing Act (“FOTETA”), because such requirement has nothing to do with a) safety of passengers and b) ensuring drug tests are accurate. See 49 U.S.C. § 45102(a); Parry, 236 F.3d at 309. Imposing a new duty of care is also inconsistent with various publications by the Office of General Counsel and Office of Drug and Alcohol Compliance of the DOT concerning shy bladder regulation at issue. (LC-ADD-50) (“There is no requirement for a collector to inform an employee that the failure to remain at the collection site is a refusal [to test].”); (LC-ADD-21) (“[T]here is no requirement for the collector to inform the employee in a shy bladder situation that failure to remain at the collection site . . . constitutes a refusal.”). “[P]lacing a duty on [the lab] in these circumstances impinges on the liability of other professionals for services rendered. A simply duty to warn of the possibilities that information may be misinterpreted is unworkable.” Smithkline Beecham Corp. v. Doe, 903 S.W.2d 347, 353 (Tex. 1995). Further, “to automatically derive such a conclusion of negligence from violation of such statutes would present considerable potential 29 for unfairness and overpunishment.” Dance v. Southampton, 95 A.D.2d 442, 449 (2d Dep’t 1983). Indeed, the Guidelines themselves state that they do not have the force of law and “should not be used to interpret or be viewed as adding to or modifying the legal requirements of the actual [regulations].” (LC-ADD-3) (emphasis in original). Appellant cites several Federal Regulations in support of its argument that the FAA and DOT Regulations and Guidelines inform the standards of care. (App. Br. at 39). The Regulations to which Appellant cites, however, have no bearing whatsoever on what is required of collectors (see Anti-Drug Program for Personnel Engaged in Specified Aviation Activities, 53 Fed. Reg. 47024-01, 47043 (Nov. 21, 1988) (discussing the role of an MRO); Procedures for Transportation Workplace Drug and Alcohol Testing Programs, 64 Fed. Reg. 69076-01 (Dec. 9, 1999) (stating that MROs must observe DOT Regulations)) or are clearly commenting on the importance of preventing false positive test results (see Omnibus Transportation Employee Testing Act of 1991, Pub. L. No. 102-143, § 2(6), 105 Stat. 953 (1991) (stating that federal drug testing regulations must safeguard an individual’s reputation); Procedures for Transportation Workplace Drug Testing Programs, 54 Fed. Reg. 49854-01 (Dec. 1, 1989) (discussing the negative impact on a person’s career if falsely labeled a drug user)). 30 Accordingly, Appellant’s argument that his negligence claims should have been allowed because the DOT Regulations and Guidelines were designed to protect him as part of a particular class of persons must be rejected. (App. Br. at 31–32). To allow Appellant’s claims to go forward when they are based solely on an alleged violation of the DOT Regulations and Guidelines would be nothing more than an end-run around the explicit restrictions in the regulations. 2. No Private Right of Action Exists Under the DOT Regulations and Guidelines Nor is this an Area in Which State Common Law Intrudes Appellant’s claims against LabCorp are premised solely on alleged violations of the DOT Regulations and Guidelines, (A-175, ¶¶ 46-48; A-273), in which no private right of action exists. Drake I, 923 F. Supp. at 392–93; Drake II, 147 F.3d at 170–71. In Drake I, 923 F. Supp. at 388, plaintiff, a former flight attendant, sued his former employer, an airline, alleging that the airline violated his rights under the FAA and DOT Regulations and under the Fourth Amendment when testing his urine. The airline moved to dismiss and the district court held that plaintiff did not have a private right of action for a violation of the DOT Regulations. Id. at 392–93. Specifically, the court concluded that “Congress in enacting the [Omnibus Transportation Employee] Testing Act [whereby the DOT Regulations were promulgated under] intended to provide a general benefit to the 31 public by increasing the level of passenger safety, and did not intend to establish a private right of action for the transportation industry’s employees.” Id. at 392 (citation omitted). In Drake II, 147 F.3d at 170–71, the Second Circuit also held “there is no implied private right of action for employees under [the DOT] regulations.” Drake, therefore, brought state common law claims against LabCorp and other defendants that were independent from the DOT Regulations. The District Court, in Drake v. Laboratory Corp. of America Holdings, 290 F. Supp. 2d 352, 375 (E.D.N.Y. 2003) (“Drake III”), and affirmed by the Second Circuit in Drake v. Laboratory Corp. of America Holdings, 458 F.3d 48 (2d Cir. 2006) (“Drake IV”), denied LabCorp’s motion to dismiss because the court found, among other things, that Drake’s state common law claims of negligence were independent of any alleged violation by LabCorp, or the other defendants, of the DOT Regulations: In sum, what is common to all of Drake’s common law claims is that they need not be dependent on the violation of any particular regulation; rather, they could be separately acceptable based on traditional state tort law. Drake III, 290 F. Supp. 2d at 375. In contrast, here, the District Court correctly found that “Pasternack’s negligence claims against LabCorp are, in fact, premised solely on violations of the DOT Regulations and Guidelines.” Pasternack III, 2014 WL 4832299, at *13, 2014 U.S. Dist LEXIS, at *36 (emphasis added). Appellant’s citation to Uhr v. 32 East Greenbush Central School District, 94 N.Y.2d 32 (1999), as authority for the proposition that a lack of a private cause of action in the regulations is irrelevant to the Court’s inquiry is inapposite. (See App. Br. at 44). In that case, this Court held after extensive discussion that no private right existed for plaintiff’s claims under New York State’s Education Law. Id. at 42. This Court affirmed the lower court’s rejection of the contention that defendants had a common law duty to perform scoliosis tests such as would give rise to a negligence cause of action. Id. (“We agree with the courts below that plaintiffs have failed as a matter of law to state a claim for common-law negligence.”). Thus, the argument that Uhr is precedent for allowing a claim in negligence for breach of a regulatory scheme is utterly misplaced. Appellant argues that “absent a common-law cause of action, [he] cannot recover for his economic injuries, including lost income and the fees and costs he incurred pursuing his administrative remedies.” (App. Br. at 36). Appellant’s argument is meritless. Here, Appellant had the right—and exercised his right—to redress any alleged violations of the DOT Guidelines through administrative avenues by appealing the FAA’s decision to the NTSB and the D.C. Circuit. See Drake II, 147 F.3d at 171 n.2. As this Court noted in both Drake I and Drake II, under the DOT Regulations, “Drake could have sought redress of the alleged regulatory violations through administrative avenues.” Drake II, 147 F.3d 33 at 171 n. 2 (citing Drake I, 923 F. Supp. at 393 n.9); see also 49 U.S.C. § 46101(a). The D.C. Circuit, in Huerta, overturned the FAA’s Emergency Order and found that Appellant’s leaving the testing facility should not have been deemed a failure to test. 513 F. App’x at 2. Thus, unlike the plaintiff in Drake I, Appellant successfully redressed any alleged DOT violations through administrative avenues by appealing the FAA’s Emergency Order to the NTSB and the D.C. Circuit and obtaining a determination in his favor. Appellant argues that the Federal Aviation Act’s “savings clause,” 49 U.S.C. § 40120(c), “expressly invite[s] states to provide remedies for violations of FAA regulations in order to fill the gaps in Congress’ deliberately incomplete remedial scheme” and that negligence claims based on “duties established by the federal drug testing regulations thus furthers the aims of the drug testing regulatory scheme.” (App. Br. 42-43) (quotation omitted). Appellant’s reliance on the savings clause is misplaced. In Salomon v. Roche Compuchem Laboratories, Inc., 909 F. Supp. 126, 128 (E.D.N.Y. 1995), the court explained that “Congress has expressly provided for enforcement of the drug testing regulations through [an] administrative mechanism.” While the savings clause permits some tort claims arising from the negligent testing and handling of the specimen itself, the clause does not envision tort claims arising from the administrative procedures apart from the actual collection and testing process. “[T]he mere fact that common law claims 34 are based upon ‘events that occur during the course of drug testing’ does not necessarily warrant their preemption . . . unless they ‘implicate the drug testing of aviation personnel in such a way that it interferes with the FAA’s stated desire to regulate such drug test in a consistent and uniform manner.’” Siotkas v. Labone, Inc., 594 F. Supp. 2d 259, 273–74 (E.D.N.Y. 2009) (quoting Drake IV, 458 F.3d at 61–62). Implying a standard of care in all regulations would interfere with the FAA’s desire to regulate drug testing of aviation personnel such that negligence would be implied from any violation of the drug testing regulations, even if the violation has no bearing on the collecting and testing of the specimen. Under New York law, LabCorp, as a collector of Appellant’s urine sample, owed him a duty of care to collect and test his urine sample in a reasonable manner. Landon, 22 N.Y.3d at 6–7; Coleman, 30 F. Supp. 2d at 364–65; Santiago, 956 F. Supp. at 153; Drake V, 2007 WL 776818, at *2–3, 2007 U.S. Dist. LEXIS, at *5–8. Here, Appellant does not allege that LabCorp breached either duty. Indeed, Appellant concedes, as he must, that LabCorp maintained the proper chain of custody over the sample and accurately reported the results of his drug test as negative. (See A-171, ¶¶ 28-29). The finding by the District Court in Pasternack III, 2014 WL 4832299, at *13, 2014 U.S. Dist LEXIS, at *36, is in harmony with the holdings of other courts in New York and the Second Circuit; i.e., the only duty LabCorp owed to Appellant was to collect his specimen and conduct the test in a 35 reasonable manner. See Landon, 22 N.Y.3d at 6–7; Coleman, 30 F. Supp. 2d at 364–65; Santiago, 956 F. Supp. at 153; Drake V, 2007 WL 776818, at *2–3, 2007 U.S. Dist. LEXIS, at *5–8. The cases cited by Appellant illustrate the difference between the duty Appellant seeks to impose based on a regulation and the common law duty that exists based on traditional tort law principles. For example, in Warshaw v. Concentra Health Services, 719 F. Supp. 2d 484, 505–06 (E.D. Pa. 2010), (App. Br. at 29), plaintiff’s negligence claim was allowed because it did not rest on the argument that defendant breached or violated a regulation. Similarly, in Balistrieri v. Express Drug Screening, LLC, No. 04-C-0989, 2008 WL 906236, at *13, 2008 U.S. Dist. LEXIS 26839, at *42 (E.D. Wis. Mar. 31, 2008), (App. Br. at 26), the court only allowed negligence claims to go forward that were independent of any violation of a regulation.5 In Cutler, 2009 WL 4674124, at *7, 2009 U.S. Dist. LEXIS 112742, at *21, (App. Br. at 26), the court explained that “the violation of a regulation is evidence of a breach only if an underlying duty exists. . . . [T]he mere fact that a statute defines due care does not in and of itself create a duty enforceable by tort law.” (quotation omitted). In addition, in Ishikawa, 343 F.3d at 1132–34, (App. Br. at 25), the Ninth Circuit held that plaintiff’s negligence 5 Among other claims, Balistrieri dismissed a negligence claim against the defendant laboratory for failing to advise plaintiff of the “shy bladder” procedure. 2008 WL 906236, at *15, 2008 U.S. Dist. LEXIS 26839 at *48–49. 36 claim arose under the common law duty to exercise reasonable care, not under the federal drug testing guidelines. And again, in Lynn, 692 So. 2d at 1004, (App. Br. at 30), the court held that defendant hospital’s liability “stems from a breach of the duty of ordinary care” which resulted in the reporting of a false positive drug test. Appellant does not, and cannot, cite to a single case for the proposition that a violation of the DOT Regulations and Guidelines gives rise to a negligence claim under New York law or that LabCorp’s failure to explain the “shy bladder” procedure is a cognizable breach of duty under New York law. Likewise, Appellant’s reliance on Lopes v. Rostad, 45 N.Y.2d 617, 623 (1978), and McSweeney v. Rogan, 209 A.D.2d 386, 387 (2d Dep’t 1994), is misguided. (App. Br. at 41). In these cases, the ordinance that gave rise to the duty was specified when the laws were passed. Here, there is clearly no private right of action or duty that flows from the DOT Regulations and Guidelines. Drake II, 147 F.3d at 170–71; (see LC-ADD-3). Appellant appears to argue that because the regulatory scheme is all-encompassing, a duty of care must arise. There is neither logic in nor legal support for that argument. Where, as here, it is settled under federal law that no private cause of action exists for breach of such a comprehensive scheme, no separate duty of care under negligence law can arise. See, e.g. Chan v. City of New York, 1 F.3d 96, 104 (2d Cir. 1993) (explaining that private rights of action are foreclosed where a regulatory scheme “is sufficiently 37 comprehensive to demonstrate congressional intent to preclude the remedy of suits under [other sources of law]”). C. The DOT Regulations and Guidelines do Not Establish an Industry Standard Appellant argues that “the FAA and DOT drug testing Regulations and Guidelines supply the ‘professional standards’ in the drug testing arena.” (App. Br. at 40). Appellant is incorrect. There is nothing to suggest that the DOT Regulations and Guidelines establish an industry standard on the point at issue. Indeed, not all drug tests are subject to the Regulations or Guidelines, only those involving safety-sensitive employees in the transportation industry. 49 C.F.R. § 40.1(b). Even if LabCorp owed Appellant a duty based on the Regulations and Guidelines, however, LabCorp did not breach its duty. First, Appellant’s argument assumes that the DOT Regulations and Guidelines required LabCorp to explain the “shy bladder” procedure or to tell him that leaving the facility could be deemed a failure to test. No such requirement exists. See, 49 C.F.R. § 40.193. A July 2014 publication issued by the Office of General Counsel and Office of Drug and Alcohol Compliance of the Department of Transportation concerning the very regulation at issue here discussed whether a collector may give an employee permission to leave a collection site prior to completion of the testing process (the “July Publication”). (LC-ADD-50). The July Publication states that “[t]here is no requirement for a collector to inform an 38 employee that the failure to remain at the collection site is a refusal [to test].”6 (LC-ADD-50) (emphasis added). Similarly, any argument that LabCorp’s silence was an implicit permission for Appellant to leave the LabCorp Facility was also rejected by the DOT in the July Publication. (LC-ADD-50). According to the DOT, “if the collector does not inform an employee that failure to remain at the collection site is a refusal [to test], it does not mean that the collector has given the employee permission to leave the collection site.” (LC-ADD-50). The DOT’s comments in the July Publication provide “official and authoritative guidance and interpretation concerning [the DOT Regulations]” and are consistent with the holding of the District Court’s finding that there was no breach of a duty under the DOT Regulations and Guidelines for its failure to stop Appellant from leaving the LabCorp Facility before completing his test. (LC-ADD-49). 6 Appellant claims that LabCorp’s actions “gave him a false sense of safety” such that a duty arises. (App. Br. at 37, n.12). This argument is another red herring. All of the cases Appellant cites in support of this proposition are inapposite. (App. Br. at 37) (citing Heard v. City of New York, 82 N.Y.2d 66 (1993); Nallan v. Hemsley-Spear Inc., 50 N.Y.2d 507 (1980); Giglio v. Saratoga Care Inc., 117 A.D.3d 1143 (3d Dep’t 2014); Kievman v. Philip, 84 A.D.3d 1031 (2d Dep’t 2011); and McKinney v. Bellevue Hosp., 183 A.D.2d 563 (1st Dep’t 1992)). None of these cases concerned a plaintiff who was an experienced physician and MRO and thus had knowledge regarding the potential consequences of his own actions. 39 Second, it is well settled that regulations unrelated to a claim for negligence are not admissible. For example, regulations concerning motor vehicle licensing are not relevant or admissible in a negligence action. [V]iolation of the reporting requirement [which requires drivers to give notice of disability to the Commissioner] is an omission that falls in the same class as failure to obtain a license before driving. Neither the reporting statute nor the statute that requires a driver to obtain a license before driving specifies the correct method of operating or equipping the vehicle, so that there is in fact no standard of care to adopt for negligence actions. Dance, 95 A.D.2d at 448–49. This is also true with professional licensing, where New York courts have held, “the alleged statutory violation of failing to obtain a license does not establish a standard of care that relates to working without a license, and therefore a negligence per se cause of action is unsustainable.” Silverboys, LLC v. Skordas, No. 653874/2014, 2015 N.Y. Misc. LEXIS 3266, at *10–11, 2015 NY Slip Op 31711(U), at *10–11 (Sup. Ct. N.Y. County Sept. 4, 2015); see also Washington v. Nedd, No. 25395/2008, 31 Misc. 3d 1211(A), 2011 NY Slip Op 50564(U), at *3 (Sup. Ct. Queens County Apr. 13, 2011) (“[T]he fact that co-defendant Nedd drove the tow truck with a suspended license did not relate directly to the issue of his operation of the vehicle” and hence the regulations were inadmissible). Likewise, in connection with the Fair Housing Act, the Appellate Division has held the “Act was not intended to create a standard of care in 40 negligence litigation.” Hand v. Gilbank, 300 A.D.2d 1067, 1068 (2d Dep’t 2002) (quotation omitted). The analysis in Ferguson v. Hanson Aggregates New York, Inc., 103 A.D.3d 1174, 1175–76 (4th Dep’t 2013), is particularly helpful. In that case, the Fourth Department examined whether plaintiff could sustain a common law negligence claim against his defendant employer, a mine facility, for injuries he sustained allegedly due to violations of New York Labor Law. The court held that while an alleged violation of those regulations as they relate to defendant's common-law and statutory duty to maintain the premises in a reasonably safe condition so as to provide a safe place to work may be considered as some evidence of defendant's negligence . . . inasmuch as defendant's alleged failure to comply with the regulation entitled "Site-specific hazard awareness training" (30 CFR 46.11) is unrelated to its duty with regard to the premises, any failure to comply with that regulation cannot be used as evidence of defendant's breach of its common-law or statutory duty to provide a safe place to work in this case. Id. at 1176–77.7 Similarly, any alleged violation of the FAA and DOT Guidelines for failure to explain the “shy bladder” procedure to subjects or warn subjects that 7 Appellant’s cited cases are distinguishable since the violations of the regulations or guidelines at issue all relate to a failure to exercise due care. See Bauer v. Female Acad. of the Sacred Heart, 97 N.Y.2d 445, 454 (2002) (defendant school’s failure to install proper safety equipment for window cleaners pursuant to state Industrial Code requirements proximately caused plaintiff to sustain injuries when he fell from three stories); Trimarco v. Klein, 56 N.Y.2d 98, 107 (1982) (defendant landlord’s failure to install shatterproof glazing in bathroom glass enclosure door proximately caused plaintiff’s injuries when he tried to enter the bathtub and the door shattered); Nichter v. 41 leaving the facility could be deemed a refusal to test is unrelated to a collector’s duty to perform a test in a reasonable manner such that it can report accurate results. II. THE RELIANCE ELEMENT OF A FRAUD CLAIM CANNOT BE MET BY RELIANCE ON STATEMENTS MADE TO A THIRD PARTY WHERE THERE IS NO ALLEGATION SUCH STATEMENTS WERE MADE FOR THE PURPOSE OF BEING COMMUNICATED TO PLAINTIFF OR WITH THE INTENT THAT SUCH REPRESENTATIONS WOULD REACH AND INFLUENCE PLAINTIFF The Second Circuit has certified the following question to this Court: [W]hether a plaintiff may establish the reliance element of a fraud claim under New York law by showing that a third party relied on defendant’s false statements resulting in injury to the plaintiff. Pasternack IV, 807 F.3d at 24. Under New York law, the answer to this question under the circumstances alleged here has been uniformly “no.” The Second Circuit certified this question because of its uncertainty as to whether its precedents in Cement & Concrete Workers District Council v. Lollo, 148 F.3d 194 (2d Cir. 1998) and City of New York v. Smoker-Spirits, Inc., 541 F.3d 425 (2d Cir. 2008), rev’d on other grounds by Hemi Group, LLC v. City of New York, 559 U.S. 1 (2010), correctly applied New York’s law. The discussion that follows cites New York State Hartley, 192 A.D.2d 842, 844 (3d Dep’t 1993) (school bus driver’s failure to adhere to safety manual proximately caused plaintiff to sustain injuries while crossing the street). 42 decisions, as opposed to the federal decisions which the Second Circuit did not find dispositive.8 As Appellant states in his brief, “[t]he ‘essence of fraud’ is an intentional deceit to induce reliance for personal gain.” (App. Br. at 49) (citing People v. Mancuso, 255 N.Y. 463, 484 (1931)). That is the context in which the Second Circuit’s question must be considered: intentional deceit for personal gain. Appellant’s fraud claim stems from his allegation that “LabCorp, through its employee, made . . . statements [“concerning Dr. Pasternack’s urine specimen collection to the FAA investigators”] for the purpose of inducing the FAA to rely on them.” (A-179, ¶¶ 67-68). However, New York State law mandates that statements made by a defendant’s employee to a federal agency’s investigators in the course of an investigation, even if untrue, cannot establish the reliance element for a fraud claim against the witness’s employer. 8 In addition to the two Second Circuit cases, LabCorp also relied on Siotkas v. Labone, Inc. in its brief to the Second Circuit. 594 F. Supp. 2d 259, 275–76 (E.D.N.Y. 2009) (dismissing fraud claim brought by airline pilots who alleged defendant inaccurately reported results of a drug test to employer, resulting in loss of licenses, because plaintiffs “failed to establish that they relied on defendant’s misrepresentations”). In Siotkas, the court noted that even while defendant “may have fraudulently misrepresented facts to Delta, [plaintiffs] in no way relied on [defendant’s] reports.” Id. at 276. LabCorp additionally relied on Odyssey Re (London) Ltd. v. Stirling Cooke Brown Holdings Ltd., 85 F. Supp. 2d 282, 293 (S.D.N.Y. 2000) (dismissing fraud claim where plaintiff failed to allege that defendants “made any statements directly to [plaintiff], let alone any that directly contained falsehoods or misrepresentation”). Moreover, the Second Circuit did not find the authority by Appellant dispositive. (App. Br. at 48 n.16). 43 A. A Plaintiff Cannot Prove Reliance Through a Third Party’s Reliance on Alleged Misrepresentations The general principle in New York is that a plaintiff cannot sustain a cause of action for fraud if defendant’s alleged misrepresentation did not form the basis of reliance by plaintiff. This is well-settled under recent New York law from this Court as well as the four Appellate Divisions. In Securities Investor Protection Corp. v. BDO Seidman, LLP, 95 N.Y. 2d 702, 711 (2001) (“SIPC”), this Court, in answering a certified question from the Second Circuit, reaffirmed this principle and found that plaintiff’s claim for fraud failed where the intended recipient of defendant’s audits was the National Association of Securities Dealers (NASD), not plaintiff.9 The Court found that plaintiff had no claim because it had not seen or relied on the statements in defendant’s audits, and as a matter of law could not claim reliance on the NASD’s reliance on same. In so finding, this Court wrote: The principle we reaffirm today is well rooted in New York law. Plaintiff cannot sustain a cause of action for fraud if defendant's misrepresentation did not form the basis of reliance (Brackett v Griswold, 112 NY 454; Warren v Forest Lawn Cemetery & Mausoleum, 222 AD2d 1059). . . .Beyond the general and unremarkable principle that liability for fraud can be imposed through 9 The certified question in SIPC was: “May a plaintiff recover against an accountant for fraudulent misrepresentations made to a third party where the third party did not communicate those misrepresentations to the plaintiff, but where defendant knew that the third party was required to communicate any negative information to the plaintiff and plaintiff relied to his detriment on the absence of any such communication?” Id. at 709. 44 communication by a third party, the differences between Tindle v Birkett (171 NY 520) and the instant case are clear. In Tindle, plaintiff received defendant's misrepresentations in the form of a positive credit report upon which it relied. In this case, although the complaint alleges BDO made a variety of misrepresentations, it also alleges that SIPC did not specifically know of any of them. SIPC cannot claim reliance on alleged misrepresentations of which it was unaware even by implication. SIPC, 95 N.Y.2d at 709–10. The plaintiff’s allegation in SIPC is similar to that presented here where the FAA allegedly relied on challenged statements which Appellant did not even know about. In support of his argument, Appellant relied on three nineteenth- century Court of Appeals cases in his brief to the Second Circuit—Eaton Cole & Burnham Co. v. Avery, 83 N.Y. 31 (1880); Bruff v. Mali, 36 N.Y. 200 (1867); and Rice v. Manley, 66 N.Y. 82 (1876)—and again relies on ancient precedent here. (App. Br. at 45-49) (citing Rice and Piper v. Hoard, 107 N.Y. 73 (1887)). These fraud cases find intentional direct causation of injury to the plaintiff as a result of the misstatements to a third party. The Second Circuit did not find Eaton, Bruff, or Rice dispositive for the following reasons: As the district court notes, however, the three cases are distinguishable. In Eaton and Bruff, the third parties acted as conduits to relay the false statements to the plaintiffs, who then relied on the false statements to their detriment. Eaton, 83 N.Y. at 33, 35; Bruff, 36 N.Y. at 200‐02, 206. Rice expressly declined to resolve the issue, noting in dicta that ‘it matters not whether false representations be made to the party injured or to a third party.’ Rice, 66 N.Y. at 45 87. Eaton, Bruff, and Rice thus do not answer the question before us. Pasternack IV, 807 F.3d at 23; see Eaton, 83 N.Y. at 38–39 (upholding liability for fraud where defendant misrepresented its financial condition to third party merchant to induce the third party to instead conduct business with defendant); Rice, 66 N.Y. at 87–88 (reversing trial court order rejecting fraud claim where defendant posed as plaintiff and falsely stated to third party cheese seller that plaintiff no longer wished to purchase cheese in order to purchase the product himself); Bruff, 36 N.Y. at 205–06 (upholding liability for fraud where defendants induced plaintiff to purchase valueless company stock by authenticating false shares and placing the shares into the market). In an equally nondispositive nineteenth-century case cited by Appellant, Piper, 107 N.Y. at 75, the defendant’s false statements to a third party (plaintiff’s mother) that plaintiff would receive land where defendant kept the land for himself was clearly an “intentional deceit to induce reliance for personal gain.” (App. Br. at 49) (citing Mancuso, 255 N.Y. at 484 (1931)). The question thus remains when a plaintiff may use a defendant’s statements made to a third party as a basis for a plaintiff’s reliance. The Third Department has spoken most recently to this issue in Bynum v. Keber, 135 A.D.3d 1066 (3d Dep’t 2016). In Bynum, the Third Department reversed the lower court’s denial of defendant’s motion to dismiss plaintiff’s fraud claim where plaintiff, the 46 mother of a child injured at a music festival, sued the promoters of the festival for fraud based on the promoters allegedly misrepresenting the anticipated attendance at the festival to the municipalities that issued permits allowing the festival to take place. Id. The Third Department wrote: Contrary to plaintiff's contention, the third-party reliance doctrine is inapplicable to the facts of this case, as plaintiff does not allege that defendants' representations to the relevant permitting authorities regarding the expected attendance at Camp Bisco were made “for the purpose of being communicated to [plaintiff]” or with the intent that such representations would “reach and influence [her]” (Eaton Cole & Burnham Co. v. Avery, 83 N.Y. 31, 35 [1880]; see Wildenstein v. 5H & Co, Inc., 97 AD3d 488, 490 [2012]; compare Buxton Mfg. Co. v. Valiant Moving & Stor., 239 A.D.2d 452, 453–454 [1997]; Desser v. Schatz, 182 A.D.2d 478, 479–480 [1992] ). Id. at 1068. The distinction drawn in Bynum is critical because as this Court stated in SIPC, a plaintiff cannot sustain a cause of action for fraud if defendant’s alleged misrepresentation did not form the basis of reliance by plaintiff. Statements made to a third party must be made for the purpose of being communicated to plaintiff or made so as to reach or influence the action of the plaintiff. Here, there is no allegation that Ms. Montalvo’s statements to the FAA investigators were intended to be communicated to Appellant, or that Ms. Montalvo had any intent that her statements would reach and influence Appellant in any way, and there is no allegation they did. 47 All four Appellate Division decisions addressing this issue are in accord. In 2012, in Wildenstein, the First Department dismissed a fraud cause of action against an individual building contractor for allegedly making misrepresentations to plaintiff’s building manager and condominium board noting, “[g]enerally, however, a plaintiff cannot claim reliance on misrepresentations a defendant made to third parties.” 97 A.D.3d at 490 (citing Briarpatch Ltd., L.P. v. Frankfurt, Garbus, Klein & Selz, P.C., 13 A.D.3d 296, 297 (1st Dep’t 2004)). In Briarpatch, plaintiffs asserted fraud claims against defendant on the sole basis of a letter written by defendant to a third party. 13 A.D.3d at 297. In dismissing plaintiffs’ claims, the court held that plaintiffs “cannot and do not claim reliance” on the letter at issue, and, therefore, the claims “were not pleaded with sufficient particularity.” Id. In 2006, in Aymes v. Gateway Demolition Inc., 30 A.D.3d 196, 197 (1st Dep’t 2006), the First Department also held that alleged statements made to a third party could not form the basis for a fraud claim. There the plaintiff was a property owner suing a demolition company hired by the City of New York to demolish property on plaintiff’s property. Id. at 196. In dismissing plaintiff’s fraud claim, the court held that plaintiff “lacks standing because the alleged misrepresentations were made to the City, not to plaintiff or the previous property owner. Moreover, there is no allegation that the supposed misrepresentations were 48 made for the purpose of influencing the actions of either plaintiff or the previous property owner.” Id. at 197 (citations omitted). The one case where the First Department has allowed a claim based on third party reliance to proceed was starkly different from Wildenstein and Aymes because the statements made were directly intended to extinguish a property right of plaintiff. In Desser v. Schatz, 182 A.D.2d 478, 479–80 (1st Dep’t 1992), the individual defendants Schatz and Sheen’s representatives falsely and intentionally stated to Chemical Bank that a mortgage was fully paid when it was not, in order to extinguish plaintiff’s claim to a building. The statements thus were made with the intent of reaching and damaging plaintiff to the pecuniary benefit of defendants. The Second Department also follows the general rule that fraud claims cannot lie where a misrepresentation was made to a third party. In Garelick v. Carmel, 141 A.D.2d 501, 502 (2d Dep’t 1988), defendant attorneys were hired by plaintiff’s mother to draft a deed conveying land to plaintiff. The land was not properly conveyed to plaintiff and plaintiff sought relief based in part on a fraud claim. Id. The Second Department dismissed plaintiff’s fraud claim because the “complaint [did] not contain any allegation setting forth alleged material representations by the defendants . . . to the plaintiff.” Id. 49 In contrast, in Buxton Mfg. Co. v. Valiant Moving & Storage, Inc., 239 A.D.2d 452, 453–54 (2d Dep’t 1997), the Second Department found a fraud claim to be stated against an individual where that individual deceived the Department of Agriculture by falsely certifying that all of its subcontractors on a certain project, including plaintiff, had been paid as part of a request that the Department of Agriculture release remaining project funds to the individual’s employer. The Second Department also upheld a fraud claim asserted by an infant who suffered birth defects in utero. Ruffing v. Union Carbide Corp., 308 A.D.2d 526 (2d Dep’t 2003). Here the claim was brought by an infant in reliance on an intentionally false representation made to the infant’s mother by her employer. Id. at 526–27. The infant plaintiff based the fraud claim on “willfully deceptive statements” made by the defendant while the infant was in utero regarding the safety of the mother’s work environment, on which the court found plaintiff relied to its detriment (the plaintiff was born with birth defects). Id. at 527, 531. This case is similar to Piper, 107 N.Y. at 75–76. In that case, defendant induced plaintiff’s mother to marry him in order to receive a land interest which required the purchaser to have an heir at death. Id. Defendant falsely promised plaintiff’s mother that the land would transfer to a child born of their marriage upon its birth, however defendant refused to transfer the land when plaintiff was born. Id. This Court upheld the trial court’s judgment against the defendant for 50 fraud because the “the settlement was something in which the children were interested, and were privy to the party promising” and therefore “[i]n this way [plaintiff] is the very person injured by the fraud.” Id. at 79. The Fourth Department is also in accord with the general principle that fraud claims cannot lie where a misrepresentation was made to a third party. In Warren v. Forest Lawn Cemetery & Mausoleum, 635 N.Y.S.2d 874 (1995), a case cited by this Court in SIPC, 95 N.Y.2d at 709, the Fourth Department upheld the dismissal of a fraud action where it was alleged that the Forest Lawn Cemetery had relied on defendant’s misrepresentation that plaintiff had consented to the disinterment of his mother’s remains. The Fourth Department wrote: “Plaintiff is not a proper party to allege fraud because no misrepresentation was made to him, nor did he allege that he relied on any misrepresentation.” Id. at 874. As these cases uniformly demonstrate, New York has never found a fraud claim sufficient where the misstatements made to a third party were not specifically intended to be communicated to or reach or influence the plaintiff. In short there must be a design to directly injure the plaintiff for gain. This is in stark contrast to the situation here. Appellant’s cause of action for fraud is based on the alleged statements by LabCorp’s employee, Ms. Montalvo, to FAA investigators that Appellant was on his cell phone and uncooperative during the test. (A-172-73, ¶¶ 33-34). Even if these statements were false, Appellant does not have standing 51 to rely upon them as a predicate for his fraud claim because they were directed to the FAA without any intent to reach or influence him. SIPC, 95 N.Y.2d at 711. Appellant’s contention, therefore, that “[t]he FAA justifiably relied on LabCorp’s false statements,” is insufficient as a matter of law. (A-180, ¶ 69). Appellant’s failure to allege any facts indicating that he knew about or relied on Ms. Montalvo’s statements is fatal to his fraud claim. SIPC, 95 N.Y.2d at 710. The alleged misstatement was made to investigators at the FAA, not Appellant, as part of the FAA investigation; Appellant did not rely on the statement but instead claims the investigators did as part of the mix in their decision in determining to lift Appellant’s FAA certifications; Appellant has not alleged there was any intent by Ms. Montalvo to deceive Appellant for personal gain as opposed to her intent to answer the FAA investigators’ questions; Appellant has not alleged LabCorp or Ms. Montalvo benefitted in any pecuniary way from the alleged misstatement; Appellant has not suffered any injury as a result of the statement since his “injury” derives from the finding of the FAA — a finding which Appellant successfully appealed. Under the settled law of this state, a plaintiff must show that he, and not a third party, relied on the alleged misstatement. Here, Appellant has not alleged any facts that would satisfy New York’s pleading requirements for reliance in a fraud claim. 52 B. Appellant Does Not Allege any Intent on LabCorp’s Part that the Representations Were Made to Defraud Appellant As stated above, Appellant fails to allege facts sufficient to infer that LabCorp intended to defraud him. This is a fatal flaw. See, e.g., First Credit Alliance Corp. v Arthur Andersen & Co., 65 N.Y.2d 536, 554 (1985), rev’d on other grounds, First Interstate Credit Alliance, Inc. v. Arthur Andersen & Co., 150 A.D.2d 291 (1st Dep’t 1989) (dismissing complaint for failure to allege facts demonstrating scienter); Chem. Corn Exch. Bank v. Wassung, 7 N.Y.2d 337, 339 (1960) (dismissing complaint for failure to allege intent to defraud); Friedman v. Anderson, 23 A.D.3d 163, 167 (1st Dep’t 2005) (“A fraud claim is not actionable without evidence that the misrepresentations were made with the intent to deceive.”). Appellant must allege facts that give rise to a “strong inference of fraudulent intent,” N.Y. University v. Continental Insurance Co., 87 N.Y.2d 308, 319 (1995) (dismissing fraud claim where “no inference of fraudulent intent” could be drawn from plaintiff’s compilation of facts in complaint); Board of Managers of Beacon Tower Condominium v. 85 Adams Street, LLC., 136 A.D.3d 680, 685 (2d Dep’t 2016) (“the complaint must provide some minimal factual basis that gives rise to a strong inference of fraudulent intent”) (quotation omitted), such that the defendant intended to deprive plaintiff of a concrete benefit from the fraudulent statement. CPC Int’l Inc. v. McKesson Corp., 70 N.Y.2d 268, 285 (1987) (cause 53 of action for common-law fraud must allege that defendant “knowingly uttered a falsehood intending to deprive the plaintiff of a benefit”) (quotation omitted). Likewise here, although Appellant alleges that Ms. Montalvo’s “statements to the FAA” were known “to be false, or in reckless disregard for the truth,” (A-179, ¶ 67), Appellant has failed to demonstrate that LabCorp intended these statements to defraud him—or the FAA. Appellant’s failure to allege facts indicating LabCorp’s intent to deceive him in order to deprive him of a benefit is fatal to his fraud claim. C. Appellant Cannot Show Ms. Montalvo’s Statements Caused His Injury Appellant cannot show that any misrepresentations made by Ms. Montalvo to the FAA concerning his demeanor during the Drug Test were the cause of the FAA’s decision to suspend his airman certificates and AME designation. Although Appellant alleges that a LabCorp employee, Ms. Montalvo, told FAA Investigators that he was on his cell phone and was uncooperative during the Drug Test, the FAA determined that he “refused to test” because he left the LabCorp Facility, not because he was on the phone or uncooperative. See 49 C.F.R. § 40.191(a)(2) (“As an employee, you have refused to take drug test if you: . . .(2) Fail to remain at the testing site until the testing process is complete. . . .”); (see also A-201-02, ¶¶ 7-13; A-248, ¶ 10) (finding that Appellant did not refuse to take the Drug Test because he was uncooperative under 49 C.F.R. § 40.191(a)(8), 54 but rather he refused to take the Drug Test because he left the LabCorp Facility in violation of 49 CFR § 40.191(a)(2)). Thus, the FAA’s determination that Appellant refused to test was based on the fact, which was true, that he left the LabCorp Facility before completing his Drug Test. Appellant’s injuries, if any,—the temporary loss of his airman certificates, AME designation, and any resulting loss of compensation—were caused by the legal determination of the FAA and the ALJ. Appellant’s injuries, therefore, were caused by decisions made by third parties over whom LabCorp had no control. The D.C. Circuit found that “[t]here is no dispute that [Appellant] left the testing facility before the testing process was complete. However, . . . [a]fter careful review of the record in this case, we find that the Board’s conclusion, that [Appellant] lacked permission to leave the testing facility and, thus, ‘refused’ a mandatory drug test, fails for lack of substantial evidence.” Huerta, 513 F. App’x at 2 (emphasis added). In other words, the D.C. Circuit found that based on the facts, the FAA should not have concluded that Appellant’s conduct constituted a refusal to test. Appellant’s injury was the result of the FAA’s actions, not Ms. Montalvo’s statements. 55 D. It Would Not be in the Public Interest to Permit a Fraud Claim to Proceed Where Reliance is Based on Statements Made by a Witness in a Quasi-Judicial Proceeding Appellant has not been left without remedy: he exercised his FAA appeal rights and had the adverse determination overturned. See Huerta, 513 F. App’x at 1. He should not now be permitted to sue the employer of a witness for statements made to the FAA investigators. Public policy recognizes that it is of fundamental importance to the administration of justice that witnesses not be discouraged from participation in judicial or quasi-judicial proceedings by fear of private litigation. See, e.g., Rosenberg v. Metlife, Inc., 8 N.Y.3d 359, 365 (2007) (recognizing that in the defamation context, public policy requires that statements made in quasi-judicial proceedings be immunized to ensure that fear of civil litigation does not have an adverse impact on the administration of justice). Plaintiff is unable to cite to any case where reliance on a witness’s statement made as part of a quasi-judicial proceeding was held to be sufficient for a fraud claim. If it becomes the law in this state that a successful party in an administrative proceeding can allege fraud against a witness who cooperated with investigators, the courts will be inundated with lawsuits from disgruntled litigants. CONCLUSION F or the foregoing reasons, both certified questions should be answered in the negative. Dated: New York, New York April 1, 2016 Respectfully submitted, KELLEY DRYE & WARREN LLP Robert 1. Steiner Sarah L. Reid 101 Park Avenue New York, New York 10178 (212) 808-7800 Attorneys for Defendant-Respondent Laboratory Corporation of America Holdings 56 Urine Specimen Collection Guidelines United States Department of Transportation Office of Drug and Alcohol Policy and Compliance Revised July 3, 2014 LC-ADD-1 DOT Urine Specimen Collection Guidelines 2 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 DOT Urine Specimen Collection Guidelines for the U.S. Department of Transportation Workplace Drug Testing Programs (49 CFR Part 40) Revised July 3, 2014 [previous editions become obsolete]. These guidelines apply only to employers and individuals who come under the regulatory authority of the U.S. Department of Transportation (DOT) and those individuals who conduct urine specimen collections under DOT regulations. The term “employee” is used throughout this document and has the same meaning as “donor” as used on the Federal Drug Testing Custody and Control Form (CCF). These guidelines are a complete revision of the DOT Urine Specimen Collection Procedures Guidelines, 49 CFR Part 40, for Transportation Workplace Drug Testing Programs. It contains minimal graphics and formatting to ease transmission and downloading of the document from the Internet. All information appearing in these guidelines is in the public domain and may be used or reproduced without permission from DOT or others. Citation of the source is appreciated. This document may be updated or modified based on additional interpretations or other procedural changes. Collectors and service agents should check the ODAPC web site periodically to ensure that they have the latest version: www.dot.gov/odapc . LC-ADD-2 DOT Urine Specimen Collection Guidelines 3 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 INTRODUCTION The Department of Transportation's (DOT) Operating Administrations – Federal Aviation Administration, Federal Motor Carrier Safety Administration, Federal Railroad Administration, Federal Transit Administration, Pipeline and Hazardous Materials Safety Administration – and United States Coast Guard (now with the Dept. of Homeland Security) have issued regulations requiring anti-drug programs in the aviation, highway, railroad, transit, pipeline, and maritime industries. The DOT Agencies' rules require that employers conduct drug testing according to provisions of 49 CFR Part 40, "Procedures for Transportation Workplace Drug Testing Programs." The procedures for collection of urine under these rules are very specific and must be followed whenever a DOT-required urine specimen collection is performed. (The only exception is the Federal Railroad Administration's Post-Accident Toxicological Testing Program in which a railroad representative will provide the collector specific instructions and a testing kit.) These procedures, including use of the Federal Drug Testing Custody and Control Form (CCF), apply only to DOT-required testing. While employers may use our collection and testing procedures for testing under employer or state authority, they must not use a Federal CCF, nor can they imply that company tests are conducted using DOT authority. The collector has a major role in the success of the DOT’s drug testing program. The collector is the one individual in the testing process with whom all employees have direct, face-to-face contact. Without the collector assuring the integrity of the specimen and collection process, the test itself may lose validity. Without the collector's sensitivity to an employee's privacy, the entire testing program may be subject to criticism. It is imperative that collectors fully understand and follow these procedures. These guidelines, together with 49 CFR Part 40 and the DOT operating administrations' rules, will provide collectors with the information needed in the performance of their collection duties. The information in this document addresses and provides guidance concerning normal collection procedures and some of the more common problems or situations encountered. However, information contained in this publication should not be used to interpret or be viewed as adding to or modifying the legal requirements of the actual rule. LC-ADD-3 DOT Urine Specimen Collection Guidelines Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 4 TABLE OF CONTENTS SECTION 1. COLLECTOR ........................................................................................................... 5 SECTION 2. COLLECTION SITE ................................................................................................ 6 SECTION 3. COLLECTION SUPPLIES....................................................................................... 7 SECTION 4. FEDERAL DRUG TESTING CUSTODY AND CONTROL FORM ..................... 8 SECTION 5. INFORMATION EMPLOYERS PROVIDE TO COLLECTORS ........................ 10 SECTION 6. EMPLOYEE IDENTIFICATION .......................................................................... 10 SECTION 7. COLLECTION PROCEDURES............................................................................. 11 SECTION 8. SHY BLADDER PROCEDURES .......................................................................... 20 SECTION 9. DIRECTLY OBSERVED COLLECTIONS .......................................................... 22 SECTION 10. MONITORED COLLECTIONS .......................................................................... 24 SECTION 11. PROBLEM COLLECTIONS ............................................................................... 25 SECTION 12. BLIND QUALITY CONTROL SAMPLES ......................................................... 28 SECTION 13. CORRECTING COLLECTION PROBLEMS ..................................................... 28 APPENDIX A – TRAINING REQUIREMENTS FOR COLLECTORS .................................... 31 APPENDIX B – COLLECTION SITE SECURITY AND INTEGRITY .................................... 33 APPENDIX C – DOT STANDARDS FOR URINE COLLECTION KITS ................................ 34 APPENDIX D – DIRECT OBSERVATION PROCEDURES .................................................... 36 APPENDIX E – QUESTIONS AND ANSWERS ....................................................................... 37 APPENDIX F – OPERATING ADMINISTRATIONS’ RULES (SUMMARY) ........................ 37 LC-ADD-4 DOT Urine Specimen Collection Guidelines 5 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 SECTION 1. COLLECTOR Part 40 defines a collector as a trained person who instructs and assists employees at a collection site, who receives and makes an initial inspection of the urine specimen provided by those employees, and who initiates and completes the Federal Drug Testing Custody and Control Form (CCF). Note: DOT does not require or provide collector certification. Collectors need to have documentation reflecting that they have met appropriate training requirements at Appendix A. Any individual, who has received training specified in 49 CFR Part 40 (§40.33) for conducting the required collection procedure, may serve as a collector except in the following situations: 1. The immediate supervisor of a particular employee may not act as the collector when that employee is tested, unless no other collector is available and the supervisor is permitted to do so under a DOT operating administration’s drug and alcohol regulation. (The immediate supervisor may act as a monitor or observer (same gender) if there is no one else available at the collection site to conduct a monitored or observed collection.); 2. An employee who is in a safety-sensitive position and subject to the DOT drug testing rules should not be a collector, an observer, or a monitor for co-workers who are in the same testing pool or who work together with that employee on a daily basis. This is to preclude any potential appearance of collusion or impropriety; 3. An individual working for an HHS-certified drug testing laboratory (e.g., as a technician or accessioner) may not act as a collector if that individual can link the employee with the specimen drug test result or laboratory report; and, 4. The employee may not be the collector of his or her own urine specimen. Note: To avoid a potential conflict of interest, a collector should not be someone that is related to the employee (e.g., spouse, ex-spouse, relative) or a close personal friend (e.g., fiancée). A collector should have appropriate identification, which includes the collector’s name and the name of the Collection Company or clinic. The collector is required to provide his or her identification if requested by the employee. There is no requirement for the collector to have a picture I.D. or to provide his or her driver's license with an address or telephone number. Also, the collector is not required to provide any certification or other documentation to the employee documenting the collector's training. However, the collector must provide this documentation on request to DOT agency representatives and to employers and service agents (SA) or Consortium/Third Party Administrators (C/TPAs) who are using or negotiating to use that collector’s services. The employer must provide the collector with the name and telephone number of the appropriate Designated Employee Representative (DER) and C/TPA, where applicable, to contact about any problems or issues that may arise during the collection process. LC-ADD-5 DOT Urine Specimen Collection Guidelines 6 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 SECTION 2. COLLECTION SITE A collection site is a place (permanent or temporary) selected by the employer where employees present themselves for the purpose of providing a urine specimen for a DOT-required drug test. Generally, there are two types of collection facilities: 1. A single-toilet restroom, with a full-length privacy door, or 2. A multi-stall restroom, with partial-length doors. A collection site must have: 1. A restroom or stall with a toilet for the employee to have privacy while providing the urine specimen. Whenever available, a single toilet restroom, with a full-length privacy door, is preferred. All types of restrooms including a mobile facility (e.g., a vehicle with an enclosed toilet) are acceptable. 2. A source of water for washing hands that, if practical, is external to the restroom where urination occurs. If the only source of water available is inside the restroom, the employee may wash his or her hands, and then the collector must secure the water source (e.g., use tamper-evident tape, cut off the water supply) before the collection takes place. If water is not available at the collection site, the collector may provide moist towelettes outside the restroom. 3. A suitable clean surface for the collector to use as a work area and for completing the required paper work. A second type of facility for urination, which can be used as a collection site, is a multi-stall restroom. Such a site must provide substantial visual privacy (e.g., a toilet stall with a partial- length door) and meet all other requirements listed above (2 and 3). Additionally, if a multi-stall restroom is used, the collector must either: 1. Secure all sources of water and other substances that could be used for adulteration and substitution (e.g., water faucets, soap dispensers) and place bluing agent in all toilets or secure the toilets to prevent access; or 2. Conduct all collections as monitored collections (See Section 10). No one but the employee may be present in the multi-stall restroom during the collection, except the monitor in the event of a monitored collection or the observer in the event of a directly observed collection. Note: The collector’s work area may be located outside the restroom. However, if there is no appropriate space available outside the restroom to serve as a secure, clean work area and the restroom is either a multi-stall facility or a single stall facility with a partial door for privacy, and is large enough to accommodate a work area, the collector may locate the work area inside the restroom as long as all procedures for a monitored collection are met. LC-ADD-6 DOT Urine Specimen Collection Guidelines 7 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 All collection sites must meet the requirement of §40.43 including the following security requirements: 1. Procedures or restrictions to prevent unauthorized access to the site during the collection; 2. Procedures to prevent the employee or anyone else from gaining unauthorized access to the collection materials/supplies. The collector must also ensure that the employee does not have access to items that could be used to adulterate or dilute the specimen (e.g., soap, disinfectants, cleaning agents, water); Note: See “DOT’s 10 Steps to Collection Site Security and Integrity” at Appendix B. 3. Procedures to ensure that all authorized persons are under the supervision of a collector or appropriate site personnel at all times when permitted into the site; and, 4. Procedures to provide for the secure handling and storage of specimens. Note: The testing site is that portion of the facility where the collector performs the paper work, seals the specimens, and where urination occurs. It does not necessarily include the total physical facility (e.g., clinic). Additionally, unauthorized personnel are any individuals that are not specifically authorized by the regulation, the collector, or employer to be present at the collection site. SECTION 3. COLLECTION SUPPLIES The following items must be available at the collection site in order to conduct proper collections: 1. For each DOT drug test, a collection kit meeting the requirements listed at Appendix C of these guidelines. 2. Federal Drug Testing Custody and Control Forms (CCF). 3. Bluing (coloring) agent to add to the toilet bowl/water tank to prevent an employee from diluting the specimen. 4. The collector should have available tamper-evident tape for securing faucets, toilet tank tops, and other appropriate areas, and signs, when necessary, that can be posted to prevent entry into collection areas. Note: Single use disposable gloves are recommended for use by collectors while handling specimens. LC-ADD-7 DOT Urine Specimen Collection Guidelines 8 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 SECTION 4. FEDERAL DRUG TESTING CUSTODY AND CONTROL FORM The CCF must be used to document every urine collection required by the DOT drug testing program. The CCF must be a five-part carbonless manifold form. This form may be viewed on the DOT web site [ http://www.dot.gov/odapc/ ] or the Department of Health and Human Services (HHS) web site [ http://workplace.samhsa.gov/ ]. CCFs are also available from a number of different sources (e.g., laboratories, service agents) although they are usually part of the urine collection kits provided by a laboratory. The CCF consists of the following five copies: Copy 1. Test Facility Copy - accompanies the specimen to the laboratory Copy 2. Medical Review Officer Copy - sent to the MRO Copy 3. Collector Copy - retained by the collector Copy 4. Employer Copy - sent to the employer Copy 5. Employee Copy - given to the employee The CCF is completed as follows: Step 1 (Copy 1). This step is completed by the collector or employer representative prior to the employee providing a urine specimen. The employer and MRO names, addresses, and telephone and fax numbers may be preprinted or handwritten. If the employer has designated a service agent to receive the results from the MRO, the employer’s address may be omitted and the service agent’s address may be used. However, in all cases, the specific employer’s name, telephone and fax numbers must be included. A clinic or collection site name may not be used in lieu of an employer name. The collector enters the employee’s social security number or employee’s ID number after verifying the employee’s identity. The collector also marks the appropriate box to indicate the reason for the test and the appropriate box for the type of drug tests to be performed (all DOT drug tests are for five drugs). The collector is to check the DOT Agency whose authority the specimen is collected. For example, if the employee’s specimen is collected under the authority of the Federal Motor Carrier Safety Administration (FMCSA) regulation, the collector would check the “DOT” and “FMCSA” boxes. The collector then enters the information required for the collection site (this information may also be preprinted). The collector’s telephone number is critical, since the laboratory or the MRO may need to contact the collector if they have questions related to a collection. Step 2 (Copy 1). This step is completed by the collector after receiving the specimen from the employee and observing the temperature of the specimen. This step requires the collector to mark the appropriate box to indicate if the temperature of the specimen is within the required temperature range. This step also requires the collector to indicate whether it is a split specimen or single specimen collection, to indicate if no specimen was collected and why, and to indicate if it was an observed collection and why. Note: Because all DOT collections are split specimen collections, the collectors should ALWAYS check the split specimen box. LC-ADD-8 DOT Urine Specimen Collection Guidelines 9 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 Step 3 (Copy 1). This step instructs the collector to seal and date the specimen bottles, to date the bottles seals after placing them on the bottles, to have the employee initial the bottle seals after placing them on the bottles, and then instruct the employee to complete step 5 on the MRO copy (Copy 2). Step 5 (Copy 2). This step is completed by the employee (listed as donor on the CCF). The employee reads the certification statement, prints his or her name, provides date of birth, daytime and evening telephone numbers, date of collection, and signs the form. After the employee completes this portion of the CCF, the collector reviews it to ensure that all the required information was provided. Step 4 (Copy 1). This step is initiated by the collector and then completed by the laboratory after the laboratory accessions the specimen. This step requires the collector to sign the form to certify that the specimen was collected, labeled, sealed, and released for shipment to the laboratory in accordance with Federal requirements. The collector is also required to note the time of the collection, the date of collection, and the specific name of the delivery service to whom the specimen is released for shipment to the laboratory. Note: There is no requirement for couriers, express carriers, or postal service personnel to add additional documentation to the chain of custody for the specimens during transit because they do not have direct access to the specimens or the CCF. Chain of custody annotations resume when the shipping container/package is opened and accessioned at the laboratory. Step 5(a) (Copy 1). This step is completed by the laboratory to report the test result of the primary specimen. Step 5(b) (Copy 1). This step is completed by the laboratory to report the test result of the split specimen if the split specimen is tested. Step 6 (Copy 2). This step is completed by the MRO in reporting the results of the primary specimen to the employer. Step 7 (Copy 2). This step is completed by the MRO in reporting the results of the split specimen to the employer. The bottom area of Copy 1 is reserved for the tamper-evident specimen bottle seals/labels. There must be two seals/labels to accommodate collecting split specimens (i.e., one marked with the letter "A" to designate the primary specimen and the other marked with the letter "B" to designate the split specimen) to accommodate collecting split specimens. Note: No one (including collection site personnel or the collector) is permitted to require an employee to sign a consent, release, or waiver of liability, or indemnification agreement with respect to any part of the drug testing process. Collection sites (clinics) may not use “generic” consent forms for DOT-required urine specimen collections, even if their clinic policy requires consent from the general patient population. LC-ADD-9 DOT Urine Specimen Collection Guidelines 10 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 SECTION 5. INFORMATION EMPLOYERS PROVIDE TO COLLECTORS 49 CFR Part 40 requires the employer or its service agent – for example a C/TPA -- to ensure the collector has the following information when conducting a urine specimen collection for it: (a) Full name of the employee being tested. (b) Employee SSN or ID number. (c) Laboratory name and address (can be pre-printed on the CCF). (d) Employer name, address, phone number, and fax number (this can be pre-printed on the CCF at Step 1-A). (e) DER name and telephone number (and C/TPA, where applicable). (f) MRO name, address, phone number, and fax number (can be pre-printed on the CCF at Step 1-B). (g) The DOT Agency that regulates the employee’s safety-sensitive duties (the checkmark can pre-printed in the appropriate box on the CCF at Step 1-D) (h) Test reason, as appropriate: Pre-employment; Random; Reasonable Suspicion/Reasonable Cause; Post-Accident; Return-to-Duty; and Follow-up. (i) Whether the test is to be observed or not [see 40.67(a) & (b)]. (j) (Optional) C/TPA name, address, phone, and fax number (can be pre-printed on the CCF). SECTION 6. EMPLOYEE IDENTIFICATION The employee must provide appropriate identification to the collector at the outset of the collection process. Acceptable forms of identification include: 1. A photo identification (e.g., drivers license, employee badge issued by the employer, or any other picture identification issued by a Federal, state, or local government agency), or 2. Identification by an employer or employer representative, or 3. Any other identification allowed under an operating administration’s rules. Note: If the employee cannot produce positive identification, the collector must contact a DER to verify the identity of the employee. The collection should not proceed until positive identification is obtained. However, if an owner/operator or other self-employed individual does not have proper identification, the collector should record in the remarks section that positive identification is not available. The owner/operator or other self- LC-ADD-10 DOT Urine Specimen Collection Guidelines 11 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 employed individual should be asked to provide two items of identification bearing his/her signature. The collector then proceeds with the collection. When the donor signs the certification statement, the collector should then compare the signature on the CCF with the signatures on the identification provided previously by the owner/operator or other self-employed individual. If the signatures appear consistent, the collection process continues. If the signature does not match signatures on the identification presented, the collector should make an additional note in remarks section stating "signature identification is unconfirmed." Unacceptable forms of identification include: 1. Identification by a co-worker, 2. Identification by another safety-sensitive employee, 3. Use of a single non-photo identification card (e.g., social security card, credit card, union or other membership cards, pay vouchers, voter registration card), or 4. Faxed or photocopies of identification document. SECTION 7. COLLECTION PROCEDURES The collector must do the following before each collection to deter potential tampering, adulteration, alteration, or substitution of the specimens: 1. Secure any water sources or otherwise make them unavailable to employees (e.g., turn off water inlet, tape handles to prevent opening faucets); 2. Ensure that the water in the toilet and tank (if applicable) has bluing (coloring) agent in it. Tape or otherwise secure shut any movable toilet tank lid, or put bluing in the tank; 3. Ensure that no soap, disinfectants, cleaning agents, or other possible adulterants are present; 4. Inspect the site to ensure that no foreign or unauthorized substances are present; 5. Ensure that undetected access (e.g., through a door or window not in your view) is not possible; 6. Secure areas and items (e.g., ledges, trash receptacles, paper towel holders, under-sink areas, dropped ceilings) that appear suitable for concealing contaminants; and 7. Recheck items (1) through (6) following each collection to ensure the site’s continued integrity. If the collection site uses a facility normally used for other purposes, such as a public restroom or hospital examining room, the collector must also ensure before the collection that: LC-ADD-11 DOT Urine Specimen Collection Guidelines Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 12 1. Access to collection materials and specimens is effectively restricted; and 2. The facility is secured against access during the procedure to ensure privacy to the employee and prevent distraction of the collector. Limited-access signs must be posted. Note: See “DOT’s 10 Steps to Collection Site Security and Integrity” at Appendix B. To avoid distraction that could compromise security, the collector is limited to conducting a collection for only one employee at a time. However, during the 3 hour waiting period that an employee can consume fluids (shy bladder), the collector may conduct a collection for another employee. In this case, the employee with the shy bladder must be monitored to ensure the continued integrity of the test (see Section 8). When a specific time for an employee's test has been scheduled, or the collection site is at the employee’s work site, and the employee does not appear at the collection site at the scheduled time, the collector must contact the DER to determine the appropriate interval within which the DER has determined the employee is authorized to arrive. If the employee's arrival is delayed beyond that time, the collector must notify the DER that the employee has not reported for testing. Note: For a pre-employment test, if an employee fails to appear, fails to provide a urine specimen, or fails to remain at the collection site, this is not considered a refusal provided the employee left the testing site or did not provide a specimen before the testing process commenced (i.e., the employee was given the collection kit or cup by the collector). Note: There is no requirement for a collector to inform the employee that failure to remain at the collection site or otherwise fails to cooperate with the testing process constitutes a refusal. It is a best practice for the collector to inform the employee that such behavior could lead an employer to determine that a refusal occurred. The following steps describe a typical urine collection conducted under the DOT-mandated procedures: 1. The collector prepares the collection site to collect urine specimens. All collection supplies must be available, the area properly secured, water sources secured, and bluing (coloring) agent placed in all toilets as required by Part 40 and reiterated in Sections 2 and 3 of these guidelines. 2. The collector begins the collection without delay after the employee arrives at the collection site. Do not wait because the employee is not ready or states he or she is unable to urinate. In most cases, employees who state they cannot provide a specimen will, in fact, provide sufficient quantity to complete the testing process. Note: If an alcohol breath test is also scheduled, the alcohol test should be conducted first, if practicable, though the rule (§40.61(b)(1)) example suggests some situations where there can be an exception to this normal process. 3. The collector requests the employee to present an acceptable form of identification. If the employee cannot produce positive identification, the collector must contact the DER to verify the identity of the employee (see Section 6 for further guidance). If the employee asks the collector LC-ADD-12 DOT Urine Specimen Collection Guidelines 13 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 to provide identification, the collector must show the employee some form of identification. It must include the collector’s name and the name of the collector’s employer. It does not have to be picture identification or include the collector’s home address or telephone number. 4. The collector explains the basic collection procedures to the employee and shows the employee the instructions on the back of the CCF. 5. The collector ensures that the required information is provided at the top of the CCF (the laboratory name and address and a pre-printed specimen ID number which matches the ID number on the specimen bottle seals). If the information is not already preprinted, the collector begins entering the required information in Step 1 of the CCF: - Employer's name, address, telephone and fax number, and I.D. number (if applicable); - MRO name, address, telephone and fax number; - Employee SSN or employee ID number (refusal by the employee to provide a SSN is not a refusal to test, but requires the collector to annotate this in the remarks section); - Reason for test; - Drug test to be performed; and - Collection site information. Note: Part 40 requires a specific MRO's name and address on the CCF rather than the name of the clinic or medical facility. An employer must provide to the collector the name and telephone number of the appropriate DER. This may be part of the CCF information that is pre-printed or may be separately documented. If there is no employer or DER telephone number on the CCF, the collector should write in the DER name and telephone number on the CCF (if this information is available) so that either the collector or the MRO may get in touch with a company representative when any problems arise related to that specimen. Note: The CCF may be pre-printed with the DOT and Agency designation boxes already checked. If it is not, the employer must ensure the collector has this information. 6. The collector directs the employee to remove any unnecessary outer clothing (e.g., coat, jacket, hat, etc.) and to leave any briefcase, purse, or other personal belongings he or she is carrying with the outer clothing. The employee may retain his or her wallet. If the employee asks for a receipt for any belongings left with the collector, the collector must provide one. Note: To safeguard employee’s belongings, procedures may be established where the belongings are locked (at the collection site or in the bathroom) or other alternate methods may be developed. For example, if an employee comes to the collection site with his or her medications and desires that the collector secure the medication, the collector may place the medication in a locked cabinet, if available, or alternately, could seal the medication in an envelope, secure the envelope with tamper-evident tape and retain the envelope in a secure place. LC-ADD-13 DOT Urine Specimen Collection Guidelines 14 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 Note: The collector may encourage the employee to also leave, with his or her other belongings, any other items that the employee will not need or may be prohibited from carrying into the restroom. Note: The employee must not be asked to remove other articles of clothing, such as shirt, pants, dress, or under garments. Additionally, the employee must not be requested or required to remove all clothing in order to wear a hospital or examination gown. An exception may be made, if the employee is also undergoing a physical examination authorized by a DOT operating administration’s rule, in conjunction with the drug test, which normally includes wearing a hospital gown. Work boots or cowboy boots do not have to be removed unless the collector has a reason to suspect that the employee has something in them that may be used to adulterate or substitute a specimen. When an employee is asked to remove his or her hat or head covering, and refuses to do so based on religious practice, the collector may exempt the employee from removal of the head covering, unless the collector has an observable indicator that the employee is attempting to hide inside the head covering adulterants or other substances which may be used in an attempt to adulterate or substitute a specimen. 7. The collector directs the employee to empty his or her pockets and display the items to ensure that no items are present that could be used to adulterate the specimen. If nothing is there that can be used to adulterate a specimen, the employee places the items back into the pockets and the collection procedure continues. If the employee refuses to empty his or her pockets, this is considered a refusal to cooperate in the testing process. Note: If an item is found that appears to have been brought to the collection site with the intent to adulterate the specimen, a directly observed collection procedure becomes a requirement. If the item appears to be inadvertently brought to the collection site, secure the item and continue with the normal collection procedure. For example, a bottle of eye drops may have been brought inadvertently and would have to be secured by the collector and the collection would proceed. However, a bottle of liquid or urine would suggest intent to tamper with the specimen and a directly observed collection would be required. Whatever the employee brings into the collection site, the collector should return it to the employee at the end of the collection. Items, such as suspected urine, plastic bags with fluid in them, artificial or mechanical objects for providing substituted urine, etc., should be fully described in an attached memorandum for record, copies of which should be sent to the MRO and the employer. 8. The collector instructs the employee to wash and dry his or her hands, under the collector's observation, and informs the employee not to wash his or her hands again until after the employee provides the specimen to the collector. The employee must not be allowed any further access to water or other materials that could be used to put into the specimen. If the employee refuses to wash his or her hands – after being directed to do so – this is a refusal to test. Note: The employee may use soap and, if practicable, it should be a liquid or cream. A solid bar of soap gives the employee the chance to conceal soap shavings under his or her fingernails and subsequently use them to attempt to adulterate the specimen. LC-ADD-14 DOT Urine Specimen Collection Guidelines 15 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 9. The collector either gives to the employee or allows the employee to select the collection kit or collection container (if it is separate from the kit) from the available supply. Either the collector or the employee, with both present, then unwraps or breaks the seal of the kit or collection container. Note: Ensure the employee takes only the collection container into the room used for urination. The sealed specimen bottles remain with the collector. Note: Even if the collection kit is sealed, the collection container must still be sealed or individually wrapped in a plastic bag or shrink wrapping; or must have a peelable, sealed lid or other easily visible tamper-evident system. Do not unwrap or break the seal on any specimen bottle at this time. Unwrap only the collection container. 10. The collector directs the employee to go into the room used for urination, provide a specimen of at least 45 mL, not to flush the toilet, and return with the specimen as soon as possible after completing the void. (In many restrooms, a toilet tank into which bluing agent may be placed is not accessible to the collector. When the employee flushes the toilet, he or she can use the clear (un-blued) water to potentially dilute the specimen. Inadvertently flushing the toilet does not automatically require any corrective action by the collector or a recollection. However, to guard against this action, the collector may want to place a card with instructions not to flush by the toilet handle or tape or otherwise secure the handle with tamper-evident tape.) The collector may set a reasonable time limit for the employee to be inside the bathroom and this time frame should be explained to the employee. Note: The collector should also tell the employee that the temperature of the specimen is a critical factor and that the employee should bring the specimen to the collector as soon as possible after urination. The collector should inform the employee that if it is longer than 4 minutes from the time the employee urinates into the container and the collector takes the specimen temperature, the potential exists that the specimen may be out of range and an observed collection may be required. Note: The collector must pay close attention to the employee during the entire collection process to note any conduct that clearly indicates an attempt to substitute or adulterate a specimen. If the collector detects such conduct, the collector must complete the collection and immediately begin a new collection under direct observation using a second CCF and a new kit. The collector then provides an appropriate comment on the "Remarks" line in Step 2 on the first CCF and second CCF indicating that this is the first of two or second of two (i.e., 1 of 2, 2 of 2) collections, the specimen ID numbers of the first and second CCF, the reason for the second collection, and that the second collection was conducted under direct observation (check appropriate box in Step 2 of the CCF). This will ensure that the laboratory and the MRO know that two separate specimens are being submitted for testing; the first one possibly being adulterated or substituted. Additionally, the collector must inform the collection site supervisor and the DER that a collection took place under direct observation and the reason for having done so. 11. After the employee gives the specimen to the collector, the collector must check the temperature of the specimen, check the specimen volume, and inspect the specimen for adulteration or substitution, as described below: LC-ADD-15 DOT Urine Specimen Collection Guidelines 16 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 - The collector should check the temperature of the specimen as soon as the employee hands over the specimen, but no later than four minutes after the employee comes out of the restroom. The acceptable temperature range is 32°-38°C/ 90°-100°F. Temperature is determined by reading the temperature strip originally affixed to or placed on the outside of the collection container. If the temperature is within the acceptable range, the "Yes" box is marked in Step 2 on the CCF and the collector proceeds with the collection procedure. (If the temperature is out of range, the collector marks the “No” box in Step 2 and initiates an observed collection.) - The collector then checks to make sure that the specimen contains a sufficient amount of urine (a minimum of 45 mL for all DOT collections). If the volume is sufficient, the collector checks the box on the CCF (Step 2) indicating that this was a split specimen collection. (This may be done at the same time that the collector checks the temperature box.) - The collector must inspect the specimen for unusual color, presence of foreign objects or material, or other signs of tampering or adulteration. If it is apparent from this inspection that the employee has adulterated or substituted the specimen (e.g., the specimen is blue, exhibits excessive foaming when shaken, has smell of bleach), a second collection using direct observation procedures must be conducted immediately. If the temperature is outside the acceptable range, the volume is less than 45 mL, or the specimen may have been adulterated, the collector follows procedures in Section 11- Problem Collections. 12. After the employee hands the collection container to the collector, the collector unwraps or opens the specimen bottles. (The employee may be permitted to do this, however, the recommended “best practice” is for the collector to perform this procedure.) Bottles may be shrink-wrapped or secured by other easily discernable tamper-evident methodology and may be wrapped separately or together. Note: Both the collector and employee will maintain visual contact of the specimen to the greatest extent possible until the labels/seals are placed over the specimen bottle caps/lids. If practical, the collector may permit the employee to wash his or her hands right after the employee gives the collection container to the collector (and the collector checked the temperature), provided the employee and the collector can still maintain visual control of the specimen collection container. Note: The following are considered refusals to test: • The employee admits to the collector that he or she adulterated or substituted their specimen. • The employee behaves in a confrontational way that disrupts the collection process. In either of these refusal situations, the collector discards any specimen the employee provided previously and notifies the DER as soon as possible. LC-ADD-16 DOT Urine Specimen Collection Guidelines 17 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 13. The collector, not the employee, then pours at least 30 mL of urine from the collection container into a specimen bottle and places the lid/cap on the bottle. This will be the primary specimen or "A" bottle. The collector, not the employee, then pours at least 15 mL into a second bottle and places the lid/cap on the bottle. This will be the "B" bottle used for the split specimen. (The collector may first pour the requisite amount of specimen into each bottle and then secure the lids/caps on each bottle.) Note: The collector should not fill the primary or split specimen bottle up to the cap because a completely full bottle is more likely to leak in transit. Additionally, when a split specimen bottle is full and subsequently frozen, it may cause the bottle material to crack and then leak during transit as the specimen thaws. 14. The collector, not the employee, must then remove the tamper-evident seals from the CCF and place them on each bottle. The collector should also ensure that the seal labeled as “A” is placed on the primary bottle with at least 30 mL of urine and that the seal labeled as “B” is placed on the bottle with at least 15 mL of urine. The seal must be centered over the lid/cap and down the sides of the bottle to ensure that the lid/cap cannot be removed without destroying the seal. The collector, not the employee, writes the date on the seals. The employee is then requested to initial the seals. The employee must be present to observe the sealing of the specimen bottles. If the employee fails or refuses to initial the seals, the collector must note this in the “Remarks” line of the CCF and complete the collection process; this is not considered a refusal to test. Note: The collector must not ask the employee to initial the labels/seals while they are still attached to the CCF; they must be initialed after they are placed on the bottles. The collector should also inform the employee to use care during the initialing process to avoid damaging the labels/seals. Note: Occasionally, the tamper-evident label/seal provided with the CCF will not properly adhere to the specimen bottle because of environmental conditions (e.g., moisture, temperature, specimen bottle material) or may be damaged or broken during the collection process. When this occurs, the collector should use the following corrective procedures: (a) If the seal is broken while being removed from the chain of custody form or during the application of the first seal on the primary bottle, the collector should transfer the information to a new CCF and use the seals from the second form. (b) If one seal is already in place on a bottle and the second seal is broken while being removed from the CCF or is broken during application on the second bottle or while the employee is initialing either seal, the collector should initiate a new CCF and provide an appropriate comment on the “Remarks” line in Step 5. The seals from the second CCF should be placed perpendicular to the original seals to avoid obscuring information on the original seals and must be initialed by the employee (both sets of employee initials should match). The collector should draw a line through the Specimen ID number and bar code (if present) on the original seals to ensure that the LC-ADD-17 DOT Urine Specimen Collection Guidelines 18 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 laboratory does not use that number for reporting the results. The collector should not pour the specimen into new bottles. (c) In both cases, the collector should ensure that all copies of the original (first) CCF are destroyed or disposed of properly (e.g., shredded, torn into pieces). (d) If the collector inadvertently reverses the seals (i.e., places the “A” bottle seal on the split bottle and vise-versa) and the collector subsequently notices this, the collector should note this in the “Remarks” line and continue the collection process. Laboratories have procedures that permit them to “re-designate” the bottles. Note: There is no corrective procedure available if the seal is broken after the employee leaves the collection site. Note: Since the specimen bottle is now sealed with tamper-evident tape and does not have to be under the employee's direct observation, the employee is allowed to wash his or her hands if he or she desires to do so. 15. The collector directs the employee to read, sign, and date the certification statement, and provide date of birth, printed name, and day and evening contact telephone numbers in Step 5 of Copy 2 of the CCF. Note: If the employee refuses to sign the form or provide date of birth, printed name, or telephone numbers, the collector must make a notation on the "Remarks" line to that effect and complete the collection. If the employee refuses to fill out any information, the collector must, as a minimum, print the employee’s name in the appropriate place. This does not constitute a refusal to test. 16. The collector completes the collector’s portion in Step 4 on the CCF (Copy 1) by printing his or her name (the name may be pre-printed), recording the date and time of the collection, signing where indicated, and entering the specific name of the delivery or courier service transferring the specimens to the laboratory. 17. The collector then ensures that all copies of the CCF are legible and complete. The collector removes Copy 5 from the CCF and gives it to the employee. Note: At this time, the collector can suggest that the employee list any prescription and over-the-counter medications he or she may be taking on the employee’s copy (Copy 5) of the CCF, but not on any other copy. This information may help the employee remember what medications he or she may have taken if a non-negative result is reported by the laboratory to the MRO. 18. The collector places the specimen bottles and Copy 1 of the CCF inside the appropriate pouches of the leak-resistant plastic bag, and seals both pouches. If the employee has not had the opportunity to wash his or her hands, they may do so now. The collector then informs the employee that he or she may leave the collection site. LC-ADD-18 DOT Urine Specimen Collection Guidelines 19 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 19. Any urine specimen left over in the collection container after both specimen bottles have been appropriately filled and sealed should be discarded at this time. Excess urine may be used to conduct clinical tests (e.g., protein, glucose) if the collection was conducted in conjunction with a physical examination required by a DOT operating administration’s regulation. No further testing (e.g., adulteration testing, DNA, additional drugs) may be conducted on this excess urine and the employee has no right to demand that the excess urine be turned over to the employee. 20. The collector places the sealed plastic bag in an appropriate shipping container (e.g., box, express courier mailer) designed to minimize the possibility of damage during shipment. More than one sealed plastic bag can be placed into a single shipping container if there are multiple collections. The collector seals the shipping container as appropriate. If a laboratory courier hand-delivers the specimens from the collection site to the laboratory, the collector prepares the shipment as directed by the courier service. In this case, the plastic bag may not need to be placed into a shipping container, but still needs to be transported by the courier in a manner that protects the bottles from damage. Note: If the laboratory courier does not hand-deliver the specimens to the laboratory, but subsequently places the specimens into a commercial delivery system, the specimens must be placed into a shipping container to minimize damage in transit. 21. The collector then sends Copy 2 of the CCF to the MRO and Copy 4 to the DER (or service agent if authorized by the employer). The collector must fax or otherwise transmit these copies to the MRO and DER within 24 hours or during the next business day and keep Copy 3 for at least 30 days, unless otherwise specified by applicable DOT operating administration’s regulations. Note: The MRO copy (Copy 2) may be faxed to the MRO’s secure fax machine, it may be scanned and the image sent to the MRO’s secure computer, or it may be mailed or sent by courier to the MRO. (It is recommended that the MRO copy be faxed, since it is critical for the MRO to have this document to expeditiously conduct the verification process.) In the case where the MRO copy (Copy 2) is faxed or the scanned image is sent securely to the MRO, the collector or the collection site should maintain the MRO copies together with the collector’s copies for 30 days. Retention is necessary in case the MRO’s copy is lost in the mail or the faxed or scanned copy is not legible and another copy is required by the MRO. The transmission process must be coordinated between the collection site and the MRO to ensure that transmission procedures meet the MRO’s requirements (e.g., MROs must provide secure fax numbers to collection sites, some MROs may want hard copies mailed; others may want only faxed copies). 22. The collector or collection site must ensure that each specimen collected is shipped to a laboratory as quickly as possible, but in any case within 24 hours or during the next business day. 23. If the specimen will not be shipped immediately, the collector is responsible for ensuring its integrity and security. Specimens in plastic bags, which have not been placed into shipping containers or which are awaiting a laboratory courier, must be kept in a secure location. Access to the specimens must be effectively restricted. LC-ADD-19 DOT Urine Specimen Collection Guidelines 20 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 Note: After specimens are placed into shipping containers that are subsequently sealed, the shipping containers may be placed with other containers or packages that the collection site has waiting to be picked up by a courier. It is expected that collection sites will use reasonable security to ensure that all of their packages are relatively secure and not subject to damage, theft, or other actions that would potentially raise questions related to the integrity of the specimens. Note: Couriers, postal employees, and other personnel involved in the transportation of the sealed shipping container are not required to make, and should not attempt to make, additional chain of custody entries on the custody and control form. The entire collection process is now complete. SECTION 8. SHY BLADDER PROCEDURES The term "shy bladder" refers to a situation when the employee does not provide a sufficient amount of urine (45 mL) for a DOT-required drug test. If an employee tells the collector, upon arrival at the collection site, that he or she cannot provide a specimen, the collector must still begin the collection procedure regardless of the reason given. The collector should tell the employee that most individuals can provide 45 mL of urine, even when they think they cannot urinate, and direct the employee to make the attempt to provide the specimen. At the point in the collection procedure where the collector and employee unwrap/open a collection container, the collector does the following: 1. The collector requests the employee to go into the rest room and try to provide a specimen. Note: The employee demonstrates his or her inability to provide a valid specimen when the employee comes out of the rest room with an insufficient quantity of specimen or an empty collection container. 2. If the employee provided an initial insufficient specimen, the collector discards the insufficient specimen. The collector then annotates in the “Remarks” line the time when the employee provided the insufficient specimen. This is the time when the “shy bladder” collection process starts. Note: If there was actually no specimen provided on an attempt, the same collection container may be used for the next attempt (the employee may keep possession of the container during the waiting period). The collector uses the same CCF and continues to document subsequent collections on the same form. Note: If the insufficient specimen is also out of temperature range (assuming there was sufficient specimen to activate the temperature strip) or shows evidence of adulteration or tampering, the collector completes the collection process, does not discard the specimen, but instead sends the insufficient specimen (temperature out of range or adulterated) to the laboratory and immediately initiates another collection under direct observation. LC-ADD-20 DOT Urine Specimen Collection Guidelines 21 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 3. The collector explains to the employee the process for a shy bladder collection and urges the employee to drink up to 40 ounces of fluids, distributed reasonably through a period of up to three hours, or until the individual has provided a sufficient urine specimen, whichever occurs first. It is not a refusal to test if the employee declines to drink. Note: Collectors should be sensitive to how frequently they should ask the employee to provide a specimen. For example, asking the employee to provide a specimen every half hour may not produce sufficient specimen, although in total, the amount would have been at least 45 mL. In this case, the collector needs to determine if a longer time is needed for the employee to consume fluids and produce a sufficient volume of specimen. If the employee refuses to drink fluids, this is not considered a refusal to test, although the collector should explain to the employee that not drinking sufficient fluids may result in the employee’s inability to provide a sufficient specimen and would require a medical evaluation. Under no circumstances can a collector “combine” urine collected from separate voids to create one specimen of sufficient volume. 4. If the employee refuses to make the attempt to provide a new urine specimen or leaves the collection site before the collection process is completed, the collector must discontinue the collection, note the fact on the “Remarks” line of the CCF (Step 2), and immediately notify the DER. This is a refusal to test. Note: As with other collections situations, there is no requirement for the collector to inform the employee in a shy bladder situation that failure to remain at the collection site or otherwise fails to cooperate with the testing process constitutes a refusal. It is a best practice for the collector to inform the employee that such behavior could lead an employer to determine that a refusal occurred. 5. If the employee has not provided a sufficient specimen within three hours of the first unsuccessful attempt to provide the specimen, the collector must discontinue the collection, note the fact on the “Remarks” line of the CCF (Step 2), and immediately notify the DER. Note: The collector should maintain a record in the “Remarks” line on the CCF of the time of each attempt, whether there was any specimen provided or the quantity of specimen provided, and the amount of fluids that the employee was given to drink. During the waiting period that the employee can consume fluids, the employee must be monitored to ensure the continued integrity of the test. While, as noted above, there is no requirement for the collector to do so, it is a good practice for the collector to inform the employee that he or she is not permitted to leave the collection site and that doing so could lead an employer to determine that a refusal occurred. 6. The collector then sends Copy 2 of the CCF to the MRO and Copy 4 to the DER. This is done even if the employee did not provide any specimen in order to notify the MRO and the employer of the problem. The collector must send or fax these copies to the MRO and DER within 24 hours or the next business day. LC-ADD-21 DOT Urine Specimen Collection Guidelines 22 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 SECTION 9. DIRECTLY OBSERVED COLLECTIONS A directly observed collection procedure is the same as a routine collection procedure with the additional requirement that an observer directly watches the urine go from the employee’s body into the collection container. The observer must be the same gender as the employee; there are no exceptions to this requirement. Note: See “DOT’s Direct Observation Procedures” at Appendix D. An observed collection is required when: 1. The employer or DER directs the collector (or collection site) to conduct a collection under direct observation. Note: The employer is required to conduct a directly observed collection, with no advance notice to the employee when: 1. The laboratory reports an invalid specimen and the MRO reports that there was not an adequate medical explanation for the result. 2. Because the split specimen test could not be performed (e.g., split lost, inadequate volume). 3. The MRO reports a negative-dilute result with a creatinine concentration greater than or equal to 2 mg/dL but less than or equal to 5 mg/dL. 4. The test is a return-to-duty or follow-up test. Note: An employee may not “volunteer” to have his or her specimen collected under direct observation. 2. The collector observed materials brought to the collection site or the employee’s conduct clearly indicated an attempt to tamper with a specimen. 3. The temperature on the original specimen was out of range or the specimen appeared to have been tampered with. Note: The collector may serve as the observer when the collector is the same gender as the employee. If not, the collector must call upon another individual (who is the same gender as the employee) to act as the observer. The collector must verbally instruct the observer as to the procedures the observer must follow and specifically inform the observer not to take the specimen from the employee, but have the employee bring it to the collector. It is recommended that the collector have a short written outline of the direct observation procedures to provide to and review with the observer. LC-ADD-22 DOT Urine Specimen Collection Guidelines 23 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 An observed collection is conducted in the following manner: 1. The collector must explain to the employee why a directly observed collection is being conducted. If the directly observed collection is requested by the employer, the collector may state the reason (if known) or may only state that the employer requested a directly observed collection. 2. The collector must complete a new CCF for the directly observed collection and mark the “reason for test” block (Step 1) the same as for the first collection (unless it is a return-to-duty or follow-up test). 3. The collector then checks the “Observed, (Enter Remark)” box and enters the reason in the “Remarks” line (Step 2) and the name of the observer if it is someone other than the collector. 4. In a case where two sets of specimens are being sent to the laboratory because of suspected tampering with the first specimen, the collector enters on the “Remarks” line of the CCF (Step 2) for each specimen a notation to this effect (e.g., collection 1 of 2, or 2 of 2) and the CCF specimen ID number of the other specimen. 5. The collector, if the same gender as the employee, or the same gender observer enters the restroom or facility where urination occurs with the employee. The observer must request the employee to raise his or her shirt, blouse, or dress/skirt, as appropriate, above the waist or navel, and lower clothing and underpants sufficient to show the observer – by turning around – that the employee does not have a prosthetic device. After the observer has determined that the employee does not have such a device, the observer may permit the employee to return clothing to its proper position and then conduct the observed collection. Note: There are three basic types of devices employees could “wear.” [Of course, there could be other devices, here are examples of some devices]: 1. One device has a long plastic tube connected to a bottle containing heated urine. 2. Another device consists of a short plastic tube attached to a battery- heated plastic bag. 3. One device goes a step further by replacing the tube with very realistic prosthetic genitalia designed to match the employee’s skin tone. 6. The observer must watch the employee urinate into the collection container. Specifically, the observer must personally and directly watch the urine go from the employee’s body into the collection container (use of mirrors or video cameras is not permitted). Note: If it is a multi-stall restroom, the observer must enter the stall with the employee. Note: With respect to direct observation collections, the following situations are considered refusals to test: LC-ADD-23 DOT Urine Specimen Collection Guidelines 24 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 • The employee declines to allow a directly observed collection required or permitted by Part 40 to occur. • The employee fails to follow the observer’s instructions to raise and lower their clothing and to turn around to permit the observer to determine if the employee has a prosthetic or other device that could be used to interfere with the collection process. • The employee possesses or wears a prosthetic or other device that could be used to interfere with the collection process. In either of these situations, the collector discards any specimen the employee provided previously and notifies the DER as soon as possible. 7. After the employee has completed urinating into the collection container, the employee and observer leave the enclosed toilet stall/restroom and the employee hands the collection container directly to the collector. The observer must maintain visual contact of the collection container until the employee hands the container to the collector. If the observer is the collector, the collector may receive the collection container from the employee while they are both in the enclosed toilet stall/restroom. 8. If the collector learns that a directly observed collection should have taken place, but was not, the collector must inform the employer that the employee must be directed to return for an immediate recollection under direct observation. SECTION 10. MONITORED COLLECTIONS A monitored collection is one that is conducted under less than completely private conditions, utilizing a multi-stall restroom. If there is no practicable work place outside of the restroom, the collector may set up an area within the multi-stall restroom to be used as a work area and for finalizing the required paper work. (A collection which is not monitored may also be conducted in a multi-stall restroom, provided that the collector secures all of the stalls (bluing agent, etc.), secures all water sources and other potential sources of adulterants (soap dispensers) in the restroom, and posts signs or otherwise secures the restroom from entry by unauthorized personnel.) A monitored collection is conducted in the following manner: 1. The collector must secure the room being used for the monitored collection so that no one except the employee and the monitor can enter it until after the collection has been completed. 2. The monitor must be the same gender as the employee, unless the monitor is a medical professional (e.g., nurse, doctor, physician’s assistant, technologist or technician licensed or certified to practice in the jurisdiction in which the collection takes place). The monitor can be a different person from the collector and need not be a qualified collector. LC-ADD-24 DOT Urine Specimen Collection Guidelines 25 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 3. If someone other than the collector is to monitor the collection procedure (i.e., the collector is not a medical professional), the collector must verbally instruct that person to use the following procedures (if the collector is the monitor, the collector must also follow these procedures): (a) A monitor stands outside the stall and does not watch the employee urinate. If the monitor hears sounds or makes other observations indicating an attempt to tamper with a specimen by the employee, there must be an additional collection conducted under direct observation. (b) A monitor must ensure that the employee takes the collection container directly to the collector as soon as the employee has exited the enclosure. 4. When someone besides the collector has acted as the monitor, the collector must note that person’s name in the “Remarks” line of the CCF (Step 2). 5. If the employee declines to permit a collection authorized under Part 40 to be monitored, it is a refusal to test. SECTION 11. PROBLEM COLLECTIONS CATHETERIZATION. If an employee needs medical attention (e.g., an injured employee in an emergency medical facility who is required to have a post-accident test), treatment takes priority and should not be delayed to collect a specimen. If an employee is catheterized as part of a medical procedure (following an accident), once the employee’s medical condition is stabilized and the employee can give his or her consent to the collection (e.g., understand that a DOT collection is required, can sign the CCF), a urine specimen should be obtained from that employee. Procedures similar to those listed below may be used when an external urine bag is involved. A urine specimen must not be collected, by catheterization or other means, from an unconscious employee to conduct a DOT-required drug test. Catheterization of a conscious employee to obtain a urine specimen for a DOT-required test is also not authorized. However, an employee who normally voids through intermittent or self-catheterization is required to provide a specimen in that manner if he or she is required to produce a specimen for a DOT test. If able to, the employee may provide the specimen directly from the catheter into the collection container in the privacy of a restroom. If an employee, who normally voids through self-catheterization, declines to do so, this would constitute a refusal to test. EXTERNAL URINE BAG. The following procedures should be used in the collection of a urine specimen from an employee who has a medical condition requiring an indwelling catheter or excretion of urine into an external bag. The urine specimen should be a freshly voided specimen. An employee with an indwelling catheter may urinate directly into a collection container. In the case of an employee with an external bag, the employee should be asked to empty his or her bag in the privacy of a bathroom, show the empty bag to the collector, and then drink sufficient fluids at the collection site to provide 45 mL of urine, which can be subsequently poured by the employee from the bag into a collection container in the privacy of a bathroom. In this case, the temperature of the specimen would not be a critical factor. If the specimen temperature is out of range, a direct LC-ADD-25 DOT Urine Specimen Collection Guidelines 26 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 observation collection would not necessarily be required because of the nature of the collection. The collector should be keenly aware of the potential embarrassment that this type of collection can cause the employee and should conduct the collection with appropriate decorum. This procedure would not have to be done in a medical environment/health clinic or by a collector of the same gender, although the collector may try to accommodate the employee (e.g., conduct the collection at a medical facility, have the same gender collector) if the employee requests this and if it would not significantly delay the collection process. If the employer is aware of this situation prior to the actual collection (e.g., because the employee had previously expressed a desire to provide the specimen in a medical setting, requested a same gender collector, told the employer about the medical condition and its impact on urine collection for drug testing), the employer (collection site) may establish or modify procedures as needed to permit the employee to provide a specimen in a way consistent with the employee’s privacy while still meeting regulatory requirements. In the case of a collection based on a post-accident or reasonable suspicion requirement, the collector may attempt to honor the employee’s request (for the collection to be conducted in a medical setting or for the collector to be the same gender) if the collection can be accomplished within a reasonable time frame. The above scenario assumes that the employee’s medical condition is not one that decreases or completely prohibits renal output, and that the employee can produce normal amounts of urine that is excreted into an external bag. Therefore, an employee with this or similar medical conditions would be subject to the same testing requirements (e.g., pre-employment, random) and to the “shy bladder” protocol (three hours and 40 ounces of fluids) as an employee with no medical condition. If an employee who normally voids in this manner declines to provide a urine specimen under these conditions, it would constitute a refusal to test. TEMPERATURE. The collector should check the temperature of the specimen as soon as the employee hands over the specimen, but no later than four minutes after the employee comes out of the restroom. The acceptable temperature range is 32°-38°C/ 90°-100°F. Temperature is determined by reading the temperature strip originally affixed to or placed on the outside of the collection container after the employee hands the specimen to the collector. (a) If the temperature is within the acceptable range, the "Yes" box is marked in Step 2 on the CCF and the collector proceeds with the collection procedure. (b) If the temperature is outside the acceptable range, the "No" box is marked in Step 2 on the CCF and if the temperature was below or above the acceptable range should be noted in the “Remarks” line. The collector completes the collection process for the “first” specimen and immediately begins a “second” collection under direct observation using a second CCF and a new kit. The collector then provides an appropriate comment on the "Remarks" line in Step 2 on the first CCF and second CCF indicating that this is the first of two or second of two collections, the specimen ID numbers of the first and second CCF, the reason for the second collection, and that the second collection was under direct observation. This will ensure that the laboratory and the MRO know that two separate specimens are being submitted for testing; the first one possibly being adulterated or substituted. Additionally, the collector must inform the collection site supervisor and the DER that a collection took place under direct observation and the reason for doing so. LC-ADD-26 DOT Urine Specimen Collection Guidelines 27 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 Note: There is no requirement to take the employee’s body temperature if the specimen temperature is out of range. If the collector suspects that the temperature strip was not activated, the collector should pour the urine specimen into another collection container with a temperature strip or into a specimen bottle which has a temperature strip attached, and use this method to determine the specimen temperature. Collectors should not introduce any other object (e.g., litmus paper, testing strips, etc.) into the specimen in the collection container or the bottles. SPECIMEN VOLUME. The collector checks to make sure that the specimen contains a sufficient amount of urine (a minimum of 45 mL for all DOT collections). If the volume is sufficient, the collector checks the box on the CCF (Step 2) indicating that this was a split specimen collection. (This may be done at the same time that the collector checks the temperature box.) If the volume is less than 45 mL, the action taken will depend on whether the temperature of the specimen is in or outside the acceptable temperature range. (a) If the temperature is in the acceptable range, the specimen is discarded and a second specimen is collected. The collector may use the original CCF for the second specimen, but should annotate in the “Remarks” line the time that the first insufficient specimen was provided by the employee and the fact that this is a second collection (the time annotation is important since this may become a “shy bladder” situation). The collector should use a new specimen collection container, if these are available separately or a new kit. (b) If the temperature is outside the acceptable range, a second specimen must be collected under direct observation and both specimens are sent to the laboratory for testing. The collector must use a separate CCF and kit for each specimen and provide an appropriate comment on each CCF to indicate why two specimens were collected. ADULTERATION OR SUBSTITUTION. The collector must inspect the specimen for unusual color, presence of foreign objects or material, or other signs of tampering or adulteration. If it is apparent from this inspection that the employee has adulterated or substituted the specimen (e.g., the specimen is blue, exhibits excessive foaming when shaken, has smell of bleach), a second collection using direct observation procedures must be conducted immediately. The first specimen and the second specimen collected using direct observation are both sent to the laboratory for testing. The first specimen is always sent to the laboratory even though it may have had an insufficient volume, but showed signs of tampering. If the employee does not provide the required amount of urine for the second collection using direct observation, the collector annotates the time the second specimen was not provided and initiates the shy bladder procedures. If after 3 hours the employee still cannot provide a sufficient amount of specimen, the collector ends the collection process and informs the DER. The collector must send or fax Copy 2 of the CCF to the MRO and Copy 4 to the DER within 24 hours or the next business day. The collector must send the original specimen to the laboratory with an annotation that the specimen was suspected of being adulterated or substituted, that a second collection was attempted, but that a shy bladder prevented collection of a second specimen. LC-ADD-27 DOT Urine Specimen Collection Guidelines 28 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 Note: In a case where the employee refuses to provide another specimen, refuses to provide a specimen under direct observation, or admits to the collector that he or she adulterated or substituted their specimen, the collector discards any specimen the employee provided previously during the collection and then notifies the DER that the employee refused to comply with a DOT test. SECTION 12. BLIND QUALITY CONTROL SAMPLES An employer or Consortium/Third Party Administrator (C/TPA) with an aggregate of 2000 or more DOT-covered employees, must send blind quality control samples to laboratories they use. If the employer or C/TPA has an aggregate of fewer than 2000 DOT-covered employees, they are not required to provide blind quality control samples. To each laboratory to which an employer or C/TPA sends at least 100 specimens in a year, they must transmit a number of blind quality control samples equivalent to one percent of the specimens sent to that laboratory, up to a maximum of 50 blind quality control samples in each quarter (i.e., January-March, April-June, July-September, October-December). A C/TPA must apply this percentage to the total number of DOT-covered employees' specimens it sends to the laboratory. Blind quality control sample submissions must be evenly spread throughout the year. Note: In general, the employer determines who will conduct the regulatory requirement for the employer to submit blind quality control samples. It may be the employer itself, the collection site, MRO, or the C/TPA. However, regardless of who purchases the blind quality control samples, they must be submitted through the normal collection procedures used by the employer and must be indistinguishable by the laboratory from normal specimens sent by the collection site for DOT testing. The collector always submits the blind quality control sample using the same CCF as that used for an employee specimen. The collector provides the required information to ensure that the CCF has been properly completed as well as providing fictitious initials on the specimen bottle labels/seals. Since there is no employee, the collector must indicate that the sample is a "blind quality control" on the MRO copy where the employee would normally provide a signature (Step 5 on Copy 2 of the CCF). Note: For a blind quality control sample, Copies 4 and 5 of the CCF (the employer and employee copy) may be discarded by the collector, unless the employer or the service agent requires the employer copy (in this case, the collector must ensure that the employer copy has the same “blind quality control” annotation as the MRO copy). All blind quality control samples must be submitted as DOT split specimen collections. Blind quality control samples may be obtained from companies listed on the HHS Internet web site (http://workplace.samhsa.gov/). SECTION 13. CORRECTING COLLECTION PROBLEMS The collector has the responsibility of trying to successfully complete a collection procedure for each employee. LC-ADD-28 DOT Urine Specimen Collection Guidelines 29 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 1. If, during or shortly after the collection process, the collector becomes aware of any event that prevents the completion of a valid test or collection (e.g., a procedural or paperwork error), the collector must try to correct the problem promptly, if doing so is practicable. The collector may initiate another collection as part of this effort. There is one exception: when the collector learns that a directly observed collection should have been conducted, but was not, the collector must notify the employer to direct the employee to return for an immediate recollection under direct observation. 2. If another collection is necessary, the collector must begin the new collection procedure as soon as possible, using a new CCF and a new collection kit. Note: If the collector becomes aware of a problem that can be corrected, but which has not already been corrected, the collector must take all practicable actions to correct the problem so that the test is not cancelled. 3. If the problem resulted from the omission of required information, the collector must, as the person responsible for providing that information, supply in writing the missing information and a statement that it is true and accurate. For example, suppose the collector forgot to make a notation on the “Remarks” line of the CCF that the employee did not sign the certification. The collector would, when the problem is called to his or her attention, supply a signed statement that the employee failed or refused to sign the certification and that the collector’s signed statement is true and accurate. The collector must supply this information on the same business day on which he or she is notified of the problem, transmitting it by fax or courier. 4. If the problem is the use of a non-Federal CCF or an expired Federal form, the collector must provide a signed statement (e.g., a memorandum for record). The documentation must state that the incorrect form contains all the information needed for a valid DOT drug test, and that the incorrect CCF was used inadvertently or as the only means of conducting a test, in circumstances beyond the collector’s control. The memorandum must also list the steps the collector took to prevent future use of non- Federal or expired Federal CCFs for DOT tests. This information must be supplied to the laboratory on the same business day that the collector is notified of the problem, and may be transmitted by fax or courier. The use of a non-Federal form does not, in and of itself, present a reason for the laboratory to reject the specimen for testing or for the MRO to cancel the test. 5. The collector must maintain a copy of the written and dated documentation of correction with the appropriate CCF. The collector must also mark the CCF in such a way (e.g., stamp noting correction, written notation) that it would be obvious on the face of the CCF that the corrected (missing) information was supplied. When an HHS certified laboratory receives specimen bottles and the associated CCF, it checks to see if the specimen ID number on the specimen bottle labels/seals matches the number on the CCF, that the specimen bottle seals are intact, that there is sufficient specimen volume, and that the CCF has been properly completed by the collector. If there is any discrepancy and/or error of omission (i.e., the collector did not sign the chain of custody, the collector did not check the temperature box), the laboratory will contact the collector to determine if the discrepancy and/or LC-ADD-29 DOT Urine Specimen Collection Guidelines 30 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 missing information can be recovered. That is, the collector can provide a signed statement attesting to the fact that he or she inadvertently forgot to properly document the CCF. Note: If a fatal flaw exists in the collection process or a memorandum for record or other written statement cannot be provided by the collector to related to a correctable flaw, the laboratory will report "Rejected for Testing" to the MRO and provide an appropriate comment as to why the specimen was not tested. If the reason for rejecting the test was a collector error, when a test is cancelled by the MRO, the collector who collected the specimen will need to go through an error correction training process within 30 days addressing the specific problem that caused the specimen to be cancelled. Note: Once contacted by the laboratory or the MRO, the collector should immediately provide a statement or memorandum to recover the discrepancy and/or error of omission. Laboratories are required by HHS to retain these specimens for a minimum of 5 business days before they may be discarded; therefore, it is critical that the collector respond immediately to the laboratory’s request for corrective action. LC-ADD-30 DOT Urine Specimen Collection Guidelines 31 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 APPENDIX A – TRAINING REQUIREMENTS FOR COLLECTORS To be permitted to act as a collector in the DOT drug testing program, you must meet the following requirements: (a) Basic information. You must be knowledgeable about 49 CFR Part 40, the current “DOT Urine Specimen Collection Procedures Guidelines,” and DOT agency regulations applicable to the employers for whom you perform collections, and you must keep current on any changes to these materials. The DOT Urine Specimen Collection Procedures Guidelines document is available from ODAPC, U.S. Department of Transportation, 1200 New Jersey Ave, SE, W62- 300, Washington DC, 20590, 202-366-3784, or on the ODAPC web site: http://www.dot.gov/odapc. (b) Qualification training. You must receive qualification training that provides instruction on the following subjects: (1) All steps necessary to complete a collection correctly and the proper completion and transmission of the CCF; (2) “Problem” collections (e.g., situations like “shy bladder” and attempts to tamper with a specimen); (3) Fatal flaws, correctable flaws, and how to correct problems in collections; and (4) The collector’s responsibility for maintaining the integrity of the collection process, ensuring the privacy of employees being tested, ensuring the security of the specimen, and avoiding conduct or statements that could be viewed as offensive or inappropriate; (c) Initial Proficiency Demonstration. Following your completion of qualification training under paragraph (b) above, you must demonstrate proficiency in collections by completing five consecutive error-free mock collections. (1) The five mock collections must include two uneventful collection scenarios, one insufficient quantity of urine scenario, one temperature out of range scenario, and one scenario in which the employee refuses to sign the CCF and initial the specimen bottle tamper-evident seal. (2) Another person must monitor and evaluate your performance, in person or by a means that provides real-time observation and interaction between the instructor and trainee, and attest in writing that the mock collections are “error-free.” This person must be a qualified collector who has demonstrated necessary knowledge, skills, and abilities by -- (i) Regularly conducting DOT drug test collections for a period of at least a year; (ii) Conducting collector training under this part for a year; or (iii) Successfully completing a "train the trainer" course. (d) Schedule for qualification training and initial proficiency demonstration. The following is the schedule for qualification training and the initial proficiency demonstration you must meet: (1) If you became a collector before August 1, 2001, and you have already met the requirements of paragraphs (b) and (c) of this section, you do not have to meet them again. (2) If you became a collector before August 1, 2001, and have yet to meet the requirements of paragraphs (b) and (c) of this section, you must do so no later than January 31, 2003. (3) If you become a collector on or after August 1, 2001, you must meet the requirements of paragraphs (b) and (c) of this section before you begin to perform collector functions. LC-ADD-31 DOT Urine Specimen Collection Guidelines 32 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 (e) Refresher training. No less frequently than every five years from the date on which you satisfactorily complete the requirements of paragraphs (b) and (c) above, you must complete refresher training that meets all the requirements of paragraphs (b) and (c). (f) Error Correction Training. If you make a mistake in the collection process that causes a test to be cancelled (i.e., a fatal or uncorrected flaw), you must undergo error correction training. This training must occur within 30 days of the date you are notified of the error that led to the need for retraining. (i) Error correction training must be provided and your proficiency documented in writing by a person who meets the requirements of paragraph (c)(2) above. (ii) Error correction training is required to cover only the subject matter area(s) in which the error that caused the test to be cancelled occurred. (iii) As part of the error correction training, you must demonstrate your proficiency in the collection procedures of this part by completing three consecutive error-free mock collections. The mock collections must include one uneventful scenario and two scenarios related to the area(s) in which your error(s) occurred. The person providing the training must monitor and evaluate your performance and attest in writing that the mock collections were “error-free.” (g) Documentation. You must maintain documentation showing that you currently meet all requirements of this section. You must provide this documentation on request to DOT agency representatives and to employers and C/TPAs who are using or negotiating to use your services. LC-ADD-32 DOT Urine Specimen Collection Guidelines 33 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 APPENDIX B – COLLECTION SITE SECURITY AND INTEGRITY DOT’s 10 Steps to Collection Site Security and Integrity Office of Drug and Alcohol Policy and Compliance U.S. Department of Transportation 1. Pay careful attention to employees throughout the collection process. 2. Ensure that there is no unauthorized access into the collection areas and that undetected access (e.g., through a door not in view) is not possible. 3. Make sure that employees show proper picture ID. 4. Make sure employees empty pockets; remove outer garments (e.g., coveralls, jacket, coat, hat); leave briefcases, purses, and bags behind; and wash their hands. 5. Maintain personal control of the specimen and CCF at all times during the collection. 6. Secure any water sources or otherwise make them unavailable to employees (e.g., turn off water inlet, tape handles to prevent opening faucets, secure tank lids). 7. Ensure that the water in the toilet and tank (if applicable) has bluing (coloring) agent in it. Tape or otherwise secure shut any movable toilet tank top, or put bluing in the tank. 8. Ensure that no soap, disinfectants, cleaning agents, or other possible adulterants are present. 9. Inspect the site to ensure that no foreign or unauthorized substances are present. 10. Secure areas and items (e.g., ledges, trash receptacles, paper towel holders, under-sink areas, ceiling tiles) that appear suitable for concealing contaminants. LC-ADD-33 DOT Urine Specimen Collection Guidelines 34 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 APPENDIX C – DOT STANDARDS FOR URINE COLLECTION KITS 1. Collection Container a. Single-use container, made of plastic, large enough to easily catch and hold at least 55 mL of urine voided from the body. b. Must have graduated volume markings clearly noting levels of 45 mL and above. c. Must have a temperature strip providing graduated temperature readings 32-38 º C / 90-100 º F, that is affixed or can be affixed at a proper level on the outside of the collection container. Other methodologies (e.g., temperature device built into the wall of the container) are acceptable provided the temperature measurement is accurate and such that there is no potential for contamination of the specimen. d. Must be individually wrapped in a sealed plastic bag or shrink wrapping; or must have a peelable, sealed lid or other easily visible tamper-evident system. e. May be made available separately at collection sites to address shy bladder situations when several voids may be required to complete the testing process. 2. Plastic Specimen Bottles a. Each bottle must be large enough to hold at least 35 mL; or alternatively, they may be two distinct sizes of specimen bottles provided that the bottle designed to hold the primary specimen holds at least 35 mL of urine and the bottle designed to hold the split specimen holds at least 20 mL. b. Must have screw-on or snap-on caps that prevent seepage of the urine from the bottles during shipment. c. Must have markings clearly indicating the appropriate levels (30 mL for the primary specimen and 15 mL for the split) of urine that must be poured into the bottles. d. Must be designed so that the required tamper-evident bottle seals made available on the CCF fit with no damage to the seal when the employee initials it nor with the chance that the seal overlap would conceal printed information. e. Must be wrapped (with caps) together in a sealed plastic bag or shrink wrapping separate from the collection container; or must be wrapped (with cap) individually in sealed plastic bags or shrink wrapping; or must have peelable, sealed lid or other easily visible tamper-evident system. f. Plastic material must be leach resistant. LC-ADD-34 DOT Urine Specimen Collection Guidelines 35 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 3. Leak-resistant Plastic Bag a. Must have two sealable compartments or pouches which are leak-resistant; one large enough to hold two specimen bottles and the other large enough to hold the CCF paperwork. b. The sealing methodology must be such that once the compartments are sealed, any tampering or attempts to open either compartment will be evident. 4. Absorbent material Each kit must contain enough absorbent material to absorb the entire contents of both specimen bottles. Absorbent material must be designed to fit inside the leak-resistant plastic bag pouch into which the specimen bottles are placed. 5. Shipping Container a. Must be designed to adequately protect the specimen bottles from shipment damage in the transport of specimens from the collection site to the laboratory (e.g., standard courier box, small cardboard box, plastic container). b. May be made available separately at collection sites rather than being part of an actual kit sent to collection sites. c. A shipping container is not necessary if a laboratory courier hand-delivers the specimen bottles in the plastic leak-proof bags from the collection site to the laboratory. LC-ADD-35 DOT Urine Specimen Collection Guidelines 36 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 APPENDIX D – DIRECT OBSERVATION PROCEDURES DOT’s Direct Observation Procedures Office of Drug and Alcohol Policy and Compliance U.S. Department of Transportation 1. DOT’s 49 CFR Part 40 directly observed collections are authorized and required only when: ● The employee attempts to tamper with his or her specimen at the collection site. -- The specimen temperature is outside the acceptable range; -- The specimen shows signs of tampering ~ unusual color / odor / characteristic; or -- The collector finds an item in the employee’s pockets or wallet which appears to be brought into the site to contaminate a specimen; or the collector notes conduct suggesting tampering. ● The Medical Review Officer (MRO) orders the direct observation because: -- The employee has no legitimate medical reason for certain atypical laboratory results; or -- The employee’s positive or refusal [adulterated / substituted] test result had to be cancelled because the split specimen test could not be performed (for example, the split was not collected). ● The test is a Follow-Up test or a Return-to-Duty test. 2. The observer must be the same gender as the employee. 3. If the collector is not the observer, the collector must instruct the observer about the procedures for checking the employee for prosthetic or other devices designed to carry “clean” urine and urine substitutes AND for watching the employee urinate into the collection container. ● The observer requests the employee to raise his or her shirt, blouse or dress / skirt, as appropriate, above the waist, just above the navel; and lower clothing and underpants to mid-thigh and show the observer, by turning around, that the employee does not have such a device. ● If The Employee Has A Device: The observer immediately notifies the collector; the collector stops the collection; and the collector thoroughly documents the circumstances surrounding the event in the remarks section of CCF. The collector notifies the DER. This is a refusal to test. ● If The Employee Does Not Have A Device: The employee is permitted to return clothing to its proper position for the observed collection. The observer must watch the urine go from the employee’s body into the collection container. The observer must watch as the employee takes the specimen to the collector. The collector then completes the collection process. 4. Failure of the employee to permit any part of the direct observation procedure is a refusal to test. LC-ADD-36 DOT Urine Specimen Collection Guidelines 37 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 APPENDIX E – QUESTIONS AND ANSWERS Periodically, DOT will publish questions and answers specific to the collector and the collection process. These will be posted on the ODAPC web site: www.dot.gov/odapc . All collectors are encouraged to check the site to ensure that they have the most current information to help them conduct DOT-required specimen collections appropriately. Collectors who do not have access to the Internet may obtain copies of the questions and answers from ODAPC by calling 1-202-366- 3784. APPENDIX F – OPERATING ADMINISTRATIONS’ RULES (SUMMARY) 49 CFR Part 40 (§40.33(a)) states that collectors must be knowledgeable about the DOT agency regulations applicable to the employers for whom the collectors conduct urine specimen collections. The following is a list of regulations which govern an employer’s implementation of the DOT drug and alcohol testing rules: The FMCSA regulation is 49 CFR Part 382. The FRA regulation is 49 CFR Part 219. The FAA regulation is 14 CFR Part 120. The FTA regulation is 49 CFR Part 655. The PHMSA regulation is 49 CFR Part 199. The USCG regulation is 46 CFR Parts 4, 5, and 16. Drug and alcohol testing (including collection) procedures are 49 CFR Part 40. The following pages contain a short summary of some of the operating administrations’ requirements. Copies of the complete rule texts are available on the ODAPC web site: http://www.dot.gov/odapc. LC-ADD-37 DOT Urine Specimen Collection Guidelines 38 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 Federal Motor Carrier Safety Administration - (FMCSA) Covered employee: A person who operates (i.e., drives) a Commercial Motor Vehicle(CMV) with a gross vehicle weight rating (gvwr) of 26,001 or more pounds; or is designed to transport 16 or more occupants (to include the driver); or is of any size and is used in the transport of hazardous materials that require the vehicle to be placarded. Types of tests for drugs: Pre-employment, random, reasonable suspicion, post-accident, return- to-duty, and follow-up. Types of tests for alcohol: Pre-employment (optional), random, reasonable suspicion, post- accident, return-to-duty, and follow-up. Definition of accident requiring testing: Any accident involving a fatality requires testing. Testing is also required in accidents in which one or more motor vehicles are towed from the scene or in which someone is treated medically away from the scene; and a citation is issued to the CMV driver. Reasonable-suspicion determination: One trained supervisor or company official can make the decision based upon specific, contemporaneous, articulable observations concerning the appearance, behavior, speech, or body odors of the employee. Pre-duty alcohol use prohibitions: Four (4) hours prior to performance of duty. Actions for BACs 0.02 – 0.039: The employee cannot be returned to duty until the next day or the start of the employee’s next regularly scheduled duty period, but not less than 24 hours following the test. Employee training: Employer must provide educational materials explaining drug and alcohol regulatory requirements and employer’s policies and procedures for meeting regulation requirements. Distribution to each employee of these educational materials and the employer’s policy regarding the use of drugs and alcohol is mandatory. Supervisor training: One-hour of training is required on the specific, contemporaneous physical, behavioral, and performance indicators of probable drug use. One-hour of training is also required on the specific, contemporaneous physical, behavioral, and performance indicators of probable alcohol use. Reportable employee drug and alcohol violations: No requirements to report violations to FMCSA. Other: Drivers are prohibited from using alcohol for eight hours following an accident (as described above) or until they have undergone a post-accident alcohol test, whichever occurs first. LC-ADD-38 DOT Urine Specimen Collection Guidelines 39 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 Federal Railroad Administration - (FRA) Covered employee: A person who performs hours of service functions at a rate sufficient to be placed into the railroad’s random testing program. Categories of personnel who normally perform these functions are locomotive engineers, trainmen, conductors, switchmen, locomotive hostlers/helpers, utility employees, signalmen, operators, and train dispatchers. Types of tests for drugs: Pre-employment, random, reasonable suspicion, reasonable cause, post-accident, return-to-duty, and follow-up. Types of tests for alcohol: Pre-employment (optional), random, reasonable suspicion, reasonable cause, post-accident, return-to-duty, and follow-up. Definition of accident requiring testing: FRA’s post-accident testing rule requires urine and blood specimen collection from surviving employees and also tissue from deceased employees (these collection procedures go well beyond the normal Part 40 procedures). For surviving employees, these specimens are collected at an independent medical facility. FRA regulation, 49 CFR Part 219 Subpart C, stipulates the level of events requiring testing and who has to be tested. The collected specimens are analyzed only at FRA’s contract laboratory. Post-accident testing provides FRA with accident investigation and usage data. Reasonable-suspicion determination: One trained supervisor can make the decision for alcohol testing based upon specific, contemporaneous, articulable observations concerning the appearance, behavior, speech, or body odors of the employee. A decision to conduct a drug test requires two supervisors (only the on-site supervisor must be trained). Reasonable-cause determination: Employers are authorized to use federal authority to test covered employees after specific operating rule violations or accidents/incidents which meet the criteria in 49 CFR Part 219 Subpart D. Pre-duty alcohol use prohibitions: Four (4) hours prior to performance of duty or after receiving notice to report for covered service, whichever is the shorter period. Actions for BACs 0.02 – 0.039: The employee cannot be returned to duty until the start of the employee’s next regularly scheduled duty period, but not less than 8 hours following the test. Railroads are prohibited from taking further disciplinary action under their own authority. Employee training: Employer must provide education materials that explain the requirements of the FRA rules as well as railroad policies and procedures with respect to meeting these requirements. Supervisor training: A total of three hours of training is required: one-hour on the specific, contemporaneous physical, behavioral, and performance indicators of probable drug use; one- hour of similar training on probable indicators of alcohol use; and one-hour of training on how to determine if an accident qualifies for post-accident testing. LC-ADD-39 DOT Urine Specimen Collection Guidelines 40 FRA (continued) Reportable employee drug and alcohol violations: No requirements to report violations to FRA. Engineers, who are the only certificate holders in the rail industry, will have their certificates reviewed for suspension or revocation by the employer when a FRA violation occurs. Note that a FRA alcohol violation occurs at 0.04 percent or greater. When a locomotive engineer is in a voluntary referral program, the counseling professional must report the engineer’s refusal to cooperate in the recommended course of counseling or treatment. Other: Anyone with direct or immediate supervisory authority over an employee may not collect that person’s urine, saliva, or breath. Refusal to test results in a mandatory minimum nine-month removal from covered service. During this nine-month period, there is no prohibition against the employee working a non- covered service position if agreeable to the employer. Locomotive engineers (or other employees certified as a locomotive engineer at the time of the alcohol or drug violation) required both alcohol and drug return-to-duty tests; and both alcohol and drug follow-up tests. Locomotive engineers who have a DUI are required by Part 240 to be evaluated to determine whether they have an active substance abuse disorder. A DUI is not considered to be a violation of FRA regulations if it occurred during the employee’s off-duty time; therefore, any testing would be conducted under employer authority. Employers must provide a voluntary referral program which allows an employee to self-refer for treatment, and a co-worker report program which allows one employee to refer another for treatment before the employer identifies a problem. Both of these employee assistance programs guarantee that employees will retain their jobs if they cooperate and complete the required rehabilitation program. For an engineer who is in a voluntary referral program, the counseling professional must report the engineer’s refusal to cooperate in the recommended course of counseling or treatment to the employer. Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 LC-ADD-40 DOT Urine Specimen Collection Guidelines 41 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 Federal Aviation Administration - (FAA) Covered employee: A person who performs flight crewmember duties, flight attendant duties, flight instruction duties, aircraft dispatch duties, aircraft maintenance or preventive maintenance duties; ground security coordinator duties; aviation screening duties; air traffic control duties, and operations control specialist duties. Note: Anyone who performs the above duties directly or by contract for a part 119 certificate holder authorized to operate under parts 121 and/or 135, air tour operators defined in 14 CFR part 91.147, and air traffic control facilities not operated by the Government are considered covered employees. Types of tests for drugs: Pre-employment, random, reasonable cause, post-accident, return to duty, and follow-up. Types of tests for alcohol: Pre-employment (optional), random, reasonable suspicion, post- accident, return to duty, and follow-up. Definition of accident requiring testing: Accident means an occurrence associated with the operation of an aircraft which takes place between the time any person boards the aircraft with the intention of flight and all such persons have disembarked, and in which any person suffers death or serious injury, or in which the aircraft receives substantial damage. Testing must occur if employee's performance either contributed to the accident or cannot be completely discounted as a contributing factor of the accident. The decision not to test an employee must be based on a determination, using the best information available at the time of the determination that the employee's performance could not have contributed to the accident. Reasonable cause determination (drugs): Two of the employee's supervisors, one of whom is trained, shall substantiate and concur in the decision to test the employee. If the employer is not an air carrier operating under 14 CFR part 121 and has 50 or fewer employees, a single trained supervisor can make the determination. A trained supervisor makes the determination based upon specific contemporaneous physical, behavioral or performance indicators of probable drug use. Reasonable suspicion determination (alcohol): One trained supervisor makes the determination based upon specific, contemporaneous, articulable observations concerning the employee's appearance, behavior, speech, or body orders. Pre-duty alcohol use prohibitions: Eight (8) hours prior to performance of flight crewmember duties, flight attendant duties, and air traffic controller duties. Four (4) hours prior to performance of other duties. Actions for BACs 0.02 - 0.039: If the employer chooses to return the employee to covered services within 8 hours, the BAC retest must be below 0.02. LC-ADD-41 DOT Urine Specimen Collection Guidelines 42 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 FAA (continued) Employee training (drugs): An employer must train all employees who perform safety- sensitive duties on the effects and consequences of prohibited drug use on personal health, safety, and work environment, and on the manifestations and behavioral cues that may indicate drug use and abuse. Employers must also implement an education program for safety-sensitive employees by displaying and distributing informational materials, a community service hot-line telephone number for employee assistance and the employer's policy regarding drug use in the work place which must include information regarding the consequences under the rule of using drugs while performing safety-sensitive functions, receiving a verified positive drug test result, or refusing to submit to a drug test required under the rule. Employee training (alcohol): Employers must provide covered employees with educational materials that explain the alcohol misuse requirements and the employer's policies and procedures with respect to meeting those requirements. The information must be distributed to each covered employees and must include such information as the effects of alcohol misuse on an individual's health work, personal life, signs and symptoms of an alcohol problem; and the consequences for covered employees found to have violated the regulatory prohibitions. Supervisor training (drugs): One-hour of training is required on the specific, contemporaneous physical, behavioral, and performance indicators of probable drug use. In addition, supervisors must receive employee training as defined above. Reasonable recurrent training is also required. Supervisor training (alcohol): One-hour of training is required on the physical, behavioral, speech, and performance indicators of probable alcohol misuse. Reportable employee drug and alcohol violations: Each employer must notify the FAA about any covered employee who holds a certificate issued under 14 CFR Parts 61 (pilots and flight and ground instructors), 63 (flight engineers and navigators), or 65 (air traffic control tower operators, aircraft dispatchers, airframe or power plant mechanics, and repairmen) who has refused to take a drug or alcohol test. The MRO may report a positive or refusal (i.e. adulterated, substituted results or no medical explanation for providing an insufficient specimen) on behalf of the employer. Each employer must notify the FAA about any safety-sensitive employee who is required to hold an airman medical certificate issued under 14 CFR Part 67 who has a positive drug test result, an alcohol test result of 0.04 or greater, or who has refused to submit to testing. The MRO may report a positive or refusal (i.e. adulterated, substituted results or no medical explanation for providing an insufficient specimen) on behalf of the employer. Each employer must not permit an employee who is required to hold a medical certificate under part 67 to perform a safety-sensitive function to resume that duty until the employee has received a new medical certificate issued by the FAA Federal Air Surgeon and the employer has ensured that the employee meets the return to duty requirements of Part 40. (Medical certificates are not operating certificates but employees cannot continue to perform airman duties without a medical certificate.) LC-ADD-42 DOT Urine Specimen Collection Guidelines 43 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 FAA (continued) According to FAA’s regulation 14 CFR part 120, Subpart E, section 120.113(d), when a MRO verifies a drug test result or a SAP performs the initial evaluation, they must ask the employee whether he or she holds or would be required to hold an airman medical certificate issued under 14 CFR part 67 of this chapter to perform a safety-sensitive function for the employer. [This requirement only applies to MROs and SAPs who provide services for FAA regulated employers.] If the employee answers in the affirmative, the employee must obtain an airman medical certificate issued by the Federal Air Surgeon dated after the drug and/or alcohol violation date. The SAP must wait until the employee obtains their airman medical certificate before reporting to an employer that the employee demonstrated successful compliance with the SAP's treatment and/or education recommendations. LC-ADD-43 DOT Urine Specimen Collection Guidelines 44 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 Federal Transit Administration - (FTA) Covered employee: A person who performs a revenue vehicle operation; revenue vehicle and equipment maintenance; revenue vehicle control or dispatch (optional); Commercial Drivers License non-revenue vehicle operation; or armed security duties. Types of tests for drugs: Pre-employment, random, reasonable suspicion, post-accident, return- to-duty, and follow-up. Types of tests for alcohol: Pre-employment (optional), random, reasonable suspicion, post- accident, return-to-duty, and follow-up. Definition of accident requiring testing: Any accident involving a fatality requires testing. Testing following a non-fatal accident is discretionary: If the employer can show the employee’s performance could not have contributed to the accident, no test is needed. Non-fatal accidents that may require testing must have disabling damage to any vehicle or immediate medical attention away from the scene to meet the testing threshold. Reasonable-suspicion determination: One trained supervisor or company official can make the decision based upon specific, contemporaneous, articulable observations concerning the appearance, behavior, speech, or body odors of the employee. Pre-duty alcohol use prohibitions: Four (4) hours prior to performance of duty. Actions for BACs 0.02 – 0.039: If the employer chooses to return the employee to covered service within 8 hours, the BAC re-test must be below 0.02. Employee training: Employer must provide education with display and distribution of informational materials and a community service hot-line telephone number, if available. One-hour of training on the effects and consequence of prohibited drug use on personal health, safety, and the work environment, and on the signs and symptoms that may indicate prohibited drug use. Distribution to each employee of the employer’s policy regarding the use of drugs and alcohol with signed receipt is mandatory. Supervisor training: One-hour of training is required on the specific, contemporaneous physical, behavioral, and performance indicators of probable drug use. One-hour of training is also required on the specific, contemporaneous physical, behavioral, and performance indicators of probable alcohol use. Reportable employee drug and alcohol violations: No requirements to report violations to FTA. Other: Anyone with direct or immediate supervisory authority over an employee may not collect that person’s urine, saliva, or breath. LC-ADD-44 DOT Urine Specimen Collection Guidelines 45 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 Pipeline and Hazardous Materials Safety Administration - (PHMSA) Covered employee: A person who performs on a pipeline or liquefied natural gas (LNG) facility an operation, maintenance, or emergency-response function. Types of tests for drugs: Pre-employment, random, reasonable cause, post-accident, return-to- duty, and follow-up. Types of tests for alcohol: Post-accident, reasonable suspicion, return-to-duty, and follow-up. Definition of accident requiring testing: An accident is one involving gas pipeline facilities or LNG facilities or involving hazardous liquid or carbon dioxide pipeline facilities. Reasonable-suspicion determination: One trained supervisor can make the decision based upon signs and symptoms. Reasonable-cause determination: One trained supervisor can make the decision based upon reasonable and articulable belief that the employee is using prohibited drugs on the basis of specific, contemporaneous physical, behavioral, or performance indicators of probable drug use. Pre-duty alcohol use prohibitions: Four (4) hours prior to performance of duty. Actions for BACs 0.02 – 0.039: If the employer chooses to return the employee to covered service within 8 hours, the BAC retest must be below 0.02. Employee training (Drugs): Employer must provide EAP education with display and distribution of informational materials; display and distribution of a community service hot-line telephone number; and display and distribution of the employer’s policy regarding the use of prohibited drugs. Employee Training (Alcohol): Employer must develop materials that explain policies and procedures (as well as names of those who can answer questions about the program) and distribute them to each covered employee. Supervisor training: One-hour of training is required on the specific, contemporaneous physical, behavioral, and performance indicators of probable drug use. One-hour of training is also required on the specific, contemporaneous physical, behavioral, and performance indicators of probable alcohol use. Reportable employee drug and alcohol violations: No requirements to report violations to PHMSA. LC-ADD-45 DOT Urine Specimen Collection Guidelines 46 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 United States Coast Guard - (USCG) Covered employee: A person who is on board a vessel acting under the authority of a license, certificate of registry, or merchant mariner's document. Also, a person engaged or employed on board a U.S. owned vessel and such vessel is required to engage, employ or be operated by a person holding a license, certificate of registry, or merchant mariner's document. Types of tests for drugs: Pre-employment, periodic, random, reasonable cause, and post- serious marine incident (SMI), return-to-duty, and follow-up. Types of tests for alcohol: 49 CFR Part 40 alcohol-testing requirements do not apply to the Maritime Industry. 46 CFR Part 4.06 requires post-SMI chemical testing for alcohol use. 33 CFR Part 95.035 allows for a marine employer or a law enforcement officer to direct an individual to undergo a chemical test for intoxicants when reasonable cause exists or a marine casualty has occurred. Definition of incident requiring testing: An SMI is defined in 46 CFR 4.03-2. In general, an SMI is: A discharge of 10,000 gallons or more of oil into the navigable waters of the United States, whether or not resulting from a marine casualty; a discharge of a reportable quantity of a hazardous substance into the navigable waters or into the environment of the United States, whether or not resulting from a marine casualty; or a marine casualty or accident required to be reported to the Coast Guard, involving a vessel in commercial service, and resulting in any of the following: One or more deaths; an injury to any person (including passengers) which requires professional medical treatment beyond first aid, and, in the case of a person employed on board a commercial vessel, which renders the person unable to perform routine vessel duties; damage to property in excess of $100,000; actual or constructive total loss of any inspected vessel; or actual or constructive total loss of any uninspected, self-propelled vessel of 100 gross tons or more. Reasonable-cause determination (drugs): The marine employer must have a reasonable and articulable belief that the individual has used a dangerous drug. This belief should be based on the direct observation of specific, contemporaneous physical, behavioral, or performance indicators of probable use and where practicable based on the observation of two persons in supervisory positions. Reasonable-cause determination (alcohol): The employee was directly involved in the occurrence of a marine casualty or the individual operated a vessel and the effect of the intoxicant(s) consumed by the individual on the person's manner, disposition, speech, muscular movement, general appearance or behavior is apparent by observation. Pre-duty alcohol use prohibitions: Four (4) hours prior to performance of scheduled duty. Employee training: Employer must provide education with display and distribution of informational materials and a community service hot-line telephone number. Distribution to each employee of the employer’s policy regarding the use of drugs and alcohol is mandatory. Training must include the effects of drugs and alcohol on personal heath, safety, and work environment; and manifestations and behavioral cues that may indicate drug and alcohol use and abuse. LC-ADD-46 DOT Urine Specimen Collection Guidelines 47 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 USCG (continued) Supervisor training: One-hour of training is required on the effects of drugs and alcohol on personal heath, safety, and work environment; and manifestations and behavioral cues that may indicate drug and alcohol use and abuse. Reportable employee drug and alcohol violations: Results of all post-SMI tests and positive drug test results for all mariners who hold a license, certificate of registry or merchant mariner's document must be reported to the nearest Coast Guard Officer in Charge, Marine Inspection. LC-ADD-47 DOT Urine Specimen Collection Guidelines 48 Office of Drug and Alcohol Policy and Compliance Revised – July 3, 2014 U.S. Department of Transportation Office of the Secretary Office of Drug and Alcohol Policy and Compliance 1200 New Jersey Avenue, S.E. W62-300 Washington, D.C. 20590 202.366.3784 202.366.3897 fax www.dot.gov/odapc ODAPCwebmail@dot.gov Changes from previous version [October 1, 2010]: o Page 2: Removed the introductory statement from the Secretary of Transportation (now available on our web site) o Page 41: Added a new FAA safety-sensitive employee category known as “Operations Control Specialist.” o Updated web site addresses/ hyperlinks, as needed. o Modified language throughout the document to clarify concepts and to identify when actions are required versus simply permitted by the regulation. These edits are italicized throughout this document and the items italicized, underlined, and bolded from the 2010 revisions to this document were returned to normal text. o Removed effective dates in Section 4 that have passed. o Section 13 was reorganized. o Removed Section 14. LC-ADD-48 PART 40 QUESTIONS AND ANSWERS The Office of General Counsel and Office of Drug and Alcohol Policy and Compliance of the Department of Transportation are providing these questions and answers. They constitute official and authoritative guidance and interpretation concerning 49 CFR Part 40 (see 49 CFR 40.5). These Questions and Answers are dated 07/14. LC-ADD-49 §§ 40.73; 40.191; 40.193; 40.333; 40.355(i) 07/14 Question: When may a collector give an employee permission to leave a collection site? Answer: • A collector may give an employee permission to leave the collection site only after the testing process is complete. o For tests conducted under § 40.73, the testing process is complete when both the employee and the collector complete the chain of custody form in the order specified in § 40.73(a)(1)-(6). At that time, the collector must advise the employee that he or she may leave the collection site. o For tests conducted under § 40.193, the testing process is complete only after the employee has provided a sufficient specimen and the steps in § 40.73(a)(1)-(6) are complete, or the employee has not provided a sufficient specimen within three hours of the first unsuccessful attempt to provide a specimen. • There is no requirement for a collector to inform an employee that the failure to remain at the collection site is a refusal. Therefore, if the collector does not inform an employee that failure to remain at the collection site is a refusal, it does not mean that the collector has given the employee permission to leave the collection site. If an employee leaves prior to the completion of the testing process, the employer must decide whether the employee’s actions constitute a refusal. LC-ADD-50 §§ 40.73; 40.191; 40.193; 40.333; 40.355(i) 07/14 Question: What happens if an employee leaves the collection site prior to the completion of the testing process? Answer: • As noted in § 40.191(a)(2), failure to remain at the collection site until the testing process is complete generally constitutes a refusal to test. • If an employee leaves the collection facility prior to the testing process being completed, the collector must inform the employer as required under § 40.191(d). The employer, as required under § 40.355(i), must then determine whether the employee’s actions constitute a refusal to test. To make this determination, the employer should consider the information documented on the CCF and the advice and information received from the collector and service agents, as well as any supporting information provided by the employee (i.e., in the event of a medical emergency, copies of hospital admission records/EMS records/police records, etc). • The employer must document its decision, and the solid reasoning for the decision, in all collection site refusal determinations. Copies of these decisions, and the information relied on in making those decisions, must be maintained in accordance with § 40.333 and the applicable modal recordkeeping requirements. If during the course of an inspection, the DOT determines that you have not properly documented these determinations, you may be subject to penalty in accordance with these regulations. LC-ADD-51