Tenn. Comp. R. & Regs. 1200-06-03-.05

Current through October 22, 2024

Section 1200-06-03-.05 - LICENSURE DISCIPLINE, CIVIL PENALTIES, ASSESSMENT OF COSTS, SUBPOENAS, AND SCREENING PANELS

(1) Upon a finding by the Board that a licensee has violated any provision of the Tennessee Medical Laboratory Act (T.C.A. §§ 68-29-101, et seq.) or the rules promulgated pursuant thereto, the Board may impose any of the following actions separately or in any combination which is deemed appropriate to the offense:

(a) Private Censure - This is a written action issued by the Board to the licensee for minor infractions of these rules. It is informal and advisory in nature and does not constitute a formal disciplinary action.

(b) Public Censure or Reprimand - This is a formal disciplinary action consisting of a written admonishment issued by the Board to a licensee for one (1) time and less severe infractions.

(c) Probation - This is a formal disciplinary action which places a licensee on close scrutiny for a fixed period of time. This action may be combined with conditions which must be met before probation will be lifted and/or which restrict the licensee's activities during the probationary period.

(d) Licensure Suspension - This is a formal disciplinary action which suspends a licensee's right to operate a medical laboratory for a fixed period of time. It contemplates the reentry of the licensee into operation under the license previously issued.

(e) Licensure Revocation - This is the most severe form of disciplinary action which removes a licensee from the operation of a medical laboratory and terminates the license previously issued. If revoked, it relegates the violator to the status he or she possessed prior to application for licensure. However, the Board may in its discretion allow the reinstatement of a revoked license upon conditions and after a period of time it deems appropriate. No petition for reinstatement and no new application for licensure from a medical laboratory whose license was revoked shall be considered prior to the expiration of at least one (1) year unless otherwise stated in the Board's revocation Order.

(f) Civil Penalty - A monetary disciplinary action assessed by the Board pursuant to paragraph (5) of this rule.

(g) Once ordered, probation, suspension, revocation, or any other condition of any type of disciplinary action may not be lifted unless and until the licensee petitions, pursuant to paragraph (2) of this rule, and appears before the Board after the period of initial probation, suspension, revocation, or other conditioning has run and all conditions placed on the probation, suspension, revocation, have been met.

(2) Order of Compliance - This procedure is a necessary adjunct to previously issued disciplinary orders and is available only when a petitioner has completely complied with the provisions of a previously issued disciplinary order, and wishes or is required to obtain an order reflecting that compliance.

(a) The Board will entertain petitions for an Order of Compliance as a supplement to a previously issued order upon strict compliance with the procedures set forth in subparagraph (b) in only the following three (3) circumstances:

1. When the petitioner can prove compliance with all the terms of the previously issued order and is seeking to have an order issued reflecting that compliance; or

2. When the petitioner can prove compliance with all the terms of the previously issued order and is seeking to have an order issued lifting a previously ordered suspension or probation; or

3. When the petitioner can prove compliance with all the terms of the previously issued order and is seeking to have an order issued reinstating a license previously revoked.

(b) Procedures

1. The petitioner shall submit a Petition for Order of Compliance, as contained in subparagraph (c), to the Board's Administrative Office that shall contain all of the following:

(i) A copy of the previously issued order; and

(ii) A statement of which provision of subparagraph (a) the petitioner is relying upon as a basis for the requested order; and

(iii) A copy of all documents that prove compliance with all the terms or conditions of the previously issued order. If proof of compliance requires testimony of an individual(s), including that of the petitioner, the petitioner must submit signed statements from every individual the petitioner intends to rely upon attesting, under oath, to the compliance. The Board's consultant and administrative staff, in their discretion, may require such signed statements to be notarized. No documentation or testimony other than that submitted will be considered in making an initial determination on, or a final order in response to, the petition.

2. The Board authorizes its consultant and administrative staff to make an initial determination on the petition and take one of the following actions:

(i) Certify compliance and have the matter scheduled for presentation to the Board as an uncontested matter; or

(ii) Deny the petition, after consultation with legal staff, if compliance with all of the provisions of the previous order is not proven and notify the petitioner of what provisions remain to be fulfilled and/or what proof of compliance was either not sufficient or not submitted.

3. If the petition is presented to the Board the petitioner may not submit any additional documentation or testimony other than that contained in the petition as originally submitted.

4. If the Board finds that the petitioner has complied with all the terms of the previous order an Order of Compliance shall be issued.

5. If the petition is denied either initially by staff or after presentation to the Board and the petitioner believes compliance with the order has been sufficiently proven the petitioner may, as authorized by law, file a petition for a declaratory order pursuant to the provisions of T.C.A. § 4-5-223 and rule 1200-10-01-.11.

(c) Form Petition

Petition for Order of Compliance Tennessee Medical Laboratory Board

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(3) Order Modifications - This procedure is not intended to allow anyone under a previously issued disciplinary order, to modify any findings of fact, conclusions of law, or the reasons for the decision contained in the order. It is also not intended to allow a petition for a lesser disciplinary action. All such provisions of Board orders were subject to reconsideration and appeal under the provisions of the Uniform Administrative Procedures Act (T.C.A. §§ 4-5-301, et seq.). This procedure is not available as a substitute for reconsideration and/or appeal and is only available after all reconsideration and appeal rights have been either exhausted or not timely pursued. It is also not available for those who have accepted and been issued a reprimand.

(a) The Board will entertain petitions for modification of the disciplinary portion of previously issued orders upon strict compliance with the procedures set forth in subparagraph (b) only when the petitioner can prove that compliance with any one or more of the conditions or terms of the discipline previously ordered is impossible. For purposes of this rule the term "impossible" does not mean that compliance is inconvenient or impractical for personal, financial, scheduling or other reasons.

(b) Procedures

1. The petitioner shall submit a written and signed Petition for Order Modification on the form contained in subparagraph (c) to the Board's Administrative Office that shall contain all of the following:

(i) A copy of the previously issued order; and

(ii) A statement of why the petitioner believes it is impossible to comply with the order as issued; and

(iii) A copy of all documents that proves that compliance is impossible. If proof of impossibility of compliance requires testimony of an individual(s), including that of the petitioner, the petitioner must submit signed and notarized statements from every individual the petitioner intends to rely upon attesting, under oath, to the reasons why compliance is impossible. No documentation or testimony other than that submitted will be considered in making an initial determination on, or a final order in response to, the petition.

2. The Board authorizes its consultant and administrative staff to make an initial determination on the petition and take one of the following actions:

(i) Certify impossibility of compliance and forward the petition to the Office of General Counsel for presentation to the Board as an uncontested matter; or

(ii) Deny the petition, after consultation with legal staff, if impossibility of compliance with the provisions of the previous order is not proven and notify the petitioner of what proof of impossibility of compliance was either not sufficient or not submitted.

3. If the petition is presented to the Board the petitioner may not submit any additional documentation or testimony other than that contained in the petition as originally submitted.

4. If the petition is granted a new order shall be issued reflecting the modifications authorized by the Board that it deemed appropriate and necessary in relation to the violations found in the previous order.

5. If the petition is denied either initially by staff or after presentation to the Board and the petitioner believes impossibility of compliance with the order has been sufficiently proven the petitioner may, as authorized by law, file a petition for a declaratory order pursuant to the provisions of T.C.A. § 4-5-223 and rule 1200-10-01-.11.

(c) Form Petition

Petition for Order Modification Tennessee Medical Laboratory Board

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(4) The provisions of the Uniform Administrative Procedures Act, T.C.A. §§ 4-5-301, et seq., shall govern the hearing and judicial review of all disciplinary proceedings.

(5) Civil Penalties

(a) Purpose - The purpose of this is to set out a schedule designating the minimum and maximum Civil Penalties which may be assessed pursuant to T.C.A. §63-1-134.

(b) Schedule of Civil Penalties

1. A Type A Civil Penalty may be imposed whenever the Board finds the medical laboratory or collection station which is required to be licensed by the Board guilty of a willful and knowing violation of the Tennessee Medical Laboratory Act, or regulations promulgated pursuant thereto, to such an extent that there is, or is likely to be an imminent, substantial threat to the health, safety and welfare of an individual patient or the public. For purposes of this section, willfully and knowingly operating a medical laboratory or collection station without a license from the Board is one of the violations of the Tennessee Medical Laboratory Act for which a Type A Civil Penalty is assessable.

2. A Type B Civil Penalty may be imposed whenever the Board finds the medical laboratory or collection station which is required to be licensed by the Board is guilty of a violation of the Tennessee Medical Laboratory Act, or regulations promulgated pursuant thereto, in such a manner as to impact directly on the care of patients or the public.

3. A Type C Civil Penalty may be imposed whenever the Board finds the medical laboratory or collection station which is required to be licensed by the Board is guilty of a violation of the Tennessee Medical Laboratory Act, or regulations promulgated pursuant thereto, which is neither directly detrimental to the patients or public, nor directly impacts their care, but has only indirect relationship to patient care or the public.

(c) Amount of Civil Penalties

1. Type A Civil Penalties shall be assessed in the amount of not less than $500 nor more than $1,000.

2. Type B Civil Penalties may be assessed in the amount of not less than $100 and not more than $500.

3. Type C Civil Penalties may be assessed in the amount of not less than $50 and not more than $100.

(d) Procedures for Assessing Civil Penalties

1. The Division of Health Related Boards may initiate a Civil Penalty assessment by filing a Memorandum of Assessment of Civil Penalty. The Division shall state in the memorandum the facts and law upon which it relies in alleging a violation, the proposed amount of the civil penalty and the basis for such penalty. The Division may incorporate the Memorandum of Assessment of Civil Penalty with a Notice of Charges which may be issued attendant thereto.

2. Civil Penalties may also be initiated and assessed by the Board during consideration of any Notice of Charges. In addition, the Board may, upon good cause shown, assess a type and amount of civil penalty which was not recommended by the Division.

3. In assessing the Civil Penalties pursuant to these rules the Board may consider the following factors:

(i) Whether the amount imposed will be a substantial economic deterrent to the violator;

(ii) The circumstances leading to the violation;

(iii) The severity of the violation and the risk of harm to the public;

(iv) The economic benefits gained by the violator as a result of non-compliance; and,

(v) The interest of the public.

4. All proceedings for the assessment of Civil Penalties shall be governed by the contested case provisions of Title 4, Chapter 5, Tennessee Code Annotated.

(6) Assessment of costs in disciplinary proceedings shall be as set forth in T.C.A. §§ 63-1-144 and 68-29-136.

(7) Subpoenas

(a) Purpose - Although this rule applies to persons and entities other than medical laboratories, it is the Board's intent as to medical laboratories that they be free to operate without fear that such operation or its documentation will be unduly subjected to scrutiny outside the profession. Consequently, balancing that intent against the interest of the public and patients to be protected against substandard care and activities requires that persons seeking to subpoena such information and/or materials must comply with the substance and procedures of these rules.

It is the intent of the Board that the subpoena power outlined herein shall be strictly proscribed. Such power shall not be used by the Division or Board investigators to seek other incriminating evidence against medical laboratory personnel when the Division or Board does not have a complaint or basis to pursue such an investigation. Thus, unless the Division or its investigators have previously considered, discovered, or otherwise received a complaint from either the public or a governmental entity, then no subpoena as contemplated herein shall issue.

(b) Definitions - As used in this chapter of rules the following words shall have the meanings ascribed to them:

1. Probable Cause

(i) For investigative subpoenas shall mean that probable cause, as defined by case law at the time of request for subpoena issuance is made, exists that a violation of the Medical Laboratory Practice Act or rules promulgated pursuant thereto has occurred or is occurring and that it is more probable than not that the person(s), or items to be subpoenaed possess or contain evidence which is more probable than not relevant to the conduct constituting the violation.

(ii) The utilization of the probable cause evidentiary burden in proceedings pursuant to this rule shall not in any way, nor should it be construed in any way to establish a more restrictive burden of proof than the existing preponderance of the evidence in any civil disciplinary action which may involve the person(s) or items that are the subject of the subpoena.

2. Presiding Officer - For investigative subpoenas shall mean any elected officer of the Board, or any duly appointed or elected chairperson of any panel of the Board.

(c) Procedures

1. Investigative Subpoenas

(i) Investigative Subpoenas are available only for issuance to the authorized representatives of the Tennessee Department of Health, its investigators and its legal staff.

(ii) An applicant for such a subpoena must either orally or in writing notify the Board's Unit Director of the intention to seek issuance of a subpoena. That notification must include the following:

(I) The time frame in which issuance is required so the matter can be timely scheduled; and

(II) A particular description of the material or documents sought, which must relate directly to an ongoing investigation or contested case, and shall, in the instance of documentary materials, be limited to the records of the patient or patients whose complaint, complaints, or records are being considered by the Division or Board.

(III) In no event shall such subpoena be broadly drafted to provide investigative access to medical laboratory records of other patients who are not referenced in a complaint received from an individual or governmental entity, or who have not otherwise sought relief, review, or Board consideration of any medical laboratory personnel's conduct, act, or omission; and

(IV) Whether the proceedings for the issuance is to be conducted by physical appearance or electronic means; and

(V) The name and address of the person for whom the subpoena is being sought, or who has possession of the items being subpoenaed.

(iii) The Board's Unit Director shall cause the following to be done:

(I) In as timely a manner as possible arrange for either an elected officer of the Board or any duly appointed or elected chairperson of any panel of the board to preside and determine if issuing the subpoena should be recommended to the full board; and

(II) Establish a date, time and place for the proceedings to be conducted and notify the Presiding Officer, the applicant and the court reporter; and

(III) Maintain a complete record of the proceedings including an audio tape in such a manner as to:

I. Preserve a verbatim record of the proceeding; and

II. Prevent the person presiding over the proceedings and/or signing the subpoena from being allowed to participate in any manner in any resulting disciplinary action of any kind, formal or informal, which involves either the person or the documents or records for which the subpoena was issued.

(iv) The Proceedings

(I) The applicant shall do the following:

I. Provide for the attendance of all persons whose testimony is to be relied upon to establish probable cause; and

II. Produce and make part of the record copies of all documents to be utilized to establish probable cause; and

III. Obtain, complete and provide to the Presiding Officer a subpoena which specifies the following:

A. The name and address of the person for whom the subpoena is being sought or who has possession of the items being subpoenaed; and

B. The location of the materials, documents or reports for which production pursuant to the subpoena is sought if that location is known; and

C. A brief, general description of any materials, documents or items to be produced pursuant to the subpoena; and

D. The date, time and place for compliance with the subpoena.

IV. Provide the Presiding Officer testimony and/or documentary evidence which, in good faith, the applicant believes is sufficient to establish that probable cause exists for issuance of the subpoena as well as sufficient proof that all other reasonably available alternative means of securing the materials, documents or items have been unsuccessful.

(II) The Presiding Officer shall do the following:

I. Be selected only after assuring the Board's Unit Director that he or she has no prior knowledge of or any direct or indirect interest in or relationship with the person(s) being subpoenaed and/or the licensee who is the subject of the investigation; and

II. Commence the proceedings and swear all necessary witnesses; and

III. Hear and maintain the confidentiality, if any, of the evidence presented at the proceedings and present to the full board only that evidence necessary for an informed decision; and

IV. Control the manner and extent of inquiry during the proceedings and be allowed to question any witness who testifies; and

V. Determine, based solely on the evidence presented in the proceedings, whether probable cause exists and if so, make such recommendation to the full Board; and

VI. Not participate in any way in any other proceeding whether formal or informal, which involves the matters, items or person(s) which are the subject of the subpoena. This does not preclude the Presiding Officer from presiding at further proceedings for issuance of subpoenas in the matter.

(III) The Board shall do the following:

I. By a vote of two thirds (2/3) of the Board members issue the subpoena for the person(s) or items specifically found to be relevant to the inquiry, or quash or modify an existing subpoena by a majority vote; and

II. Sign the subpoena as ordered to be issued, quashed or modified.

2. Post-Notice of Charges Subpoenas - If the subpoena is sought for a contested case being heard with an Administrative Law Judge from the Secretary of State's office presiding, this definition shall not apply and all such post-notice of charges subpoenas should be obtained from the office of the Administrative Procedures Division of the Office of the Secretary of State pursuant to the Uniform Administrative Procedures Act and rules promulgated pursuant thereto.

(d) Subpoena Forms

1. All subpoenas shall be issued on forms approved by the Board.

2. The subpoena forms may be obtained by contacting the Board's Administrative Office.

(e) Subpoena Service - Any method of service of subpoenas authorized by the Tennessee Rules of Civil Procedure or the rules of procedure for contested cases of the Tennessee Department of State, Administrative Procedures Division may be utilized to serve subpoenas pursuant to this rule.

(8) Screening Panels - The Board adopts, as if fully set out herein, rule 1200-10-01-.13, of the Division of Health Related Boards and as it may from time to time be amended, as its rule governing the screening panel process.

Tenn. Comp. R. & Regs. 1200-06-03-.05

Original rule filed October 26, 1979; effective December 10, 1979. Amendment filed December 14, 1981; effective January 28, 1982. Amendment filed September 30, 1987; effective November 14, 1987. Repeal filed May 3, 1995; effective July 17, 1995. New rule filed January 7, 1997; effective March 23, 1997. Amendment filed December 1, 2000; effective February 14, 2001. Amendment filed March 22, 2001; effective June 5, 2001. Repeal and new rule filed June 18, 2002; effective September 1, 2002. Amendment filed July 8, 2004; effective September 21, 2004. Amendments filed May 16, 2005; effective July 30, 2005. Amendment filed March 16, 2007; effective May 30, 2007.

Authority: T.C.A. §§ 4-5-202, 4-5-204, 4-5-217, 4-5-223, 4-5-311, 63-1-122, 63-1-134, 63-1-138, 63-1-144, 68-29-104, 68-29-105, 68-29-109, 68-29-111, 68-29-122, 68-29-126, 68-29-128, 68-29-129, 68-29-130, 68-29-131, 68-29-132, 68-29-136, and 68-29-405.