5 Colo. Code Regs. § 1005-2-5.5

Current through Register Vol. 47, No. 11, June 10, 2024

Section 5 CCR 1005-2-5.5 - Proficiency Testing (PT) requirements for certified forensic toxicology laboratories

5.5.1 Proficiency Testing (PT) is the evaluation of unknown specimens which determines target values for those unknown specimens and is required for each approved category the laboratory is certified in.

5.5.2 PT material must be obtained from a PT provider that is accredited to the ISO/IEC 17043 standards and can provide appropriate biological specimens that are applicable to the testing the laboratory performs.

5.5.3 Prior to initial certification, the laboratory must at minimum, have successfully participated in one proficiency testing event(s) within the preceding 12 months in the category for which the laboratory seeks certification and must have received a satisfactory score(s) for each of those event(s) as defined in Part 5.

5.5.4 To maintain continued laboratory certification, a laboratory must demonstrate successful PT performance for each category in which the laboratory is certified.

5.5.5 For each approved category of testing, PT samples shall be:

5.5.5.1 Tested for all analytes reported by the laboratory that are present in the PT samples, and

5.5.5.2 Tested by each technical personnel annually, and

5.5.5.3 Tested using approved standard operating procedures, and

5.5.5.4 Tested in the same manner as subject samples, and

5.5.5.5 Reported to the PT provider, and

5.5.5.6 The laboratory must request that the proficiency testing provider provide a consultant copy of their PT survey results to:

Colorado Department of Public Health and Environment

Laboratory Services Division

Certification Program 8100

Lowry Boulevard

Denver, CO 80230-6828

5.5.6 Blood Alcohol Testing

5.5.6.1 A laboratory must demonstrate successful PT performance in a minimum of 3 alcohol PT testing events per year. Each event must consist of a minimum of 4 specimens each. The PT provider will evaluate the results and forward them to the laboratory as well as to the Department.

5.5.6.2 Other forensically significant volatiles, such as acetone, methanol and isopropanol, may be included in one or more PT samples in each of the 3 events. The laboratory must be able to detect any volatile included in the PT samples and must retain documentation of this detection with the PT results.

5.5.6.3 Scoring Criteria for Blood Alcohol Proficiency Testing

5.5.6.3.1 PT results must be returned to the PT provider within the time specified by the PT provider. Results received after the due date will not be scored and will be considered an unsatisfactory performance resulting in a score of 0 for the testing event. The laboratory must contact the PT provider and the Department if extenuating circumstances prevent timely response to a PT event.

5.5.6.3.2 An acceptable blood alcohol PT result is one that falls within +/-10% of the reported mean.

5.5.6.3.3 The laboratory must investigate any score less than 100% and undertake corrective action as needed. The investigation outcome and corrective action must be provided to the Department upon request.

5.5.5.3.4 The PT results will be reviewed by the Department to determine if successful PT performance has been achieved. If a laboratory has consecutive "Unsatisfactory" evaluations, or achieves an "Unsatisfactory" score in 2 of any 3 consecutive PT events, the PT performance is deemed "Unsuccessful". The "Unsuccessful" determination may result in a "Directed Plan of Correction" specified by the Department, or suspension/limitation of certification for the failed analyte.

5.5.7 Urine, Blood and Postmortem Drug Testing

5.5.7.1 For blood drug, urine drug and postmortem screening and confirmation certification, the laboratory must demonstrate successful PT performance.

5.5.7.1.1 For blood drug certification the laboratory must participate in a minimum of two PT events annually that include blood samples.

5.5.7.1.2 For urine drug certification the laboratory must participate in a minimum of two PT events annually that include urine samples.

5.5.7.1.3 For laboratories performing only postmortem forensic toxicology testing the laboratory must participate in a minimum of two PT events annually that include a combination of blood and urine samples and other postmortem matrices when available.

5.5.7.2 Scoring criteria for drug proficiency testing

5.5.7.2.1 PT results must be returned to the PT provider within the time specified by the PT provider. Results received after the due date will not be scored and will be considered an "Unsatisfactory" performance resulting in a score of 0 for the testing event. The laboratory must contact the PT provider and the Department if extenuating circumstances prevent timely response to a PT event.

5.5.7.2.2 All analytes listed and reported (qualitatively and quantitatively) by the laboratory must be analytically tested in the PT challenges in the same manner as subject samples.

5.5.7.2.3 A satisfactory event score is the positive identification and when applicable, quantitation of 80% of the target analytes present with no false positives. Any false positive will result in an "Unsatisfactory" score for the PT event.

5.5.7.2.3.1 Scoring is as follows: if a laboratory only reports an analyte qualitatively, the total possible points for that analyte will be 4 points.

Total points possible:

A. Each possible positive identification is 4 points.

B. Each quantitative result is worth a possible 2 points.

Note: quantitative results will be subject to further point restrictions when standard deviation (SD) values are given by the PT provider.

Laboratory's points:

A. Each correctly identified analyte is 4 points.

B. Each false negative is 0 points (i.e., no qualitative result given).

C. Each quantitative result within 1 standard deviation (SD) is 2 points.

D. Each quantitative result within 2 SD is 1 point.

E. Each quantitative result outside 2 SD is 0 points.

F. Each correctly identified negative specimen is 4 points.

G. Each false positive is minus (-) 25 points and is automatically considered an unsatisfactory event.

Laboratory's Score = (laboratory's points / total possible points) * 100

5.5.7.2.4 Whenever a laboratory receives an unsatisfactory PT event (less than 80%), the laboratory must investigate and undertake corrective action as needed. The investigation outcome and corrective action documentation must be provided to the Department upon request.

5.5.7.2.5 Whenever a quantitative result reported by the laboratory in a PT challenge is considered "Unacceptable" by the PT provider (outside ±2SD or 30% from the mean, whichever is greater), the laboratory must undertake and document corrective action. The corrective action documentation must be retained with the PT results.

5.5.7.2.6 A laboratory will be suspended from a category for "Unsuccessful" PT performance if consecutive "Unsatisfactory" PT events occur, or two out of three consecutive "Unsatisfactory" PT events occur. A laboratory may be reinstated to active status after successful participation in the next PT challenge. Failure to achieve a "Satisfactory" score in the next test event will result in the revocation of the certificate and require two successful PT events before the laboratory may be eligible to reapply for certification. The laboratory may request the PT provider send one extra set of PT samples when suspension status occurs.

5 CCR 1005-2-5.5

41 CR 04, February 25, 2018, effective 3/17/2018

42 CR 02, January 25, 2019, effective 2/14/2019