Current through Register Vol. 35, No. 11, June 11, 2024
Section 7.33.2.8 - LABORATORIESA. Initial certification. Any laboratory seeking certified status for alcohol or drug testing in blood shall submit a request in writing to the director of SLD. Applicants shall furnish the materials listed below to the director of SLD for review and approval. SLD shall review the materials and inspect the location of the applicant laboratory within 60 days of receipt. SLD shall issue a certificate to any laboratory that meets the standards and successfully completes the required proficiency testing requirements. (1) Laboratories seeking SLD certification for blood alcohol analysis shall submit: (a) written documentation of the scientific training and experience in toxicology or clinical/analytical chemistry of its director and all personnel who will perform tests;(b) written copies of the analytical methods, techniques and equipment it proposes to use;(c) a proposed set of quality control/ assurance measures;(d) results of all required proficiency tests;(e) evidence that the lab has adequate space, equipment and materials to perform blood alcohol analysis.(2) Laboratories seeking SLD certification for drug analysis in blood shall submit:(a) written documentation of the scientific training and experience in toxicology or clinical/analytical chemistry of its director and all personnel who will perform tests;(b) written copies of the analytical methods, techniques and equipment it proposes to use;(c) a proposed set of quality control/ assurance measures;(d) results of all required proficiency tests;(e) evidence that the lab has adequate space, equipment and materials to perform drug testing on blood.(f) proof of accreditation by the American board of forensic toxicology (ABFT) in forensic toxicology or by the American society of crime lab directors /laboratory accreditation board (ASCLD/LAB) in the field of forensic science testing in the discipline of toxicology in the category of testing of blood/urine drug testing, or the current accrediting body.B. Continuing responsibilities of laboratories. (1) Each SLD-certified laboratory shall adhere to an SLD-approved written standard operating procedure and shall maintain evidence of its compliance.(2) Each SLD-certified laboratory shall be subject to inspection by authorized personnel of SLD prior to certification and may be re-inspected at any time during the period for which certification was granted.(3) SLD-certified laboratories are required to submit to the director of SLD any changes in their analytical personnel, analytical methodology or analytical equipment for approval a minimum of 20 days prior to commencing analysis with the new personnel, methodology or equipment.(4) SLD-certified laboratories shall maintain records containing all pertinent facts relating to analyses performed for a minimum period of five years. All records shall be sufficiently complete as to allow verification by an independent chemist, unaffiliated with the SLD-certified laboratory. Such records shall be open to inspection by authorized personnel of SLD.(5) SLD certified laboratories shall submit to SLD copies of all results of tests for alcohol or other drugs within 30 days of the completion of the blood analysis. The name of the scientist responsible for reviewing the test data and determining the final result shall be provided on the report.(6) All SLD-certified laboratories shall establish and maintain adequate SLD-approved quality control measures and shall maintain complete records of their quality control programs. These records shall be available for inspection by SLD personnel upon demand and shall be maintained for a minimum period of five years.(7) Those laboratories certified in drug testing shall maintain their ABFT or ASCLD/LAB accreditation or accreditation from the current accrediting body with required proficiencies.(8) Proficiency testing. (a) SLD shall require that each laboratory certified for blood alcohol testing complete the analysis of a minimum of eight samples each year. These tests include proficiencies issued by SLD as well as proficiencies issued by other certifying agencies. In the case of proficiency samples provided by SLD, certified laboratories must return test results within ten days of their receipt. Performance is considered satisfactory if the results of all analyses in a single year fall within acceptable limits based on considerations that include, but are not limited to, the subject analytes and the sample matrix. Acceptable limits for alcohol proficiencies for blood samples are: (i) ± 10 percent of the alcohol content of the specimen if the known alcohol content is 0.10 grams per 100 milliliters or more;(ii) ± 0.01 grams per 100 milliliters if the known alcohol content is less than 0.10 grams per 100 milliliters.(b) Drug proficiency testing shall be in accordance with accrediting agency standards.C. Recertification. SLD certified laboratories may be certified for a period not to exceed one year to conduct blood tests subject to the following standards, procedures, conditions and on-site inspections: (1) all laboratory certifications shall expire annually on June 30;(2) SLD certified laboratories must apply for renewal of certification annually; all applications must be received at least 60 days prior to the expiration date of the laboratory's certification;(3) applications for renewal of certification shall include the following: (a) the same information regarding personnel, techniques and equipment as described in Subsection A of this section;(b) results of all proficiency tests performed in the previous year including SLD proficiencies as well as proficiencies issued by other certifying agencies;(4) continued certification of a laboratory shall depend on compliance with approved methods, qualified staff and facilities, and satisfactory performance in the proficiency testing.D. Denial, suspension, and revocation. (1) SLD may refuse to certify or may suspend or revoke the certification of any SLD-certified laboratory for any one or more of the following causes:(a) failure to comply with any of the previously stated requirements for certification in Subsection A of this section;(b) fraud or deceit in applying for or obtaining the certification or renewal thereof;(c) loss of professional certification or affiliation of staff;(d) loss of required accreditation of lab;(e) any serious or repeated violation of any rule of SLD;(f) any major violation of the standards for laboratories, facilities, personnel or equipment relevant to the testing procedures that are the subject of this rule;(g) for good cause, including but not limited to perjury, fraud or incompetence;(h) failure to perform analyses and proficiency testing in a satisfactory manner as specified by SLD.(2) SLD shall provide notice to the laboratory of any proposed adverse action.(3) Any laboratory seeking review of unsatisfactory proficiency test results may request a stay of suspension or revocation for good cause. The request must be in writing to the director of SLD.(4) Any laboratory that has had their SLD certification denied, revoked or suspended may request a hearing pursuant to Subsection F of 7.33.2.18 NMAC.(5) Any laboratory that has had their SLD certification revoked may not re-apply for a minimum of one year after the notice of final action or after the completion of any requested hearing whichever is later.(6) Any laboratory denied certification or renewal of certification may not re-apply for certification until 90 days after the completion of any requested hearing or 90 days after the notice of final action, whichever is later. Subsequent denials will require that six months, not 90 days, elapse prior to re-application.7.33.2.8 NMAC - Rp, 7.33.2.9 NMAC & 7.33.2.16 NMAC, 04-30-2010