Office Of Forensic Toxicology Services

Summary Statement of Deficiencies D0000 An onsite recertification survey was conducted from 08/27/2024 through 08/28/2024. Standard level deficiencies were cited. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: I. Based on review of the laboratory's procedure manual, manufacturer's instructions, direct observation, patient reports, collector instructions, and interview with technical supervisor 1, the laboratory failed to establish urine and oral fluid specimen handling written policies and procedures for 3 of 11 urine drug analytes and 2 of 9 oral fluid drug analytes. Findings included: 1. Review of the laboratory's procedure manual for urine drug analytes Ethyl Glucuronide (EtG), Synthetic Cannabinoids-3 (K2-3), and Fentanyl screened on the Beckman Coulter AU5800 did not include: a) specimen storage, preservation, stability, b) transport conditions, c) acceptability and rejection. ARK Diagnostics EtG, K2-3, and Fentanyl reagent manufacturer's instructions stated to store at "2-8C" and analyze "within 7 days of collection" or freeze samples at "-20 C." 2. Review of the laboratory's procedure manual for oral fluid drug analytes Ethyl Alcohol and Cocaine/Benzoylecgonine screened on the Beckman Coulter AU5800 did not include: a) specimen storage, preservation, stability, b) transport conditions, c) acceptability and rejection. Immunalysis Ethyl Alcohol reagent manufacturer's instructions did not include specimen requirements. Immunalysis Cocaine /Benzoylecgonine reagent manufacturer's instructions stated "Quantisal Oral Fluid Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- Collector" specimens were stable "for 10 days from time of collection if stored at room temperature (22-25C)." 3. During an observation on 08/27/2024 at 10:18 am, the laboratory received urine specimens from one of their local collectors for urine drug screening on the Beckman Coulter AU5800. The courier was observed delivering seven (7) cardboard boxes with 30 urine specimens in each box on a dolly. A sampling of those analyzed and reported were specimens # 38617804, 38618348, 38617827, 38617983, and 38618354 (collected 08/26/2024). The instructions provided to the collectors for oral fluids did not include specimen storage, preservation, stability, transport conditions, acceptability and rejection. The instructions provided to the collectors for the urine specimens stated, "The sample will then be placed in the box in the specimen refrigerator for transport." The storage temperature was not defined. Refer to D5317. 4. During an interview on 08/27/2024 at 4:30 pm, technical supervisor 1 was unable to provide oral fluid and urine specimen handling studies. She stated oral fluid specimens were not tested daily and are stored in the refrigerator awaiting testing. The laboratory procedures did not include refrigerator temperatures for oral fluids, the storage requirements were "room temperature (30C or 22-25C)" per the manufacturer. She confirmed there were no transport conditions instructions and urine specimens are delivered by the courier at room temperature. The laboratory's urine drug screen and oral fluid drug screen procedures did not include all established specimen handling requirements. II. Based on review of the laboratory's procedure manual, manufacturer's instructions, direct observation, patient test reports, and interview with technical supervisor 1, the laboratory failed to ensure their procedures included manufacturer's specimen requirements for 2 of 12 analytes (Ethyl Alcohol and Creatinine) tested on the Beckman Coulter AU5800. Findings included: 1. Review of the laboratory's procedure manual for urine creatinine stated, "If not analyzed immediately, specimens may be stored unrefrigerated for up to 7 days following collection." Review of the Siemens Syva Creatinine Validity Test specimen manufacturer's instructions stated, "Analyze freshly collected urine specimens as soon as possible. Creatinine in urine is stable for 1-2 days when stored at 2-10C." Review of the laboratory's procedure manual for urine Ethyl Alcohol stated, "If not analyzed immediately, specimens may be stored unrefrigerated for up to 5 days following collection." The temperature for "unrefrigerated" was not defined. Review of the Siemens Syva Emit II Plus Ethyl Alcohol Assay specimen manufacturer's instructions stated, "For transporting, maintain the specimen temperature at 2-8C." 2. During an observation on 08/27/2024 at 10:18 am, the laboratory received urine specimens from one of their local collectors for urine drug screening on the Beckman Coulter AU5800. A sampling of those analyzed and reported for Ethyl Alcohol and Creatinine included specimens # 38617804, 38618348, 38617827, 38617983, 38618354 (collected 08/26/2024). The specimens were not transported in conditions of "2-10C" or "2-8C." 3. The laboratory was unable to provide urine stability studies to support their written procedure for storage at "unrefrigerated for up to 7 days" and "unrefrigerated for up to 5 days." 4. During an interview on 08/27/2024 at 4:30 pm, technical supervisor 1 confirmed there were no transport conditions instructions provided to collectors/couriers and urine specimens were delivered by the courier at room temperature. III. Based on review of laboratory's procedure manuals and direct observation, the laboratory failed to ensure urine specimen requirements were consistent for urine drug screen on the Beckman Coulter AU5800 and urine confirmation testing on the gas chromatography mass spectrometry (GC-MS) and liquid chromatography mass spectrometry (LCMS) for 7 of 11 drug analytes. Findings included: 1. Review of the laboratory's procedure manual for GCMS testing amphetamines, benzoylecgonine, 6-acetylmorphine, opiates, methadone, phencyclidine, delta9-tetrahydrocannabinol (THC), and LCMS testing fentanyl and norfentanyl stated, "It is recommended that urine specimens be -- 2 of 5 -- stored at 2-8C. For prolonged storage, freezing of specimens is recommended." Review of the laboratory's procedure manual for Beckman Coulter AU5800 screening amphetamines, benzoylecgonine, 6-acetylmorphine, opiates, methadone, phencyclidine, and THC, stated, "If not analyzed immediately, specimens may be stored unrefrigerated for up to 7 days following collection." Review of the laboratory's procedure manual for Beckman Coulter AU5800 screening fentanyl did not include specimen requirements. The urine specimen submitted for screening is used for confirmation testing upon request. The specimen storage requirements were not consistent with one another for screening and confirmation testing. 2. During an observation on 08/27/2024 at 10:18 am, the laboratory received urine specimens from one of their local collectors for urine drug screening on the Beckman Coulter AU5800. The specimens were not transported at "2-8C" as defined by the laboratory's GCMS and LCMS specimen requirements. The laboratory did not ensure specimen storage and handling requirements were consistent in their written procedures for Beckman Coulter AU5800 screening and GCMS and LCMS confirmation testing. Word Key: C = degree Celsius D5315 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(c) The laboratory must refer a specimen for testing only to a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by CMS. This STANDARD is not met as evidenced by: Based on review of the laboratory's test menu, interview with staff, Centers for Medicare & Medicaid Services-116 (CMS-116) database, and specimen tracking report, the laboratory failed to refer 163 of 163 synthetic cannabinoids-3 (K2-3) specimens for confirmation testing to a CLIA-certified laboratory. Findings included: 1. Review of the laboratory's test menu included screening K2-3 drug analyte on the Beckman Coulter AU5800. 2. During an interview on 08/28/2024 at 10:03 am, technical supervisor 1 and technical supervisor 2 stated K2-3 specimens were referred for confirmation testing to the District of Columbia (D.C.) Office of Chief Medical Examiner laboratory, who is accredited by the American Board Forensic Toxicology. 3. A search for the laboratory in the CMS-116 database did not include a CLIA number for the D.C. Office of Chief Medical Examiner laboratory. 4. According to a specimen tracking report from 01/01/2023 through 12/31/2023, a total of 163 K2-3 urine specimens were referred to the non-CLIA certified laboratory for confirmation testing. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on review of collection instructions, procedure manuals, and direct observation, the laboratory failed to include all specimen requirements in their instructions to collectors for urine and oral fluid drug testing. Findings included: 1. Review of "Drug Testing Protocol and Procedure for Urine Sample Collection" did not include the -- 3 of 5 -- following: a) Specimen storage and preservation. The procedure stated, "The sample will then be placed in the box in the specimen refrigerator for transport." Storage temperature and stability was not defined. b) Conditions for specimen transportation. The laboratory's procedures included "unrefrigerated" for drug screen testing, "2-8C" for confirmation testing, or did not include any specimen handling requirements. Refer to D5311. c) Specimen acceptability and rejection criteria. The laboratory's "Specimen Processing" procedure stated, "Any discrepancy in specimen identity or integrity causes refusal of the specimen by the laboratory staff." 2. Review of the collection instructions for Oral Fluid did not include the following: a) Specimen labeling, including patient name or unique patient identifier and specimen source. b) Specimen storage and preservation. The instructions stated, "The collector is placed in a transport tube containing a buffer which stabilizes the specimen for shipping and storage." Storage and shipping conditions were not defined. The stability at a defined condition was not provided. c) Conditions for specimen transportation. The laboratory's procedures included defined "room temperatures" (22-25C or up to 30C) with stability or did not include any specimen handling requirements. Refer to D5311. d) Specimen acceptability and rejection criteria. The laboratory's "Specimen Processing" procedure stated, "Any discrepancy in specimen identity or integrity causes refusal of the specimen by the laboratory staff." 3. During an observation on 08 /27/2024 at 10:18 am, the laboratory received urine specimens from one of their local collectors for urine drug screening on the Beckman Coulter AU5800. A sampling of those analyzed and reported were specimens # 38617804, 38618348, 38617827, 38617983, 38618354 (collected 08/26/2024). The laboratory did not ensure all written specimen handling requirements were provided to the collectors for urine and oral fluids. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on review of establishment studies, laboratory procedures, and interview with technical supervisor 1, the laboratory failed to establish urine specimen requirements for their new LCMSMS fentanyl and norfentanyl method effective 03/2024. Findings included: 1. Review of the laboratory's establishment studies for fentanyl and norfentanyl method on the LCMSMS included laboratory director signature and date of approval 01/29/2024 and effective 03/2024. The data and summary did not include specimen establishment requirements, storage temperature/s, stability, preservation, and conditions for transportation. 2. Review of the laboratory's "Initial Validation of Confirmatory GC/MS and LC-MS/MS Testing Method" procedure did not include methods for establishing specimen requirements. 3. Review of the laboratory's "LCMSMS-FENT" procedure stated, "It is recommended that urine specimens be -- 4 of 5 -- stored at 2-8C. For prolonged storage, freezing of specimens is recommended." The laboratory did not have studies to support the defined specimen storage temperature. 4. During an interview on 08/27/2024 at 4:30 pm, technical supervisor 1 confirmed specimen stability studies had not been completed as part of the fentanyl and norfentanyl LCMSMS establishment protocol. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on interview with technical supervisor 1, review of temperature logs and the Rees Scientific system, the laboratory failed to have a quality assessment (QA) program that identified and corrected issues with their Rees Scientific temperature monitoring system for 175 of 308 days (10/2023 through 08/2024). Findings included: 1. During an interview on 08/28/2024 at 11:00 am, technical supervisor 1 displayed the Rees Scientific temperature monitoring system on the computer. She stated the laboratory's refrigerators, freezers, and rooms were monitored and documented electronically by this system every 15 minutes. In addition, the staff documented temperatures from thermometers on paper logs for refrigerators, freezers, and rooms. Temperature logs from 2023 and 2024 were reviewed for completion. 2. During a sampling review of the Rees Scientific temperature monitoring system included the "Walk-In Specimens" refrigerator (defined range 2-8C) from 01/21/23 through 08/27 /2024. The Rees Scientific temperature monitoring system was not operational from 10 /24/2023 through 01/31/2024, 03/14/2024 through 04/03/2024, and 05/07/2024 through 07/02/2024 (175 days). 3. During an interview on 08/28/2024 at 11:00 am, technical supervisor 1 was asked whether their QA program monitored the Rees System to ensure it was operational, she stated their QA had not monitored and identified this issue. -- 5 of 5 --

Summary Statement of Deficiencies D0000 The Office of Forensic Toxicology Services was surveyed under 42 CFR part 493 CLIA regulations. The following standard deficiency was found during the announced routine CLIA recertification survey performed on March 16, 2023: D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of the laboratory Standard Operating Procedures (SOP) and an interview with the Laboratory Director, the laboratory failed to follow its policy to review 1 of 2 SOPs at least on an annual basis, and every change to the SOP from the last survey. Findings Include: 1. Review of the Quality Assurance Confirmation Unit (QA-1, QA Program), section B.6.1 stated, "The director is ultimately responsible for the SOPs. He/ She must review, approve and sign each SOP pertaining on an annual basis and must review, approve, and sign every change to an SOP." 2. On the day of the survey, 3/16/2023 at 1 pm, a review of the Immunoassay/Screening Urine Section SOP, revealed that the SOP was not reviewed at least on an annual basis, and every change to the SOP from the last survey. 3. Interview with the Laboratory Director on 3 /16/2023 at 1:40 pm confirmed the laboratory did not follow the established written policy QA-1, QA Program SOP regarding SOP review, approval, and signature. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 Federal surveyors from the Division of Clinical Laboratory Improvement & Quality CLIA Operations, Centers for Medicare and Medicaid Services (CMS) - Philadelphia CMS Office conducted an announced CLIA Recertification survey at the Office of Forensic Toxicology Services- 90K laboratory on March 16, 2021. The laboratory was surveyed under 42 CFR part 493 CLIA requirements. Specific deficiencies cited are as follows: D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation, inventory records review and staff interview the laboratory failed to discard current in use lot of expired Dimethyl Sulfoxide (DMSO) reagents . Findings include: 1. During a tour of the Pretrial Services Agency (PSA) laboratory testing area on March 16, 2021 at approximately 9:55am, the tour revealed 3 of 3 current lot at the time of the survey of expired bottles of Dimethyl Sulfoxide (DMSO). a. Lot # : SHBJ45963 2. An inventory document on the outside of the reagent storage cabinet detailed: a. Type of Reagent: (DSMO) Quantity: 3 Expiration date : February- 2021. 3. During the exit interview on March 17, 2021 at approximately 1:00 PM, the laboratory director confirmed the above finding. D6121 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observations of routine patient test performance, including patient Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- preparation, if applicable, specimen handling, processing and testing. This STANDARD is not met as evidenced by: Based on review of competency records, policy and procedures, and staff interview the laboratory technical supervisor#1 failed to follow competency assessment policy to directly observe staff during the 2020 competency assessments for 90K laboratory testing personnel. Findings include 1. On March 17, 2021, during a review of 2020 competency records of 90K laboratory evaluation period of July 2020- December 2020, the records revealed, in the section titled " Directly Observing Performance of Routine Drug of Abuse Tests", a diagonal line crossing out the entire section with no information of dates or initials of the reviewer. a.5 out of 5 testing personnel had no information completed 2. Review of staff competency Assessment Section procedures states " all competency assessment shall be recorded showing date and results and shall be kept confidential" 3. CMS surveyor #2 asked Technical Supervisor (TS#1) of the section why were the other sections completed in the assessment and not direct observation? TS#1 stated " I couldn't do it due to distancing issue with COVID-19". 4. During the exit interview on March 17, 2021 at approximately 1:00 PM, the laboratory director confirmed the above finding. -- 2 of 2 --

Summary Statement of Deficiencies D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of proficiency testing documents and interview with staff, the laboratory has failed to retain all documented evidence of twice annual accuracy assessments performed for at least two years, as seven of seven testing events of College of American Pathologists (CAP) Urine Drug Confirmation (UDC) Proficiency Testing (PT) surveys, the facility participated in from January 2017 through October 2018, there was no records maintained by the facility that showed how analyte results were obtained. Findings include: 1. The surveyor noted the facility uses quarterly participation in the College of American Pathologists (CAP) Urine Drug Confirmation (UDC) Proficiency Testing (PT) surveys to periodically assess its' urine drug GCMS confirmation testing methology. 2. During 2017 in four of four events (2017 A-D) there was no record of retained CAP UDC PT runs, batch history, worksheet, and result forms, saved by the facility. 3. During 2018 in three of three events (2018 A-C) there was no record of retained CAP UDC PT runs, batch history, worksheet, and result forms, saved by the facility. 4. During an interview with the lab director and technical supervisor at approximately 1:45pm on Nov 27, 2018, there was an admission that records of CAP UDC PT event participation by the facility showing how the results were actually obtained in the same manner as patient specimens were not maintained by the facility. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) policy, sample testing worksheets and interview with staff, the laboratory failed to establish policy and procedures that ensures positive identification and integrity of College of American Pathologists (CAP) PT specimens from the time of receipt of the survey through completion of testing and reporting of results for one of four CAP PT Urine Drug Confirmatory (UDC) testing events that contained ten (10) specimen testing bottles during 2017. Finding include: 1. The surveyor reviewed Management Instruction: CAP Forensic Urine Drug Testing (Confirmatory) PT dated March 25, 2013 and noted in the section titled 'Receipt of Survey' the following instructions were stated for testing personnel to follow "Upon receipt of the survey a file is created in DTMS using CAP as the Donor ID, CAP as the last name and the survey name (UDCA 2013 for example) as the first name. The specimen bottles can then be assigned specimen numbers (choose new specimen numbers to obtain a DTMS generated 9000 series ID number) and tests." 2. The batch review results worksheet created for CAP UDC 2017-B Event showed the printed labels (Specimen numbers) as 9000-1529 through 1538 created on May, 3, 2017 and each Donor ID was listed as 'CAP, UDCB 2017' for each of ten of ten specimen bottles. There was no further specimen ID delination as to which UDC 2017-B Bottle (identified as 1-10) corresponded to the Specimen numbers 9000-1529 through 1538. 3. During interview with the Technical Supervisor, General Supervisor and Lab Director at approximately 11:00am on November 27, 2018, there was an admission that testing personnel did not always record specific CAP bottle ID numbers along with specimen numbers generated by the LCMS to ensure positive identified and intregity of CAP PT samples testing. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of CAP PT event summary reports, management instructions and interview with staff, the laboratory failed to ensure all results of CAP UDC event results reviewed in five of seven total events reviewed, including: four testing events during 2017 and one event during 2018, were properly evaluated; all analytes the laboratory reported as part of its urine confirmatory testing processes had there accuracy verified at least twice per year, and all results that were identified by CAP as either unsatisfactory and/or unsuccessful had