Summary:
Summary Statement of Deficiencies D0000 A scheduled initial survey was conducted 11/13/20 at Fernandez Community Center. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Clinical Laboratories. The laboratory performs urine drug screen testing on the ThermoFisher Indiko Plus analyzer for the following 10 analytes: Heroin Metabolite, Amphetamine, Benzodiazepine, Buprenorphine, Cocaine, Ethanol, Hydrocodone, Methadone, Oxycodone and Cannabinoids (THC). The laboratory's estimated annual test volume per year is 10,400, as stated on the Center for Medicare & Medicaid Services (CMS)-116 form submitted at time of survey. Total number of patients tested since June 2018 until time of survey is approximately 3,510. Based on survey findings, an Immediate Jeopardy situation was identified. The laboratory was notified at approximately 1:30 p.m. 11/13/20. The laboratory director/technical consultant failed to provide overall management and direction to the laboratory for the toxicology testing performed. The following Conditions were not met: D5022- Toxicology 493.1213 D6000-Laboratories performing moderate complexity testing; laboratory director 493.1403 D6063-Laboratories performing moderate complexity testing; testing personnel 493.1421 D3033 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(i) In addition, the laboratory must retain records of test system performance specifications that the laboratory establishes or verifies under 493.1253 for the period of time the laboratory uses the test system but no less than 2 years. This STANDARD is not met as evidenced by: Based on review of laboratory performance specification records and interview with testing personnel (TP) #1 11/13/20, the laboratory failed to retain the raw data used to determine the validation of performance specifications for the Indiko Plus analyzer. Findings: Review of performance specification records revealed EP Evaluator Graphs were used to demonstrate precision, accuracy and linearity for each of the analytes Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- tested on the Indiko Plus analyzer. The records failed to include the raw data used to create the EP Evaluator Graphs. Interview with TP #1 at approximately 12:00 p.m. confirmed the laboratory had not retained the raw data. He stated the performance specification testing was performed by the ThermoFisher representative and he was unsure where it would be. D5022 TOXICOLOGY CFR(s): 493.1213 If the laboratory provides services in the subspecialty of Toxicology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory records, and interviews with TP #1 11/13/20, the laboratory failed to meet all specified requirements for the performance of toxicology testing on the Indiko Plus analyzer. Findings: 1. The laboratory failed to verify the accuracy of all testing performed on the Indiko Plus toxicology analyzer at least twice annually since June 2018, a period of approximately 29 months in which verification of accuracy was not performed. See D5217. 2. The laboratory failed to have complete and current procedures for the testing performed on the Indiko Plus analyzer. See D5403. 3. The laboratory failed to monitor and document the conditions essential for proper storage of reagents, calibrators, controls and patient specimens and failed to monitor and document conditions essential for accurate and reliable testing on the Indiko Plus analyzer since June 2018, a period of approximately 29 months in which patient testing was performed. See D5413. 4. The laboratory failed to verify the precision of the Indiko Plus analyzer and failed to verify the LIS LabTrak accurately receives and transmits data as established by the manufacturer before beginning patient testing in June of 2018. See D5421. 5. The laboratory failed to document required maintenance for the Indiko Plus analyzer and failed to perform maintenance of the LIS LabTrak since June 2018, a period of approximately 29 months in which patient testing was performed. See D5429. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of laboratory procedures, lack of verification of accuracy records and interview with TP #1 11/13/20, the laboratory failed to verify the accuracy of all testing performed on the Indiko Plus toxicology analyzer at least twice annually since June 2018, a period of approximately 29 months in which verification of accuracy was not performed. Findings: Review of laboratory procedure, "External Monitoring Program", revealed "External quality assurance procedures are used to compare the performance between different laboratories and are important for maintaining the long- term accuracy of analytical methods...If available, the laboratory must participate in external programs..." The procedure then explains how results should be processed and evaluated. Review of laboratory procedure, "Quality Assessment Program", under section "Proficiency Proformance Evaluations" revealed "The laboratory tests that are -- 2 of 10 -- not CLIA regulated for PT purposes and therefore are tested twice per year by a scientifically defensible means to verify accuracy." Review of laboratory procedure, "Quality Improvement Plan", under section "Department Specific Process: Toxicology" revealed "2. API Quality Improvement Programs: The Toxicology department participates in the API PT program and inter-laboratory blind sample comparison with a CLIA/COLA accredited laboratory." Review of laboratory records revealed no documentation the laboratory participated in an "external monitoring program", the API PT program or an "inter-laboratory blind sample comparison" to verify the accuracy of testing performed on the Indiko Plus analyzer. Interview with TP #1 at approximately 1:00 p.m. confirmed the laboratory had not participated in any "external monitoring program" to verify the accuracy of testing performed. He stated he did not realize the laboratory needed to do this. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)