Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on May 24, 2021. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on document review and interview with the staff, it was determined the laboratory failed to document inspection of the Eyewash bottles as required. The Findings include: 1. The review of maintenance records revealed that the laboratory failed to document inspection on the Eyewash bottles, as required on a weekly basis, according to the procedure manual for 2019, 2020, and thus far 2021. 2. During an interview with TP#3 and TP#4(CMS-209) on May 24, 2021 in the conference room, it was confirmed the laboratory failed to document an inspection on the Eyewash bottles as required for 2019, 2020, and thus far 2021. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. 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 -- (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on laboratory record review and staff interview, the laboratory failed to record humidity as required for syphilis testing. The Findings include: 1. The temperature records revealed that the laboratory failed to record humidity for syphilis testing, as required for 2019, 2020, and thus far 2021. 2. During an interview with the TP#3 and TP#4(CMS-209) on May 19, 2021 at approximately 12:30 PM in the conference room, it was confirmed that the laboratory failed to record humidity for 2019, 2020, and thus far 2021. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control (QC) document review and staff interview, the laboratory failed to document QC on syphilis testing. Findings include: 1. Based on review of QC documents, controls were performed on patient reports, but not documented in a log for 2019, 2020, and 2021, at the time of the survey. 2. During an interview TP#3 and TP#4(CMS-209) on May 25, 2021 at approximately 12:45 PM in the conference room, it was confirmed controls were not documented in a QC log for 2019, 2020, and 2021. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on Quality Assurance(QA) manual review and interview with the staff, the Lab Director(LD) failed to review all QA documents on a monthly basis as required by Clinical Laboratory Improvement Amendments (CLIA). Findings include: 1. Quality Assurance (QA) documents review revealed the laboratory director, did not review quality assurance documents as required for 2019, 2020, and 2021. 2. During an interview with the TP#3 and TP#4(CMS 209) in the conference room on May 19, 2021 at approximately 12:40 PM, it was confirmed the LD did not review QA documents as required in 2019, 2020 and 2021. -- 2 of 2 --