Summary:
Summary Statement of Deficiencies D2029 MYCOBACTERIOLOGY CFR(s): 493.825(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the first quarter 2023 (Q1-2023), of the College of American Pathologist (CAP) proficiency testing records, random review of seven (7) patient testing records, and interviews with the laboratory director (LD) and technical supervisor (TS); it was determined that the laboratory failed to attain an overall testing event score of at least 80 percent in Mycobacteriology. The findings included: 1. For Q1-2023, CAP reported an unsatisfactory proficiency testing result for Mycobacteriology with score of 67%. 2. The LD and TS affirmed on September 12, 2023, at approximately 10:30 a.m. that the laboratory received the unsatisfactory score stated in 1. 3. Based on the laboratory's testing declaration submitted on 9/12/2023 and signed by the LD on 9/7/2023, the laboratory analyzed and reported approximately 600 Mycobacteriology test annually including acid fast smears and organism identification. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual, lack of documentation, the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- surveyor's observation, and interview with the laboratory director (LD) and the technical supervisor (TS); it was determined that the laboratory failed to perform and document maintenance and calibration as defined by the manufacturer and with at least the frequency specified by the manufacturer for the laboratory's small equipment. The findings included: 1. The laboratory's standard operating procedure (SOP) indicated that preventive maintenance and calibration be performed on all equipment and instruments used in the laboratory. 2. The LD and TS confirmed on September 12, 2023, at approximately 1:50 p.m. that the laboratory failed to follow the manufacturer's instructions on preventive maintenance and calibration of small equipment such as timers, vortexes, microcentrifuges, mixers, and rotators. 3. According to the test volume declared by the laboratory on 9/7/2023 the laboratory performs approximately 23,920 diagnostic tests annually. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the surveyor's observation, review of the laboratory quality control (QC) records, Individualized Quality Control Plan (IQCP), and log of patients' results, and interview with the testing personnel (TP); it was determined that the laboratory failed to establish quality control procedures that monitor the accuracy and precision of the complete analytic process including the number, the type, and the frequency of the QC materials when performing tests using various concentrations of Sodium Chloride (NaCl) solutions. 1. On the day of the survey September 12, 2023, at approximately 12:00 p.m., the surveyor observed while reviewing quality control logs and the IQCP in place for identification of Vibrio spp. that QC for NaCl different concentration solutions was not performed and documented when the procedure was performed. 2. For one (1) out of one (1) random patient test results reviewed for identification of Vibrio spp., no QC was performed or documented for NaCl various concentration solutions used for the identification and speciation of Vibrio spp. organisms. 4. The LD and TP confirmed on September 12, 2023, that the laboratory lacked an established policy, procedure, and log for QC when using NaCl various concentration solutions. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on interview with laboratory director (LD) and technical supervisor (TS) and review of two (2) randomly chosen patients' reports; it was determined that the laboratory failed to inform the authorized providers of the tests interpretation for the presence or absence of SARS-CoV-2 (Covid19), Influenza, and Respiratory Syncytial virus (RSV) RNA when samples testing results were reported. The findings included: 1. For two (2) out of two (2) positive and negative testing results for Covid19, Influenza, and RSV RNA reviewed on September 12, 2023, the report submitted to the authorized providers showed no interpretation of the results. 2. The LD and TS affirmed that no interpretation of the results was provided to the sample submitters for Covid-19, Influenza and RSV RNA in the final reports. 3. The laboratory tests and reports approximately 3,200 samples annually for the presence or absence of Covid19, Influenza, and RSV RNA. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. This STANDARD is not met as evidenced by: Based on review of the laboratory's records for policies and procedures, patients' test results records, proficiency testing reports, direct observation by the surveyors during the lab tour, and interviews with the laboratory director, technical supervisor, and testing personnel on September 12, 2023; it was determined that the laboratory director failed to ensure that several aspects of the preanalytic, analytic, and postanalytic phases of laboratory testing were monitored. See D2029, D5429, D5441, and D5807. -- 3 of 3 --