Ucsb Student Health Services Laboratory

Summary Statement of Deficiencies D2020 BACTERIOLOGY CFR(s): 493.823(a) 493.823(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 the surveyor's review of the American Proficiency Institute (API) proficiency testing (PT) results and an interview with the technical consultant (TC); it was determined that the laboratory failed to obtain an overall testing event score of at least 80 percent (%) in Bacteriology. The findings include: 1. The laboratory was enrolled in API PT program and received an unsatisfactory score of 67% for susceptibility testing in the second event of 2022 (Q2-2022). 2. A

Summary Statement of Deficiencies 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. (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 the surveyor's observation during the lab tour on the lack of calibrated thermometers in the refrigerators, freezers, heating blocks, etc. to verify digital temperature readings and interview with the laboratory's technical supervisors (TS) and testing personnel (TP); it was determined that the laboratory failed to monitor the digital temperature readings of equipment essential for proper storage of reagents and specimens that adversely affect patient test results. The findings included: 1. On the day of the survey, September 14, 2023, at approximately 2:35 p.m. based on the surveyors' observation and interview with the TS and TP; the laboratory failed to have up to date calibrated thermometers on the refrigerators, freezers, etc., that verify accurate digital thermometers readings which affect reagents and patients' samples testing. 2. The TS and TP confirmed on 9/14,/2023, at approximately 3:00 p.m. that the laboratory had no up to date calibrated thermometers in the refrigerators, freezer, heating blocks, etc. to verify digital temperature readings. 3. Based on the laboratory's submitted testing declaration volume, the laboratory tested and reported approximately 87,809 samples annually. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) 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 -- 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 surveyor's observation, and interview with the laboratory's technical supervisors (TS) and testing personnel (TP); 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 14, 2023, at approximately 3:00 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 9/14/2023 the laboratory performs approximately 87,809 diagnostic tests annually. 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 technical supervisors and testing personnel on September 14, 2023; it was determined that the laboratory director failed to ensure that several aspects of the analytic phase of laboratory testing were monitored. See D5413 and D5429. -- 2 of 2 --

Summary Statement of Deficiencies D3005 FACILITIES CFR(s): 493.1101(a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. This STANDARD is not met as evidenced by: Based on direct observation of the facilities layout, observation of the of the laboratory's SARS-CoV-2 RNA (COVID-19) Polymerase Chain Reaction (PCR) testing, and interviews with the technical supervisor (TS) and testing personnel (TP) on November 10, 2021 on its molecular amplification procedure; it was determined that the laboratory failed to ensure that the molecular amplification procedures which are not contained in closed systems have a unidirectional flow with separate areas for specimen preparation, RNA extraction, amplification, and product detection. The findings included: 1. The laboratory performed PCR testing for the presumptive detection of SARS-CoV-2 using the COVID-19 PCR Atilla thermo-amplification kit and amplification method on the BioRad instrument. 2. During the laboratory tour on 11/10/2021 at approximately 1:30 p.m. the surveyor observed that RNA extraction, preparation of reagents, and sample template addition were all performed in the same open area without unidirectional flow. 3. The TS and TP confirmed by interview on November 10, 2021 that the laboratory's molecular PCR testing for the presumptive detection of SARS-CoV-2 RNA was not set up in an unidirectional flow area. 4. Based on laboratory records, the laboratory performed and reported approximately 2,468 SARS-CoV-2 Real Time PCR molecular diagnostic tests annually. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system 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 -- must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on the incomplete laboratory's verification of performance documentation for the high complexity testing SARS-CoV-2 (COVID-19) RNA detection by the Polymerase Chain Reaction (PCR), interviews with the laboratory's technical supervisor (TS) and the testing personnel (TP), and two (2) randomly selected patient test records for COVID-19 reviewed from 11/08/2021 and 11/19/2021; the laboratory failed to demonstrate that it established performance specifications comparable to those established by the manufacturer. The findings included: 1. The laboratory had only documentation to show for determination of accuracy with no raw data by PCR performance specifications prior to reporting patient test results. The laboratory must be able to demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (A) Accuracy (B) Precision (C) Reportable range of test results for the test system (D) Sensitivity and (E) Specificity. 2. The laboratory was unable to provide for review additional documents using patient samples to establish the performance specifications in 1. 3. The TS affirmed at the time of the survey on 10/11/2021 at approximately 12:00 p. m. that no documents could be retrieved to show that the SARS-CoV-2 RNA detection by PCR performance specifications were performed prior to reporting patient test results when the laboratory went live testing and reporting COVID-19 diagnostic tests. 4. Based on the estimated annual tests volumes reported on 11/10/2021; the laboratory performed and reported approximately 2,468 SARS-CoV-2 PCR test. The precision and reliability of the reported results could not be assured. D6083 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) The laboratory director must ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed. This STANDARD is not met as evidenced by: Based on the surveyor's direct observations of the laboratory's SARS-CoV-2 PCR testing processes and interview with the laboratory's technical supervisor and testing personnel on November 10, 2021; the laboratory director failed to ensure that the physical plant and environmental conditions of the laboratory were appropriate for the testing performed. Findings include: See D3005. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's policies & procedures, performance specifications validation and verification records, and interview with the laboratory's technical supervisor on November 10, 2021 at approximately 1;00 pm; the laboratory failed to perform verification/validation procedures adequately. The findings include: See D5421 -- 3 of 3 --