Summary:
Summary Statement of Deficiencies D3029 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(2) Test procedures. Retain a copy of each test procedure for at least 2 years after a procedure has been discontinued. Each test procedure must include the dates of initial use and discontinuance. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's test report and interview with the laboratory technical supervisor on January 23, 2024, at 2:04 pm, the laboratory failed to retain its discontinued test procedure. The findings include: 1. The laboratory performed COVID PCR test using Biospeedy reagents on the Atila instrument. A total of 15 samples reviewed. The laboratory reported negative test result for the sample ID 221200093. The internal control for the sample had a Ct value of 44.96. However, the laboratory could not provide the test procedure used therefore, the sample's results cannot be assessed. The laboratory had an ownership change and did not have the test procedure used for the testing. Therefore, the accuracy of the COVID test results rendered by the laboratory cannot be assured and might have harmed patients. 2. The laboratory technical supervisor on January 23, 2024, at 2:04 pm, affirmed that the laboratory did not know what test procedure was used and the laboratory did not have a copy of the test procedure used. 3. The laboratory's testing declaration form, signed by the laboratory director on 1/22/2024 stated that the laboratory performs approximately 9,600 tests in virology, annually. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that 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 -- provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on Surveyor review of laboratory's test validation and quality assessment records, and interview with the laboratory technical supervisor on January 23, 2024, at 2:40 pm, it was determined that the laboratory did not meet the requirement under 493. 1253, and 493.1289 to fulfil the analytic systems condition. The laboratory's failure to meet the condition may have potentially harmed and affected patient care. The findings include: 1. The laboratory failed to establish and verify (validation) its test performance specifications, see D5423. 2. The laboratory failed to document all validation activities, see D5427. 3. The laboratory failed to assess analytical systems quality, see D5791. 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 Surveyor review of laboratory's test validation records, and interview with the laboratory technical supervisor on January 23, 2024, at 2:40 pm, the laboratory failed to establish and verify (validation) its UTI and RPP tests panels. The findings include: 1. The laboratory developed and performed molecular PCR test for its UTI and RPP panels using Biospeedy reagents on Atila instrument. However, the laboratory did not have any records showing that it had validated the UTI panel test and performed precision for the RPP panel test. Therefore, the accuracy of the UTI and RPP panels tests results rendered by the laboratory cannot be assured and might have had harmed patients. 2. The laboratory technical supervisor on January 23, 2024, at 2:40 pm, affirmed that the laboratory did not have the tests validation records. 3. The laboratory's testing declaration form, signed by the laboratory director on 1/22 /2024 stated that the laboratory performs approximately 12,000 tests, annually. D5427 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(c) (c) Documentation. The laboratory must document all activities specified in this section. This STANDARD is not met as evidenced by: -- 2 of 5 -- Based on Surveyor review of laboratory's test validation records, and interview with the laboratory technical supervisor on January 23, 2024, at 2:40 pm, the laboratory failed to document all test validation activities. The findings include: see D5423 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 Surveyor review of laboratory's policy and procedure, patients test and quality assessment records, and interview with the laboratory technical supervisor on January 23, 2024, at 2:40 pm, the laboratory failed to establish the quality assessment for the analytical system. The findings include: 1. The laboratory developed and performed tests in bacteriology and virology by molecular PCR technique. It ran UTI and RPP panels which include COVID test. The laboratory lacked its test validation records. The laboratory did not have a system in place to assess the quality of its work. Quality assessment is an ongoing review process that encompasses all facets of the laboratory's technical and non-technical functions at all location/sites where testing is performed. When the laboratory discovers an error or identifies a potential problem, actions must be taken to correct the situation. This correction process involves identification and resolution of the problem, and development of policies that will prevent recurrence. QA of the Analytic System includes assessing: Test procedures; Accurate and reliable test systems, equipment, instruments, reagents, materials, and supplies; Specimen and reagent storage condition; Equipment /instrument/test/system maintenance and function checks; Establishment and verification of method performance specifications; Calibration and calibration verification; Control procedures; Comparison of test results;