Summary:
Summary Statement of Deficiencies D0000 An initial survey was conducted on May 13, 2026, wherein the laboratory was found not in compliance with the CLIA regulations under the following CONDITION: 493. 1100 Condition: Facility administration. 493.1230 Condition: General laboratory systems. 493.1250 Condition: Analytic systems. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). This CONDITION is not met as evidenced by: Based on the surveyors' review of the laboratory's 14 patient test records, lack of quality control documentation, quality assessment records, lack of verification of performance specifications documentation, observations during the tour, and interviews with the technical consultant (TC) and laboratory assistant (LA) on May 13, 2026, it was determined that the laboratory failed to meet applicable requirements under 493.1105. 1. The laboratory failed to retain its test requisition records. See D3027 2. The laboratory failed to retain records for quality control, patient test records and records documenting analytic system activities. See D3031 3. The laboratory failed to maintain its records for the verification of performance specifications for various tests. See D3033 . D3027 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(1) Test requisitions and authorizations. Retain records of test requisitions and test 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 -- authorizations, including the patient's chart or medical record if used as the test requisition or authorization, for at least 2 years. This STANDARD is not met as evidenced by: Based on the lack of documentation, review of 14 randomly chosen patient test results from 08/20/2024 to 04/23/2025, and interviews with the technical consultant (TC) and laboratory assistant (LA) on May 13, 2026, it was determined that the laboratory failed to follow their retention policy and procedure as reviewed at the time of the survey. The findings include: 1. The surveyor reviewed 14 patient records wherein the laboratory was unable to retrieve 13 test requisitions for the years 2024 and 2025. Accession # Report Date 240816001 08/20/2024 240816003 08/20/2024 240819001 08/20/2024 241107001 11/07/2024 241118003 11/18/2024 241118001 11/19/2024 241126002 11/27/2024 241126004 11/27/2024 250114001 01/10/2025 250211002 02 /05/2025 250320001 03/20/2025 250409001 04/09/2025 250422001 04/23/2025 2. The TC and LA confirmed by interviews on May 13, 2026, at approximately 1:15 p. m. that the laboratory failed to retain their test requisition records to verify any final reports for the years 2024 and 2025. 3. According to the testing declaration form (Lab- 144) submitted at the time of survey, the laboratory performed and reported approximately 3,000 tests annually including the time when test requisitions were not properly retained. . D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on the review of the laboratory's protocol of record retention, a total of 14 patient test records covering the period from 08/20/2024 to 04/23/2025, lack of quality control and quality assessment documentation, and interviews with the technical consultant (TC) on May 13, 2026; it was determined that the laboratory failed to retain the quality control, patient test records and quality assessment documentation. The findings include: 1. Review of the laboratory's written policy for record retention showed that the laboratory was required to retain both hard-copy and electronic documentation of quality control, patient test records, and quality assessment documentation, including preventive maintenance and