Summary:
Summary Statement of Deficiencies D5301 TEST REQUEST CFR(s): 493.1241(a) (a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on review of patient requisition information and interviews with laboratory personnel during the onsite survey conducted on June 2, 2026, it was determined that the laboratory failed to ensure that all tests were ordered by authorized individuals prior to accepting test requisitions. 180 of the 1712 tests were ordered by individuals who were not authorized to order clinical laboratory tests in the state of California. The findings included: 1. The reference laboratory performed high-complexity virology testing for the detection of sexually transmitted infections (STIs). 2. On the day of the survey, the surveyor reviewed patient requisitions from 05/20/2026 to 06/01 /2026. The surveyor observed that on 06/01/2026, approximately 180 tests had been ordered by an individual who did not have the qualifications required to order clinical laboratory tests in the state of California. On June 2, 2026, at approximately 1:00 pm, testing personnel confirmed that these tests had been ordered by an unauthorized person. 3. According to laboratory records, the laboratory performed and reported approximately 1712 STIs tests from May 20, 2026, through June 1, 2026. 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 provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the number and severity of the deficiencies cited herein, the Condition: Analytic Systems was not met. The laboratory failed to ensure that laboratory personnel followed the written procedures manual. See D5401 The laboratory failed to establish a written procedure manual that included the entering results into patient records and reporting patient results. See D5403 The laboratory failed to establish test performance specifications before reporting patient results. See D5423 D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the written procedure manuals, test records, including thirteen (13) patient sample reports from 05/20/2026 to 06/01/2026, and interviews with laboratory testing personnel on June 2, 2026, it was determined that laboratory personnel did not follow the written procedures manual for repeat criteria. The findings included: 1. The laboratory performed high-complexity virology testing for the detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Mycoplasma genitalium (MG) and Trichomonas vaginalis (TV). According to the laboratory procedure manual, if the internal control (IC) fails, the extraction should be repeated. If IC fails again, the result must be reported as invalid. 2. On June 2, 2026, at approximately 12:00 p.m., laboratory testing personnel stated that the laboratory repeated all positive tests in duplicate and accepted the results if both results matched. During the survey, the surveyor reviewed 13 repeated samples and found inconsistencies with the established policies and procedures. ACC# 2434589U: The initial run failed for IC; the test was repeated in duplicate. The results of one repeat were positive for CT, and one was negative for CT; the test was reported as positive for CT. ACC# 2434461U: On the initial run, CT and MG were positive; the test was repeated once. The result of the single repeat was positive for MG and negative for CT; the test was reported as positive for MG and negative for CT. ACC# 24344754U: On the initial run, CT was positive; the test was repeated in duplicate. The results of one repeat were positive for CT, the other was negative for CT; the test was reported as inconclusive. 3. According to laboratory records, the laboratory performed and reported approximately 1712 STIs tests from May 20, 2026, through June 1, 2026. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of -- 2 of 6 -- results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)