Summary:
Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: . Based on record review and interview with the Owner, the laboratory failed to retain its molecular amplification original cycle threshold (Ct) values for its quality control, patient testing, and wipe tests for 5 (August 2023 to December 2023) of 5 months since the laboratory began testing using these methods. Findings include: 1. A review of the laboratory's patient testing and quality control documentation for its molecular testing panels revealed the laboratory had manually transcribed "+" on the plate maps indicating when wells on the 96-well plates had positive amplification. 2. A review of the laboratory's "LOD Vaginitis" policy revealed a section stating, "After consulting with the Streamline Scientific and re-evaluating the data, the limit of detection (LOD) was determined for the Vaginitis assays to be 36.00 Ct." 3. The surveyor requested the original cycle threshold (Ct) values for the laboratory's quality control, patient testing, and wipe tests on 12/20/23 at 2:08 pm, 12/26/23 at 2:01 pm, and 12/27/23 at 12:32 pm and the records were not made available. 4. An interview on 12/27/23 at 12:45 pm with the Owner confirmed the Ct values for the laboratory's quality control, patient testing, and wipe tests were not available. 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 7 -- 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 record review, observation, and interviews, the laboratory failed to ensure reagents and collection tubes had not exceeded expiration dates (refer to D5417), failed to establish performance specifications for its Sexually Transmitted Infection (STI) and Chlamydia and Gonorrhea (CT/NG) molecular assay panels (refer to D5423), failed to perform control procedures at least every date of patient testing for its Urinary Tract Infection (UTI), Vaginitis, Sexually Transmitted Infection (STI), and Chlamydia and Gonorrhea molecular-based panels (refer to D5445), and failed to perform