Urgent Care - Veteran's Blvd, The

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(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: A Follow-up/Validation survey was performed at The Urgent Card Veteran's Blvd, CLIA ID 19D2247047, on April 15, 2024 through April 16, 2024. Based on review of the laboratory's policy and procedure manual, and interview with personnel, the laboratory failed to establish a complete policy and procedure manual. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not include the following policies: a) Twice a year instrument comparison of test results for the same tests performed on multiple instruments b) Maintenance procedures and frequency of performance for PCR hoods 2. In interview on April 16, 2024 at 12:38 pm, the Technical Supervisor stated she did not update the laboratory's policies to include twice a year instrument comparison and PCR hood maintenance procedures. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: A Follow-up/Validation survey was performed at The Urgent Care Veteran's Blvd, 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 -- CLIA ID 19D2247047, on April 15, 2024 through April 16, 2024. Based on review of policies and interview with laboratory personnel, the Laboratory Director failed to ensure that a complete and approved procedure manual was available to all personnel. Refer to D5401. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Validation survey was performed at The Urgent Care Veteran's Blvd, CLIA ID 19D2247047, on November 6, 2023 through November 7, 2023. The Urgent Care Veteran's Blvd was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1250 CONDITION: Analytic systems 42 CFR 493.1290 CONDITION: Postanalytic systems 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing; Laboratory Director 42. CFR 493.1409 CONDITION: Laboratories performing moderate complexity testing; Technical Consultant 42 CFR 493.1441 CONDITION: Laboratories performing high complexity testing; Laboratory Director 42 CFR 493.1447 CONDITION: Laboratories performing high complexity testing; Technical supervisor 42 CFR 493.1487 CONDITION: Laboratories performing high complexity testing; Testing Personnel D3033 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(i) In addition, the laboratory must retain records of test system performance specifications that the laboratory establishes or verifies under 493.1253 for the period of time the laboratory uses the test system but no less than 2 years. This STANDARD is not met as evidenced by: Based on review of the laboratory's performance specification records and interview with personnel, the laboratory failed to retain their Laboratory Information System (LIS) verification records for at least two (2) years. Findings: 1. In interview on October 6, 2023 at 11:53 am, the Technical Consultant stated patient testing began in June 2022. 2. Review of the laboratory's performance specification records revealed the laboratory did not include the following: a) Initial LIS validation to ensure patient results were transmitted accurately for Urinary Tract Infections (UTI) , Sexually Transmitted Infections (STI) and SARS COV-2 testing for two (2) QuantStudio 5 analyzers (Quancy 1 and 2) b) 2023 LIS verification records for STI (Quancy 2) and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 24 -- SARS COV-2 (Quancy 1 and 2) testing 3. In interview on October 7, 2023 at 10:23 am, the Technical Consultant confirmed the laboratory did not have documentation of an initial LIS validation in 2022 and the identified records for 2023. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, proficiency testing records, and interview with personnel, the laboratory failed to retain proficiency testing records for at least two (2) years for one (1) of three (3) Microbiology events reviewed in 2023. Findings: 1. Review of the laboratory's "Proficiency Testing Procedures" policy revealed "All records of external PT testing are kept for at least two years." 2. Review of the 2023 American Proficiency Institute (API) proficiency testing (PT) records for the "Microbiology-3rd Event" revealed the laboratory did not retain the supporting documents to include instrument printouts and laboratory data for results submitted for Urinary Tract Infections, Sexually Transmitted Infections and SARS COV-2. 3. In interview on November 6, 2023 at 11am, the Technical Consultant confirmed the Microbiology Event 3 data was not in the proficiency testing binder. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, proficiency testing records, and interview with personnel, the laboratory failed to successfully verify the accuracy of SARS COV-2 testing at least twice annually in 2023. Findings: 1. Review of the laboratory's "Proficiency Testing Procedures" policy revealed "Two failing events of (2 of 3 consecutive failures) for the same analyte are termed unsuccessful and indicate a fundamental problem with the test method.