Summary:
Summary Statement of Deficiencies D0000 An announced validation survey of the laboratory was conducted on 11/20/2024. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. STANDARD LEVEL DEFICIENCIES were cited. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of laboratory's policies/procedures, instructions to clients, surveyor's observations and staff interview, the laboratory failed to ensure specimens were labeled with collection date and/or patient's date of birth for thirty-two of thirty-four specimens observed. Findings included: 1. Review of laboratory's policy/procedure "General Laboratory Information" (GEN-001, Version 1.0, last reviewed 04/28/2022) revealed: "SPECIMEN LABELING Specimens should be labeled with: the patient's name, date of birth, date and time collected, and initials of the collector." And, "Specimens that are not properly labeled or are labeled incorrectly will be rejected." 2. Review of laboratory's instructions to clients "Nasopharyngeal Specimen Collection Instructions" and "Urine Specimen Collection Instructions" revealed: "All specimens submitted to laboratory must have a completed requisition form and the following information labeled on the collection tube in legible format: - full name of patient - date of birth - date of specimen collection" 3. Surveyor's observations on 11/20/2024 at 1315 hours in the laboratory's specimen preparation/extraction room revealed 23 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- urine samples and 11 Viral Transport media samples stored in the refrigerator. Examination of specimen labeling revealed thirty-two of the thirty-four stored samples did not have annotations of collection date/time on the specimen container and three of the thirty-four stored samples did not have documentation of patient's date of birth. These were: UTI (urinary tract infection) 11/20 Run 1: Sample # (number) 1 - not labeled with date/time of collection Sample #2 - not labeled with date /time of collection Sample #3 - not labeled with date/time of collection Sample #4 - not labeled with date/time of collection Sample #5 - not labeled with date/time of collection Sample #6 - not labeled with date/time of collection Sample #7 - not labeled with date/time of collection Sample #8 - not labeled with date/time of collection Sample #9 - not labeled with date/time of collection Sample #10 - not labeled with date/time of collection Sample #11 - not labeled with date/time of collection, or patient's date of birth Sample #13 - not labeled with date/time of collection Sample #14 - not labeled with date/time of collection, or patient's date of birth Sample #15 - not labeled with date/time of collection, or patient's date of birth Sample #17 - not labeled with date/time of collection Sample #18 - not labeled with date/time of collection Sample #19 - not labeled with date/time of collection Sample #20 - not labeled with date/time of collection Sample #21 - not labeled with date/time of collection Sample #22 - not labeled with date/time of collection Sample #23 - not labeled with date/time of collection COVID 11/20 Run 1: Sample #1 - not labeled with date/time of collection Sample #2 - not labeled with date/time of collection Sample #3 - not labeled with date/time of collection Sample #4 - not labeled with date /time of collection Sample #5 - not labeled with date/time of collection Sample #6 - not labeled with date/time of collection Sample #7 - not labeled with date/time of collection Sample #8 - not labeled with date/time of collection Sample #9 - not labeled with date/time of collection Sample #10 - not labeled with date/time of collection Sample #11 - not labeled with date/time of collection 4. In an interview on 11/20/2024 at 1325 hours in the office, the laboratory's General Supervisor (as indicated on submitted Form CMS 209) confirmed the findings. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of laboratory's policies/procedures, instructions to clients, surveyor's observations, FedEx packaging and labeling instructions, patient test volumes and staff interview, the laboratory's Quality Assurance failed to identify and correct issues with specimen labeling for two of four test platforms performed by the laboratory in 2023 and 2024. Refer to D5311 A and B. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. -- 2 of 4 -- This STANDARD is not met as evidenced by: A. Based on review of laboratory's quality control (QC) records, policies/procedures, patient test/instrument records, patient final reports and staff interview, the laboratory failed to ensure all controls were acceptable prior to releasing patient reports for three of eleven patients' UTI (urinary tract infection) Assay tests with failed internal controls reviewed from April of 2024. Findings included: 1. Review of laboratory's "Quality Control Log/UTI Biorad #269" revealed UTI Run 1 from 04/30/2024 had the following annotation for