Summary:
Summary Statement of Deficiencies D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the College of American Pathologist (CAP) laboratory proficiency testing (PT) results, Casper Report 155, six (6) randomly selected patient records ranging from 01/03/2022 to 03/01/2024, and interviews with the laboratory director (LD) and technical supervisors (TSs); it was determined that the laboratory failed to attain an overall testing event score of at least 80 percent in Bacteriology which is an unsatisfactory performance. The findings included: 1. The laboratory attained a score of 72% for Bacteriology on the analyte "Bacterial Identification" obtaining Unacceptable Grades for samples D-08 and D-10 for the second PT event of 2022 (Q2-2022) 2. The LD and TSs affirmed on 3/14/2024 at approximately 3:25 p.m. that the laboratory received the above unsatisfactory proficiency testing scores. 3. Based on the laboratory's annual testing declaration submitted 3/14/2024 at the time of the survey, the laboratory performed and reported approximately 1,104 bacteriology organisms identifications on patients' samples. D2056 VIROLOGY CFR(s): 493.831(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the WSLH Proficiency Testing (PT) records and interviews with Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- the laboratory director (LD) and the technical supervisors (TSs); it was determined that the laboratory failed to attain a score of least 80 percent of acceptable responses for Measles and Mumps (MM) PCR testing. The findings included: 1. Based on review of PT records for the second event of 2023 (Q2-2023), WSLH reported an unsatisfactory score of 66% for MM tests performed as follow: Sample Result Acceptable Score MM-10 Positive Positive Pass MM-11 Negative Positive Fail MM- 12 Negative Negative Pass 2. The LD and TSs affirmed that the laboratory received the above unsatisfactory PT score for Q2-2023. 3. Based on the laboratory's testing declaration at the time of the survey on March 14, 2024, the laboratory reported 97 patient samples for Virology including Measles and Mumps tests. D2077 GENERAL IMMUNOLOGY CFR(s): 493.837(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of the proficiency testing (PT) records for the first event of 2023 (Q1- 2023), and interviews with the laboratory director (LD) and technical supervisors (TS); it was determined that the laboratory failed to participate a testing event for General Immunology which is unsatisfactory performance and resulted in a score of 0 for the testing event. The findings included: 1. Laboratory proficiency testing records showed the laboratory attained an overall score of 0% for General Immunology testing during Q1-2023 as follow: Oral HIV test = 0.0 % 2. The LD and TS affirmed on March 14, 2024, at approximately 3:25 p.m. the unsatisfactory score of 0% obtained by the laboratory on General Immunology testing for Q1-2023. 3. Based on the annual test volume reported at the time of survey, the laboratory performed and reported approximately 5,236 tests for General Immunology. D3003 FACILITIES CFR(s): 493.1101(a)(2) The laboratory must be constructed, arranged, and maintained to ensure contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized. This STANDARD is not met as evidenced by: Based on surveyor observation during the laboratory tour, review of records, and interview with the laboratory director (LD) on March 14, 2024; it was determined that the laboratory failed to perform the decontamination procedure for the cabinet where the master mix used for polymerase chain reaction (PCR) is prepared. Findings include: 1. During the laboratory tour at approximately 4:00 p.m. the surveyors' observed that the cabinet where the master mix is prepared had no log for -- 2 of 5 -- decontamination procedure nor was a procedure present at the time of the survey. 2. During an interview on March 14, 2024, at approximately 4:00 p.m., the LD confirmed that the laboratory failed to provide documentation for decontamination of patient specimens, equipment, and desk materials, when processing samples on the bench. 3. The laboratory's testing declaration form, signed by the laboratory director on March 14, 2024, stated that the laboratory performs approximately 20,350 samples annually. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (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. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)