Summary:
Summary Statement of Deficiencies D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on record review, the laboratory did not request that the proficiency test provider (API) report proficiency test scores for testing performed on the hematology analyzer to CMS (Centers for Medicare & Medicaid Services). Findings: 1. The Proficiency test results for the hematology analyzer were not reported on the CASPER report 96D (CLIA application and survey summary) for the laboratory. 2. The proficiency test providers reports in 2023, to the laboratory, evaluating the laboratorys performance for the hematology analyzer did not state that the proficiency test scores (performance) were reported to CMS. 3. The API website for reporting laboratory proficiency test evaluations does not show that the CLIA number associated with the Germantown office was enrolled for proficiemcy testing. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of proficiency testing records, and interview, the laboratory did not Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- rotate proficiency testing among all testing staff. Findings: 1. At the time of the survey, the laboratory had at least two staff members that should have shared or rotated duties for testing proficiency test samples and reporting the results to the proficiency test provider for evaluation of performance, but only one testing person performed the proficiency testing for in 2023. 2. This was confirmed during interview with testing person #1 on the afternoon of the day of survey. D2011 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(3) Laboratories that perform tests on proficiency testing samples must not engage in any inter-laboratory communications pertaining to the results of proficiency testing sample (s) until after the date by which the laboratory must report proficiency testing results to the program for the testing event in which the samples were sent. Laboratories with multiple testing sites or separate locations must not participate in any communications or discussions across sites/locations concerning proficiency testing sample results until after the date by which the laboratory must report proficiency testing results to the program. This STANDARD is not met as evidenced by: Based on review of written procedures, the hematology laboratory (CBC testing on the hematology analyzer) did not have written procedures to ensure proficiency test results were not compared between the Rockville office laboratory and the Germantown office laboratory prior to reporting results to the proficiency test provider for evaluation. Findings: 1. Proficiency test providers mail a set of unknown samples to laboratories for testing, the providers receive the test results and evaluate the laboratories accuracy. A proficiency test event occurs each time a shipment of unknown samples is received by the laboratory. 2. Testing staff rotate between the Rockville and Germantown office. For each proficiency test event, both offices receive the same proficiency testing samples from the same proficiency testing provider as each duplicate set of samples arrive in two separate boxes at the Rockville office before having one box of samples taken to the Germantown office for testing. 3. There is no written procedure to ensure that the results obtained from the two offices are not compared between the two laboratories prior to reporting to the proficiency test provider for scoring or evaluating performance, and that the same person does not perform the proficiency testing at both offices for the same test event. 4. If the laboratories cannot ensure that different people perform the proficiency testing for the Germantown and Rockville laboratories for a single proficiency test event, then the laboratory will need to use a different proficiency test provider for each location. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on interview and review of the laboratory reagent log, the laboratory did not maintain a record of the manufacturer's name, lot number and expiration date of the hematology reagent pack used for hematology testing on the analyzer to ensure they -- 2 of 3 -- were not used past expiration. Findings: 1. The last recorded reagent on the laboratory log was on May 14, 2021. 2, This was confirmed during interview with testing person #1 on the afternoon of the day of survey. D5783