Summary:
Summary Statement of Deficiencies D0000 An initial survey was completed on 01-27-2025. Immediate Jeopardy existed for the following condition level deficiencies: 42 C.F.R. 493.801 Condition: Enrollment and testing of samples 42 C.F.R. 493.1230 Condition: General laboratory systems 42 C.F. R. 493.1250 Condition: Analytic systems 42 C.F.R. 493.1403 Condition: Laboratories performing Moderate complexity testing; laboratory director D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: 2000 A Based on direct observation, review of laboratory policy and procedures, review of American Proficiency Institute (API) records, and interview with testing personnel (TP) #2, the laboratory failed to enroll in proficiency testing challenges in 2023 through 2025 for four of four microbiology sub-specialties: bacteriology (0005), mycology (0025), parasitology (0035), and virology (0045). Findings Include: 1. Direct observation during a tour of the laboratory on 01-22-2025, at 11:10 am, the surveyor identified the GeneXpert Dx analyzer (serial number 120000042). The surveyor also identified four cartridge types being utilized by the laboratory these included the Xpert Xpress MVP (ref XPRSMVP-10), Xpert Xpress Strep A (ref XPRSTREPA-10), Xpert Xpress SARS-CoV-2_Flu_RSV plus (ref XPRS4PLEX-10) and Xpert CT/NG (ref GXCT/NG-10). 2. Review of each GeneXpert cartridge Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 15 -- instructions for use (IFU) revealed that they were used to test the analytes as follows: a. Xpert Xpress Strep A (ref XPRSTREPA-10) Streptococcus pyogenes group A b. Xpert Xpress SARS-CoV-2_Flu_RSV plus (ref XPRS4PLEX-10) SARS-CoV-2, Respiratory Syncytial Virus (RSV), Influenza A, Influenza B. c. Xpert Xpress MVP (ref XPRSMVP-10) Bacterial Vaginosis (BV), Candida species, Trichomonas Vaginalis d. Xpert CT/NG (ref GXCT/NG-10) Chamydia trachomatis, Neisseria gonorrhoeae 3. Review of laboratory policies and procedures revealed a document titled "Proficiency Testing" which stated, "The laboratory will be enrolled in an approved Proficiency testing program for all regulated analytes as specified in Subpart I, Proficiency testing Programs for non waived testing, of the CLIA regulations. For each unregulated analyte tat the laboratory is not enrolled in a CMS approved PT program, we will perform and compare the results of external split- specimen testing on at least five specimens twice a year in periodic intervals." 4. Review of laboratory's API proficiency testing records revealed the laboratory failed to enroll in PT for bacteriology (0005) for group A streptococcus, bacterial vaginosis screening, Neisseria gonorrhoeae and chlamydia trachomatis; mycology (0025) for Candida species; parasitology (0035) for trichomoniasis; and virology (0045) for Sars-CoV-2, Respiratory Syncytial Virus (RSV), Influenza A, Influenza B. 5. Review of laboratories test volume worksheet revealed the laboratory performed 1010 patient tests in the specialty of microbiology from July 2024 through January 2025. 6. During the survey on 01-22-2025, at 01:13 pm, TP #2 confirmed the surveyor's findings that the laboratory had failed to enroll in or perform proficiency testing for the sub- specialties of bacteriology, mycology, parasitology, and virology. D2000 B Based on review of the federal CASPER report 0096D, American Proficiency Institute (API) proficiency test (PT) records, and interview with testing personnel (TP) #2, the laboratory failed to attain a score of 80% for Red Blood Cell count (RBC) in the specialty of hematology for testing event 2 of 2024 (see D2121). D2121 HEMATOLOGY CFR(s): 493.851(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the federal CASPER report 0096D, American Proficiency Institute (API) proficiency test (PT) records, and interview with testing personnel (TP) #2, the laboratory failed to attain a score of 80% for Red Blood Cell count (RBC) in the specialty of hematology for testing event 2 of 2024. Findings Include: 1. Review of the federal CASPER report 0096D revealed the following unsatisfactory scores for API PT event 2 of 2024: a.60% - Red blood cell count (RBC) 2. Review of the laboratory's API records for hematology event 2 of 2024 confirmed the laboratory had unacceptable scores (60%) for red blood cell count for event 2 of 2024 and no