Summary:
Summary Statement of Deficiencies D0000 An onsite validation survey was completed on March 18, 2025, the following deficiencies are a result of lack of proficiency testing scores obtained from the national database or lack of documentation to establish a means to verify the accuracy twice a year. The facility was found to be out of compliance with the following CONDITION LEVEL DEFICIENCY: D2000 42 C.F.R. 493.801 Condition: Enrollment and testing of samples 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: Based on review of proficiency testing (PT) records for 2023, 2024 2025 and interview with the general supervisor (GS) #1, the laboratory failed to establish a means to verify the accuracy twice a year for the non-regulated gram stain tissue testing and acid fast bacilli tissue stain testing in 2023, 2024, and to date March 18, 2025 (Refer to D2003). D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) (2)(ii) For those tests performed by the laboratory that are not included in subpart I of 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 -- this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1). This STANDARD is not met as evidenced by: Based on review of proficiency records for 2023, 2024, and to date March 18, 2025, and interview with the general supervisor (GS) #1, the laboratory failed to establish a means to verify the accuracy for 2 of 2 non-regulated analytes twice a year in 2023, 2024, and to date March 18, 2025. Findings: 1. Review of proficiency records for for 2023, 2024, and to date March 18, 2025 and lack of documentation to prove accuracy showed the laboratory failed to prove accuracy of the non-regulated gram stain tissue testing and acid fast bacilli tissue testing in 2023, 2024, and to date March 18, 2025. 2. Interview with the GS #1 on March 18, 2025 at 10:00 AM confirmed the laboratory failed to establish a means to verify the accuracy of the non-regulated gram stain tissue testing and acid fast bacilli tissue testing twice a year. D5503 BACTERIOLOGY CFR(s): 493.1261(a)(2) (a)(2) Each week of use for Gram stains. This STANDARD is not met as evidenced by: Based on lack of gram stain quality control (QC) records, and interview with general supervisor (GS) #1, the laboratory failed to document positive and negative reactivity each week of use for gram stains from January 2023 to date March 18, 2025. Findings: 1. Review of gram stain QC showed no gram stain QC performed from January 2023 to date March 18, 2025. 2. The laboratory performs approximately 800 gram stains annually. 3. Interview with the GS #1 on March 18, 2025 at 10:00 AM confirmed the laboratory failed to document positive and negative reactivity each week of use for gram stains. -- 2 of 2 --