Summary:
Summary Statement of Deficiencies D2005 ENROLLMENT CFR(s): 493.801(a)(4) (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 review of laboratory American Proficiency institute (API) proficiency testing (PT) records, federal Certification and Survey Provider Enhanced Reports (CASPER) 0096D, lack of documentation, and interview with the laboratory representative (LR), the laboratory failed to authorize API to release the PT data to United States Department of Health and Human Services (HHS) to make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act for three of three PT events in 2026. Findings Include: 1. Review of the federal CASPER Report 0096D revealed a lack of PT scores for the laboratory. 2. Review of the laboratory's API PT records revealed performance results for three testing events were not released to HHS for 2026. A. API 2026 Immunology Event two [testing began after Event one in 2026] Diagnostic Immunology- Syphilis Serology B. API 2026 Microbiology Event one and API 2026 Microbiology Event two Bacteriology - Molecular Bacti- Pneumonia Molecular Bacti- Respiratory Molecular Bacti- STI Molecular Bacti- Vaginal Mycology Molecular Mycology- Vaginal Parasitology Molecular Parasite- STI Molecular Parasite- Vaginal Virology HPV Genotyping Human Papillomavirus Molecular Virology- Pneumonia Molecular Virology- STI Molecular Virology- Respiratory 3. During the survey on 09/02/2026 at 9:39 am, interview with the LR confirmed the laboratory failed to authorize API to release the PT data to HHS to make PT results available to the public for three of three PT events in 2026. 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 -- D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, American Proficiency Institute (API) proficiency testing (PT) records, lack of documentation, and interview with the laboratory representative (LR); the laboratory failed to perform bi-annual method accuracy evaluations (proficiency testing/ split sample analysis) for 19 of 76 markers performed in the specialty of Microbiology for three PT events in 2026. Findings include: 1. Review of laboratory policies and procedures revealed the procedure titled, "Alternative PT Assessment", which stated, under "II. Policy", "1. The laboratory will utilize split sample testing to assess the accuracy of laboratory testing not covered by the enrollment in proficiency testing ... 3. Split testing will be done twice per year." 2. Review of laboratory records revealed the laboratory performed real-time Polymerase Chain Reaction (qPCR) testing for 76 markers in the subspecialties of Bacteriology, Mycology, Parasitology, and Virology. Acinetobacter baumannii Adenovirus Bocavirus Bordetella bronchiseptica Bordetella parapertussis Bordetella pertussis Chlamydophila pneumoniae Coronavirus 229E Coronavirus HKU1 Coronavirus NL63 Coronavirus OC43 Enterobacter cloacae Enterovirus Haemophilus influenzae Human metapneumovirus A Human metapneumovirus B Human parainfluenza virus 1 Human parainfluenza virus 2 Human parainfluenza virus 3 Human parainfluenza virus 4 Influenza A & B Klebsiella aerogenes Klebsiella pneumoniae Legionella Pneumophila Methicillin resistance gene: mecA Moraxella catarrhalis Mycoplasma pneumoniae Parechovirus Pneumocystis jirovecii Pseudomonas aeruginosa Respiratory syncytial Virus (RSV) Rhinovirus A Rhinovirus B SARS-COV-2 (Coronavirus) Staphylococcus aureus Streptococcus pneumoniae Streptococcus pyogenes (Group A) Chlamydia trachomatis Mycoplasma genitallum Neisseria gonorrhoeae Trichomonas vaginalis Ureaplasma urealyticum Haemophilus ducreyi Herpes Simplex Virus Type 1 (HSV-1) Herpes Simplex Virus Type 2 (HSV- 2) Treponema pallidum Human papillomavirus 16 (HPV-16) Human papillomavirus 18 (HPV-18) Human papillomavirus 45 (HPV-45) Atopobium vaginae Bacterial vaginosis Bacteroides fragilis Bacterial Vaginosis-Associated Bacterium (BVAB2) Candida albicans Candida dubliniensis Candida glabrata Candida krusei Candida lusitaniae Candida parapsilosis Candida tropicalis Enterococcus species Escherichia coli Gardnerella vaginalis Key BV markers Lactoba cillus crispatus Lactobacillus gasseri Lactobacillus iners Lactobacillus jensenii Megasphera 1 Megasphera 2 Mobiluncus curtisii Mobiluncus mulieris Mycoplasma hominis Prevotella bivia Streptococcus agalactiae (Group B) Candida Species 3. Review of the laboratory's API PT records revealed the laboratory lacked bi-annual method accuracy (proficiency testing/ split sample) evaluations for the following 19 of 76 qPCR markers tested in the laboratory. Haemophilus influenzae Influenza A & B Methicilin restiance gene: mecA Pneumocystis jirovecii Atopobium vaginae Bacteroides fragilis Enterococcus species Escherichia coli Lactobacillus crispatus Lactobacillus gasseri Lactobacillus iners Lactobacillus jensenii Megasphera 1 Megasphera 2 Mobiluncus curtisii Mobiluncus mulieris Mycoplasma hominis Prevotella bivia Streptococcus agalactiae (Group B) 4. Interview with the LR on 09/02/2026, at 11:17 am, confirmed the laboratory failed to perform bi-annual method accuracy evaluations (proficiency testing/ split sample analysis) for 19 of 76 analytes performed in the specialty of Microbiology for three PT events in 2026. -- 2 of 2 --