Summary:
Summary Statement of Deficiencies D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) (e)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed and that-- This STANDARD is not met as evidenced by: Based on review of policies and procedures, laboratory records, lack of documentation, and interview with the technical consultant (TC); the laboratory director (LD) failed to ensure the laboratory was enrolled in an approved proficiency testing (PT) program for all regulated analytes performed in the specialties of chemistry and hematology from the beginning of patient testing on 11/10/2024, through the date of enrollment with the College of American Pathologists (CAP), 03 /11/2025. Findings include: 1. Review of policies and procedures revealed the policy titled, "POCT [Point of Care Testing] Quality Management Program", which stated, under "Section IV: Proficiency Testing ...B. Procedure", "1. POCT units must participate in an appropriate CAP or CAP accepted proficiency testing program(s), based on the patient testing being performed." 2. Interview with the TC on 04/22 /2025, at 09:17 am, confirmed that testing in the specialties of chemistry and hematology began on 11/10/2024. 3. Review of laboratory records revealed the laboratory performing the following regulated chemistry and hematology analytes: Specialty: Analyte: Chemistry pH [315] Chemistry pO2 [325] Chemistry pCO2 [335] Chemistry Sodium [475] Chemistry Potassium [465] Chemistry Chloride [355] Chemistry Carbon Dioxide [351] Chemistry Glucose [415] Chemistry Urea Nitrogen [505] Chemistry Creatinine [405] Hematology Hematocrit [785] Hematology Hemoglobin [795] 4. Review of laboratory records revealed the laboratory enrolled in CAP PT on 03/11/2025 for the above mentioned regulated chemistry and hematology analytes. 5. Interview with the TC on 04/22/2025, at 10:35 am, confirmed the LD failed to ensure the laboratory was enrolled in an approved PT program for all 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 -- regulated analytes performed in the specialties of chemistry and hematology from the beginning of patient testing on 11/10/2024, through the date of enrollment with CAP, 03/11/2025. -- 2 of 2 --