Pediatric Choice Clinic, Dayton

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records and interview with the lab supervisor, it was determined that the laboratory director failed to sign the attestation sheets for the 2nd and 3rd events for 2022. The findings include: 1. Review of the laboratory's PT records revealed the following: -Attestation pages not signed by the lab director for the following: Hematology 2022 event two -Attestation pages not signed by the lab director for the following: Hematology 2022 event three 2. Interview with the lab supervisor on June 7, 2023 at 12:30pm confirmed the above findings. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual, review of laboratory records and interview with the lab supervisor, the laboratory failed to follow their policy for documentation of temperature and humidity in June 2023. The findings include: 1. 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 -- Review of the laboratory's procedure titled "Reagent Management" stated the following: "Document all temperatures daily" and "Document humidity daily". Additionally, review of the "Laboratory temperature/humidity log" stated "This log must be completed each day of patient testing. Record all temperatures and humidity as indicated with the initials of the individual recording". 2. Review of the "Temperature/humidity log" for June 2023 revealed the following: -June 1, 2023: No documentation of refrigerator temperature recorded -June 2 and June 5, 2023: No documentation of room temperature, refrigerator temperature or humidity recorded 3. Interview with the lab supervisor at approximately 9:35 a.m. on June 7, 2023 confirmed the laboratory failed to ensure that the procedure for temperature and humidity documentation was followed for three of seven days in June 2023. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of manufacturer complete blood count (CBC) quality control package insert and interview with the lab supervisor, the laboratory failed to label CBC quality control vials with corrected expiration date on the date of the survey (06.07.2023). The findings include: 1. Observation of the laboratory on June 7, 2023 at 9:35 a.m. revealed a Horiba ABX Micros-60 CBC instrument (serial #512CS95442) in use for patient testing. Also observed were three levels of Horiba Minotrol controls (Lot number MX441) that were not labeled with corrected expiration date. 2. Review of the manufacturer quality control package insert revealed the following statement: "Open tubes are stable for 16 days provided they are handled properly". 3. Interview with the lab supervisor on June 7, 2023 at 9: 35a.m. confirmed the laboratory had not labeled CBC quality control vials with corrected expiration date on the date of the survey (06.07.2023). -- 2 of 2 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: ================================== Based on review of laboratory's IQCP (Individualized Quality Control Plan) for taxo discs and SSA media for performing strep screen throat cultures, lack of weekly Quality Control (QC) documentation and interview with the Laboratory Manager, determined the laboratory failed to follow their IQCP for performing weekly QC for 2017 and 2018. The findings include: 1. Review of IQCP for taxo discs and SSA media states to perform weekly quality controls with known organisms. 2. Lack of weekly QC documentation for taxo discs and lack of QC documentation for SSA media for 2017 and 2018. 3. Interview at approximately 12:30 p.m. August 2, 2018 with the Laboratory Manager confirmed the laboratory was performing taxo disc and SSA media QC with each new lot number, but the QC for the SSA media was not documented for the 2 year period. ==================================== D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) The laboratory director is responsible for the overall operation and administration 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 -- the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: =================================== Based on review of 2 SSA strep screen culture reports for July 2018, package insert for performing strep screen cultures and interview with the laboratory manager, determined the laboratory failed to follow manufacturer's instructions for incubation time. The findings include: 1. Review of 2 SSA strep screen culture reports for 7/19/18 and 7/26/18 were documented as being read at 96 hours (4 days). 2. Package insert for performing strep screen throat cultures states to read cultures no longer than 48 hours. 3. Interview at approximately 12:00 p.m. August 2, 2018 with the laboratory manager confirmed that SSA throat cultures planted on Thursdays were not read until the following Monday (4 days or 96 hours) due to office not open on weekends, which fails to follow manufacturer's instructions for incubation time. ================================== -- 2 of 2 --