Central Arkansas Pediatric Clinic

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Through review of package insert, observation, and interview it was determined that laboratory supplies were available for use when they have exceeded their expiration date. Finding follows: A) Review of the eSwab package insert states do not use after expiration date, which is printed on the outer box and on each individual sterile collection unit and the specimen transport tube label. B) On 01/06/2023 at 1209, 10 of 10 eSwab transport system tubes for the collection and preservation of aerobic, anaerobic, and fastidious bacteria were found in a drawer. The expiration date on all eSwab 2022-09-30 (lot number 211631000). C) In an interview on 1/06/2023 at 12:25 laboratory staff member (number 21 on form CMS-209) confirmed that eSwab were accessible for use for all testing personnel when they had exceeded the expiration date. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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: Through a review of the API Hematology/Coagulation proficiency test attestation records for 2019 and 2020, and interview with laboratory staff, it was determined the testing personnel failed to attest to the routine integration of proficiency test samples in the patient workload for six of six surveys reviewed. Survey findings follow: A) Review of the six attestation statements for API Hematology/Coagulation events in 2019 and 2020 revealed that testing personnel signatures appeared to have been printed in similar hand-writing. B) In an interview, at approximately 11:10 on 1/20 /21, the laboratory staff member, identified as number two on the CMS-209 form, stated that they coordinate proficiency testing and they print the names assigned to test the samples and that personnel had not signed the attestation forms identified above. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Through observations made during a tour of the laboratory and interview it was 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 -- dertermined that the laboratory had supplies that had exceeded the expiration date available for use. Findings follow: A) During a tour of the laboratory on 11/20/21 at approximately 02:00 PM, five of five BD Na Citrate blood collection tubes lot # 0072408 with an expiration date of 2020-12-31 were observed in a separate laboratory annex on the first floor of the clinic. B) In an interview on 1/20/21 at approximately 02:30 PM the laboratory staff members, identified as numbers two and sixteen on the CMS 209 form, confirmed that the tubes, identified above, had exceeded their expiration date and were available for use. -- 2 of 2 --

Summary Statement of Deficiencies D5781