Healthy Connections, Inc - Hot Springs Central

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 observation and interview with laboratory staff it was determined that the laboratory had supplies available for use after their expiration date. Findings follow: A) During a tour of the laboratory on 04/23/24 at 2:22 p.m. one (of three) expired McKesson Consult Mononucleosis Test Cassette (Lot: 222D11, MFR# 5012, expiration date 03/31/24) was observed in the laboratory. B) In an interview on 04/23 /24 at 2:28 p.m. the laboratory's technical consultant confirmed that the item, identified above, had exceeded it's expiration date and was available for use. 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 D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Through review of American Proficiency Testing Institute (API) laboratory files, laboratory policy and procedure and interview it was determined that the laboratory tested proficiency test samples in duplicate on four of four proficiency testing events in 2021 and 2022. Findings follow: A) Review of proficiency test instrument printouts for API Hematology/Coagulation 2021 event #3 ,API Hematology/Coagulation 2022 event #1, API Chemistry Core 2021 event #3 and API Chemistry Core 2022 event #1 revealed that all twenty specimens in the four events were tested in duplicate. B) In an interview on June 9, 2022 at 11:30 am, when asked the reason the proficiency test samples were tested in duplicate, the laboratory staff members, identified as numbers two and three on the CMS 209 form, stated it was because many of the proficiency test results were abnormal. C) Review of policy and procedure for testing revealed that there was no requirement for testing patients with abnormal results in duplicate. D) In an interview on June 9 2022 at 11:30 am the laboratory staff member, identified as number 3 on the CMS 209 form, stated that there was no policy requiring that patients with abnormal values be tested in duplicate and that all samples in the proficiency testing events identified above had been tested in duplicate. D5783