Pediatric Associates Of West Memphis-Marion

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of temperature and humidity records, lack of documentation and interview; the laboratory failed to document

Summary Statement of Deficiencies D2005 ENROLLMENT CFR(s): 493.801(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: . Through a review of the Casper 0096D, proficiency testing records, lack of documentation and interview with staff, it was determined the laboratory failed to provide the proficiency testing organization with the CLIA certification number to allow for reporting of Proficiency testing results to Arkansas Department of Health (ADH) for three of three proficiency testing events in 2020. Survey Findings follow: A. A review of Casper 0096D report for Pediatric Associates revealed no proficiency testing scores for the Hematology in 2020 for three of three proficiency testing events. B. A review of American Association of BioAnalysts (AAB) performance summary for the first, second and third Proficiency testing events of 2020 revealed the reports did not contain the laboratory's CLIA certification number. C. Upon request the laboratory could not provide documentation that the proficiency testing results for three of three proficiency testing events in 2020 had been reported to ADH. D. In an interview on 9/10/2021 at 10:30, laboratory personnel #3, stated the laboratory failed to report the CLIA number to AAB resulting in the proficiency testing score not being transmitted to ADH. 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 --