Adams Medical Center

Summary Statement of Deficiencies D0000 An unannounced revisit survey was performed on August 27, 2024 as a follow-up to the July 22, 2024 recertification survey. The Department of Licensing and Regulatory Affairs has evaluated this facility and determined it is not compliance with CLIA regulations at the standard level (42 CFR Part 93, effective April 24, 2003). D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: . Based on observation and interview with the Testing Personnel, the laboratory failed to establish maintenance protocols to ensure centrifuge performance for accurate and reliable qualitative urine toxicology results for one (August 2024) of one month the laboratory started using the centrifuge. Findings include: 1. The surveyor observed the laboratory's centrifuge used to prepare urine specimens for qualitative urine toxicology testing on 8/27/24 at 9:36 am. 2. An interview with the Testing Personnel at 9:36 am revealed the laboratory did establish a policy for centrifuge maintenance and no maintenance or function checks for the centrifuge were performed prior to use for patient testing. 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 D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: . Based on observation and interview with Testing Personnel (TP) #1, the laboratory failed to perform and document thermometer calibrations and/or replace an expired thermometer for 1 (S/N 181007403) of 1 thermometers in use. Findings include: 1. During a tour of the laboratory on 12/13/2022 at 9:12 am the surveyor observed a thermometer in the Frigidaire refrigerator/freezer with an expiration date of 2/06/2020 in use. 2. When queried on 12/13/2022 at 9:15 am, TP1 was not able to provide the surveyor documentation to show the thermometer had been calibrated. 3. An interview on 12/13/2022 at 9:15 am, TP1 confirmed the laboratory failed to perform and document thermometer calibrations and/or replace the expired thermometer. 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 D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Consultant, the laboratory failed to verify the accuracy of its toxicology testing at least twice annually for 2 (September 2018 to September 2020) of 2 years reviewed. Findings include: 1. A review of the laboratory's proficiency testing records revealed one testing event was performed in 2019. 2. A review of the laboratory's established "Proficiency Testing (PT) and Split-Specimen Testing" revealed a section stating, "Split-Specimen testing is required on five specimens twice each year for all unregulated analytes not enrolled in PT. This is a quality assurance external comparison, as well. Our yearly QA review should consider enrolling unregulated analytes in PT instead of performing split- sample testing. The annual QA review of split-specimen testing should also verify that: Split-specimen testing is performed for all unregulated analytes not enrolled in PT (five specimens twice a year). Split-specimen testing results are reviewed by staff. Split-specimen testing results are reviewed by the laboratory director or technical consultant.

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --