Summary:
Summary Statement of Deficiencies D0000 An announced CLIA validation survey was conducted at Caremed Clinic LLC on 10 /16-17/2025. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D5400 493.1205 Condition: Analytic Systems D6000 493.1403 Condition: Moderate Complexity Laboratory Director D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to have a policy that included imminently life-threatening test results, or panic or alert values, or a protocol for reporting these values (See D5403); failed to ensure that controls in the Specialty Hematology were labeled with open and expiration dates (See D5415); failed to ensure verification of performance specifications for multiple analytes and tests in the Subspecialties of General Chemistry, Endocrinology and Virology prior to patient testing. (See D5421); failed to ensure two levels of controls were performed and documented in the Subspecialty of Endocrinology (See D5447); and failed to failed to ensure positive and negative controls were performed and documented in the Subspecialty of Virology (See D5449). D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)