James Highsmith Md Llc

Summary Statement of Deficiencies D0000 AMENDED An announced CLIA recertification survey was conducted at James Highsmith MD on 06/18/20. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 lack of documentation and interview with the Lab Assistant the laboratory failed to have the manufacturer's instructions for the microscope to define the maintenance requirements during the time of the survey. Findings Included: Review of instrument manufacturer's instructions (MI) revealed that there was no MI available for review for the microscope. Interview on 06/18/20 at 11:30 AM the Lab Assistant confirmed that the microscope did not come with MI. 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 review of scabies peer review records and interview with the Lab Assistant, the laboratory failed to verify the accuracy of the scabies test results at least every 6 months.. Findings included: During review of scabies peer review records, it was found that the laboratory last performed the scabies peer review June 2017. During an interview on 05/30/18 at 10:15 AM, the Laboratory Assistant confirmed the scabies peer review had only been performed once (June 2017) since the initial survey which was conducted on 02/03/17. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (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. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)