Summary:
Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on the lack of a written laboratory procedure manual and an interview with the office manager, the laboratory failed to to establish and follow written procedures to ensure patient identification, labeling, testing and reporting of results. FINDINGS: The office manager confirmed on March 6, 2020 at approximately 9:45 AM, that the laboratory failed to establish and follow written procedures for patient identification and specimen integrity from collection through reporting test results for the Provider Performed Microscopy Procedures (PPMP) potassium hydroxide (KOH), fern test and wet mounts. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on lack of competency assessment written procedure and an interview with the office manager, the laboratory failed to establish a written procedure for competency assessment for the providers performing PPMP testing. FINDINGS: The office Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- manager confirmed on March 6, 2020 at approximately 9:35 AM, that the laboratory failed to establish and follow written procedures for competency assessment based on specific skills for KOH, wet mounts and Fern test; proficiency in using a microscope; ability to detect and identify elements present in a specimen; ability to differentiate significant elements from debris or artifacts and understanding that PPMP specimens are labile. 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 the lack of twice yearly verification and confirmed at survey with the office manager, the laboratory failed to verify the accuracy for KOH, wet mounts and Fern tests. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on lack of written standard operating procedures (SOP) and confirmed at survey with the office manager, the laboratory failed to establish written policies /procedures for the KOH, wet mount and Fern tests. 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)