Summary:
Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based surveyor's review of the Siemens Multistix 10SG & Uristix 2 packet inserts, lack of laboratory quality control (QC) records and an interview with the clinical supervisor and office manager, the laboratory failed to test QC material for the Siemens' 10 SG & Multistix 2 Urine reagent strip. FINDINGS: The clinical supervisor and office manager confirmed on February 19, 2020 at approximately 1:30 PM, that the laboratory failed to follow the manufacturer's instruction for: Siemens' 10 SG & Uristic 2 (glucose & protein) Urine reagent strips which requires 2 levels of controls to be performed when a new vial of test strips is opened. 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 clinical supervisor and office manager, the laboratory failed to to establish and follow written procedures to ensure patient identification, labeling, testing and reporting of Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- results. FINDINGS: The clinical supervisor and office manager confirmed on February 19, 2020 at approximately 1:30 PM, 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), wet mounts and Fern test. 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 clinical supervisor and office manager, the laboratory failed to establish a written procedure for competency assessment for the providers performing PPMP testing. FINDINGS: The clinical supervisor and office manager confirmed on February 19, 2020 at approximately 1:35 PM, 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 PPM 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 clinical supervisor and office manager, the laboratory failed to verify the accuracy for KOH, wet mounts and Fern tests. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on on lack of Quality Assessment (QA) policy and confirmed at survey with the clinical supervisor and office manager, the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in the general laboratory systems. D5401 PROCEDURE MANUAL -- 2 of 3 -- 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 clinical supervisor and 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)