Summary:
Summary Statement of Deficiencies 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 review of policies and procedures manuals, personnel records, and interview with the technical supervisor; the laboratory failed to establish and follow written policies and procedures to assess consultant competency. Findings include: 1. Review of the laboratory's policies and procedures manual revealed that there was no policy that describes the laboratory's process for assessing competency of personnel who fulfil the duties and responsibilities of persons in the following positions: a. Clinical Consultant b. Technical Supervisor/Technical Consultant c. General Supervisor 2. Review of personnel records revealed that there was no documentation to show that a competency assessment was performed, from January 1, 2017 to March 11, 2019, on the following personnel : a. Clinical Consultant b. Technical Supervisor/Technical Consultant c. General Supervisor 3. At 10:40 AM on 03/11/19, the Technical Supervisor confirmed the surveyor's findings. 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. 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 -- This STANDARD is not met as evidenced by: Based on observation, review of the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification (FORM 116) and laboratory policies and procedures manuals, and interview with the technical supervisor; the laboratory failed to have a written procedure, for all tests, assays, and examinations it performs. Findings include: 1. At 10:00 AM on 03/11/19, the surveyor did a "walk-through" of the laboratory, where she observed the following laboratory equipment and analyzers: a. Microscope (Urinalysis and Manual Differentials and Cell Morphology) b. Horiba AB XL80 CBC Analyzer c. ALPHA WASSERMAN ACE AXCEL Chemistry Analyzer d. ACL Coagulation Analyzer e. TOSOH AIA 900 Automated Immunoassay Analyzer 2. Review of Form 116 revealed that the laboratory listed the following specialty/subspecialty as tests it performed: a. Routine Chemistry b. Urinalysis c. Hematology 3. Review of laboratory policies and procedures revealed that there were no procedures that instructed laboratory personnel on performing Urinalysis and Manual Differentials and/or Cell Morphology. 4. At 11:30 AM on 03 /11/19, the Technical Supervisor confirmed the surveyor's findings. 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)