Summary:
Summary Statement of Deficiencies D0000 A Validation Survey was conducted on April 9-13, 2018 at Avoyelles Hospital-Blood Gas Laboratory-CLIA ID # 19D0464915. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard deficiencies were cited. 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 observation, record review, and interview with personnel, the laboratory failed to establish written policies that would ensure positive identification of patient samples for blood gas testing performed on the Opti-CCA analyzer. Findings: 1. Observation by surveyors on April 9, 2018 revealed the laboratory utilized the Opti- CCA analyzer for blood gas testing. 2. Review of the laboratory's policy and procedure manual revealed the laboratory did not have a written policy for specimen labeling/identification in the blood gas instrument. 3. In interview on April 10, 2018 at 10:00 am, Personnel 4 stated the laboratory did not have a written policy indicating the patient identification information to be entered into the blood gas instrument. 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. 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 -- This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to ensure written policies and procedures to assess competency for the Technical Consultants were complete. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed Personnel 2 and Personnel 3 serve as the Technical Consultants. 2. Review of the laboratory's policies and procedures revealed the laboratory did not have a policy for competency assessment of the Technical Consultant. 3. Review of personnel records revealed competency assessments for the duties of Technical Consultant were not performed. 4. In interview on April 9, 2018 at 3:45 pm, Personnel 4 stated the laboratory competency assessments for the identified personnel were not performed. 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 the record review and interview with personnel, the laboratory failed to have a complete policies and procedure manual. Findings: 1. Review of the laboratory's documents and records revealed the laboratory did not have written polices and procedures that included: a) Description of action to take if test system becomes inoperable b) Individualized Quality Control Plan (IQCP) 2. In interview on April 9, 2018 at 3:40 pm, Personnel 4 confirmed the laboratory did not have the identified policies. 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)