Summary:
Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record and patient sample log review and interview with the technical consultant (TC), the laboratory did not handle bacteriology PT specimens in the same manner as patient samples. Findings: 1. All patient samples which enter the laboratory are recorded on a patient log. 2. A review of patient logs from January, 2016 to February, 2018 showed that bacteriology PT samples were not documented on the patient log along with patient specimens in 7 of 7 PT events. 3. During an interview on 3/1/18 at 1:15 PM, the TC confirmed that bacteriology PT samples were not listed individually on the patient log in the same manner as patient specimens. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Based on proficiency testing (PT) record review and interview with the technical consultant (TC), the laboratory did not ensure that a copy of all PT documents were maintained by the laboratory for a minimum of two years from the date of the PT testing event. Findings: 1. A review of PT records from event 1, 2016 to event 1, 2018 showed that the attestation statements for 4 out of 7 events in Bacteriology were not present at the time of the survey; and 2. Two of 7 PT results summaries which are to be signed and dated by the laboratory director indicating that the results have been reviewed and found to be acceptable were not present at the time of the survey. 3. During an interview on 3/1/18 at 1:15 PM, the TC confirmed that the laboratory did not maintain all PT documents for a minimum of two years from the date of the PT testing event. 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 competency assessment record review and interview with the technical consultant (TC), the laboratory did not establish written policies and procedures for assessing the competency of the TC based on the position responsibilities listed in Subpart M- CFR 493.1413. Findings: 1. A review of competency assessment records showed that at the time of the survey there was no competency assessment available for the TC. 2. During an interview on 3/1/18 at 1:15 PM, the TC confirmed that the laboratory director had not performed a competency assessment on the TC. 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)