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 surveyor review of the Competency Assessment (CA) records and interview with the Technical Supervisor (TS), the laboratory failed to perform CA correctly on one out of one testing personnel in 2017. The findings include: 1. The laboratory did not document what records were reviewed and how CA was assessed. 2. The TS confirmed on 8/7/18 at 11:00 am that CA was not performed correctly. 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 review of the Procedure Manual and interview with the Technical Supervisor (TS), the laboratory failed to follow Specimen collection and Specimen labeling procedure from May 2015 to the date of survey. The finding includes: 1. Both procedures stated "Upon receipt of the specimens from the patient, immediately check 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 -- and record the temperature strip' but there was no evidence that this procedure was followed. 2. The TS confirmed on 8/7/18 at 12:00 pm that the laboratory did not follow the procedure. D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the Technical Supervisor (TS), the laboratory failed to record a discontinuance date on the procedure not performd in the laboratory on the date of survey. The finding includes: 1. There was no discontinuance date on the Methadone metabolite (EDDP) and Ethyl Glucuronide (ETG) procedures in the PM. 2. The TS confirmed on 8/7/18 at 10:45 am that a discontinuance date was not documented. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of the Assay Package Inserts (API) and interview with the Technical Supervisor (TS), the laboratory failed to follow Methadone assay procedure from initaition of testing to the date of survey. The finding includes: 1. The API stated "Samples within a pH of 3 to 11 are suitable for testing with this assay" but the laboratory did not check pH of any sample tested. 2. The TS confirmed on 8/7/18 at 1: 45 pm that API was not followed. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: a) Based on surveyor review of the Final Report (FR) and interveiw with the Technical Supervisor (TS), the laboratory failed to indicate the test "Report Date" on the FR from initiation of testing to the date of survey. The TS confirmed on 8/7/18 at -- 2 of 6 -- 1:15 pm that test report date was not on all FR. b) Based on surveyor review of the FR and interveiw with the TS, the laboratory failed to report Urine Drug Screen (UDS) test results accurately from initiation of testing to the date of survey. The findings include: 1. There were no cut off limits reported for UDS tests on the FR. 2. The laboratory performed non Food and Drug Administration cleared tests and there was no statement stating "The performance characteristics of this test were determined by (Laboratory Name). It has not been cleared or approved by the U.S. Food and Drug Administration" on FR. 3. The TS confirmed on 8/7/18 at 1:30 pm that cut off limits and the above statement was not on the FR. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on surveyor review of the Personnel Files and interview with the Technical Supervisor (TS), the Laboratory Director failed to ensure that the Testing Personnel (TP) was qualified to perform high complexity Urine Drug testing from 2/14/18 to the date of survey. The finding includes: The TP was not qualified by education. Cross refer to 6101 D6101 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(11) The laboratory director must employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart. This STANDARD is not met as evidenced by: Based on surveyor review of the Personnel Files and interview with the Technical Supervisor (TS), the Laboratory Director failed to ensure that an individual performing Urine Drug testing was qualified by education to do high complexity testing from 2/14/18 to the date of survey. The TS confirmed on 8/7/18 at 1:00 PM that the laboratory was not aware that TP was not qualified. D6108 LABORATORY TECHNICAL SUPERVISOR CFR(s): 493.1447 The laboratory must have a technical supervisor who meets the qualification requirements of 493.1449 of this subpart and provides technical supervision in accordance with 493.1451 of this subpart. This CONDITION is not met as evidenced by: Based on review of the work records and interview with the Technical Supervisor (TS), the TS failed to provide technical supervision in accordance with CFR 493.1451. The findings include: 1. The TS did not ensure quality conrol and -- 3 of 6 -- calibration programs were maintained. Cross refer to D 6117 2. The TS did not ensure that the laboratory took