Summary:
Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Technical Supervisor (TS), the laboratory failed to maintain all PT records for Urine Toxicology tests performed with the College of American Pathologists (CAP) in the C- 2017 and A - 2018 events. The finding includes: 1. The laboratory did not have the attestation page for PT results in event UT-A 2018. 2. The laboratory did not have the attestation page and work records for PT results in event UT-C 2017 and UT- A 2018. 2. The TS confirmed on 7/24/18 at 10:00 am that all PT records were not maintained. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. 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 surveyor review of the Final Reports, Instrument Data Base and interview with the Technical Supervisor (TS), the laboratory failed to retain records for Urine Toxicology performed on the AbSciex Triple Quad 6500 from November 2017 thru March 2018. The findings include: 1. A review of the instrument history revealed Quality Control, Calibration, Internal Standards and Patient Results were not retained for the time period above. 2. The TS stated at the time of the survey the above records were not available as printed results or on a back up drive. 3. The TS confirmed on 7 /24/18 at 2:10 pm that work records were not retained. 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 surveyor review of the Procedure Manual (PM) and interview with the Technical Supervisor (TS), the laboratory failed to establish a policy for manual integration of Urine Toxicology chromatography peaks from November 2017 to the date of survey. The TS confirmed on 7/24/18 at 1:20 pm that the laboratory did not establish the above policy. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of work records and interview with the Technical Supervisor (TS), the laboratory failed to have a Hydrolysis control procedure to monitor the accuracy of the analytic process for Urine Toxicology tests run on the ABSciex Triple Quad 6500 from November 2017 to the date of survey. The TS confirmed on 7/24/18 at 2:10 pm that the laboratory did not have a Hydrolysis control procedure . D5467 CONTROL PROCEDURES CFR(s): 493.1256(d)(9)(g) -- 2 of 4 -- Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- When using calibration material as a control material, use calibration material from a different lot number than that used to establish a cut-off value or to calibrate the test system. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual, Calibrators, Controls and interview with the Technical Supervisor (TS), the laboratory failed to use different lot numbers of calibrators to make the calibrator and control for Urine Toxicology tests from November 2017 to the date of the survey. The TS confirmed on 7/24/18 at 11:10 am the laboratory did not use different lot numbers. D5779