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 Testing Personnel (TP), the laboratory failed to maintain the Attestation Statements (AS) signed by the analyst for tests performed with the American Proficiency Institute for all events in the calendar years 2017 and 2018. The TP confirmed on 11/15/18 at 11:20 am that AS were not signed. 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. 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 2 -- Based on surveyor review of Quality Control (QC) records, and interview with the Testing Personnel (TP), the laboratory failed to retain all QC records for Prostate- Specific Antigen tests performed on the Qualigen Fast Pack analyzer from 12/19/16 to the date of survey. The finding includes; 1) The laboratory did not retain manufactures QC values cards for control material. 2) The TP confirmed on 11/15/18 at 11:00 am that QC value cards where not retained. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) 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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records and interview with the Testing Personnel (TP) the laboratory failed to verify that the assayed QC materials were within the acceptable ranges before they were put into use for Prostate-Specific Antigen (PSA) performed on the Qualigen Fast Pack analyzer from 12/19/16 to the date of survey. The TP confirmed on 11/15/18 at 10:30 am that the laboratory did not verify QC materials for PSA performed on Qualigen Fast Pack analyzer. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records, Procedure Manual (PM) and interview with the Testing Personnel (TP), the Laboratory Director failed to ensure that the established QC program was maintained for laboratory services provided from 12/119/16 to the date of the survey. The finding includes; 1.The monthly QC review sheet in the PM was not completed or reviewed. 2.The TP was unaware of the use of monthly control sheets as stated in the PM. 3.The TP confirmed 12/19/16 at 10:50 am the LD did not ensure the QC plan was maintained. -- 2 of 2 --