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 proficiency test (PT) record review, lack of documentation, and interview with staff, the laboratory failed to retain Human Chorionic Gonadotropin (HCG) PT test records for 2 of 6 events reviewed (events 1 and 3 of 2017). Findings include: 1. HCG PT records for events 1 and 3 of 2017 failed to include instrument print-outs, the testing program report forms, and the attestation statement signed by the analyst and the laboratory director. 2. The technical consultant stated on 02/27/2019 at approximately 10:30 a.m., PT paperwork from the Pleasant Grove location was sent to him at their Sandy location for review and signatures and was supposed to be sent back to the Pleasant Grove location to file with the Pleasant Grove PT records. The laboratory was not able to locate the missing paperwork at either location. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, 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 -- 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: Based on TOSOH immunoassay instrument print-out review, patient test report review and interview with staff, the test report failed to include the location where sperm morphology testing was performed for 4 of 5 semen analysis test reports and 1 of 5 endocrinology test reports reviewed. Finding include: 1. The Pleasant Grove TOSOH instrument print-out documented Estradiol (E2), Human Chorionic Gonadotropin (HCG), Prolactin (PR), and Lutenizing Hormone (LH) testing for patient 48533 tested on 04/23/2017 performed by an employee not employed by the Pleasant Grove Laboratory. 2. The test report for patient 48533 tested on 04/23/2017 lists the testing location as Reproductive Care Center, Sandy, UT. 3. Semen analysis test reports for patient 53974 tested on 01/31/2018, patient 56398 tested on 04/18 /2018, patient 56415 tested on 08/16/2018, and patient 53890 tested on 10/15/2018, failed to include the location where the sperm morphology portion of the semen analysis was performed. 4. In interview with staff on 02/27/2019 at approximately 12: 00 p.m., the technical supervisor stated the sperm morphology portion of semen analysis for their Pleasant Grove laboratory is routinely performed by him at their Sandy location, and on 04/23/2017 endocrinology testing (E2, HCG, PR, and LH) on patients from their Sandy location had been tested on the Pleasant Grove analyzer because the Sandy analyzer was not in service. Staff stated the testing location is automatically added to the test report by their laboratory information system based on the location where the testing was ordered and does not always reflect the location where testing is actually performed. -- 2 of 2 --