Taste & Smell Clinic,The

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 record review and interview, the laboratory did not report results of chemistry proficiency testing in the same manner as patient specimens. Findings: 1. The laboratory performs proficiency testing for calcium and magnesium. If the quality control is unacceptable during the testing of proficiency test samples, the laboratory will retest the specimens and average the test results of the failed test run and the results obtained from the repeated test run instead of reporting the test results from the repeated test run, and documenting that the test was repeated because the quality control failed for the first test run; and 2. This was confirmed during interview with staff during the afternoon of the day of survey. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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 record review and interview, the laboratory did not document each activity performed by testing staff for chemistry proficiency testing. Findings: 1. Both staff members were documented on the attestation records for all three proficiency test events of 2019; and 2. During interview on the afternoon of the day of survey, analyst 1 stated that she or the other analyst may prepare the specimen for testing, but the other analyst may operate the analyzer. The attestation did not identify who prepared the specimen for testing and who operated the analyzer. 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)

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on the review of the laboratory's policies and procedures, instrument printouts, work sheets, and Proficiency Testing (PT) records and interview with Staff Number (#) 1 and #2 and the Laboratory Director (LD) on May 15, 2018 at approximately 11: 50 AM and on May 16, 2018 at approximately 2:00 PM, respectively, the laboratory failed to test PT samples for Magnesium and Calcium the same number of times as patient specimens for four (4) of the four (4) testing events reviewed (2017 MLE-M1,- M2, and M3; 2018 MLE- M1). The findings included: 1. Review of the laboratory's policies and procedures manual with a revision date of February 24, 2016 revealed instructions, to read "...MLE SAMPLES ONCE (WITH 5X STATISTICAL AVERAGING) UNLESS TECHNICAL DIFFICULTIES ARISE WHICH WOULD NECESSITATE DUPLICATE READING FOR NON MLE SAMPLES." 2. Review of worksheets and instrument printouts revealed that staff run MLE samples multiple times and reported the average as detailed below: (a) The staff run 2017 MLE-M1 samples on 2/8/17, 2/14/17, and two (2) times on 2/15/17. Although the staff repeated patient specimens along with the MLE samples on 2/8/17, the staff further repeated MLE samples on 2/14/17 and 2/15/17 and reported the average. (b) The staff run 2017 MLE-M2 samples on 5/17/17, 5/24/17 and 5/25/17. Although the staff repeated patient specimens along with the MLE samples on 5/17/17, the staff further repeated MLE samples on 5/24/17 and 5/25/17 and reported the average. (c) The staff run 2017 MLE-M3 samples on 9/13/17, and two (2) times on 9/27/17, and reported the average. (d) The staff run 2018 MLE-M1 samples two (2) times on 2/7/18, and once on 2/21/18 and reported the average. 3. Although the staff signed the attestation forms, indicating that MLE samples were tested the same as patient specimens, interview with the LD 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 Staff #1 and #2, confirmed that staff repeated MLE samples more times than patient specimens. Note: This deficiency is a repeat deficiency from the March 28, 2012 and April 2, 2014 re-certification surveys. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on the review of the laboratory's policies and procedures and review of the laboratory's accuracy verification record and interview with the Laboratory Director (LD), on May 16, 2018 at approximately 2:00 PM, the laboratory failed to perform accuracy verification. There was no documented evidence of twice a year accuracy verification in 2017 for two (2) of the four (4) tests not listed in Subpart I, the Proficiency Testing Program for Non-waived Testing (Zinc and Copper). The findings included: 1. Review of the laboratory's policies and procedures with the revision date of April 30, 2018, revealed that the laboratory will send specimens for Zinc (Zn) and Copper (Cu) bi-annually to a reference laboratory for accuracy verification. 2. Although the LD stated that accuracy verification specimens were sent to a reference laboratory, in 2017, there was no documented evidence for verification. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on the review of Medical Laboratory Evaluation (MLE), the Proficiency Test (PT) provider, reports and the review of the laboratory's quality assessment record and confirmation by interview with the Laboratory Director (LD) on May 15, 2018 at approximately 2:20 PM, the laboratory failed to investigate and take