Summary:
Summary Statement of Deficiencies D0000 On 08/17/20 at 9:28 AM an entrance conference was conducted with Facility Representatives. The Representatives were informed the purpose of the visit was to conduct a complaint survey. On 08/17/20 at 1:30 PM an exit conference was conducted with Facility Representatives. The Representatives were given the opportunity to present additional infomation. No information was presented. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions for the Clinitek Status for Urinalysis and Microalbumin, DCA Vantage Hgb A1c, and CoaguChek XS PT, a review of laboratory quality control, maintenance, and temperature logs, it was determined the laboratory failed to follow manufacturer's instructions for quality control, maintenance, and storage requirements. Survey findings include: A. The laboratory failed to perform maintenance and quality control on the Clinitek Status used for Urinalysis and Microalbumin 1) Clinitek Urine Chemistry Analyzer Maintenance Log stated, "Clean the table daily or more often if buildup is seen." The Multistix Reagent Strip and Clinitek Microalbumin 2 (for use with the Clinitek Urine Chemistry Analyzer) instructions for use stated, "Test positive and negative quality controls with new lots, new shipments of reagents, and when you open a new bottle of reagent strips. Test reagents monthly that are stored for more than 30 days." 2) A review of the "Instrument Maintenance Form" showed the daily maintenance for the Clinitek Status was documented 0 of 22 days of operation in April 2020, 0 of 21 days in May 2020, 11 of 22 days in June 2020, 17 of 23 days of operation in July 2020, and 0 of 11 days in August 2020. 3) Review of the Urinalysis/Microalbumin Quality Control 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 -- Forms showed the monthly quality control for Urinalysis and Microalbumin was not documented in 2 of 7 months reviewed. There was no documented quality control in April or May of 2020. 4) At the time of survey (8/17/2020 10:44 AM) Laboratory Personnel #2 (as listed on the Personnel Identification Worksheet) stated the Clinitek quality control was late being performed because she had been too busy and she is new at this and their technical consultant had not had time to train her. 5) At 11:06 AM Laboratory Personnel #2 asked the Surveyor to teach her how to run quality control on the Clinitek and stated that she had not been trained to run it. B. The laboratory failed to perform maintenance on the DCA Vantage A1c. 1) The DCA Vantage Hgb A1c Operator's Manual stated the following required maintenance: Weekly - clean the Onboard Barcode Reader Window; and Quarterly - Removing and cleaning the Cartridge Spring and Cartridge Area, Change air filter, and Optical Test. 2) A review of the DCA Vantage Analyzer Maintenance Log showed no weekly maintenance documented in April, May, June, or August of 2020. Maintenance was documented in four of eight months reviewed. C. The laboratory failed to document that laboratory temperatures were acceptable on days of laboratory operation. 1) A review of manufacturer's instructions for waived testing showed the following storage temperature requirements: DCA Vantage - Store reagents at 2-8 degrees Celsius; Clinitek Status - Multistix and Microalbumin store strips at 15 to 30 degrees Celsius; and Coaguchek XS - Store strips at 2 - 30 degrees Celsius. 2) In a review of the Daily Patient Log it was determined the laboratory performed testing on 13 days in April, 9 days in May, and 7 days in June prior to temperatures being documented on 6/16 /2020. 3) A review of the Laboratory Temperature Forms for 2020 showed the laboratory did not document acceptable temperatures in April 23 of 23 days, in May 21 of 21 days, and in June 12 of 22 days (temperatures were not documented through June 15). -- 2 of 2 --