Summary:
Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies, the laboratory's QS11 Temperature Logs for June 2019 to August 2021, and staff interview, it was revealed the laboratory failed to ensure the Advantik QS Cryostat temperature readings were within the laboratory's acceptable range listed in the Moh's Cutting Procedure for 12 of 15 days reviewed from June 2019 to August 2021. Findings include: 1. A review of the laboratory's policy titled 'Moh's Cutting Procedure' revealed the following: "To begin the Moh's procedure the cryostat needs to be turned to -20C to -25C." 2. Review of the QS11 Temperature Logs for June 2019 to August 2021 revealed the following 12 days where the temperature exceeded the laboratory policy's allowable range (-20C to -25C) : 6/27/19 -27 11/12/19 -30 11/14/19 -29 3/3/20 -32 3/5/20 -33 5/19/20 -33 6/4 /20 -33 11/5/20 -31 12/1/20 -31 3/30/21 -29 4/13/21 -28 4/15/21 -29 3. A random Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- review of patient records revealed the following 8 patient's specimens were resulted when the Advantik QS Cryostat's temperature was documented outside of the laboratory policy's acceptable range: Patient: M20-091 Patient: M20-092 Resulted: 5 /18/20 Patient: M20-097 Patient: M20-098 Resulted: 6/4/20 Patient: M20-208 Patient: M20-209 Resulted: 11/5/20 Patient: M20-218 Resulted: 12/1/20 Patient: M21-086 Resulted 4/15/21 4. An interview with the office manager on 9/8/21 at 9:20 a.m. in the laboratory, after review of the records, confirmed the above findings. D5781