Summary:
Summary Statement of Deficiencies 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 environmental logs and an interview with Testing Personnel (TP) #1, the surveyor determined the laboratory failed to review the instrument manufacturer's required environmental parameters and establish an acceptable range for room temperature, and failed to document the actual freezer temperatures for more than two years since the previous survey on 11/29/2017. The findings include: 1. A review of the 2018-2020 environmental logs revealed the testing personnel had utilized a vaccine refrigerator temperature log each day of patient testing, however, the records failed to specify an acceptable range for room temperature, and failed to specify the actual freezer temperatures (testing personnel had checked a box for less than or equal to -17 degrees C [Celsius]). 2. During an interview on 2/26/2020 at 4:00 PM, the surveyor reviewed the manufacturer's insert for BioRad Liquicheck Immunoassay controls (QC), which specified storage requirements of -20 to -70 degrees C. TP #1 confirmed checking a box for less than or equal to -17 degrees C did not document the QC was maintained at the required storage temperature of -20 degrees C or colder. 3. As the interview continued the surveyor and the testing personnel then reviewed the manufacturer's operating environmental requirements for analyzers in use, as follows: A) Tosoh AIA-360: Temperature 15-30 degrees C B) Beckman Coulter AcT diff 2: Temperature 16-35 degrees C C) Vital Envoy 500: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- Temperature 18-32 degrees C TP #1 reviewed and confirmed the manufacturer specified environmental parameters, however the laboratory had failed to collate this information and document the acceptable room temperature ranges on the environmental logs. . D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on reviews of the maintenance logs and maintenance procedures in the Operator's Manual for the DCA Vantage analyzer, and an interview with Testing Personnel (TP) #1, the surveyor determined the laboratory: 1) failed to perform and document the weekly and quarterly maintenance with the frequency required by the manufacturer on the DCA Vantage analyzer (used for Urine Microalbumin/Creatinine testing); 2) failed to perform and document the six month decontamination maintenance on the Tosoh AIA-360; and 3) failed to document the quarterly and annual maintenance on the ISE (Ion-Selective Electrode) modules on the Vital Envoy 500. This was noted to occur for the last two years since the previous survey on 11/29 /2017. The findings include: 1. A review of the maintenance logs revealed no documentation of maintenance for the DCA Vantage (used for Urine Microalbumin /Creatinine, a non-waived moderate-complexity test). 2. A review of the Maintenance procedures on page 97 in the DCA Vantage Operator's Manual, revealed the following: "...Weekly Cleaning the on-board barcode reader window Cleaning the exterior Quarterly Removing and cleaning the cartridge spring and cartridge area Changing the air filter Optical Test" As needed procedures were also listed in the manual. 3. A review of the maintenance logs for the Tosoh AIA-360 revealed no documentation of the six-month decontamination and bottle filter change maintenance from November 2017 thru 2019. 4. A review of the maintenance logs for the Vital Envoy 500 revealed no documentation of quarterly maintenance (replace ISE tubing, and Sodium, Potassium and Chloride electrodes). The dates of the annual maintenance in 2018 and 2019 were not documented; this maintenance was performed during the service technician's annual PM (Preventative Maintenance) and included replacement of the ISE reference electrode. 5. During an interview on 2/26/2020 from 3:40-3:50 PM, the above records were reviewed with TP #1, who stated she replaced the ISE electrodes when the analyzer prompted the user, however she was unable to provide the surveyor with the specific dates. TP #1 stated she performed the maintenance for the Tosoh and Envoy 500, however she was "not good about documenting" it. Thus the above noted finding were confirmed. . D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a -- 2 of 7 -- minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a review of the calibration and calibration verification (C/V) records for the Tosoh AIA-360 and the Vital Envoy 500, a lack of C/V records for Urine Microalbumin/ Creatinine performed on the DCA Vantage, and interviews with Testing Personnel (TP) #1, the surveyor determined the laboratory failed to perform calibration verifications at least every six months as per CLIA regulations. The findings include: 1. A review of the records for the Tosoh revealed PSA has a two- point calibration. The laboratory performed routine Chemistry testing on the Vital Envoy 500 which calibrated the electrolytes with two calibrators, and other tests with one multi-calibrator. Analytes calibrated with less than three calibrators must have a calibration verification (C/V) performed every six months. 2. A review of the Vital Envoy 500 C/V records revealed the following: A) C/V on 9/12/2017 (reviewed during the previous survey) B) C/V on 6/26/2018 (nine and a half months after the previous C/V) C) C/V on 5/14/2019 (ten and a half months after the previous C/V) D) C/V on 2/07/2020 (nine months after the previous C/V) 3. A review of the Tosoh AIA- 360 C/V records revealed the following: A) C/V on 9/12/2017 (reviewed during the previous survey) B) C/V on 8/21/2018 (eleven months after the previous C/V) C) C/V on 5/14/2019 (eight months after the previous C/V) D) C/V on 2/07/2020 (nine months after the previous C/V) 4. During an interview on 2/26/2020 at 2:35 PM, the surveyor asked TP #1 how often PSA and Envoy 500 tests should have a calibration verification. TP #1 stated every six months. The surveyor then asked if the laboratory had performed two C/V in 2018 and 2019 on the above instruments. TP #1 stated she was unable to find the second C/V's performed in 2018, and she had missed the second C/V in 2019; it was not performed until 2/7/2020. The surveyor further confirmed no C/V was performed on Bilirubin in 2018 or 2019; Bilirubin required a separate C/V kit, and no C/V was performed until 2/7/2020. 5. During a later interview on 2/26/2020 at 3:45 PM, the surveyor confirmed the laboratory also utilized the DCA Vantage analyzer for Urine Microalbumin/Creatinine testing (a non- waived, moderate-complexity test). This test was calibrated using a calibrator card, and the laboratory had never performed C/V's on this test. 6. During the exit summation on 2/26/2019 at approximately 4:00 PM, the surveyor reviewed the deficiencies and also noted a lack of review and approval of the C/V data by the Laboratory Director or Technical Consultant to ensure no