Summary:
Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the clinical staff competency assessment (CA) policy and interview with testing personnel (TP) #1, the laboratory failed to follow their written procedure to assess the competency 1 of 2 (TP) for each individual test system they performed in 2021. Findings include: 1. The clinical staff competency assessment policy, point #2 states, "Competency assessment must be assessed a minimum of twice in the first year of employment of testing personnel and annually there after". 2. On the day of survey, 09/13/2021, the laboratory was unable to provide CA records for the first year of employment for 1 of 2 TP (TP#1 started testing on 08/27/2020), for each test system performed in the departments of Clinical chemistry, Hematology, immunology and Virology in 2021. 3. The TP# 1 confirmed the findings above on 09 /13/2021 around 12:05 pm. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of laboratory policies and interview with testing personnel (TP)#1, the laboratory failed to have all laboratory procedures signed and dated by the current 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 -- laboratory director (LD) from 09/13/2019 to 09/13/2021. Findings include: 1. On the day of survey, 09/13/2021, a review of a sampling of the laboratory procedures, revealed the laboratory procedures in use were not signed by the LD. 2. TP# 1 confirmed the findings above on 09/13/2021 around 2:05 pm. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the laboratory records, lack of documentation and interview with testing personnel (TP) #1, the laboratory failed to demonstrate and document verification of performance specifications for accuracy and precision on the Ortho Clinical Diagnostics Vitros-ECiQ for Covid-19 antibody testing before reporting patient test results in 2020. Findings Include: 1. On the days of survey 09/13/2021, the laboratory could not provide verification of performance specifications for accuracy and precision activities performed on the Ortho Clinical Diagnostics Vitros-ECiQ for Covid-19 testing before reporting patient test result in 2020. 2. TP# 1 confirmed the finding above on 09/13/2021 around 1:00 p.m. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on observation of the laboratory, lack of documentation and interview with testing personnel (TP) #1, the laboratory failed to establish a maintenance policy to assess the maintenance/function of 3 of 3 thermometers used to monitor the laboratory room, freezer and refrigerator temperatures and 4 of 4 Thermo Scientific Finnpipettes in use on 08/13/2021. Findings Include: 1. On the day of survey, 09/13/2021, observation of the laboratory revealed, the following thermometers and mechanical pipettes in use in the laboratory on 09/13/2021: 4 of 4 Thermo Scientific Finnpipettes: 2 ml Fixed Volume. 100 -1000 micro liter. 3 ml Fixed Volume. 5 ml Fixed Volume. 3 of 3 unlabeled thermometers 2. The laboratory could not provide a maintenance policy for the thermometers and pipettes. 3. The laboratory could not provide -- 2 of 5 -- purchase records or previous maintenance/function check records performed on the thermometers and pipettes. 4. TP#1 confirmed the findings above on 09/13/2021 around 02:50 pm. 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 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 calibration verification records and interview with testing personnel (TP) #1, the laboratory failed to perform calibration verification on the Ortho Clinical Diagnostics Vitros-ECiQ for Vitamin D, Vitamin B and Covid-19 twice annually in 2020 and 2021. Findings Include: 1. On the day of survey, 09/13/2021, a review of calibration verification records revealed, the laboratory did not perform calibration verification on the Ortho Clinical Diagnostics Vitros-ECiQ for Vitamin D, Vitamin B and Covid-19 at least twice annually in 2020 and 2021. 2. TP#1 confirmed the finding above on 09/13/2021 around 02:00 pm. D5781