Apex Diagnostic Laboratories

Summary Statement of Deficiencies 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 a review of the CAP (College of American Pathologists) proficiency testing (PT) records, and interviews with the Technical Consultant and the Technical Supervisor, the laboratory failed to produce acceptable quantitative results for 42% of the positive drugs on the 2019-2021 Drug Monitoring for Pain Management (DMPM) CAP surveys. The findings include: 1. A review of the PT records revealed the laboratory failed to produce acceptable quantitative results on the Sciex Triple Quad LC/MS (Liquid Chromatography/Mass Spectrometry) platform for 42 out of 101 (42%) positive drugs on the 2019-2021 DMPM CAP surveys, as follows: A) 2019 DMPM-A: 3 samples with a total of 17 positive drugs, however on a) Sample 01: 2 of 6 drugs were lower than the acceptable ranges b) Sample 02: 2 of 5 drugs were lower than the acceptable ranges B) 2019 DMPM-: 3 samples with a total of 14 positive drugs, however on Sample 06, 2 of 6 drugs were lower than the acceptable range C) 2020 DMPM-A: 3 samples with a total of 18 positive drugs, however on a) Sample 01: 3 of 5 drugs were higher than the acceptable ranges b) Sample 02: 1 of 6 drugs was lower than the acceptable ranges c) Sample 03: 2 of 7 drugs were lower than the acceptable ranges D) 2020 DMPM-B: 3 samples with a total of 19 positive drugs, however on a) Sample 05: 6 of 6 drugs were higher than the acceptable ranges b) Sample 06: 4 of 6 drugs was higher than the acceptable ranges c) Sample 07: 5 of 7 drugs were higher than the acceptable ranges, with 1 of 7 was lower than the acceptable ranges E) 2021 DMPM-A: 3 samples with a total of 16 positive drugs, however on a) Sample 01: 3 of 5 drugs were lower than the acceptable ranges b) Sample 02: 2 of 5 drugs were lower than the acceptable ranges c) Sample 03: 5 of 6 drugs were lower than the acceptable ranges F) 2021 DMPM-B: 3 samples with a total 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 -- of 17 positive drugs, however on Sample 06, 4 of 6 drugs was lower than the acceptable ranges 2. During interviews on 1/5/2022 between 11:40 AM and 12:20 PM, the Technical Supervisor confirmed the quality control results were always within acceptable ranges, however she was unable to give a definitive reason for the discrepancies in the CAP PT quantitative results for this laboratory when compared with a majority of other labs using LC/MS platforms; the Technical Supervisor theorized lower cutoff ranges for their platform, diluting samples that tested above the linear limit, and PM (Preventative Maintenance) issues during the COVID pandemic as possible reasons. The surveyor explained the laboratory was required to have a mechanism verifying the accuracy of their quantitative results at least twice annually. If CAP did not have participants using comparable LC/MS procedure platforms, the laboratory must find another method to verify the accuracy of their quantitative results. . D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on reviews of the Horiba ABx Micros 60 Hematology analyzer records, and an interview with the Technical Consultant and the Technical Supervisor, the surveyor determined the laboratory failed to follow the laboratory's procedure on calibration frequency. This affected two of four Hematology calibrations in 2020-2021. The findings include: 1. A review of the Horiba ABx Micros 60 Hematology analyzer records revealed the following: A) No calibration in March 2020; a note documented the Horiba technician would not come because of COVID B) Acceptable calibration on 9/21/2020 C) Acceptable calibration on 4/27/2021 D) No calibration in October 2021; a note dated 1/4/2022 from the Technical Consultant documented Horiba had stopped "drop shipments" (standing orders) so the laboratory had missed performing the calibration. 2. During an interview on 1/5/2022 at 3:04 PM, the surveyor asked how often Horiba calibrations should be performed. The Technical Consultant and Technical Supervisor confirmed the policy has been to perform calibrations every six months. The Technical Supervisor explained she had not realized the laboratory should have ordered the calibrator and performed the calibration when the Horiba technician was unable to make site visits. In addition, the Technical Consultant and Technical Supervisor confirmed no one noticed drop shipments were discontinued in late 2021, so a calibration was not performed until the day of the survey on 1/5/2022. . D6090 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(ii) The laboratory director must ensure the results are returned within the timeframes -- 2 of 3 -- established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of the API (American Proficiency Institute) proficiency testing (PT) records, and an interview with the Technical Consultant, the Laboratory Director failed to ensure results were submitted within the timeframes established by API for one of two 2020 Urine Drug Screen (UDS) surveys. The findings include: 1. A review of the API 2020 PT records revealed no scores for the 2020 Event #2 UDS survey. Only instrument printouts dated 10/27/2020 were available for this survey. 2. During an interview on 1/5/2021 at 9:20 AM, the surveyor requested the 2020 Event #2 UDS records. The Technical Consultant explained the laboratory did not submit the results by the deadline, and received a 0 % score for "Failure to Participate" SURVEYOR ID#32558 Licensure and Certification Surveyor -- 3 of 3 --

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a review of the Hematology calibration records and an interview with the current Technical Consultant (TC), the laboratory failed to ensure one of two 2018 calibrations on the Horiba ABx Micros 60 Hematology analyzer was performed and documented. The findings include: 1. A review of calibration records for the Horiba Hematology analyzer revealed documentation of calibrations performed on 8/4/2017 and 8/28/2018. 2. During an interview on 12/5/2018 at 5:20 PM, the current TC was asked for documentation of the Horiba calibration from the first half of 2018. The TC explained the usual procedure in the laboratory was to have the Horiba Service Technician perform a calibration during the "PM" (Preventative Maintenance) service call, and the laboratory staff performed the other calibration in August each year. 3. As the interview on 12/5/2018 continued, the TC provided the surveyor with a copy of the "Service Report" from February 2018, however the "Calibration" box on the report was not checked; the report documented the technician had run QC (quality controls), but there was no indication he had performed a calibration. The TC further stated the Horiba Technician always performed a calibration during the PM service, however the 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 -- laboratory had been unable to obtain a copy of the calibration for their records. Thus the above noted findings 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 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 verification (C/V) records for the Roche Cobas e411 Immunochemistry analyzer, and an interview with the current Technical Consultant (TC), the surveyor determined the laboratory failed to perform and/or document one of two 2018 calibration verifications every six months as required by laboratory policy. The findings include: 1. A review of the calibration verification (C /V) records for the Roche Cobas e411 Immunochemistry analyzer (for Vitamin B12, Folate, Prolactin, Thyroid Stimulating Hormone [TSH], and Free T4 testing) revealed the laboratory performed and documented calibration verification (C/V) on 9/15/2017 and 8/22/2018. 2. During an interview on 12/5/2018 at 5:15 PM, the TC confirmed all the above tests are calibrated with only one or two calibrators. [Analytes calibrated with less than three calibrators must have a C/V performed every six months.] However, the TC stated the personnel had been unable to find the missing C/V documentation from early 2018. Thus, the above noted findings were confirmed. . D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of installation and validation documentation for the Hitachi CLA-1 analyzer for Allergy testing and interviews with the Technical Consultant and Testing Personnel #1, the Laboratory Director failed to document review and approval of the initial validation procedures as verifying the manufacturer's performance specifications for the analyzer, before patient testing began. The findings include: 1. A review of the documentation under the Validation Section for the Hitachi CLA-1 analyzer revealed correlations on three split samples were used to establish accuracy and precision for the Food panel (used for qualitative allergy testing). A validation page in this section was signed by the previous Technical Consultant "for Dr. [Name of Laboratory Director]" and dated "12/10/2016". Also included in this section was a faxed page to Testing Personnel #2 from Hitachi technical support. At the bottom of the fax was a handwritten note, "Validation Approved", signed by the Laboratory Director; the notation was not dated. 2. In a separate section of the binder with a small pink "Correlation" tab were the correlations on three split samples dated 11/10/2016 used to establish accuracy and precision for the South East (SE) Inhalant Panel on the Hitachi CLA-1. There was no documentation of review by the Technical Consultant or the Laboratory Director. 3. During an interview and review of these records on 12/7 /2018 at 2:30 PM, the surveyor asked the current Technical Consultant (TC) if he knew when the Laboratory Director (LD) had approved the validation procedure; the TC stated he had the LD sign on the faxed sheet included with the Food Panel data "yesterday" (12/4/2018), and was not sure if the Laboratory Director had reviewed the SE Inhalant Panel data since it was in a separate section. The surveyor then asked when patient testing began on the Hitachi; Testing Personnel #1 checked the patient worksheets and stated 4/11/2017. Thus the above noted findings were confirmed. SURVEYOR: Laura T. Williams, BS, MT (ASCP) Licensure and Certification Surveyor -- 3 of 3 --