Oxford Primary Care

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of American Academy of Family Physicians (AAFP) Proficiency Testing records and an interview with the Laboratory Director, the laboratory failed to maintain a copy of instrument printouts for proficiency testing samples. This was noted on two out of five Hematology Proficiency Testing Events from 2021 to 2022. The findings include: 1. A review of AAFP Proficiency Testing records revealed the 2021 Hematology Event A and 2021 Hematology Event C instrument printouts were not retained. 2. During an interview on 08/31/2022 at 11:30 AM, the Laboratory Director confirmed the above findings. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials 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 -- using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the Sysmex XP-300 analyzer quality control records and an interview with the Laboratory Director, the laboratory failed to document a method monitoring Hematology quality control (QC) shifts and trends over time from the date of the last survey (12/03/2022) to the date of the current survey (08/21/2022). This was noted for four out of six months reviewed. The findings include: 1. A review of the Sysmex XP-300 analyzer quality control records revealed Levy Jennings charts were not retained for all three levels of Hematology QC in order to monitor shifts and trends in January 2021, April 2021, July 2021, and July 2022. 2. During an interview on 08/31/2022 at 2:20 PM, the Laboratory Director confirmed the above noted findings. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of Sysmex XP-300 analyzer quality control (QC) records, Alfa Wassermann Ace Axcel analyzer quality control records, patient result logs, and an interview with the Laboratory Director, the laboratory failed to ensure at least two levels of quality control were run and acceptable, prior to analyzing patient specimens and reporting the results. This was noted two days out of 6 months reviewed from Jan 2021 to Jul 2022. The findings include: 1. A review of the QC records for the Sysmex XP-300 analyzer revealed no controls were run on 01/11/2021. The patient result log revealed two patient Complete Blood Count (CBC) tests were performed. 2. A review of the QC records for the Alfa Wassermann Ace Axcel analyzer revealed no controls were run on 04/29/2021. The patient result log revealed five patient Complete Metabolic Panel (CMP) tests were performed. 3. During an interview on 08/31/2022 at 3:00 PM, the Laboratory Director confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies 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 Alfa Wasserman Ace Axcel Chemistry analyzer and an interview with the Laboratory Director, the surveyor determined the the laboratory failed to perform and document C /V's for two out of seventeen analytes during the first half of 2020. The findings include: 1. A review of the records for the Alfa Wasserman Ace Axcel Chemistry analyzer revealed all analytes were calibrated with one- or two-calibrator kits. CLIA 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 -- regulations specify analytes calibrated with less than three calibrators must have a calibration verification (C/V) performed every six months. 2. A review of the Chemistry analyzer records revealed the laboratory performed a C/V on fifteen analytes on 5/11/2020, however there was no documentation of a C/V on Carbon Dioxide (CO2) or Total Bilirubin (TBil). 3. In an interview on 12/3/2020 at 1:45 PM, the Laboratory Director confirmed the above noted findings, stating CO2 and TBil were possibly missed because these tests required a different C/V kit. . D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a lack of quality control records and an interview with the Laboratory Director, the laboratory failed to document Chemistry and Hematology quality control (QC) shifts and trends over time for a one year period since November 2019. The findings include: 1. During the initial tour, the surveyor reviewed the analyzers in use and the test menu for this laboratory. The Laboratory Director stated patient testing began the end of November 2019. 2. A review of the QC records for the Alfa Wasserman Ace Axcel Chemistry analyzer and the Sysmex XP-300 Hematology analyzer revealed only the daily QC instrument printouts were available. The laboratory had no records documenting the monitoring of QC shifts and trends over time. (Examples include printing Levi-Jennings charts or periodically submitting data to a QC company's Interlaboratory Quality Assurance Program [IQAP]). 3. During an interview on 12/3/2020 at 12:45 PM, the Laboratory Director confirmed the above noted findings. . 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; This STANDARD is not met as evidenced by: Based on a review of the Chemistry records, and an interview with the Laboratory Director, the surveyor determined the the laboratory failed to perform and document -- 2 of 3 -- complete validations of the manufacturer's performance specifications for three out of seventeen analytes on the Alfa Wasserman Ace Axcel Chemistry analyzer, before patient testing began. The findings include: 1. A review of the October 2019 validation records for the Alfa Wasserman Ace Axcel Chemistry analyzer revealed the Laboratory Director had failed to ensure validations for three analytes were completed before the instrument was used for patient testing in November 2019. The following records were missing: A) Calcium: no documentation of precision or reportable range studies B) Total Cholesterol: no documentation of precision studies [The laboratory could find no documentation these studies were performed.] C) Potassium (K): invalid precision and reportable range studies; documentation showed K values were imprecise with a "canceled" error, and the reportable range study was not linear. 2. During an interview on 12/3/2020 at 1:25 PM, the Laboratory Director confirmed the above noted findings. SURVEYOR ID #32558 Licensure and Certification Surveyor -- 3 of 3 --