Covington Pediatrics

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of the 2018 - 2021 API (American Proficiency Institute) proficiency testing (PT) records, personnel records, and an interview with Testing Personnel (TP) #2 and the Laboratory Director, the surveyor determined the laboratory failed to ensure proficiency testing samples were rotated between all personnel who performed moderate complexity Hematology testing on patients. This was noted on seven of nine surveys events reviewed. The findings include: 1. A review of API attestation statements revealed the employee listed as TP #2 on the previous Form CMS-209 (Laboratory Personnel Report) from the 6/26/2018 survey had signed the attestation as the testing personnel and had performed all the testing on the following Hematology surveys: 2018-Event #3, 2019-Events #1 and #2, and 2020- Event #1 [Records for the 2019-Event #3 were not available, and were printed during the survey; the attestation statement was not signed. Refer to D3037.] 2. A review of API attestation statements revealed TP #2 listed on the current Form CMS-209 had signed the attestation as the testing personnel and had performed all the testing on the following Hematology surveys: 2020-Event #2 (while being supervised by TP #4), 2020-Event #3, and 2021-Event #1. 3. A review of the personnel files of testing personnel listed on the current Form CMS-209 revealed, TP #1 and #4 had been qualified to perform moderate complexity Hematology testing since the previous survey (on 6/26/2018). TP #3 was a recently hired employee, trained to perform Hematology testing on 10/5/2020. There was no record of TP #1, #3 or #4 performing PT. 4. During an interview on 5/5/2021 at 12:05 PM, the TP #2 confirmed she had performed all the Hematology proficiency testing because she was "in charge of 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 6 -- lab"; TP #4 had supervised her performing the PT on 2020-Event #2, because "it was her first time". (The surveyor noted TP #2 was hired and trained in September 2017.) TP #2 further confirmed the person "in charge of the lab" (listed as TP #2 on the previous Form CMS-209) had also performed all the PT in late 2018 thru early 2020. 5. During an interview with the Laboratory Director on 5/5/2021 at 12:15 PM, the surveyor reviewed PT deficiencies, and explained all testing personnel listed on the CMS-Form 209 must periodically participate in the performance of proficiency testing, not just the person "in charge of the lab". . D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of the 2018 - 2021 API (American Proficiency Institute) proficiency testing (PT) records, and an interview with Testing Personnel (TP) #2 and the Laboratory Director, the surveyor determined the laboratory failed to ensure proficiency testing records for one of nine surveys were retained for at least two years. The findings include: 1. A review of API PT records revealed no results (scores) with review sheet, no program forms, no attestation statement and no instrument printouts for the 2019-Event #3 survey. 2. During an interview on 5/5/2021 at 12:05 PM, TP #2, confirmed she was unable to find these records, so she printed scores, program forms, and the attestation statement (unsigned) from the API website. TP #2 confirmed she was unable to find the instrument printouts, and the original signed attestation statement. 3. During an interview on 5/5/2021 at 12:15 PM, the surveyor reviewed PT deficiencies with the Laboratory Director. . D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on reviews of API (American Proficiency Institute) proficiency testing records, Sysmex XP-300 Hematology quality control and calibration records, inadequate quality assurance documentation, and interviews with Testing Personnel #2, the Practice Manager and the Laboratory Director (who also serves as one of the Technical Consultants), the surveyor determined the laboratory failed to implement an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the quality of the analytic systems. These systemic failures were noted to occur during a nine-month period in 2020. The findings include: 1. Refer to D2007, D5437, D5441, D5447, and D5791. . D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) -- 2 of 6 -- 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 Sysmex XP-300 Hematology calibration records, and an interviews with Testing Personnel #2, the Practice Manager, and the Laboratory Director, the surveyor determined the laboratory failed to ensure calibrations were performed with the frequency required by the manufacturer in 2020 - 2021. The findings include: 1. A review of Sysmex XP-300 calibration records revealed the following: A) 11/4/2019: Documentation of an acceptable calibration with an expiration date in early May 2020 B) The next calibration was performed during a service call on 9/14/2020; this calibration expired on March 2021. 2. During an interview on 5/5/2021 at approximately 2:30 PM, the surveyor asked if calibrations had been performed every six months, as required by the manufacturer. The Office Manager and Testing Personnel stated Sysmex may not have been performing calibrations in early 2020 due to COVID-19. When asked about the calibration due in March 2021, the Office Manager stated there was confusion on whether the laboratory had a current service agreement; the Manager stated they did and had provided Sysmex with a copy of it. . 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 reviews of the Sysmex XP-300 Hematology Quality Control (QC) records and an interview with the Laboratory Director, the surveyor determined the laboratory failed to review and monitor for shifts and trends to assess accuracy and precision of test performance over time in 2020- 2021. The findings include: 1. A review of the QC records for the Sysmex XP-300 Hematology analyzer revealed the daily QC printouts were retained for the 2018 - 2021 survey period. The laboratory had elected to submit the QC data to the Sysmex Insight website (the Sysmex Interlaboratory -- 3 of 6 -- Quality Assurance Program) as a method of monitoring the QC for shifts and trends over time. 2. The surveyor reviewed the Sysmex Insight reports from 8/20/2018 thru 1 /3/2020. For dates thereafter, no Sysmex Insight reports were available. Testing Personnel #2 printed six reports covering the time period of 12/30/2019 thru 5/5/2021 on the day of the survey at the surveyor's request. 3. A review of the Sysmex Insight reports revealed a nine-month period with notifications from Sysmex of positive biases that required action for Hemoglobin, MCH (Mean Corpuscular Hemoglobin) and MCHC (Mean Corpuscular Hemoglobin Concentration) on the following reports: A) Lot #9365: 12/30/2019 thru 4/6/2020 B) Lot #0084: 4/6/2020 thru 6/26/2020 C) Lot #0168: 6/22/2020 thru 9/23/2020 There was no documentation of investigation and