East Alabama Family Practice

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 reviews of the Beckman Coulter AcT diff calibration and quality control records, and an interview with the Clinical Manager (also Testing Personnel #1), the surveyor determined the laboratory failed to follow the manufacturer's instructions to verify calibrations by running quality controls (QC) and perform/document the Carryover studies, for two out of five calibrations of the Hematology analyzer performed in 2018 - 2020. The findings include: 1. A review of calibration records for the Beckman Coulter AcT diff revealed the instrument was calibrated on 4/17/2018 at 10:27 AM. However, there was no documentation QC was run after the calibration. (Three levels of QC were only run in the morning 6:40 to 6:44 AM.) 2. A review of the 11/4/2019 AcT diff calibration revealed no documentation of Carryover studies. 3. A review of the Coulter AcT diff Operator's Guide, under the CALIBRATION section on page 5-16 revealed, "...16. Verify calibration by running 4C PLUS Cell Control. ...". The performance of Reproducibility and Carryover were also included in the calibration procedure. Carryover instructions were on page 5-7 with the notation," Carryover...Prints PASS or FAIL message for the carryover test.". 4. During an 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 -- interview and review of the records on 10/8/2020 at 12:00 PM, the Clinical Manager reviewed and confirmed the above noted findings. The surveyor then asked if any patient CBC's (Complete Blood Counts) were performed after the 4/17/2018 calibration. At 12:25 PM, the manager stated five patient CBC's were run after 10:27 AM on that date. . D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the 2018-2020 Beckman Coulter AcT diff quality control records (QC), and an interview with the Clinical Manager (also Testing Personnel #1), the surveyor determined the laboratory failed to follow the manufacturer's instructions to enter the lot number (#) and expiration when entering new cell control information. The laboratory failed to document the correct lot number and expiration date for over 21 months from 9/10/2018 to 6/23/2020. The findings include: 1. A review of the daily Hematology QC printouts revealed the same QC lot #'s: 69900 (Low), 79900 (Normal), and 89900 (High), and the same expiration date, 9/10/2018 were documented on the records for over 21 months from 9/10/2018 to 6/23/2020. 2. A comparison of the acceptable ranges on the QC records each day with the values on the Coulter QC assay sheets in use for that same period revealed the correct values were in use. Only the lot number and expiration dates were incorrect. 3. A review of the Coulter AcT diff Operator's Guide, under the CELL CONTROL "ENTERING CELL CONTROL INFORMATION", Section 2 on page 2-3 revealed, "...5. Select the cell control level (L, N, or H) by touching the level indicator. ... [The surveyor also noted the option of selecting "A"for "all", however the instructions specified "Not for use when entering the lot number or expiration date.".] ...6. Enter the lot number ... ... 7. Enter the expiration ... 4. During an interview on 10/8/2020 at 1:10 PM, the Clinical Manager stated she noticed the wrong lot numbers and the expiration date (9/10/2018) when she entered the new control information on 6/24/2020. The Manager then reviewed the Operator's Manual with the surveyor, and stated the previous manager had failed to follow the manufacturer's instructions. The previous manager had entered the correct values, but had failed to use the option that allowed entry of the lot #/expiration. . 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 the 2018-2020 Beckman Coulter AcT diff Hematology analyzer quality control (QC) records and an interview with the Clinical Manager (also Testing Personnel #1), the surveyor determined the laboratory failed to ensure at least two -- 2 of 3 -- levels of Hematology QC were within acceptable limits before patient testing began. This was noted on one day of patient CBC (Complete Blood Count) testing in April 2019. The findings include: 1. A review of the daily Hematology QC instrument printouts revealed on 9/6/2019 only the Low QC was acceptable. The surveyor noted several parameters on the Normal and High QC were outside acceptable ranges. 2. During an interview and review of the QC records on 10/8/2020 at 1:15 PM, the Clinical Manager confirmed the above noted findings. When asked if any patient testing was performed on 9/6/2019, the Manager stated 11 patient CBC's were run. SURVEYOR ID#32558 Licensure and Certification Surveyor -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of the CMS (Centers for Medicare and Medicaid) CASPER reports (#153 / #155), a review of API (American Proficiency Institute) proficiency testing evaluations, and a telephone interview with the testing personnel on May 18, 2020, the surveyor determined the laboratory failed to successfully participate in Hematology testing for two consecutive testing events, Event #3, 2019 and Event #1, 2020. The laboratory scored zero percent (0 %), due to the laboratory's "Failure to Participate," as determined by API. These zero scores resulted in an initial unsuccessful proficiency testing participation for the laboratory. The findings include: 1. A review of the CASPER reports revealed the laboratory scored zero percent (0 %) 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 -- for Hematology testing for Event #3, 2019 and Event #1, 2020, two consecutive testing events. API scored the laboratory "Failure to Participate" for both events. 2. A review of the API proficiency testing records revealed zero percent scores for each analyte in Hematology, due to the laboratory's failure to participate, resulting in zero percent scores for the specialty. 3. During a telephone interview with the testing personnel on May 18, 2020, the surveyor inquired of the causes of the failures. The testing personnel explained the laboratory's results for Event #3 of 2019 were postmarked a day late (mailed a day prior to submission deadline); thus were not received by API in time for grading. API scored this event as a failure to participate. The testing personnel also stated the laboratory had not performed a self-evaluation of the results. For Event #1, 2020, the laboratory attempted to submit the results online; however the results were not received by API. According to the testing personnel, API was called and stated the submissions were affected by COVID-19 and transmission failures. The surveyor inquired of the testing personnel as to when the results were submitted, specimens received in the laboratory, and downtimes due to the COVID 19 emergency. The testing personnel stated the laboratory was closed on March 25 - 27. The specimens were received in the laboratory for testing on March 10th, but the laboratory staff was not informed. The submission deadline was March 27; but the laboratory did not test the specimens until March 31, after the submission deadline. According to the testing personnel, patient testing continued during this time, except for the dates the laboratory was closed (March 25, 26 and 27). D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on a review of the CMS (Centers for Medicare and Medicaid) CASPER reports (#153 / #155), a review of API (American Proficiency Institute) proficiency testing evaluations, and a telephone interview with the testing personnel on May 18, 2020, the surveyor determined the laboratory failed two consecutive Hematology testing events, due to the laboratory's failure to submit the testing results prior to the submission deadlines. This affected Event #3, 2019 and Event #1, 2020. These failures lead to the laboratory's initial unsuccessful proficiency testing participation. The findings include: Refer to D2016. D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(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)(4)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of the CMS (Centers for Medicare and Medicaid) CASPER reports -- 2 of 3 -- (#153 / #155), a review of API (American Proficiency Institute) proficiency testing evaluations, and a telephone interview with the testing personnel on May 18, 2020, the surveyor determined the laboratory failed two consecutive Hematology testing events, due to the laboratory's failure to submit the testing results prior to the submission deadlines. The Laboratory Director failed to ensure the laboratory staff submitted the testing results within the time-frames, established by the proficiency testing provider and necessary for grading. This affected Event #3, 2019 and Event #1, 2020. These failures lead to the laboratory's initial unsuccessful proficiency testing participation. The findings include: Refer to D2016 and D2127. -- 3 of 3 --

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 2015-2017 American Proficiency Institute (API) proficiency testing records, CMS-209 form, policy and procedure manual, and an interview with Testing Personnel #1 (TP #1), the laboratory failed to ensure proficiency testing samples were rotated between all personnel who routinely perform moderate complexity testing on patients. This was noted on seven of seven surveys reviewed. The findings include: 1. A review of the API attestation statements revealed TP #1 performed all of the proficiency testing surveys from the third event of 2015 until the third event of 2017. 2. A review of the CMS-209 form revealed TP # 2, # 3, and # 4 were full time and had been qualified to perform moderate complexity patient testing since the previous survey conducted on 11/23/2015. 3. A review of the laboratory policy dated 2/27/2008 revealed " Proficiency testing will be rotated among all laboratory workers. The same person will not run each of the three testing events..." 4. During an interview conducted on 1/19/2018 at 12:00 PM, TP #1 confirmed proficiency testing should be rotated among all laboratory personnel who perform patient testing. Jeremy Westry, BS, MT (ASCP) Licensure and Certification Surveyor Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --