Prattville Pediatric Assoc

Summary Statement of Deficiencies D0000 The surveyor determined this laboratory is in substantial compliance with the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88). 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 --

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 calibration records for the Beckman Coulter DxH 520 Hematology analyzer, a review of the manufacturer's instructions, and an interview with the Technical Consultant, the laboratory failed to ensure: (1) repeatability and reproducibility was performed and documented each time a calibration was performed; and (2) the "calibration verification" was performed after the calibration. These problems were noted to have occurred on three of three 2022-2023 calibrations. The findings include: 1. A review of calibration records for the Beckman Coulter DxH 520 Hematology analyzer revealed the following: (1) Regarding Repeatability and Carryover, the laboratory failed to perform and document these studies, as follows: (A) 2/28/2022: No documentation of Repeatability and Carryover (B) 8/18/2022: No documentation of Repeatability (C) 2/13/2023: No documentation of Repeatability (2) Regarding the "Calibration Verification", the laboratory failed to verify three of three calibration as per manufacturer's instructions. 2. A review of the Beckman Coulter DxH 520 "Instructions for Use Manual", under Chapter 11 Quality Assurance revealed, "...Calibration... ...17. Verify calibration using DxH 500 calibrator..." [page Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 11-6] A further review of the procedure revealed instructions on how to perform the Repeatability and Carryover studies with the calibration, as follows: "...Running Repeatability..." [page 11-6] and "Running Carryover..." [page 11-8]. 3. During an interview and review of the manual on 8/2/2023 at 12:50 PM, the Technical Consultant confirmed the laboratory had failed to perform calibrations as per the manufacturer's instructions. . D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on reviews of personnel records, AAB (American Association of Bioanalysts) proficiency testing (PT) records, calibration records, quality assurance (QA) records, and the exit interview with the Technical Consultant, the surveyor determined the laboratory failed to follow quality assurance procedures as an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the quality of the analytic systems. These failures were noted to occur since the previous survey on 12 /14/2021. The findings include: 1. Personnel A review of the QA procedures (documented in the "Monthly Quality Assurance Checklist") revealed the laboratory failed to follow the "Personnel Policy" which specified: A) "Personnel evaluations were performed as necessary". The surveyor noted four of eight testing personnel performing patient testing on the Beckman Coulter DxH 520 with no documentation of semiannual or annual competency evaluations. (Refer to D6053 and D6054.) B) The laboratory further failed to implement QA reviews to ensure all Testing Personnel provided required educational documentation before performing patient testing. (Refer to D6045.) 2. Proficiency Testing A review of the QA procedures revealed the laboratory failed to follow the "Proficiency Testing policy" which specified, "All proficiency test results were evaluated." The surveyor noted no documentation of review for survey Event Q1-2022 until the day of the survey. The surveyor further noted Event Q3-2022 was not not printed and reviewed until the day of the survey. 3. Quality Control (QC) A review of the QA procedures revealed the laboratory failed to implement and follow "Quality Control Policies" to ensure calibrations on the Beckman Coulter DxH 520 were performed as per the manufacturer's instructions. (Refer to D5437). 4. During the exit interview on 8/2/2023 at 3:15 PM the above noted deficiencies were reviewed and confirmed with the Technical Consultant. . D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: Based on reviews of personnel files, and an interview with the Technical Consultant, -- 2 of 4 -- the Technical Consultant, failed to ensure two of five new Testing Personnel provided documentation of their education to ensure the minimal requirements of a High School diploma (or equivalent) were met. The Technical Consultant further failed to ensure training on the Beckman Coulter (BC) DxH 520 Hematology analzer was performed and dated for one of five new Testing Personnel to ensure training was performed before she began patient CBC (Complete Blood Count) testing. The findings include: 1. A review of personnel files revealed no documentation of education for Testing Personnel #7 and #8. Testing Personnel must provide a High School diploma (or equivalent), or a degree in a Chemical, Physical, or Biological science before performing patient testing on the Beckman Coulter DxH 520, a moderate complexity analyzer. 2. A further review of the records revealed the training for Testing Personnel #7 was not dated. The Technical Consultant stated she did not know when the training was performed. 3. During an interview and review of the records on 8/2/2023 12:10 PM, the Technical Consultant confirmed these findings. . D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on reviews of personnel files and an interview with the Technical Consultant, the Technical Consultant, failed to ensure one new Testing Personnel had documentation of the semiannual competency evaluation. This affected one of eight Testing Personnel listed on the Form CMS-209 (Laboratory Personnel Report). The findings include: 1. A review of personnel files revealed Testing Personnel #1 had training for moderate complexity testing on the Beckman Coulter DxH 520, dated 3/10 /2022 and 4/11/2022. However, there was no documentation of a semi-annual competency evaluation, due the second half of 2022. 2. During an interview and review of the records on 8/2/2023 12:10 PM, the Technical Consultant confirmed these findings. . D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on reviews of personnel files and an interview with the Technical Consultant, the Technical Consultant, failed to ensure three Testing Personnel had documentation of the annual competency evaluations. This affected three of eight Testing Personnel listed on the Form CMS-209 (Laboratory Personnel Report). The findings include: 1. A review of personnel files for Testing Personnel who performed moderate complexity testing on the Beckman Coulter DxH 520 analyzer revealed the following: A) Testing Personnel #2 had an annual competency evaluation dated 2/28/2021, however there was no documentation of annual competency assessments in 2022 or 2023. B) Testing Personnel #3 had an annual competency evaluation dated 9/29/2021, -- 3 of 4 -- however there was no documentation of annual competency assessment in late 2022. C) Testing Personnel #4 had an annual competency evaluation dated 9/22/2021, however there was no documentation of annual competency assessment in late 2022. 2. During an interview and review of the records on 8/2/2023 at 12:10 PM, the Technical Consultant confirmed these findings. SURVEYOR ID #32558 Licensure and Certification Surveyor -- 4 of 4 --

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 2 Operator's Manual, calibration and quality control records, and an interview with the Laboratory Manager, the surveyor determined the laboratory failed to follow the manufacturer's instructions to verify calibrations by running quality controls (QC), for three out of four calibrations of the Hematology analyzer performed in 2017 - 2018. The findings include: 1. A review of calibration records for the Beckman Coulter AcT diff 2 revealed the instrument was calibrated on the following dates: A.) 6/09/2017 at 12:13 PM B.) 12/27 /2017 at 9:51 AM, and C.) 12/12/2018 at 2:21 PM However, there was no documentation QC was run after these calibrations. 2. A review of the Coulter AcT diff Operator's Guide, under the CALIBRATION section on page 5-18 revealed, "... 17. Verify calibration by running 4C PLUS Cell Control. ..." 3. During an interview on 3/7/2019 at 2:35 PM, the surveyor reviewed with the Laboratory Manager, Coulter's directions to perform QC after calibration of the Hematology analyzer. The Manager then checked with Testing Personnel #1 who stated she did perform QC after calibrations. However the laboratory only provided QC performed in the early 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 -- morning (before the calibrations) for the above dates, thus the above noted findings were confirmed. . D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on a lack of training documentation in the personnel files for Testing Personnel (TP) #4, #5, and #6, and an interview with the Laboratory Manager, the Laboratory Director failed to ensure training for three of three new testing personnel was documented before patient testing began. The Director further failed to ensure TP #1 was trained to perform calibrations of the Beckman Coulter AcT diff 2 Hematology analyzer as per manufacturer's instructions. [Refer to D5437 for further details.] The finding include: 1. A review of the employee records provided for TP #4 (hired December 2017), #5 (hired November 2017), and #6 (hired May 2018) revealed no documentation of training. A generic "Laboratory Personnel Evaluation" was completed, however the facility did not specify the tests for which the personnel were trained, or the details and extent of the training. The surveyor further noted these testing personnel had not participated in the proficiency testing in 2017-2018. [The laboratory failed to provide evidence the sixth standard on the Personnel Evaluation form, "Accuracy in test performance...with PT or blind samples" had been assessed to ensure their training had been sufficient.] 2. A further review of the personnel records revealed the a letter for each of the above testing personnel. The following letter was signed by the Laboratory Director, "Effective [ Date ] [ Name of Employee ] has been adequately trained to perform laboratory procedures at Prattville Pediatric Associates.". 3. The surveyor further noted the Laboratory Director had failed to ensure TP #1 was correctly trained to follow the manufacturer's instructions when performing three out of four calibrations on the Beckman Coulter AcT diff 2 Hematology analyzer in 2017-2018. [Refer to D5437 for additional details..] 4. During an interview on 3/7/2019 at 11:30 AM, the surveyor asked the Laboratory Manager about the scope of responsibilities for TP #4, #5, and #6. The Manager stated the testing personnel performed patient CBC (Complete Blood Count) testing on the Beckman Coulter AcT diff 2 automated Hematology analyzer, and waived testing. The surveyor then asked how the training was documented; the Manager stated the laboratory considered the letter signed by the Laboratory Director (see #2 above) as documentation of the training. The Manager confirmed the laboratory did not use a manufacturer's training checklist or a lab-developed training list that detailed the employee's training and responsibilities. SURVEYOR ID#32558 Licensure and Certification Surveyor -- 2 of 2 --