J Michael Karst Md Pa

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of the Policy and Procedure (P&P) Manual and an interview with the Testing Personnel 1 (TP1), the Laboratory Director (LD) failed to document review and approval of the new Complete Blood Count (CBC) procedure performed on the Beckman Coulter (BC) DxH 500 analyzer. The surveyor noted the BC DxH 500 procedure was in the P&P manual but had no evidence of approval by the LD before patient testing began on 08-15-2023 through the date of the current survey on 05-30-2025. The findings include: 1. A review of the P&P Manual revealed the new CBC procedure for the BC DxH 500 Hematology analyzer had no documentation of the LD's review and approval (as indicated by his signature and date) before patient testing began on 08-15-2023. 2. During the exit conference on 05-30-2025 at 12:07 PM, TP1 confirmed the above findings. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and This STANDARD is not met as evidenced by: Based on a review of the Beckman Coulter (BC) DxH 500 Hematology analyzer verification records and an interview with Testing Personnel 1 (TP1), the Laboratory Director (LD) failed to document review and approval of the installation procedures 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 -- as verification of the manufacturer's performance specifications before patient testing began. The surveyor noted the missing documentation from the date of installation, 08- 15-2023 to the date of the current survey, 05-30-2025. The findings include: 1. A review of the verification records for the BC DxH 500 Hematology analyzer revealed no documentation of the LD's review and approval (as indicated by signature and date) of installation procedures verifying the manufacturer's performance specifications. Patient Complete Blood Count (CBC) testing began 08-15-2023. 2. A further review of the Hematology Method Comparison cover page revealed the LD failed to sign and date the evaluation to indicate review and approval of the data. 3. During the exit conference on 05-30-2025 at 12:07 PM, TP 1 confirmed the above findings. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based on a review of the personnel records and interviews with Testing Personnel 1 (TP1), the Technical Consultant (TC) failed to ensure competency assessments for Testing Personnel (TP) listed on the CMS-209 (Laboratory Personnel Report), performing moderate complexity tests included all six CLIA minimal regulatory requirements. The surveyor noted two of the six requirements were missing on the semi-annual and annual competencies. The findings include: 1. A review of the 2023- 2025 personnel records revealed TP competency assessments for the Hematology specialty had no documentation for two of the six CLIA minimal regulatory requirements. The missing two requirements were as follows: (1) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. (2) Assessment of problem-solving skills. 2. The TP1 confirmed the above findings during the exit conference on 5-30- 2025 at 12:07 PM. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) 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 a review of Personnel records and an interview the Testing Personnel 1 (TP1), the Technical Consultant (TC) failed to assess competency of Testing Personnel (TP) at least semi-annually during the first year of patient testing. This was noted for one of the two TP listed on the CMS 209 (Laboratory Personnel Report) from 2023-2025. The findings include: 1. A review of Personnel records revealed TP2 had no evidence of semi-annual competency assessment available for review during the survey. 2. The TP1 confirmed the above findings on 05-30-2025 at 12:07 PM during the exit conference. -- 2 of 3 -- D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on a review of Personnel records and an interview the Testing Personnel 1 (TP1), the Technical Consultant (TC) failed to perform competency assessment of the Testing Personnel (TP) annually. This was noted for one of the two TP listed on the CMS 209 (Laboratory Personnel Report) from 2023-2025. The findings include: 1. A review of Personnel records revealed TP1 had no evidence of an annual competency assessment performed and completed for 2023. 2. The TP1 confirmed the above findings on 05-30-2025 at 12:07 PM during the exit conference. -- 3 of 3 --

Summary Statement of Deficiencies D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

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 calibration and calibration adjustment records for the Beckman Coulter AcT diff Hematology analyzer, reviews of the laboratory's Coulter AcT diff Procedure, and the calibration instructions in the Operator's Manual, a review of Quality Control (QC) records, and interviews with the Technical Consultant, the laboratory failed to: I) Perform a calibration every six months as per laboratory procedure; II) Perform a calibration when critical parts were replaced, as per laboratory procedure; III) Perform and document the Reproducibility and Carryover before calibrating the instrument, as per manufacturer's instructions; IV) Verify calibrations and calibration factor adjustments by running at least two levels of QC, as per manufacturer's instructions. This was noted on calibrations and calibration factor adjustments performed from January 2019 thru July 2021. The findings include: I) 1. A review of the laboratory's Coulter AcT diff Procedure (Page 4 of 13), under "Calibration" revealed, "...The laboratory must verify calibration every six months ...". 2. A review of calibrations and calibration factor adjustments records revealed the laboratory performed a calibration using the S-CAL calibrator on 1/10/2019, 2/6 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 -- /2020, and 2/11/2021. There was no documentation of a calibration performed the second half of 2019 or 2020. 3. During the exit conference at 3:20 PM on 8/19/2019, the Technical Consultant stated the testing personnel were supposed to perform calibrations twice a year, however he did not know where the documentation might be. II) 1. A review of the laboratory's Coulter AcT diff Procedure (Page 4 of 13), under "Calibration" revealed, "...The laboratory must verify calibration every six months ... . ....Calibration verification is also required if one or more of the following occur: Critical parts are replaced ...". 2. A review of laboratory records revealed the WBC (White Blood Cell) Chamber was replaced on 4/29/2019; there was no documentation of a calibration. 3. A review of calibrations and calibration factor adjustments records revealed the Sample Aspiration Syringe was replaced on 4/30 /2020; there was no documentation of a calibration. 4. During a review of the records on 8/19/2021 at 2:00 PM, the Technical Consultant confirmed a calibration was not performed on 4/29/2019 or 4/30/2020, when critical parts were replaced. III) 1. A review of the Beckman Coulter AcT diff Operator's Manual under Calibration on page 5-2 revealed, "BEFORE CALIBRATING Before calibrating, you must first prepare the instrument: ...2. Do Reproducibility. 3. Do Carryover. ..." 2. A review of calibrations and calibration factor adjustments records revealed the following: A) Calibration performed 1/10/2019; there was no documentation of Carryover studies B) Calibration performed 2/11/2021; there was no documentation of Carryover studies 3. During a review of the records on 8/19/2021 at 2:00 PM, the Technical Consultant confirmed the above noted findings. IV) 1. A review of the Beckman Coulter AcT diff Operator's Manual under Calibration revealed, "...16. Verify calibration by running 4C PLUS cell control. ...". 2. A review of calibrations and calibration factor adjustments records revealed the following: A) Calibration factor adjustment on 3/21/2019 at 10: 16 AM; no QC was performed afterwards B) Calibration factor adjustment on 10/31 /2019 at 11:07 AM; all three levels of QC performed afterwards (11:11, 11:12 and 11: 14 AM) were outside of acceptable ranges C) Calibration factor adjustment on 11/11 /2019 at 4:03 PM; Low and Normal QC were performed the following morning, however the Low QC was outside acceptable ranges D) Calibration factor adjustment on 12/12/2019 at 11:55 AM; no QC was performed afterwards E) Calibration performed on 2/6/2020 at 12:48 PM; the Low and Normal QC performed afterwards were outside acceptable ranges F) Calibration factor adjustment on 8/27/2020 at 12:04 PM; no QC was performed afterwards G) Calibration factor adjustment on 9/24/2020 at 11:44 AM; all three level of QC performed afterwards were outside acceptable ranges H) Calibration factor adjustment on 10/15/2020 at 9:40 AM; only one level of QC was performed afterwards, with no documentation of a second level of QC run I) Calibration factor adjustment on 11/19/2020 at 10:49 AM; no QC was performed afterwards J) Calibration performed on 2/11/2021 at 12:42 PM; no QC was performed afterwards K) Calibration factor adjustment on 7/8/2021 at 10:40 AM; no QC was performed afterwards 2. During the exit summation on 8/19/2021 at 3:20 PM, the Technical Consultant explained quality control drifts were the reason for the frequent QC adjustments; but offered no other explanation for the unacceptable quality control performance, after the adjustments were made. Additionally, the Technical Consultant stated he thought the testing personnel were running QC after he performed calibrations and calibration factor adjustments, however he had not remained in the lab to ensure they had. . 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 -- 2 of 3 -- 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 the calibration and calibration adjustment records for the Beckman Coulter AcT diff Hematology analyzer, reviews of the laboratory's Coulter AcT diff Procedure, and the calibration instructions in the Operator's Manual, a review of Quality Control (QC) records, and interviews with the Technical Consultant, 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 since the previous survey on 10/9/2018. The findings include: 1. A review of calibration and calibration factor adjustment records for the Beckman Coulter AcT diff Hematology analyzer revealed the laboratory failed to implement quality assurance procedures to ensure: A) a full calibration including Reproducibility, Carryover and at least two levels of QC within acceptable limits was performed every six months as per the laboratory procedure. B) a full calibration was performed whenever critical components were replaced, as per the laboratory procedure and the manufacturer's instructions C) QC was run and within acceptable ranges each time a calibration was performed or calibration factor adjustments were made. (Refer to D5437.) 2. The surveyor further noted calibration factor adjustments were frequently made (twelve times in a two and a half year period) without investigating whether other factors were causing trends or bias in the QC data. A review of the manufacturer's instructions under Calibration Overview on Page 5-1 in the Beckman Coulter AcT diff Operator's Manual revealed, "...If recalibration appears necessary, but you have not replaced a component affecting calibration, do NOT recalibrate the instrument. 1. First, thoroughly clean your analyzer following the Clean the Baths procedure ... 2. Then reanalyze a new vial of control material. ...If results remain outside expected ranges, call your Beckman Coulter representative. ...". There was no evidence the Baths were cleaned, as per instructions, or Beckman Coulter was contacted to determine why the analyzer calibration was frequently drifting. 3. During the exit conference at 3:20 PM on 8/19/2019, these concerns were reviewed and discussed with the Technical Consultant. SURVEYOR ID# 32558 Licensure and Certification Surveyor -- 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 MLE (Medical Laboratory Evaluation) proficiency testing (PT) records (attestation statements), a review of personnel training records, and an interview with the Technical Consultant, the surveyor determined the laboratory failed to ensure proficiency testing was performed by personnel who routinely performed laboratory testing on patient specimens. This affected one of six PT events reviewed by the surveyor. The findings include: 1. A review of the PT records for 2018 MLE - M1 testing event, performed in the first quarter of 2018, revealed the Technical Consultant signed the attestation statement as the testing personnel for the Hematology testing (Complete Blood Count). 2. Based on a review of the personnel training records, Testing Personnel (TP) #1 had trained on 11/30/2017 - 12/28/2017 to perform the laboratory testing, including Complete Blood Count testing. 3. In an interview on 10/09/2018 at 11:35 AM, the surveyor asked the Technical Consultant (TC) if he had performed the testing for Event 1 of 2018, and why. The Technical Consultant stated he had new personnel, and wanted to ensure the proficiency testing was done correctly. The TC stated TP#1 was trained, but still not experienced. The TC further explained he was not a usual laboratory testing personnel of patient specimens, and stated he had never performed testing on a patient specimen in this laboratory. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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 -- 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require