Marilyn S Norton Md Inc

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on interviews with laboratory director and a review of the laboratory's policies and procedures manuals on November 25, 2025, it was determined that the laboratory failed to have policies and procedures manuals for general laboratory systems, preanalytical, analytical, and post-analytical testing. The findings included: 1. It was the practice of the laboratory to perform hematology to analyze CBC using Horiba ABX micro-ES 60 analyzer. 2. On November 25, 2025, at approximately 12:00 pm, the laboratory director confirmed that the laboratory did not maintain a copy of policies and procedures for general laboratory, preanalytical, analytical, and post- analytical systems. 3. The laboratory's testing declaration form, signed by the laboratory director on November 17, 2025, stated that the laboratory had performed 104,000 hematology testing annually. 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 D0000 A proficiency testing desk review survey was performed on 04/23/2025, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing]; and D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. 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 desk review of Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and AAB - Medical Laboratory Evaluation (AAB) report (for proficiency testing events: 2024-3 and 2025- 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 -- 1), the laboratory failed to achieve satisfactory performance for two of three consecutive proficiency events in 2024 and 2025, for the analyte - HCT. The findings include: 2024 third event, HCT - 0%, 2025 first event, HCT - 60%. A review of the 2023 and 2024 proficiency testing scores from AAB confirmed the above findings. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and AAB - Medical Laboratory Evaluation (AAB) report (for proficiency testing events: 2024-3 and 2025- 1), the laboratory failed to achieve satisfactory performance for two of three consecutive proficiency events in 2024 and 2025, for the analyte - HCT. The finding include: 2024 third event, HCT - 0%, 2025 first event, HCT - 60%. A review of the 2023 and 2024 proficiency testing scores from AAB confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D report and AAB records for 2024-3 and 2025-1 events, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D report AAB records for 2024-3 and 2025-1 proficiency testing events, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) testing result reports, and interview with the laboratory staff, it was determined that the laboratory failed to attain an overall testing event score of at least 80 percent was unsatisfactory performance. The findings included: a. The laboratory uses Horiba EX 60 analyzer to perform Complete Blood Count (CBC) reporting WBC with automated cell differentials, RBC, Hemoglobin (Hgb), Hematocrit (Hct), and Platelet Count (Plt). b. The laboratory enrolled with MLE (Medical Laboratory Evaluation) proficiency testing program to ensure accuracy and reliability of the patient testing result reports. c. The laboratory attained an overall testing event score of 0 % for CBC in the M-3, 2021 PT event, which was unsatisfactory performance. d. The laboratory staff attested (3/9/2023 @ 11:35 AM) that the laboratory attained an overall testing event score of 0% for CBC in the M-3, 2021 PT event, which was unsatisfactory performance. e. The laboratory performed CBC in approximately 1650 patient samples monthly. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) testing result reports, and 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 -- interview with the laboratory staff, it was determined that the laboratory failed to review and evaluate the results obtained on proficiency testing performed. The findings included: a. The laboratory failed to review and evaluate the results obtained on proficiency testing performed. b. The laboratory uses Horiba EX 60 analyzer to perform Complete Blood Count (CBC) reporting WBC with automated cell differentials, RBC, Hemoglobin (Hgb), Hematocrit (Hct), and Platelet Count (Plt). c. The laboratory enrolled with MLE (Medical Laboratory Evaluation) proficiency testing program to ensure accuracy and reliability of the patient testing result reports. d. Review of the MLE 2022 M3 PT records including analyte scores, the laboratory attained scores of 80% for Erythrocyte Count (RBC), Hematocrit, and Leukocyte (WBC), respectively. e. The laboratory failed on the sample HD-11 for RBC, Hematocrit, and WBC with a "*" mark, where "*" indicates result unacceptable. f. There were no evidence or documents to indicate that the PT score records ever been reviewed and/or discussed the failures with the appropriate laboratory personnel who perform CB routinely. g. The laboratory staff attested (3/9/2023 @ 11:45 am) that the laboratory failed to review and evaluate the results obtained on proficiency testing performed with appriopriate testing personnel. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) testing result reports, and interview with the laboratory staff, it was determined that the laboratory failed to document all activities of reviewing, evaluating and verification the testing and the scores when received after the proficiency testing performed. The findings included: a. The laboratory failed to document all activities of reviewing, evaluating and verification the testing and the scores when received after the proficiency testing performed b. The laboratory uses Horiba EX 60 analyzer to perform Complete Blood Count (CBC) reporting WBC with automated cell differentials, RBC, Hemoglobin (Hgb), Hematocrit (Hct), and Platelet Count (Plt). c. The laboratory enrolled with MLE (Medical Laboratory Evaluation) proficiency testing program to ensure accuracy and reliability of the patient testing result reports. d. There were no evidence or documents to indicate that the PT scores ever been reviewed and/or discussed the failures with the appropriate laboratory personnel who perform CBC daily, see D- 5211 and D-6018. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of the laboratory's patient result reports, and interview with the laboratory staff, it ws determined that the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess and, to ensure accuracy, reliability of the patient test result reports. The findings included: a. The laboratory -- 2 of 4 -- failed to follow written policies and procedures for an ongoing mechanism to monitor, assess and to ensure accuracy, reliability of the patient test result reports. b. The laboratory uses Horiba EX 60 analyzer to perform Complete Blood Count (CBC) reporting WBC with automated cell differentials, RBC, Hemoglobin (Hgb), Hematocrit (Hct), and Platelet Count (Plt). c. The laboratory personnel manually data entered each of CBC analyte out of the Horiba analyzer print-out result report to its office computer system and the provider/health personnel will review the manually entered CBC results from the computer terminal to treat the patients. d. Randomly review of 6 manually data entry FINAL patient results report against the Horiba analyzer print-out patient result report sheet, an inaccurate result manually entered was found in a patient FINAL report. e. The patient, Patient Number 26311, Report Date: 2/27/2023 10:16 AM with DOB: 6/11/1996, the FINAL report for Hgb was manually entered as 13. with respect to the Horiba instrument print-out result of Hgb 13.9, which was incorrectly manually entered. f. The laboratory staff attested (3/9 /2023 @ 12:25 PM) that an inaccurate patient FINAL result report of Hgb was noted and incorrect. This FINAL report has been "Audit" (QA) by the laboratory personnel according to the "Audit" policies and procedures once before, but did not catch it. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the laboratory's patient result reports, and interview with the laboratory staff, it was determined that the laboratory director failed to ensure that the proficiency testing samples were tested as required. The findings include: a. The laboratory director failed to ensure that the proficiency testing samples were tested as required. b. The laboratory uses Horiba EX 60 analyzer to perform Complete Blood Count (CBC) reporting WBC (Leukocyte) with automated cell differentials, RBC (erythrocyte), Hemoglobin (Hgb), Hematocrit (Hct), and Platelet Count (Plt). c. The laboratory enrolled with MLE (Medical Laboratory Evaluation) proficiency testing program to ensure accuracy and reliability of the patient testing result reports. d. The laboratory attained an overall testing event score of 0 % for CBC in the M-3, 2021 PT event, which was unsatisfactory performance see D-2122. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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