Francis X Walsh Md Pc

Summary Statement of Deficiencies D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to ensure the approved procedure for the Horiba ABX Pentra 60C+ contained the established normal ranges for Complete Blood Counts (CBC) in the specialty of hematology. Findings include: 1. Record review on 10/18/2023 of the 'ABX Pentra 60 C+ Laboratory Procedure Manual' revealed the lack of the following procedures: a. Reference ranges for male and female patients. b. Reportable ranges that correspond with the reportable ranges established and approved by the laboratory director (LD) during validation of the instrument. The laboratory was using the following reportable ranges for the following analytes: Male Female WBC: 4.5-10.5 4.0-10.0 RBC: 4.5- 6.50 3.8-5.8 HGB: 13.0-17.0 11.5-16.0 PLT: 150-500 150-500 2. Record review on 10 /18/23 of the Horiba ABX Pentra 60C+ validation records revealed the following reportable ranges were obtained and approved by the LD on 10/27/21. WBC: 0.4- 138.32 RBC: 0.23-8.2 HGB: 0.66-24.55 PLT: 11.03-3093 3. Staff interview with the office manager on 10/18/23 at 11:30 AM confirmed the above findings. 4. The laboratory performs 3,551 CBC tests annually. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) 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 -- Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to ensure the final test reports included units of measurement for Complete Blood Counts (CBC) in the specialty of hematology. Findings include: 1. Record review on 10/18/2023 of the final test reports for patent #1 and 2 from the electronic medical record (Athena Health) revealed the lack of units of measurement for each CBC analytes. 2. Staff interview with the office manager on 10/18/23 at 11:40 AM confirmed the above finding. 3. The laboratory performs 3,551 CBC tests annually. D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to ensure the final CBC test reports from electronic medical record contained the correct reference ranges listed on the Horiba ABX Pentra 60 C+ instrument printouts in the specialty of hematology. Findings include: 1. Record review on 10/18/23 of the final EMR report for patient 1 (P-1) and patient 2 (P-2) revealed the following ranges were reported: Neutrophils# (NEU): 1.4-7.0 Lymphocytes# (LYM): 0.7-3.1 Monocytes# (MO): 0.4- 0.9 2. Record review on 10/18/23 of the Horiba ABX Pentra 60C+ instrument printout for P-1 and P-2 revealed the following ranges were listed: Neutrophils# (NEU): 2.0- 7.5 Lymphocytes# (LYM): 1-4 Monocytes# (MO): 0.2-1 3. Staff interview on 10/18 /2023 at 1:00 PM with the office manager confirmed the above findings. 4. The laboratory performs 3,551 CBC tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to undertake and document appropriate remedial action for the unacceptable proficiency testing (PT) scores obtained in the specialty of hematology. Findings include: 1. Record review on 02/24/2022 of the laboratory's PT records from "AccuTest Performance Report Cycle 02-2020 for Instrument Model: ABX Micro 60 (CBC)" revealed the following: a. The analyte white blood cells (WBC) differential received an overall unacceptable score of 93.33% b. The analyte hematocrit % received an unacceptable score of 80.00%. c. Investigation and/or

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on record review and staff interview the laboratory failed to enroll in proficiency testing (PT) for the specialty of hematology. Findings include: 1. Record review of the Centers for Medicare Medicaid Services (CMS) CASPER Report 0155D on 8/28/19 revealed no scores for the following analytes for Event 1 2019: a. #0760 Hematology b. #0765 Cell I.D. or WBC Diff c. #0775 RBC d. #0785 HCT (Non-waived) e. #0795 HGB (Non-waived) f. #0805 WBC g. #0815 Platelets Scores of 100% for the above analytes for Event 2 2019 were documented utilizing the Accutest Inc. proficiency testing program. 2. Record review of the laboratory's test menu on 8/28/19 revealed the laboratory performs Complete Blood Counts (CBC) utilizing the Horiba ABX Micros 60 analyzer. 3. Staff interview with the testing personnel #1 on 8/28/19 at 1:14 PM confirmed the above findings. TP1 stated the accountant did not pay the PT program fee and therefore the laboratory was not enrolled until after Event 1 deadline had passed. 4. The laboratory performs 5,643 CBCs annually. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) 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 -- The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)