Pediatric Associates Inc Of Brockton

Summary Statement of Deficiencies D2128 HEMATOLOGY CFR(s): 493.851(e) (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 of the laboratory's American Proficiency Institute (API) proficiency testing (PT) scores and staff interview, the laboratory failed to investigate and perform

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 of the laboratory's American Proficiency Institute (API) proficiency testing (PT) scores and staff interview, the laboratory failed to investigate and perform

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Pediatric Associates Inc of Brockton laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. 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) 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 interview with the Nurse Manager on 4/27/2022, the laboratory failed to indicate on the patient final test report the correct address of the laboratory where the test was performed as evidenced by the following: The surveyor reviewed eight (8) patient final test reports between February 2020 and November 2021. The review revealed: The laboratory failed to indicate the correct address of the laboratory location where the test was performed on six (6) out of eight (8) patient final test reports in the EPIC EMR. The laboratory implemented the new EPIC EMR in 9/2020. The address of the laboratory on the patient final test reports was 370 Oak Street, Brockton, MA 02301. The laboratory's address on the CLIA certificate is 291 East Center Street, West Bridgewater, MA 02379. The Nurse Manager confirmed on 4 /27/2022 at 12:15 PM that the patient final test reports in the EPIC EMR did not indicate the correct address of the laboratory where the test was performed. The laboratory performs 3,908 hematology tests 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 CLIA paper desk review of proficiency testing was conducted on 3/4/22 for the Pediatric Associates of Brockton laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. Based on evidence of a second occurrence of unsuccessful proficiency testing performance for the White Blood Count (WBC) differential analyte, the following Condition level deficiencies were deemed to be not met: Condition 42 CFR 493.803 - Proficiency Testing - Successful Participation. Condition 42 CFR 493.1403 - 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: 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 -- Based on record review on 3/4/22 of calendar years 2020 and 2021 proficiency testing results (three testing events), the laboratory failed to successfully participate (achieve a score of 80 percent or more) in the American Proficiency Institute (API) proficiency testing program for the White Blood Count (WBC) differential analyte as evidenced by the following First Unsuccessful Occurrence: The laboratory achieved a testing event score for the WBC differential analyte of zero (0) percent for the third testing event of 2020 and the first testing event of 2021 resulting in the first instance of unsuccessful performance for the WBC differential analyte . Second Unsuccessful Occurrence: The laboratory achieved a testing event score for the WBC differential analyte of zero (0) percent for the first and third testing events of 2021 resulting in the second instance of unsuccessful performance for the WBC differential analyte. Based on this evidence the laboratory failed to undertake the appropriate training and/or technical assistance necessary to correct the problem of unsuccessful proficiency testing performance for the WBC differential analyte. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(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 record review of calendar year 2020 American Proficiency Institute (API) proficiency testing results, the laboratory failed to attain a testing event score of at least 80 percent for all hematology analytes as evidenced by the following testing event scores: White Blood Cell (WBC) differential analyte: 1. 2020 API testing event 3 - score of 0%. 2. 2021 API testing event 1 - score of 0%. 3. 2021 API testing event 3 - score of 0%. The WBC differential analyte scores were confirmed in a telephone interview with the office manager on 3/4/21 at 11:30 AM who stated that the erroneous results were due to data entry errors. 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 the deficiencies cited herein, the laboratory director failed to ensure that effective remedial action was instituted in response to unsatisfactory proficiency testing results resulting in repeated unsuccessful performance for WBC differential in the specialty of Hematology. Refer to D2016 and D2130. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on evidence of unsuccessful proficiency testing performance for the White Blood Cell Identification analyte (automated differential), the following Condition level deficiency was deemed to be not met: Condition 42 CFR 493.803 - Proficiency Testing - Successful Participation. . 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 proficiency testing performance review for calendar years 2020 and 2021 (three testing events), the laboratory failed to successfully participate (achieve a score of 80 percent or more) in a proficiency testing program for the white blood cell identification analyte (automated differential). The laboratory achieved performance 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 -- scores of zero (0) percent for the third testing event of 2020 and the first testing event of 2021 for the white blood cell identification analyte (automated differential) . Based on this evidence the laboratory failed to undertake the appropriate training and/or technical assistance necessary to correct the problem of unsuccessful proficiency testing performance for the white blood cell identification analyte. D2130 HEMATOLOGY CFR(s): 493.851(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 proficiency testing performance review for calendar years 2020 and 2021 (three testing events), the laboratory failed to achieve satisfactory performance for the same analyte for two out of three proficiency testing events as evidenced by the following: The laboratory achieved performance scores of zero (0) percent for the third testing event of 2020 and the first testing event of 2021 for the white blood cell identification analyte (automated differential) resulting in unsuccessful performance for the analyte. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Pediatric Associates of Brockton laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. 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 record review and interview, the laboratory failed to provide documentation to verify that calibrations were performed following the manufacturer's test system instructions as evidenced by the following: The manufacturer's instructions for calibration of the CELL-DYN Emerald Hematology analyzer indicated that calibrations must be performed every six months according to the policy "Emerald User Guide and Policy and Procedure for Obtaining Hemoglobin and CBC." A review of calibration records from calendar years 2017, 2018, and 2019 revealed that calibrations were performed on 8/22/17, 3/23/18, 2/13/19, 3/12/19, and 4/1/19. Testing Person One interviewed on 9/4/19 at 1:00 PM confirmed that calibrations were not performed every 6 months per the test system's instructions. 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 --