Putnam County Pediatrics, Pllc

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on 11.08.2022 the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 a desk review of the Center for Medicare and Medicaid Services CASPER Report 0155D (CMS 155), the laboratory's American Proficiency Institute (API) proficiency testing records,and staff interview, the laboratory failed to successfully 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 -- participate in the specialty of Hematology for the analytes automated white blood cell differential (WBC Diff), Hematocrit (HCT), and Platelet (PLT) for three out of five testing events, resulting in non-initial unsuccessful PT participation (refer to D2130 and D2131). 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 a desk review survey of the CMS 155, the laboratory's 2020 and 2021 API PT records, and phone interview with the office manager, the laboratory failed to maintain satisfactory performance in three out of five PT events for the WBC Diff, HCT, and PLT analytes, resulting in non-initial unsuccessful PT participation. The findings include: 1. Review of the CMS 155 revealed the following unsatisfactory PT scores for the WBC Diff , HCT and PLT analytes: 2020 Event two: WBC Diff: 0% HCT: 0% PLT: 0% 2021 Event one: WBC Diff: 27% HCT: 40% PLT: 40% 2021 Event three: WBC Diff: 47% HCT: 20% PLT: 20% 2. Review of the laboratory's API PT performance evaluation records revealed the following unsatisfactory scores for WBC Diff, HCT and PLT analytes: 2020 Event two: WBC Diff: 0% HCT: 0% PLT: 0% 2021 Event one: WBC Diff: 27% HCT: 40% PLT: 40% 2021 Event three: WBC Diff: 47% HCT: 20% PLT: 20% 3. Phone interview with the office manager on November 8, 2022 at approximately 9:45 am confirmed the survey findings. D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review survey of the CMS 155 report, the laboratory's 2020 and 2021 American Proficiency Institute (API) proficiency testing (PT) records, and interview with the office manager, the laboratory failed to achieve satisfactory performance for the overall specialty of Hematology in three out of five PT events in 2020 (event 2) and 2021 (events 1 and 3). The findings include: 1. Review of CASPER CMS 155 report, the laboratory received the following unsatisfactory scores (satisfactory is 80% or greater) for specialty of Hematology in three of five events: 2020 Event 2: 0% 2021 Event 1: 64% 2021 Event 3: 24% 2. Review of the American Proficiency Institute (API) performance evaluation records revealed the laboratory received the following unsatisfactory scores (satisfactory is 80% or greater) for specialty of Hematology in three of five events: 2020 Event 2: 0% 2021 Event 1: 64% 2021 Event 3: 24% 3. Phone interview with the office manager on November 8, 2022 at approximately 9:45 am confirmed the survey findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 -- 2 of 3 -- 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 review of the CMS 155 report, the laboratory's API PT records, and interview with the office manager, the laboratory director failed to provide overall management and direction to the lab for successful participation in proficiency testing (refer to D6016). 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 a desk review survey of the CMS 155 and the laboratory's 2020 and 2021 API PT evaluation records, staff interview, and laboratory communication, the laboratory director failed to ensure successful participation in an HHS approved proficiency program (refer to D2130 and D2131). -- 3 of 3 --

Summary Statement of Deficiencies 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: The laboratory failed to maintain satisfactory performance in two out of three proficiency testing (PT) events for Cell I.D. or White Blood Cells (WBC) Differential (DIFF), Hematocrit (HCT), and Platelets (PLTS) ) analyte resulting in the 1st unsuccessful PT performance in 2021.(Refer to D2130). D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services Casper report 155D (CMS 155) and American Proficiency Institute (API) evaluation reports, the laboratory failed to achieve satisfactory performance for Cell I.D. or White Blood Cells (WBC) Differential (DIFF), Hematocrit (HCT), and Platelets (PLTS) ) analyte in two out of three testing eventresulting in the 1st unsuccessful PT performance in 2021. The findings include: 1. 1) Review of the CMS 155D revealed the following scores: Event 2-2020 Cell ID or WBC Diff, HCT, PLTS a score of 0% Event 1-2021 Cell ID or WBC Diff score of 27%, HCT, PLTS a score of 40% 2. Review of the laboratory's API evaluation report revealed the following scores: Event 2-2020 Cell ID or WBC Diff, HCT, PLTS a score of 0% , Event 1-2021 Cell ID or WBC Diff score of 27%, HCT, PLTS a score of 40% -- 2 of 2 --

Summary Statement of Deficiencies 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: The laboratory failed to maintain satisfactory proficiency testing (PT) performance in two out of three testing events for the Red Blood Cell (RBC) analyte resulting in the 1st unsuccessful PT occurrence for the RBC analyte in 2020. (Refer to D2130) D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a 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 -- score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services Casper report 155 (CMS 155), American Proficiency Institute (API) evaluation reports and phone interview with the office manager, the laboratory failed to return the 2nd proficiency testing (PT) event 2020 for the Hematology specialty resulting in a score of 0% for the testing event. The findings include: 1. Review of the CMS 155 report revealed a score of 0% for the following analytes: cell I.D or White Blood Cells (WBC) differential, red blood cell (RBC), hematocrit (HCT), hemoglobin (HGB), WBC and Platelets (PLTs) analytes. 2. Review of API evaluation report revealed a score of 0% for the following analytes: cell I.D or WBC differential, RBC, HCT, HGB, WBC and PLTs analytes. 3. Phone interview on September 15, 2020 at 11:00 A.M. with the office manager revealed the laboratory did not return the PT 2nd event 2020 due to the analyzer has not been calibrated since January 24th 2020. 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 review of the Centers for Medicare and Medicaid Services Casper report 155 (CMS 155) and American Proficiency Institute (API) evaluation reports, the laboratory failed to achieve satisfactory performance for Red Blood Cell (RBC) analyte in two out of three testing event resulting in the 1st unsuccessful PT performance in 2020. The findings include: 1. 1) Review of the CMS 155 revealed the following scores for the RBC analyte: 2019 Event three = 20% 2020 Event two = 0% 2. Review of the laboratory's API evaluation report revealed a score of 20% for the 3rd event 2019, and a score of 0% for the 2nd event 2020. 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: The Laboratory Director failed to ensure laboratory protocols were followed for Proficiency Test (PT) and Complete Blood Count (CBC) analyzer calibrations in 2020. (Refer to D6007) D6007 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(1) 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 -- 2 of 3 -- and for assuring compliance with the applicable regulations. (E) The laboratory director must-- (E)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: Based on review of failed PT for the 2nd event 2020 and lack of CBC calibration per phone interview with the office manager, it was determined the Laboratory Director failed to ensure that laboratory protocols were followed for PT and CBC analyzer calibration in 2020. The findings include: 1. Review of the failed Proficiency Test for the 2nd event 2020 revealed PT was not performed. 2. Per phone conversation with the office manager on September 15th, 2020 at 11:00 A.M stated instrument calibration was not performed at 6-month intervals; therefore, PT was not performed for the 2nd event 2020. -- 3 of 3 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual, and interview with the lead testing person, the laboratory failed to have a procedure to include all six criteria for assessing personnel competency. The findings include: 1) Review of the laboratory procedure manual revealed the following six criteria were not included in the annual competency assessment procedure: direct observation of routine patient test performance; monitoring the recording and reporting of test results; review of intermediate test results or worksheets, quality control records, proficiency testing results and preventative maintenance records; direct observation of performance of instrument maintenance and function checks; assessment of test performance through previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and assessment of problem solving skills in 2020. 2) Interview on January 16, 2020 at 12:30 p.m. with the lead testing person confirmed the testing personnel annual competency procedure did not include the six criteria for testing personnel competency assessment required by the Centers for Medicare and Medicaid Services (CMS). D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that 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 -- provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on procedure manual review, manufacturer's instructions for the Hematology CELL-DYN Emerald Operator's Manual on calibration and interview with the lead testing person the laboratory failed to have a written procedure manual for the Complete Blood Count (CBC) test and calibration records for the Cell-Dyn Emerald CBC analyzer in 2018 and 2019. (Refer to D5403 and D5439). D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) 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)

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 2016 and 2017 Proficiency Testing (PT) attestation records and an interview with the primary testing person, it was determined the laboratory did not involve 3 of 5 testing personnel in rotating PT samples for complete blood counts during the 2 year period. Findings include: 1. A review of PT records from 2016 and 2017 disclosed the 2 lab persons did all testing of PT samples. 2. An interview with the primary testing person at 12:30pm on April 2, 2018 confirmed only 2 of 5 persons running PT samples for the 2 year period. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. 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 -- This STANDARD is not met as evidenced by: Based on review of the proficiency testing attestation sheets and interview with the Laboratory Supervisor determined that the attestation sheets were not signed by the Medical Director or testing personnel in 2016 and 2017. The findings include: 1. Review of the proficiency testing attestation sheets revealed 5 out of 6 attestation sheets were not signed by the Medical Director or testing personnel in 2016 and 2017. 2. Interview with the Laboratory Supervisor on April 2, 2017 at 12:40 confirmed 5 out of 6 attestation sheets were not signed by the Medical Director or testing personnel in 2016 and 2017. 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 review of American Proficiency Institute (API) Performance Summary statement and interview with the Laboratory Supervisor determined the laboratory has Unsuccessful participation in Hematology Erythrocyte count during 2016 and 2017. The findings include: 1. Review of API Performance Summary statement revealed the laboratory failed to achieve successful participation for the 3rd event in 2016 score of 60% and 2nd event in 2017 score of 40% for Hematology Erythrocyte count. 2. Interview with the Laboratory Supervisor on April 2, 2018 at 12:45 confirmed that the lab failed to achieve e successful participation for the 3rd event in 2016 score of 60% and 2nd event in 2017 score of 40% for Hematology Erythrocyte count. 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 review of the Proficiency testing agency, American Proficiency Institute (API), performance summary document and interview with the Laboratory Supervisor -- 2 of 4 -- determined the laboratory failed to achieve satisfactory performance for the 3rd event in 2016, score of 60% and the 2nd event in 2017 score of 40%. The findings include: 1. Review of API Performance Summary revealed the laboratory failed to achieve satisfactory performance for the same analyte in the 3rd event in 2016 and the 2nd event in 2017. 2. Interview with the Laboratory Supervisor on April 2, 2018 at 12:55 confirmed the laboratory failed to achieve satisfactory performance for the same analyte in the 3rd event in 2016 and the 2nd event in 2017. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of quality control records and an interview with the Laboratory Supervisor determined the laboratory failed to retain daily quality control and analyzer background check printouts for 2016 and 2017. The findings include: 1. There were no quality control and analyzer background check printouts available for review from 2016 and 2017. 2. Interview with the Laboratory Supervisor on April 2, 2018 at 1:00 pm confirmed the laboratory failed to retain the quality control and analyzer background checks printouts for 2016 and 2017. 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