Pediatric And Adolescent Medicine Llp

Summary Statement of Deficiencies D0000 Based on a proficiency testing (PT) desk review survey performed on November 18, 2024, 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 review of Centers for Medicare & Medicaid Services (CMS) Proficiency Testing (PT) Certification and Survey Provider Enhanced Reporting system (CASPER 0155D) and College of American Pathologists (CAP) PT summary reports, 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 -- the laboratory failed to successfully participate in the CMS approved PT program for two of three consecutive testing events in the Hematology subspecialty for the RBC (Red Blood Cell) test analyte in 2024, resulting in non-initial unsuccessful performance. 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 CMS PT CASPER 0155D and CAP PT summary reports from 2024, the laboratory failed to achieve satisfactory performance (80% or greater) for two of three consecutive testing events in the Hematology subspecialty for the RBC test analyte. FINDINGS: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: RBC Test Analyte: 2024 Second Event = 60% 2024 Third Event = 20% 2. A review of the proficiency testing scores from CAP (2024) 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 review of CMS PT CASPER 0155D and CAP PT summary reports from 2024, the laboratory director (LD) failed to provide overall management and direction of the laboratory services. Refer to D2016. 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 CMS PT CASPER 0155D and CAP PT 2024-2 and 2024-3 summary reports, the LD failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2130. -- 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: Based on a proficiency testing ( PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT reports and PT records from the College of American Pathologists (CAP) PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the specialty Hematology and the test analytes Red Blood Cell Count (RBC) and Platelets. The following scores were assigned: Hematology 2017 third event = 0% [failure to participate- sent results in past due date] 2018 first event = 0% [failure to participate- sent results in past due date] 2018 second event = 100% 2018 third event = 73% RBC 2017 third event = 0% [failure to participate- sent results in past due date] 2018 first event = 0% [failure to 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- sent results in past due date] 2018 second event = 100% 2018 third event = 60% Platelet 2017 third event = 0% [failure to participate- sent results in past due date] 2018 first event = 0% [failure to participate- sent results in past due date] 2018 second event = 100% 2018 third event = 0% This is considered repeatedly unsuccessful PT performance. 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 PT desk review of the CMS PT reports and PT records from the CAP PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analytes Red Blood Cell Count (RBC) and Platelets. The following scores were assigned: RBC 2017 third event = 0% [failure to participate- sent results in past due date] 2018 first event = 0% [failure to participate- sent results in past due date] 2018 second event = 100% 2018 third event = 60% Platelet 2017 third event = 0% [failure to participate- sent results in past due date] 2018 first event = 0% [failure to participate- sent results in past due date] 2018 second event = 100% 2018 third event = 0% This is considered repeatedly unsuccessful PT performance. 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 PT desk review of the CMS PT reports and PT records from the CAP PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the specialty Hematology. The following scores were assigned: Hematology 2017 third event = 0% [failure to participate- sent results in past due date] 2018 first event = 0% [failure to participate- sent results in past due date] 2018 second event = 100% 2018 third event = 73% This is considered repeatedly unsuccessful PT performance. 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 PT desk review of the CMS PT and CAP PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure -- 2 of 3 -- that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the specialty Hematology and the test analytes RBC and Platelets. 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 PT desk review of the CMS PT and CAP PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the specialty Hematology and the test analytes RBC and Platelets. The following scores were assigned: Hematology 2017 third event = 0% [failure to participate- sent results in past due date] 2018 first event = 0% [failure to participate- sent results in past due date] 2018 second event = 100% 2018 third event = 73% RBC 2017 third event = 0% [failure to participate- sent results in past due date] 2018 first event = 0% [failure to participate- sent results in past due date] 2018 second event = 100% 2018 third event = 60% Platelet 2017 third event = 0% [failure to participate- sent results in past due date] 2018 first event = 0% [failure to participate- sent results in past due date] 2018 second event = 100% 2018 third event = 0% This is considered repeatedly unsuccessful PT performance. -- 3 of 3 --

Summary Statement of Deficiencies 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 the quality control (QC) records, assay range sheets, patient test reports and an interview with the practice manager and testing person, the laboratory failed to retain copies of manufacturers assay sheets for at least 2 years. Findings Include: It was confirmed by the practice manager and laboratory testing person on November 13, 2018 at approximately 2:30 pm that the laboratory failed to retain the manufacturer's assay sheets for the Coulter AcT Diff II analyzer for the following lot numbers: 069700, 069701, 068400, 068100, 068600, 088600, 069200 and 069600. This is a recitation from the August 10, 2017 survey. 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. 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 -- This STANDARD is not met as evidenced by: Based on a review of calibration records and confirmed in an interview with the laboratory testing person, the laboratory failed to calibrate the Coulter AcT Diff II hematology analyzer every six months. Findings Include: 1) It was confirmed with the laboratory testing person on November 13, 2018 at approximately 1:30 pm that the laboratory failed to follow the manufacturers and CLIA regulations to calibrate the Coulter AcT Diff II every six months. 2) Calibration was performed in October 2017, then in July 2018. 3) The Coulter AcT Diff II was due to be calibrated in April 2018. The laboratory was out of calibration for 3 months. 4) Approximately 345 patient specimens were tested and results released during that time. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a review of calibration records, and confirmed in an interview with the laboratory testing person, the laboratory director failed to ensure that the QC program for hematology was maintained to assure the quality of laboratory services. Refer to: Refer to D3031 and D5437 -- 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: Based on a proficiency testing ( PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT reports and PT records from the College of American Pathologists (CAP) PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the specialty Hematology and the test analytes Cell Identification (Cell I.D.), Red Blood Cell Count (RBC), Hemoglobin (Hgb), Hematocrit (Hct), White Blood Cell Count (WBC) and Platelets. The following scores were assigned: 2017 third event = 0% [failure to participate- 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 -- sent results in past due date] 2018 first event = 0% [failure to participate- sent results in past due date] This is considered an unsuccessful PT performance for non- participation. 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 PT desk review of the CMS PT reports and PT records from the CAP PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analytes Cell Identification (Cell I.D.), Red Blood Cell Count (RBC), Hemoglobin (Hgb), Hematocrit (Hct), White Blood Cell Count (WBC) and Platelets. The following scores were assigned: 2017 third event = 0% [failure to participate- sent results in past due date] 2018 first event = 0% [failure to participate- sent results in past due date] This is considered an unsuccessful PT performance for non-participation. 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 PT desk review of the CMS PT reports and PT records from the CAP PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the specialty Hematology. The following scores were assigned: 2017 third event = 0% [failure to participate-sent results in past due date] 2018 first event = 0% [failure to participate-sent results in past due date] This considered a unsuccessful PT performance for non-participation. 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 PT desk review of the CMS PT and CAP PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the specialty Hematology and the test analytes Cell I.D., RBC, Hgb, Hct, WBC and Platelets. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES -- 2 of 3 -- 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 PT desk review of the CMS PT and CAP PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the specialty Hematology and the test analytes Cell I.D., RBC, Hgb, Hct, WBC and Platelets. The following scores were assigned: 2017 third event = 0% [failure to participate- sent results in past due date] 2018 first event = 0% [failure to participate- sent results in past due date] This is considered an unsuccessful PT performance for non-participation. -- 3 of 3 --