Northeast Pediatrics And Adolescent Medicine Pllc

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) Proficiency Testing (PT) Hematology and sub-speciality Bacteriology records for the 2019, 2020 and 2021 test events and an interview with the testing person, the laboratory director and testing personnel failed to sign the attestation forms attesting that the PT samples were tested in the same routine manner as patient specimens. FINDINGS: 1. Review of the printed instrument Hematology reports and the bacteriology log sheets for the 2019, 2020 and 2021 samples, the laboratory failed to test the hematology and bacteriology specimens in the same routine manner as patient specimens by the testing personnel for all three events in 2020 and the 1st event 2021. a. Twenty-three routine testing personnel perform the moderate complexity testing, automated Complete Blood Count (CBC) and Group B Strep testing. 2. The testing person confirmed on May 6, 2022 at approximately 10:00 AM, that the attestation forms for all three events in, 2020 and 1st event 2021 were not signed by the laboratory director and the routine testing personnel, therefore, it could not be determine if the PT samples were tested in the same manner as patient specimens by the testing personnel. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. 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 -- This STANDARD is not met as evidenced by: Based on the review of 2019, 2020 and 2021 API PT records and an interview with the testing person, the laboratory failed to retain documentation to include signed attestation forms for all three event if 2020, 1st event of 2021 Hematology and signed PT summary reports for the sub-speciality Bacteriology/Group B Strep 1st event in 2020 and 1st event 2022. Refer to D2009 and D6021 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 the review of 2019, 2020 and 2021 API PT summary reports and an interview with the testing person, at the time of survey, the laboratory failed to review and evaluate the API PT summary reports for the sub-Specialty Bacteriology/Group B Strep challenges for all 1st event of 2020 and the 1st event of 2022. THIS IS A REPEATED DEFICIENCY FROM THE SURVEY CONDUCTED ON AUGUST 27, 2019 D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's Quality Assessment (QA) policy, lack of annual QA review records in 2020 & 2021 and an interview with the testing person, the laboratory failed to follow their established QA policy and correct problems identified and monitor the remedial actions to ensure the problems do not recur. FINDINGS: 1. The API PT summary reports did not include evidence of review and evaluation of the PT results for the sub-Specialty Bacteriology/Group B Strep challenges for all 1st event of 2020 and the 1st event of 2022. 2. The laboratory failed to rotate the API PT samples among the twenty-three testing personnel who routinely perform hematology and bacteriology testing 3. The testing person confirmed on May 6, 2022, at approximately 11:30 AM, that the laboratory failed to perform an annual QA review as required by their established QA procedure. Refer to D2009 and D5211 THIS IS A REPEATED DEFICIENCY FROM THE SURVEY CONDUCTED ON AUGUST 27, 2019 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. -- 2 of 3 -- This CONDITION is not met as evidenced by: Based on review of laboratory procedures, laboratory records and an interview with the testing person, the laboratory director failed to provide overall management of the laboratory. FINDINGS: The laboratory director failed to implement and maintain the

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 a review of competency policies, staff competency records and an interview with the laboratory testing person, the laboratory failed to follow their establish written policies and procedures to assess the competency of the laboratory testing personnel that perform both Bacteriology/throat cultures and Hematology/CBC testing. FINDINGS: The laboratory manager/testing person confirmed on August 27, 2019 at approximately 2:00 PM, that the laboratory did not follow the established competency evaluation policy. The laboratory did not perform annual competency for nine of nineteen staff members in 2018. 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 the surveyor's review of College of American Pathologists (CAP) proficiency testing (PT) reports and an interview with the laboratory manager/testing person, the laboratory failed to evaluate, perform and document remedial action for PT scores of less than 100% for the following analytes: 2018 first event: Urine colony counts = 80% 2018 third event: Urine colony counts = 80% 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 -- D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on a surveyor's review of the laboratory's Quality Assurance (QA) policy and confirmed in an interview with the laboratory manager/testing person, the laboratory failed to follow their established written QA policy and perform an annual QA review, as required by the laboratory's QA policy, for the calendar year 2018. 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

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 test analyte Hematocrit (HCT). The following scores were assigned: 2018 first event = 60% 2018 second event = 100% 2018 third event = 60% This is considered unsuccessful PT performance. Refer to D2130. D2130 HEMATOLOGY 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 -- 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 analyte Hematocrit (HCT). The following scores were assigned: 2018 first event = 60% 2018 second event = 100% 2018 third event = 60% This is considered 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 that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the test analyte HCT. 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 test analyte HCT. The following scores were assigned: 2018 first event = 60% 2018 second event = 100% 2018 third event = 60% This is considered unsuccessful PT performance. -- 2 of 2 --