Northeast Pediatrics And Adolescent Medicine, Llp

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. 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 5, 2022 at approximately 10:30 AM, that the attestation forms for 2019, 2020 and 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. D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory 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 5 -- This STANDARD is not met as evidenced by: Based on surveyor's review of the 1st event of 2020 and 1st event of 2022 API PT summary reports and confirmed in an interview with the testing person, at the time of survey, the laboratory failed to obtain an overall score for the sub-specialty Bacteriology/Group B Strep. The following score was assigned: 2020 first event = 60% 2022 first event = 60% D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the 3rd event of 2021 API PT summary reports and an interview with the testing person, the laboratory failed to participate successfully in proficiency testing for the speciality Hematology. The following scores were assigned: 2021 third event = 0% D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review 3rd event of 2021 API PT summary reports, lack of

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 American Proficiency Institute (API) PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Cell Identification (Cell I.D.)/White Blood Cell Differential (WBC Diff.). The following scores were assigned: 2021 first event = 67% 2021 second event = 100% 2021 third event = 0% (failure to participate) This is considered y unsuccessful PT performance. Refer to D2130. 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 -- D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on PT desk review of the CMS PT data reports and PT records from the API PT program, the laboratory failed to participate successfully in proficiency testing for the speciality Hematology and the test analyte's White Blood Cell Count (WBC); Red Blood Cell Count (RBC); Hemoglobin (HgB), Hematocrit (Hct) and Platelet Count. The following scores were assigned: 2021 third event = 0% (failure to participate) This is considered unsatisfactory PT performance. 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 API PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Cell I.D./WBC Diff. The following scores were assigned: 2021 first event = 67% 2021 second event = 100% 2021 third event = 0% (failure to participate) 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 API 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 speciality Hematology and the test analyte's Cell I. D/WBC Diff, RBC, Hct, HgB, WBC and Platelet Count. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) -- 2 of 3 -- 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 API 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 speciality Hematology and the test analyte's Cell I. D/WBC Diff, RBC, Hct, HgB, WBC and Platelet Count. The following scores were assigned: Cell I.D./WBC Diff 2021 first event = 67% 2021 second event = 100% 2021 third event = 0% (failure to participate) This is considered unsuccessful PT performance. Speciality Hematology, WBC, RBC, HgB, Hct and Platelet Count. 2021 third event = 0% (failure to participate) This is considered unsatisfactory PT performance. -- 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: Based on proficiency testing (PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT data reports and PT records from the American Proficiency Institute (API) PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Cell Identification (Cell I.D.) /White Blood Cell Differential (WBC Diff.) The following scores were assigned: 2020 third event = 60% 2021 first event = 67% 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 PT desk review of the CMS PT data reports and PT records from the API PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Cell Identification (Cell I.D.)/White Blood Cell Differential (WBC Diff.) The following scores were assigned: 2020 third event = 60% 2021 first event = 67% 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 API 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 Cell Identification (Cell I.D.)/White Blood Cell Differential (WBC Diff.) 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 API 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 Cell Identification (Cell I.D.)/White Blood Cell Differential (WBC Diff.) The following scores were assigned: 2020 third event = 60% 2021 first event = 67% This is considered unsuccessful PT performance -- 2 of 2 --

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on surveyor's review of the manufacturer's package inserts for McKesson True Track Smart Glucometer and OraQuick Advanced HIV 1/2 , Siemens Multistix 10 SG urine test strips and interview with the laboratory manager/testing person, the laboratory failed to follow the manufacturer's requirements for performing external controls with each new kit for above tests. FINDINGS: 1. The surveyor reviewed the manufacturer's package insert and the quality control (QC) requirements for the test kits at survey. 2. The laboratory manager/testing person confirmed on August 27, 2019 at approximately 10:30 AM, that the laboratory failed to follow the manufacturer's requirements for external controls and perform the required QC for the following test kits and tests: a. McKesson True Track Smart Glucometer and test strips requires low and high controls be tested with each new lot of test strips. The last date the reagent test strips (# MT1727 exp. date 10/13/17) were tested was on 9/16/16 using control lots low 5BC1A04 and high 4BC2A04. b. OraQuick Advanced HIV 1/2 test kit requires positive and negative controls be tested with each new kit. The last date the reagent test strips (6627812 exp. date 3/14) were tested was on 3/17 using control lots negative 6626032 and positive 6626031. c. The laboratory failed to retain copies of the Consult urine controls range sheets, controls that are used to perform quality control on the Siemens Multistix 10 SG urine test strips. The surveyor was unable to determine if the control results were in range. The current urine reagent test strips in use (#612057 exp. date. 6/30/20) were tested with controls negative #098783 and positive #098734 exp. date. 4/19, last date tested 5/24/18. 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 -- 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 surveyor's review of Quality Control (QC) records for the Abbott Emerald hematology analyzer and an interview with the laboratory manager/testing person, the laboratory failed to retain copies of the control & calibration assay information sheets from 1/1/2018 through survey date. FINDINGS: The laboratory director/testing person confirmed on August 27, 2019 at approximately 11:30 AM that the laboratory failed to retain the control and calibration assay information sheets Abbott Emerald analyzer from 01/2018 through survey date. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on the surveyor review of College of American Pathologists (CAP) Proficiency Testing (PT) records for calendar years 2018 and 2019 and confirmed in an interview with the laboratory manager/testing person, the laboratory failed to retain documentation to include signed attestation forms and a signed PT summary reports for the 1st and 2nd events of 2019 hematology, urine sediment and bacteriology challenges. 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 -- 2 of 6 -- 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 the PT scores of less than 100% for the following analytes: 2019 first event: Platelets = 80% Cell ID = 80% 2019 second event: Cell ID = 80% 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. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a surveyor's review of temperature records an and interview with the laboratory manager/testing person, the laboratory failed to follow the manufacturer's temperature requirement for the LifeSign Uricult urine culture paddle system. FINDINGS: The laboratory manager/testing person confirmed on August 27, 2019 at approximately 11:00 AM, that the laboratory failed to record the laboratory room temperature from 1/1/2018 through survey date. The LifeSign Uricult urine culture paddle system requires a storage temperature of 45-77 F. 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) -- 3 of 6 -- 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 a surveyor's review of hematology calibration records for the Abbott Emerald hematology analyzer and interview with the laboratory manager/testing person, calibration of the hematology analyzer was not performed at the frequencies required by the laboratory's calibration protocol and by the manufacturer of the analyzer. FINDINGS: 1. The laboratory manager/testing person confirmed on August 27, 2019 at approximately 11;00 AM, that the laboratory failed to perform the required calibration for the hematology analyzer in the calendar year 2018. a. The laboratory's calibration policy and the manufacturer of the hematology analyzer require analyzer calibration every six months. 2. The documentation of the Abbott Emerald analyzer calibration available for review was for calibration performed on 2 /28/17, 9/2/17 and 8/23/19. The hematology analyzer was therefore out of calibration from 3/3/18 through 8/23/19. 3. Approximately 1000 patient specimens were tested and reported for hematology during the above time period when analyzer was out of calibration. 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 surveyor's findings and an interview with the laboratory manager/testing person, the laboratory director failed to provide overall management of the laboratory. FINDINGS: The laboratory director failed to: 1. ensure that a