Child Health Associates

Summary Statement of Deficiencies D6033 TECHNICAL CONSULTANT-MODERATE COMPLEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on record review and interview with the laboratory director (LD), the laboratory failed to provide documentation to verify that the designated technical consultant (TC) met the qualification requirements of 493.1411 for the specialty of microbiology, specifically the specialties of bacteriology and virology as evidenced by the following: At the time of the survey the laboratory failed to provide documentation to verify that the designated TC had one year of training or experience, or both, in non-waived testing, in the designated specialty of microbiology. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; AND (b)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for 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 -- example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i)(A) Hold an earned doctoral or master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(3)(i)(B) Meet either requirements in 493.1405(b)(3)(i)(B) or (b)(4)(i)(B) or (C); AND (b)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i)(A) Have earned a bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(4)(i)(B) Meet 493.1405(b)(5)(i)(B); and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(5)(i) Have earned an associate degree in medical laboratory technology, medical laboratory science, or clinical laboratory science; and (b)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. (b)(6) For blood gas analysis, the individual must- (b)(6)(i) Be qualified under paragraph (b)(1), (2), (3) or (4) of this section; or (b)(6)(ii)(A) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; and (b)(6)(ii)(B) Have at least 2 years of laboratory training or experience, or both, in blood gas analysis; or (b) (7) Notwithstanding any other provision of this section, an individual is considered qualified as a technical consultant under this section if they were qualified and serving as a technical consultant for moderate complexity testing in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. This STANDARD is not met as evidenced by: Based on record review and interview with the laboratory director (LD), the laboratory failed to ensure the designated technical consultant (TC) met the qualification requirements of 493.1411 for the specialty of microbiology, specifically the subspecialties of bacteriology and virology: Findings include: 1. Record review on 8/25/2026 of the laboratory's CMS form 209 as compared to the CMS form 209 from the 12/17/2024 survey revealed the TC had the subspecialties of bacteriology and virology added since the last survey. 2. Record review on 8/25/2026 of the personnel records for the TC revealed: a. The TC was an M.D. licensed to practice medicine in the state of Massachusetts. b. The personnel file did not contain documentation to verify that the TC had at least one year of training or experience, or both, in non- waived testing, in the designated specialty of microbiology. 3. During an interview with the LD on 8/25/2026 at 11:00 AM: a. The LD confirmed that they did not have at least one year of training or experience, or both, in non-waived testing, in the designated specialty of microbiology. b. The LD stated the laboratory did not have anyone available who was qualified to fulfill the role of TC for the specialty of microbiology. 4. The laboratory performs 1,095 tests annually in the specialty of microbiology. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Child Health Associates laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. Refer to Conditions of Participation for Clinical Laboratories 42 CFR Part 493. 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. This STANDARD is not met as evidenced by: Based on proficiency testing review and interview, the laboratory failed to maintain a copy of all proficiency testing records as evidenced by the following: a) A review of proficiency testing records for calendar years 2020, 2021, and 2022 (6 testing events) revealed the fact that the attestation statements provided by the proficiency testing program were not signed by the analyst and the laboratory director or designee for four (4) of the six (6) testing events reviewed (College of American Pathologists (CAP) proficiency testing for the third hematology testing events of 2020 as well as the three testing events of 2021. b) In addition, for two (2) of the six (6) testing events, the attestation and coding forms used to report the results to the proficiency testing company were not retained by the laboratory (the first and second testing 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 of 2022). c) Testing person #2 interviewed on 11/1/22 at 8:55 am confirmed that the above attestation statements were either not retained or signed by the analysts and laboratory director or designee. -- 2 of 2 --