Kids First Pediatric Specialists

Summary Statement of Deficiencies D0000 A recertification survey was completed on 7/19/2023. It was determined that the following condition-level deficiencies existed: 42 Code of Federal Regulation (CFR) 493.1409 Technical Consultant - Moderate Complexity D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY 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 document review, the laboratory failed ensure one (SP-7) of three personnel performing responsibilities of a Technical Consultant (TC) was qualified from January 27, 2023 to the date of the survey (refer to D6035). 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 possess qualifications that are equivalent to those required for such certification; 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 one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or 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 -- subspecialty areas of service for which the technical consultant is responsible (for 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) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on record review, the laboratory failed ensure one ( SP-7) of three personnel performing responsibilities of a Technical Consultant (TC) was qualified from January 27, 2023, to the date of the survey. Findings Include: 1.Review of "Laboratory Personnel Report (CLIA)", signed by the laboratory director on 7/07 /2023, indicated the following: a) SP-4 is a testing person b) SP-5 is a testing person. c) SP-6 is a testing person. d) SP-7 is a testing person. 2. Review of "Competency Assessment Checklists" for SP-4, SP-5, and SP-6 performed on dates: 1/27/23, 2/02 /23, and 2/07/23 revealed SP-7 (testing person) signed off as the "observer" for competency involving "CBC direct observation ...in specimen handling, processing, and testing" on analyzer Cell Dyn Emerald, SN: 250322-001698. 3. Review of personnel files for SP-7 indicated the highest education achieved was high school. 4. Review of "Quality Assessment Statement of Fact" for 2023 Quality Assurance Minutes signed by the laboratory director on 6/15/23, under number 7. 493.1239: G: General Lab System Assessment: letter r, states "100% of all personnel have been assessed for competency within 12 months" but did not specify who was responsible for competency evaluation. 5. Review of SP-7's job description/ responsibilities signed on 8/09/21 did not specify performance or observation of competency as one of the duties of a testing person. 6. Annual Test Volume for Hematology is approximately 345. -- 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 document review and interview, the laboratory failed to successfully participate in the American Proficiency Institute (API) proficiency testing (PT) program for the analyte cell identification (ID) during PT testing event 3 in 2020 and testing event 1 in 2021. (Refer to D2128). D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons 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 -- other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on document review and interview (email confirmation), the laboratory failed to achieve a proficiency test (PT) score of 80% or higher for cell identification (ID) during two consecutive PT events (Events 3, 2020 and Event 1, 2021), resulting in unsatisfactory performance. Findings include: 1. Review of "CASPER Report 0155D" indicated the laboratory received unsatisfactory scores for cell ID: a) Event 3, 2020 = 67% b) Event 1, 2021 = 0% 2. Review of proficiency testing scores from American Proficiency Institute (API), indicated the above failing scores for event three in 2020 and event one in 2021. 3. In interview on 5/20/21 at 10:15 a.m. SP-1 (Laboratory Technician), confirmed (via email), the unsatisfactory scores from API (Proficiency Testing Provider) for the above listed analyte, cell ID. -- 2 of 2 --