Columbia Pediatric Clinic

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the Laboratory Personnel Report (Form CMS-209), the laboratory procedure manual and staff interview, the current laboratory director failed to approve the laboratory procedure manual for 2023. The findings include: 1. Review of the Laboratory Personnel Report (Form CMS-209) revealed the current laboratory director to be different than the laboratory director that signed the procedure manual in 2023. 2. Review of the laboratory procedure manual revealed lack of signatures by the current laboratory director. 3. Interview with the current laboratory director, the technical consultant, office manager and lead testing personnel on 1.24.24 at 12:00 p. m. confirmed that the current laboratory director assumed responsibility for the laboratory in May 2023 and failed to approve the laboratory procedure manual upon taking over directorship. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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: The laboratory failed to maintain satisfactory proficiency testing (PT) performance for the hemoglobin analyte in 2019 event two and 2020 event one, resulting in the first unsuccessful PT occurrence for the hemoglobin analyte. (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. 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 desk review of the Centers for Medicare and Medicaid Services Casper report 155 (CMS 155) and the laboratory's 2019 and 2020 proficiency testing (PT) records, the laboratory failed to maintain satisfactory performance for the hemoglobin analyte in two out of three PT events, resulting in the first unsuccessful PT occurrence for the hemoglobin analyte. The findings include: 1) Review of the CMS 155 revealed the following unsatisfactory PT scores for the hemoglobin analyte: 2019 event two: 0% 2020 event one: 0% 2) Review of the laboratory's proficiency testing records revealed the following: 2019 event two: Sample numbers FH2-06, FH2-07, FH2-08, FH2-09 and FH2-10 scored as unacceptable, resulting in an overall score of 0% for the hemoglobin analyte. 2020 event one: Sample numbers FH2-01, FH2-02, FH2-03, FH2-04, and FH2-05 scored as unacceptable, resulting in an overall score of 0% for the hemoglobin analyte, and the first unsuccessful PT occurrence for the hemoglobin analyte. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Intakes: TN00050273 Surveys were performed on the following two laboratories as follows: On December 5, 2019, a recertification survey was performed on Columbia Pediatric Clinic, 44D2068197, located at 1003 Reserve Blvd., Suite 110, Spring Hill, TN 37174 (Laboratory A). On January 28, 2020, a complaint survey was performed on Columbia Pediatric Clinic, 44D0315886, located at 1600 Nashville Hwy., Columbia, TN 38401 (Laboratory B). Laboratory A performs complete blood count with differential on the Horiba ABX Micros 60 and neonatal bilirubin on the Unistat Bilirubinometer. Laboratory B performs complete blood count with differential on the Horiba ABX Micros 60, neonatal bilirubin on the Unistat Bilirubinometer, urine microscopy and wet prep. Both laboratories are enrolled and participate in proficiency testing with the same proficiency testing program, the College of American Pathologists (CAP). D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Columbia Pediatric Clinic failed to ensure its laboratories did not participate in any communications or discussions across sites/locations concerning proficiency testing (PT) sample results until after the date the PT results were due. (Refer to D2011) 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 -- D2011 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(3) Laboratories that perform tests on proficiency testing samples must not engage in any inter-laboratory communications pertaining to the results of proficiency testing sample (s) until after the date by which the laboratory must report proficiency testing results to the program for the testing event in which the samples were sent. Laboratories with multiple testing sites or separate locations must not participate in any communications or discussions across sites/locations concerning proficiency testing sample results until after the date by which the laboratory must report proficiency testing results to the program. This STANDARD is not met as evidenced by: Based on review of Laboratory B quality assurance and proficiency testing records, Laboratory A quality assurance and proficiency testing records, and interviews with the director of Laboratory A, the director of Laboratory B, and the clinical manager, the Columbia Pediatric Clinic failed to ensure laboratories did not participate in communications or discussions across sites/locations concerning proficiency testing (PT) sample results until after the date the PT results were due in 2019. The findings include: 1) Review of Laboratory B quality assurance and proficiency testing records revealed the following: Presence of complete blood count (CBC) instrument printouts for proficiency testing samples from Laboratory A for 2019 event two. The printouts were faxed to Laboratory B prior to the PT program's results due date. Instrument printouts for 2019 event two were faxed to Laboratory B on May 28, 2019 (PT sample numbers FH2-06, FH2-07, FH2-08, FH2-09, FH2-10). The PT results for 2019 event two had an assigned due date by the PT provider for May 28, 2019. 2) Review of Laboratory A quality assurance records and proficiency testing event cutoff dates provided by the laboratory's PT provider revealed the following: Presence of complete blood count (CBC) instrument printouts for proficiency testing samples from Laboratory B for 2018 event two and 2019 event two. The printouts for both events were faxed to Laboratory A prior to the PT program results due date. Instrument printouts for 2018 event two were faxed to Laboratory A on May 25, 2018 (PT sample numbers FH2-06, FH2-07, FH2-08, FH2-09, FH2-10). The PT results for 2018 event two had an assigned due date by the PT provider for May 29, 2018. Instrument printouts for 2019 event two were faxed to Laboratory A on May 28, 2019 (PT sample numbers FH2-06, FH2-07, FH2-08, FH2-09, FH2-10). The PT results for 2019 event two had an assigned due date by the PT provider for May 28, 2019. 3) Interviews with the director of Laboratory A, the director of Laboratory B, and the clinical manager on January 28, 2020 at 2:45 p.m. confirmed the Columbia Pediatric Clinic failed to ensure laboratories did not participate in inter-laboratory communication concerning PT results until after the date the PT results were due for 2019 event two Hematology. The interview also confirmed that Laboratory B received faxed proficiency testing instrument printouts from Laboratory A for 2019 event two. Furthermore, it was determined that Laboratory B faxed proficiency testing results to Laboratory A for 2018 event two and 2019 event two. 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: The director of Laboratory B failed to ensure Laboratory B did not participate in any communications or discussions across sites/locations concerning proficiency testing (PT) sample results until after the date the PT results were due. (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 review of Laboratory B quality assurance records, Laboratory B proficiency testing records, and interviews with the directors of Laboratory A and Laboratory B and the clinical manager, the director of Laboratory B failed to ensure Laboratory B did not participate in any inter-laboratory communication across sites/locations concerning proficiency testing (PT) results until after the date the PT results were due in 2019. The findings include: 1) Review of Laboratory B quality assurance records revealed the presence of complete blood count instrument printouts for proficiency testing sample numbers FH2-06, FH2-07, FH2-08, FH2-09, FH2-10 that were performed at a sister laboratory (Laboratory A). The date the proficiency testing CBC instrument printouts were faxed from Laboratory A to Laboratory B was May 28, 2019 for five of five proficiency testing samples. 2) Review of the laboratory's proficiency testing records revealed the results due date for 2019 event two was May 28, 2019. 3) Interviews with the director of Laboratory A, the director of Laboratory B and the clinical manager on January 28, 2020 at 2:45 p.m. during exit confirmed the director for Laboratory B failed to ensure Laboratory B did not participate in inter- laboratory communication with Laboratory A regarding proficiency testing results until after the PT results due date for 2019 event two. -- 3 of 3 --