Norton Children's Medical Group - Jeffersonville

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was completed on 10/24/2023. It was determined that the following condition-level deficiencies existed: 42 Code of Federal Regulation (CFR) 493.803(a)(b)(c) Successful Participation 42 CFR 493.1403 Moderate Complexity Laboratory Director 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: Repeat deficiency Based on document review and interview, the laboratory failed to successfully participate in the American Academy of Family Physicians (AAFP) and American Proficiency Institute (API) proficiency testing (PT) programs for one of one analyte (bilirubin, total) tested in the subspecialty of Routine Chemistry. The 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 -- laboratory had 0 percent PT testing scores for three out of four PT testing events 2022 (Event C), 2023 (Event 2), and 2023 (Event 3) for both bilirubin and routine chemistry (Refer to D2096). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Repeat Deficiency Based on document review and interview, the laboratory failed to successfully participate in American Academy of Family Physicians (AAFP) and American Proficiency Institute (API) proficiency testing (PT) programs for one of one analyte (bilirubin, total) tested in the subspecialty of Routine Chemistry. The laboratory had 0 percent PT testing scores for three out of four PT testing events 2022 (Event C), 2023 (Event 2), and 2023 (Event 3) for both bilirubin and routine chemistry. Findings include: 1. Review of the AAFP "Proficiency Testing Evaluation AAFP PT 2002-C" indicated the laboratory received 0 percent scores for chemistry and bilirubin (total). 2. Review of the API "Proficiency Summary 2023 Chemistry- Core- 2nd Event" indicated 0 percent scores for chemistry and bilirubin, total. Notes stated, "Failure to Participate". 3. Patients' records indicated the following patients reviewed had testing performed when the PT failures occurred: Patient Date Test PT6 12/28/22 Bilirubin PT8 6/05/23 Bilirubin 4. Annual Test Volume for Routine Chemistry is approximately 100. 5. Review of the API 2023 "Proficiency Testing Performance Evaluation 2023 Chemistry-Core-3rd Event" indicated 0 percent scores for chemistry and bilirubin, total. Notes states, "Failure to Participate". 6. On 10/24 /2023 at 5:33 pm, SP1 acknowledged that the laboratory received 0 percent scores for chemistry and bilirubin, total for event C, 2022; event 2, 2023; and event 3, 2023. 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 document review and interview, the laboratory director failed to ensure the laboratory successfully participated in American Academy of Family Physicians (AAFP) and American Proficiency Institute (API) proficiency testing (PT) programs for one of one analyte (bilirubin, total) tested in the subspecialty of Routine Chemistry. The laboratory had 0 percent PT testing scores for three out of four PT testing events 2022 (Event C), 2023 (Event 2), and 2023 (Event 3) for both bilirubin and routine chemistry (Refer to D6017). D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) The laboratory director is responsible for the overall operation and administration of -- 2 of 3 -- 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)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on document review and interview, the laboratory director failed to ensure the laboratory returned proficiency testing results within established time frames for the American Academy of Family Physicians (AAFP) and American Proficiency Institute (API) proficiency testing (PT) programs for one of one analyte (bilirubin, total) tested in the subspecialty of Routine Chemistry. The laboratory had 0 percent PT testing scores for three out of four PT testing events 2022 (Event C), 2023 (Event 2), and 2023 (Event 3) for both bilirubin and routine chemistry due to failure to participate. Findings include: 1. Review of the AAFP "Proficiency Testing Evaluation AAFP PT 2002-C" indicated the laboratory received 0 percent scores for chemistry and bilirubin (total). 2. Review of the API "Proficiency Summary 2023 Chemistry- Core- 2nd Event" indicated 0 percent scores for chemistry and bilirubin, total. Notes stated, "Failure to Participate". 3. Review of the API 2023 "Proficiency Testing Performance Evaluation 2023 Chemistry-Core-3rd Event" indicated 0 percent scores for chemistry and bilirubin, total. Notes states, "Failure to Participate". 4. On 10/24/2023 at 5:33 pm, SP1 acknowledged that the laboratory received 0 percent scores for chemistry and bilirubin, total for event C, 2022; event 2, 2023; and event 3, 2023. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey was completed on 7/18/2023. It was determined that the following condition-level deficiencies existed: 42 Code of Federal Regulation (CFR) 493.803(a)(b)(c) Successful Participation 42 Code of Federal Regulation (CFR) 493.1409 Technical Consultant - Moderate Complexity 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 American Academy of Family Physicians (AAFP) and American Proficiency Institute (API) proficiency testing (PT) programs for one of one analyte (bilirubin, total) tested in the subspecialty of Routine Chemistry. The laboratory had 0 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- percent PT testing scores for two out of three PT testing events 2022 (Event C) and 2023 (Event 1) for both bilirubin and routine chemistry (Refer to D2096). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on document review and interview, the laboratory failed to successfully participate in American Academy of Family Physicians (AAFP) and American Proficiency Institute (API) proficiency testing (PT) programs for one of one analyte (bilirubin, total) tested in the subspecialty of Routine Chemistry. The laboratory had 0 percent PT testing scores for two out of three PT testing events 2022 (Event C) and 2023 (Event 1) both bilirubin and routine chemistry. Findings include: 1. Review of the AAFP "Proficiency Testing Evaluation AAFP PT 2002-C" indicated the laboratory received 0 percent scores for chemistry and bilirubin (total). 2. Review of the API "Proficiency Summary 2023 Chemistry- Core- 2nd Event" indicated 0 percent scores for chemistry and bilirubin, total. Notes stated, "Failure to Participate". 3. On 7 /18/23 at 11:15am, SP-1 (Technical Consultant) acknowledged that the laboratory received 0 percent scores for chemistry and bilirubin, total for events C, 2022 and event 2, 2023. SP-1 further indicated samples were not submitted properly for event 2, 2023 due to a block by Norton Security after a security breach. Clerical person (not listed on the CMS 209) tried to submit in by phone but was unsuccessful. 4. Patients' records indicated two of ten patients reviewed had testing performed when the PT failures occurred: Patient Date Test PT6 12/28/22 Bilirubin PT8 6/05/23 Bilirubin 5. Annual Test Volume for Routine Chemistry is approximately 100. 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 document review and interview, the laboratory failed to attain an overall event score of at least 80 percent in the American Academy of Family Physicians (AAFP) proficiency testing (PT) program for six of six regulated analytes (cell identification or white blood count differential, red blood cell count, hematocrit, hemoglobin, and platelet count) tested in the subspecialty of Hematology. The laboratory had 0 percent PT testing scores for PT testing events 2022 (Event C). Findings include: 1. Review of the AAFP "Proficiency Testing Evaluation AAFP PT 2002-C" indicated the laboratory received 0 percent scores for Hematology and the following regulated analytes: cell identification or white blood count differential, red blood cell count, hematocrit, hemoglobin, and platelet count. 2. On 7/18/23 at 11: 15am, SP-1 (Technical Consultant) acknowledged that proficiency test the laboratory received 0 percent scores for Hematology and cell identification or white blood count differential, red blood cell count, hematocrit, hemoglobin, and platelet count for event C, 2022. 3. Patients' records indicated the following patient had Complete Blood -- 2 of 4 -- Count (CBC) with Differential testing performed with included all hematology analytes when the unsatisfactory performance occurred: Patient (PT) Date Test PT5 11 /09/22 CBC 5. Annual Test Volume for Hematology is approximately 1,500. 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-2) of two personnel performing responsibilities of a Technical Consultant (TC) was qualified from January 24/2023 to 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 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. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on record review, the laboratory director failed ensure one (SP-2) of two personnel performing responsibilities of a Technical Consultant (TC) was qualified from January 24/2023 to date of the survey (refer to D6035). Findings Include: 1. Review of "Laboratory Personnel Report (CLIA)", signed by the laboratory director on 7/10/2023 indicated the following: a) SP-1 is a Technical Consultant. b) SP-2 is a testing person. c) SP-5 is a testing person. 2. Review of personnel file for SP-2 indicated the highest education completed was a high school diploma. 3. Review of "Competency Evaluation Profile" for SP-5 signed by SP-2 (testing person) on 1/24/23 revealed SP-2 initialed as the preceptor/trainer for competency involving "CBC functions/daily control/ Review/ procedures" on analyzer Sysmex XN330, SN: 13836. 4. Review of Standard Work Instruction document, under "Personnel Assessment" states, all laboratory staff will be evaluated annually for competency, but did not specify who was responsible for competency evaluation. 5. Annual Test Volume for Routine Chemistry is approximately 100. -- 4 of 4 --

Summary Statement of Deficiencies D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed include two control materials of different concentrations at least once a day patient specimens are assayed for one of one test (Bilirubin) performed in the subspecialty of Routine Chemistry for one (PT#10) of five Bilirubin patients reviewed. Findings included: 1. Review of patients records indicated PT#10 had a billirubin test performed on 8/5/2021 at 9:13 am. 2. Review of the quality control log for "Unistat Bilirubinometer" indicated no quality control had been performed on 8/5/2021 when PT#11 had been tested. 3. Manufacturer's instructions for the "Reichert Unistat Bilirubinometer" revised 2003 states, "7.1 Use of Commercial Serum Controls Analysis of at least a normal and abnormal level of a commercial serum control, assayed for total bilirubin, is recommended for checking performance of the Reichert Unistat Biliruinometer." 4. On 12/14/201 at 2pm, SP3 (CMA Manager) acknowledged the quality control log showed that no quality control was performed on 8/5/2021 when PT#10 had been tested. 5. Annual Test Volume for Bilirubin is approximately 300. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to follow their policy for quality assessment monitoring for three of four quarters in 2021 (Quarters 1, 2, and 3) and 1 (Quarter 1) of four quarters in 2020 for one of one test (Bilirubin) performed in the subspecialty of Routine Chemistry and for one of four quarters in 2020 and one of two quarters (Quarter 1) when testing was performed in 2021 for five of five tests (White blood Cell (WBC), Red Blood Cell (RBC), Hemoglobin (HGB), Hematocrit (HCT), and Platelet (PLT)) performed in the specialty of hematology. Findings include: 1. Review of the policy "Quality Assurance Monitoring", last revision 3/26 /2014, indicated, "All quality monitoring results will be reviewed by the laboratory director (or designee) quarterly. These results will also be reviewed with appropriate staff quarterly in staff meetings. All quality assurance monitoring date will be retained for 2 years." 2. Review of quality assessment documents for 2020 and 2021 indicated the following: a. There was no review of Quarter four data for 2020 (October, November, and December) for the Routine Chemistry and Hematology testing performed. b) There was no review of quality assurance documents for Quarter 1, Quarter 2 or Quarter 3 for 2021 for the Routine Chemistry testing performed. c) Hematology testing stopped in March of 2021 and did not continue until Quarter 4, 2021. The "Quarterly Quality Assurance" documents dated March 2021 indicated the Hematology machine was "down" and testing ceased waiting on the new machine. i) The "Quarter Quality Assurance" document: dated March 2021 and reviewed by the laboratory director on 3/31/2021, marked "N" or no for "Quality control is run according to our written policies. Any

Summary Statement of Deficiencies D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons 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 record review, lack of documentation, and interview, the laboratory failed to take and document appropriate training and remedial action for three of three unacceptable analyte scores [red blood cell count (RBC), hematocrit (Hct), and platelet] for one of three challenges (2018-C) in Hematology for 2018. Findings include: 1. The laboratory was enrolled in the American Academy of Family Physicians (AAFP) for proficiency testing (PT). The results of challenge C from 2018 (print date 11/16/2018) were: --RBC: 60% --Hct: 60% --Platelet: 60% 2. The policy, 'Proficiency Testing', reviewed 7/22/11, read: 'Compares results with previous testing. Implement and documents

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations (42 CFR 493, effective April 24, 2003). No deficiencies were cited. 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 --