Norton Children's Medical Group-Elizabethtown

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The laboratory was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; 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: Based on a proficiency testing desk review of the Certification and Survey Provider 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 -- Enhanced Reporting (CASPER)-0155 and American Proficiency Institute (API) 2023 records (2nd and 3rd events), the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of Routine Chemistry for Bilirubin (Bili, Total) analyte (Refer to D 2088 and D2089). D2088 ROUTINE CHEMISTRY CFR(s): 493.841(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 a proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER)-0155 and American Proficiency Institute (API) 2023 records (2nd and 3rd event), the laboratory failed to achieve an overall testing event score of satisfactory performance (80%) for two (2) of two (2) consecutive testing events for the specialty of Routine Chemistry. 1. A review of the Casper -0155 report revealed the following: Routine Chemistry 2023 - 2nd Event The laboratory received an unsatisfactory score of 0%. Routine Chemistry 2023- 3rd Event The laboratory received an unsatisfactory score of 0%. 2. A review of proficiency testing records from API 2023 confirmed the above findings. D2089 ROUTINE CHEMISTRY CFR(s): 493.841(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 a proficiency testing desk review of the CASPER-0155 and API records 2023 (2nd and 3rd events), the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte for two (2) of two (2) consecutive testing events for the Bilirubin (Bili, Total) analyte. 1. A review of the CASPER-0155 report revealed the following: Bili, Total 2023-2nd Event The Laboratory received an unsatisfactory score of 0%. Bili, Total 2023- 3rd Event The Laboratory received an unsatisfactory score of 0%. 2. A review of proficiency testing records from API 2023 confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. -- 2 of 3 -- 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 a proficiency testing desk review of the CASPER-0155 Individual Laboratory Report and API 2023 records (2nd and 3rd events), the laboratory director failed to provide overall management and direction of the laboratory services. (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 a proficiency testing desk review of the CASPER-0155 and API 2023 records (2nd and 3rd events), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. (Refer to D2088 and D2089). -- 3 of 3 --

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 staff interview and record review of proficiency testing (PT) results from American Academy of Family Physicians (AAFP) on 02/09/2022, the laboratory director failed to ensure proficiency test results were reviewed for one (1) out of three (3) events for 2021. Findings include: 1. The laboratory scored a sixty percent (60%) for the analyte White Blood Cell (WBC) count for the AAFP PT 2nd event of 2021. The laboratory scored an eighty percent (80%) for the analytes Red Blood Cell (RBC) count, Hematocrit (Hct) and Hemoglobin (Hgb) for the AAFP PT 2nd event of 2021. Record review revealed that the laboratory failed to document a

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on record review and staff interview on 02/04/2020, the laboratory failed to verify the performance specifications established by the manufacturer, for precision and accuracy prior to reporting patient test results when the Reichert Unistat Bilirubinometer was installed 05/22/2018. Findings include: 1. Review of records of installation performed 05/22/2018, failed to reveal verification of accuracy to ensure the testing method produced correct results. 2. Review of records of installation performed 05/22/2018, failed to reveal assessments of day-to-day, run-to-run, and with-in run precision to ensure reproducibility was verified prior to reporting patient results. 3. Testing Personnel acknowledged in an interview at 11:15 AM on 02/04 /2020, the laboratory failed to have a system in place to ensure accuracy and precision performance specifications were verified and comparable to those established by the manufacturer prior to patient testing. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification 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 -- procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on record review and staff interview 02/04/2020, the laboratory failed to perform calibration verification every six months from 10/10/2018 to 02/04/2020 for the neonatal bilirubin analyte performed on the Reichert Unistat Bilirubinometer analyzer. Findings include: 1. The laboratory failed to provide documentation of calibration verification including a minimal (zero), mid-point, and a maximum value to verify the reportable range for bilirubin performed on the Unistat Bilirubinometer. 2. Testing personnel acknowledged in an interview at 11:15 AM on 02/04/2020, the laboratory failed to have a system in place to ensure calibration verification was performed every six months on the Unistat Bilirubinometer. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies 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 record review and staff interview on 02/09/2018, the laboratory director failed to follow laboratory policy and sign annual competency assessments for four of eleven employees in 2016 and 2017. Findings include: Review of the the laboratory's Quality Assessment compliance list revealed "Employee Competencies are completed initially and at 6 months for new hires, then once per year and signed by Lab Dir." Testing Personnel #1 had competencies 06/01/2016 and 05/10/2017. There was no evidence of the Laboratory Director's signatures. Testing Personnel #4 had competencies 06/01/2016 and 05/10/207. There was no evidence of the Laboratory Director's signatures. Testing Personnel #7 had competencies 06/01/2016 and 05/09 /2017. There was no evidence of the Laboratory Director's signatures. Testing Personnel #11 had competencies 06/24/2016 and 05/09/2017. There was evidence of the Laboratory Director's signatures. Testing Personnel acknowledged in an interview at 1:30 PM on 02/09/2018, the laboratory failed to have a system in place to ensure laboratory policy for competency assessment was followed. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. 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 review of personnel files and staff interview on 02/09/2018, the technical consultant failed to perform and document a semiannual competency assessment on two of eleven testing personnel responsible for moderate complex testing. Findings include: Review of the personnel file revealed Testing Personnel #3 was hired 03/26 /2017. There was no evidence of a semiannual competency assessment. Review of the personnel file revealed Testing Personnel #8 was hired 03/26/2017. There was no evidence of a semiannual competency assessment. Testing personnel acknowledged in an interview at 1:30 PM on 02/09/2018, the laboratory failed to establish a system to ensure competency assessments were performed and documented at least semiannually during the first year of hire on personnel responsible for moderate complex testing. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of personnel files and staff interview on 02/09/2018, the technical consultant failed to perform and document annual competency assessments on three of eleven testing personnel. Findings include: There was no evidence of a competency assessment performed on Testing Personnel #2 in 2017. There was no evidence of a competency assessment performed on Testing Personnel #5 in 2017. There was no evidence of a competency assessment performed on Testing Personnel #6 in 2017. Staff acknowledged in an interview at 1:30 PM on 02/09/2017, the laboratory failed to have a system in place to ensure competency assessments were performed on all Testing Personnel annually. -- 2 of 2 --