Norton Children's Medical Group - Prospect

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing (PT) scores obtained from the national database and verified with the PT 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 (PT) desk review of the Certification and Survey 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 -- Provider Enhanced Reporting-0155 and American Proficiency Institute 2024 records (1st and 2nd events), the laboratory failed to successfully participate in a PT program. The laboratory failed to successfully participate in the specialty of Hematology for Hematocrit (HCT), Cellular Identification or White Blood Cell Differential (Cell ID or WBC Diff), Red Blood Cell (RBC), Hemoglobin (HGB), White Blood Cell Count (WBC Count), and Platelets for 2 of 2 testing events. Refer to D2130 and D2131. 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. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) desk review of the Certification and Survey Provider Enhanced Reporting (CASPER)-0155 and American Proficiency Institute (API) 2024 records (1st and 2nd events), the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in 2 of 2 consecutive testing events in Hematology for Hematocrit (HCT), Cellular Identification or White Blood Cell Differential (Cell ID or WBC Diff), Red Blood Cell (RBC), Hemoglobin (HGB), White Blood Cell Count (WBC Count), and Platelets. The findings include: 1.Review of the CASPER -0155 report revealed the following: Hematology 2024- 1st Event Laboratory received an unsatisfactory score of 0% for HCT Hematology 2024- 2nd Event Laboratory received an unsatisfactory score of 0% for HCT. Hematology 2024- 1st Event Laboratory received an unsatisfactory score of 0% for Cell I.D. or WBC Diff Hematology 2024- 2nd Event Laboratory received an unsatisfactory score of 0% for Cell I.D. or WBC Diff Hematology 2024- 1st Event Laboratory received an unsatisfactory score of 0% for RBC. Hematology 2024- 2nd Event Laboratory received an unsatisfactory score of 0% for RBC. Hematology 2024- 1st Event Laboratory received an unsatisfactory score of 0% for HGB. Hematology 2024- 2nd Event Laboratory received an unsatisfactory score of 0% for HGB. Hematology 2024- 1st Event Laboratory received an unsatisfactory score of 0% for WBC Count. Hematology 2024- 2nd Event Laboratory received an unsatisfactory score of 0% for WBC Count. Hematology 2024- 1st Event Laboratory received an unsatisfactory score of 0% for Platelets. Hematology 2024- 2nd Event Laboratory received an unsatisfactory score of 0% for Platelets. 2. A PT desk review from API 2024 PT records confirmed the above findings. D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for 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 a proficiency testing (PT) desk review of the Certification and Survey Provider Enhanced Reporting (CASPER)-0155 and American Proficiency Institute (API) 2024 records (1st and 2nd events), the laboratory failed to achieve overall satisfactory performance (80% or greater) for 2 of 2 consecutive events in the specialty of Hematology. The findings include: 1. Review of the Casper-0155 report -- 2 of 3 -- revealed the following: Hematology 2024- 1st Event Laboratory received an unsatisfactory score of 0% for the Hematology. Hematology 2024- 2nd Event Laboratory received an unsatisfactory score of 0% for the Hematology. 2. A PT desk review from API 2024 PT records 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. 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 (PT) desk review of the Certification and Survey Provider Enhanced Reporting-0155 and American Proficiency Institute 2024 records (1st and 2nd events), it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services to ensure successful PT participation of the specialty of Hematology, Hematocrit, Cellular Identification or White Blood Cell Differential, Red Blood Cell, Hemoglobin, White Blood Cell Count, and Platelets testing during 2 of 2 testing events. 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 (PT) desk review of the Certification and Survey Provider Enhanced Reporting-0155 and American Proficiency Institute 2024 records (1st and 2nd events), the laboratory director failed to ensure that the PT samples were tested as required under Subpart H during 2 of 2 testing events. Refer to D2130 and D2131. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Recertification Survey was conducted on 07/16/2024. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. 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 policy review, document review, and confirmed in staff interview, the laboratory failed to maintain attestation statements signed by the testing personnel (TP) that performed the testing for 1 of 7 proficiency testing (PT) events reviewed. Findings included: Review of the laboratory's policy titled, "Retention Times for Records and Specimens," revised on 07/19/2023, revealed, "Policy: The following are the minimum required retention times for various records and Specimens." The policy specified, "Proficiency Testing: Two (2) years- records of test handling, preparation, processing, examination, results of reporting, the signed attestation statement and feedback reports." Review of the laboratory PT performance revealed the laboratory participated in the American Proficiency Institute (API) Hematology/Coagulation third event in November 2022 with scores of 100%. Original printouts were available 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 -- to document the results of the five PT samples, which were analyzed on 11/28/2022. Review of the "Attestation Statement" for the "2022 Hematology/Coagulation - 3rd [third] Event" revealed, "SIGNATURES REQUIRED- For all PT results, an attestation statement must be signed by testing personnel and the laboratory director and retained for a minimum of 2 years." The Attestation Statement reflected the PT testing was electronically submitted on 11/28/2022 and was signed by the Laboratory Director (LD). The LD signature date was not completed, and there were no signatures of the TP who performed the testing or information regarding which TP tested each sample set. During an interview on 07/16/2024 at 9:40 AM, the Technical Consultant (TC) stated the original attestation statement documentation was discarded because staff did not realize the original documentation needed to be kept until November 2024 to satisfy the two-year retention period requirement. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 01/10/2023, and the facility was found to not be in substantial compliance with the laboratory requirements at 42 CFR Part 493. The condition at 42 CFR 493.1409, laboratories performing moderate complexity testing; technical consultant was not met and additional standard level deficiencies were cited. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on interview and record review, it was determined the facility had no procedure in place to verify the accuracy of the Uricult test utilized for urine colony counts. The findings include: Review of the "Clinical Laboratory Improvement Amendments (CLIA) Application for Certification", completed by the Laboratory Director and dated 01/04/2023, revealed the facility used the Uricult to perform urine cultures. Review of the facility's Uricult (a method used for the detection of various types of bacteria that commonly caused urinary tract infections) test performance for urine collection, signed by the Laboratory Director on 08/26/2021, revealed there was not a procedure for performing the required accuracy verification. Interview with Testing Personnel #1, on 01/10/2023 at 12:45 PM, revealed the required accuracy verification was not being performed. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- 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 -- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on interview and record review, it was determined the facility failed to run a negative and positive control for urine colony counts. The findings include: Review of the "Clinical Laboratory Improvement Amendments (CLIA) Application for Certification", completed by the Laboratory Director and dated 01/04/2023, indicated the facility used the Uricult, a moderate complex procedure subject to the requirements for quality control, to perform urine cultures. Review of the facility's Uricult (a method used for the detection of various types of bacteria that commonly caused urinary tract infections) test performance for urine collection, signed by the Laboratory Director on 08/26/2021, revealed there was not a procedure for performing the required quality controls. Interview with Testing Personnel #1, on 01/10/2023 at 12:45 PM, revealed the required quality controls were not being performed. 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 interview and record review, it was determined the facility did not currently have a qualified Technical Consultant (TC). This failure had the potential to impact the quality of laboratory testing, as there was no one performing the duties of a TC. The findings include: Review of email correspondence the surveyor received from the TC of record, on 12/20/2022, revealed the TC was closing their laboratory consulting business effective 01/01/2023. Review of the "Laboratory Personnel Report Clinical Laboratory Improvement Amendments (CLIA)" document, signed by the Laboratory Director (LD) and dated 01/04/2023, revealed no one held the position of TC. Review of the "CLIA Application for Certification", completed by the LD and dated 01/04 /2023, revealed the facility performed two (2) non-waived, moderate complex tests: the complete blood count (a set of medical laboratory tests that provide information about the cells in a person's blood) and the Uricult (a test used for the detection of various types of bacteria that commonly cause urinary tract infections). Review of the TC of record's personnel file revealed the TC retired, effective 01/01/2023. Interview with Testing Personnel #1 and the Practice Manager, on 01/10/2023 at 11:40 AM, revealed the facility did not have a TC and the LD was acting as the TC. Interview with the LD, on 01/10/2023 at 11:50 AM, revealed the facility did not have a TC. Further interview revealed several options were discussed to fill the void of the TC position, such as the LD or the nurse practitioner serving as the TC. However, even though he and the nurse practitioner had the education requirements, neither met the requirements for the clinical experience. D6034 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 The laboratory must employ one or more individuals who are qualified by education -- 2 of 3 -- and either training or experience to provide technical consultation for each of the specialties and subspecialties of service in which the laboratory performs moderate complexity tests or procedures. The director of a laboratory performing moderate complexity testing may function as the technical consultant provided he or she meets the qualifications specified in this section. This STANDARD is not met as evidenced by: Based on interview and record review, it was determined the facility did not have a qualified Technical Consultant (TC). This failure had the potential to impact the quality of laboratory testing as there was no one performing the duties of a TC. The findings include: Review of email correspondence the surveyor received from the TC of record, on 12/20/2022, revealed the TC was closing their laboratory consulting business effective 01/01/2023. Review of the "Laboratory Personnel Report (CLIA)" document, signed by the Laboratory Director (LD) and dated 01/04/2023, revealed no one held the position of TC. Review of the "Clinical Laboratory Improvement Amendments (CLIA) Application for Certification", completed by the LD and dated 01/04/2023, revealed the facility performed two (2) non-waived, moderate complex tests: the complete blood count (a set of medical laboratory tests that provide information about the cells in a person's blood) and the Uricult (a test used for the detection of various types of bacteria that commonly cause urinary tract infections). Review of the TC of record's personnel file revealed the TC retired, effective 01/01 /2023. Interview with Testing Personnel #1 and the Practice Manager, on 01/10/2023 at 11:40 AM, revealed the facility did not have a TC and the LD was acting as the TC. Interview with the LD, on 01/10/2023 at 11:50 AM, revealed the facility did not have a TC. Further interview revealed several options were discussed to fill the void of the TC position, such as the LD or the nurse practitioner serving as the TC. However, even though he and the nurse practitioner had the education requirements, neither met the requirements for the clinical experience. The clinical experience must include hands-on experience performing clinical testing or a formal rotation through a medical residency program or laboratory internship program. -- 3 of 3 --

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 desk review of Bacteriology proficiency testing results from the American Proficiency Institute on 11/09/2018, the laboratory failed to successfully participate in the Throat Culture certified analyte in three consecutive testing events. This is the second unsuccessful proficiency failure. See the first unsuccessful failure dated 12/18 /2017. See D2020 and D2028 D2020 BACTERIOLOGY CFR(s): 493.823(a) 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 -- 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 desk review of Bacteriology proficiency testing results from American Proficiency Institute on 11/09/2018, the laboratory failed to attain an overall testing score of 80 percent in three of five testing events. Findings include: The laboratory scored 33 percent in the second testing event of 2017, scored 67 percent in the third testing testing event of 2017, and scored 60 percent in the third testing event of 2018 for unsatisfactory performances. D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for 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 desk review of Bacteriology proficiency testing results from American Proficiency Testing agency on 11/09/2018, the laboratory failed to achieve satisfactory performance for three of five testing events for a second unsuccessful performance in the specialty of Bacteriology. Findings include: Unsatisfactory performances were obtained in the second and third testing events of 2017 with scores of 33 percent and 67 percent respectively and a score of 60 percent in the third testing of 2018. 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 review of Bacteriology proficiency testing results from the American Proficiency Institute on 11/09/2018, the laboratory director failed to fulfill the responsibility of evaluating the laboratory's performance of Throat cultures. Findings include: The

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on staff interview and record review on 06/22/18, it was determined the facility failed to monitor and document the percent humidity for the laboratory where the testing was performed. Percent humidity was not recorded from May 3, 2016 through June 21, 2018. Findings include: Review of the Manufacturer's Operation Manual for the ACT-diff Hematology Analyzer, revealed the operating range for percent humidity should be between twenty percent (20%) and eighty-five percent (85%). Review of the Maintenance Log, revealed there was no documented evidence the percent humidity had been monitored from May 3, 2016 through June 21, 2018. Testing personnel acknowledged in an interview, on 06/22/18 at 10:30 AM, the laboratory failed to have a system in place to ensure the percent humidity was monitored and documented daily. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided 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 -- specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on staff interview, and review of the Procedure Manual for the ACT-Diff Hematology Analyzer on 06/22/18, it was determined that the laboratory failed to perform and document calibration procedures in accordance with manufacturer's instructions. Findings include: Review of the Procedure Manual for the ACT-Diff Hematology Analyzer, revealed calibration verification should be performed at least every six (6) months. However, there was no documented evidence the laboratory performed calibration verification between July 16, 2016, through May 8, 2018. Testing personnel acknowledged in an interview on 6/22/18 at 10:28 AM, the laboratory failed to have a system in place to ensure calibration of the ACT-Diff Hematology analyzer be performed and documented in accordance with manufacturer's requirements. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on staff interview and record review on 06/22/18, it was determined the laboratory failed to ensure normal values were available to the authorized person for six (6) of six (6) patient test reports. Findings include: A Complete Blood Count (CBC) was reported on Patient #1 on 03/16/16; however, the report failed to include reference ranges for each analyte. A CBC was reported on Patient #2 on 04/19/16; however, the report failed to include reference ranges for each analyte. A CBC was reported on Patient #3 on 05/16/16; however, the report failed to include reference ranges for each analyte. A CBC was reported on Patient #4 on 10/10/17; however, the report failed to include reference ranges for each analyte. A CBC was reported on Patient #5 on 11/14/17; however, the report failed to include reference ranges for each analyte. A CBC was reported on Patient #6 on 01/17/18; however, the report failed to include reference ranges for each analyte. Testing personnel acknowledged in an interview on 06/22/18 at 11:15 AM, the laboratory failed to have a system in place to ensure normal values were available and reported on patient test reports. -- 2 of 2 --