Norton Children's Medical Group-Stonestreet

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 01/19/2023 and the facility was found to not be in substantial compliance with the laboratory requirements at 42 CFR Part 493, with deficiencies cited. 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 interview and record review, the facility failed to meet the condition of participation for proficiency testing (PT): successful participation by not meeting the standard requirements at D2130. Specifically, the facility failed to successfully participate in PT for hematology for two (2) consecutive events (2021-B and 2021-C). The findings include: Review of graded PT reports revealed the facility failed to meet 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 -- the standard requirements at D2130 by failing to successfully participate in two (2) consecutive hematology PT events. The testing scores for 2021-B and 2021-C were as follows: -White blood cell count (WBC) 60% (2021-B) and 60% (2021-C) -Red blood cell count (RBC) 40% (2021-B) and 60% (2021-C) -Hemoglobin (HGB) 60% (2021- B) and 60% (2021-C) -Hematocrit (HCT) 40% (2021-B) and 60% (2021-C) Refer to D2130 for further details. 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 interview, record review and review of the facility's policies, the facility failed to achieve satisfactory performance for hematology, as evidenced by proficiency testing (PT) scores of less than 80% for white blood cell (WBC) count, red blood cell (RBC) count, hemoglobin (HGB), and hematocrit (HCT) for two (2) consecutive PT events reviewed (2021-B and 2021-C). The findings include: Review of the facility policy titled, "Proficiency Testing", dated 03/24/2021, revealed "The laboratory shall subscribe on a continuous basis to a PT program, which is recognized and acceptable to CMS (Centers for Medicare and Medicaid Services)". The policy further revealed "Review of all PT results and alternative assessment results are completed within one (1) month of the date reports and results become available to the laboratory". Additionally, the policy revealed "All unacceptable PT results and alternative assessment results are documented, investigated, and

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 06/06/2018, the laboratory failed to monitor and document the humidity of the laboratory where the testing was performed. Humidity was not recorded from June 9, 2016 through June 5, 2018. Findings include: The Manufacturer's operations manual for the Sysmex CBC analyzer lists an operating range for humidity for the anayzer between thirty percent (30%) and eighty-five percent (85%). Review of Maintenance log revealed no documented evidence the humidity had been monitored from June 9, 2016 through June 5, 2018. Testing personnel acknowledged in an interview at 10:30 am on 06/06 /2018 the laboratory failed to have a system in place to ensure the humidity was monitored and documented daily. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. 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 staff interview and record review on 06/06/2018, the Technical Consultant failed to perform and document annual competency using the 6 mandated competency assessment requirements for testing personel. Competency assessment was performed using zero (0) of six (6) methods of assessment for two (2) out of seven (7) employees from January 1, 2017 to December 31, 2017. Findings include: Record review revealed competency assessments failed to include direct observation of routine patient test performance, direct observation of performance of instrument maintenance function checks and calibration, monitoring the recording and reporting of test results, review of worksheets, review of quality control records, review of proficiency test results, review of maintence records, assessment of testing external proficiency testing samples and problem solving skills. An interview with the staff on 06/06/2018 at 9:10 AM, revealed the facility failed to have a system in place to ensure competency was performed using all six mandated competency assessment requirements. -- 2 of 2 --