East Tn Childrens Hospital Primary Care Corp

Summary Statement of Deficiencies D0000 The following deficiencies are the result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility 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] 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 Certification and Survey Provider Enhancement Reporting (CASPER)-0155 report and American Proficiency Institute 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 -- (API) Proficiency Testing program 2023 records, the laboratory had not successfully participated 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 Bacteriology. (Refer to D2028) 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 a Proficiency Testing (PT) desk review of the CMS CASPER Report 0155D and the laboratory's 2023 Proficiency Testing (PT) performance summary records from the American Proficiency Institute (API) Proficiency Testing program, the laboratory failed to maintain satisfactory performance for Bacteriology in the 2nd and 3rd events 2023, resulting in the initial unsuccessful PT occurrence. The findings include: 1. A review of the CMS 0155D report revealed the following unsatisfactory Bacteriology analyte scores: -2nd event 2023= 0% -3rd event 2023= 50% 2. A review of the laboratory's API Proficiency Testing records revealed unsatisfactory Microbiology (Group C/G Strep (molecular)) scores of 0% for the 2nd event 2023 and 50% for the 3rd event 2023, resulting in the intial unsuccessful PT occurrence. -- 2 of 2 --

Summary Statement of Deficiencies 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 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 observation of the laboratory, review of manufacturer's instruction manual, laboratory records, and interview with the laboratory liaison, the laboratory failed to follow manufacturer's instructions for calibration in 2022 and 2023. The findings include: 1. Observation of the laboratory on July 5, 2023 at 9:10 a.m. revealed the Reichert Unistat Bilirubinometer on the counter in use for pediatric patient testing for total bilirubin. (Serial number 00690-1013). 2. Review of the manufacturer's instruction manual revealed that the Bilirubinometer is to be calibrated at least every six months, or earlier if indicated by quality control data, using stable assayed glass calibration cuvette. 3. Review of laboratory records revealed no records were present for calibration of the Bilirubinometer from July 2022 through date of survey (July 6, 2023). 4. Interview with the laboratory liaison on July 6, 2023 at 12:30 p.m. confirmed the laboratory failed to follow the manufacturer's instructions for calibration of the Bilirubinometer every six months in 2022 and 2023. 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 D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: =================================== Based on review of 2021 Hematology and Chemistry Proficiency Testing (PT) attestation sheets and upon interview with the lead lab liaison, determined the PT samples were not tested by six of seven testing personnel as listed on the Laboratory Personnel Report Form 209. The findings include: 1. Review of the Hematology and Chemistry PT records for 2021 revealed only one of seven testing personnel's signature on the attestation sheets. 2. Interview with the lead lab liaison on February 2, 2022 at approximately 12:30 p.m. confirmed the attestation sheets for 2021 Hematology and Chemistry PT were signed by only one of seven testing personnel. ==================================== 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 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 manufacturer's storage requirement for bilirubin control materials, freezer temperature documentation for 2018 and interview with Primary Laboratory Supervisor, determined the laboratory failed to ensure bilirubin controls were stored at the correct temperature. The findings include: 1. Manufacturer's storage requirement for bilirubin control materials is less than minus 20 degrees Celsius. 2. Freezer temperature documentation where bilirubin control materials are stored has been documented out of range low (warmer than minus 20 degrees Celsius) for 2018. 3. Interview with the primary laboratory supervisor at approximately 3:00 p.m. October 25, 2018 confirmed the bilirubin control materials were not stored at temperatures less than 20 degrees Celsius for 2018. =================================== D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within 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 manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: =================================== Based on calibration verification requirements for the Reikert Bilirubin instrument, lack of documentation of daily calibration verification for 2017 and 2018 and interview with the primary laboratory supervisor, determined the laboratory failed to perform daily calibration verifications for the two year period. The findings include: 1. Calibration verification is required to be performed daily using known calibration cuvettes for the Reikert Bilirubin instrument. 2. Lack of documentation of daily calibration verification for 2017 and 2018. 3. Interview with the primary laboratory supervisor at approximately 3:30 p.m. October 25, 2018 confirmed there was no daily calibration verifications documented for the two year period. =================================== D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: =================================== Based on lack of training and/or competency documentation for 2 of 2 testing personnel, who transferred to current facility in 2018, and upon interview with the primary laboratory supervisor, determined the laboratory director failed to ensure all personnel have documented training and/or competency prior to patient testing. The findings include: 1. Lack of training and/or competency documentation for 2 of 2 testing personnel, upon transfer from a sister facility in 2018, who have been performing Complete Blood Counts (CBC's) and bilirubin testing. 2. Interview with the primary laboratory supervisor at approximately 3:00 p.m. October 25, 2018 confirmed there was no documentation of training and/or competency for 2 of 2 testing personnel upon transferring from a sister facility in 2018, prior to performing CBC's and bilirubin testing. ==================================== -- 2 of 2 --