Elliot Hospital Point Of Care Testing

Summary Statement of Deficiencies D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) (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 review of new testing personnel records from 2024, 2025, and 2026 and interview with the laboratory's Human Resources Compliance Program Manager (HR1), , the laboratory director (LD) failed to ensure educational qualifications were met for 1 (TP1) out of 36 new personnel records reviewed for 2024, 2025, and 2026. Cross reference D6063 and D6065. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of 10 new testing personnel records from 2024, 2025, and 2026 and interview with the technical consultants (TC1, and TC2), the technical consultants failed to ensure 2 of 2 new testing personnel testing for greater than one year were assessed for competency semiannually in their first year of testing. Findings include: 1. Review on 3/12/2026 of 10 new testing personnel records from 2024, 2025, and 2026 revealed two testing personnel have been performing testing for at least one 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 -- year. Further review revealed 1 (TP2) of 2 testing personnel testing greater than one year failed to be assessed for competency semiannually within the first year; TP2 completed training in 7/11/2024, was assessed for competency on 2/12/2025 and again on 3/6/2026. TP2 failed to have a second competency assessment before July 2025. 2. Review on 3/12/2026 of patient test records from 7/12/2025 through 3/6/2026 revealed TP2 performed routine chemistry and hematology testing on 2 patients. 2. Interview on 3/12/2026 at 1:30 p.m. with TC1 and TC2 confirmed the above findings. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of new testing personnel records from 2024, 2025, and 2026 and interview with the laboratory's Human Resources Compliance Program Manager (HR1), 1 out of 36 new testing personnel records reviewed failed to meet educational qualification requirements. Refer to D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; or (b)(2) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology, or nursing from an accredited institution; or (b)(3) Meet the requirements in 493.1405(b)(3)(i)(B), (b)(4)(i)(B), (b)(4)(i)(C) or (b)(5)(i)(B); or (b)(4) Have earned an associate degree in a chemical, biological, clinical or medical laboratory science, or medical laboratory technology or nursing from an accredited institution; or (b)(5) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least a duration of 50 weeks and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(6)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of new testing personnel records from 2024, 2025, and 2026 and interview with the laboratory's Human Resources Compliance Program Manager (HR1), 1 out of 36 new testing personnel records reviewed failed to meet educational qualification requirements. Findings include: 1. Review on 3/12/2026 of 36 new testing personnel records from 2024, 2025, and 2026 revealed 1 testing personnel (TP1) of 36 personnel records reviewed failed to include documentation of educational qualifications from an accredited institution. Further review revealed only TP1 had an education from a foreign institution and TP1's personnel record failed to include an evaluation of TP1's credentials to determine the equivalency of their education to an education obtained in the United States (U.S.). TP1 was the only -- 2 of 3 -- personnel reviewed who had a foreign education. 2. Interview on 3/12/2026 at 9:00 a. m. with HR1 revealed an evaluation of TP1's foreign education was not performed to determine the U.S. equivalency. -- 3 of 3 --

Summary Statement of Deficiencies D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. This STANDARD is not met as evidenced by: Based on record review and staff interview, 1 out of 7 new testing personnel in surgical services failed to have training completed before analyzing patient samples in 2021 and 2022. Findings include: 1. Review on 5/10/2022 of the laboratory's procedure titled "Clinical Staff Laboratory Competency Assessment Policy for Non- Waived Testing" revealed instruction to perform the competency checklist on testing personnel prior to reporting patient results. 2. Review on 5/10/2022 of the laboratory's procedure titled "Laboratory Designee Policy" revealed Technical Consultants are responsible for ensuring employees are trained and documentation of competency assessment(s) are completed. 3. Review on 5/10/2022 of personnel records for surgical services revealed 1 of 7 new testing personnel failed to complete and have completed documentation of training and initial competency assessment prior to analyzing 2 patient specimens on 12/21/2021, 3 patient specimens on 2/28/2022, and 3 patient specimens on 3/7/2022. 4. Interview on 5/10/2022 at 2:30 p.m. with the Technical Consultant/Nurse Educator (TC) for surgical services revealed the nursing practice to train was to have the new personnel perform patient testing while being observed by another trained testing personnel. The TC was not aware that the entire training/competency assessment documentation needed to be completed prior to any new testing personnel performing patient testing. 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 D3003 FACILITIES CFR(s): 493.1101(a)(2) The laboratory must be constructed, arranged, and maintained to ensure contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized. This STANDARD is not met as evidenced by: Based on observation of the Surgical Day Care (SDC) i-STAT meter and staff interview, the laboratory failed to ensure the i-STAT meter was maintained to minimize contamination. Findings include: 1) Observation of the SDC i-STAT meter on 3/4/2020 at 8:50 a.m. revealed a piece missing from a corner of the meter's exterior. 2) Interview with Technical Consultant (TC1) on 3/4/2020 at 8:50 confirmed the above finding. 3) 4) Interview with Technical Consultant (TC2) on 3/4/2020 at 11: 00 a.m. revealed the SDC performed, on average, 1-2 prothrombin (PT/INR) tests per day using the i-STAT. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation of the Surgical Day Care (SDC) i-Stat meter, review of procedures, and staff interview, the laboratory failed to clean and maintain the SDC i- STAT meter used to perform 1-2 hematology tests per day. Findings include: 1) Review of the laboratory's procedure titled "I-STAT Testing" revealed, on page 15 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 -- under Maintenance, instruction to "Clean the i-STAT with a Sani-Cloth between patient uses." 2) Observation of the i-STAT in SDC on 3/4/2020 at 8:50 a.m. revealed a red substance consistent with dried blood and a yellowish substance on the sides of the meter. 3) Interview with Testing Personnel (TP1) and Technical Consultant (TC1) on 3/4/2020 at 8:50 a.m. confirmed the meter was not clean. TP1 cleaned the exterior surface of the i-STAT at this time. 4) Interview with Technical Consultant (TC2) on 3 /4/2020 at 11:00 a.m. revealed the SDC performed, on average, 1-2 prothrombin (PT /INR) tests per day using the i-STAT. 5) This is a repeat deficiency from the initial certification survey completed on 9/28/2018. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of Surgical Day Care (SDC) laboratory refrigerator temperature logs and staff interview, the laboratory failed to retain the SDC refrigerator temperature log for January 2020. Findings include: 1) The SDC laboratory refrigerator temperature logs from July 2019 through February 2020 were requested by the surveyor on 3/4/2020. The laboratory failed to provide the SDC refrigerator temperature log for January 2020. 2) Interview with two Technical Consultants (TC1 and TC2) on 3/4/2020 at 11:00 revealed the laboratory was not able to locate the SDC laboratory refrigerator temperature log for January 2020. 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 observation of Surgical Day Care's (SDC) laboratory refrigerator, review of refrigerator temperature logs and staff interview, the laboratory failed to document SDC refrigerator temperatures for 38 of 213 days in July 2019 through December 2019 and February 2020, the SDC refrigerator is used to store prothrombin (PT/INR) test cartridges and the SDC averages 1-2 patient PT/INR tests each day. Findings include: 1) Observation of the SDC laboratory refrigerator on 3/4/2020 at 9:00 a.m. revealed the PT/INR test cartridges for the i-STAT test system are stored in the refrigerator. 2) Review of the SDC laboratory refrigerator temperature logs from July 2019 through December 2019 and February 2020 revealed no temperatures were documented on the following [38] days: 7/26/2019, 8/2/2019, 8/5/2019, 8/31/2019, 9 /14/2019, 9/15/2019, 9/27/2019, 9/28/2019, 9/29/2019, 10/2/2019, 10/5/2019, 10/6 /2019, 10/16/2019, 10/26/2019, 10/30/2019, 11/1/2019, 11/2/2019, 11/3/2019, 11/23 -- 2 of 4 -- /2019, 11/24/2019, 11/28/2019, 11/29/2019, 12/4/2019, 12/7/2019, 12/8/2019, 12/11 /2019, 12/25/2019, 12/30/2019, 2/5/2020, 2/8/2020, 2/10/2020, 2/11/2020, 2/12/2020, 2/15/2020, 2/26/2020, 2/22/2020, 2/28/2020, and 2/29/2020. The laboratory failed to provide the SDC refrigerator temperature log for January 2020. 3) Interview with two Technical Consultants (TC1 and TC2) on 3/4/2020 at 11:00 a.m. confirmed the above findings. TC2 revealed the SDC performs on average 1-2 PT/INR tests per day, Monday through Friday. D5781

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation, record review and staff interview, the laboratory failed to observe procedures for disinfecting the specimen collection cite and hematology point of care testing equipment to ensure protection from biohazardous materials. Findings include: 1) Observation on 9/27/2018 at 10:20 a.m. in the Coumadin Clinic at Cardiology laboratory site revealed testing personnel sterilized the patient's finger and immediately reached for and dried the finger with non-sterile gauze before the lancing the finger. After the testing was completed, the backside of the meter was not wiped as part of the disinfecting procedure. 2) Observation of two CoaguChek XS Pro meters on 9/28/2018 at 10:15 a.m. the Coumadin Clinic Senior Health laboratory site revealed the presence of a red/brown substance consistent with dry whole blood on the backside of one of two of the meters. 3) Review on 9/28/2018 of the laboratory's "INR Testing using the CoaguChek XS Pro System" effective October 2014 revealed instruction on page five to "Clean the selected finger with an alcohol wipe. Allow to air dry." Further review revealed instruction on page 8 to "...wipe the meter's exterior clean." 4) Interview on 9/28/2018 at 10:15 a.m. with the technical consultant confirmed the above findings. 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 --