Mckenzie County Healthcare Systems

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on record review, policy review, and staff interview, the laboratory failed to review and evaluate proficiency testing results for 1 of 3 chemistry events (Event 1) in 2024. Findings include: 1. Reviewed on 02/11/25, the Event 1-2024 chemistry proficiency testing records lacked evidence of results review and evaluation of analytes with less than 100% scores including: - D-dimer 60% - pH (potential of hydrogen) 80% - pCO2 (partial pressure of carbon dioxide) 80% - pO2 (partial pressure of oxygen) 80% 2. Reviewed on 02/11/25, the policy "Proficiency Program," dated 11/15/16, stated, ". . . Procedure . . . Evaluate all test results upon receipt. Graded specimens are reviewed. Document any

Summary Statement of Deficiencies D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on observation, manufacturer's instructions review, record review, policy review, and staff interview, the laboratory failed to use the correct International Sensitivity Index (ISI) and mean normal protime (PT) values for calculating the International Normalized Ratios (INRs) for 28 of 34 days (2/24-3/21 and 3/26) in 2023 since the laboratory began using a new lot number of Neoplastine (thromboplastin reagent used to analyze protime tests) on their coagulation analyzer on 02/24/23. The laboratory performed approximately 50 tests during this timeframe. Findings include: 1. Observation of the Stago STA Compact MAX coagulation analyzer at 11:55 a.m. on 03/29/23 revealed an ISI of 1.22 and a patient normal mean of 12.9 used to calculate patient INRs. 2. Reviewed at 12:00 p.m. on 03/29/23, the undated STA Neoplastine CI Plus (protime reagent) package insert for lot number 261888 stated the ISI for Stago STA Compact MAX analyzer as 1.22. The document stated, ". . . check that the value taken into account corresponds exactly to that of the reagents being used." 3. Reviewed at 12:05 p.m. on 03/29/23, the laboratory's records for validation of Neoplastine lot number 261888, dated February 2023, revealed a patient normal mean of 13.0. 4. Reviewed on 03/29/23, the manufacturer's instructions for STA Neoplastine CI Plus, dated May 2019, stated, ". . . 2/ Summary and Explanation . . . The PT is commonly used for monitoring vitamin K antagonist therapy . . . It is well known that the PT value of a plasma may vary according to the origin of the thromboplastin reagent and to the instrument used to measure it. . . . the PT ratio is converted into the International Normalized Ratio (INR). The INR value corresponds to the value of the ratio of the patient's PT to that of the standard PT raised to the ISI (International Sensitivity Index) power of the thromboplastin used. . . 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 -- . 5. Reviewed on 03/29/23, the policy "Stago-Neoplastine - Determination of Prothrombin Time (PT)," effective 07/01/18, stated, ". . . Reference Interval . . . If PT- INRs are reported, a lot specific ISI value and Reference Time or geometric mean must be entered into the instrument. . . . in order for the correct calculation of the INR. . . ." 6. Reviewed at 3:00 p.m. on 03/29/23, the STA Compact MAX maintenance records from 02/24/23 through 03/28/29 showed the following documentation of the ISI and patient normal mean programmed into the analyzer: - 02/24/23 through 03/21 /23: ISI 1.28 and patient normal mean 12.9 (values from the previous lot number of Neoplastine). - 03/26/23: patient normal mean 12.9 (value from the previous lot number of Neoplastine). 7. During interview at 12:15 p.m. on 03/29/23, a technical supervisor (#1) stated the laboratory began using a new lot number of Neoplastine reagent on 02/24/23 and confirmed the patient normal mean entered into the analyzer was incorrect on 03/29/23 at 11:55 a.m. During interview at 3:00 p.m. on 03/29/23, a technical supervisor (#1) confirmed the laboratory's documentation of the coagulation analyzer's ISI and patient normal mean values showed incorrect values from 02/24/23 through 03/21/23 and an incorrect patient normal mean on 03/26/23. -- 2 of 2 --

Summary Statement of Deficiencies 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 record review, staff interview, and policy review, the laboratory failed to twice annually verify the accuracy of two of two non-regulated analytes (Human Immunodeficiency Virus antibody and Hepatitis C antibody) in 2020. The laboratory performed approximately 171 Human Immunodeficiency Virus (HIV) and 119 Hepatitis C antibody patient tests in 2020. Findings include: 1. Reviewed at 4:05 p.m. on 09/22/21, the laboratory's test menu listed HIV and Hepatitis C antibodies available for patient testing. 2. Reviewed at 4:10 p.m. on 09/22/21, the 2020 proficiency testing records indicated the laboratory did not participate in proficiency testing for HIV and Hepatitis C antibodies. 3. Upon request at 11:30 a.m. on 09/23/21, the laboratory failed to provide evidence of twice annual accuracy verification for HIV and Hepatitis C antibodies in 2020. 4. During interview at 12:45 p.m. on 09/23 /21, a general supervisor (Personnel #1) confirmed the laboratory performed HIV and Hepatitis C antibody patient testing in 2020 and did not twice annually verify the accuracy of these tests in 2020. 5. Reviewed at 2:40 p.m. on 09/23/21, the policy "Proficiency Testing Results," effective 06/14/18, stated, "Policy/Procedure . . . C. All non-regulated analytes are verified and documented 2X [times]/year." D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high 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 record review, staff interview, and policy review, the technical supervisor failed to evaluate and document the competency at least semi-annually for two of four new testing personnel (Testing Personnel #1 and #2) hired in 2019-2020. Findings include: 1. Reviewed at 8:30 a.m. on 09/23/21, the competency evaluation records lacked evidence of six month competency evaluations for Testing Personnel #1 in 2020 and Testing Personnel #2 in 2021. 2. During interview at 12:20 p.m. on 09/23 /21, a general supervisor (Personnel #1) confirmed the technical supervisor had not completed six month competency evaluations for Testing Personnel #1 who started in November 2019 and for Testing Personnel #2 who started in July 2020. 3. Reviewed at 2:40 p.m. on 09/23/21, the policy "Competency," effective 06/18/18, stated, "Procedure . . . E. . . . competency testing is done in the Lab at 6 months . . ." D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on record review, staff interview, and policy review, the technical supervisor failed to evaluate and document the competency for one of three testing personnel (Testing Personnel #3) requiring annual competency evaluations in 2020. Findings include: 1. Reviewed at 8:30 a.m. on 09/23/21, the competency evaluation records lacked evidence of an annual competency evaluation for Testing Personnel #3 in 2020. 2. During interview at 12:20 p.m. on 09/23/21, a general supervisor (Personnel #1) confirmed the technical supervisor had not completed an annual competency evaluation in 2020 for Testing Personnel #3 who started in September 2019. 3. Reviewed at 2:40 p.m. on 09/23/21, the policy "Competency," effective 06/18/18, stated, "Procedure . . . E. . . . competency testing is done in the Lab at 6 months, then again annually. . . ." -- 2 of 2 --