Nocona General Hospital

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. 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 laboratory policy, proficiency testing records, the Centers for Medicare & Medicaid Services (CMS)-209 laboratory personnel report, and interview with facility personnel, the laboratory failed to include 2 of 11 testing personnel who routinely perform patient testing in proficiency testing for 2022 and 2023. The findings included: 1. Based on review of the laboratory policy "Paperless / Electronic Proficiency Testing", stated the following: "Testing ... 3.The specimens will be placed on the next patient run and treated as routine tests. Proficiency specimens must be tested the same number of times and in the same manner as patient specimens are routinely tested." 2. Based on a review of proficiency testing records and the CMS- 209 laboratory personnel report, all proficiency testing events from the 2022 through 2 events in 2023 were performed by Testing Person 1 (TP-1), Testing Person 3 (TP- 3), Testing Person 4 (TP-4), Testing Person 5 (TP-5), Testing Person 6 (TP-6), Testing Person 7 (TP-7), Testing Person 8 (TP-8), or Testing Person 10 (TP-10): 2022 Chemistry-Core - 1st Event was performed by TP-1, TP-3, TP-4, TP-7, TP-10 2022 Hematology/ Coagulation- 1st Event was performed by TP-1, TP-4 2022 Microbiology - 1st Event was performed by TP-1, TP-3, TP-4, TP-8, TP-10 2022 Chemistry-Core - 2nd Event was performed by TP-1, TP-4, TP-5 2022 Hematology/ Coagulation- 2nd Event was performed by TP-1, TP-4 2022 Microbiology - 2nd Event was performed by TP-1, TP-4 2022 Chemistry-Core - 3rd Event was performed Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- by TP-1, TP-4 2022 Hematology/ Coagulation- 3rd Event was performed by TP-1 2022 Microbiology - 3rd Event was performed by TP-1, TP-4 2023 Hematology/ Coagulation - 1st Event was performed by TP-1 and TP-4 2023 Chemistry-Core - 1st Event was performed by TP-1, TP-4, TP-5, TP-6, TP-7 2023 Chemistry-Core - 2nd Event was performed by TP-1, TP-3, TP-4, TP-7 Testing Persons 9 and 11 did not participate in proficiency testing in 2022 and 2023. 3. During an interview at 12:10 pm on 07/10/2023, the Technical Consultant/TP-1 confirmed the above findings. 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 review of laboratory policy, American Proficiency Institute (API) proficiency testing (PT) records and confirmed in interview, the laboratory failed to review and evaluate the ungraded results obtained on proficiency testing for 2 of 3 events in 2022 (hematology event 1 and 3) and 1 of 1 events in 2023 (microbiology event 1). The findings included: 1. Review of the laboratory's PT policy "Paperless / Electronic Proficiency Testing" revealed: "Testing ... 5. Returned results will be evaluated ASAP. A score of 80% for each analyte and an overall score of 80% in each specialty must be attained. Failure to achieve an overall satisfactory score of two consecutive events or two out of three events is an unsuccessful performance. 6. Remedial action and documentation will be made for each unacceptable result." The policy failed to address ungraded proficiency testing results. 2. Review of the API 2022 Hematology 1st and 3rd Events revealed the following PT results: 2022 Event 1 EDUCATIONAL BLOOD CELL IDENTIFICATION Analyte/Method: Basophil (DIF) (%) Sample- DIF-01 Performance- Not Graded Analyte/Method: Eosinophil (DIF) (%) Sample- DIF-01 Performance- Not Graded Analyte/Method: Lymphocyte (DIF) (%) Sample- DIF-01 Performance- Not Graded Analyte/Method: Lymphocyte, reactive (DIF) (%) Sample- DIF-01 Performance- Not Graded Analyte/Method: Monocyte (DIF) (%) Sample- DIF-01 Performance- Not Graded Analyte/Method: Neutrophil, segmented (DIF) (%) Sample- DIF-01 Performance- Not Graded Analyte /Method: Platelet estimate (DIF) Sample- DIF-01 Performance- Not Graded Analyte /Method: Blood Cell ID (Educational) Samples- ECI-01, ECI-02, ECI-03, ECI-04, ECI-05 Performance- Not Graded 2022 Event 3 BLOOD CELL IDENTIFICATION Analyte/Method: Blood Cell Identification Sample- BCI-14 Performance- Not Graded EDUCATIONAL BLOOD CELL IDENTIFICATION Analyte/Method: Basophil (DIF) (%) Sample- DIF-03 Performance- Not Graded Analyte/Method: Lymphocyte (DIF) (%) Sample- DIF-03 Performance- Not Graded Analyte/Method: Monocyte (DIF) (%) Sample- DIF-03 Performance- Not Graded Analyte/Method: Neutrophil, segmented (DIF) (%) Sample- DIF-03 Performance- Not Graded Analyte/Method: Platelet estimate (DIF) Sample- DIF-03 Performance- Not Graded Analyte/Method: Blood Cell ID (Educational) Samples- ECI-11, ECI-12, ECI-13, ECI-14, ECI-15 Performance- Not Graded Further review of the event revealed the API performance review was signed by the laboratory director. No documentation of result evaluation of Samples DIF-01, ECI-01, ECI-02, ECI-03, ECI-04, ECI-05, DIF-03, ECI-11, ECI- 12, ECI-13, ECI-14, and ECI-15 by the laboratory director was provided. 3. Review of the API 2023 Microbiology 1st Event revealed the following PT results: Analyte /Method: BioFire FilmArray RP2.1/Influenza A Sample- RSP-04 Performance- Not Graded Further review of the event revealed the API performance review was signed -- 2 of 9 -- by the laboratory director. No documentation of result evaluation of Sample RSP-04 by the laboratory director was provided. 4. During an interview at 12:10 pm on 07/10 /2023, the Technical Consultant confirmed the above findings. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of laboratory policy, American Proficiency Institute (API) proficiency testing (PT) records and confirmed in interview, the laboratory failed to correctly evaluate and document

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Centers for Medicare and Medicaid Services) national database and verified with the proficiency testing company, American Proficiency Institute (API). The laboratory was found to be NOT in compliance with the conditions of participation of the CLIA program based on the following CONDITION LEVEL DEFICIENCIES: 493.803 Successful participation [proficiency testing] 493.1441 Laboratories performing high complexity testing; laboratory director Note: The CMS 2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 An entrance conference was held with the laboratory representatives. The survey process was discussed, and survey forms were provided. An opportunity for questions and comments was given. Noted deficiencies and plans of correction were discussed with the laboratory representatives at the exit conference. The laboratory representatives were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be NOT in compliance with the CLIA conditions for specialties /subspecialties surveyed for 42 CFR 493.1100 Facility Administration 493.1217 Immunohematology 493.1250 Analytic Systems 493.1403 Laboratory Director, (moderate complexity) 493.1441 Laboratory Director (high complexity) Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory records, patient records, and confirmed in interview, the laboratory failed to document the Wright Gemsa (hematology differentials) stain adequacy (reactivity/stain quality) for patient slides. Findings were as follows: a. At the time of of the survey January 21, 2020 the surveyor asked for documentation for the quality control for the Wright Gemsa stain used for Blood manual differentials. The laboratory failed to produce any documentation. b. During an interview on 01/21 /20 at 10:20 AM, the General Supervisor confirmed the stain adequacy for Wright Gemsa was not documented .. D5783