Hardtner Medical Center

Summary Statement of Deficiencies D0000 A Recertification survey was performed at Hardtner Medical Center, CLIA #19D0465142 on January 30, 2023 through February 1, 2023. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 observation by surveyor, review of the laboratory's test menu, proficiency test (PT) records and interview with personnel, the laboratory failed to verify the accuracy of performance for C-Reactive Protein (CRP) at least twice per year. Findings: 1. Observation by the surveyor during the laboratory tour on January 30, 2023 at 2:00 pm revealed the laboratory utilizes the Ortho Diagnostics Vitros 350 Chemistry analyzer for patient testing. 2. Review of the laboratory's test menu provided by the facility revealed the laboratory performs patient testing on the Vitros 350 chemistry analyzer for C-Reactive Protein (CRP). 3. Review of the laboratory's 2021 and 2022 proficiency testing records revealed the laboratory did not have documentation of testing for the verification of accuracy of performance at least twice annually for CRP. 4. In interview on January 31, 2023 at 11:18 am, Technical Consultant 1 stated she was unaware that CRP was not included on the proficiency testing events in 2021 and 2022. Technical Consultant 1 confirmed the laboratory did not verify the accuracy for CRP at least twice annually. 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 -- D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedures and interview with personnel, the laboratory failed to establish a complete policy and procedure manual. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not have written policies that included the following: a) Blood Bank: detailed, written procedures for performing new lot of reagent verifications b) Blood Bank: detailed, written procedures for labeling uncrossmatched blood as such upon release from the laboratory 2. In interview on January 31, 2023 at 2:15 pm, General Supervisor 2 confirmed the laboratory did not have written policies for the identified items above. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 An offsite PT Desk Review was performed on May 19, 2022 at Hardtner Medical Center - (CLIA #19D0465142). Hardtner Medical Center was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803 CONDITION: Successful Participation 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing; Laboratory Director 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 review of proficiency testing results from the CMS-153D, CMS-155D and College of American Pathologist (CAP), the laboratory failed to successfully perform in proficiency testing as evidenced by: 1. The laboratory failed to achieve satisfactory 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 -- performance for Lithium in three consecutive events resulting in a non-intial unsuccessful performance. Refer to D2118. D2118 TOXICOLOGY CFR(s): 493.845(f) Failure to achieve satisfactory performance for the same analyte or test in 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 review of proficiency testing results from the CMS-153D, CMS-155D and College of American Pathologists (CAP), the laboratory failed to achieve satisfactory performance for Lithium in three consecutive events resulting in a non-intial unsuccessful performance. Findings: 1. Review of the CMS-153D report, CMS-155D report, and College of American Pathologist (CAP) proficiency testing results revealed the laboratory did not score at least 80% for Lithium in the following events: a) Event 1 of 2021: 60% b) Event 2 of 2021: 60% c) Event 3 of 2021: 0% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of proficiency testing records and interview with personnel, the Laboratory Director failed to provide overall management and direction for the laboratory. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the CMS-153D and CMS-155D reports and the College of American Pathologists (CAP) proficiency testing records, the laboratory director failed to ensure that proficiency testing samples are satisfactory as required. Findings: 1. The laboratory failed to achieve satisfactory performance for Lithium in three consecutive events resulting in a non-intial unsuccessful performance. Refer to D2118. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A PT Desk Review was performed on September 8, 2021. Hardtner Medical Group- 19D04625142 was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803 CONDITION: Successful Participation 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing; Laboratory Director 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 review of proficiency testing results from the CMS-153, CMS-155D and College of American Pathologist (CAP), the laboratory failed to successfully perform in proficiency testing as evidence by: 1. The laboratory failed to achieve satisfactory 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 -- performance of at least 80% for Lithium in two consecutive events resulting in initial unsuccessful performance. Refer to D2118. D2118 TOXICOLOGY CFR(s): 493.845(f) Failure to achieve satisfactory performance for the same analyte or test in 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 review of proficiency testing results from the CMS-153, CMS-155D and College of American Pathologist (CAP), the laboratory failed to achieve satisfactory performance for Lithium in two consecutive events resulting in initial unsuccessful performance. Findings are: 1. Review of College of American Pathologist (CAP) proficiency testing results and CMS Report 0153D and 0155D revealed the laboratory failed to score at least 80% for Lithium in the following events: Event 1 of 2021: 60% Event 2 of 2021: 60% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to provide overall management and direction for the laboratory. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: The laboratory director failed to ensure that proficiency testing samples are satisfactory as required. Findings: 1. The laboratory failed to achieve a score of at least 80% for Lithium in two consecutive events, resulting in initial unsuccessful performance. Refer to D2118. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Recertification survey was performed at Hardtner Medical Center, CLIA ID # 19D0465142, on May 21, 2021 through May 27, 2021. Hardtner Medical Center was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1250 CONDITION: Analytic systems 42 CFR 493.1403 CONDITION: Laboratories Performing Moderate Complexity Testing, Laboratory Director 42 CFR 493.1409 CONDITION: Laboratories Performing Moderate Complexity Testing, Technical Consultant 42 CFR 493.1441 CONDITION: Laboratories Performing High Complexity Testing, Laboratory Director D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of the manufacturer's package insert, test menu, and interview with personnel, the laboratory failed to establish their own means and ranges for quality control (QC) material utilized for Erythrocyte Sedimentation Rate (ESR) testing per manufacturer's requirements. Findings: 1. Observation by surveyor during laboratory tour on May 24, 2021 at 2:12 pm revealed the laboratory utilizes the Wintrobe tubes manual method for ESR testing. 2. In interview on May 26, 2021 at 1:28 pm, the Laboratory Manager stated ESR controls are not established. The Laboratory Manager further stated according to the insert these should be established. 3. Review of the "ESR-Chex" package insert under "Expected Results" section revealed " Upon receipt of a new control lot, it is recommended that an individual laboratory establish its own mean and limits." 4. Review of the laboratory's test menu revealed the laboratory performs 698 ESR tests annually. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 23 -- D3013 FACILITIES CFR(s): 493.1101(e) Records and, as applicable, slides, blocks, and tissues must be maintained and stored under conditions that ensure proper preservation. This STANDARD is not met as evidenced by: Based on observation by surveyor and interview with personnel, the laboratory failed to ensure proficiency testing records were stored under conditions that ensured preservation. Findings: 1. Observation by surveyor on May 26, 2021 at 5:00 pm revealed the laboratory's College of American Pathologists (CAP) proficiency testing documents that included attestation statements and reporting forms were stored in brown cardboard boxes. Surveyor further observed damp proficiency testing documents that included water stains and rust marks from rusty staples. 2. In interview on May 27, 2021 at 9:25 am, the laboratory's manager (General Supervisor) stated the laboratory's proficiency testing records are stored under a cabinet that leaks. D3025 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(d) Investigation of transfusion reactions. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as appropriate, to Federal and State authorities. This STANDARD is not met as evidenced by: Based on review of nursing administration policies, laboratory policies, and interview with personnel, the laboratory failed to define specific criteria for suspected transfusion reactions. Findings: 1. Review of the laboratory's blood bank procedures revealed the laboratory had the following three (3) transfusion reaction documents signed by the Laboratory Director in January 2016: a) "Suspected Blood Transfusion Reaction Report:" The following clinical symptoms were listed: "temp elevation of 2 degrees above the initial temp/chills, tachycardia, chest pain, low back pain, significant variation from baseline B/P (>/= 15 % higher or lower than baseline), urticaria/rash/pruritis, dyspnea, asthmatic episode/wheezing, facial or glottal edema, nausea and vomiting, other" b) "Transfusion Reaction QA/QI Monitoring Tool:" The following "reactions" were listed: "temp elevation of 2 degrees above the initial temp /chills, tachycardia, chest pain, low back pain, significant increase or drop in B/P (30 mm hg systolic or 20 mm hg diastolic), Urticaria/rash/pruritis, dyspnea, ashtmatic episode/wheezing, facial or glottal edema, nausea and vomiting, and other" c) "Investigation of Suspected Transfusion Reaction" policy with the following "Immediate: hemolysis with symptoms, febrile non-hemolytic reaction, anaphylaxis, urticaria, non-cardia pulmonary edema, marked fever and shock, congestive heart failure, hemoloysis without symptoms, red cell incompat. Ab to WBC (HLA) ag, Ab to IgA, Ab to plasma proteins, Ab to Wbc (HLA) ag, bacterial contaminant, volume overload, physical destruction of RBC's. Delayed: hemolysis, graft vs host disease, post transfusion purpura, iron overload, hepatitis or AIDS, protozoal infection, anamnestic response to antigens, engraftment of transfused lymph's, anti-platelet Ab, multiple transfusion (100 + units) , usually NANB:OCC. B, usually malaria." 2. Review of the "Nursing Department Protocol" revealed the following signs/symptoms that would initiate the transfusion reaction procedure: " temp elevation of 2 degrees -- 2 of 23 -- above the initial temp, tachycardia, chest pain, low back pain, significant variation from baseline B/P (>/= 15 % higher or lower than baseline), urticaria/rash/pruritis, asthmatic episode/wheezing, facial or glottal edema, nausea, and vomiting, fluid overload: chest pain, dyspnea, decrease in urinary output, edema." 3. Further review of the "Nursing Department Protocol" revealed the "Transfusion Reaction QA/QI Monitoring Tool," "Blood Administration Plan of Care," and "Suspected Blood Transfusion Reaction Report" forms were included. The clinical symptoms listed in "Suspected Blood Transfusion Reaction Report" provided by the Manager of the Surgery Department did not match the one provided by the laboratory. The following clinical symptoms were listed: "chills, vomiting, chest pains, oozing from wound, hives, facial edema, rash, frothy sputum, rapid temp. increase, headache, hematuria, dyspnea, nausea, itching, back pain, immediate post transfusion jaundice, cyanosis, decreased B/P, coughing, and other." 4. Review of the following four (4) transfusion reaction work-ups from 2019 through 2021 revealed the nursing staff completed a "Suspected Blood Transfusion Reaction Report" whose clinical symptom criteria and form did not match those included with their protocol or the laboratory's protocol: a) May 23, 2019: Patient 17400-0091 b) June 21, 2019: Patient 260025-0145 c) January 21, 2020: Patient 43661-0002 d) January 14, 2021: Patient 150063-0118 5. Surveyor was provided three (3) " Suspected Blood Transfusion Reaction Reports" that had differing clinical symptoms for a suspected transfusion reaction listed. 6. In interview on May 27, 2021 at 12:40 pm, the Manager of the Surgery Department stated the nursing forms for transfusion reactions were implemented in 2016. The Manager of the Surgery Department confirmed the forms and criteria utilized by nursing for suspected transfusion reactions did not match the nursing department's protocol or the laboratory's forms and criteria. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation by surveyor, record review, and interview with personnel, the laboratory failed to ensure the quality of testing within the analytic systems. Findings: 1. The laboratory failed to establish a complete policy and procedure manual. Refer to D5401. 2. The laboratory failed to establish complete policies and procedures. Refer to D5403. 3. The laboratory failed to ensure policies and procedures were updated to current practices. Refer to D5407. 4. The laboratory failed to document visual inspections on blood culture bottles before use per manufacturer's requirements. Refer to D5411. 5. The laboratory failed to ensure blood bank reagents had not exceeded their expiration dates. Refer to D5417. 6. The laboratory failed to perform reportable range and reference range studies for D-dimer testing. Refer to D5421. 7. The laboratory failed to perform calibration procedures for phosphorus, total bilirubin, triglycerides, creatinine, and uric acid testing at least every six (6) months per manufacturer requirements. Refer to D5439. 8. The laboratory failed to establish their own means and ranges for QC material utilized for Urinalysis testing. Refer to D5469 I. 9. The laboratory failed to establish their own means and ranges for QC material -- 3 of 23 -- utilized for D-dimer testing. Refer to D5469 II. 10. The laboratory failed to ensure quality control was performed prior to patient samples for four (4) dates for serum human chorionic gonadotropin (HCG) and Rheumatoid Factor (RF) tests. Refer to D5481. 11. The laboratory failed to document quality control for blood bank testing prior to patient testing. Refer to D5559. 12. The laboratory failed to have complete documentation of