Mitchell County Hospital

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard deficiencies were cited. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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, review of the laboratory's environmental records, review of patient records from September 2024 to December 2024, and confirmed in interview, the laboratory failed to follow its own policy on performing patient testing for RPR's within the allowable temperature range for 12 of 121 days. Findings include: 1. Review of the laboratory's policy titled "RPR Equipment Testing Procedure" approved by the laboratory director on 08/12/2015 stated: "ROOM TEMPERATURE READINGS: A. Check the room temperature before doing RPR's. It MUST read (23-28 C). B. Do not run RPR's if the room temperature is out of range ..." 2. Review of the laboratory's environmental records from September 2024 to December 2024 determined the recorded temperature ranges were outside the laboratory's policy for acceptable limits for the following days: September 2024: a. 09 /02/2024: 22C b. 09/03/2024: 22C c. 09/13/2024: 22C d. 09/17/2024: 21C e. 09/20 /2024: 21C October 2024: a. 10/07/2024: 22C b. 10/10/2024: 22C c. 10/17/2024: 22C November 2024: a. 11/05/2024: 21C b. 11/13/2024: 22C c. 11/25/2024: 22C December 2024: a. 12/31/2024: 21C 3. Review of patient final reports from September 2024 to December 2024 determined patient testing for RPR's was performed while recorded temperatures were outside the laboratory's acceptable limits: September 2024: a. Sample ID: 819093 b. Sample ID: 819215 c. Sample ID: 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 -- 820598 d. Sample ID: 820611 e. Sample ID: 821147 f. Sample ID: 821570 October 2024: a. Sample ID: 823416 b. Sample ID: 823815 c. Sample ID: 824888 November 2024: a. Sample ID: 827446 b. Sample ID: 828510 c. Sample ID: 829942 December 2024: a. Sample ID: 834058 4. The general supervisor (as listed on the CMS-209 form) confirmed the findings during an interview conducted on 01/15/2025 at 1116 hours in the conference room. Key: RPR - Rapid Plasma Reagin C - degrees Celsius CMS - Centers for Medicare and Medicaid Services D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on 1/11/2023, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6076 - 42 C.F.R. 493.1403 Condition: Laboratory Director, high complexity 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, proficiency testing records from American Association of Bioanalysts (AAB) 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 3 -- (API), the laboratory failed to achieve successful performance in two of three testing consecutive events from 2021 and 2022 for blood bank compatibility testing, resulting in unsuccessful performance. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, American Association of Bioanalysts (AAB) testing records from 2021, and American Proficiency Institute (API) testing records from 2022, the laboratory failed to achieve an overall testing event score of satisfactory performance (less than 100%) for two of three consecutive testing events for the blood bank compatibility testing. Two out of three overall testing event scores of unsatisfactory performance result in unsuccessful PT performance. Findings were: 1. A review of the CASPER Report 155 listed the following scores for two of three compatibility testing in 2021 and 2022. 2021 AAB Event 3 80% 2022 API Event 2 80% 2. A proficiency desk review of AAB testing records from 2021 and API testing records from 2022 had the following unsatisfactory scores in compatibility testing: 2021 AAB Nonchemistry 3rd Event: Compatibility Testing - 80.0 2022 API Immunohematology 2nd Event: Compatibility testing - 80% D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile American Association of Bioanalysts (AAB) testing records from 2021, and American Proficiency Institute (API) testing records from 2022, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for blood bank compatibility testing. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile American Association of -- 2 of 3 -- Bioanalysts (AAB) testing records from 2021, and American Proficiency Institute (API) testing records from 2022 proficiency testing records, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for Blood bank compatibility testing for two of three overall testing events from 2021 and 2022. Refer to D2181. -- 3 of 3 --

Summary Statement of Deficiencies D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Review of policies and procedures, patient test records, quality control records and interview of facility personnel found the laboratory failed to ensure that quality control procedures were performed each day of patient testing in Immunohematology. The laboratory failed to document quality control testing for ABO and Rh testing on two of 57 days between January 1, 2021 and August 24, 2021. The findings included: 1. Review of the procedure titled Blood Bank Quality Control procedure using Immucor Reagent corQC Test System (approved by the laboratory director 11/21 /2006) found under the heading Purpose: " The purpose of Daily quality assurance in the Blood Bank is to confirm the reliability of the test system which includes reagents, test procedures and equipment. The minimum quality control testing required each day of use is: Positive control tested daily Anti-A, Anti-A,B, Reverse Group A1 and B, Screening Cells Monospecific Anti-IgG. Negative Control tested daily Anti-A, Anti-A,B, Reverse Group A1 and B, Screening Cells Monospecific Anti-IgG. " 2. Review of patient test records between January 1, 2021 and August 24, 2021 found that the laboratory failed to perform and document quality control procedures on the 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 -- following dates when patient specimens were tested for ABO, Rh, and antibody screening procedures: March 16, 2021 - patient 668644 was tested for ABO and Rh without documentation of quality control procedures. August 20, 2021 - patient 685720 (crossmatch only) had one unit of blood tested for ABO and Rh without documentation of quality control procedures. 3. Review of Blood Bank quality control records found: a. March 5 through March 25, 2021, quality control procedures were documented for the following dates: March 5, 2021 March 6, 2021 March 8, 2021 March 10, 2021 March 25, 2021 Quality control records were reviewed by the General supervisor on April 16, 2021 and by the Laboratory Director on May 28, 2021. b. August 19 through August 23, 2021, quality control procedures were documented for August 19, 2021 and August 23, 2021. No documentation of Quality control records review by the laboratory director and or the general supervisor as of August 24, 2021. 4. Interview of the General Supervisor conducted on August 24, 2021 at 2:12 PM confirmed that there was no documentation of quality control activities conducted prior to testing patients and donor units on the two dates. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed and failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780: 493.803 Condition: Successful participation 493.807 Condition: Reinstatement of laboratories performing nonwaived testing 493.1441 Condition: Laboratories performing high 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 the CMS-155 proficiency testing report, the American Association Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- of Bioanalysts (AAB)) proficiency testing records for 2017, 2018 and 2019 and interview of facility personnel the laboratory failed to successfully participate in a proficiency testing for Bacteriology. (See D 2020 and D 2021) D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: Based on review of the CMS-155 proficiency testing report, the American Association of Bioanalysts (AAB)) proficiency testing records for 2017, 2018 and 2019 and interview of facility personnel the laboratory failed to successfully participate in a proficiency testing for Bacteriology. (See D 2020 and D 2021) D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Review of the laboratory's CMS 155 report, the American Association of Bioanalysts (AAB) Non-Chemistry proficiency testing records from 2017, 2018 and 2019 and staff interview found the laboratory failed to attain an overall testing event score of 80% or higher in three of three consecutive testing events of 2018 for Bacteriology (Q1, Q2 and Q3). The findings included: 1. Review of the CMS report 155( printed February 4, 2019) found that the AAB proficiency testing agency reported a score of 0% for Bacteriology in the 2018 Q1 and Q2 Non Chemistry testing events. Review of the CMS report 155( printed February 15, 2019) found that the proficiency testing agency reported a score of 0% for Bacteriology in the 2018 Q1 and Q2 Non Chemistry testing events. 2. A review of the laboratory's American Proficiency Institute's bacteriology proficiency testing records from 2018 found: 2018 Q1 Cumulative scores - The laboratory was not given a score for Culture ID or Susceptibility testing. Code Dc ( Discontinued from reporting to CMS) was noted in each of the result fields. 2018 Q2 Cumulative Scores- The laboratory was not given a score for Culture ID or Susceptibility testing. The fields were blank. 2018 Q3 Cumulative scores - The specialty of Bacteriology does not appear on the report. 3. Interview of the General Supervisor conducted on February 12, 2019 at 11:16 AM -- 2 of 6 -- confirmed that the laboratory stopped testing Culture ID and Susceptibility testing at the end of 2017. She went on to say that she did not renew the proficiency testing for bacteriology in 2018 because she was no longer testing. She said she notified the state agency, but did not notify the Proficiency testing agency of discontinued testing in Culture ID and Susceptibility because she thought not renewing the order was enough. Further interview of the general supervisor conducted on February 15, 2019 at 10:30 AM found that she had communicated with the proficiency testing agency regarding the reported scores of 0% and was informed that they would look into the coding for discontinued testing and resubmit them to CMS. In this process, a score of 0% for the Q3 2018 Bacteriology testing event was generated. D2021 BACTERIOLOGY CFR(s): 493.823(b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Review of the laboratory's CMS 155 report, the American Association of Bioanalysts (AAB) bacteriology proficiency testing records from 2017, 2018 and 2019 and staff interview found the laboratory failed to successfully participate in three of three consecutive testing events of 2018 (Q1, Q2 and Q3). The findings included: 1. Review of the CMS report 155( printed February 4, 2019) found that the proficiency testing agency reported a score of 0% for Bacteriology in the 2018 Q1 and Q2 Non Chemistry testing events. Review of the CMS report 155( printed February 15, 2019) found that the proficiency testing agency reported a score of 0% for Bacteriology in the 2018 Q1 and Q2 Non Chemistry testing events. 2. A review of the laboratory's American Proficiency Institute's bacteriology proficiency testing records from 2018 found: 2018 Q1 Cumulative scores - The laboratory was not given a score for Culture ID or Susceptibility testing. Code Dc ( Discontinued from reporting to CMS) was noted in each of the result fields. 2018 Q2 Cumulative Scores- The laboratory was not given a score for Culture ID or Susceptibility testing. The fields were blank. 2018 Q3 Cumulative scores - The specialty of Bacteriology does not appear on the report. 3. Interview of the General Supervisor conducted on February 12, 2019 at 11:16 AM confirmed that the laboratory stopped testing Culture ID and Susceptibility testing at the end of 2017. She went on to say that she did not renew the proficiency testing for bacteriology in 2018 because she was no longer testing. She said she notified the state agency, but did not notify the Proficiency testing agency of discontuned testing in Culture ID and Susceptibility because she thought not renewing the order was enough. Further interview of the general supervisor conducted on February 15, 2019 at 10:30 AM found that she had communicated with the proficiency testing agency regarding the reported scores of 0% and was informed that they would look into the coding for discontinued testing and resubmit them to CMS. In this process, a score of 0% for the Q3 2018 Bacteriology testing event was generated. -- 3 of 6 -- D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a review of proficiency testing records (3 testing events per year) from 2017 and 2018, and interview facility personnel the laboratory failed to attain an overall compatibility testing event score of at least 100% which constitutes unsatisfactory performance. Findings included: 1. Review of proficiency testing records found that the laboratory attained a score of 0% in the American Association of Bioanalysts (AAB) 2018 Q1 testing event for compatibility testing. The laboratory submitted unacceptable responses for five of five specimens, resulting in a score of 0% for Compatibility testing. 2. Interview of the general supervisor conducted on February 12, 2019 at 11:44 AM confirmed that the laboratory results submitted were the same as on their original worksheet and that no further action was taken other than review of recorded results and Quality control results. She stated that the agglutination was "1+ to 2+" (reactivity) for specimens 1-5, so they reported the result as Immediate Spin only, incompatible. 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 a review of the laboratory testing records, patient test records, and interview of facility personnel it was revealed that the laboratory failed to enroll in a proficiency testing program for each of the each of the specialties and subspecialties for which it seeks certification, or have another means to verify the accuracy of results for Serum Ketones . The findings included: 1. A review of facility records found no documentation of the laboratory participating in a CMS approved proficiency testing program, or have another means to verify the accuracy of results at least twice each year in 2017, 2018 or 2019 for serum Ketones and White Blood Cell (WBC) and Red Blood Cell (RBC)counts for body fluids. 2. Review of patient test records found that the laboratory tested: 20 patient specimens for serum Ketones in 2018 2 patient specimens in 2019 and 0 patient specimens in 2018 for body fluid cell count procedures. 3. Interview of the General Supervisor listed on the CMS report 209 Laboratory Personnel Report conducted on February 13, 2019 at 9:51 AM confirmed that the laboratory did enroll but failed to test specimens and submit responses for serum ketones to the proficiency testing program for serum ketones, and the laboratory did not enroll in, or participate in a proficiency testing program for body fluids or have another method to verify the accuracy of results.. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- -- 4 of 6 -- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the quality control records, patient testing records, and confirmed in interview with the General Supervisor, the laboratory failed to include a negative and positive control each day of patient testing for the serum Acetest procedure. The findings included: 1. Review of quality control records found no documentation of quality control testing for Acetest reagent tablets. 2. Review of patient test records found that the laboratory tested 20 patient specimens in 2018 without testing a negative and positive quality control each day of testing. 3. Interview of the general supervisor conducted on February 13, 2019 at 09:41 AM confirmed the above findings. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Review of proficiency testing records and interview of facility personnel found that the laboratory director failed to ensure that