Mitchell County Hospital Health Systems

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) (b)The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on the review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) documentation and interview with the general supervisor (GS) #1, the laboratory failed to examine or test, as applicable, the proficiency testing samples for Fetal Screen in the same manner as it tests patient specimens in 2024. Findings: 1. Review of the "Proficiency Test Failures

Summary Statement of Deficiencies 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 the review of proficiency testing (PT) records from American Proficiency Institute (API), the laboratory failed to successfully participate in PT under the specialty Routine chemistry for the regulated analyte: 0255 ALT (SGPT). (Refer to D2096) D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- 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 proficiency testing (PT) on the CMS CASPER Report 0155D, the provider American Proficiency Institute (API) for Chemistry and attempted phone interview (voicemail left with laboratory supervisor), the laboratory failed to achieve an acceptable score of 80% or higher for two consecutive testing events for the regulated chemistry analyte: 0255 ALT (SGPT). Findings: 1. Review of API PT scores for 2023 Event 1 revealed a 60% performance score for ALT (SGPT). 2. Review of the API PT scores for 2023 Event 2 revealed a 60% performance score for ALT (SGPT). 3. An attempted phone interview with the lab manager on July 5, 2023 at 3:45 p.m. and review of the CMS CASPER Report 0155D confirmed, the laboratory failed to achieve an acceptable score of 80% or higher for two consecutive testing events for the regulated chemistry analyte: ALT (SGPT). -- 2 of 2 --

Summary Statement of Deficiencies 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: Review of policies and interview with the technical consultant (TC) revealed, the laboratory failed to follow it's own policy for quarterly alarm checks on the Blood Bank refrigerators at the time of survey. Findings: 1. Review of policy "Blood Bank Refrigerator Alarm Checks", dated 4/11/2019 revealed: a. "The high and low temperatures of activation must be checked and the results recored. Alarms, according to the AABB standards, must be set to activate temperatures that will allow proper action to be taken before the blood or componenets reach an undesirable temperatoure. Alarm checks will be done quarterly" b. This policy was signed by the current Laboratory Director on 4/11/2019. 2. Review of the blood bank alarm check logs revealed: a. The "Low Temperature of Activation Log (No Lower than 1 degree C)" had three alarm checks since 12/20/21. The dates on the log of the low alarm checks were performed on 12/20/2021, 7/31/2022, and 1/23/2023. b. The "High Temperature of Activation Log (No Higher than 6 degrees C)" had three alarm checks since 12/20/21. The dates on the log of the high alarm checks were performed on 12 /20/2021, 7/31/2022, and 1/23/2023. 3. The blood bank refrigerator alarm checks for the "low" and "high" were performed semi-annually or every six months. 4. Interview with the TC on March 29, 2023 at 1:11 p.m. confirmed, the laboratory failed to follow it's own policy for performing quarterly alarm checks on the Blood Bank refrigerators in this facility. 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 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 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: A proficiency testing record review on May 5, 2020 revealed the laboratory failed to successfully participate in proficiency testing from American Proficiency Institute (API) for the regulated analyte Cell ID or WBC Diff. Findings include: 1. Third event 2019 revealed a score of 24% for Cell ID or WBC Diff. 2. First event 2020 revealed a score of 0% for Cell ID or WBC Diff. The laboratory failed to achieve an acceptable score of 80% or higher for two of three consecutive events which resulted in unsatisfactory performance for the regulated analyte Cell ID or WBC Diff. (refer to D2130) 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 -- D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: A proficiency testing record review on May 5, 2020 revealed the laboratory failed to successfully participate in proficiency testing from American Proficiency Institute (API) for the regulated analyte Cell ID or WBC Diff. Findings include: 1. Third event 2019 revealed a score of 24% for Cell ID or WBC Diff. 2. First event 2020 revealed a score of 0% for Cell ID or WBC Diff. The laboratory failed to achieve an acceptable score of 80% or higher for two of three consecutive events which resulted in unsatisfactory performance for the regulated analyte Cell ID or WBC Diff. -- 2 of 2 --

Summary Statement of Deficiencies 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: A desk review on 9 April 2019 revealed the laboratory failed to successfully participate in proficiency testing from American Proficiency Institute (API) for the analyte PCO2 Blood Gas. The results are as follows: 1. Second event 2018 revealed a score of 60% 2. First event 2019 revealed a score of 40% The laboratory failed to achieve an acceptable score of 80% or higher for two of three consecutive events which resulted in unsatisfactory performance for the regulated analyte PCO2. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- 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 desk review for proficiency testing from the provider API for Chemistry, the regulated analyte PCO2 for blood gas revealed the following performance scores for PT: 1. Second testing event 2018 reveled a PCO2 score of 60% 1. First testing event 2019 revealed a PCO2 score of 40% The laboratory failed to achieve an acceptable score of 80% or higher for two of three consecutive testing events for the analyte PCO2. -- 2 of 2 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Review of Profile-V MedTox package insert, quality control (QC) records from January to July 2018, and interview with the Technical Consultant revealed that the laboratory failed to perform the quality control as required by the manufacturer. Findings were: 1. The package insert for the PROFILE-V MEDTOXSCAN Test states that external controls should be run routinely once per week. 2. Review of quality control records for January 2018 to July 2018 found that QC was performed: Lot: 833075-19 January 11, 2018 Lot: TD041J19 February 14, 2018 and March 16, 2018 Lot: TD070M19 April 25, 2018 and May 26, 2018 Lot: TD081K20 June 7, 2018 and July 26, 2018 3. Interview with the Technical Consultant at 11:45 AM on August 1, 2018 confirmed QC was performed monthly instead of weekly per manufacturer guidelines and that six patients were tested during July 2018. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for 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 -- sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory policies/procedures, lack of quality control (QC) results during 1/1/2017 to 7/31/2018, and interview with the Technical Consultant, the laboratory failed to check each batch of bacteriology media to ensure it supported the growth, or as appropriate, selected or inhibited specific organisms to produce the intended biochemical responses. Findings were: 1. A review of the laboratory's procedure for QC of microbiology culture media and the IQCP did not include performing QC for each batch or shipment for the following microbiology media in use: Blood agar, MacConkey agar; CNA/MacConkey biplate, Tryptic Soy agar, and Spectra MRSA agar. 2. Interview with the technical consultant on 8/1/2018 at 11:00 confirmed the lab was not performing quality control on each batch of media with controlled organisms to ensure the media supported intended growth and/or the intended response. -- 2 of 2 --