Crittenden Community Hospital

Summary Statement of Deficiencies D0000 A recertification survey was initiated on 10/01/2025 and concluded on 10/02/2025. The facility was found to not be in compliance with the laboratory requirements of 42 CFR Part 493 with standard deficiencies 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 policy review, document review, and interview, the laboratory failed to provide evidence of a self-evaluation for 3 tests of 14 proficiency testing events scored as "not graded" by the Proficiency Testing Provider. This is the second occurrence for this citation. The Findings include: Review of the laboratory policy titled, "Proficiency Testing Process and Review," revised 08/04/2015, revealed "Please note that all Ungraded and Educational Challenge materials are checked for acceptable range. This is done by going to API website www.api-pt.com for results of participant's data summary. The results are printed and attached to the proficiency results. If re-testing is needed, this is performed and results are documented on the proficiency results." Review of the American Proficiency Institute Comparative Evaluation for the "2024 Hematology/Coagulation - 3rd Event", revealed the Body Fluid Crystals CVS-03 were not graded. Review of the American Proficiency Institute Comparative Evaluation, for the "2024 Immunology/Immunohematology - 3rd event revealed the DAT-Polyspecific DAT-05 and Mycoplasma Antibody MYC-06 were not graded. No documentation of self-evaluation by the laboratory for any of the ungraded PT samples above was available for review. During an interview on 10/02 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 -- /2025 at 2:15 PM in the conference room, General Supervisor #1 confirmed that a self- evaluation of the ungraded PT samples was not performed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Recertification Survey was initiated on 07/12/2023 and concluded on 07/13/2023. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies 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 document review and interview, the laboratory failed to document the evaluation of proficiency testing results returned as "not graded" by the proficiency testing agency for eight (8) of eight (8) proficiency testing (PT) results. The Findings include: Review of the American Proficiency Institute report, titled "Proficiency Testing Performance Evaluation" for the 2021 Hematology/Coagulation - 2nd Event, revealed the blood cell identification for sample BCI-07 was not graded. No documentation of self-evaluation by the laboratory was provided. Review of the American Proficiency Institute report, titled "Proficiency Testing Performance Evaluation" for the 2021 Hematology/Coagulation - 3rd Event, revealed the vaginal wet prep (KOH) for sample VKP-03 was not graded. No documentation of self- evaluation by the laboratory was provided. Review of the American Proficiency Institute report, titled "Proficiency Testing Performance Evaluation" for the 2022 Chemistry - Core - 2nd Event, revealed the troponin for samples CM-07, CM-08, and CM-09 were not graded. No documentation of self-evaluation by the laboratory was provided. Review of the American Proficiency Institute report, titled "Proficiency Testing Performance Evaluation" for the 2022 Hematology/Coagulation - 2nd Event, 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 -- revealed the vaginal wet prep for sample VA-02 was not graded. No documentation of self-evaluation by the laboratory was provided. Review of the American Proficiency Institute report, titled, "Proficiency Testing Performance Evaluation" for the 2022 Hematology/Coagulation - 3rd Event, revealed the blood cell identification for sample BCI-14 was not graded. No documentation of self-evaluation by the laboratory was provided. Review of the American Proficiency Institute report, titled "Proficiency Testing Performance Evaluation" for the 2022 Immunology/Immunohematology - 1st Event, revealed the compatibility for sample SER-05 was not graded. No documentation of self-evaluation by the laboratory was provided. During an interview, on 07/12/2023 at 4:00 PM, the General Supervisor confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review performed on October 11, 2022 the laboratory was found to be out of compliance for the following conditions: D2016 - SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) D6000 - MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 D6076 - LABORATORY DIRECTOR CFR(s): 493.1441 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 CMS database proficiency performance report (155D) and American Proficiency Institute (API) performance evaluation for 2021 and 2022 the laboratory failed to attain satisfactory performance scores for 2 out of 3 consecutive Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- testing events resulting in unsatisfactory participation for the analytes of infectious mononucleosis (Inf mono), rheumatoid factor (RF), antibody detection, ABO group, D (Rho), and compatibility testing. (See D2084, D2162, D2163, D2172, and D2181 D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(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 record review of CMS 155D and API performance evaluation for 2021 and 2022 showed that the laboratory failed to attain satisfactory scores for 2 out of 3 testing events resulting in unsuccessful performance for the analytes of Infectious mononucleosis and Rheumatoid Factor for 2021 3rd event and 2022 2nd event. Findings: 1) A review of 155D showed 2021 Event 3 score of 0% Inf mono and 0% RF, 2022 Event 2 score of 0% Inf mono and 0% RF 2) A review of API showed 2021 Event 3 score of 0% Inf mono and 0% RF, 2022 Event 2 score of 0% Inf mono and 0% RF D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(f) Failure to achieve satisfactory performance for the same analyte 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 record review of CMS 155D and API performance evaluation for 2021 and 2022 showed that the laboratory failed to attain satisfactory scores for 2 out of 3 testing events resulting in unsuccessful performance for ABO group and D typing for 2021 3rd event and 2022 2nd event. Findings: 1) A review of 155D showed 2021 Event 3 score of 0% ABO and 0% D, 2022 Event 2 score of 0% ABO and 0% D 2) A review of API showed 2021 Event 3 score of 0% ABO and 0% D, 2022 Event 2 score of 0% ABO and 0% D D2163 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(g) 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 record review of CMS 155D and API performance evaluation for 2021 and 2022 showed that the laboratory failed to achieve an overall score of satisfactory for 2 out of 3 testing events resulting in unsuccessful performance for ABO/RHO for 2021 -- 2 of 4 -- 3rd event and 2022 2nd event. Findings: 1) A review of 155D showed 2021 Event 3 score of 0% ABO/RHO, 2022 Event 2 score of 0% ABO/RHO 2) A review of API showed 2021 Event 3 score of 0% ABO/RHO, 2022 Event 2 score of 0% ABO/RHO D2172 UNEXPECTED ANTIBODY DETECTION CFR(s): 493.861(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 record review of CMS 155D and API performance evaluation for 2021 and 2022 showed that the laboratory failed to achieve an overall score of satisfactory for 2 out of 3 testing events resulting in unsuccessful performance for antibody detection for 2021 3rd event and 2022 2nd event. Findings: 1) A review of 155D showed 2021 Event 3 score of 0% antibody detection, 2022 Event 2 score of 0% antibody detection 2) A review of API showed 2021 Event 3 score of 0% antibody detection, 2022 Event 2 score of 0% antibody detection 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 record review of CMS 155D and API performance evaluation for 2021 and 2022 showed that the laboratory failed to achieve an overall score of satisfactory for 2 out of 3 testing events resulting in unsuccessful performance for compatibility testing for 2021 3rd event and 2022 2nd event. Findings: 1) A review of 155D showed 2021 Event 3 score of 0% compatibility testing, 2022 Event 2 score of 0% compatibility testing 2) A review of API showed 2021 Event 3 score of 0% compatibility testing, 2022 Event 2 score of 0% compatibility testing 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 CMS 155D and API performance evaluation for 2021 and 2022 the laboratory director failed to provide overall management and direction to the lab for successful participation in proficiency testing. (See D6016) D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) -- 3 of 4 -- 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 record review of CMS 155D and API performance evaluation for 2021 and 2022 showed that the laboratory failed to attain satisfactory scores for 2 out of 3 testing events resulting in unsuccessful performance for the analytes of Infectious mononucleosis and Rheumatoid Factor for 2021 3rd event and 2022 2nd event. (See D2084) 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 review of CMS 155D and API performance evaluation for 2021 and 2022 the laboratory director failed to provide overall management and direction to the lab for successful participation in proficiency testing. (See 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: Record review of CMS 155D and API performance evaluation for 2021 and 2022 showed that the laboratory failed to attain satisfactory scores for 2 out of 3 testing events resulting in unsuccessful performance for ABO, D, antibody detection and compatibility testing for 2021 3rd event and 2022 2nd event. (See D2162, D2163, D2172 and D2181) -- 4 of 4 --

Summary Statement of Deficiencies D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interview on 10/08/2019, 10/09/2019, and 10/10 /2019, the laboratory failed to perform and document a positive reactivity for each substrate tested on the Microscan Identification Panels when new lot numbers were received and put into use. Findings include: 1. Review of quality control documentation for the NUC 73 Gram Negative Identification Panels failed to include a positive reaction for the H2S and TDA substrates. 2. Review of quality control documentation for the PBPC 20 Gram Positive Breakpoint Combo Panels failed to include a positive reaction for the ARA, INU, and RAF substrates. The general supervisor acknowledged in an interview at 10:00 AM on 10/09/2019, the laboratory failed to have a system in place to ensure a positive reactivity was confirmed for all substrates tested on the Microscan Identification Panels prior to patient testing. 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 sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its 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 -- 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 record review and staff interview on 10/08/2019, 10/09/2019, and 10/10 /2019, the laboratory failed to check each new batch of Blood Agar Plates, MacConkey Plates, Hektoen, and MacConkey II with Sorbital for sterility prior to use for patient testing. Findings include: 1. Review of the Microbiology Policy and Procedure Manual revealed the Microbiology Quality Control Policy states "Perform sterility check of the media by incubating one plate overnight." 2. Review of quality control documentation failed to reveal results for sterility on new batches of media prior to patient testing. The general supervisor acknowledged in an interview at 10:00 AM on 10/09/2019, the laboratory failed to have a system in place to ensure the policy for sterility was followed when new batches of media was received. -- 2 of 2 --