Crenshaw Community Hospital

Summary Statement of Deficiencies D0000 The following deficiencies are a result of off-site proficiency testing (PT) desk review of scores in the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and verified with the laboratory's proficiency testing provider, American Proficiency Institute (API). The laboratory was found to be out of compliance with CONDITION LEVEL DEFICIENCIES, as follows: 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 off-site proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and 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 -- Medicaid Services [CMS]), and PT evaluation reports from American Proficiency Institute (API), the laboratory failed to successfully participate (achieve scores of 80% or greater) in proficiency testing for Prothrombin Time (PT) an analyte in the specialty of Hematology. The laboratory failed two consecutive PT events in 2025, resulting in initial unsuccessful proficiency testing performance. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (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: Based on off-site proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the American Proficiency Institute (API), the laboratory failed to successfully participate (achieve scores of 80% or greater) in proficiency testing for Prothrombin Time resulting in initial unsuccessful performance. The findings included: 1. Based on review of the CASPER Reports 153D and 155D, Individual Laboratory Profile reports, the laboratory received the following failing scores for Prothrombin Time, resulting in unsatisfactory performances for two consecutive events, as follows: A. 2025-Event 1: 60% B. 2025- Event 2: 20% 2. A review of the laboratory's proficiency testing results from API confirmed the above findings. 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 off-site proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and proficiency testing evaluation reports from American Proficiency Institute (API), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on off-site proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from American Proficiency Institute (API), the laboratory director failed to ensure the laboratory had successful -- 2 of 3 -- participation in an HHS approved proficiency testing program for Prothrombin Time for two consecutive PT events in 2025. Refer to D2130. -- 3 of 3 --

Summary Statement of Deficiencies 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 American Proficiency Institute (API) Proficiency Testing (PT) evaluation records, and an interview with the Laboratory Manager (LM), the laboratory had unsuccessful PT scores on 3 unregulated analytes. Failures were noted on three events from 2022-2023. The findings include: 1. A review of the PT evaluation records revealed the laboratory utilized the API PT program to verify the accuracy of laboratory procedures, however, the laboratory failed the following PT events with no other documented method of accuracy verification: A) 2022-Chemistry Second Event: Folate-0%, Vitamin B12-0% B) 2023-Chemistry First Event: Folate- 50%, Vitamin B12-50% C) 2022-Immunology Second Event-CRP-50% D) 2023- Immunology First Event-CRP-50% 2. LM confirmed these findings during the exit conference on 09-25-2024 at 12:46 PM. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) Proficiency Testing (PT) evaluation records,

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 a review of the Centers for Medicare and Medicaid Services CASPER reports and American Proficiency Institute Proficiency Testing (PT) Evaluations, the laboratory failed to successfully participate in PT for Total Cholesterol for two consecutive testing events, Event #1 and #2, 2022. The findings include: Refer to D2096. 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 review of the Centers for Medicare and Medicaid Services CASPER reports and American Proficiency Institute (API) Proficiency Testing (PT) Evaluations, the laboratory failed to satisfactorily perform in PT for Total Cholesterol (Chemistry) for two consecutive testing events, Event #1 and #2, 2022. These failures resulted in an initial unsuccessful participation. The findings include: 1. A review of the CASPER reports revealed the laboratory scored the following: Event #1, 2022 Total Cholesterol 0 % (zero percent) Event #2, 2022 Total Cholesterol 0 % 2. A review of the API PT evaluations confirmed the above noted scores. -- 2 of 2 --

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a review of the EPOC System Standard Operating Procedure, a lack of calibration verification records, and an interview with the acting Technical Consultant, the laboratory failed to perform calibration verifications at least every six months as per CLIA regulations. The findings include: 1. A review of the EPOC records revealed no calibrations verification records since the initial validation performed on 02/13/2020. Patient testing on the EPOC started on 02/20/2020. 2. A 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 -- review of the EPOC System Standard Operating Procedure page 14 revealed "... Calibration Verification...Performance of this procedure at defined intervals may be required by regulatory or accreditation bodies..." Analytes calibrated with less than three calibrators must have a calibration verification performed every six months as per CLIA regulations. 3. During an interview at 8:50 AM on 02/04/2021, the acting Technical Consultant confirmed the laboratory had not performed calibration verifications since the initial validation in February 2020. . D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of quality control records for ACL Elite D-Dimer, the manufacturer's package insert for the D-Dimer control, and an interview with the acting Technical Consultant, the laboratory failed to establish the mean and standard deviation for the D-Dimer controls, as per manufacturer's instructions. One lot number of controls had been in use for D-Dimer since addition to the ACL Elite test menu on 11/03/2020. The findings include: 1. A review of quality control records for the ACL Elite D-Dimer revealed quality control acceptable ranges were not established when D-Dimer controls for lot B33168 were put into use. 2. A review of the package insert for the D-Dimer control revealed "...The Low and High D-Dimer Controls concentration ranges were determined over multiple runs on IL Coagulation Systems using a specific lot of D-Dimer reagents. The mean of the control range determined in each laboratory may vary due to the lot of reagent used. Due to differences in reagents and instrumentation, each laboratory should establish its own Target Value and Acceptance Range (mean and standard deviation)...". 3. During an interview on 02/04 /2021 at 12:40 PM, the Technical Consultant confirmed the mean and standard deviation were not established for D-Dimer Controls. . D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of the initial test validation records for the ACL Elite D-Dimer and an interview with the acting Technical Consultant, the surveyor determined the Laboratory Director failed to document approval of the validation before patient testing began. This affected one of three new instruments/analytes installed, since the previous survey on May 08-09, 2018. The findings include: 1. A review of the 11/03 /2020 validation records for the ACL Elite D-Dimer revealed no documentation of the LD's review and approval (as indicated by a signature and date). 2. During an interview on 02/04/2021 at 12:40 PM, the acting Technical Consultant confirmed patient testing started on 11/06/2020 on the ACL Elite D-Dimer. . D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of personnel listed on Form CMS-209 (Laboratory Personnel Report), a review of the personnel files, and an interview with the Technical Consultant, the surveyor determined the Technical Consultant failed to ensure five of six testing personnel had documentation of annual competency evaluations in 2019 and 2020. The findings include: 1. A review of employee records provided by the Human Resources (HR) representative revealed missing competency evaluations for the testing personnel. The acting Laboratory Manager was able to locate some additional files in the laboratory, however there was no documentation of annual competency evaluations for the following Testing Personnel (TP): A) TP #1: No 2020 evaluation B) TP #2: No 2020 evaluation C) TP #3: No 2020 evaluation D) TP #4: No 2019 evaluation E) TP #6: No 2020 evaluation 2. During an interview on 2/3/2021 at 11:00 AM, the acting Laboratory Manager had telephoned the previous Manager / Technical Consultant, who stated all the employees had participated in the annual hospital Skills Fair Training and competency assessments. She believed this was sufficient. 3. In an interview on 2/3/2021 at 11:15 AM, the Emergency Room Nurse Manager provided the surveyor a list of the competencies covered during the annual hospital Skills Fair Training. These included general reviews (safety, handwashing, HIPAA, COVID prevention, ect.) for all hospital employees. The Nurse Manager further stated, "Specific department competencies should be handled by the manager or supervisor." SURVEYOR ID #32558 Licensure and Certification Surveyor -- 3 of 3 --

Summary Statement of Deficiencies 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 test menu, proficiency testing (PT) records, and an interview with the Technical Consultant, the surveyor determined the laboratory failed to either enroll in PT or implement another method of semi-annual accuracy verification for Vitamin B12, Folate and Ammonia testing in 2016-2017. The findings include: 1. A review of the API (American Proficiency Institute) PT records revealed the laboratory did not perform PT for Vitamin B12, Folate, or Ammonia in 2016 and 2017. A review of patient records revealed these tests were in use for patient testing since before the previous survey on 8/9/2016. 2. In an interview on 5/19/2018 at 10:00 AM, the Technical Consultant (also the Laboratory Manager) was asked if the laboratory had performed PT on Vitamin B12, Folate, or Ammonia in 2016 and 2017, or if the laboratory had implemented another method of accuracy verification for these tests. The Technical Consultant stated she had missed including these tests on the PT order in 2016-17, and confirmed the laboratory had not implemented another method to verify their accuracy semi-annually. SURVEYOR: Laura T. Williams, BS, MT (ASCP)Licensure and Certification Surveyor 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 --