Meade District Hospital

Summary Statement of Deficiencies 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 a review of the laboratory procedure "Blood Bank Alarm Testing" and interview with technical consultant #3 (TC #3), the laboratory failed to follow written procedures to perform quarterly blood bank alarm checks. 1. Review of the procedure "Blood Bank Alarm Testing", it stated "The blood bank refrigerator alarm must be tested quarterly". The procedure is signed by laboratory director. 2. Review of the "Blood Bank Temperature Alarm Check" log, showed only two alarm checks in 2024 and one alarm check in 2025 currently. 3.Review of the "Blood Bank Temperature Alarm Check" log, revealed the following alarms performed: a. 2024: 6/10/2024 and 12/4/2024 b. 2025: 8/18/2025 4. Interview with TC #3 on August 19, 2025, at 10:50 a. m. confirmed, the laboratory failed to follow written procedures to perform quarterly alarm checks on the blood bank refrigerator. 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 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 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 the CMS116 test volumes for bacteria culture, lack of quality control (QC) results from 11/1/21 to 5/17/2023, and interview with the general supervisor (GS) #3 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: 1. Review of the CMS116 form revealed this laboratory performed approximately 1025 bacterial cultures annually. 1. A request was made for QC of microbiology culture media for each batch and/or shipment for the following microbiology media in use: Blood agar, MacConkey agar; chocolate agar, carrot broth and thioglycollate broth. No documentation was provided to demonstrate that the media used was checked to ensure it supported the growth, or as appropriate, selected or inhibited specific organisms to produce the intended biochemical responses from 11/1/21 to 5/17/23. 2. Interview with the GS #3 on 5/17 /23 at 11:05 a.m. confirmed the lab was not performing quality control on each batch of media with controlled organisms to ensure it supported the growth, or as appropriate, selected or inhibited specific organisms to produce the intended biochemical responses. D5783

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a lack of available documentation and confirmed during interview with the general supervisor (GS), the laboratory failed to have procedures approved, signed, and dated by the current laboratory director before use. Findings: 1. Upon review of the laboratory procedures, the current laboratory director did not approve, sign, and date the laboratory procedure/policy for: 34 of 34 procedures in Blood Bank and 15 of 15 procedures in Microbiology at time of survey. 2. Interview with the GS on October 12, 2021 at 11:30 a.m. confirmed, the laboratory failed to have procedures approved, signed, and dated by the current laboratory director before use. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: 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 -- Based on an absence of thermometer and hygrometer function check records or certificates of accuracy, protocols for thermometer and hygrometer function checks and interview with the general supervisor (GS), the laboratory failed to define and perform a function check protocol for 9 of 11 thermometers and 2 of 2 hygrometers. Findings: 1. No documentation was available for function checks on 9 of 11 thermometers and 2 of 2 hygrometers at the time of survey. 2. No documentation was available for the certification of accuracy (NIST traceable) on 9 of 11 thermometers and 2 of 2 hygrometers at the time of survey. 3. Protocols for the function checks of thermometers and hygrometers were not made available at the time of survey. 4. Interview with the GS on October 12, 2021 at 12:10 p.m. confirmed, the laboratory failed to define and perform a function check protocol for 9 of 11 thermometers and 2 of 2 hygrometers. D5459 CONTROL PROCEDURES CFR(s): 493.1256(d)(5)(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-- Each electrophoretic procedure include, concurrent with patient specimens, at least one control material containing the substances being identified or measured. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based upon a review of quality control (QC) data in hematology and interview with general supervisor (GS), the laboratory failed to establish the criteria of acceptability, by documentation and procedure, for new lots of QC material before use on the hematology analyzer for 24 of 24 months: September 2019 to September 2021. Findings were: 1. During a review of QC data in hematology, the GS failed to provide testing data and evaluation for new lots of QC material for the Beckman DXH 600 prior to use. No evidence verifying acceptability of new lot of QC material was performed and reviewed before use in 24 of 24 months at time of survey. 2. Procedures for the Beckman DXH 600 in hematology which established the criteria for new lot of QC material were not made available at the time of survey. 3. Interview with the GS on October 12, 2021 at 1:15 p.m. confirmed, the laboratory failed to establish the criteria of acceptability, by documentation and procedure, for new lots of QC material before use on the hematology analyzer for 24 of 24 months: September 2019 to September 2021. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based upon review of QC and patient test records from the last 6 months, April 1, 2021 to October12, 2021, and interview with testing personnel #5 (TP#5) revealed the Technical Consultant (TC) failed to ensure acceptable levels of analytic performance -- 2 of 3 -- were maintained for the OPTI arterial blood gas analyzer. Findings: 1. Examination of the OPTI arterial blood gas analyzer QC and patient test records revealed no review documentation by the TC for 6 months from April 1, 2021 to October 12, 2021. 2. Interview with TP#5 on October 12, 2021 at 2:45 p.m. confirmed, the TC failed to ensure acceptable levels of analytic performance were maintained for the OPTI arterial blood gas analyzer. -- 3 of 3 --

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 (PT)record review on June 2, 2020 revealed the laboratory failed to successfully participate in PT from American Proficiency Institute (API) for Compatability Testing. Findings: 1. Review of Second Event 2019 revealed a score of 80% for Compatability Testing. 2. Review of First Event 2020 revealed a score of 0% for Compatability Testing. The laboratory failed to achieve an acceptable score of 100% or higher for two of three consecutive events which resulted in unsatisfactory performance for Compatability Testing. (refer to D2181) D2181 COMPATIBILITY TESTING 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 -- 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: A PT desk review and phone interview on June 2, 2020 revealed the laboratory failed to successfully participate in PT from API for Compatability Testing. Findings: 1. Review of Second Event 2019 revealed a score of 80% for Compatability Testing. 2. Review of First Event 2020 revealed a score of 0% for Compatability Testing. 3. The laboratory manager on June 2, 2020 at 3:20 pm in phone interview confirmed the PT results were not submitted to API within the specified time frame for the First Event 2020 for Compatability Testing and resulted in a score of 0 for the testing event. The laboratory failed to achieve an acceptable score of 100% or higher for two of three consecutive events which resulted in unsatisfactory performance for Compatability Testing. -- 2 of 2 --

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: 1. A review of manufacturer's instructions for Rediplastin , quality control and quality assessment records for coagulation, observation of the laboratory's equipment, and interview with staff on April 23, 2019 revealed that the laboratory did not verify the performance specifications of The ACL Top 300, prior to reporting patient test results for new lot of Rediplastin . The laboratory failed to verify accuracy for 5 months out of 11 months for Prothrombin Time (PT). Findings: a. During the interview with the General Supervisor #1 on April 23, 2019 @ 1230, review of the information stored on the ACL TOP 300 instrument and records of the normal patient mean for lot N0688780 and lot# RN0278177, revealed that the patient normal mean of 11.7 sec for N0688780 was not inputted into the ACL TOP 300. Therefore the accuracy of the PT wasn't verified from November 7, 2018 to April 23, 2019. b. Quality control and quality assessment records for ACL Top 300 coagulation analyzer on April 23, 2019 did not include determination of the Prothrombin Time (PT) for patient normal range for the current lot of Rediplastin in use from November 7, 2018 to April 23, 2019. Therefore the accuracy or reliability can not be verified. 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 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: Based on interview with General Supervisor #1 and the review of the package inserts and patient test logs, the laboratory failed to perform external quality control (QC) for moderate complexity testing for SERUM HCG. Findings: 1. Review of patient logs showed external quality control was not performed each day of patient testing on 1/5 /2018, 1/10/2018, 1/11/2018, 1/31/2018, 2/12/2018. 2. No IQCP has been completed to allow the lab to reduce the frequency of QC for SERUM HCG. The interview occurred on 10/9/2018 @ 1150. 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 --