Mercy Hospital Booneville

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based upon a review of the laboratory's policy and procedure manual, lack of documentation, and interview with laboratory staff, it was determined that the laboratory failed to follow written policy and procedure for specimen collection, specimen labeling, and specimen storage and processing. Findings follow: A) During review of the laboratory's policy and procedure manual the surveyor found a policy named "MW LABQ Mercy Lab Quality Management System" which stated: "Each area in which specimens are collected and or processed has written procedures for: Specimen collection, labelling and preservation; Ensuring patient identification at the time of specimen collection; Specimen packaging and transport; Registration/order rejection; Specimen rejection and suboptimal specimens; Acceptance from authorized source; Variance and/or SAFE reporting; Add on functions." B) Upon request, the laboratory was unable to show policies at each draw station. C) In an interview on 4/29 /25 at 2:03pm, when asked if their were written policies governing specimen collection, labeling, storage and processing, at each collection point; the General Supervisor confirmed there were not. D5401 PROCEDURE MANUAL CFR(s): 493.1251(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 5 -- (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 laboratory policies and procedures for chemistry, a review of the chemistry lot changeover records, and interviews with laboratory staff, the laboratory failed to follow written procedures for Chemistry standard deviation (SD) range calculation. Survey findings include: A) The laboratory chemistry QC policy named "BNVAR LABQ Quality Control for Chemistry Policy" states: "Unassayed Material is run to accumulate a minimum of 20 data points to establish our inhouse mean and standard deviation. This study is performed before the supply of the previous lot number is exhausted." B) A review of the chemistry lot changeover records from May of 2024 showed data for 20 samples of a new lot being ran prior to use. The documentation included a note stating "Keep your current SD. As far as range - after your run your samples, find the mean of each one. From your mean, use your current SD to find your range for each." This note was initialled by the previous lab director. C) Upon request, there was no documentation provided of ranges being calculated for the new lot. D) In an interview, at 3:01pm on 4/30/25, the General Supervisor confirmed that SD ranges weren't calculated during the May 2024 lot changeover. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based upon observation, review of temperature and humidity records, lack of documentation and interview; the laboratory failed to monitor the temperature and humidity of freezers, refigerators, and rooms on each day of operation in which supplies and instruments with storage temperature requirements were located. Findings follow: A) During a tour of the laboratory on 4/29/25 at 9:32am., the surveyor observed a main laboratory room containing laboratory items with temperature and humidity storage/operation requirements (examples include a Sysmex xn430 and cobas 311 along with their reagents), as well as freezers and refigerators containing reagents with temperature requirements. B) A review of the laboratory's complete 2024 temperature and humidity records revealed that temperatures were not recorded for the "Summit Freezer" on January 28, July 20, December 1, 7, 8, and 13. Temperatures were not recorded for the "Dandy Freezer" on July 20. Temperatures were not recorded for the "Reagent Refrigerator" on July 20, September 19, and December 1. Laboratory Humidity was not recorded on December 1. C) In an -- 2 of 5 -- interview on 5/1/25 at 09:20 a.m, the laboratory general supervisor confirmed that temperature humidity records for the above dates were not recorded, and there was no quality assurance remediation. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. This STANDARD is not met as evidenced by: Based on a review of the laboratory policy and procedure "Hematology Analyzer Quality Control Policy", Levey-Jennings (LJ) Reports for October 2024, December of 2024, January 2025, and February of 2025 for Mean Corpuscular Volume (MCV) hematology analysis, and through interviews with laboratory staff; the laboratory failed to monitor, over time, the accuracy of hematology test results. Survey findings include: A) A review of the "Hematology Analyzer Quality Control Policy" revealed a policy stating " Quality Control is printed off monthly and reviewed by the lab director to determine if any shifts or trends are identified." B) A review of the 10/8/24 through 11/5/24 Sysmex XN-L Levey-Jennings charts for QC-42651401 XN-L Control level 1, QC-42651402 XN-L Control level 2, and QC-42651403 XN-L Control level 3, showed MCV values above the mean for each day. A review of the 12 /1/24 through 12/31/24 Sysmex XN-L Levey-Jennings charts for QC-42651401 XN-L Control level 1, QC-42651402 XN-L Control level 2, and QC-42651403 XN-L Control level 3, showed MCV values above the mean for each day. A review of the 1/1 /25 through 2/28/25 Sysmex XN-L Levey-Jennings charts for QC-43491401 XN-L Control level 1, QC-43491402 XN-L Control level 2, and QC-43491403 XN-L Control level 3, showed MCV values above the mean for each day. C) A review of the quality assurance records for 2024 and 2025 found no mention of shifts in MCV analysis. D) Upon request, the laboratory was unable to provide documentation of

Summary Statement of Deficiencies D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: . Based pm a review of manufacturer's instructions titled, "Lot Conversion Protocol", review of the proficiency test "Performance Review and

Summary Statement of Deficiencies D0000 A desk review of proficiency testing was performed on October 10, 2022. The laboratory was found to be not in compliance with the following conditions: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6076 - 42 C.F.R. 493.1441Condition: 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 2021 and 2022 CMS CASPER Reports 155D, 153D and 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 -- American Proficiency Institute (API) proficiency testing results, the laboratory failed to successfully participate in three of five proficiency testing events in the specialty Immunohematology for the analyte compatibility testing. 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 review of 2021 and 2022 CMS CASPER Reports 155D, 153D and the American Proficiency Institute(API) proficiency testing results, the laboratory failed to achieve satisfactory performance in three of five proficiency testing events for the analyte compatibility testing as evidenced by: A. The laboratory received a score of 60% for compatibility testing in the first proficiency testing event of 2021. B. The laboratory received a score of 80% for compatibility testing in the third proficiency testing event of 2021. C. The laboratory received a score of 80% for compatibility testing in the second proficiency testing event of 2022. 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. 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 record review of CMS 155D and API performance evaluation from 2021 and 2022, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for compatibility testing. Refer to D2181. -- 2 of 2 --

Summary Statement of Deficiencies D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Through a review of the policy and procedure manual, quality control(QC) data for 2020 and 2021, lack of documentation, as well as interviews with staff, it was determined the laboratory failed to monitor the accuracy and precision of the quality control process and failed to monitor over time the accuracy and precision of test performance. As evidenced by: A. Through a review of the policy and procedure manual it was determined the laboratory failed to have a policy to monitor shifts and trends for the evaluation of accuracy and precision over time to meet the laboratory's established criteria for the Cobias E 411 Chemistry analyzer. B. A review of Levy Jennings charts for August 2020 (one of three months reviewed) revealed: Level 1 Control Lot #00381162, Thyroid Stimulating Hormone (TSH) results were below the assayed mean of 1.27 ( 22 points): Calcium (CA) results were above the assayed mean of 8.68 ( 35 points). Level II Control Lot #00381165, TSH results were above the assayed mean of 3.31(14 points) and below the mean (16 points): CA results were above the assayed mean of 12.41 (30 points) and Vancomycin results were below the assayed mean of 6.68 (33 points). C. A review of Levy Jennings charts for January 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 -- 2021 (two of three months reviewed) revealed Level I Control Lot #00381162, TSH results were below the assayed mean of 1.26 (22 points): Alanine Aminotransferase (ATL) results were below the assayed mean of 25.0 (32 points): Phosphorus results were above the assayed mean of 6.96 (31 points) and CA results were blow the assayed mean of 8.62 (33 points): Glucose (GLU) results were below the assayed mean of 79.7 (30 points): A review of Level II Control Lot #56932 Alkaline Phosphatase (ALP) results were above the assayed mean of 335.2 (26 points): Valporic Acid results were below the assayed mean of 142.4 (35 points): Calcium results were above the assayed mean of 12.5 (33 points) and GLU results were below the assayed mean of 273.8 (30 points): A review of Cardiac Level I Control Lot #00482370 revealed PRO-BNP results showed a shift with 23 points above the mean: the assayed mean of 368.8 (23 points). D. A review of Levy Jennings Charts for April 2021 (three of three months reviewed) revealed: Level 1 Control Lot #56931, Amylase results were above the assayed mean of 84.4 (21 points): A review of Cardiac Control Level I revealed Troponin results were above the assayed mean of 23.4 (29 points). E. There was no documentation that the laboratory had identified the shifts or trends in test performance or any actions performed to address the shirt or trends. F. In an interview on 6/17/2021 at 10:00 a.m., laboratory personnel #8 (as listed on form CMS-209) confirmed the laboratory did not evaluate the accuracy and precision over time to meet established criteria of acceptability. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: . Through review of the CMS form 209, personnel records, lack of documentation, and interview with staff, it was determined that the technical consultant failed to document personnel competency on an annual basis for the general supervisor. Survey findings follow: A. A review of personnel records for one of eight testing personnel revealed that the technical consultant failed to evaluate the competency for the general supervisor (as listed on form CMS 209) for 2020 and 2021. B. Upon request, the laboratory could not provide competency evaluations for the personnel identified above. C. In an interview on 6/16/2021 at 10:30 a.m., laboratory personnel #8 confirmed that competency evaluations had not been performed on her duties as general supervisor. -- 2 of 2 --

Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Through a review of May, August, and October 2018 coagulation quality control and patient results on instrument test strips from the IL ACL 7000 coagulation instrument, and interviews with laboratory staff, it was determined that on one of three occasions when quality control was unacceptable, the laboratory reported patients before acceptable results were obtained for the control . Survey findings follow: A. During a review of Prothrombin Time (PT) and Partial Thromboplastin Time (PTT) quality control for May, August, and October 2018, it was revealed that on 8/19/2018 at 3:24 a.m. PT level 3 was reported as 30.5 seconds with an acceptable range of 21.5 to 30.1 seconds. PT level 3 control was not documented again until 9:39 a.m. on 8/19/2018 when the result was documented as 29.1. B. Instrument test strips from 8/19/2018 on the IL ACL 7000 coagulation instrument include PT results for Patient #31082510 tested at 3:27 a.m. and Patient #31081792 tested at 8:06 a.m. before the quality control was acceptable at 9:39 on 8/19/2018. C. In an interview at 2:19 p.m. on 11/29 /2018, laboratory employee #6 (as listed on the form CMS-209) confirmed that patient PT results were reported before acceptable quality control results were obtained on 8 /19/2018. 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 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 -- 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; This STANDARD is not met as evidenced by: . Through a review of the new instrument validation documentation dated 5/2/2018 for the Cobas e411 Chemistry Analyzer and validation documentation dated 5/2/2018 for the Cobas c311 Immunochemistry Analyzer , lack of documentation, as well as interviews with staff, it was determined the Laboratory failed to have the director approve validation procedures to ensure they are adequate to determine the accuracy, precision, and other pertinent performance characteristics as evidenced by: A. A review of the validation documentation for the Cobas e411 Chemistry Analyzer and for the Cobas c311 Immunochemistry Analyzer dated 5/2/2018, revealed the validation procedures were not approved and signed by the Laboratory Director. B. In an interview on 10/29/2018 at 2:19 p.m., laboratory employee #6 (as listed on CMS form 209) confirmed the validation procedures for the for the Cobas e411 and Cobas c311 were not approved or signed by the Laboratory Director. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Through a review of personnel records for nine testing personnel listed on the form CMS-209, lack of documentation, and interviews with laboratory staff, it was determined the technical supervisor failed to evaluate high complexity testing personnel at least annually. Survey findings follow: A. Personnel records for three of nine laboratory testing personnel (#1, #2, and #3 as listed on the form CMS-209) failed to include annual competency documentation. The personnel records for employees #1, #2, and #3 failed to include documentation of annual competency assessments performed in 2017. B. In an interview at 1:18 p.m. on 11/28/2018, the laboratory general supervisor confirmed the lack of annual competency assessments in 2017 for employees #1, #2, and #3 . -- 2 of 2 --