Liberty Dayton Regional Medical Center

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on October 29-30, 2025. The laboratory was found out of compliance with the CLIA regulations (42 CFR Part 493, Requirements for Laboratories). The CONDITIONS NOT MET were: D2000 - 42 C. F.R. 493.801 Enrollment And Testing Of Samples D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a review of the laboratory's records and staff interview, the laboratory failed to have documentation of being enrolled in an HHS approved proficiency testing program for the analyte Folate in 2025. Findings include: 1. A review of the laboratory's testing records revealed the laboratory performed Folate testing using patient's serum specimens. 2. A review of the laboratory's records revealed the laboratory failed to provide documentation of enrollment in an HHS approved proficiency testing program for the analyte Folate in 2025. 3. Further review of the laboratory's records revealed the laboratory estimated performing 46 Folate tests using patient's serum specimens annually. 4. In an interview on 10/29/25 at 10:50 a.m. in the conference room, after review of the records, general supervisor #2 (as indicated on the CMS 209 form) confirmed the above findings. Key: HHS= Health and Human Services 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 -- D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of laboratory's test menu, manufacturer instructions, random patient reports and staff interview, the laboratory failed to include on the final patient report the test methodology, specimen source/type or date tested/reported for eleven of eleven molecular microbiology by polymerase chain reaction (PCR) analytes tested on the Cepheid GeneXpert XVI test system in 2025. Findings included: 1. Review of laboratory's test menu revealed the laboratory used the following panels for PCR testing/detection of eleven analytes on the Cepheid GeneXpert XVI test system: Xpert CT/GC (Chlamydia/Gonorrhoeae) - designed for detection of presence of Chlamydia trachomatis and Neisseria gonorrhoeae Xpert Xpress CoV-2/Flu/RSV Plus - designed for detection of presence of SARS-Covid19, Influenza A, Influenza B and Respiratory Syncytial Virus (RSV). Xpert Xpress MPV (Multiplex Vaginal Panel) - designed for detection of presence of Bacterial Vaginosis, Candida glabrata/Candida krusei, Candida group and Trichomonas vaginalis Xpert Xpress Strep A (Streptococcus pyogenes) - designed for detection of presence of Streptococcus pyogenes (Group A) 2. Review of manufacturer's instructions revealed the following acceptable specimen types for the above PCR test panels: Xpert CT/GC (document: 2024 Cepheid 5120- 02) acceptable specimens: vaginal swabs, endocervical swabs, pharyngeal swabs, rectal swabs, urine. Xpert Xpress CoV-2/Flu/RSV Plus (document: 2023-2024 Cepheid 10073-02) acceptable specimens: nasopharyngeal or anterior nasal swabs. Xpert Xpress MPV (document: 2023 Cepheid 10069-01) acceptable specimens: vaginal swabs. Xpert Xpress Strep A (document: 2023 Cepheid 10070-02) acceptable specimens: throat swabs. 3. Review of random patient reports for the above panels revealed results for Chlamydia trachomatis, Neisseria gonorrhoeae, Influenza A, Influenza B, RSV, Bacterial Vaginosis, Candida glabrata-krusei, Candida group, Trichomonas vaginalis and Streptococcus pyogenes were documented under the header of "Immunology/Serology" test results and did not have specifications that the tests utilized a PCR method of detection (except for Streptococcus pyogenes and SARS-CoV-2). The reports also did not have documentation of specimen source/type, or date tested/reported. The results reviewed were for the following patients: Patient MRN (medical record number): 111572 Sample collected: 10/28/2025 at 08:57 Panel Tested: Xpert Xpress CoV-2/Flu/RSV Plus and Xpert Xpress Strep A No specimen type distinction was documented between the two panels. Patient MRN: 96649 Sample collected: 09/18/2025 at 10:08 Panel Tested: Xpert Xpress MPV and Xpert CT /GC Patient MRN: 529920 Sample collected: 09/30/2025 at 14:06 Panel Tested: Xpert Xpress MPV Patient MRN: 534511 Sample collected: 10/29/2025 at 11:23 Panel Tested: Xpert Xpress CoV-2/Flu/RSV Plus and Xpert Xpress Strep A No specimen type distinction was documented between the two panels. Patient MRN: 93771 Sample collected: 10/24/2025 at 07:43 Panel Tested: Xpert Xpress CoV-2/Flu/RSV Plus and Xpert Xpress Strep A No specimen type distinction was documented -- 2 of 3 -- between the two panels. Patient MRN: 530271 Sample collected: 10/25/2025 at 15:01 Panel Tested: Xpert Xpress CoV-2/Flu/RSV Plus and Xpert Xpress Strep A No specimen type distinction was documented between the two panels. Patient MRN: 505868 Sample collected: 10/10/2025 at 12:56 Panel Tested: Xpert CT/GC Patient MRN: 107652 Sample collected: 10/28/2025 at 15:00 Panel Tested: Xpert CT/GC Results for this patient (under one collection date/time) included in the same column results for Hep C Ab (Hepatitis C Antibodies). There was no distinction between the CT/GC and Hep C Ab specimen types or testing methodologies. 4. In an interview on 10/30/2025 at 1200 hours in the conference room, the laboratory's General Supervisor number 1 (as indicated on submitted Form CMS 209) confirmed the findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted from 01/30/2024 through 02/01 /2024. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories). STANDARD LEVEL DEFICIENCIES were cited. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of laboratory's proficiency testing (PT) records and staff interview, the laboratory failed to document required attestation signatures for 2 of 19 PT events reviewed from June 2022 to December 2023. Findings included: 1. Review of laboratory's PT records revealed the laboratory used American Proficiency Institute (API) as its PT provider. 2. Review of API instructions revealed: "For all PT results, an attestation statement must be signed by testing personnel and the laboratory director and retained for a minimum of 2 years." 3. Further review of the PT records from June 2022 to December 2023 revealed the following 2 of 19 reviewed events where results did not have the attestation statements signed by the Laboratory Director or designee: API 2023 Immunology/Immunohematology 1st Event API 2023 Chemistry Misc. Verification 1st Event 4. In an interview on 01/30/2024 at 1545 hours in the office, the laboratory's General Supervisor (as listed on submitted form CMS 209) confirmed the findings. 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 10 -- 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 the review of the laboratory's policies and confirmed in an interview, the laboratory failed to have a written procedure for one of eight moderate complexity tests: serum acetest or serun ketone. The findings were: 1. Review of the laboratory's policies revealed the laboratory failed to have a written procedure for one of eight moderate complexity tests for serum acetest or serum ketone. 2. An interview with the testing personnel #14 on 02/01/2024 at 11:09 am in a conference room confirmed the above findings. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor's observations in the laboratory, review of manufacturer instructions/package inserts and staff interview, the laboratory failed to document open, reconstitution or amended expiration dates for two of two coagulation controls in use observed. Findings included: 1. Surveyor's observations on 01/31/2023 at 1140 hours in the laboratory revealed two reconstituted Hemosil controls loaded on the ACL TOP 350 coagulation analyzer, the Hemosil Abnormal Control 3 (Lot N0431121), and the Hemosil Normal Control 1 (Lot N0531900). There was no open /reconstitution date or amended expiration date documented on either of the two control vials. 2. Review of the Hemosil Abnormal Control 3 - 0020014100 manufacturer instructions (document 303981 R2 04/2018) revealed: "Reagent storage and stability ...Stability after reconstitution: - at 2-8C (Degrees Celsius) in the original vial: 24 hours - at 15-25C in the original vial: 24 hours" 3. Review of the Hemosil Normal Control 1 - 0020013900 manufacturer instructions (document 303975 R2 04 /2018) revealed: "Reagent storage and stability ...Stability after reconstitution: - at 2- 8C in the original vial: 24 hours - at 15-25C in the original vial: 24 hours" 4. In an interview on 01/31/2024 at 1209 hours in the laboratory, Testing Person number 14 (as listed on submitted form CMS 209) confirmed the findings. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: A. Based on review of the manufacturer's instructions, review of the laboratory's maintenance logs from 7/13/23 to 12/31/23, and confirmed in interview, the -- 2 of 10 -- laboratory failed to document the total of 42 of 170 days of daily maintenance, three of six monthly scheduled maintenance reviewed for Cobas pro chemistry analyzer. The findings were: 1. An interview with the technical consultant on 01/30/2024 at 10: 00 am confirmed the cobas pro chemistry analyzer go-live date was 7/13/2023, 2. Review of the manufacturer's instructions titled cobas pro integrated solutions User Guide (Publication version 3.2 Software version 0203. OS-01353-05) under List of Maintenance Intervals revealed the following: " ISE analytical unit Running a daily wash rack-performs Daily c503 analytical unit Performing maintenance of the photometric system-performs Monthly Cleaning the filters-performs Monthly e801 analytical unit Cleaning probes and nozzles-performs Daily" 3. Review of the laboratory's ISE maintenance logs from 7/13/23 to 12/31/23 revealed the laboratory failed to document 18 of 170 days of daily maintenance reviewed. 7/15/2023 7/16 /2023 7/17/2023 7/22/2023 7/23/2023 7/24/2023 7/29/2023 7/30/2023 8/5/2023 8/6 /2023 8/7/2023 8/14/2023 8/21/2023 8/22/2023 8/23/2023 9/26/2023 9/30/2023 3. Review of the laboratory's c503 maintenance logs from 7/13/23 to 12/31/23 revealed the laboratory failed to document three of six months of monthly maintenance reviewed. August, 2023-No documentation of Cleaning the filters October, 2023-No documentation of Cleaning the filters November, 2023-No documentation of Performing maintenance of the photometric system and Cleaning the filters. 4. Review of the laboratory's e801 maintenance logs from 7/13/23 to 12/31/23 revealed the laboratory failed to document 24 of 170 days of daily maintenance reviewed. 7/15 /2023 7/16/2023 7/17/2023 7/22/2023 7/23/2023 7/24/2023 7/29/2023 7/30/2023 8/5 /2023 8/6/2023 8/7/2023 8/12/2023 8/13/2023 8/14/2023 8/19/2023 8/20/2023 8/21 /2023 8/22/2023 9/22/2023 9/23/2023 9/28/2023 9/29/2023 9/30/2023 5. Random review of the daily patient volume for ISE analytical unit for above dates revealed, ISE analytical unit 7/22/2023 Total Patient Volume was 18 7/29/2023 Total Patient Volume was 12 8/6/2023 Total Patient Volume was 18 8/23/2023 Total Patient Volume was 24 9/26/2023 Total Patient Volume was 27 6. Review of the Monthly patient volume for c503 analytical unit for the above months revealed, c503 analytical unit August, 2023 Total patient volume was 2120. October, 2023 Total patient volume was 1736. November, 2023 Total patient volume was 1670. 7. Random review of the daily patient volume for e801 analytical unit for above dates revealed, e801 analytical unit 7/17/2023 Total patient volume was 18 7/24/2023 Total patient volume was 17 8 /14/2023 Total patient volume was 10 8/21/2023 Total patient volume was 11 9/23 /2023 Total patient volume was 4 9/28/2023 Total patient volume was 12 8. An interview with the testing personnel #14 on 01/31/2024 at 12:34 pm in a conference room confirmed the above findings. 44698 B. Based on review of manufacturer instructions and laboratory's maintenance records for the ACL TOP 350 coagulation analyzer, patient test volumes and staff interview, the laboratory failed to document 2 of 16 required weekly maintenance from September to December 2023. Findings included: 1. Review of the "ACL TOP Family and ACL TOP Family 50 Series Hemostasis Testing Systems Basic Operator Training Manual" (IL Training Center Rev 1.1 [2019] and Rev1.2 [2020]) instructions for instrument's maintenance revealed: "Weekly Maintenance Clean Cuvette Waste Drawer (All ACL TOP Family Models) Clean Deep Wash and Clean Cup (All ACL TOP Family Models)" 2. Review of instrument's Maintenance Log Report recorded in the instrument from September to December 2023 revealed the following 2 of 16 reviewed weeks did not have documentation of Clean Deep Wash and Clean Cup, one of the required weekly maintenance components: Week of September 17 to 23, 2023 - no documentation of Clean Deep Wash and Clean Cup Last documented: 09/16/2023 Next documented: 09 /25/2023 Week of October 29 to November 4, 2023 - no documentation of Clean Deep Wash and Clean Cup Last documented: 10/24/2023 Next documented: 11/07 /2023 3. In an interview on 01/31/2024 at 1227 hours in the conference room, the -- 3 of 10 -- laboratory's Testing Person number 14 (as listed on submitted form CMS 209) confirmed the findings. 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: Based on review of laboratory's policies/procedures, platelet poor plasma centrifuge verification studies, test volumes and staff interview, the laboratory failed to document platelet poor plasma verification every 6 months as per its own policy for 3 of 3 six-month intervals reviewed from May 2022 to December 2023. Findings included: 1. Review of laboratory's policy "Platelet Poor Plasma" (policy number 1353.04.15) revealed: "Plasma used for coagulation studies must be platelet poor. Centrifuge speed and duration must be established by the laboratory to ensure platelet counts are less than 10,000/uL (microliter). These parameters should be validated every six months or after repair or preventive maintenance of the centrifuge." 2. Review of laboratory's platelet poor plasma (PPP) centrifuge verification studies revealed the laboratory performed these studies as follows: Centrifuge: Stat Spin Express 3 Model: M502-22 Serial Number (SN): 613M50201073 Studies performed: 05/22/2022 Next PPP verification due November 2022, then May 2023, then November 2023 Studies performed: 12/09/2023 Time elapsed between studies: 19 months Centrifuge: Stat Spin Express 3 Model: M502-22 SN: 1127M50204367 Studies performed: 05/22/2022 Next PPP verification due November 2022, then May 2023, then November 2023 Studies performed: 12/09/2023 Time elapsed between studies: 19 months Centrifuge: Quest Centrifuge Model: Horizon 642E SN: not specified Studies performed: 05/22/2022 Next PPP verification due November 2022, then May 2023, then November 2023 No further studies were performed on this centrifuge to date. 3. Review of laboratory's submitted test volumes revealed the laboratory performed 9662 coagulation tests in 2023. 4. In an interview on 01/31/2024 at 1230 hours in the conference room, the laboratory's General Supervisor (as listed on submitted form CMS 209) confirmed the findings. D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of manufacturer instrument manuals, laboratory's policies -- 4 of 10 -- /procedures, new reagent lot roll-over studies, instrument establishment studies, patient test records and staff interview, the laboratory failed to document verification of INR (international normalized ratio) for each new lot of Recombiplastin (thromboplastin) for one of one reagent lot change in 2023. Findings included: 1. Review of the "ACL TOP Family and ACL TOP Family 50 Series Hemostasis Testing Systems Basic Operator Training Manual" (IL Training Center Rev 1.1 [2019]) revealed: "WARNING: Erroneous patient results may report if the INR calculation is not properly set up." 2. Review of manufacturer's "Hemostasis Performance Verification Manual" revealed: "Enter the ISI VALUE of the PT (prothrombin time) reagent (Recombiplastin) lot number in use..." And, ""Enter your current geometric Mean of Normal Reference Interval." And: "If the INR calculation is not properly set up, then erroneous patient results may be reported." 3. Review of laboratory's "ACL Top INR Calculation" (Policy 1353.04.23) revealed: "This procedure is to be performed ... ... With a change of the thromboplastin lot number." And, "The ACL Top use the mean of the normal reference interval and the ISI (international sensitivity index) value to determine the correct INR... ...Note that each lot number of reagents will have a unique ISI value and mean of normal reference interval..." The policy did not address manual verification of instrument's INR calculation, to ensure all parameters' input (mean of the normal reference interval and ISI) and the instrument's calculations were appropriate to achieve the correct result. 4. Review of laboratory's new reagent lot roll-over studies from June 2022 to December 2023 revealed the Recombiplastin new lot studies were performed on 07/27/2023 for lot number N0421616 (expiration 2024-04). The studies did not have documentation of manual verification of instrument's INR calculation to ensure all parameters' input and the instrument's calculations were appropriate to achieve the correct result. 5. Review of the ACL Top 350 (serial number 20102327) hemostasis analyzer's establishment studies performed in January 2021 revealed the studies did not have documentation of manual verification of instrument's INR calculation. 6. Review of laboratory's INR patient test records from September to December of 2023 revealed the laboratory reported 317 INR results calculated by the ACL Top 350 instrument. 7. In an interview on 01/31/2024 at 1140 hours in the conference room, the laboratory's General Supervisor (as listed on submitted form CMS 209) confirmed the findings. D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of laboratory's policies/procedures, quality control (QC) records, patient test records and volumes, and staff interview, the laboratory failed to document quality control each day of testing of ABO and Rh (D) blood typing for 3 of 579 days reviewed from June 2022 to December 2023. Findings included: 1. Review -- 5 of 10 -- of laboratory's "Quality Assurance" policy (document number 1353.08.04) revealed: "ABO/Rh typing sera are tested initially and each day of use against Confidence QC material known to be positive and negative for the respective antigen." 2. Review of laboratory's QC records and patient test logs from June 2022 to December 2023 revealed QC was not documented on the following days patient samples were tested: Date: 07/14/2022 Patient tested: 514213 Date: 06/10/2023 Patient tested: 03110 Date: 06/28/2023 Patient tested: 83110 3. Review of laboratory's submitted patient test volumes revealed the laboratory performed 328 ABO/Rh typing procedures annually. 4. In an interview on 02/01/2024 at 1135 hours in the conference room, Testing Person number 14 (as listed on submitted form CMS 209) confirmed the findings. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: A. Based on review of laboratory's temperature records, policies/procedures, Blood Bank (BB) refrigerator alarm check records, BB refrigerator's continuous temperature monitoring wheel charts and staff interview, the laboratory failed to ensure 4 of 4 BB refrigerator alarm checks from January to December 2023 were activated and recorded at the correct temperature. Findings included: 1. Review of laboratory's temperature records revealed the laboratory used continuous recording wheel charts to document temperature for the Blood Bank refrigerator where blood products were stored. 2. Review of laboratory's "Blood Bank Temperature &(and) Alarm Checks" policy (document number 1353.08.19) revealed: "The alarm will sound on the refrigerator when the temperature is grated than 5.5C (degrees Celsius) and less than 1.5C." And, "For low activation: Place the with the Thermocouple and thermometer in a pan containing ice and water slush at a temperature of -4C. ... For high activation: Place the with the Thermocouple and Thermometer in a pan containing water at 12- 15C. ... The Temperature change for the Low and High Activation should occur slowly enough that the measurements are accurate." 3. Review of laboratory's "Blood Bank Quarterly Alarm Check" records for January to December 2023 revealed the following alarm activation/deactivation temperatures: January 2023 Alarm Check performed: 01/16/2023 Low activation documented as: activated at 1.0C, deactivated at 4.0C (alarm set to sound at 1.5C; alarm check did not activate/deactivate the alarm at the correct temperature) High activation documented as: activated at 2.9C, deactivated at 3.4C (alarm set to sound at 5.5C; alarm check did not activate /deactivate the alarm at the correct temperature) April 2023 Alarm Check performed: 04/15/2023 Low activation documented as: activated at 1.0C, deactivated at 3.7C (alarm set to sound at 1.5C; alarm check did not activate/deactivate the alarm at the correct temperature) High activation documented as: activated at 2.9C, deactivated at 3.8C (alarm set to sound at 5.5C; alarm check did not activate/deactivate the alarm at the correct temperature) July 2023 Alarm Check performed: 07/17/2023 Low activation documented as: activated at 3.6C, deactivation unclear (alarm set to sound at 1.5C; alarm check did not activate/deactivate the alarm at the correct temperature) High activation documented as: activated at 2.4C, deactivated at 3.0C (alarm set to -- 6 of 10 -- sound at 5.5C; alarm check did not activate/deactivate the alarm at the correct temperature) October 2023 Alarm Check performed: 10/30/2023 Low activation documented as: activated at 3.9C, deactivated at 1.0 (alarm set to sound at 1.5C; alarm check did not activate/deactivate the alarm at the correct temperature) High activation documented as: activated at 3.0C, deactivated at 2.8C (alarm set to sound at 5.5C; alarm check did not activate/deactivate the alarm at the correct temperature) 4. Review of Blood Bank refrigerator's continuous temperature monitoring wheel charts revealed the wheel charts' recorded temperature for alarm check dates was 5.5-6C. There were no peaks recorded on the wheel charts corresponding to the activation /deactivation temperatures documented on the Blood Bank Quarterly Alarm Check log to indicate temperature changes were detected for the dates the alarm checks were performed. 5. In an interview on 02/01/2024 at 1130 hours in the conference room, Testing Person number 14 (as listed on submitted form CMS 209) confirmed the findings. B. Based on review of laboratory's temperature records, Blood Bank refrigerator's continuous temperature monitoring wheel charts and staff interview, the laboratory failed to document continuous monitoring of blood products' storage for 2 of 365 days reviewed in 2023. Findings included: 1. Review of laboratory's temperature records revealed the laboratory used continuous recording wheel charts to document temperature for the Blood Bank refrigerator where blood products were stored. 2. Review of laboratory's Blood Bank refrigerator's continuous temperature monitoring wheel charts from January to December 2023 revealed the following gaps in blood storage temperature monitoring for 2 of 365 days reviewed: Date: 04/20/2023 Temperature stopped recording 0500 hours Temperature started recording 0830 hours Time without documentation of blood product temperature monitoring: 3.5 hours Date: 05/31/2023 Temperature stopped recording 0300 hours Temperature started recording 0700 hours Time without documentation of blood product temperature monitoring: 4 hours There was no documentation to explain the gaps in temperature monitoring. 3. In an interview on 02/01/2024 at 1130 hours in the conference room, Testing Person number 14 (as listed on submitted form CMS 209) confirmed the findings. D5785

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: *** New deficiency found during the unannounced revisit performed on 12/1/21*** Based on a review of the laboratory's policies, the laboratory's platelet poor plasma study done in September 2021, and staff interview, it was revealed that the laboratory failed to have documentation of following its procedure for performing one of one platelet poor plasma studies in 2021. Findings include: 1. A review of the laboratory's policy titled 'Platelet Poor Plasma' revealed the following steps to take when performing the platelet poor plasma study: - Within 30 minutes of collection, centrifuge capped citrate tube for 10 minutes at an RCF of 1500-2000g. - Using a plastic transfer pipet, remove the top of plasma. Place this plasma in a plastic send out tube and cap. - Centrifuge the plasma (in the plastic centrifuge tube from Step 2 above) for another 10 minutes at 1500-2000g. - Using a plastic transfer pipet, remove the top of plasma from step 3 into an Elite sample cup. - Ideally, PPP should have a platelet count of less than 10x10E9 per liter. 2. A review of the laboratory's records revealed a platelet poor plasma study was done in September 2021. 3. Further review of the platelet poor plasma study revealed the technologist performing the study, ran the sample through the hematology analyzer using a 1:7 dilution. There was nothing in the laboratory's policy instructing the laboratory personnel to run the sample using a 1:7 dilution. 4. An interview with the laboratory manager on 12/1/21 at 1:20 p.m. in the laboratory, after review of the records, explained that when performing the study, 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 -- he did not spin the sample twice (as the policy instructed) and he ran the sample through the hematology analyzer using a 1:7 dilution so that the analyzer would detect the small amount of cells present in the sample. This confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on the survey conducted 01-17-2018 through 01-19-2018, the laboratory was found to be out of compliance with the following conditions of 42 CFR: 493.1240 Preanalytic Systems Moderate Complexity 493.1250 Analytic Systems Moderate Complexity 493.1403 Laboratory Director Moderate Complexity 493.1409 Technical Consultant Moderate Complexity . D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: . I. Based on review of American Proficiency Institute (API) proficiency testing documentation for 2016 and 2017, confirmed by staff interview, the laboratory director (CMS form 209) failed to attest to the routine integration of 4 of 4 events in the specialty of immunohematology. Findings: 1. API proficiency testing attestation sheets for 2016 and 2017 were reviewed. Sheets for immunohematology testing for the 3rd event 2016 and the 1st, 2nd and 3rd events 2017 were signed by the laboratory technical consultant (CMS form 209). 2. In an interview at the site on 01-17-2018, the laboratory technical consultant stated that he had reviewed and signed the attestation forms listed. 3. No documentation was made available showing the delegation of the duties of technical supervisor to any other individual. The director and technical supervisor are one and the same. . D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: . Based on surveyor observation, review of laboratory patient testing logs, laboratory policy and procedure, confirmed by staff interview, the laboratory failed to meet applicable requirements in preanalytic systems. Findings: 1. The laboratory failed to follow its own policies for acceptibility of specimens for coagulation testing. Refer to D5311. 2. The laboratory failed to provide reference lab clients with written instructions including specific information for specimen collection, preservation, storage and transport. Refer to D5317. . D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: . Based on review of laboratory policy and procedure for coaguation testing, surveyor observation and patient testing logs for 2017 and 2018, confirmed by staff interview, the laboratory failed to follow its own policy for acceptibility of specimens for coagulation testing, failing to reject 32 of 32 specimens for activated partial thromboplastin time (APTT) and 58 of 58 specimens for prothrombin time (PT) that did not meet acceptable criteria for storage temperature or time elapsed after collection. Findings: 1. Laboratory policy states: "Coagulation testing should be promptly performed on fresh, platelet poor plasma at room temperature." (Liberty Dayton Regional Medical Center Policy # 1353.04.02) A. In an interview at the site on 01-18-2018, the laboratory technical consultant stated that the laboratory began accepting patient specimens from an outside source on 05-01-2017. From that date until the time of the survey, 58 coagulation specimens from that source were tested. B. Specimens delivered from the outside source, including plasma for coagulation testing, arrived refrigerated with cold packs. In an interview at the site on 01-18-2018 the laboratory technical consultant stated all such specimens arrived refrigerated. C. Coagulation testing on specimens delivered from outside sources did not include a check for platelet poor plasma. In an interview at the site on 01-18-2018 the laboratory technical consultant stated plasma specimens for coagulation testing were not respun before testing. 2. Laboratory policy states: "If testing cannot be performed within 4 hours for APTT, platelet poor plasma should be removed from the cells and frozen at -20 Celsius (C) for up to 2 weeks." (Liberty Dayton Regional Medical Center Policy # 1353.04.02) A. In an interview at the site on 01-18-2018, the laboratory technical consultant stated that no outside source specimens for coagulation testing were respun, delivered frozen or frozen after receipt. B. Review of patient testing logs for 2017 and 2018 revealed that 32 specimens were tested for APTT more -- 2 of 9 -- than 4 hours after collection. Collection (COLL) and result (RES) dates and times for these specimens follow. Elapsed time in hours and minutes between collection and result is indicated as ET. COLL RES ET 05/01/2017 11:27 05/02/2017 14:49 27:22 05 /17/2017 11:00 05/18/2017 16:36 29:36 05/18/2017 13:30 05/19/2017 17:01 27:31 05 /23/2017 09:00 05/24/2017 21:41 36:41 06/02/2017 09:00 06/03/2017 18:14 33:14 06 /02/2017 10:00 06/03/2017 18:24 32:24 06/08/2017 15:05 06/09/2017 18:28 27:23 08 /15/2017 15:31 08/16/2017 20:14 28:43 08/23/2017 12:50 08/24/2017 16:18 27:28 09 /27/2017 13:52 09/29/2017 15:22 49:30 11/01/2017 15:00 11/02/2017 20:32 29:32 11 /16/2017 17:06 11/18/2017 06:40 37:34 11/16/2017 17:08 11/18/2017 06:40 37:32 11 /17/2017 10:30 11/20/2017 22:54 84:24 11/17/2017 11:50 11/20/2017 18:09 78:19 11 /17/2017 14:00 11/20/2017 22:54 80:54 11/17/2017 14:50 11/20/2017 22:52 80:02 11 /27/2017 16:53 11/28/2017 23:08 30:15 11/29/2017 11:23 11/30/2017 12:32 25:09 11 /29/2017 13:20 11/30/2017 12:33 23:13 11/29/2017 14:16 11/30/2017 12:32 22:16 11 /30/2017 09:20 12/01/2017 14:03 28:43 11/30/2017 10:00 12/01/2017 15:36 29:36 11 /30/2017 10:58 12/01/2017 15:35 28:37 11/30/2017 11:20 12/01/2017 16:23 29:03 11 /30/2017 11:48 12/01/2017 14:03 26:15 11/30/2017 11:58 12/01/2017 14:05 26:07 11 /30/2017 15:00 12/01/2017 15:35 24:35 12/11/2017 11:48 12/12/2017 17:54 30:06 12 /11/2017 15:30 12/12/2017 17:48 26:18 12/18/2017 11:30 12/19/2017 14:45 27:15 01 /15/2018 16:20 01/18/2018 10:16 65:56 3. Laboratory policy states: "If testing cannot be performed within 24 hours for PT, platelet poor plasma should be removed from the cells and frozen at -20 Celsius (C) for up to 2 weeks." (Liberty Dayton Regional Medical Center Policy # 1353.04.02) A. In an interview at the site on 01-18-2018, the laboratory technical consultant stated that no outside source specimens for coagulation testing were respun, delivered frozen or frozen after receipt. B. Review of patient testing logs for 2017 and 2018 revealed that 58 specimens were tested for PT more than 24 hours after collection. Collection (COLL) and result (RES) dates and times for these specimens follow. Elapsed time in hours and minutes between collection and result is indicated as ET. COLL RES ET 05/01/2017 11:27 05/02/2017 14:49 27:22 05 /17/2017 11:00 05/18/2017 16:36 29:36 05/18/2017 13:30 05/19/2017 17:01 27:31 05 /23/2017 09:00 05/24/2017 21:41 36:41 05/23/2017 11:00 05/24/2017 22:10 35:10 05 /24/2017 09:30 05/25/2017 18:22 32:52 05/26/2017 12:10 05/27/2017 17:25 29:15 05 /30/2017 08:30 05/31/2017 18:37 34:07 05/30/2017 16:00 05/31/2017 18:37 26:37 05 /31/2017 14:00 06/01/2017 17:40 27:40 05/31/2017 16:00 06/01/2017 17:10 25:10 06 /01/2017 09:00 06/02/2017 17:40 32:40 06/01/2017 09:35 06/02/2017 17:40 32:05 06 /01/2017 10:50 06/02/2017 17:40 30:50 06/01/2017 11:00 06/02/2017 17:40 30:40 06 /01/2017 11:45 06/02/2017 17:40 29:55 06/02/2017 09:00 06/03/2017 18:14 33:14 06 /02/2017 10:00 06/03/2017 18:24 32:24 06/05/2017 11:00 06/06/2017 21:12 34:12 06 /05/2017 14:00 06/06/2017 20:44 30:44 06/05/2017 16:00 06/06/2017 21:13 29:13 06 /06/2017 09:00 06/07/2017 14:44 29:44 06/06/2017 10:00 06/07/2017 14:43 28:43 06 /06/2017 13:00 06/07/2017 14:43 25:43 06/08/2017 15:05 06/09/2017 18:28 27:23 06 /12/2017 14:45 06/15/2017 16:16 73:31 07/14/2017 11:00 07/15/2017 14:19 27:19 08 /01/2017 11:12 08/02/2017 15:13 28:01 08/15/2017 15:31 08/16/2017 20:14 28:43 08 /23/2017 12:50 08/24/2017 16:18 27:28 08/23/2017 12:51 08/24/2017 21:53 33:02 09 /27/2017 13:52 09/29/2017 15:22 49:30 10/03/2017 14:42 10/04/2017 23:03 32:21 10 /11/2017 12:58 10/12/2017 16:50 27:52 11/01/2017 15:00 11/02/2017 20:32 29:32 11 /16/2017 17:06 11/18/2017 06:40 37:34 11/16/2017 17:08 11/18/2017 06:40 37:32 11 /17/2017 10:30 11/20/2017 22:54 84:24 11/17/2017 11:50 11/20/2017 18:09 78:19 11 /17/2017 14:00 11/20/2017 22:54 80:54 11/17/2017 14:50 11/20/2017 22:52 80:02 11 /27/2017 16:53 11/28/2017 23:08 30:15 11/29/2017 11:23 11/30/2017 12:32 25:09 11 /29/2017 13:20 11/30/2017 12:33 23:13 11/29/2017 14:16 11/30/2017 12:32 22:16 11 /30/2017 09:20 12/01/2017 14:03 28:43 11/30/2017 10:00 12/01/2017 15:36 29:36 11 /30/2017 10:58 12/01/2017 15:35 28:37 11/30/2017 11:20 12/01/2017 16:23 29:03 11 /30/2017 11:48 12/01/2017 14:03 26:15 11/30/2017 11:58 12/01/2017 14:05 26:07 11 -- 3 of 9 -- /30/2017 15:00 12/01/2017 15:35 24:35 12/11/2017 11:48 12/12/2017 17:54 30:06 12 /11/2017 15:30 12/12/2017 17:48 26:18 12/18/2017 11:30 12/19/2017 14:45 27:15 12 /20/2017 09:23 12/21/2017 14:37 29:14 01/15/2018 16:20 01/18/2018 10:16 65:56 . D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: . Based on review of laboratory policy and procedure, confirmed by staff interview, the laboratory failed to provide reference lab clients with written instructions that included specific information for specimen collection, preservation, storage and transport. Findings: 1. During review of laboratory policy and procedure, a copy of written instructions for reference lab clients was requested. The document supplied consisted of procedures for receipt of specimens from outside sources and did not include information on storage or transport temperature for blood specimens, or for specimen stability times. 2. In an interview at the site on 01-18-2018, the laboratory technical consultant stated that no written instructions on specimen collection, preservation, storage or transport had been supplied to reference lab clients. . D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: . Based on review of laboratory documentation and staff interview, the laboratory failed to correct identified problems in coagulation testing. Refer to 5403. Based on surveyor observation, review of laboratory documenation and staff interview, the laboratory failed to correct identified problems in blood storage. Refer to D5555. . 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 -- 4 of 9 -- 493.1253. (7) Control procedures. (8)