Bowdle Hospital

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 8/22/25. The Bowdle Hospital laboratory was found not in compliance with these requirements: D5400 and D5555. 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 observation, record review, and interview with the laboratory supervisor, the laboratory failed to ensure the continuous monitoring of the internal temperature of the blood bank refrigerator for six of twelve weeks (5/26/25 through 8/18/25) reviewed. Continuous monitoring of the blood bank refrigerator internal temperature was necessary to ensure the blood products stored within the refrigerator were continuously stored at a safe temperature (1-6 Celsius) prior to transfusion to a patient. Findings include: 1. Review on 8/22/25 at 12:20 of the blood bank refrigerator continuous temperature recording charts revealed nine occasions where the recording pen left the temperature recording chart and did not return for an extended length of time. During these time periods, there had been no documentation of the internal temperature of the blood bank refrigerator to ensure the blood had been stored at a safe temperature (1-6 Celsius). Refer to D5555. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(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 4 -- (c) Blood shall be stored in a clean and orderly environment in a manner to prevent mix-ups. Expired blood must not be in the routine inventory. Unacceptable units must be segregated from routine inventory. (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. This STANDARD is not met as evidenced by: Based on observation, review of maintenance records, and interview with laboratory staff, the laboratory failed to ensure the internal temperature of the blood bank refrigerator had been continuously monitored for six of twelve weeks (5/26/25 through 8/18/25) reviewed. Continuous monitoring of the blood bank refrigerator internal temperature was necessary to ensure the blood products had been stored at a safe temperature (1-6 Celsius) prior to transfusion to a patient. Findings include: 1. Observation on 8/22/25 at 12:15 p.m. of the laboratory's blood bank refrigerator revealed: a. The laboratory stored blood products for potential transfusion to patients in the refrigerator. b. There had been several units of blood stored in the refrigerator, including a unit tagged for transfusion to a patient. c. The refrigerator had contained a thermometer which would be manually read and the internal temperature documented on a daily basis by laboratory staff. d. The refrigerator had contained a second temperature probe connected to a continuous temperature recording unit mounted on the wall above the blood bank refrigerator. *The temperature recording chart unit consisted of a preprinted paper chart that rotated at a consistent speed and a pen that recorded the continuous internal temperature of the blood bank refrigerator on the preprinted chart. *The chart would continuously record the internal blood bank refrigerator temperature for a period of seven days. *Changes in the internal temperature would be indicated by spikes on the temperature chart. *If the internal blood bank temperature exceeded the safe storage temperature range (1-6 Celsius), an alarm would sound in the laboratory and a page would be sent to the laboratory staffs' telephones. *Every seven days the temperature chart would be replaced by laboratory staff. Review on 8/22/25 at 12:20 p.m. of the blood bank refrigerator continuous recording charts revealed: a. At approximately 4:30 a.m. on 6/9/25, the recording pen moved off of the recording chart. The temperature chart had been replaced at approximately 6:00 a.m. that same day. *There had been no record of the internal temperature of the blood bank refrigerator during that approximately 1.5 hour time period. *Laboratory staff had documented "no alarm" on the temperature recording chart. *There had been no documentation for the cause of the temperature recording malfunction. b. At approximately 1:30 a.m. on 6/20/25, the recording pen moved off of the recording chart. The temperature chart had been replaced at approximately 7:00 a.m. on 6/23/25. *There had been no record of the internal temperature of the blood bank refrigerator during that approximately 53 hour time period. *There had been no documentation on the temperature chart regarding the reason for the temperature recording malfunction. *There had been no documentation as to whether the blood bank alarm had sounded during that time period. c. At approximately 2:00 a.m. on 7/1 /25, the recording pen moved off of the recording chart. The pen returned to the chart approximately 15 minutes later indicating the blood bank refrigerator was again at a safe temperature. *Laboratory staff had documented 'power outage" on the chart as the reason for the malfunction. *Laboratory staff had documented "no alarm" on the temperature recording chart. d. At approximately 5:00 p.m. on 7/6/25, the recording pen moved off of the recording chart. The temperature chart had been replaced at approximately 7:00 a.m. on 7/7/25. *There had been no record of the internal temperature of the blood bank refrigerator during that approximately 14 hour time -- 2 of 4 -- period. *There had been no documentation on the temperature chart regarding the reason for the temperature recording malfunction. *Laboratory staff had documented "no alarm" on the temperature recording chart. e. At approximately 11:30 p.m. on 7/26 /25, the recording pen moved off of the recording chart. The temperature chart had been replaced at approximately 7:00 a.m. on 7/28/25. *There had been no record of the internal temperature of the blood bank refrigerator during that approximately 31.5 hour time period. *There had been no documentation on the temperature chart regarding the reason for the temperature recording malfunction. *There had been no documentation as to whether the blood bank alarm had sounded during that time period. f. At approximately 4:30 p.m. on 7/28/25, the recording pen moved off of the recording chart. The pen returned to the chart at approximately 7:00 a.m. on 7/29/25 indicating the blood bank refrigerator was again at a safe temperature. *There had been no record of the internal temperature of the blood bank refrigerator during that approximately 14.5 hour time period. *Laboratory staff had documented 'power outage" on the chart as the reason for the malfunction. *There had been no documentation as to whether the blood bank alarm had sounded during that time period. g. At approximately 8:00 p.m. on 7/29/25, the recording pen moved off of the recording chart. The pen returned to the chart at approximately 12:15 a.m. on 7/30/25 indicating the blood bank refrigerator was again at a safe temperature. *There had been no record of the internal temperature of the blood bank refrigerator during that approximately 4.25 hour time period. *Laboratory staff had documented 'power outage" on the chart as the reason for the malfunction. *There had been no documentation as to whether the blood bank alarm had sounded during that time period. h. At approximately 11:45 p.m. on 8/3/25, the recording pen moved off of the recording chart. The temperature chart had been replaced at approximately 7:00 a.m. on 8/4/25. *There had been no record of the internal temperature of the blood bank refrigerator during that approximately 7 hour time period. *There had been no documentation on the temperature chart regarding the reason for the temperature recording malfunction. *There had been no documentation as to whether the blood bank alarm had sounded during that time period. i. At approximately 5:30 a.m. on 8/15 /25, the recording pen moved off of the recording chart. The temperature chart had been replaced at approximately 7:00 a.m. on 8/18/25. *There had been no record of the internal temperature of the blood bank refrigerator during that approximately 73.5 hour time period. *Laboratory staff had documented 'power outage" on the chart as the reason for the malfunction. *There had been no documentation as to whether the blood bank alarm had sounded during that time period. Review of the blood bank refrigerator maintenance records revealed: *The laboratory staff checked the thermometer in the blood bank refrigerator and documented the temperature on a daily basis during the time period reviewed (5/26/25 through 8/18/25). *The blood bank refrigerator had an alarm that sounded and paged laboratory staff if the safe storage temperature was exceeded. *The blood bank alarm had been tested for high alarm activation at 5.5 degrees and low alarm activation at 1.5 degrees Celsius on a quarterly basis in 2024 and to date in 2025 by technical consultant B. There had been documentation that nursing staff responded to the alarm activation tests by contacting the laboratory staff. Interview with laboratory supervisor A on 8/22/25 at 12:25 p.m. revealed: *She confirmed the blood bank refrigerator had been used to store blood units for patient transfusion. *She confirmed the blood bank refrigerator had been connected to emergency power and had an alarm back up. *She confirmed it would take a minute or two for the emergency generator to start and provide emergency power to the blood bank refrigerator in the case of a power outage. *She confirmed she had been aware of the issue with the blood bank temperature monitoring charts failing to continuously document the internal blood bank refrigerator temperature. *She had been aware that there had been a large number of power outages over the -- 3 of 4 -- last several months. When the power failed, the blood bank temperature recording pen would move off the chart due to the lack of power. It would take less than a minute for the generator to activate providing emergency power. Once the power returned the pen would attempt to return to the temperature chart, but would get caught on the edge of the paper. *If staff were present at the time of the power outage, they would reset the recording chart pen manually. *Staff did not regularly check the blood bank recording chart on a daily basis. *Staff were present in the laboratory only from approximately 6:00 a.m. until 5:30- 6:00 p.m.. Staff would then be "on-call" until the next morning. * She thought that if there had been a temperature issue the alarm would have sounded in the laboratory and the laboratory staff would have received a page on their telephone that the safe temperature had been exceeded. Nursing staff would have heard the alarm sounding in the laboratory and would have notified the on- call laboratory staff member. *She confirmed that the blood bank alarm had not sounded when there had been a power outage and the temperature chart showed the temperature spikes caused by the pen leaving the temperature chart. *She confirmed that there had been no way to verify the internal temperature of the blood bank refrigerator during the time periods when the recording pen was off the chart. *She did not know if the blood bank temperature recording unit had a back up power source to prevent the loss of power during the frequent power outages experienced by the hospital. Interview with technical consultant B, via telephone on 8/26/25 at 11:00 a. m., revealed: *He had not been aware of the issue with the blood bank continuous temperature monitoring charts. *He had not reviewed the blood bank temperature recording charts as that had not been a part of the documentation he was required to review on his quarterly visits. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 11/7/23. Bowdle Hospital laboratory was found not in compliance with the following requirements: D2015, D5435. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to ensure specimen handling, preparation, and processing for proficiency testing (PT) had been documented for 38 of 40 PT events (College of American Pathologists [CAP] 2022 Cardiac Markers, Clinical Microscopy, Coagulation, Diagnostic Immunology, Hematology Automated Differential, and Transfusion Medicine A, B and C testing events; General Chemistry/Therapeutic Drugs B and C testing events; CAP 2023 Cardiac Markers, Clinical Microscopy, Coagulation, Hematology Automated Differential, General Chemistry/Therapeutic Drugs, Immunology, and Transfusion Medicine A, B and C testing events) reviewed. Findings include: 1. Review on 11/7 /23 of the laboratory's 2022 CAP PT events revealed: *A completed External Proficiency Survey Flow Sheet documented the receipt, condition, and date of 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 -- reconstitution for PT samples for the General Chemistry/Therapeutic Drugs and Transfusion Medicine A testing events. *Cardiac Markers, Clinical Microscopy, Coagulation, Diagnostic Immunology, Hematology Automated Differential A testing events had not had an External Proficiency Survey Flow Sheet completed. *Cardiac Markers, Clinical Microscopy, Coagulation, Diagnostic Immunology, Hematology Automated Differential, General Chemistry/Therapeutic Drugs, and Transfusion Medicine B and C testing events had not had an External Proficiency Survey Flow Sheet completed. Review of the lab's 2023 CAP PT events revealed the following had not had an External Proficiency Survey Flow Sheet completed: *Clinical Microscopy and Diagnostic Immunology A and B testing events. *Cardiac Markers, Coagulation, Hematology Automated Differential, General Chemistry/Therapeutic Drugs, and Transfusion Medicine A, B, and C testing events. Review on 11/7/23 of the laboratory's Handling Proficiency Testing Specimens procedure (last reviewed 1/28 /21) revealed: *"1. Prepare an External Proficiency Survey Flow Sheet for this survey." *"12. Upon receipt of the survey evaluation form complete the rest of the flow sheet and take appropriate actions for all results outside of the stated criteria." Interview on 11/7/23 at 11:50 a.m. with the laboratory supervisor revealed: *She had started working in the laboratory in April 2022. *She was unaware of the External Proficiency Survey Flow Sheet. *She had not completed an External Proficiency Survey Flow Sheet for any PT testing event since she had begun working in the laboratory. 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 record review and interview, the laboratory failed to calibrate the blood bank centrifuge to ensure proper centrifugation and accurate interpretation of the ABO Rh typing and crossmatch test methods. Findings include: 1. Review on 11/7/23 of the immunohematology maintenance records revealed the blood bank centrifuge had not been calibrated in 2022 or to date in 2023 to determine the combination of speed and timing of the blood bank centrifuge to ensure an optimum blood cell dot formation had been formed. That test method had been used as part of the ABO RH typing, antibody screening, and crossmatch procedures for determining patient blood type and compatibility with the donor blood units. Review of the annual test volume survey form revealed 16 ABO Rh blood types and 15 crossmatches had been performed on patient specimens during 2022. Interview on 11/7/23 at 12:10 p.m. with the laboratory supervisor revealed: *She had started working in the laboratory in April 2022. *She had not calibrated the blood bank centrifuge since she had begun work at the laboratory. *She had not been aware that the blood bank centrifuge should have been calibrated on a yearly basis. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 1/5/22. The Bowdle Hospital laboratory was found not in compliance with the following requirement: D2009. 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 record review and interview, the laboratory failed to ensure the laboratory director or their designee had signed the attestation statements of 36 of 42 College of American Pathology (CAP) proficiency testing (PT) surveys reviewed (CAP 2020 and 2021- Coagulation Limited CGL-A, CGL-B, and CGL-C; Hematology Automated Differential FH10-A, FH10-B, and FH10-C; General Chemistry Therapeutic Drugs C- A, C-B, and C-C; Cardiac Markers CAR-A, CAR-B, and CAR-C; Immunology S-A, S-B, and S-C; Clinical Microscopy CM-A, CM-B, and CM-C). The attestation statements confirmed the PT samples had been tested in the same manner as patient specimens. Findings include: 1. Review on 1/5/21 of the 2020 and 2021 completed CAP PT events revealed the following testing event attestation statements had not been signed by the laboratory director or their designee: *The 2020 Coagulation Limited CGL-A, CGL-B, and CGL-C. *The 2020 Hematology Automated Differential FH10-A, FH10-B, and FH10-C. *The 2020 General Chemistry Therapeutic Drugs C-A, C-B, and C-C. *The 2020 Cardiac Markers CAR-A, CAR-B, and CAR-C. *The 2020 Immunology S-A, S-B, and S-C. *The 2020 Clinical Microscopy CM-A, CM-B, and CM-C. *The 2021 Coagulation Limited CGL-A, CGL-B, and CGL-C. *The 2021 Hematology Automated Differential FH10-A, FH10- B, and FH10-C. *The 2021 General Chemistry Therapeutic Drugs C-A, C-B, and C- 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 -- C. *The 2021 Cardiac Markers CAR-A, CAR-B, and CAR-C. *The 2021 Immunology S-A, S-B, and S-C. *The 2021 Clinical Microscopy CM-A, CM-B, and CM-C. Review on 1/5/21 at 2:10 p.m. of a letter signed by the current laboratory director (February 2021) and by the two previous laboratory directors delegated the duty of signing the PT attestation statements to the technical consultant. Interview on 1 /5/21 at 2:10 p.m. with the general supervisor confirmed: *The attestation statements had not been signed by the laboratory director or their designee. *The technical consultant had been designated to sign the attestation statements by the laboratory director. *She had not been aware the technical consultant had not signed the attestation statements on his regular monthly visits. -- 2 of 2 --