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Based on record review and interview, the facility failed to ensure a valid, signed contract was in place with the facility's supplier of blood products, in 1 of 1 contracted agencies in a sample of 2 total contracts reviewed.

Findings include:

Review of policy #71510-001 titled, "Blood Product Storage at Moorland Reserve ED", no date, revealed, "description...Wisconsin Diagnostic Laboratories Transfusion Service will provide Moorland Reserve Emergency Department with 2 units of emergency uncrossmatched O Rh negative red blood cells for us. Moorland Reserve Emergency Department personnel and Transfusion Service personnel will be responsible for maintaining the proper storage and transportation requirements of these units."

When asked for a copy of the contract for blood bank services on 5/20/19 at 9:20AM, Director B provided a document titled, "Limited Transfusion Services Agreement", with a date of "DRAFT 03/03/2019." Review of the document revealed the effective date was left blank and the documented was not signed by either party.

Review of the document revealed, "THIS LIMITED TRANSFUSION SERVICES AGREEMENT (this "Agreement") is entered into as of _________ , 2019, between Wisconsin Diagnostics Laboratory, LLC, a Wisconsin limited liability company ("Laboratory"), and Community Memorial Hospital of Menomonee Falls, Inc., a Wisconsin nonstock, nonprofit corporation ("Provider")."

During an interview conducted on 5/20/19 at 11:42am, when asked about the status of the contract, Director B stated, "there are ongoing negotiations regarding the fee schedule, but the contract is expected to be signed by the next board meeting."

Based on record review, observation, and interview, the facility failed to ensure accurate documentation of blood product administration start and end times in 7 out of 10 patients (Patient #'s 1, 2, 3, 5, 8, 9, 10) in a total of 10 records reviewed; failed to assess complete vital signs for patients receiving blood products per policy in 6 out of 10 patients (Patients #1, 2, 5, 8, 9, 10) in a total of 10 records reviewed; failed to administer blood products within timeframes and at rates defined by facility policy in 8 out of 10 patients (Patients #2, 3, 4, 6, 7, 8, 9, 10) in a total of 10 records reviewed; and failed to monitor and document accurate temperature readings of the dedicated refrigerator used for blood storage in 7 out of a total of 140 temperature log entries reviewed.

Findings include:

Facility staff failed to follow approved policies and procedures for the administration of blood and blood products, and failed to follow approved policies and procedures for monitoring patients receiving blood and blood products. See Tag A409.

These deficient practices have the potential for negative outcome to all patients who receive blood or blood products at the facility.

Based on record review, observation, and interview, the facility failed to ensure accurate documentation of blood product administration start and end times in 7 out of 10 patients (Patient #'s 1, 2, 3, 5, 8, 9, 10) in a total of 10 records reviewed; failed to document vital signs for patients receiving blood products per policy in 6 out of 10 patients (Patients #1, 2, 5, 8, 9, 10) in a total of 10 records reviewed; failed to administer blood products within timeframes and at rates defined by facility policy in 8 out of 10 patients (Patients #2, 3, 4, 6, 7, 8, 9, 10) in a total of 10 records reviewed; and failed to monitor and document accurate temperature readings of the dedicated refrigerator used for blood storage in 7 out of a total of 140 temperature log entries reviewed.

Findings include:

Review of facility policy #65000-054 titled, "Administration of Blood and Blood Products (CMH) [Community Memorial Hospital]", no date, revealed, "Policy...Transfusion...I. Administration of blood products should be completed within the stated administration times...a. One unit of PRBCs (Packed Red Blood Cells) or WB (Whole Blood) is administered over 2 to 4 hours, in a hemodynamically stable patient...Procedure...11. Start the blood product at 60ml/hr (milliliters per hour)...12. After the first 15 minutes, obtain and document VS (vital signs). If there are no signs of an adverse reaction, increase the rate to complete blood product in time frames identified above...Procedure...4. Obtain and document a baseline set of vital signs within 30 minutes prior to initiation of transfusion...12. After the first 15 minutes, obtain and document VS (vital signs)...16. Obtain and document vital signs at the completion of the transfusion."

Patient #1's closed medical record was reviewed on 5/20/19 at 2:36PM with RN Educator G who confirmed the following:

Patient #1 was admitted to the emergency department on 12/11/18 with a chief complaint of altered mental status. Review of the "Patient Care Timeline" in the electronic medical record revealed an order placed by the attending physician on 12/12/18 at 12:49AM, "Transfuse Uncrossmatched Red Blood Cells, 2 Units."

Review of the "Certification Record of Blood Transfusion", dated 12/12/18 revealed a blood administration start time of "0100" (1:00AM). Review of the "Blood Administration" flowsheet in the emergency department electronic medical record, dated 12/12/18 revealed a blood administration start time of "0045" (12:45AM), a documentation discrepancy of 15 minutes.

Review of the "Blood Administration," "Device Data," and "Vitals I & O (intake and output) Summary" flowsheets in the emergency department electronic medical record dated 12/12/18 revealed a blood administration start time for unit 1 documented as "0045" (12:45AM). At 1:12AM, 27 minutes after the start of the transfusion, a pulse and blood pressure were documented. At 1:21AM, 36 minutes after the start of the transfusion, a temperature was documented. There was no respiratory rate documented. A full set of vitals 15 minutes after the start of the transfusion was not documented, per facility policy.

Patient #1 was transferred to another facility at 1:45AM with unit #1 still transfusing.

Patient #2's closed medical record was reviewed on 5/20/19 at 2:13PM with RN Educator G who confirmed the following:

Patient #2 was admitted to the emergency department on 10/28/18 with a chief complaint of abnormal labs and anemia (low blood count). Review of the "Patient Care Timeline" in the electronic medical record revealed an order placed by the attending physician on 10/28/18 at 10:42AM, "Transfuse Crossmatched Red Blood Cells, 2 Units."

Review of the "Certification Record of Blood Transfusion", dated 10/28/18 revealed a blood administration start time for unit 1 of "1406" (2:06PM). Review of the "Blood Administration" flowsheet in the emergency department electronic medical record, dated 10/28/18 revealed a blood administration start time for unit 1 of "1415" (2:15PM), a documentation discrepancy of 9 minutes.

Review of the "Certification Record of Blood Transfusion", dated 10/28/18 revealed a blood administration start time for unit 2 of "1510" (3:20PM). Review of the "Blood Administration" flowsheet in the emergency department electronic medical record, dated 10/28/18 revealed a blood administration start time for unit 2 of "1532" (3:32PM), a documentation discrepancy of 12 minutes.

Review of the "Blood Administration" flowsheet in the emergency department electronic medical record dated 10/28/18 revealed unit 1 of crossmatched blood was started at 2:15PM at a rate of "300ml/hr (milliliters per hour)." Further review of the record revealed the unit of blood was complete at 3:10PM; a total transfusion time of 55 minutes. The unit of blood was started at a rate faster than defined in facility policy and was completed in a timeframe less than defined in facility policy.

Review of the "Blood Administration" flowsheet in the emergency department electronic medical record dated 10/28/18 revealed unit 2 of crossmatched blood was started at 3:32PM at a rate of "300ml/hr (milliliters per hour)." Further review of the record revealed the unit of blood was complete at 5:40PM; a total transfusion time of 2 hours and 8 minutes. The unit of blood was started at a rate faster than defined in facility policy.

Review of the "Blood Administration," "Device Data," and "Vitals I & O (intake and output) Summary" flowsheets in the emergency department electronic medical record dated 10/28/18 revealed a blood administration start time for unit 1 documented as "1415" (2:15PM). At 2:17PM, 2 minutes after the start of the transfusion, a pulse, blood pressure, and respiratory rate were documented. There was no temperature documented. A full set of vitals 15 minutes after the start of the transfusion was not documented, per facility policy.

Review of the "Blood Administration," "Device Data," and "Vitals I & O (intake and output) Summary" flowsheets in the emergency department electronic medical record, dated 10/28/18 revealed a blood administration start time for unit 2 of "1532" (3:32PM). At 4:00PM, 28 minutes after the start of the transfusion, a pulse, blood pressure, and respiratory rate were documented. There was no temperature documented. A full set of vitals 15 minutes after the start of the transfusion was not documented, per facility policy.

Review of the "Blood Administration," "Device Data," and "Vitals I & O (intake and output) Summary" flowsheets in the emergency department electronic medical record dated 10/28/18 revealed a blood administration end time for unit 1 documented as "1510" (3:10PM). There were no vitals documented at this time. At 3:30PM, 20 minutes after the completion of the transfusion, a pulse, blood pressure, and respiratory rate were documented. There was no temperature documented. A full set of vitals upon completion of the blood product transfusion was not documented, per facility policy.

Review of the "Blood Administration," "Device Data," and "Vitals I & O (intake and output) Summary" flowsheets in the emergency department electronic medical record, dated 10/28/18 revealed a blood administration end time for unit 2 of "1740" (5:40PM). At 5:40PM, the documented time of completion, a pulse and respiratory rate was documented. There was no blood pressure or temperature documented. At 6:01PM, 21 minutes after the completion of the transfusion, a pulse, blood pressure, and respiratory rate were documented. There was no temperature documented. A full set of vitals upon completion of the blood product transfusion was not documented, per facility policy.

Patient #3's closed medical record was reviewed on 5/20/19 at 2:26PM with RN Educator G who confirmed the following:

Patient #3 was admitted to the emergency department on 11/20/18 with a chief complaint of left sided pain and vaginal bleeding. Review of the "Patient Care Timeline" in the electronic medical record revealed an order placed by the attending physician on 11/20/18 at 4:13PM, "Transfuse Crossmatched Red Blood Cells, 2 Units."

Review of the "Certification Record of Blood Transfusion", dated 11/20/18 revealed a blood administration end time for unit 1 of "2150" (9:50PM). Review of the "Blood Administration" flowsheet in the emergency department electronic medical record, dated 11/20/18 revealed a blood administration end time for unit 1 of "2200" (10:00PM), a documentation discrepancy of 10 minutes.

Review of the "Certification Record of Blood Transfusion", dated 11/20/18 revealed a blood administration start time for unit 2 of "2200" (10:00PM). Review of the "Blood Administration" flowsheet in the emergency department electronic medical record, dated 11/20/18 revealed a blood administration start time for unit 2 of "2150" (9:50PM), a documentation discrepancy of 10 minutes.

Review of the "Certification Record of Blood Transfusion", dated 11/20/18 revealed a blood administration end time for unit 2 of "2326" (11:26PM). Review of the "Blood Administration" flowsheet in the emergency department electronic medical record, dated 11/20/18 revealed a blood administration end time for unit 2 of "2245" (10:45PM), a documentation discrepancy of 41 minutes.

Review of the "Blood Administration" flowsheet in the emergency department electronic medical record dated 11/20/18 revealed unit 2 of crossmatched blood was started at 9:50PM at a rate of "60mL/hr (milliliters per hour)." At 10:15PM, 25 minutes after the start of the transfusion, documentation revealed a rate increase to "240mL/hr." Further review of the record revealed the unit of blood was complete at 10:45PM; a total transfusion time of 55 minutes. The unit of blood was completed in a timeframe less than defined in facility policy.

Patient #4's closed medical record was reviewed on 5/20/19 at 2:53PM with RN Educator G who confirmed the following:

Patient #4 was admitted to the emergency department on 12/13/18 for a chief complaint of abnormal labs and a low hemoglobin and hematocrit (low blood count). Review of the "Patient Care Timeline" in the electronic medical record revealed an order placed by the attending physician on 12/13/18 at 10:58AM, "Transfuse Crossmatched Blood, 2 Units."

Review of the "Blood Administration" flowsheet in the emergency department electronic medical record dated 12/13/18 revealed unit 2 of crossmatched blood was started at 4:57PM at a rate of "60mL/hr (milliliters per hour)." Further review of the record revealed the unit of blood was complete at 6:45PM; a total transfusion time of 1 hour and 48 minutes. The unit of blood was completed in a timeframe less than defined in facility policy.

Patient #5's closed medical record was reviewed on 5/20/19 at 3:00PM with RN Educator G who confirmed the following:

Patient #5 was admitted to the emergency department on 2/19/19 with a chief complaint of a history of low platelets. Review of the "Patient Care Timeline" in the electronic medical record revealed an order placed by the attending physician on 2/19/19 at 12:55PM, "Transfuse Crossmatched Platelets, 1 Unit."

Review of the "Certification Record of Blood Transfusion", dated 2/19/19 revealed a blood administration end time for unit 1 of "1530" (3:30PM). Review of the "Blood Administration" flowsheet in the emergency department electronic medical record, dated 2/19/19 revealed a blood administration end time for unit 1 of "1536" (3:36PM), a documentation discrepancy of 6 minutes.

Review of the "Blood Administration," "Device Data," and "Vitals I & O (intake and output) Summary" flowsheets in the emergency department electronic medical record, dated 2/19/19 revealed a blood administration start time for unit 1 of "1500" (3:00PM). At 3:17PM, 17 minutes after the start of the transfusion, a pulse, blood pressure, and respiratory rate were documented. There was no temperature documented. A full set of vitals 15 minutes after the start of the transfusion was not documented, per facility policy.

Review of the "Blood Administration," "Device Data," and "Vitals I & O (intake and output) Summary" flowsheets in the emergency department electronic medical record, dated 2/19/19 revealed a blood administration end time for unit 1 of "1536" (3:36PM). There were no vitals documented at this time. At 3:46PM, 10 minutes after the completion of the transfusion, a pulse, blood pressure, and respiratory rate were documented. There was no temperature documented. A full set of vitals upon completion of the blood product transfusion was not documented, per facility policy.

Patient #6's closed medical record was reviewed on 5/20/19 at 1:05PM with RN Educator G who confirmed the following:

Patient #6 was admitted to the emergency department on 7/13/18 for a chief complaint of abnormal labs and a low hemoglobin and hematocrit (low blood count). Review of the "Patient Care Timeline" in the electronic medical record revealed an order placed by the attending physician on 7/13/18 at 2:08PM, "Transfuse Crossmatched Blood, 2 Units."

Review of the "Blood Administration" flowsheet in the emergency department electronic medical record dated 7/13/18 revealed unit 1 of crossmatched blood was started at 5:37PM at a rate of "60mL/hr (milliliters per hour)." Further review of the record revealed the unit of blood was complete at 7:25PM; a total transfusion time of 1 hour and 48 minutes. The unit of blood was completed in a timeframe less than defined in facility policy.

Review of the "Blood Administration" flowsheet in the emergency department electronic medical record dated 7/13/18 revealed unit 2 of crossmatched blood was started at 7:45PM at a rate of "60mL/hr (milliliters per hour)." Further review of the record revealed the unit of blood was complete at 9:03PM; a total transfusion time of 1 hour and 18 minutes. The unit of blood was completed in a timeframe less than defined in facility policy.

Patient #7's closed medical record was reviewed on 5/20/19 at 1:14PM with RN Educator G who confirmed the following:

Patient #7 was admitted to the emergency department on 7/16/18 for a chief complaint of a sore throat. Review of the "Patient Care Timeline" in the electronic medical record revealed an order placed by the attending physician on 7/16/18 at 6:32PM, "Transfuse Crossmatched Blood, 1 Unit."

Review of the "Blood Administration" flowsheet in the emergency department electronic medical record dated 7/16/18 revealed unit 1 of crossmatched blood was started at 11:42PM at a rate of "60mL/hr (milliliters per hour)." Further review of the record revealed the unit of blood was complete on 7/17/18 at 1:19AM; a total transfusion time of 1 hour and 37 minutes. The unit of blood was completed in a timeframe less than defined in facility policy.

Patient #8's closed medical record was reviewed on 5/20/19 at 1:24PM with RN Educator G who confirmed the following:

Patient #8 was admitted to the emergency department on 7/20/18 with a chief complaint of fatigue and anemia (low blood count). Review of the "Patient Care Timeline" in the electronic medical record revealed an order placed by the attending physician on 7/20/18 at 8:54AM, "Transfuse Crossmatched Red Blood Cells, 2 Units."

Review of the "Certification Record of Blood Transfusion", dated 7/20/18 revealed a blood administration start time for unit 1 of "1230" (12:30PM). Review of the "Blood Administration" flowsheet in the emergency department electronic medical record, dated 7/20/18 revealed a blood administration start time for unit 1 of "1233" (12:33PM), a documentation discrepancy of 3 minutes.

Review of the "Certification Record of Blood Transfusion", dated 7/20/18 revealed a blood administration start time for unit 2 of "1549" (3:49PM). Review of the "Blood Administration" flowsheet in the emergency department electronic medical record, dated 7/20/18 revealed a blood administration start time for unit 2 of "1545" (3:45PM), a documentation discrepancy of 4 minutes.

Review of the "Blood Administration" flowsheet in the emergency department electronic medical record dated 7/20/18 revealed unit 2 of crossmatched blood was started at 3:45PM at a rate of "300ml/hr (milliliters per hour)." Further review of the record revealed the unit of blood was complete at 6:34PM; a total transfusion time of 2 hours and 49 minutes. The unit of blood was started at a rate faster than defined in facility policy

Review of the "Blood Administration," "Device Data," and "Vitals I & O (intake and output) Summary" flowsheets in the emergency department electronic medical record, dated 7/20/18 revealed a blood administration start time for unit 1 of "1233" (12:33PM). At 12:48PM, 15 minutes after the start of the transfusion, a pulse, blood pressure, and respiratory rate were documented. There was no temperature documented. A full set of vitals 15 minutes after the start of the transfusion was not documented, per facility policy.

Review of the "Blood Administration," "Device Data," and "Vitals I & O (intake and output) Summary" flowsheets in the emergency department electronic medical record, dated 7/20/18 revealed a blood administration start time for unit 2 of "1545" (3:45PM). At 4:00PM, 15 minutes after the start of the transfusion, a pulse, blood pressure, and respiratory rate were documented. There was no temperature documented. A full set of vitals 15 minutes after the start of the transfusion was not documented, per facility policy.

Review of the "Blood Administration," "Device Data," and "Vitals I & O (intake and output) Summary" flowsheets in the emergency department electronic medical record, dated 7/20/18 revealed a blood administration end time for unit 1 of "1530" (3:30PM). At 3:31PM, 1 minute after the completion of the transfusion, a pulse, blood pressure, and respiratory rate were documented. There was no temperature documented. A full set of vitals upon completion of the blood product transfusion was not documented, per facility policy.

Review of the "Blood Administration," "Device Data," and "Vitals I & O (intake and output) Summary" flowsheets in the emergency department electronic medical record, dated 7/20/18 revealed a blood administration end time for unit 2 of "1834" (6:34PM). There were no vitals documented at this time. At 6:12PM, 22 minutes prior to the completion of the transfusion, a pulse and respiratory rate were documented. At 6:20PM, 14 minutes prior to the completion of the transfusion, a temperature was documented. There was no blood pressure documented. No additional documentation of vitals was found after 6:20PM. A full set of vitals upon completion of the blood product transfusion was not documented, per facility policy.

Patient #9's closed medical record was reviewed on 5/20/19 at 1:46PM with RN Educator G who confirmed the following:

Patient #9 was admitted to the emergency department on 9/26/18 with a chief complaint of lightheadedness. Review of the "Patient Care Timeline" in the electronic medical record revealed an order placed by the attending physician on 9/26/18 at 11:10AM, "Transfuse Crossmatched Red Blood Cells, 2 Units."

Review of the "Certification Record of Blood Transfusion", dated 9/26/18 revealed a blood administration end time for unit 1 of "1805" (6:05PM). Review of the "Blood Administration" flowsheet in the emergency department electronic medical record, dated 9/26/18 revealed a blood administration end time for unit 1 of "1807" (6:07PM), a documentation discrepancy of 2 minutes.

Review of the "Blood Administration" flowsheet in the emergency department electronic medical record dated 9/26/18 revealed unit 1 of crossmatched blood was started at 4:23PM at a rate of "150mL/hr (milliliters per hour)." Further review of the record revealed the unit of blood was complete at 6:07PM; a total transfusion time of 1 hour and 44 minutes. The unit of blood was started at a rate faster than defined in facility policy and was completed in a timeframe less than defined by facility policy.

Review of the "Blood Administration" flowsheet in the emergency department electronic medical record dated 9/26/18 revealed unit 2 of crossmatched blood was started at 6:10PM at a rate of "150mL/hr (milliliters per hour)." Further review of the record revealed the unit of blood was complete at 8:18PM; a total transfusion time of 2 hours and 8 minutes. The unit of blood was started at a rate faster than defined in facility policy.

Review of the "Blood Administration," "Device Data," and "Vitals I & O (intake and output) Summary" flowsheets in the emergency department electronic medical record, dated 9/26/18 revealed a blood administration end time for unit 1 of "1807" (6:07PM). At 6:07PM, the time of completion, a temperature was documented. No other vitals were documented at this time. At 6:15PM, 8 minutes after completion of the transfusion, pulse, blood pressure, and respiratory rate were documented. A full set of vitals upon completion of the blood product transfusion was not documented, per facility policy.

Patient #10's closed medical record was reviewed on 5/20/19 at 2:01PM with RN Educator G who confirmed the following:

Patient #10 was admitted to the emergency department on 10/12/18 with a chief complaint of leg pain. Review of the "Patient Care Timeline" in the electronic medical record revealed an order placed by the attending physician on 10/12/18 at 1:01PM, "Transfuse Crossmatched Red Blood Cells, 2 Units."

Review of the "Certification Record of Blood Transfusion", dated 10/12/18 revealed a blood administration start time for unit 1 of "1710" (5:10PM). Review of the "Blood Administration" flowsheet in the emergency department electronic medical record, dated 10/12/18 revealed a blood administration start time for unit 1 of "1659" (4:59PM), a documentation discrepancy of 11 minutes.

Review of the "Certification Record of Blood Transfusion", dated 10/12/18 revealed a blood administration start time for unit 2 of "1850" (6:50PM). Review of the "Blood Administration" flowsheet in the emergency department electronic medical record, dated 10/12/18 revealed a blood administration start time for unit 2 of "1849" (6:49PM), a documentation discrepancy of 1 minute.

Review of the "Certification Record of Blood Transfusion", dated 10/12/18 revealed a blood administration end time for unit 2 of "2045" (8:45PM). Review of the "Blood Administration" flowsheet in the emergency department electronic medical record, dated 10/12/18 revealed a blood administration end time for unit 2 of "2044" (8:44PM), a documentation discrepancy of 1 minute.

Review of the "Blood Administration" flowsheet in the emergency department electronic medical record dated 10/12/18 revealed unit 1 of crossmatched blood was started at 4:59PM at a rate of "300mL/hr (milliliters per hour)." Further review of the record revealed the unit of blood was complete at 6:35PM; a total transfusion time of 1 hour and 36 minutes. The unit of blood was started at a rate faster than defined in facility policy and was completed in a timeframe less than defined by facility policy.

Review of the "Blood Administration" flowsheet in the emergency department electronic medical record dated 10/12/18 revealed unit 2 of crossmatched blood was started at 6:49PM at a rate of "300mL/hr (milliliters per hour)." Further review of the record revealed the unit of blood was complete at 8:44PM; a total transfusion time of 1 hour and 55 minutes. The unit of blood was started at a rate faster than defined in facility policy and was completed in a timeframe less than defined by facility policy.

Review of the "Blood Administration," "Device Data," and "Vitals I & O (intake and output) Summary" flowsheets in the emergency department electronic medical record, dated 10/12/18 revealed a blood administration end time for unit 1 of "1835" (6:35PM). There were no vitals documented at this time. At 7:00PM, 25 minutes after the completion of the transfusion, a full set of vitals (pulse, blood pressure, respiratory rate, temperature) was documented. A full set of vitals upon completion of the blood product transfusion was not documented, per facility policy.

During an interview on 5/20/19 at 1:30PM, when asked what vital signs are expected to be collected, RN Educator G stated, "a full set." When asked about the definition of a full set of vitals, RN Educator G stated, "temperature, pulse, blood pressure, and respiratory rate."

During observation and interview conducted on 5/20/19 at 10:56AM, the blood storage refrigerator in the Moorland Reserve Emergency Department was observed to have 4 different temperature monitoring devices. Manager F stated, "Respiratory Therapists are in charge of checking in the blood and monitoring the temperatures."

Device #1 was hardwired and monitored by another location.
Device #2 was a thermometer located within the refrigerator and required direct observation and recording.
Device #3 was an automatic recording wheel located on the top of the refrigerator. The wheel continuously monitors and automatically records the internal temperature of the refrigerator for a 7-day period.
Device #4 was the refrigerator's digital display.

Manager F and Respiratory Therapist (RT) D confirmed facility staff did not check and were not responsible for Device #1, and Manager F stated, "If it [Device #1] alarms, I get notified." RT D stated the expectation was that the 3 remaining devices were checked by facility staff and the readings were to be documented daily on the document titled, "Weekly Temperature Recording; Blood Storage Refrigerators Off-Site Locations; Moorland Reserve Emergency Department", dated 9/3/17. RT D also stated the automatic wheel paper was "changed every Monday morning" and the completed wheel was to be attached to the weekly temperature recording log. When asked what the temperature of the blood storage refrigerator is expected to be, RT D stated, "I think its 3 [degrees Celsius]," and the temperature on the digital display, the recording wheel, and the internal thermometer should be "plus or minus 0.2 degrees from each other."

Review of the completed logs between 12/31/18 and 5/19/19 titled, "Weekly Temperature Recording; Blood Storage Refrigerators Off-Site Locations; Moorland Reserve Emergency Department", dated 9/3/17, and the completed weekly chart wheels which were attached revealed discrepancies between the automated wheel temperature and the staff entry in 7 out of a total of 140 temperature log entries in the section titled, "Chart Recorder Temp. (Temperature)."

On 2/4/19, the automatic chart wheel revealed a recorded temperature of "0" degrees Celsius. Facility staff documented the "Chart Recorder Temp. (temperature)" on the "Weekly Temperature Recording" log as "3.0" degrees Celsius.

On 2/5/19, the automatic chart wheel revealed a recorded temperature of "0" degrees Celsius. Facility staff documented the "Chart Recorder Temp. (temperature)" on the "Weekly Temperature Recording" log as "3.0" degrees Celsius.

On 2/6/19, the automatic chart wheel revealed a recorded temperature of "0" degrees Celsius. Facility staff documented the "Chart Recorder Temp. (temperature)" on the "Weekly Temperature Recording" log as "3.0" degrees Celsius.

On 2/7/19, the automatic chart wheel revealed a recorded temperature of "0" degrees Celsius. Facility staff documented the "Chart Recorder Temp. (temperature)" on the "Weekly Temperature Recording" log as "0.0" degrees Celsius.

On 2/11/19, the automatic chart wheel failed to record a temperature. Facility staff documented the "Chart Recorder Temp. (temperature)" on the "Weekly Temperature Recording" log as "3.0" degrees Celsius.

On 2/12/19, the automatic chart wheel failed to record a temperature. Facility staff documented the "Chart Recorder Temp. (temperature)" on the "Weekly Temperature Recording" log as "3.0" degrees Celsius.

On 2/13/19, the automatic chart wheel failed to record a temperature until 3:00PM. Facility staff documented the "Chart Recorder Temp. (temperature)" on the "Weekly Temperature Recording" log as "3.0" degrees Celsius.

Based on record review and interview, the facility staff failed to obtain accurate and complete consent forms for blood product administration in 2 of 10 patients who required blood product administration out of a total of 10 records reviewed. (Patients #2, 3)

Findings include:

Review of the facility form # CMH-C-00149 titled "CHD [Community Hospital Division] - Informed Consent/Refusal for Transfusion of Blood and/or Blood Products", dated 08/16, revealed a signature area at the bottom of the form including, "Signature of Patient...(Date/Time)...Signature of person legally authorized to consent for Patient...(Date/Time)...Relationship to Patient:...Witness...(Date/Time)...Witness...(Date/Time)...Patient is unable to sign because:...*When other than the Patient consent is obtained, two (2) witnesses shall be present and sign above."

Patient #2's closed medical record was reviewed with RN Educator G who confirmed the following:
Review of Patient #2's electronic medical record revealed the "Informed Consent/Refusal for Transfusion of Blood and/or Blood Products" on 10/28/18 was not signed by Patient #2. Further review of the consent revealed a signature, date, and time in the "Signature of person legally authorized to consent for Patient...(Date/Time)" section, and "Relationship to Patient: Son." There was only 1 witness signature. The section, "Patient is unable to sign because:" is blank.

Patient #3's closed medical record was reviewed with RN Educator G who confirmed the following:
Review of Patient #3's electronic medical record revealed the "Informed Consent/Refusal for Transfusion of Blood and/or Blood Products" on 11/20/18 was not dated or timed in the "Signature of Patient" area. There was no time in the "Witness" area.

During an interview on 5/20/19 at 2:15PM, Director B and Director C stated, "The expectation is that there are 2 witnesses if someone other than the patient signs. The statement on the consent is correct; there should have been 2 witnesses for [Patient #2]'s consent."