The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

TAYLOR REGIONAL HOSPITAL 1700 OLD LEBANON ROAD CAMPBELLSVILLE, KY 42718 Sept. 27, 2019
VIOLATION: NURSING SERVICES Tag No: A0385
Based on interview, record review, and review of facility policy, it was determined the facility failed to ensure a Registered Nurse (RN) supervised and/or evaluated the nursing care for one (1) of ten (10) sampled patients (Patient #1).

On 06/21/19, Patient #1 was assessed upon admission to be in respiratory distress (short of breath, increased respiratory rate, using accessory muscles to breathe, with diminished breath sounds, and with low oxygen saturation levels in the mid 80's); however, nursing staff failed to notify a facility physician of concerns with Patient #1's respiratory status upon admission and prior to initiating a blood transfusion. In addition, the RN failed to evaluate changes in vital signs per the facility policy during the patient's blood transfusion. Patient #1 was found unresponsive "without a pulse and cyanotic" on 06/21/19 at 6:15 PM (approximately one hour and seventeen minutes) after the blood transfusion was completed.
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview, record review, and review of facility policy, it was determined the facility failed to ensure a Registered Nurse (RN) supervised and/or evaluated the nursing care for one (1) of ten (10) sampled patients (Patient #1). The facility failed to ensure nursing staff assessed and monitored the care of Patient #1 on 06/21/19. Patient #1 was assessed upon admission to be in respiratory distress (short of breath, increased respiratory rate, using accessory muscles to breathe, with diminished breath sounds, and with low oxygen saturation levels in the mid 80's); however, nursing staff failed to notify a facility physician of concerns with Patient #1's respiratory status upon admission and prior to initiating a blood transfusion. In addition, the RN failed to evaluate changes in vital signs per facility policy during the patient's blood transfusion. Patient #1 was found unresponsive "without a pulse and cyanotic" on 06/21/19 at 6:15 PM (approximately one hour and seventeen minutes) after the blood transfusion was completed.

The findings include:

Review of the facility policy titled "Recognition, Reporting and Management of Suspected Blood Transfusion Reactions/Complications," revised March 2015, revealed "the symptoms associated with transfusion related sepsis included: shaking, chills, hemoglobinuria, DIC, oliguria/anuria, fever over 102 (degrees) F or rise of 3.5 (degrees) F over pre-transfusion values, drop or rise in blood pressure of 30/mm hg (millimeters of mercury) over pre-transfusion values. Febrile non-[DIAGNOSES REDACTED] reactions were listed as: temperature increase of 2 degrees F, chills, and rigors. Immune-mediated hemolysis reactions listed were: fever rise of 2 degrees Fahrenheit, chills, pain in chest, lower back, abdomen and/or infusion site, hypotension (decrease of blood pressure by 20 mm/hg), nausea, flushing, dyspnea, [DIAGNOSES REDACTED], hemoglobinuria, bilirubinemia/bilirubinuria, Oliguria/Anuria, Acute Pancreatitis, Shock, Generalized Bleeding (DIC) and Anaphylactic Reactions (occur after infusion of only a few ML of blood component) were listed as: coughing, bronchospasm, respiratory distress, vascular instability, hypotension, nausea, abdominal cramps and vomiting, diarrhea, and shock." Continued review of the policy revealed in the event of a suspected transfusion reaction, staff were to discontinue the transfusion, evaluate the patient status and immediately follow the steps listed: "stop transfusion, disconnect transfusion from patient, do not disconnect the blood component from tubing, but place entire set up with blood in biohazard bag, keep IV line open with slow infusion of saline, contact blood bank and return unit to blood bank immediately and notify the patient's physician immediately for orders."

Review of the policy titled, "Blood and Blood Components, Administration of, revised October 2016, revealed the RN must obtain the patient's temperature/pulse/respirations and blood pressure and record them on the blood bank requisition and in the patient's record prior to administration so that a baseline was available in a case of an adverse reaction. Continued review of the policy revealed, "if the order did not state the rate of transfusion, begin transfusion slowly at the rate of 2ML per minute for the first fifteen (15) minutes. If there are no symptoms/signs of reaction after fifteen (15) minutes, the rate could be increased to a volume the patient's circulatory system could tolerate. The blood recipient must be watched closely for the first fifteen (15) minutes as most serious transfusion reactions would occur in the first 5-15 minutes. The recipient's vital signs should be checked at least every 15 minutes x four (4) first hour, every 30 minutes x 2 then every 1 hour until one hour post transfusion."

Review of the facility policy titled, "Outpatient Medication Administration and Documentation," dated June 2011, revealed medications would be safely administered to patients as prescribed by the ordering practitioner. Once the patient was in the designated area, the RN would conduct an interview with the patient. The RN would verify the order to be performed and then perform a baseline assessment. If obtaining outpatients' medications, fluids, or treatments, obtain baseline vital signs, medications allergies, height, and weight, and list medications. All patients would need a patient profile completed, which would include but was not limited to history, patient's current medications, and physical assessment. After administration of medication, the RN would assess patient vital signs, any adverse reactions, and effectiveness of medication as indicated.

Review of the facility policy titled, "Organizational Patient Assessment/Reassessment Plan," undated, revealed each patient's need for care or treatment was assessed by qualified individuals of appropriate disciplines throughout the organization. Assessment included the collection and analysis of relevant physiological, psychological, social/environmental data regarding each patient. Continued review revealed assessment was defined as the systematic collection and review of patient-specific data necessary to determine patient care and treatment needs. Reassessments were performed by RNs when there was a change in the patient's status, a significant change in the patient's vital signs, as indicated by patient condition and/or treatment, and as evaluation of treatments rendered.

Review of the medical record for Patient #1 from Emergency Medical Services (EMS) dated 06/21/19 at 8:00 AM revealed EMS picked up patient at Facility #2 and transported the patient to Facility #1 for a blood transfusion. Continued review of the record revealed at 8:24 AM Patient #1's blood pressure was 113/43 with a pulse oxygen saturation level of 96% (normal range 95 - 100) on 2 liters of oxygen and at 8:39 AM with a blood pressure of 120/90 and oxygen saturation of 94% on 2 liters of oxygen. Per the EMS record, Patient #1's care was transferred to Facility #1 at 8:49 AM.

Review of the medical record for Patient #1 (from Facility #1) revealed the facility admitted the patient on 06/21/19 at 10:12 AM with a chief complaint of "anemia" under the care of Advanced Practice Registered Nurse (APRN) #1 and Physician #3.

Review of the Admission Assessment for Patient #1 revealed RN #1 documented Patient #1 was on the unit on 06/21/19 at 10:12 AM from Facility #2. RN #1 documented that Patient #1's orientation was to "person, place and time." There was no documented evidence that Patient #1's vital signs were obtained upon admission or monitored prior to the blood transfusion.

Review of the Nursing Notes dated 06/21/19 at 10:43 AM revealed RN #1 documented Patient #1 was resting in bed, wearing two (2) liters oxygen via nasal cannula, and was fairly short of breath (SOB). RN #1 documented that Patient #1 reported he/she was more short of breath than usual, and was using accessory muscles to breathe. The RN documented the patient had diminished breath sounds over all lobes, was obese, had generalized edema, and had an existing 18 gauge intravenous (IV) site in the left forearm. Patient #1 was alert and oriented times three but was a somewhat poor historian.

Review of the Physician Orders dated 06/20/19 at 2:00 PM revealed an order written by APRN #1 for "type and cross for one (1) unit packed red blood cells (PRBC) and administer on 06/21/19 and may use established saline lock if desired." The physician's orders did not include an order for oxygen.

Review of the "Transfusion Vital Signs" dated 06/21/19 at 2:00 PM revealed the blood transfusion was started and Patient #1's temperature was 97.1, pulse rate was 111, respiratory rate was 24, and blood pressure was 96/54 with an oxygen saturation of 84%. There was no evidence in the Transfusion log or Nurse's Notes that RN #1 reassessed the patient's condition prior to initiating the blood transfusion. Patient #1's vital signs at 2:15 PM were temperature of 97.3, pulse rate - 104, respiratory rate - 24, and blood pressure - 124/94 with an oxygen saturation of 85%. The patient's blood pressure rose 40 mmHg (Millimeters of Mercury) in 15 minutes from 54 diastolic to 94 diastolic. Per facility policy if there was a rise in blood pressure of 30 mm, staff were to stop the transfusion and notify a facility physician for further orders; however, the transfusion was not stopped and the physician was not notified.

Continued review of the Transfusion log revealed Patient #1's vital signs taken at 2:30 PM were documented as temperature - 97.3, pulse rate - 115, respiratory rate - 22, and blood pressure - 84/50 with an oxygen saturation of 83%. The patient's blood pressure had decreased 40 mm systolic and 44 mm diastolic in 15 minutes. Per the facility policy, a decrease in blood pressure by 20 mmHg, staff should stop the transfusion and notify a facility physician; however, there was no evidence the physician was notified or that the transfusion was stopped. Patient #1's vital signs taken at 2:45 PM were documented as temperature of 97.3, pulse rate - 86, respiratory rate - 24, and blood pressure - 110/54 with an oxygen saturation of 82%; vital signs taken at 3:00 PM were documented as temperature of 97.5, pulse rate - 100, respiratory rate - 24, and blood pressure - 86/58 with an oxygen saturation of 83%. The patient's systolic blood pressure had decreased 24 mm; however, the patient's physician was not notified nor was the transfusion stopped per facility policy. The patient's vital signs taken at 3:30 PM were documented as temperature of 97.5, pulse rate - 124, respiratory rate - 24, and oxygen saturation of 85%; vital signs taken at 4:00 PM were documented as temperature of 97.5, pulse rate - 113, respiratory rate - 22, and blood pressure - 92/54, with an oxygen saturation of 87%; vital signs taken 4:58 PM were documented as temperature of 97.3, pulse rate - 83, respiratory rate - 24, and blood pressure - 82/50 with an oxygen saturation of 83%. There was no documented evidence of the rate or flow of the blood transfusion in the medical record.

Review of Patient #1's transfer assessment dated [DATE] at 5:51 PM revealed RN #1 documented Patient #1 was "stable" and returning to Facility #2 via EMS with an non-urgent transfer.

Review of the nurse's notes revealed RN #1 documented that at 6:15 PM on 06/21/19, Certified Nursing Assistant (CNA) #1 found Patient #1 unresponsive and called for RN #1; upon entering the room RN #1 found the patient "gray in color and unresponsive" and a code was called. RN #1 documented that "headboard was put under the patient and compressions were started."


Review of a "Progress Note" dated 06/21/19 documented by Physician #5 revealed he was called to a "Code Blue for [Patient #1] and CPR was in progress. [Patient #1] was admitted for outpatient blood transfusion and just finished first unit of blood." Continued review of the progress note revealed Physician #5 documented Patient #1's assessment was "Cardiorespiratory arrest after blood transfusion."

Review of Physician #2's "History and Physical/Discharge Death Summary" revealed Physician #2 documented Patient #1 was transferred to the facility for an outpatient blood transfusion. Following the blood transfusion, nursing staff reported the patient did fine and then was found "completely unresponsive and cyanotic in [his/her] face and extremities." Patient #1 was without pulse and a Code Blue was immediately called. Patient #1 was intubated and had a pulse at the time of Physician #2's arrival at Patient #1's room. Patient #1 was pronounced dead on 06/21/19 at 7:58 PM. Physician #2 documented assessment was "Cardiopulmonary arrest, questionable etiology."

Interview with RN #1 on 09/23/19 at 3:40 PM and 09/24/19 at 11:45 AM revealed that she was working on 06/21/19 and was the nurse assigned to Patient #1. RN #1 stated that to the best of her memory, Patient #1 arrived from Facility #2 via EMS with just an order for the blood transfusion. RN #1 stated that Patient #1 was anxious when he/she arrived and she contacted APRN #1 to obtain an order for Benadryl for Patient #1's anxiety. RN #1 stated that APRN #1 refused to give an order and RN #1 then contacted Facility #2 to speak with Physician #3. RN #1 stated Physician #3 was out of town and she was directed by Facility #2 to contact Physician #4 at another facility to obtain an order for Benadryl. RN #1 stated that Patient #1 was alert and oriented but somewhat of a poor historian; however, she felt she was okay to give consent for the blood transfusion. RN #1 stated that Patient #1's blood pressure was "crappy" and his/her oxygen saturations stayed in the mid 80's during the patient's entire stay. RN #1 stated that Patient #1 had several co-morbidities and she did not contact any provider at any point in time during Patient #1's stay regarding the patient's change in blood pressure or the patient's low oxygen saturation. RN #1 stated that she did not feel like Patient #1 was having a reaction to the blood transfusion and that is why she did not contact anyone regarding the patient's vital signs. RN #1 stated she felt like this was the patient's condition because of his/her history of Chronic Obstructive Pulmonary Disease (COPD) and did not feel like it had anything to do with the blood transfusion and that is why she did not contact a physician. Further interview with RN #1 revealed that she took the patient's vital signs at 2:00 PM and 2:15 PM and then the CNA took the rest of the documented vital signs. RN #1 stated she was in and out of Patient #1's room monitoring the blood transfusion; however, there was no documented evidence of the nurse monitoring Patient #1 in the medical record. RN #1 stated that Patient #1 was placed on 2 liters of oxygen per EMS; however, she did not obtain an order from any provider for the oxygen to be administered to Patient #1. RN #1 stated that upon admission to the facility the CNA would obtain vital signs on a patient and then nursing staff would document those vital signs in the medical record. RN #1 stated she was sure that CNA #1 obtained vital signs on Patient #1 when the patient was admitted to the facility and did not know why those were not included the medical record.

Interview with the Chief Nursing Officer (CNO) on 09/23/19 at 2:45 PM, 09/25/19 at 9:15 AM, and 09/26/19 at 1:30 PM revealed it was the expectation of the facility for nursing staff to assess and then reassess all patients regardless of their admission status in the facility. The CNO stated that RN #1 should have contacted a provider regarding Patient #1's change in vital signs during the blood transfusion. According to the CNO, RN #1 should have contacted a facility physician upon Patient #1's admission to the facility to inform them of the patient's admission, of the patient's condition, and to obtain an order for the DNR. The CNO also stated that she would never discharge a patient from the facility with a blood pressure of 82/50 and that a provider should have been contacted. Continued interview with the CNO revealed that nursing staff should monitor all blood transfusions closely and that the facility had not defined what "closely monitor" meant. The CNO also stated that CNAs did obtain vital signs for patients and that practice was standard; however, for blood transfusions it was not good practice because of the possible reactions and the RN should obtain the patient's vital signs. The CNO stated that RN #1 was a "good" nurse; however, she did not follow facility policy regarding blood transfusions.

Interview with Physician #4 (President-elect for Medical Staff) on 09/26/19 at 2:20 PM revealed when reviewing the initial vital signs for Patient #1, he stated that those particular vital signs were not contraindicated for a blood transfusion; however, Patient #1's vital signs were outside the normal range and he would expect to be notified of any vital signs that are outside of the normal range. Continued interview with Physician #4 revealed that if his patient had a blood pressure of 82/50 prior to discharge from the facility he would expect to be notified and he would come and assess the patient before he would discharge the patient from the facility. Physician #4 stated it was difficult to comment on Patient #1's condition and make recommendations without knowing the patient's history; however, he stated that if Patient #1 was his patient at the facility he would have wanted to have been informed of the patient's condition upon admission.
VIOLATION: GOVERNING BODY Tag No: A0043
Based on interviews, record review, policy review, and review of the facility's Medical Staff By Laws and Rules and Regulations, it was determined the facility failed to ensure one (1) of ten (10) sampled patients (Patient #1) was admitted to a credentialed provider who was willing to assume the responsibility for care of the patient.

On 06/21/19, Patient #1 presented to the facility with an order for a blood transfusion from a provider, Advanced Practice Registered Nurse (APRN) #1; however, the provider told the Registered Nurse (RN) caring for the patient that she had "signed off" on the patient and was no longer responsible for the patient's care. The facility initiated treatment without a physician to assume responsibility for the care of the patient.
VIOLATION: CARE OF PATIENTS - ADMISSION Tag No: A0065
Based on interviews, record review, policy review, and review of the facility's Medical Staff By Laws and Rules and Regulations, it was determined the facility failed to ensure one (1) of ten (10) sampled patients (Patient #1) was admitted to a provider who had admitting privileges and was willing to assume the responsibility for care of the patient.

The findings include:

Review of the "Medical Staff Rules and Regulations," dated 07/23/18, revealed an Advanced Practice Registered Nurse (APRN) may initiate orders on the services of the supervising physician. Further review of the document revealed the APRN did not have independent admitting privileges. Per the "Medical Staff Rules and Regulations," "Patients may be treated/admitted on ly by physicians who have submitted proper credentials and have been duly appointed to the Medical Staff by the Board of Trustees."

Review of a facility policy titled, "Non-Emergent Outpatient Level of Care Delineation," revised November 2013 and reviewed February 2018, revealed outpatient care would be provided as appropriate, based on patient need, acuity, physician order, and regulatory guidelines. Continued review of the policy revealed any patient in a "Non-Emergent Outpatient Care setting" would have an order by an independent practitioner or a mid-level practitioner in accordance with the facility's Medical Staff Bylaws, Rules & Regulations. "The Practitioner must hold a valid [state] license for patient to be treated in a Treatment Room. IF the practitioner is NOT a member of the medical staff, a qualified staff member must agree to be available for emergencies."

Review of the medical record for Patient #1 revealed the facility admitted the patient on 06/21/19 at 10:12 AM with a chief complaint of "anemia" under the care of Advanced Practice Registered Nurse (APRN) #1 and Physician #3 was listed as the "family physician."

Review of Physician Orders for Patient #1 dated 06/20/19 at 2:00 PM revealed APRN #1 wrote orders for "type and cross for one unit PRBC [packed red blood cells] and administer on 06/21/19 and may use established saline lock if desired." The order was dated 06/20/19 at 2:00 PM and was labeled as "Physician Orders" from Facility #3 (another acute care hospital).

Interview with Registered Nurse (RN) #1 on 09/23/19 at 3:40 PM and on 09/24/19 at 11:45 AM revealed she was working on 06/21/19 and was the nurse assigned to care for Patient #1. RN #1 stated that "to the best of my memory" Patient #1 arrived from Facility #2 (the skilled nursing facility where the patient lived) via EMS with an order for a blood transfusion. RN #1 stated that Patient #1 was anxious when he/she arrived and she contacted APRN #1 to obtain an order for Benadryl for Patient #1's anxiety. However, according RN #1, APRN #1 refused to give an order and stated that she had "signed off" on Patient #1 and was not responsible for the patient's care at the facility. Further interview with RN #1 revealed she contacted Facility #2 and the attending physician (Physician #3) for the patient at that facility was out of town.

Interview with the Chief Nursing Officer (CNO) on 09/23/19 at 2:45 PM, 09/25/19 at 9:15 AM, and 09/26/19 at 1:30 PM revealed APRN #1, Physician #3, nor Physician #4 had admitting privileges at the facility.

Further interview with the Chief Nursing Officer (CNO) on 09/23/19 at 2:45 PM, 09/25/19 at 9:15 AM, and 09/26/19 at 1:30 PM revealed that she understood that the facility policy regarding assigning credentialed physicians to patients that present to the facility with orders for outpatient services was not clear.

A post-survey interview on 09/30/19 at 4:52 PM with the Credentialing Specialist revealed a APRN #1 was not permitted to admit or discharge patients to or from the facility.

Interview with the CEO on 09/26/19 at 3:50 PM revealed that she is given full authority by the board to operate the facility. The CEO stated the expectation of the facility was for all staff to follow the facility's policies and procedures and to conduct themselves within their scope of practice and professional standards. The interview with the CEO revealed she was not aware until the state agency's investigation that there was confusion regarding physician assignment for patients admitted for outpatient treatments.
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on interview, record review, and review of facility policies it was determined the facility failed to protect the rights of one (1) of ten (10) sampled patients (Patient #1).

Patient #1 presented to Facility #1 on 06/21/19, and nursing staff documented that the patient requested not to be resuscitated (DNR) should an emergency occur and that the patient had an Advance Directive on file at Facility #2. However, the facility failed to implement their policy/procedure regarding the patient's rights when the patient was found unresponsive without pulse or respirations on 06/21/19 at 6:15 PM. In addition, the facility failed to follow the patient's wishes, when the patient was resuscitated and placed on a ventilator.
VIOLATION: PATIENT RIGHTS: ADVANCED DIRECTIVES Tag No: A0132
Based on interview, record review, and review of facility policies, it was determined the facility failed to protect the rights of one (1) of ten (10) sampled patients (Patient #1). Patient #1 presented to Facility #1 on 06/21/19, and nursing staff documented that the patient requested not to be resuscitated (DNR) should an emergency occur and that the patient had an Advance Directive on file at Facility #2. However, the facility failed to implement their policy/procedure regarding the patient's rights when the patient was found unresponsive without pulse or respirations on 06/21/19 at 6:15 PM. In addition, the facility failed to follow the patient's wishes, when the patient was resuscitated and placed on a ventilator.

The findings include:

Review of the facility policy titled, "Patient Rights and Responsibilities," revised November 2012 and reviewed August 2015, revealed the facility's objective was to provide high quality care while maintaining inherent responsibility to the patient. Continued review of the policy revealed the patient had the right to refuse treatment and withdraw or deny consent at any time to the extent permitted by law and to be informed of the medical consequences of his/her action.

Review of the facility policy titled, "Do Not Resuscitate (DNR), Limitation of Treatment, Comfort Measures/Palliative Care," revised July 2015, revealed patients have the right to control the decisions related to their own medical care and those decisions would be honored. The policy stated nursing staff's role was to ensure that the proper written informed consent was signed and placed in the medical record. The policy stated that informed consent could be in the form of either a copy of an advance directive requesting this action be taken or a Do Not Resuscitate/Comfort Measures/Limitation of Treatment authorization signed by the physician, appropriate decision maker, and witnessed by a Registered Nurse (RN). Continued review of the policy revealed code status would be asked on the Admission Assessment and would be documented. If any advance decisions are identified, the patient's chart should be clearly marked with red code status stickers with the appropriate identification.

Review of the medical record for Patient #1 revealed the facility admitted the patient on 06/21/19 at 10:12 AM with a chief complaint of "anemia" under the care of Advanced Practice Registered Nurse (APRN) #1 and Physician #3.

Review of the Admission Assessment for Patient #1 revealed RN #1 documented that Patient #1 was on the unit on 06/21/19 at 10:12 AM from Facility #2. RN #1 documented that Patient #1's orientation was to "person, place and time." RN #1 documented that the patient's code status was "DNR" (DNR is a medical order issued by a physician or other authorized practitioner that directs healthcare providers not to administer CPR [Cardio Pulmonary Resuscitation] in the event of cardiac or respiratory arrest) per patient request. Due to the MD being unavailable to give an order for the DNR, the RN listed on the assessment for Patient #1 to be a "full code" with a code status comment that stated "patient reports [he/she] wants to be a DNR, and MD not available to sign." RN #1 documented that Patient #1 indicated that he/she had an advance directive "on file in medical record." However, there was no documented evidence of an Advance Directive on file in the patient's medical record or that the RN attempted to obtain the Advance Directive.

Review of the Nursing Notes dated 06/21/19 at 10:43 AM revealed RN #1 documented Patient #1 was resting in bed, wearing two (2) liters oxygen via nasal cannula, and was fairly short of breath (SOB). RN #1 documented that Patient #1 reported he/she was more short of breath than usual, and was using accessory muscles to breathe. The RN documented the patient had diminished breath sounds over all lobes, was obese, had generalized edema, and had an existing 18 gauge intravenous (IV) site in the left forearm. Patient #1 was alert and oriented times three but was a somewhat poor historian. Continued review of the medical record revealed the patient received one unit of Packed Red Blood Cells (PRBC) from 2:00 PM till 4:58 PM.

Review of the Nurse's Notes dated 06/21/19 revealed RN #1 documented that at 6:15 PM Certified Nursing Assistant (CNA) #1 found Patient #1 unresponsive and called for RN #1. RN #1 found the patient "gray in color, unresponsive," without pulse or respirations, and a "code" was called. RN #1 documented that the "headboard was put under the patient and compressions were started."

Continued review of the Nursing Notes dated 06/21/19 at 7:20 PM revealed RN #1 documented "code notes" that stated Patient #1 verbalized upon admission that he/she did not want extraordinary measures and would like to be a DNR. However, the physician was out of town and unavailable to sign. The notes stated that when Patient #1 coded, the daughter, who was the patient's Power of Attorney (POA), was contacted and stated that at this time she would like for the patient to be a full code.

Review of a "Progress Note" dated 06/21/19 documented by Physician #5 revealed he was called to a "Code Blue for [Patient #1] and CPR was in progress. [Patient #1] was admitted for outpatient blood transfusion and just finished first unit of blood." Continued review of the progress note revealed Physician #5 documented that Patient #1's assessment was "Cardiorespiratory arrest after blood transfusion."

Review of Physician #2's "History and Physical/Discharge Death Summary" revealed Physician #2 documented that Patient #1 was transferred to the facility for an outpatient blood transfusion. Following the blood transfusion nursing staff reported that the patient did fine but then was found "completely unresponsive and cyanotic in [his/her] face and extremities." Patient #1 was without pulse and a Code Blue was immediately called. Patient #1 was intubated and had a pulse at the time of Physician #2's arrival to Patient #1's room. RN #1 notified Physician #2 that Patient #1 was a DNR; however, the facility had no documentation of the DNR. Physician #2 documented that he contacted Patient #1's family and updated the family on Patient #1's status. Physician #2 documented that the family stated the patient did not want to ever be on a ventilator and the family had assured the patient this would never happen. However, the family requested to leave Patient #1 on the ventilator until the family's arrival and then they would remove the ET tube. At the family's arrival the ET tube was removed and Patient #1 was pronounced dead on 06/21/19 at 7:58 PM. Physician #2 documented assessment was "Cardiopulmonary arrest, questionable etiology."

Interview with RN #1 on 09/23/19 at 3:40 PM and on 09/24/19 at 11:45 AM revealed that she was working on 06/21/19 and was the nurse assigned to Patient #1. RN #1 stated that to the best of her memory Patient #1 arrived from Facility #2 via EMS with just an order for the blood transfusion. RN #1 stated that Patient #1 was anxious when he/she arrived and she contacted APRN #1 and Physician #4 attempting to get an order for Benadryl. The RN stated the patient's primary doctor was out of town and she did not obtain a copy of Patient #1's Advance Directive or POA paperwork from Facility #2. Continued interview with RN #1 revealed she also did not contact any provider at Facility #1 nor her immediate supervisor regarding the patient's DNR status.

Interview with the Chief Nursing Officer (CNO) on 09/23/19 at 2:45 PM, 09/25/19 at 9:15 AM, and 09/26/19 at 1:30 PM revealed it was the expectation of the facility for nursing staff to follow all facility policies. The CNO stated that RN #1 was a "good" nurse; however, she did not follow facility policy regarding DNRs. The CNO stated that only a physician from the hospital (Facility #1) could give an order for the DNR after the Advance Directive was obtained or completed.
VIOLATION: QAPI Tag No: A0263
Based on interview, record review, review of QAPI meeting minutes and policy review, it was determined the facility failed to have a Quality Assurance Program that identified adverse events following the administration of blood products and change in patient condition for one (1) of ten (10) sampled patients (Patient #1).

On 06/21/19, the facility initiated a blood transfusion for Patient #1 even though the patient was assessed to be in respiratory distress (short of breath, increased respiratory rate, using accessory muscles to breathe, with diminished breath sounds, and with low oxygen saturation levels in the mid 80's). In addition, the patient had changes in vital signs during the blood transfusion that were not addressed per the facility's policy. Patient #1 was found unresponsive on 06/21/19, approximately one hour and seventeen minutes after the blood transfusion was completed. The facility reviewed/discussed the patient's "code" (need for Cardiopulmonary Resuscitation) on 07/03/19 during a QAPI meeting; however, there was no evidence the facility identified that the patient had received a blood transfusion with a possible reaction to the blood transfusion. In addition, the facility failed to identify concerns with the nurse's assessment of the patient prior to or during the blood transfusion in the QAPI Meeting. (Refer to A385 and A395.)
VIOLATION: PATIENT SAFETY Tag No: A0286
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on interview, record review, review of QAPI meeting minutes, and policy review, it was determined the facility failed to have a Quality Assurance Program that identified adverse events following the administration of blood products. On 06/21/19, the facility initiated a blood transfusion for Patient #1 even though the patient was assessed to be in respiratory distress (short of breath, increased respiratory rate, using accessory muscles to breathe, with diminished breath sounds, and with low oxygen saturation levels in the mid 80's). In addition, the patient had changes in vital signs during the blood transfusion that were not addressed per the facility's policy. Patient #1 was found unresponsive on 06/21/19, approximately one hour and seventeen minutes after the blood transfusion was completed. The facility reviewed/discussed the patient's "code" (need for Cardiopulmonary Resuscitation) on 07/03/19 during a QAPI meeting; however, there was no evidence that the facility identified that the patient had received a blood transfusion with a possible reaction to the blood transfusion. In addition, the facility failed to identify concerns with the nurse's assessment of the patient prior to or during the blood transfusion in the QAPI Meeting. (Refer to A395.)

The findings include:

Review of the facility's "Organizational Plan-Quality," undated, revealed the Quality Department was responsible for clinical documentation improvement and for providing resources/support for other quality requirements.

Review of the "Hospital Bylaws Rules and Regulations," dated 07/23/18, revealed the purpose of the Quality Assurance Committee was to improve the clinical and non-clinical process that requires staff leadership and/or participation. The Quality Assurance Committee was to assure that the committee reviews the following incidents or occurrences: Medical assessment and treatment of patients; significant medication errors; the use of blood and blood components...The effectiveness of hospital staff's response to a change or deterioration in a patient's condition.

Review of the QA Incident Reports dated July 2019 revealed Patient #1 was listed under the heading of "Other" and labeled as "Code Blue."

Review of the Quality Assurance Committee Minutes dated 07/03/19 revealed Patient #1 was presented to the Committee as an Incident Report and labeled as "other." There was no other documented evidence that Patient #1's case was discussed.

Review of the medical record for Patient #1 (from Facility #1) revealed the facility admitted the patient on 06/21/19 at 10:12 AM with a chief complaint of "anemia" under the care of Advanced Practice Registered Nurse (APRN) #1 and Physician #3.

Review of the Admission Assessment for Patient #1 revealed RN #1 documented that Patient #1 was on the unit on 06/21/19 at 10:12 AM from Facility #2. RN #1 documented that Patient #1's orientation was to "person, place and time." There was no documented evidence that Patient #1's vital signs were obtained upon admission or monitored prior to the blood transfusion.

Review of the Nursing Notes dated 06/21/19 at 10:43 AM revealed RN #1 documented that Patient #1 was resting in bed, wearing two (2) liters oxygen via nasal cannula, and was fairly short of breath (SOB). RN #1 documented that Patient #1 reported he/she was more short of breath than usual, and was using accessory muscles to breathe. The RN documented the patient had diminished breath sounds over all lobes, was obese, had generalized edema, and had an existing 18 gauge intravenous (IV) site in the left forearm. Patient #1 was alert and oriented times three but was a somewhat poor historian.

Review of the Physician Orders dated 06/20/19 at 2:00 PM revealed an order written by APRN #1 for "type and cross for one (1) unit packed red blood cells (PRBC) and administer on 06/21/19 and may use established saline lock if desired."

Review of the "Transfusion Vital Signs" dated 06/21/19 at 2:00 PM revealed the blood transfusion was started and Patient #1's temperature was 97.1, pulse rate was 111, respiratory rate was 24, and blood pressure was 96/54 with an oxygen saturation of 84%. There was no evidence in the Transfusion log or Nurse's Notes that RN #1 reassessed the patient's condition prior to initiating the blood transfusion. Patient #1's vital signs at 2:15 PM were temperature of 97.3, pulse rate - 104, respiratory rate - 24, and blood pressure was 124/94 with an oxygen saturation of 85%. The patient's blood pressure rose 40 mm (Millimeters of Mercury) in 15 minutes from 54 diastolic to 94 diastolic. Per facility policy, if there was a rise in blood pressure of 30 mm, staff were to stop the transfusion and notify a facility physician for further orders; however, the transfusion was not stopped and the physician was not notified.

Continued review of the Transfusion log revealed Patient #1's vital signs taken at 2:30 PM were documneted as temperature - 97.3, pulse rate - 115, respiratory rate - 22, and blood pressure - 84/50 with an oxygen saturation of 83%. The patient's blood pressure had decreased 40 mm systolic and 44 mm diastolic in 15 minutes. Per the facility policy, a decrease of blood pressure by 20 mm/hg, staff should stop the transfusion and notify a facility physician; however, there was no evidence the physician was notified or that the transfusion was stopped. Patient #1's vital signs taken at 2:45 PM were documented as temperature of 97.3, pulse rate - 86, respiratory rate - 24, and blood pressure - 110/54 with an oxygen saturation of 82%; vital signs taken at 3:00 PM were documented as temperature of 97.5, pulse rate - 100, respiratory rate - 24, and blood pressure - 86/58 with an oxygen saturation of 83%. The patient's systolic blood pressure had decreased 24 mm; however, the patient's physician was not notified nor was the transfusion stopped per facility policy. The patient's vital signs taken at 3:30 PM were documented as temperature of 97.5, pulse rate - 124, respiratory rate - 24, and oxygen saturation of 85%; vital signs taken at 4:00 PM were docmented as temperature of 97.5, pulse rate - 113, respiratory rate - 22, and blood pressure - 92/54 with an oxygen saturation of 87%; vital signs taken at 4:58 PM were documented as temperature of 97.3, pulse rate - 83, respiratory rate - 24, and blood pressure - 82/50 with an oxygen saturation of 83%. There was no documented evidence of the rate or flow of the blood transfusion in the medical record.

Review of Patient #1's transfer assessment dated [DATE] at 5:51 PM revealed RN #1 documented Patient #1 was "stable" and returning to Facility #2 via EMS with non-urgent transfer.

Review of the nurse's notes revealed RN #1 documented that at 6:15 PM on 06/21/19, Certified Nursing Assistant (CNA) #1 found Patient #1 unresponsive and called for RN #1; upon entering the room RN #1 found the patient "gray in color and unresponsive" and a code was called. RN #1 documented that "headboard was put under the patient and compressions were started."

Review of a "Progress Note" dated 06/21/19 documented by Physician #5 revealed he was called to a "Code Blue for [Patient #1] and CPR was in progress. [Patient #1] was admitted for outpatient blood transfusion and just finished first unit of blood." Continued review of the progress note revealed Physician #5 documented Patient #1's assessment was "Cardiorespiratory arrest after blood transfusion."

Interview with the Quality Director and Chief Nursing Officer (CNO) on 09/24/19 at 12:45 PM and 09/26/19 at 1:30 PM revealed the Quality Committee reviews all incident reports and all "Codes" are written up as incident reports. The Quality Director stated that when reviewing a "code" record there are certain things the Quality Committee members look for such as timeliness of response time, ACLS protocol followed, and code status. The Quality Director stated the Committee identified the issue with this record regarding the discrepancies in the code status for Patient #1 and they developed a new policy and had distributed the policy to all department heads, but they were not tracking whether all employees had read the policy. Continued interview with the Quality Director revealed there is no one in particular that reviews nursing documentation to ensure all care was clinically appropriate across all departments. The Quality Director indicated that Patient #1's medical record would again be taken through the facility's review process and presented to the Committee again. Per the Quality Director, the QAPI Committee should have identified Patient #1's blood transfusion and possible reaction and change in medical condition. The CNO stated she agreed that the QAPI Committee should have recognized the quality concerns with Patient #1's care.

Interview with Physician #1 (a member of the Quality Committee) and Medical Director of Laboratory Services on 09/23/19 at 11:00 AM and on 09/26/19 at 3:30 PM revealed he attended the Quality Meeting on 07/03/19 and it was never brought to his attention that Patient #1 "coded" after a blood transfusion. Physician #1 stated if it had been brought to his attention during the meeting then the record would have been reviewed regarding the blood transfusion.