HospitalInspections.org

Based on document review and staff interview, it was determined, for 1 of 1 hospital directive/ policy ("Organ Donation') regarding organ procurement, the hospital failed to ensure the hospital develop complete and comprehensive directives, policies, procedures, and/or protocols for physicians and staff based on contractual agreement regarding organ procurement.

Findings include:

1. The revised organ procurement contract (OPO #1), effective 7/1/14 was reviewed on 1/20/15. The contract required (page 18), "3.2.7 Designated Representatives. Hospital shall develop a written policy and procedure to ensure that only a [OPO #1] representative may approach the family of a Potential Donor to request donation..."

2. Hospital Directive #49, titled "Organ Donation", revised 12/11/14, was reviewed on 1/20/15. The directive required, "Procedure: I. When a patient dies, death appears imminent, or artificial support is to be discontinued, the attending physician or designee will: A. Notify family of the patient's condition. B. Notify [OPO #1]... for evaluation of suitability for donation..." The directive did not include that hospital physicians and staff are not to discuss organ procurement with patient and family. There were no other directives, policies, procedures, or protocols related to organ donation.

3. On 1/20/15 at 2:00 PM, an interview was conducted with the Clinical Nurse Educator./ Hospital Organ Procurement Coordinator (E #4). E #4 stated that the directive/ policy/ protocol did not include that only a OPO #1 representative was permitted to speak to family members about organ donation.

Based on document review and staff interview, it was determined, for 1 of 10 patient (Pt. #1) near imminent death, the hospital failed to ensure timely referral was made to the organ procurement organization (OPO #1) for potential organ donation

Findings include:

1. Hospital Directive #49, titled, "Organ Donation", revised 12/11/14, was reviewed on 1/20/15. The directive required, "...the Hospital will notify the [OPO #1] for organ/ tissue donation for individual's who's death is imminent... Notify [OPO #1]... for evaluation of suitability for donation..."

2. The revised [OPO #1] contract, effective 7/1/14 was reviewed on 1/20/15. The contract included the definition of imminent death (page 3), "1.7 Imminent Death. The term 'Imminent Death' means a patient with severe, acute brain injury, disease or illness that may or may not be traumatic in origin and: (1) Who requires mechanical ventilation; and (2) Meets one or more of the following criteria... (b) For whom physicians are evaluating a diagnosis of brain death. (c) For whom a physician has discussed with the family or is preparing to discuss with the family or has ordered withdrawal of life-sustaining therapies, consistent with the family's decision."

3. The OPO #1 contract, also included the definition of timely notification for organ donation (page 3), "1.11 Timely Notification for Organ Donation. 'Timely Notification for Organ Donation ' means notification by telephone to [the OPO #1] prior to declaration of brain death, or when a patient meets the Clinical Trigger criteria for Imminent Death. To be considered timely, notifications must be made prior to discontinuation of or decrease in pharmacological or hemodynamic support, including by not limited to discontinuation of a ventilator... prior to approaching the family about Organ donation ..."

4. On 1/20/15 at 1:00 PM, the clinical record of Pt. #1 was reviewed. Pt. #1 was a 45 year old female, admitted on 10/9/14, with a diagnosis of Acute Angioedema Tongue/Throat. Pt. #1's discharge summary dated 10/30/14, included Pt. #1 had tongue swelling and worsening edema in the Emergency Department (ED). Pt. #1 went into cardiac arrest. Pt. #1 was admitted to the Intensive Care Unit (ICU) on 10/9/14 at approximately 11:00 PM.

5. A neurologist's assessment progress note (MD #1) dated 10/15/14 at 10:00 AM, included, Pt. #1 was nonresponsive to verbal and noxious stimulation, pupils 5 - 6 cm and non responsive, and suffered brain death "no clinical evidence of cerebral brainstem reflexes..."

6. Documentation of the time the OPO #1 was called or arrived at the hospital on 10/15/14 was not documented in Pt. #1's clinical record.

7. On 1/20/14 at 10:00 AM, an interview was conducted with Pt. #1's ICU registered nurse (E #5). E #5 stated she notified the OPO #1 on 10/15/14, when Pt. #1's death was imminent, but did not recall the time.

8. On 1/21/15 at 9:20 AM, an interview was conducted with Pt. #1's Nephrologist (MD #1). MD #1 stated he discussed Pt. #1's tests indicating brain death with Pt. #1's family. MD #1 stated the Nurse called the OPO #1 and it was in the record.

9. On 1/22/15 at 2:30 PM, a phone interview was conducted with the OPO #1's Coordinator (Z #9). Z #9 stated the timing for the call to the OPO #1 was "technically late." The hospital was aware of Pt. #1's imminent brain death on 10/15/14 at 10:00 AM. The OPO #1 recommends contacting the OPO #1 within 1 hour of finding a clinical trigger for imminent brain death - loss of neurological function and call again after the death occurs (pronouncement). The hospital did not call the OPO #1 regarding imminent brain death after 10:00 AM, but did call the OPO #1 at 5:30 PM, 7 1/2 hours late, according to the OPO #1 records.

Based on document review and staff interview, it was determined, for 15 of 16 physician files reviewed (MD #3 - 17), the Hospital failed to ensure the physicians were trained on organ donation procedures, including not discussing organ procurement with bereaved families.

Findings include:

1. Hospital Directive #49, titled, "Organ Donation", revised on 12/11/14 was reviewed on 1/20/15. The directive included, "... the Hospital will notify the [Organ Procurement Organization OPO #1)]... for organ/tissue donation for individuals who's death is imminent... I. When a patient dies, death appears imminent... the attending physician or designee will: A. Notify family of patient's condition. B. Notify [OPO #1]... for evaluation of suitability for donation..." The directive did not permit physicians to solicit or discuss organ donation with family members.

2. The revised OPO #1 contract, effective 7/1/14 was reviewed on 1/20/15. The contract required (page 11), "Schedule III Responsibilities of Hospital... 3.2.3... Hospital shall... maintain the medical suitability or the Organ or Tissue until [the OPO #1 has had the opportunity to... advise the appropriate person of the option to make an anatomical gift..." The contract did not allow physicians to begin discussion of organ donation with distraught family members.

3. On 1/20/15 at 1:00 PM, the clinical record of Pt. #1 was reviewed. Pt. #1 was a 45 year old female, admitted on 10/9/14, with a diagnosis of acute angioedema of the tongue and throat. Pt. #1's discharge summary dated 10/30/14, included, "The patient was admitted... with tongue swelling in the emergency room... The patient did have a cardiopulmonary arrest... was admitted to the intensive care... did not improve and ... was found to be brain dead and... was removed from life support..."

4. A Nephrologist's (MD #1) progress note dated 10/16/14 at 2:45 PM, included, MD #1 had a "long discussion" with Pt. #1's family and the family had "unanimous agreement" Pt. #1 did not want to have organ donation. "Similar conversation yesterday".

5. On 1/21/15 at 9:20 AM, an interview was conducted with Pt. #1's Nephrologist (MD #1). MD #1 stated he discussed Pt. #1's tests indicating brain death with Pt. #1's family. The family wanted to know what was next and MD #1 informed them that someone from the OPO #1 would be coming to talk with them. All of Pt. #1's family members either agreed or did not disagree that Pt. #1 did not want to donate her organs. The family told MD #1 they did not want to meet with the OPO #1.

6. A Root Cause Analysis (RCA) and Action Plan Framework Template Gift of Hope for Pt. #1's incident dated November 2014 was reviewed on 1/21/15 at 9:00 AM. An RCA allows the hospital to review a problem and take action to reduce the potential for reoccurrence. Findings included, "Neurologist [MD #1] communicated at length with the family about the clinical situation and organ donation." The RCA did not indicate that any more than MD #1 was involved in reeducation regarding OPO #1.

7. On 1/21/15 at 10:40 AM, an interview was conducted with the Vice President of Medical Affairs (MD #2). MD #2 stated that MD #1 was counseled regarding Pt. #1's incident, including only the OPO #1 is authorized to discuss organ procurement with the family. MD #2 was asked if there was reeducation for the other hospital physicians. MD #2 stated that MD #1 was the only physician reeducated regarding the OPO #1, after Pt. #1's death.

8. On 1/22/15, sixteen physician personnel records were reviewed. Fifteen of 16 files lacked documentation of organ procurement training.

9. An interview with the OPO #1 coordinator (E#4) was conducted on 1/20/15 at 2:00 PM. E #2 stated that the OPO #1 staff training is done during orientation and during periodic presentations by the OPO #1. However, there is no physician training for OPO #1.

10. An interview with the Vice President of Quality Improvement (E #8) was conducted on 1/22/15 at 11:30 AM. E #8 stated an OPO #1 educational session was presented to the physicians "a couple of years ago" and approximately 100 physicians attended. E #8 stated that "mass physicians" (the majority) were not instructed after Pt. #1's incident, just the one neurologist and 2 physicians during a meeting on 11/17/14. E #8 agreed that additional physician education would be valuable.

11. The physician orientation instruction check list and the booklet "Ethical and Religious Directives for Catholic Health Care Services", fifth edition, also used for physician orientation, were reviewed on 1/22/15, in the afternoon. The physician orientation check list did not include the topic of organ procurement. The "Ethical and Religious Directives for Catholic Health Care Services" booklet included (pg. 28), "63. Catholic health care institutions should encourage and provide the means whereby those who wish to do so may arrange for the donation of their organs and bodily tissues..."