A2ALL-Patients Safety System Improvements in Living Donor Liver Transplantation

This is an observational as well as a time-controlled study to be conducted at four
participating A2ALL Deux Transplant Centers (TCs). The study is divided into three phases: an
observational phase (Aim 1) to conduct a comprehensive and proactive patient safety risk
assessment to describe preventable complications, near miss events, medical errors and
hazardous conditions and in the delivery of standard of care to living donor liver transplant
(LDLT) donors and recipients from the time of admission for the LDLT surgery through
discharge after LDLT surgery. The in depth observational phase continues throughout the study
and is scheduled to be completed by the end of the study (May 2015).

In phase 2-solution development and implementation phase (Aim 2): two high priority areas of
care were identified for in depth assessment and solution development. The selection of the
two high priority areas of LDLT standard of care was guided by the identification of
vulnerabilities in the systems and processes of care with a high incidence and severity of
related preventable complications and medical errors across the four participating A2ALL Deux
TCs. To date, multiple priority areas were identified, based on the ongoing review of medical
records (e.g., transition of care, glucose control, donor pain management, preoperative OR
set-up). The participating A2ALL Deux TCs agreed to focus on an in depth assessment of the
two areas that demonstrated high incidence and high severity of preventable complications and
medical errors: 1) donor pain management and 2) preoperative OR set-up process.

1. Donor Pain Management:

Upon further investigation, it was identified that living liver donors experience
significant amount of pain, in the early postoperative period but also especially a few
days after donation. Data from the four participating A2ALL Deux TCs reveal a 20%
incidence, overall, of respiratory complications (e.g. re-intubation, requirement for
application of Naloxone, etc.) directly related to the opioid use in the present LDLT
standard of care for donor pain management. Based on these data, clinicians at the four
participating A2ALL Deux TCs, in consultation with an international pain expert with
particular expertise in transplantation (Paul White, MD University of Texas Southwestern
Medical Center at Dallas, Dallas, Texas), developed an evidence-based donor pain
management solution with the aim of reducing preventable complications as well as
improving the donor pain experience. This evidence-based donor pain management solution
was developed over months through in-person and telephone meetings of transplant
surgeons, hepatologists, anesthesiologists and acute pain specialists from all four
participating A2ALL Deux TCs, in addition to the research teams. Consensus has been
reached on the key elements of the evidence-based donor pain management solution and all
four participating A2ALL Deux TCs are poised to begin implementation.

2. Preoperative OR Set-up Process:

Preventable complications, near miss events, medical errors and hazardous conditions related
to the preoperative OR set-up processes were identified. The four participating A2ALL Deux
TCs will need to engage in additional review of the detailed assessment of the
standardization and optimization of the preoperative OR set-up process and then, will
collaboratively design a standardized process over a four month period (expected conclusion
mid February 2014 in order to incorporate what occurs at the Collaborative at each site and
overall). Solutions will be designed collaboratively to reduce the incidence and severity of
related medical errors and preventable complications together with the TCs and their staff.

The measurement of solution impact to reduce preventable complications and medical errors
(Aim 3) involves the implementation of the two collaboratively developed solutions: (1)
Evidence-based donor pain management solution and (2) Standardization and optimization of the
preoperative OR set-up process. During this phase relevant metrics pre- and
post-implementation will be compared to assess the effectiveness of the implemented
solutions.

Inclusion Criteria:

A. Clinicians

1. Clinicians of both genders, of any race/ethnicity are included. Only clinicians who
are unwilling to participate will be excluded.

2. Clinicians and staff who are involved in the care of LDLT donors and recipients (e.g.,
nurses, surgeons, anesthesiologists, hepatologists, unit secretaries from medical and
surgical units, ICU, transplant coordinators, pharmacists) at the four participating
A2ALL Deux TCs.

B. Patients

1. Every donor (≥ 21 years) and recipient involved in LDLT at the four participating
A2ALL Deux TCs between 2004-2015, who were enrolled into the A2ALL cohort study Un
and/or Deux. (However, to date medical record reviews were only performed for patients
involved in LDLTs 2008 or later. Observations were initiated in December, 2011). After
enrollment of patients into the A2ALL Deux cohort study ends (anticipated May 2014),
all LDLT donors and recipients at the four participating A2ALL Deux TCs will be
approached for enrollment into this ancillary A2ALL R01 patient safety study.

2. Patients have not been and will not be excluded on the basis of race, gender, or any
other related characteristics.

Exclusion Criteria:

- No participants will be under 21 years of age. Patients will not be excluded on the
basis of age, race, gender or any other non-employment related characteristics