Blood sample mix-up led to patient's death at St. Luke's, report says

HOUSTON – A mix-up in blood samples at Baylor St. Luke’s Medical Center last year led to a botched transfusion and a patient’s death, according to a Department of Health and Human Services report released Tuesday.

According to the report, a 75-year-old woman came to the emergency room the morning of Dec. 2, 2018, and was diagnosed with bleeding on the brain. Doctors determined that she would be moved to the intensive care unit and treated with a blood and plasma transfusion. ER doctors ordered a type and screen of the woman’s blood, and she was given a transfusion about 12 hours after she came to the ER.

Early Dec. 3, within a few hours of receiving the transfusion, the woman’s blood pressure dropped and a transfusion reaction investigation was started, according to the report. The woman began suffering multiple medical issues, including four cardiac arrests within the span of three hours. She died at 12:50 p.m.

According to the report, an investigation revealed that the blood samples of the woman and another ER patient had been mixed up, which resulted in the woman receiving the wrong type of blood.

Dr. Doug Lawson, who was appointed as the hospital’s president on Jan. 14, said in a written statement that the report found “significant deficiencies” that led to the error.

“It is our responsibility to learn from these mistakes, and we take this responsibility very seriously,” Lawson said. “An incident like this should never happen.” 

One report concluded there were 122 times mistakes were made by St. Luke's employees, like mislabeling of blood specimens, drawing blood without a doctor's order and leaving bodily fluids, specifically blood vials, in a room after a patient had already been discharged. All of these mistakes were reported over the span of four months.

Lawson said the hospital has created plans of correction that outline the following major initiatives that are being instituted:

  • Modified existing hospital policies to more explicitly require a stringent verification process in collecting blood samples and the proper labeling of samples to prevent an error.
  • Added new safeguards in the hospital’s laboratory to not accept blood specimens improperly labeled and not following the dual verification process. 
  • Changed the hospital’s quality improvement program to more effectively monitor and validate the correct practice of labeling blood samples, blood administration and recognition of blood transfusion reactions.  
  • Improved our process for reporting patient safety and quality concerns from each department to ensure they quickly escalate to the senior leadership team at the hospital.
  • Instituted a broad-based training program for nurses, staff and physicians on the new policies and improved procedures, available both in-person and online.

Lawson said that he has brought in new high-level staff to oversee the corrections and make significant changes at the hospital.

This is the same hospital that was put under the microscope by federal investigators after a yearlong investigation by the Houston Chronicle and ProPublica that showed serious problems that led to a high rate of patient deaths after heart transplants at the hospital.

Lawson’s full statement

"When I recently stepped into the role of Baylor St. Luke’s Medical Center President, I made a series of commitments to our patients and their families, to our staff and physicians, and to the broader Houston community. Those commitments focused on ensuring that Baylor St. Luke’s stays true to the heart of our mission and ministry: to provide the highest quality, safest possible care, and to do so in the most compassionate way possible.

"I also appreciate that our role in caring for our community is both a responsibility and a privilege, based on trust we earn with every patient experience. I am thankful for the dedication and work of our staff and physicians, and in the compassion and expertise they bring to the bedside every day.

"Today, however, I’m sharing results of a recent hospital review that is deeply disappointing to me, our Board of Directors, and our entire Baylor St. Luke’s family because they describe patient care activities that simply does not meet our standards or expectations. These findings are the initial results from a review by the Centers for Medicare & Medicaid Services (CMS) of a patient death following a blood transfusion error in the Emergency Department. CMS reviewers found significant deficiencies that led to this incident in December. It is our responsibility to learn from these mistakes, and we take this responsibility very seriously. An incident like this should never happen.

"So that we have full transparency, I am posting the full CMS report and the Clinical Laboratory Improvement Amendments of 1988 (CLIA) report as well as the hospital’s corresponding Plans of Correction on our website. View the following documents:

"Our plans detail the steps we have taken to date to correct the deficiencies noted by CMS and the path forward to further improving the quality of our care.

"The Plans of Correction outline a number of corrections we have taken and major initiatives we are putting into place. We have:

  • Modified existing hospital policies to more explicitly require a stringent verification process in collecting blood samples and the proper labeling of samples to prevent an error.
  • Added new safeguards in the hospital’s laboratory to not accept blood specimens improperly labeled and not following the dual verification process. 
  • Changed the hospital’s quality improvement program to more effectively monitor and validate the correct practice of labeling blood samples, blood administration, and recognition of blood transfusion reactions.  
  • Improved our process for reporting patient safety and quality concerns from each department to ensure they quickly escalate to the senior leadership team at the hospital.
  • Instituted a broad-based training program for nurses, staff, and physicians on the new policies and improved procedures, available both in-person and online.

"Since the initial CMS review in January, I was appointed as President of the hospital on January 14 and we have added key new leaders at Baylor St. Luke’s who are committed to significant changes.

  • Our new Chief Medical Officer, John Byrne, M.D., brings extensive expertise in physician leadership and served as Chief Medical Officer at Hospital Corporation of America’s Gulf Coast Division’s Clear Lake Regional, Mainland, and Pearland Medical Centers.
  • Nancy Hellyer, a former hospital CEO herself, served as Chief Executive Officer at CHRISTUS Central Louisiana Region and now serves as our Acting Chief Administrative Officer.
  • Loretta Lee, RN, who brings 30 years of experience at major healthcare organizations including Baylor Scott & White All Saints Medical Center in Dallas, is now leading as our Acting Chief Nursing Officer.
  • Megan Fischer is our new Vice President of Quality, a certified professional in healthcare quality and regulatory readiness leader who has served in senior leadership roles at organizations including Hospital Corporation of America Gulf Coast, and who has successfully led organizations through multiple regulatory reviews. 

"We are creating the new role of Chief Patient Safety Officer – a top-level executive with responsibility to ensure absolute rigor in our policies and practices – and are aggressively recruiting for this position.
Further, we have retained added experts from across the country to partner with us on our reviews and corrections.

"Over the next few weeks, we will meet with CMS in a full-scale review of our hospital, our organization, and our operations, painstakingly reviewing every policy and practice we have. I expect the CMS reviews to reveal additional areas of improvement. I look forward to their expert and experienced perspectives in identifying additional areas we must address and best practices we must pursue. Between our internal quality program underway and the forthcoming CMS review, there will be no part of our hospital untouched and no stone left unturned on our journey back to excellence in clinical care.

"This is a challenging time for our hospital. While we cannot go back and change the past, we can focus our efforts on recreating the Baylor St. Luke’s you have known and trusted. To our patients, their families, our employees and physicians, and the people of this city and region we serve, we will take the steps needed to ensure Baylor St. Luke’s fulfills our mission of care and compassion. I believe we will emerge stronger than ever.

"As I look forward, I envision a Baylor St. Luke’s that is once again setting the standard for excellent patient care, innovative treatments, and medical advances. I envision an organization that is trusted by patients and families, known as much for our compassion as our skill. And I envision an organization with a culture that attracts and inspires top medical talent from across our community and from around the world.

"I appreciate the words of support we have received and those who have enthusiastically embraced the change we are leading. And I will continue to transparently keep our community apprised of our progress."