timer Asked: Apr 15th, 2020

Question Description

Case Questions:

  1. Who or what caused the death of Betsy Lehman?
  2. What was the Dana-Farber’s system for ensuring patient safety?
  3. How should the Dana-Farber respond to the Globe story ofMarch 23, 1995?
  4. What are the key issues that must be addressed in the first fewdays after the error was discovered?

How should the Dana-Farber reduce the risk of future errors?

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For the exclusive use of r. alhaidar, 2020. Harvard Business School 9-699-025 Rev. July 1, 1999 The Dana-Farber Cancer Institute … in 1991, the Harvard Medical Practice Study reported the results of a population-based study of iatrogenic injury in patients hospitalized in New York State in 1984. Nearly 4% of patients suffered an injury that prolonged their hospital stay or resulted in measurable disability. For New York State, this equaled 98,609 patients in 1984. Nearly 14% of these injuries were fatal. If these rates are typical of the United States, then 180,000 people die each year partly as a result of iatrogenic injury, the equivalent of three jumbo-jet crashes every two days.1 Lucian Leape, M.D. One morning in the spring of 1995, Dr. Stephen Sallan, Senior Oncologist at the Dana-Farber Cancer Institute (DFCI), was meeting with the other members of his committee. This was one of the many committees that had been meeting regularly since the discovery in February of the accidental overdose of a cancer patient. The patient, Betsy Lehman, had received an overdose of chemotherapy and later died. Since then, frequent articles on the front page of the Boston Globe about the incident had contributed to a climate of reassessment and crisis at the hospital. The various hospital committees had been charged with reviewing the incident in detail and understanding how the hospital’s management and information systems might have contributed to the overdose. The lawyer on the committee took a call that morning. It was the front lobby desk notifying them that the Massachusetts Department of Health had just arrived at the DFCI for a surprise inspection and asking where the delegation should be sent. Ten minutes later the phone rang again. Once again it was the front desk. The Joint Commission for the Accreditation of Healthcare Organizations (JCAHO), had also arrived unexpectedly and was preparing for its own inspection. (See notes in Exhibit 1 regarding the regulatory role of the JCAHO.). As a result of these inspections, the Dana-Farber was placed on probation by the JCAHO on April 12, 1995. By the end of May, the Massachusetts Department of Public Health released a 33-page Statement of Deficiencies citing deficiencies at DFCI and the JCAHO put the hospital on probation. 1 Leape L. Error in medicine. JAMA 1994; 272 (23): 1851–87. Lecturer Richard Bohmer and Ann Winslow (DBA ’02) prepared this case as the basis for class discussion rather than to illustrate either effective or ineffective handling of an administrative situation. Copyright © 1999 by the President and Fellows of Harvard College. To order copies or request permission to reproduce materials, call 1-800-545-7685 or write Harvard Business School Publishing, Boston, MA 02163. No part of this publication may be reproduced, stored in a retrieval system, used in a spreadsheet, or transmitted in any form or by any means—electronic, mechanical, photocopying, recording, or otherwise—without the permission of Harvard Business School. 1 This document is authorized for use only by rawan alhaidar in Business of Healthcare 2020 taught by Soma Somasundaram, University of San Diego from Feb 2020 to Jul 2020. For the exclusive use of r. alhaidar, 2020. 699-025 The Dana-Farber Cancer Institute The Dana-Farber Cancer Institute The Dana-Farber Cancer Institute is one of the nation’s premier comprehensive cancer hospitals, renowned for its successes in treating complex and difficult cases and for its research into the causes and cures of cancer. It is located in the middle of Boston’s Longwood medical area, very near the Brigham and Women’s Hospital (BWH), Beth Israel–Deaconess Medical Center, Boston Children’s Hospital, and Harvard Medical School. The Dana-Farber, as it is commonly known, was originally established as the Children’s Cancer Research Foundation in 1947 by Dr. Sidney Farber, then a pathologist at Boston’s Children’s Hospital. In the 1940’s the only treatments for cancer were surgical removal of tumors and radiation therapy. Cancers that had metastasized (spread to other areas of the body) were regarded as incurable. Dr. Farber’s vision was that children’s cancer, particularly systemic cancers such as leukemia, could be cured if researchers and clinicians worked as a team. He envisioned the union of research laboratories and patient care. As David Nathan, CEO of the Dana-Farber since 1995, explained, “The problems of the patients would be brought up to the labs and ideas from the labs would go down to the patients.” The history of the Dana-Farber is intimately tied to the history of its funding. Initial funding for the Children’s Cancer Research Foundation came from the Variety Club of New England. In 1948, the Variety Club organized a radio broadcast from the bedside of a young patient with lymphoma known as “Jimmy” as he was visited by members of the Boston Braves baseball team.2 The donations that poured in to buy Jimmy a TV set on which to watch Braves’ games were the beginning of the “Jimmy Fund,” the charity now almost synonymous with the Dana-Farber. The Jimmy Fund subsequently became the official charity of the Boston Red Sox (who took over in 1953 when the Braves moved to Milwaukee), Ted Williams and the Massachusetts Chiefs of Police Association. In 1974, the institution’s name was changed to the Sidney Farber Cancer Center to honor its founder, and in 1983, the name was changed to the Dana-Farber Cancer Institute to acknowledge the major contributions made over twenty years by the Charles A. Dana Foundation. The first Children’s Cancer Research Foundation facility, the Jimmy Fund building, was built in 1951 and housed research laboratories. It was expanded in the 1960s to include outpatient services, mostly for children. According to Dr. Farber’s original vision, the organization was to consist of research laboratories and outpatient clinics, but not inpatient beds.3 Inpatient care was provided at Children’s Hospital. However, as research and patient care grew to include adult patients, the doctors at the Dana-Farber were faced with the problem of where to admit adult patients. In particular, the new technique of bone marrow transplant (BMT) required the patient services of a general hospital. A joint program existed between the Dana-Farber and the Hematology Department at the Brigham and Women’s Hospital. However when the BWH would not permit Dana-Farber physicians to admit patients and retain control of their clinical care, the Dana-Farber decided to open its own inpatient service, initially for BMT patients (in 1979), and later, for general oncology patients. In fact, the system for hospital reimbursement in effect since 1983 favored the opening of inpatient beds at the Dana-Farber. General hospitals, such as the Brigham and Women’s, are 2 On May 22nd, 1998 the original “Jimmy”, Einar Gustafson, 62, returned to the Dana-Farber for its 50th anniversary. In a 1971 interview Dr. Farber recounted, “They insisted they needed a name. I said, in desperation, ‘Well, call him Jimmy!’ And that’s how the title came about. But let me tell you about that boy. He was actually one of the first children to respond to the new chemical treatments we developed. And today, he is in his middle thirties, the father of a fine family, and has required no treatment for years.” Boston Globe, May 17, 1998, page C13. 3 Inpatient beds require the support of a significant infrastructure that includes operating rooms, intensive care units, radiology and laboratory services and a blood bank, all of which must be available 24 hours a day. 2 This document is authorized for use only by rawan alhaidar in Business of Healthcare 2020 taught by Soma Somasundaram, University of San Diego from Feb 2020 to Jul 2020. For the exclusive use of r. alhaidar, 2020. The Dana-Farber Cancer Institute 699-025 reimbursed for all Medicare and many non-Medicare patients on a DRG4 basis. On the other hand, specialty hospitals, such as the Dana-Farber, were permitted to charge Medicare and other insurers full costs. This revenue allowed the Dana-Farber to finance its expansion. The institute roughly doubled in size between 1985 and 1995. In 1995, the Dana-Farber had 57 licensed beds, 2,088 inpatient admissions (with an occupancy of 68.2%), and 55,427 outpatient visits. However, the question of whether the institute should maintain such a small number of inpatient beds has always been a point of debate at the Dana-Farber. In 1994 the Dana-Farber began negotiations with the Brigham and Women’s Hospital, which by then was a member of Partners Healthcare System, to move inpatient care to the Brigham. The early focus of the Farber’s inpatient work had been the care of medical, mostly hematological, cancers. Increasingly, however, patients receiving chemotherapy were treated as outpatients, coming in to the clinic for their medications in the morning and leaving in the afternoon. Furthermore, surgery and chemotherapy were being used in concert. Surgeons from the Brigham and oncologists from the Farber collaborated on the management of solid tumors and ran joint outpatient clinics at the Dana-Farber. Jointly caring for inpatients at the Brigham, which had all the clinical support services required, was a natural next step. Research at the Dana-Farber On the other hand, the Dana-Farber’s research mission has never been in doubt. The Institute has a long and distinguished history of both basic science and clinical research. Dr. Farber and his colleagues were instrumental in the invention of chemotherapy. Dr. Farber was the first to achieve temporary remissions of acute lymphocytic leukemia (1947) and Wilms tumor of the kidney (1954). Baruj Benacerraf, a former President of the Dana-Farber, was awarded a Nobel Prize in Medicine in 1980 for identifying genetically determined structures on cells that regulate the immune system’s attack on foreign invaders. In fiscal 1995, the Dana-Farber received over $100 million in funding from the National Cancer Institute, other institutes of the National Institutes of Health, foundations, and industry. (See Exhibit 2). Basic science research has always been undertaken in laboratories at the Dana-Farber. When a researcher believed that new findings could benefit patient care, a clinical trial was initiated. There are several types of clinical trials. Phase I and phase II trials are designed to understand the effects of a drug in the human body. They examine the toxicity and effectiveness of the drug and the way that the body metabolizes the drug. Phase I trials require that blood samples be drawn as often as every few minutes for a period of several hours. Phase III trials are undertaken after a drug has been tested in a small group of people and the correct dosage has been established. They examine the efficacy of the treatment in a larger sample of patients. Phase III trials compare this drug treatment to patients who are receiving conventional therapy. All trials are implemented using a research protocol, a lengthy and detailed document that describes the following: 1) the objectives of the research and its rationale, 2) the details of the drugs to be administered (dosage, frequency and route of administration), including the way in which the correct dose is to be calculated for any individual patient, 4 The Diagnosis Related Group (DRG) system was introduced in 1983 by the Health Care Financing Administration, the federal body that oversees Medicare. Under this system a hospital is paid a fixed amount per patient admission, based on the patient’s diagnosis. The reimbursement does not depend on the resources expended on the care of that patient. 3 This document is authorized for use only by rawan alhaidar in Business of Healthcare 2020 taught by Soma Somasundaram, University of San Diego from Feb 2020 to Jul 2020. For the exclusive use of r. alhaidar, 2020. 699-025 The Dana-Farber Cancer Institute 3) the treatment to be administered (either investigational or conventional), 4) the criteria by which eligible patients are identified as potential candidates for the trial, 5) the method of randomly assigning patients to the intervention and control arms of the trial, 6) the endpoints being measured, and 7) the way in which the wellbeing of patients will be monitored over time (e.g., the type and frequency of lab tests). In 1995, the Dana-Farber had between 90 and 150 active research protocols in progress in the clinics and inpatient units. Protocols were 50 to 75 pages long. Each protocol was created by the principal investigator and his or her team. Several committees reviewed protocols before they were implemented. The role of the Institutional Review Board (IRB) was to review every research proposal that might affect patient care. The IRB ensured that the research was scientifically sound and that the study was designed in such a way that it would yield meaningful information. The IRB also attended to the safety of patients by reviewing the information given to patients, the patient consent documents, the processes for admitting patients to the study and taking patients out of the study, and the methods for monitoring the patient’s health. The IRB reviewed the progress of a study regularly and had the power to terminate a study if there was any threat to patient safety or if the treatment proved so much better than usual care that all patients should receive it. The agency that funded a study (e.g., National Cancer Institute) also reviewed the research protocol. th In 1995, all research protocols at DFCI were handled by the Protocol Office on the 15 floor of the Dana Building. Every protocol was kept on file, and modifications, which were frequently made, were always recorded with the original document, ensuring that the Protocol Office always had the most recent version. Modifications included changes to the dosage or dosing schedule and/or laboratory testing regimens. The nurses and pharmacists caring for the patient could review the modified protocols in the protocol office. When a patient was being treated under a research protocol, a copy of the protocol consent was kept in his or her record on the patient care units. Chemotherapy All tumors, benign and malignant, are characterized by the uncontrolled growth of abnormal cells and an absence of normal programmed cell death. Cancers whose growth is restricted to a local area can be removed surgically. Those that are not localized, such as malignancies of the blood and cancers that have already spread to distant sites (“metastasized”) are treated with chemotherapy. Most chemotherapeutic agents block essential processes by which cells replicate, and therefore kill all replicating cells. Because cells in the cancer are replicating at a greater rate than noncancerous cells, the cancerous cells are killed preferentially. But chemotherapeutic agents are also harmful to normal cells, especially those with higher rates of turnover, such as the cells lining the intestines and white blood cells, a component of the immune system. Common side effects of chemotherapy include immune suppression, nausea and hair loss. The extent of these side effects is related to the dose of the drugs. Less common toxicities related to these drugs include heart and lung dysfunction. Chemotherapy is usually delivered in courses, each lasting several days, every few weeks. The time off the drugs allows normal tissues time to recover. White blood cell numbers decrease 4 This document is authorized for use only by rawan alhaidar in Business of Healthcare 2020 taught by Soma Somasundaram, University of San Diego from Feb 2020 to Jul 2020. For the exclusive use of r. alhaidar, 2020. The Dana-Farber Cancer Institute 699-025 after each course of chemotherapy and recover in the intervening days. Each course is preceded by blood tests to check that the white blood cell numbers are back up to the normal range, and that heart, liver, and kidney function are not disturbed. The dose of chemotherapy is calculated based on the body surface area of the patient (i.e., milligrams per meter squared), which is calculated from the patient’s height and weight. Patients are weighed prior to each course of therapy. Doses of chemotherapy can be expressed by either daily or course doses. The course doses are the sum of the daily doses. Because of the well known side effects of the chemotherapy, patients are given additional medications, such as anti-nausea drugs. Typically, because of their potential side effects, chemotherapy drugs have well defined upper limits for the dose per day, per course or per lifetime. When drugs are used in combination, drug-drug interactions may change the acceptable upper dose limits. In the case of routine chemotherapy, drugs are well known and doses are sufficiently standardized that they are often preprinted on standard drug order sheets called “standing orders.” In the case of research trials, where new drugs, drug combinations or doses are being tested, there is much less standardization, and upper dose limits are less clear. At an institution such as the Dana-Farber, in which approximately 30% of patients are participating in a research trial, staff administering chemotherapy may see unusual drug combinations or great variation in the drugs prescribed and their doses. Inpatient clinical care In 1995, patients came to the Dana-Farber via a number of routes. They were either referred to the institute by a primary care practitioner or an oncologist or surgeon in community practice, or they referred themselves. Typically patients were first seen by a Dana-Farber attending physician in the outpatient clinic and assigned an oncology fellow. The physicians confirmed the diagnosis and planned the course of treatment. If appropriate, an inpatient admission was booked. The “orders” (detailed instructions for the chemotherapy) were written by the physician in the patient’s medical record. On average five to six patients were admitted each weekday afternoon to each of the four 13bed inpatient units. One unit was for bone marrow patients only, one was for medical oncology only, and the other two were mixed. One of the mixed units preferentially admitted leukemia patients, who stay longer in private rooms, and so it tended to have fewer admissions. The average length of stay was five days for patients receiving chemotherapy and four weeks for those having bone marrow transplant. Patients were admitted for either routine chemotherapy, chemotherapy on a research protocol, a bone marrow transplant, or they were admitted for the management of complications secondary to chemotherapy (such as fever in a patient with a decreased white blood cell level). On arrival to the Dana-Farber, patients first went to the admitting registration desk, then to phlebotomy to have blood for baseline tests drawn and then to the inpatient unit. Occasionally, if a patient was returning to DFCI and was familiar with the hospital, he might go to phlebotomy before registration. Because of its small size, the Dana-Farber was able to offer very personalized “boutiquest th th style” service. Outpatient clinics were on the 1 floor, and inpatient units were on the 12 and 14 th floors. There was no 13 floor. Upon arriving at an inpatient unit, a patient met his primary nurse and was formally admitted to the unit. Each new patient was assigned a primary nurse and two or three associate nurses. The primary nurse was the patient’s first point of contact with the unit. The associate nurses cared for the patient when the primary nurse was off duty. On subsequent admissions, patients were almost always admitted back to the same unit and to the same primary nurse. Over time, patients and their primary nurses got to know each other and formed lasting therapeutic relatio ...
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