April 25, 2014
From: Matthew Pitoniak, Board Chair, on behalf of the Cooley Dickinson Health Care Board of Trustees
Joanne Marqusee, President and CEO, Cooley Dickinson Health Care
To: Cooley Dickinson Staff and Medical Staff
Re: Cooley Dickinson Hospital’s 2014 CMS/DPH Survey of Childbirth Center
As you know from a letter shared with you March 13, Massachusetts Department of Public Health (DPH) officials recently visited Cooley Dickinson Hospital to conduct a review, following several event reports that the hospital submitted. DPH acts on behalf of The Centers for Medicare and Medicaid Services (CMS) and issues a report on surveys it conducts. The CMS report detailed deficiencies found in the survey and asked us to provide plans of correction for each citation. We await CMS’s official acceptance of our plans of correction. Meanwhile, we encourage you to use the link below to read the summary of CMS’s survey findings and how we are responding, as well as to review the survey report itself.
In our earlier letter, we reported on the tragic loss of a baby. There are also two other patients who recently died and three other incidents that occurred in the Childbirth Center. We are actively assessing these events to make every possible improvement. DPH has also reviewed the three other incidents and found no citations.
Of course, we reported all the cases to the DPH right away. We informed the public about one case where our investigation identified processes which could be put in place immediately. Further investigation in two other cases has uncovered other areas for process improvement, which is what we wish to communicate now.
As trustees, we are saddened and sobered by the tragic deaths. Our hearts go out to the family members. Cooley Dickinson staff reached out to the families to express their profound sympathy for their losses and to offer support.
Because we are a community-based board, we recognize as well the profound effect on staff when, despite our efforts to offer the highest standard of care, outcomes are not positive. They too are grieving.
We don’t know if the outcomes would have been different if we already had in place the steps we took as a result of our investigation of these cases and the additional steps we are taking in follow up to the CMS report.
Even as we wait for CMS to accept our plan of correction, we are well on our way to a complete reorganization of our Childbirth Center and the physician and certified nurse midwife practices associated with Cooley Dickinson, a reorganization designed to make the care as safe as it can be. We are doing this by strengthening best practices; adding instructional tools and resources and re-educating staff and providers about managing complications of pregnancy and childbirth; and securing consultative and provider support from our parent organization, Massachusetts General Hospital.
Cooley Dickinson remains committed to quality and safety goals articulated in our quality compass and to providing the best health care in the most appropriate setting. The CMS survey allows an opportunity to re-evaluate our policies, processes, and systems of care — not just in the Childbirth Center, but throughout our organization — to be sure our staff and physicians are doing their utmost to provide the safe, high-quality care we want to give and that our patients and our community expect and deserve.
The Board’s quality and safety committee, the Patient Care Excellence Committee, and the full Board of Trustees are closely monitoring the hospital’s response to this situation. We promise that Cooley Dickinson will be a stronger hospital and that the care provided here will be better because of what we’ve learned and the actions we are taking to improve.
Cooley Dickinson Health Care Board of Trustees
Matthew Pitoniak, Chair
Michael L. Blute, Sr., MD
David Brown, MD
James Donnelly, MD
Joanne Marqusee, President and CEO
Elizabeth Mort, MD, MPH
Henry Rosenberg, MD
Margaret Russo, MD
Peter Siersma, MD
Peter L. Slavin, MD
Geoffrey Zucker, MD
Cooley Dickinson Hospital
Summary of 2014 Childbirth Center Survey Findings
If you have any questions or comments about the Department of Public Health/Centers for Medicare and Medicaid Service survey or the findings, please contact Tammy Cole-Poklewski, RN, MS, director of quality, patient safety, and care transitions, firstname.lastname@example.org, 413-582-4736 or Mark Novotny, MD, FACP, FHM, FACHE, chief medical officer, email@example.com, 413-582-2134.
As in the cover letter, the Cooley Dickinson Hospital Community would like to once again express its sincere apologies to the patients and families affected by the tragic incidents which took place in the Childbirth Center.
Because of the technical detail of the survey report and plans of correction, the structure of which causes a lot of repetition, we have summarized below the highlights of the report and our corrective action plan.
During a CMS survey, the reviewer is looking to see that health care organizations comply with Conditions of Participation that must be met in order to participate in Medicare and Medicaid programs. We have included the section of regulation cited in each deficiency for easy reference. Sensitive information in the report has been removed to protect patient privacy; the PDF is included in the link at the end of this summary.
1. Governing Body (42 CFR §482.12)
2. Patient Rights (42 CFR §482.13)
These two Conditions of Participation are grouped together in this summary because the CMS findings in these areas were very similar.
What did CMS find?
Cooley Dickinson filed six Childbirth Center reports with the Massachusetts Department of Public Health between 2012 and 2014. The CMS surveyor reviewed materials related to the six reports, which referenced 12 patients (six mothers and six babies) during her visits on Jan. 31 and Feb. 3 and 4. CMS expressed concerns about the Board of Trustees’ oversight of the Childbirth Center. CMS identified issues related to hospital policies, the effectiveness of a transfer agreement with another hospital; and the care that three of the twelve patients received.
In two cases, CMS cited the need for better implementation of hospital policies. These policies related to the chain of command, electronic fetal monitoring, and maternal hypertension.
In the third case about which CMS had concerns, the surveyor found an inefficient process to transfer a patient to a hospital that offered the highest level of maternity care. The patient had a unique clinical presentation that rapidly devolved into a life-threatening condition. Staff performed a STAT Cesarean section. The final diagnosis was that a stroke occurred. Even though the stroke had already occurred, transfer was made to provide for a higher level of neurological care in order to see if anything more could be done. The transfer process led to sending the patient to a different hospital about 100 miles away.
Finally, CMS expressed concern that an emergency code carts were not documented as being checked daily. The concern was that if the code carts were not documented as being checked, it could mean that checks were not taking place and lead to a situation of not having the necessary materials for patients needing emergency treatment. While this finding did not affect any of the patients whose care CMS reviewed, the surveyor noted during a tour of the Childbirth Center that the checklists were incomplete.
Why is this important?
We want to provide the best possible care for every patient. Part of providing high-quality care involves developing policies that reflect latest awareness of best practices, such as from organizations like the American College of Obstetricians and Gynecologists (ACOG), and having the hospital staff understand and implement them. Hospitals, and their governing bodies, are expected to constantly strive to achieve and maintain the best possible care. The Board of Trustees has been involved in not only monitoring quality, but seeking to improve and optimize the way monitoring is done. Notwithstanding, the involvement of the Board could be improved and steps have been taken in this direction.
What are we doing about it?
The Chair of the Board of Trustees reiterated the board’s responsibility for overseeing the quality of care at the hospital. The Board unanimously voted to support the implementation of a Plan of Correction that CMS is now reviewing. The Board Chair began doing visits in hospital departments to call attention to the importance of a culture of safety; other Board members will also do rounds.
Even before the CMS visit, the hospital began corrective action based on its investigation into the cases that CMS reviewed. In January, we hired an expert obstetric consultant to conduct a one-month evaluation of the service and recommend improvements. We put in place a targeted education plan to include fetal monitoring and maternal hypertension. In addition, our parent organization, Massachusetts General Hospital, retained Benjamin Sachs, MD, a national advocate for patient safety and former chair of obstetrics at Beth Israel Deaconess Medical Center, to identify ways to optimize the quality and safety of obstetric care.
This has led to updates in our chain-of-command policy and education for staff about the updates. Moving forward, all safety event investigations will seek to monitor compliance with this new policy.
Another action is to implement twice-daily patient safety consultations involving representatives (doctors, certified nurse midwives, nurses) from each discipline caring for patients to review the care of all current obstetric patients to identify and best manage known risks. This is in addition to a 24-hour, 7-day-a-week safety hotline to provide another option for staff to report any safety concern, and do so anonymously if they wish.
We purchased a web-based educational program for staff and began re-educating all nurses, certified nurse midwives, and obstetricians on the latest in fetal monitoring. As we reported in our Plan of Correction to CMS, staff completed that training March 26. However, in addition to this we have updated our fetal monitoring policy and will validate staff’s understanding of it. We also have secured 24/7 consultation from Mass General in maternal fetal medicine as an additional resource for the obstetricians and certified nurse midwives at CDH. The consultants at Mass General can remotely access the Cooley Dickinson fetal heart monitoring system. Cooley Dickinson and Mass General’s affiliation took effect last July; Cooley Dickinson remains independently licensed. Obstetrics is one of the first service lines that Cooley Dickinson and Mass General are coordinating; this began in December.
We offered education about alternative methods of delivery for circumstances such as the variation in anatomy and we provided electronic access for Childbirth Center staff to the office practice medical records.
The hospital developed guidelines for managing hypertension in pregnancy; the guidelines are based on November 2013 recommendations from ACOG. By May 1, the guidelines will be converted to a computerized order set, which helps clinicians follow each recommended action. This, and clinical practice guidelines, will assist with early detection and recognition of complications and with treatment. OB providers and nursing staff will also complete online training to confirm they understand CDH policies about high blood pressure and its complications in pregnancy.
In addition, CDH required all obstetricians, certified nurse midwives, and emergency department physicians to participate in a physician and provider education program about recognizing and treating preeclampsia. New providers will be required to view a tape of that program within 30 days of hire.
We secured a commitment from the hospital to which we had difficulty transferring a patient to respond to a transfer request within 15 minutes and communicated to providers a new, streamlined process to arrange a transfer to that hospital in western Massachusetts. That process is working well.
We implemented a double-check process of daily audits of the code carts in the Childbirth Center to not only make sure that the checks are occurring, but are being documented. If 100 percent compliance is achieved after 90 days of checks, the audits will occur weekly. Because daily audits are required of all clinical areas of the hospital, we have extended double-checks to all clinical areas.
CDH also developed an obstetric trigger tool that is based on the work of the Institute for Healthcare Improvement (IHI). According to IHI, hospitals need a more effective way to identify events that have the potential to cause harm to patients in order to identify changes to prevent and reduce harm. If the hospital’s quality database identifies a trigger, the chief of obstetrics reviews the case, identifies areas for improvement, and reports monthly to the Perinatal Safety Committee. We are converting this process from a retrospective review to a real-time early notification process.
Mass General obstetric leaders have now begun to serve as resources to the Cooley Dickinson obstetrics team and Mass General will add expertise to the quality and safety committee of the Board of Trustees, the Patient Care Excellence (PaCE) Committee, and the Perinatal Safety Committee, which oversees quality for the obstetrics department at CDH. A senior faculty member/physician will join each committee. Additionally, CDH labor and delivery nurses, certified nurse midwives, and obstetricians are being offered the opportunity to spend time shadowing their counterparts at Mass General to observe best practices and build relationships.
Finally, to increase attention to the importance of patient safety organization-wide, leaders began safety huddles five days per week that include managers from departments throughout the hospital. The purpose of the daily safety huddle is to identify and correct recent safety risks and plan ahead to identify and mitigate potential risks. Members of the hospital senior leadership team and physician leaders now convene twice weekly to provide oversight of patient safety-related initiatives under way.
3. Quality Improvement Activities (42 CFR §482.21)
This Condition of Participation requires that hospitals identify opportunities for improvement and changes that will lead to improvement; focus on high-risk, high-volume areas; and consider problems in those areas. The surveyor identified two issues.
The first issue cited was the challenges providers were having when they needed to transfer an OB patient. In interviews, the surveyor heard about the communication challenges with the referral hospital.
The second issue identified was obstetrician fatigue. Cooley Dickinson staff is aware that fatigue can play a role in the safe delivery of patient care and conducted a review of provider staffing levels in our Childbirth Center. The internal investigation included discussions with many of its providers. We concluded that OB staffing levels were not an issue in the cases reviewed. As you may know, four obstetrical providers left Cooley Dickinson between October and December 2013 to pursue opportunities elsewhere, while another obstetrician went on maternity leave during this period. We acknowledge our conclusion was different from the CMS reviewer. However, because this is always a concern we feel confident our new policies will allow any concern related to this issue to be quickly communicated and dealt with.
Constantly evaluating care, finding ways to improve it, and implementing improvements are part of the hospital’s responsibility to be sure that our staff and providers are taking the best possible care of every patient and family. We need to learn from the findings of the CMS surveyor and strengthen our internal reviews and follow-up of harm events.
We have informed providers about a streamlined approval process to transfer patients to the closer hospital with the higher level of maternity care. In addition, that hospital has agreed to approve transfers within 15 minutes and to approach transfers as if all will be accepted unless the hospital does not have a bed available. The Cooley Dickinson Perinatal Safety Committee is reviewing weekly all transfers for timeliness and any potential patient care issues. To make sure that obstetricians are not experiencing work fatigue, the hospital is monitoring weekly how many shifts OBs have worked and limiting the number of on-call shifts for the doctors. We have hired three locum tenens (temporary) physicians to help relieve workload, a new permanent obstetrician started working April 1 and another is scheduled to start Aug. 15. Finally, Mass General will provide physician coverage several days a month to Cooley Dickinson until the new full-time OB provider starts.
4. Medical Staff (42 CFR §482.22)
5. Medical Staff Organization & Accountability (42 CFR §482.22[b])
These two Conditions of Participation are grouped together in this summary because the CMS findings in these areas were very similar.
The same concerns raised regarding the Governing Body, described in items #1 and #2, were applied to the Medical Staff. In addition, improvements in the peer review process were identified. “Peer review” is the name for the process through which medical staff colleagues evaluate the care they offer. It is noted in the CMS report that the Medical Staff did not identify obstetrician work fatigue as a problem.
It is important for the Medical Staff to provide the best possible care of every patient and family. Medical Staff is expected to be responsible for the quality of the care its members offer patients. The Medical Staff has been involved in monitoring quality. Notwithstanding, the process has been improved.
Many of the actions we described in our discussion of items #1 and #2 address CMS’s findings. An additional step we took to enhance communication is that Childbirth Center staff and physicians and certified nurse midwives established a trigger phrase. If a team member uses the phrase, it indicates there is a staff concern that the team needs to address.
In response to CMS’s concerns about Cooley Dickinson’s peer review process, we reported that the care of the three patients reviewed by CMS is also the subject of peer review by Cooley Dickinson’s Medical Staff Quality Improvement Committee. Besides the internal reviewers on that committee, the peer review of the three cases included external review by two senior physicians from Mass General. The committee plans to act on the peer review by May 1. Any actions taken will be confidential, as outlined in federal law (the Health Care Quality Improvement Act of 1986).
The actions discussed in item#3 will address CMS concerns about provider fatigue. In addition, the obstetricians were reminded about their professional obligation to inform the chief medical officer or medical staff president immediately if they believe fatigue is affecting their work performance. If such a report is made, the chief medical officer will address the situation.
6. Nursing Services (42 CFR §482.23)
The same concerns raised regarding the Governing Body, described in items #1 and #2, were applied to the Nursing Staff. In addition, concerns related to nursing staffing levels were identified. This was due to the charge nurse not being readily available to assist other nurses in some of the cases CMS reviewed.
Finally, the surveyor observed a difference between the certification requirements for nurses working in Cooley Dickinson’s main operating rooms and the obstetrics nurses working in the Childbirth Center surgical suite, where cesarean sections are performed. The report noted that nurses in the main operating rooms had to have Advanced Cardiac Life Support (ACLS) training while childbirth nurses did not.
It is important for leaders of nursing services to be sure that nurses are taking the best possible care of every patient and family, to monitor the quality of nursing care, and to determine the number and types of nursing personnel and staff needed to provide nursing care in the hospital.
Many of the actions we described in our discussion of items #1 and #2, such as required fetal monitoring training and validating understanding of updated policies, address the findings in this item. In addition, the hospital hired a full-time obstetric nurse educator.
Finally, Advanced Cardiac Life Support (ACLS) training is now required for Cooley Dickinson Childbirth Center nurses. Until all of the nurses there have the certification, they will be under the supervision of a nurse with ACLS when they are caring for patients recovering from C-sections.
We are very sorry for the events that occurred in our childbirth center and extend our deepest sympathies to the families who were impacted by them. Our internal investigations of events and the CMS survey have identified some important opportunities for us to improve care and safety. We are actively addressing these opportunities so we can be sure that staff and physicians are doing their utmost to provide the safe, high-quality care we want to give and that our patients and our community expect and deserve.
View the redacted DPH/CMS report here: http://j.mp/1faBYgS
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