The Centers for Medicare and Medicaid Services deemed St. Michael Medical Center in Silverdale to be back in substantial compliance with participation requirements for Medicare and Medicaid programs last month after investigators scrutinizing the facility found a number of concerns at the hospital in recent months, raising the possibility that the facility could lose vital funding.
Staff with the state’s Department of Health who opened a Medicare investigation at the facility on behalf of the federal government zeroed in on a number of findings in visits to the facility in October and November 2022, according to investigative documents obtained by the Kitsap Sun through the Freedom of Information Act. Investigators then found the hospital to be out of compliance with three broad participation conditions related to patient rights, emergency services and the hospital’s quality assessment and performance improvement program and detailed a number of specific issues.
Documents noted visits to the hospital last year from Oct. 18 through Nov. 3 and on Nov. 9 and 10 for a “health and safety complaint investigation” related to several case files. A report noted that after a follow-up visit from Feb. 6 through Feb. 8 this year to verify corrections of “condition-level” deficiencies the facility remained not in compliance, noting continuing issues.
Among the findings were determinations that a patient died during a period of short staffing in the hospital’s emergency department last fall, that the hospital failed to ensure there was a standardized process to provide adequate staff and timely assessments and reassessments for patients, that the facility lacked a proper overarching program for monitoring care quality and that the hospital handled its use of seclusion and restraints improperly, according to the documents.
Early last month, a spokesperson for CMS told the Kitsap Sun that a 2022 complaint investigation resulted in the non-compliance finding and said the hospital would have the opportunity to demonstrate corrective action prior to a possible termination date of April 28.
The CMS spokesperson said Monday that the facility was notified that it was found to be back in substantial compliance with the federal government’s conditions of participation last month after an on-site revisit by the Department of Health confirming that corrections were in place.
Said hospital president Chad Melton in a statement provided by Virginia Mason Franciscan Health: “I’m pleased to confirm that the most recent CMS visit determined St. Michael Medical Center to be in substantial compliance with federal requirements for participating in the Medicare and Medicaid programs. Over the past several months, we have been implementing our approved action plan to ensure the corrections we made are hardwired into our daily operations. I am grateful for the progress our team has made in reducing wait times, improving our processes in the emergency department, and increasing our staffing levels to ensure we continue to provide the best care possible for our community.”
VMFH’s statement touted improved staffing levels at the hospital and a nurse headcount that has grown by 40 between October and March. VMFH also said the hospital’s weekly median arrival to triage time decreased from 15 minutes in December to four minutes or less as of April.
“We’ve made significant progress on streamlining emergency department processes, through implementing the Virginia Mason Production System (VMPS) and other improvements, such as co-locating a triage nurse at the registration desk to more quickly assess and triage patients based on their acuity,” the statement said.
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Staffing and patient assessments
In the documents, investigators highlighted concerns they found regarding timely assessments and reassessments of patients who came to the hospital for emergency care. Following the 2022 visits, they wrote that the hospital “failed to define and ensure a standardized process to provide adequate personnel and timely assessments and reassessments” to meet the needs of three specific patients who had come to the facility in September and October.
Perhaps the most concerning of the findings is their linking the death of an 81-year-old patient in September to short staffing at the hospital.
An investigator noted that a shift report from the evening that patient arrived – Sept. 26, 2022 – showed that the emergency department, while operating down 11 nurses, had 81 patients and 36 “boarder” patients – those who remain in the emergency department while awaiting bed placement. The remaining 14 nurses were left to care for 117 patients – an approximate ratio of 8 patients per nurse – not counting those patients waiting in the lobby or any new patients who might show up to the hospital, the documents said.
Here’s how the man’s final hours on Sept. 26 and 27 are logged by the records:
- 3:07 p.m.: The man arrived at the hospital with a chief complaint of a fainting episode and low blood pressure earlier in the day.
- 3:21 p.m.: The man was triaged and assigned an emergency severity index (ESI) level of 2 (emergent).
- 3:31 p.m.: Protocols for an electrocardiogram (EKG) and a blood test for troponin – to measure potential heart damage, the documents said – were initiated.
- 3:35 p.m.: A physician was notified that the EKG had been completed.
- 4:14 p.m.: The blood test showed that the man had elevated levels of troponin.
- 5:03 p.m.: The man was returned from a triage room to the lobby.
- 7:36 p.m.: EKG results indicated evidence of a strain on the man’s heart, and the abnormal EKG was confirmed by a physician.
- 7:59 p.m.: A physician evaluation began – nearly five hours after the man arrived at the hospital. Investigators found no documentation that the man was reassessed for four hours and 44 minutes.
- 10:25 p.m.: Results of a chest scan showed the man had a massive blood clot in a crucial lung area.
- 10:52 p.m.: An order was placed for thrombolysis/thrombectomy to dissolve and remove the clot, and the man was taken to the hospital’s interventional radiology suite.
- 1:05 a.m.: Mid-procedure, the man became unresponsive and emergency resuscitation started.
- The man was intermittently unresponsive and resuscitated multiple times between 1 a.m. and 3 a.m., when life-saving efforts stopped “due to medical futility.”
In an interview with an investigator in November, the patient’s triage nurse said that “she was alone in triage with a full waiting room and that there were so many people waiting for triage that she did not have time to review lab results for patients who had already been triaged, or perform any reassessments, so she was not aware of (the patient’s) elevated troponin level, abnormal EKG, or any possible changes in condition. (The nurse) also stated that there were no additional (nurses) available to help with patient triage.”
The night shift triage nurse who took over after that nurse told an investigator that the lobby was full, but prior to beginning triage for new patients, she reviewed test results for about 25 patients who had been triaged previously, noted the patient’s elevated troponin level and reported it to an emergency department physician. A second troponin test and a check of the man’s vital signs were completed at 7:53 p.m., and the repeat test also showed the troponin levels were elevated. The man was then taken to an emergency department room.
In an interview with an investigator, the hospital’s interim emergency department manager said that patients “triaged as ESI 2 are emergent and should begin receiving evaluation and treatment rapidly.”
The patient’s emergency department physician told an investigator that the department “frequently was not fully staffed with RNs. (The physician) stated that, based on presentation and history, (the patient) may have benefited from a more timely physician evaluation.”
Investigators also highlighted the care of another patient, a 76-year-old man, who arrived at the facility on Sept. 21:
- 10:20 p.m.: The man arrived at the emergency department from an urgent care facility to be evaluated for a possible stroke after he had twice experienced confusion and had nonsensical speech earlier that day.
- A triage nurse performed a rapid exam for stroke symptoms that was negative. The man was assigned an ESI of 2 (emergent) and directed to wait in the lobby.
- 6:51 a.m., Sept. 22: The man was evaluated by a physician. An investigator noted that no reassessment was documented during the eight hours and 38 minutes that the man waited in the lobby.
In an interview with an investigator, the patient’s triage nurse said that the lobby had been full of patients and because of the number of people waiting to be triaged, there wasn’t time to reassess patients. The nurse reported that their practice was to notify the charge nurse when the lobby was overwhelmed with patients waiting for triage and treatment but said that there was often no one available to help. That nurse was “not aware of any parameters defining the reassessment of patients waiting for treatment.”
An investigator noted that a report from the time that the 76-year-old patient had been at the facility showed that the emergency department had a census of 42 emergency department patients and 30 “boarder” patients. At 11 p.m., the department was short four nurses, leaving 12 nurses to care for the 72 patients – a ratio of six patients per nurse – not counting those patients waiting in the lobby or any new patients who might show up to the hospital, the documents said.
An investigator found that the hospital’s policy covering patient assessments said that “reassessment is ongoing and dependent and driven by patient condition. Parameters for assessment and reassessment are not objectively defined.”
Following the February visits, investigators again noted issues with patient evaluations.
Again highlighting the care of a group of four patients who received emergency care, investigators found the “hospital failed to ensure staff perform timely focused assessments” to meet their needs.
Here’s how investigators logged the care of one of those patients, a 65-year-old who came to the emergency department with chest pain the afternoon of Feb. 5 and was several hours later admitted to the hospital for a heart attack and high blood pressure:
- 2:18 p.m.: The patient presented to the department with a complaint of chest pain.
- 2:32 p.m.: The patient’s initial vital signs recorded an abnormal and significantly elevated blood pressure. An investigator found no documentation that the vital sign measurements were repeated or that a provider was notified of the abnormal vital signs at that time.
- 2:34 p.m.: The patient was triaged and assigned an ESI level of 3 with an updated chief complaint of abdominal pain. An EKG was completed a few minutes later, a provider was notified and the patient was then returned to the waiting room.
- 7:36 p.m.: The patient was transferred from the waiting room to the emergency department – five hours and 18 minutes after arriving – and placed in an overflow hallway chair. The investigator found no documentation that a four-hour reassessment was completed by staff while the patient remained in the waiting room as required by hospital policy.
- 8:07 p.m.: A note added by a nurse to medical records stated that “full assessment deferred to md (physician) due to high acuity low staffing.”
- 9:08 p.m.: Vital signs recorded an abnormal and elevated respiratory rate and an abnormal high blood pressure – six hours and 35 minutes after the last set of vital signs was recorded.
- 9:09 p.m.: The patient was diagnosed and admitted to the hospital for a heart attack and dangerous high blood pressure.
- An investigator could find no documentation that a focused assessment for cardiac concerns or abdominal pain was performed before admission to the hospital.
Speaking with an investigator in October, a group of emergency department charge nurses described the escalation process for periods when the department was short staffed. They said that the process was to notify a manager when they were on duty or to notify a house supervisor if the manager was not present, and if the house supervisor was not able to solve the issue, they were to notify an administrator who was on call. The charge nurses reported that additional nursing staff members were usually not available.
A group of house supervisors at the hospital spoke about their individual approaches to solving staffing issues in the emergency department, including inconsistent escalation through the chain of command to the administrator on call, an investigator wrote. The staff said that escalating to the administrator on call was “often not productive if the AOC was a non-nursing person such as a social work manager or a pharmacist, so sometimes the AOC would not be contacted.”
The charge nurses reported that they could call Olympic Ambulance to send EMTs to help monitor patients in the lobby, though they reported that there was no systematic process for determining when assistance was needed. An investigator reported reviewing a document that tracked the use of EMTs from July 15 through Oct. 13 last year that showed that the hospital had used them to provide patient monitoring for 275.5 hours during that period.
In October last year, an investigator spoke with two hospital executives who said that the facility had not assessed the competency levels of the EMTs and said that the hospital was unaware that the EMTs used in the hospital were practicing outside the scope of their credentials because an EMT credential was a prehospital credential, according to the documents.
The executives “stated that many attempts were being made to mitigate nursing shortages, but confirmed that there was no immediate mitigation process in place to provide adequate nursing staff on a daily basis.”
Seclusion and restraints
Following the 2022 visits, investigators faulted the hospital’s use of restraints and seclusion, noting the cases of four specific patients in which provider orders did not specify what type of restraint should be used for those patients and that records did not document the use of “less restrictive” alternatives prior to using restraints. Records also noted that the hospital failed to ensure that a licensed provider or specially trained nurse completed a one-hour face-to-face assessment for those four patients who were placed in violent or self-destructive restraints or seclusion.
“Failure to specify the type of restraint to be used and to attempt the least restrictive alternative is a violation of patient rights, and places patients at risk for physical and psychological harm, loss of personal freedom, and death,” investigators wrote.
After the February follow-up visits, investigators again noted issues in that area.
They noted that the hospital’s restraint and seclusion policy, last approved in December, directed that those placed in restraints or seclusion for violent or self-destructive behavior be observed continuously and that staff record documentation of a patient’s psychological status, circulation and signs of injury every 15 minutes.
- An investigator found no documentation that a patient was evaluated every 15 minutes as required by policy after he was placed in four-point restraints in January for about two hours following violent behavior he showed towards staff and himself.
- A surveyor found no evidence that staff had monitored a patient who came to the facility in February and was placed in soft wrist restraints after she became combative and refused to keep a medical device on. Records and an interview indicated that the patient was restrained for about three hours. A nurse confirmed that there had been no documentation of patient restraint, and a surveyor found no evidence that the patient’s care plan was updated to reflect restraint and no evidence a provider ordered physical restraint.
- An investigator found no documentation that a face-to-face evaluation was performed by a provider for a patient who in January was placed in seclusion and then released from restraints about three hours later after the patient began yelling and screaming and attempted to grab a nurse and a technician while they were trying to administer medication for anxiety. A staff member acknowledged that provider documentation did not reflect that the patient was placed in seclusion.
Care quality program
Participation conditions require that a hospital have a facility-wide, data-driven quality assessment and performance improvement program and that evidence of such a program be maintained for CMS review.
Investigators found last year that the Silverdale hospital had failed to maintain such a program, noting issues like a failure to systematically collect and analyze quality indicator data, a failure to develop action plans when performance goals were not being met and a failure of executive leadership “to address priorities for improved quality of care and patient safety and that all improvement activities are evaluated.”
“Failure to systematically collect and analyze hospital-wide performance data limited the hospital’s ability to identify problems and formulate action plans,” a surveyor wrote last year. “This reduced the likelihood of sustained improvements in clinical care and patient outcomes.”
Speaking with an investigator in October last year, the interim manager for the emergency department said that there were “no current quality indicators or performance improvement projects related to emergency department throughput, staffing, patient harm or errors.”
A hospital quality manager said then that there was no master spreadsheet for the hospital that showed all indicators, prioritization and monthly monitoring results and that they did not receive monthly data from departments or committees.
“There are assigned indicator owners that monitor the ongoing data collection,” the investigator wrote. “When indicators fall below threshold and necessitate a focused process improvement plan, the indicator owners are responsible for that. There was no standardized process for the number of months below threshold that would trigger a performance improvement project. The quality manager would not know that a performance improvement project was needed, or in process, unless the indicator owner reported it” at a meeting.
Emergency preparedness
Investigators also faulted the facility for its emergency preparedness following a cyberattack last fall that left hospital staff without access to key internal systems like patient records for several days.
An investigator noted that the hospital’s downtime policy, for use during periods when computers were not available, lacked “actionable procedures for a cyberattack causing a complete outage of all computer systems resulting in prolonged use of paper charting” and determined that the hospital had failed to develop a testing and training program specific to cyberattacks.
According to the documents, an investigator found a cyberattack training that focused on how to recognize and report email phishing attempts and said that the hospital’s orientation and annual emergency preparedness online training provided guidance on emergency response notification systems and staffing models for standards of care but said that neither provided information on attacks in which computers were completely inaccessible.
The division director of emergency preparedness management told an investigator that there were plans to do cyberattack training in June last year but said that the training had been cancelled.
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