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Based on interviews, review of medical records and review of hospital documents, including policies and procedures, it was determined that the governing body failed to ensure that the hospital developed an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. This program would assure that the safety of all patients in the hospital were assessed and evaluated, including patients who had been either restrained or not restrained, and who sustained de-cannulations or experienced other negative events.

Reference deficiencies written at Tag A0115 - Patient Rights

Reference deficiencies written at Tag 0144 - Patient Rights

Reference deficiencies written at Tag A0263 - Quality Assurance/Process Improvement

Based on review of the hospital's policies and procedures, document review, and interview, it was determined that the hospital's governing body failed to ensure that the rights of all patients in the hospital were protected and that their safety was assured.


As evidenced in the findings detailed throughout this report, the cumulative effect of these systemic problems resulted in the hospital failing to protect the safety of Patient #1 and failing to implement corrective measures where necessary to assure the safety of all patients in the hospital.

-Failure to assure the safety of Patient #1. Reference Tag A0144

-Failure to investigate and evaluate safety concerns related to the safety of Patient #1, and to subsequently develop and implement corrective actions to protect the safety of all patients in the hospital. Reference Tag A0263

CONDITION IS NOT MET as evidenced by:


Based on interviews, review of hospital Policies & Procedures and documents, the hospital failed to develop and implement a quality assurance - process improvement plan that addressed the safety and comfort of all patients in restraints, as opposed to tracking only the number of days patients were restrained in the hospital. The hospital also failed to develop and implement a quality assurance-process improvement plan that addressed the safety of patients who had incidents such as decannulations, and who were unrestrained at the time.

The cumulative effect of systemic problems resulted in the hospital failing to ensure that the the hospital developed an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program for the assessment of patients who had been either restrained or unrestrained and had sustained de-cannulations or other events.

Based on interviews, review of medical records, review of hospital policy and review of internal hospital documents, it was determined that the hospital failed to protect the safety of Patient #1. The hospital's failure to recognize and investigate the events around the care of Patient #1, and implement corrective measures where necessary, potentially placed all patients in the hospital at risk for injury or death.

Findings include:
Patient #1 was admitted to Kindred Hospital on 12/15/2012 with a medical history that included hypertrophic cardiomyopathy [a potentially life-threatening cardiac condition], septic shock [life-threatening blood infection], renal failure requiring dialysis, as well as respiratory failure. At the time the patient was admitted to Kindred Hospital, s/he had a tracheostomy which had been placed [a surgical procedure] 5 days earlier and the patient still required mechanical ventilation.
At the time of admission, the patient was not restrained.
On 12/16/2012, a dictated progress note from Physician #2 stated "emergent trach [tracheostomy] tube change after patent damaged the tube by pulling off pilot balloon and possibly put trach into false tract. Patient is anxious. Delirious...This should be considered super high risk airway with high risk airway protocols. Tracheostomy care with suctioning as necessary. Physical restraint until patient stops pulling at trach. [S/he] has already selft [sic] decannulated, self extubated before coming to Kindred at this morning yanked critical safety part off [her/his] trach tube irreversibly damaging it requiring urgent and difficult trach tube replacement...physical restraint until [s/he] stops groping at tracheostomy tube".
The dictated consultation report was not available in the medical record at the time it was dictated, and was placed in the medical record after the patient had been discharged.
The history and physical also documented that the patient had pulled out her/his tracheostomy tube at the previous hospital.
The consultant physician's dictated report of 12/16/2012 stated "...the patient has been delirious with waxing and waning levels of alertness. [S/he] has been pulling at tubes and lines even before coming to Kindred, self extubated on 12/10...[S/he] should be considered at super high risk airway [sic] with high risk airway protocols in place. [S/he] should remain in physical restraints until [s/he] stops pulling at the trachea...."
The dictated history and physical report was not available in the medical record at the time it was dictated, and was placed in the medical record after the patient had been discharged.
At 10:01 am on 12/16/2012, Physician #2 ordered the patient to be placed in restraints. The physician's order read: "Reason for hand mitten restraint and monitoring: pull, disturb medical equipment, including pulling of tubes/line, risk of injury to self due to inability to understand or remain oriented, Start STAT [immediately]..."
At 10:17 am on 12/16/2012, the Registered Nurse (RN #1) assigned to the patient acknowledged in the electronic medical record that s/he had received the physician's order for restraints. The nurse later documented that s/he had not restrained the patient as the physician had ordered, but had instead placed a "sitter" at the patient's bedside.
There was no documentation in the medical record that the RN had discussed her/his decision with the physician. The RN stated in an interview that s/he had not notified the physician that s/he had not implemented the restraint order, because s/he used her/his "nursing judgement" and determined that the restraints were not necessary.
The EMR did not document that the physician spoke directly to RN#1 about the need to restrain the patient, or about the importance of maintaining the "high risk airway". Neither the physician or the RN could recall if the RN had been present when the physician replaced the patient's tracheostomy tube on the morning of 12/16/2012, or if the physician had spoken directly to the RN regarding the restraint order.
The EMR did not document direct, personal communication between the physician, the RN and/or the RRT. The lack of communication between the members of the health care team potentially contributed to the lack of understanding about the importance of placing the patient in restraints to assure that the high risk airway was maintained.
On 12/16/2012, at 6 pm, Certified Nursing Assistant (CNA) #1 documented:
"Repositioned self. Pt. is able to turn in [her/his] bed without assistance. Currently will be monitering [sic] with a 1:1 due to the patient trying to decannulate and get out of bed."
There was no further documentation from CNA #1.
The patient remained unrestrained and, at an unknown time on the evening of 12/16/2012, the patient did decannulate [accidental or purposeful removal of a tracheostomy tube]. The Registered Respiratory Therapist and the hospital physician both tried to replace the tracheostomy tube but could not establish an adequate airway. The patient was emergently transferred to another hospital where s/he died on January 19, 2013.
The hospital provided a copy of the death certificate for Patient #1, which had been faxed to the hospital on September 20, 2013. The death certificate was dated January 24, 2013 and documented the date of the patient's death as January 19, 2013. The death certificate also contained the following information:
Cause of death Interval between Onset and Death
a. Anoxic encephalopathy Weeks
b. Respiratory failure complicated by displacement
of tracheostomy tube Weeks
c. Hypertrophic cardiomyopathy Years

Interview with RN #1
On 10/17/2013, RN #1 was asked why the physician's order, written at 10:01AM on 12/16/2012 had not been implemented. The RN stated "I used my nursing judgment" and that s/he was trying to use the "least invasive" [sic] restraint possible. The RN confirmed that s/he had not called the ordering physician to discuss her/his "nursing judgment" and her/his decision to not implement the physician's restraint order.
Interview with Registered Respiratory Therapist (RRT) #1
On 10/16/2013, RRT #1 was interviewed about her/his care of Patient #1. The RRT stated that s/he recalled the patient because the patient had been transferred to another hospital. S/he stated that s/he had come on duty on 12/16/2012, at 6 pm, and was told the vent [ventilator] was alarming. The RRT stated that s/he knew the patient had been pulling at the tracheostomy tubing while in the hospital, and before this incident, RRT #3 had witnessed the patient do the same thing.
RRT #1 stated that the patient then decannulated [removed the breathing tube] himself. S/he did not recall if s/he saw it happen or if the tube was half inside the airway or if air was leaking.
RRT #1 stated that s/he pushed in the tracheostomy tube and tried to get it in place, but the volume wouldn't go up [indicated the tubing was not in the correct place]. The RRT stated that s/he tried again to place the tube and reposition the tube, but the volume would not go up. S/he stated that s/he then started to "bag" [artificially breathe for the patient, via the tracheostomy tube] the patient with 100% oxygen. The patient's face began to swell and s/he realized the tracheostomy tubing was not in the correct place. S/he then stated that s/he called Physician #4 who was in the hospital at the time, and the physician came to the bedside immediately.
The RRT stated that Physician #4 called Physician #2 and also called the ambulance. The RRT stated that s/he wanted Physician #5 to tell the RRT what to do besides try to reposition the tracheostomy tubing. S/he stated that s/he had tried to reposition the tubing "and probably shouldn't have".
Interview with Sitter #1
The CNA was interviewed on 10/17/2013. The CNA, who had been the "sitter" for Patient #1, stated that s/he had received and reviewed a job description for the position of "sitter". The CNA stated that sitters were assigned to one patient only, that they were to do personal care for the patient and they were supposed to document their actions in the medical record. The sitter was unable to recall the patient specifically and her/his comments about the patient were based on her/his documentation in the medical record.
Interim Chief Executive Officer Interview re: Sitters
Orders from Physician #2 for the implementation, and discontinuation, of restraints were reviewed and discussed with the Interim Chief Executive Officer (ICEO). The use of a "sitter" was discussed, and the ICEO described a "sitter" as a person who was to sit at the bedside of a patient to help prevent a patient from harming her/himself.
The ICEO stated the "sitters" were staff who had no assigned function but to sit at the bedside of a particular patient, and could be CNAs or respiratory therapists or other staff who were certified or registered. The "sitters" purpose was to keep the patient from potentially harming her/himself by pulling out airways, tubing or other self-harming activities.
The ICEO and the investigator reviewed the medical record for Patient #1, both in hard copy and online. When asked to identify the sitters' documentation of the patient's status, or any interventions utilized to maintain/enhance patient safety, the ICEO stated that "sitters" did not document in the medical record. S/he stated that the "sitters" were only to observe or distract the patient they were sitting with, and they did not perform care or interventions for the patient.
When asked to provide a position description for the role of "sitter", the ICEO provided a position description which s/he stated had been developed at the corporate level, but not adopted by the 1st Hill campus.
Physician Interviews
Physician #1
Physician #1 was interviewed on 10/16/2013. The physician stated that s/he worked at the hospital part-time and at the time Patient #1 was admitted, s/had been covering for Physician #3. Review of the patient's medical record revealed that Physician #1 had admitted Patient#1 to Kindred Hospital, and performed the admission history and physical examination.
Physician #1 stated that s/he had not heard since about this case until approximately "a couple of months ago". The physician stated that no one in hospital administration had discussed the case with her/him and that s/he had not been asked to participate in any quality review or root cause analysis regarding events related to Patient #1.
When asked if the hospital had a policy to request a pulmonary physician consultation on "fresh" tracheostomy patients, Physician #1 stated that s/he was not aware of such a policy but this case "shows its a good idea".
Physician #1 stated that s/he understood the concerns Physician #2 had about "fresh traches" [patients with recently performed tracheostomies], especially since Patient #1's body build [the patient had a thick neck] put her/him at higher risk [for losing or dislodging the tracheostomy tube].
Physician #2
Physician #2 was interviewed on 10/16 and 10/23/2013. S/he stated that on the morning of 12/16/2012, s/he had been called at home by a respiratory therapist (RT) to come to the hospital to evaluate the patient because the patient had pulled her/his pilot balloon off of her/his tracheostomy tubing. Physician #2 stated that s/he asked the RT to help the patient compensate by other means until s/he could get to the hospital.
Physician #2 stated that when s/he arrived at the hospital, s/he could see that the RT had been correct, and that the patient needed to have a new tracheostomy tube placed. The physician stated that not everything s/he needed for the procedure was present at the patient's bedside, and s/he had to gather items. The physician stated that replacing the tracheostomy tube was complicated and difficult, but the tube that s/he placed "looked good at the time."
Physician #2 stated that s/he had been "very emphatic" that the patient needed to be prevented from pulling out the tracheostomy tube because the patient had pulled the tube out at a previous hospital, and s/he had had a difficult time putting in the new tube. The physician stated that s/he had written orders for restraints, but could not recall if the patient's RN or a registered respiratory therapist (RRT) had been present at the time of the tracheostomy replacement.
Physician #2 stated that s/he had not been asked to formally consult on the patient at that time, but s/he came to the hospital because the RT had called her/him. The physician stated that s/he believed that the RTs did "something to the trache" [tracheostomy] after s/he left the hospital on the morning of 1216/2012.
Physician #2 stated that s/he believed that something happened to the patient's tracheostomy tube and the RTs tried to fix it. The physician stated s/he believed that because another physician had told her/him that the patient had developed "severe sub Q emphysema" [swelling from air seeping into the tissues around the face and throat] which was so severe that the physician could not find the patient's mouth.
On 10/16/2013, Physician #2 stated that at more than 6 months after the events involving Patient #1, there had been no investigation and evaluation of the patient's care. The physician stated that her/his requests to have the care evaluated by the Quality and Intensive Care Committees were refused.
Physician #2 stated that s/he had made her/his first request for an investigation and review of the patient's care as early as mid-January, 2013 and as recently as Oct. 11, 2013. S/he stated that s/he had requested a root cause analysis of the event, and also a review by the Quality Council, the Medical Executive Committee, the Intensive Care Committee and the High Risk Airway Committee, but had been turned down. The physician stated that "all people involved should have evaluated the situation". S/he stated that the ICEO told her/him that the patient's case did not need to be reviewed because the patient's death was not related to events at Kindred.
Physician #2 stated that a utilization review had been conducted because the Medical Director for the patient's insurance company had sent a letter of complaint to the hospital which stated the insurer/Medical Director was "concerned". The physician stated that the letter had not requested a response from the hospital.
When asked if the same situation still existed and something similar could happen again that night, Physician #2 stated "Oh, it could happen tonight!"
On 10/23/2013, Physician #2 stated that s/he had been called by the hospital's ICEO and informed that no RT's had "touched the vent" [ventilator]. The physician stated that s/he then walked the ICEO through the medical record and showed the ICEO where, sometime around 7 am, there had been changes made to the ventilator. The settings had been changed from "volume mode to pressure support and other changes had been made as well".
Physician #2 stated "there should be some doctor who, if I say I've got a problem with treatment on 'patient Y', then there is a way to have something happen". The physician stated that, while there were medical directors of specific areas such as Intensive Care, there was no over-arching, hospital medical director, there was no medical person in administration and all reviews were done by by nursing personnel in administration.
Physician #3
Physician #3 was interviewed on 10/28/2013. The physician stated that her/his position at Kindred Hospital was that of physician advisor to Quality and Utilization Review. S/he stated that s/he was not the medical director, but had been the medical director up until about 4 months prior. Physician #3 stated that the current medical director was Physician #4.
When asked to describe the hospital's investigation into the care of Patient #1, the physician stated that the "ICU committee looked at it" and that Physician #2 had responded to an insurance carrier's letter of concern. Physician #3 stated that the Intensive Care Committee and the Quality Council looked at specific issues and it was identified that there was "not a good process for identifying patients with high risk airways".
Physician #3 stated that s/he sat on the Medical Executive Committee and this case had not come up for peer review. Physician #3 was asked if there was a peer review process in place at the hospital, and s/he stated that there was a process but that this case was not sent to peer review because it was determined that it was more of a "procedural issue" involving policies, procedures and processes, than it was an issue involving physician care.
Physician #3 stated that they had also "looked at" the restraint policy. The physician stated that the internal review found that there was "not good documentation of the patients condition and need for restraints" and that the nursing documentation was "conflicting".
Physician #3 stated that s/he did not have any concerns with the care provided by Physician #2, but believed that there were issues of concern regarding communication between the physician and the nurse(s). Physician #3 also stated that the hospital's electronic (EMR) did not have a good pathway for restraint orders.
Physician #4
Physician # 4 was interviewed on 10/29/2013. The physician stated that s/he sat on the Medical Executive Committee, the Intensive Care Committee, the Quality Council and s/he did chart review, M&M [mortality and morbidity] review and peer review for the hospital. The physician stated that s/he was the medical director for the Swedish-Kindred care collaboration, but that Physician #3 was the current Medical Director for Kindred.
Physician #4 stated that s/he did not review the case of Patient #1, and s/he did not currently care for patients at Kindred.
Physician #4 stated that the EMR at Kindred was "clunky and cumbersome" and made it difficult to piece together the story. The physician also stated that the EMR "does impact smooth chart review". When asked to describe specific issues with the EMR, the physician stated that what was/is lacking is a place in the EMR for narration from both the physicians and nurses, because that would help both physicians and nurses with care.
Physician #4 also stated that s/he had informed administration of Kindred that M&M case reviews need to be conducted. The physician stated that there is not a specific M&M committee at the present time, but s/he has recommended that there be one. The physician stated that currently there are no "big forum meetings" to review care.
Physician #4 stated that the Quality Council reviews some cases, but the focus is so broad the council doesn't focus on specific cases.
Physician #5
Physician #5 had been the in-house hospital physician at the time that Patient #1 decannulated. On 12/16/2012, Physician #5 documented that s/he had been "...called by RN for decreasing O2 sat [decreased level of oxygenation in the body]". The physician documented that s/he called Physician #2, who had changed the patient's tracheostomy tube earlier that day, and the two physicians decided to transfer the patient to another hospital for emergency evaluation of the patient's airway by an ENT [ear, nose and throat specialty physician].
Review of the medical record revealed that the patient had been "bagged" [provided oxygen by manually forcing air/oxygen into the patient's airway via the tracheostomy tube] until the patient was transferred, by ambulance, from Kindred to another hospital.
Physician #5 was interviewed on 10/23/2013, and stated that s/he did not recall much about the patient and has not reviewed the patient's medical record. The physician stated that s/he did remember that the patient had decannulated and s/he had tried to redo the tracheostomy. S/he stated that the RT had already tried twice [to reposition the tracheostomy tube] and s/he tried once, but there was already some trauma [to the patient's airway].
When asked if there had been any Quality Assurance activities around this case since the complaint investigation started on 10/3/2013, s/he stated "no, nothing".
Physician #6
Physician #6 was interviewed on 10/23/2013. The physician stated that s/he had been associated with the hospital since August, 2013. S/he stated that s/he had not been asked to conduct a Peer Review, but had been requested to perform a quality review, to evaluate where things could have been improved. The physician stated that s/he had performed a quality review, and there was no formal report of the findings. Physician #6 stated that s/he became aware of the case, and involved in quality review of the case, because Physician #2 had asked that the case be reviewed.
When asked to describe what her/his review revealed, Physician #6 stated that the hospital's EMR does not always make things clear and it was hard to get exact information about what happened.
The physician stated that it was not clear from the EMR review whether Physician #2 had spoken directly with the nursing staff about her/his concerns about the patient's tracheostomy. The physician also stated that the EMR needs to have a place for the RNs to have "open documentation" [narrative text].
Physician #6 stated that s/he thought the case would/should be discussed in M&M committee, but the M&M committee does not yet exist. S/he stated that s/he and Physician #4 were trying to put the committee together.
Physician Peer Review - ICEO and Physician Review
The Interim Chief Executive Officer stated that Physician #6 had done a peer review of the case to determine if Physician #2 [who changed the patient's tracheostomy tubing and wrote the orders for patient restraints] had performed according to peer standards. Documentation of the review performed by Physician #6 was reviewed and found to contain what appeared to be only a timeline of events, not an evaluation of physician care.
The last documentation in the undated document stated:
"1.) Recommend Discuss in M&M [mortality and morbidity committee]
--Intubate patient endotracheally
--Nursing communication with physicians
--Physician communication with nursing"
On 10/23/2013, Physician #6 was asked if there were written guidelines for peer review, and asked to discuss the content of his review. Physician #6 stated that s/he was not aware of written guidelines for a peer review, but what s/he had been asked to do was a quality of care review.
Physician #6 stated that one of her/his primary concerns was that everyone wasn't up to date with a new high risk airway [patient] protocol and that communication was a component in the events that unfolded around the care of Patient #1.
When asked if the case had been discussed yet in the M&M committee, Physician #6 stated that the M&M committee did not yet exist and s/he and Physician #4 were "trying to put it together".
Review of Policies and Procedures Regarding the Management of High Risk Airways

Hospital leadership was asked to provide documentation of policies and procedures or other guidelines, which were used to guide staff practice in the management of high risk airways.
No policy and procedure was provided that defined a high-risk airway, or the role of each discipline in the management of a high-risk airway.

Hospital Investigation into Events Related to Patient #1
On 10/17/2013, the Chief Nursing Officer (CNO) stated that s/he had had a brief conversation with RN #1 regarding the failure of RN #1 to implement physician's orders for restraints. The CNO said the discussion was informal and undocumented because s/he had never had complaints about the RN before and s/he thought the RN did a good job.
However, on subsequent interview on 10/24/2013, the CNO was asked to describe her/his investigation into, and evaluation of, the care provided to Patient #1. The CNO stated that s/he had not had a conversation with RN #1, but that s/he had discussed the events with the house supervisor at the time. When the CNO was asked why s/he had not had a discussion with RN #1, the CNO stated that s/he had never had a concern about RN #1 brought to her/his attention before.
The CNO was asked if s/he had reviewed previous restraint orders that RN #1 might have received, or previous documentation by the RN, and the CNO stated that s/he had not.
On 10/24/2013, the CNO stated that on 3/11 and 3/24/2013, s/he had asked the nursing supervisors to discuss restraint documentation with staff during daily "huddles". The CNO confirmed that s/he did not know if those discussions had taken place or not.
The CNO also stated that s/he had not had follow-up discussions with nursing supervisor or staff nurses to ascertain if other staff nurses might have the understanding that they were permitted to use "nursing judgment" in lieu of implementing physicians' orders.
On 10/24/2013 the CNO stated "I thought [RN #1's] judgement was good". The CNO also stated that s/he thought that Patient #1 "got good care. I don't think [s/he] was neglected. If you follow the policy, then yes."
Interview with the ICEO, CNO and DQM, as well as review of the hospital's quality assurance/process improvement (QAPI) plan and QAPI documentation revealed that none of the events described above had been captured in any QAPI process, outside of the patient's return to a Short-Term Acute Care hospital. The events had not been evaluated to determine if the patient had received safe and appropriate care, specifically regarding the failure of RN #1 to implement the orders of Physician #2 to restrain Patient #1 to protect the patient's airway, nor had the actions of other caregivers such as all physicians involved with the care of the patient, RN #5, RRT #1 or others been evaluated.
Unrestrained Patients with Incidents and Failure to Assess for Patient Safety
Review of the medical records of the 5 patients who were identified as having decannulated themselves in July and August, 2013 revealed that only Patient #4 had been restrained at the time of the decannulation. Patients #1, 2,5, and 6 had been unrestrained at the time of the decannulations. Patient #2 had decannulated her/himself 5 times in the month of July and was not restrained at any of those times. S/he was briefly restrained following the third self decannulation.

The patients' medical records were reviewed for evidence that the patients had been assessed for safety without the use of restraints, as well as the potential need for anti-anxiety medication and/or pain medication. Safety assessments led to the assignment of sitters for Patients #1, 2 and 10 during part of their hospital stay.

Based on interview, review of hospital policy and review of credentialing files, it was determined that the hospital failed to ensure that independent practitioner training requirements were specified in hospital policy. The hospital's failure to do so resulted in 6 of of 6 physicians who were interviewed, not having training and education regarding the safe and appropriate utilization of restraints and/or seclusion. The hospital's failure potentially placed all patients in the hospital at risk for unnecessary loss of freedom, privacy and dignity as well as physical harm from the unsafe and incorrect use of restraints, as well as for an unsafe setting when restraints were not used but potentially could have prevented a patient injury.

Findings:

On October 24, 2013, the Interim Chief Executive Officer and the Director of Quality Management confirmed that the hospital had not identified training requirements for those practitioners authorized to order restraints, in either hospital policy or in the Medical Staff bylaws.

The hospital's "Physician General Hospital Orientation Manual", contained one page that addressed restraints. Page 66, "Staff Education Regarding Restraints" stated in part:

"All staff who have direct patient contact must have ongoing education and training in the proper and safe use of restraints. Training is provided during orientation, and competency of restraint use is validated during orientation of clinical staff who provide care to patients in restraints."
Hospitals must provide effective and efficient care in a safe environment that respects the rights, dignity and well being of the patients we serve. The use of Restraints is a complex care issue and requires complete understanding, defined systems and processes for restraining use and documentation, and a commitment to restrain reduction while maintaining the safest environment possible for patients...
he hospital, through its Performance Improvement Program, identifies opportunities to reduce risks associated with restraint use and strives to eliminate the use of restraints through innovative, less restrictive methods of protecting the patient's well being."


Review of the hospital's policy "Use of Physical or Chemical Restraints: General Requirements" revealed the following directive:

"POLICY:
...3. Restraint use requires an order by a physician or licensed independent practitioner (LIP) responsible for the patient's care and authorized under this policy to order restraint use...
6. The Hospital actively monitors the use of restraints through its Quality Assurance process to minimize restraint use and ensure that staff have the appropriate competencies related to restraint use..."

VI. Quality Assurance/Performance Improvement, Training and Competency
...B. Training and Competency
1. Staff (employees and contracted) having direct patient care responsibilities/contact shall be trained in:
A The patient's right to be free of restraints used for discipline, convenience, coercion or which are not medically necessary.
B. The proper and safe use of restraints, and
C. The use of techniques and alternatives to protect and maintain the well being of patients...
2. Training is to be provided during initial orientation and competency reassessment is [sic] to be conducted annually for application of restraints.

Interviews with Physicians #1, #2, #3, #4, #5 and #6, conducted from October 16 through October 29, 2013, confirmed that none of the physicians had received training on the correct and safe use of restraints at Kindred Hospital. Physician #1 stated that s/he may have seen something pertaining to restraints, but it was a "read thing".

Review of physician credentialing files for Physicians #1, #2, #3 and #5 revealed that the physicians had been sent an email that directed them to read directives about restraints. The email had been sent to the physicians by the hospital's administrative staff, and did not require a response back to the hospital management.



Reference citation written at Tag A0144

Based on interview, review of medical records, review of hospital policies and review of internal hospital documents, it was determined that the hospital failed to develop and implement a Quality Assurance Process Improvement plan with quality indicators which were measured, tracked and analyzed regarding the safety of services and quality of care around restraint use and patient injury when restraints were not used.

The hospital's failure to develop and implement such a plan contributed to the hospital's failure to recognize patient safety issues around the care of Patient #1, and placed all patients at potential risk for similar events involving lack of safety.

Quality Assurance Process Improvement and Failure to Investigate Events
Review of the hospital's quality assurance/process improvement (QAPI) plan and QAPI documentation revealed that none of the events described above had been captured in any QAPI process, with the exception of the Patient's return to a Short Term Acute Care hospital. The events had not been investigated and evaluated to determine if the patient had received safe and appropriate care, specifically regarding the failure of RN #1 to implement the orders of Physician #2 to restrain Patient #1 to protect the patient's airway.
The hospital Interim Chief Executive Officer was interviewed each day of the onsite investigation. The Director of Quality Management for Kindred 1st Hill was interviewed on 10/3, 10/16, 10/17 and 10/24/2013. Both confirmed that the hospital quality assessment/process improvement program tracked only the number of days patients were in restraints.
Both confirmed that the hospital did not evaluate patient injuries including decannulations or "circuit breaks" [instances in which equipment or tubing had become dislodged or non-functioning] due to the actions of the patients, the hospital did not evaluate if the patients had been adequately assessed and evaluated for pain and/or anxiety or other comfort measures and the hospital did not evaluate whether the patients would have potentially been safer had they been restrained.
The Interim Chief Executive Officer and the Director for Quality Management for the 1st Hill campus both confirmed that the QAPI program did not track, trend or monitor QAPI information for anything related to patient restraints, except for the number of days patients had been in restraints.
The hospital tracked Incident Reports, which included tracheostomy decannulations by patients. There was no evidence that this information was analyzed. The hospital also did not demonstrate that interventions were developed, implemented or evaluated based on the findings from incident reports.

Although the hospital was aware of the emergent condition of Patient #1, it did not investigate the events around the patient's decline and transfer out of the hospital. The hospital's failure to do so resulted in the hospital not modifying the hospital-wide QAPI plan to assure that necessary patient safety indicators were monitored for all patients who sustained injuries while unrestrained.