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Based on interview, policy review and review of the governing body meeting minutes, the hospital failed to identify a dedicated governing body that was responsible for the conduct of the hospital; which had the potential to affect all patients who currently reside in the hospital.

Review of the Bylaws of HeatlhEast Care System, effective January 1, 2010 identified under article IV section 4.1 General Powers, "The property, affairs, and business of the Corporation shall be managed by or under the direction of the Board of Directors, at all times in a manner consistent with and in furtherance of the charitable purposes of the Corporation set forth in Articles of Incorporation." Section 4.2 Number Qualification; election. "The board of Directors shall consist of (a) ex officio directors pursuant to Section 4.4 hereof, and (b) directors elected by the Board. The Directors shall be person who also serve as directors of St John's, St. Joseph's and Woodwinds." Review of the HeatlhEast Board of Directors meeting minutes from December 10, 2009 through October 13, 2010 all identify the following: "Joint meeting: This meeting is a joint meeting of the Board of Directors of each of the following corporations: HeatlhEast Care System, HeatlhEast St Joseph's Hospital, HeatlhEast St John's Hospital, HeatlhEast Woodwinds and HeatlhEast Medical Research Institute." The bi-monthly meeting minutes from December 10, 2009 through October 12, 2010 identify the governing body takes actions for credentialing, privileging, Quality Improvement reports, officer appointments, budget approval, bylaws, and rules and regulations for each of the four hospitals. Each of the meetings consist of the following agenda: Medical Staff Report, HMRI Report (HeastEast Medical Research Institute), Audit and Finance Committee, Consent Agenda (approval of minutes from other boards and resolutions related to amendments tot the HeatlhEast Care system), Quality of Care Committee, Physician Credentialing, and various other topics which include Infection Prevention and Control, H1N1 update, Presidents Report, Board Chair's Report and election of officers. There are some months which nothing was identified or discussed during the governing board meeting about Bethesda Hospital. The April 8, 2010 and October 14, 2010 do not identify any topics discussed for Bethesda Hospital but topics about the other hospital were discussed.

During interview on 1-10-11 at 1:50 p.m. the Chief Executive Officer (CEO) stated "we have one governing board for all four hospitals, for HeatlhEast." During a meeting on 1-13-11 at 11:45 a.m. with the CEO, Dr-K, Dr-A (Medical Director) and lawyer-A stated they have one single board which oversees all four hospitals which included; Bethesda Hospital, St John's, St. Joseph and Woodwind Hospitals. When they meet "we call it a joint meeting of the district." Each of the hospitals issues are discussed during the governing board meeting. The governing board are responsible for approving medical staff, credentialing, hiring of the CEO, and approving the budgets. They also stated that HeatlhEast has a Medical Executive Committee (MEC) which is a board that is also responsible for all four hospitals. Members of the MEC are physicians from all four hospitals and are responsible for credentialing and approving all HeatlhEast medical staff. But, the final approval of these staff members are made by the governing board of HeatlhEast.

The facility failed to individually assess the safety and appropriateness for the use of restraints for the least restrictive device; failed to ensure safe application of restraints according to manufactures guidelines; and did not provide adequate staff education for the use of locked restraints which affected 5 of 18 patients (P9; P7; P4, P5; P10) with restraints in the survey sample.

The hospital failed to comply with the manufactures recommendations for the use of canopy net beds and locked wrist/ankle restraints. For additional information refer to A167.

The hospital failed to comprehensively assess the appropriateness for pelvic restraints while in canopy net bed, pelvic restraints, and wheelchair seatbelts. For additional information refer to A 164.

The hospital failed to provide adequate staff education for unlocking wrist restraints. For further information see A194.

Based on interview, policy review and review of the medical staff meeting minutes, the hospital failed to identify one medical staff for the entire hospital that was responsible for the quality of medical care provided to patients by the hospital which had the potential to affect all patients who currently reside in the hospital.

Review of the HealthEast Medical Staff bylaws last revised on 09/09 preamble indicated, "HealthEast has been established to provide quality care to patients utilizing the facilities within this organization. To effectively and efficiently provide this quality care, the physician, dentists and podiatrist practicing at HealthEast facilities have organized a single medical staff. The medical staff of HealthEast has been delegated the responsibility and authority for assuring the quality of medical care at HealthEast facilities, and the medical staff accepts and assumes this responsibility subject to the ultimate authority vested in the Board of Directors of HealthEast." The HealthEast facilities include the following hospitals Bethesda, St Johns, St Josephs and Woodwinds.

The HealthEast Medial Staff Bylaws 12.2 identify an Executive Committee which consists of: "Membership on the Executive Committee shall include the Chief Medical Officer, the medical directors from the acute care hospitals, the chairs of the Credential Committee and the Quality Institute Council, the clinical council chairs, the chiefs of staff of the acute care hospitals, the President of Medical Staff and the president-elect or immediate past president of the medical staff until the president-elect assumes office under Article 13.1.4. c. In addition, the Adult CareClinical Council Leadership Committee shall appoint two additional representatives from the Adult Care clinical council to the Executive Committee, so that, taking into account the speciality of the chair of the Adult Care clinical council, the Executive Committee has representation from internal medicine, family medicine and hospitalist specialties." The duties of the Executive Committee are to receive and act upon reports and recommendations from clinical councils, committees and officers of the staff concerning patient care evaluations and other quality review, evaluation and monitoring functions..." This Executive Committee also review policies, make recommendations about credentialing, insure professional ethical conduct and various other duties. Review of the Medical Executive Committee organizational chart identify that all four hospitals had voting membership within this committee, but the voting membership was not equal. Review of the organization chart identified chiefs of staff from each hospital, and the clinical council chairs of various committees which included Mental Health, Emergency, OB/GYN, Radiology, Pediatrics, Adult Care, Surgery, Cancer Care, Heart Care, Neurology, Orthopaedics, Spine Care and Critical Care had voting membership. This revealed that Bethesda had three voting members, Woodwinds had two voting members, St Josephs had five voting members and St Johns had eight voting members.

During an interview on 1-10-11 at 3;00 p.m. Dr. A stated that the Medical Executive Committee (MEC) has physicians membership from all HealthEast hospitals, which includes Bethesda, St Johns, St Josephs and Woodwinds. . The MEC oversees the bylaws to enure they are being followed by the medical staff. They are also responsible for quality agenda, over sight of all medical staff and are responsible for credentialing. He stated, each hospital also has a separate Physician Leadership Committee which report their finding/information to the MEC. The Physician Leadership Committee, is site specific. They identify physician issues, QA, patient satisfaction, and chart completion concerns.

During a meeting on 1-13-11 at 11:45 a.m. with the CEO, Dr-K, Dr-A (Medical Director) and lawyer-A identified HeatlhEast has a Medical Executive Committee (MEC) which is a board that is also responsible for all four hospitals. Members of the MEC are physicians from all four hospitals and are responsible for credentialing and approving all HeatlhEast medical staff.

Review of the Executive Committee of HealthEast Medical Staff from January to November 2010, revealed a meeting was completed every other month. This included 23 voting members from all four hospitals and 16 additional members from all four hospitals were present at these meetings but were none voting members. The agenda/topics of the MEC meetings consisted of Delinquent Records, Peer Review Executive Session, MEC Work Groups, Credentialing, New Business and Clinical Council Quality Reports. These Clinical Council Quality Reports included information about orthopedics surgeons, obstetrics, heart care and pediatrics. Bethesda hospital does not provide any of these services in their hospital.

Based on observation, interview and policy review the facility failed to ensure anesthesia services were provided in a well organized in the electroconvulsive therapy (ECT) treatment of the Outpatient Services Department in which they were administering anesthesia for 4 of 4 patients (P1, P2, P3, P4) reviewed that had ECT. Findings include:

The hospital policies did not identify what type of reporting or documentation requirements were needed for patients who received electroconvulsive therapy (ECT) treatment in the Outpatient Services Department. Refer to A1002 for additional information.

The hospital did not ensure a comprehensive pre-anesthesia assessment had been completed for patients that received ECT under general anesthesia in the Outpatient Services Department. Refer to A1003 for additional information.

The hospital did not ensure a comprehensive post-anesthesia evaluation was completed for patients who received a general anesthetic in the Outpatient Services Department. Refer to A1005 for additional information.

Based on observation, staff interview and record review the facility failed to comprehensively assess the use of restraint devices to assure the least restrictive interventions was utilized for 5 of 14 patients (P9; P7; P4, P5; P10) reviewed with restraints. Findings include:

P9 was not comprehensively assessed for the use of a canopy net bed.

P9 was admitted to the facility on 9/16/10, with diagnoses that included, but were not limited to: brain injury secondary to acute respiratory failure due to cerebrovascular accident (stroke).

Review of the integrated nursing and physician progress notes dated 10/8/10 and timed 1500 (3:00 p.m.), revealed that the resident was pleasant and cooperative with medications and cares. The nursing and physician progress note dated 10/8/10 at 2030 (8:30 p.m.) identified that the patient had a good evening and was cooperative during cares. None of the progress notes dated 10/8/10 identified behavior that supported the use of a net bed or pelvic restraint.

On 1/12/11, at 12:00 noon the Clinical Nurse Specialist was interviewed during which she confirmed that the medical record did not show that P9 had been assessed for the use of canopy net bed on 10/9/10, according to the facility policy.

Patient-7 (P7) lacked a comprehensive assessment for the use of a pelvic restraint and canopy net bed to ensure the least restrictive intervention was used.
P7 was admitted to the hospital on 1/4/2011, at 7:10 p.m. with physical and cognitive deficits after a subdural hematoma evacuation of a frontal Meningioma (a meningioma is a tumor that arises from the meninges-the membranes that surround your brain)
During a tour of the unit on 1/11/2011, at 3:42 p.m., P7 was noted to have a canopy net bed in place and registered nurse (RN-G) stated a pelvic restraint is used when P7 is up in a wheelchair. During an interview on 1/11/2011, at 3:42 p.m., RN-G stated that "due to P7's age, impulsivity and risk for falls that could lead to a hip fracture, the restraints were implemented."

Review of the integrated nursing and physician progress notes dated 1/4/2011 and timed 2300 (11:00 pm), revealed that the resident was "sleeping on a hi/low bed with a tab alarm and a floor bed." An Initial Non-Violent Restraint Flowsheet was initiated on 1/5/2011 and timed 1630 (4:30 p.m.) The area for clinical justification for these restraints was incomplete. A pelvic restraint when in chair and canopy net bed for hours of sleep and scheduled rest periods was initiated. The progress notes failed to identity rational for the use of the more restrictive restraint devices which were the net bed or pelvic restraint for P7.

During observation on 1/12/2011, at approximately 3:00 p.m. with RN-G identified that P7 now had a seatbelt instead of a pelvic restraint. There was no indication of why P7 was changed from a pelvic restraint to a seatbelt.

Patient-4 (P4) lacked a comprehensive assessment for the use of a pelvic restraint and canopy net bed to ensure the least restrictive intervention was used.

P4 was admitted to the hospital on 1/06/2011, at 1:25 p.m. for behavior dyscontrol related to the diagnoses of an intracranial hemorrhage due to a cerebral aneurysm in 10/1999. A series of electroconvulsive therapy (ECT) was ordered as part of the treatment plan.

During the initial tour of the hospital on 1/10/2011 in the afternoon, P4 was observed on the secured unit on 1/10/2011, restrained with a pelvic restraint when sitting a Broda chair. A Posey canopy net bed was observed on the bed in P4's room.

Further review of the P4's medical record revealed on 1/6/2011, at 3:15 p.m. he was restless and impulsive and that he attempted to ambulate when an attempt was made to take vital signs. P4 was placed in a pelvic restraint for safety at 2:00 p.m. and a canopy net bed was ordered for hours of sleep and and scheduled rest periods dated 1/6/2011. The dictated note by Physician-B on 1/6/2011, at 8:45 p.m. indicated that P4 required the assistance of 3 staff and the use of a "Vail-Bed" (canopy net bed) to control his motoric behaviors and to prevent the patient from suffering a severe back injury as a result of falls. The dictated note also indicated that P4 at no time demonstrated actively resistive, threatening or combative behaviors with staff. Further assessment for restraint use was not found in the medical record for the pelvic restraint and canopy net bed restraint used starting on 1/6/2011 for P4.


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P5 was not comprehensively assessed for the use of a seatbelt in a wheelchair.

P5 was admitted on 1/7/2011, with a diagnosis of Ischemic stroke. The integrated progress notes dated 1/7/2011 at 2100 and 1/8/2011 at 2400, identified the patient as a being alert and responding to voice and stimuli but confused and not being able to verbalize or express needs/emotions/pain etc. A note dated 1/12/2011 at 0800 noted a visitor came to visit and the P5 was observed to respond to questions by shaking her head to "yes" and "no" questions. The integrated progress notes dated 1/7/2011 through 1/12/2011 identified the patient was up in the wheelchair at least once a day.

Initial non violent restraint flowsheet dated 1/8/2011, 1/10/2011, 1/11/2011 and 1/12/2011 were reviewed. They did not identify a wheelchair with seatbelt as a restraint being used for the patient but it did identify a pelvic restraint when in chair (1/11/2011).
The Integrated Plan of Care-Fall Risk Reduction dated 1/7/2011 was reviewed. It identified physical therapy 1/8/2011 identifying the resident as severe cognitive impairment and high risk of falls. Mobility was identified as "Dependent". A balance test was not tried. Fall Reduction Interventions included but not limited to: close monitoring by staff, specialized seating/positioning (tilt), anti-tip bars on wheelchair and seat belt alarm.

On 1/11/2011 at 2:00 p.m. and 1/12/2011 at 1:35 p.m., a Clinical Specialist of Behavioral Health (CSBH)-A was interviewed. She indicated the patient P5 did not use a pelvic restraint but did use a seatbelt when seating in the wheelchair and P5 was not able to remove the seatbelt. The CSBH stated that seatbelts used in the wheelchairs were not considered a restraint and therefore, had not been comprehensively assessed as restraints. All wheelchairs brought to the floor form physical therapy had seatbelts which were used for safety and positioning purposes. When the patients were assessed at high risk for falls, these seatbelts were used as an intervention for fall prevention. She verified because of this reason, a comprehensive assessment for the use of wheelchairs with seatbelts had not been completed for P5.


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P10 was not comprehensively assessed for the use of a pelvic restraint.

P10 was admitted to the facility on 10/4/10, with a diagnosis of a stroke. The integrated admission assessment dated 10/4/10, indicated the P10 was alert, forgetful, confused, and followed simple commands. The facility assessment also revealed P10 had barriers that may affect learning due to cognition that limited the ability to understand.

P10 received an order for a pelvic restraint on 10/17/10, at 2:00 p.m. for impulsive behavior and pulling at invasive lines or tubes and P10 did not respond to verbal or non-verbal redirection. The progress notes dated from 10/14/10 through 10/20/10 were reviewed and the progress notes lacked a comprehensive assessment for the use of the pelvic restraint.

On 1/13/11, at 9:15 a.m. the director of nursing (DON) was interviewed. The DON acknowledged the medical record lacked a comprehensive assessment for the use of the pelvic restraint.


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The facility restraint policy reviewed and revised on 9/09, noted the registered nurse (RN) or the licensed independent practitioner (LIP) was responsible to assess a patient's need for the restraint. The assessment was to include the age and cognitive development of the patient, the risk associated with the cognitively or physically limited patients, the use of the admission assessment to determine any contraindications or concerns related to the use of the restraints, any changes in physiological status (such as pain, medications, hydration), provisions to meet the basic needs food, water, safety, mobility and elimination. The RN or the LIP was to document the results of the assessments in the patient's medical record.

The medical records for P9, P7, P4, P5 and P10 lacked evidence of a comprehensive assessment for the use of the restraint devices.

Based upon observation, interview and record review, the hospital failed to ensure restraints were used in a safe manner for 1 of 1 patients (P4) observed in locked wrist and ankle restraints and for 2 of 3 patients (P9, P8) who utilized a net beds. Findings include:

The hospital restraint policy "Use of Restraint and Seclusion", last reviewed September 2009, did not indicate where the keys should be located to unlock locked wrist and ankle restraints in the event of a patient emergency.

Patient P4 was observed on 1/12/2011 at 9:08 a.m. as he was beginning to undergo ECT while under general anesthesia in a procedure room in the Outpatient Services Department. Restraint devices, which consisted of thick fabric, were attached to both of his wrists and to both of his ankles. The straps of the devices were attached to the side rails of the cart which were in the up position. All of the devices were locked. Physician-B, CRNA-A (a contract employee), RN-B and the Clinical Director of Outpatient Services were the only hospital personnel in the procedure room.

The Clinical Director of the Outpatient Services area was interviewed on 1/12/2011 at 9:30 a.m.. When asked where the key to unlock the restraints was located, she checked her key ring and stated she did not have a key to unlock the restraints. The Director then asked the Registered Nurse, who was assisting in the procedure room (RN-B), if she had a key to unlock the restraints. RN-B stated she did not have a key nor did she know where a key was located in the outpatient department. Nurse Aide (NA-A), who regularly worked in the Outpatient Services procedure rooms, stated she had a key to unlock the restraint devices. She stated she was not always in the procedure rooms as she also transported patients, ambulated patients, and discharged patients.

During interview on 1-13-11 at approximately 1:00 p.m. Physician-B stated he was aware of the location of the restraint key, and was approximately 15-20 feet from the patient at all times during and after the procedure. He stated there was a key located on the wall of the Lead RN's office and that NA-A also has a restraint key on them at all times.

A review of information from the Posey company, obtained from the manufacturer's web site, indicated "Posey keys must be readily available to staff at all times. In an emergency, it is difficult to cut the cuffs with scissors to free the patient".

A review of the hospital policy titled "Use of Restraint and Seclusion", last reviewed by the Restraint Committed on September 2009 and approved on 9/30/2009, did not identify where a key to unlock the restraint devices should be located in the event of a patient emergency when the restraint may need to be removed.




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Patient (P)-9 was put in a restraint (net bed) on 10/9/10, that was not used according to manufacturer's recommendation to ensure a safe environment for the patient.

P9 was admitted to the facility on 9/16/10, with diagnoses that included, but were not limited to: brain injury secondary to acute respiratory failure due to cerebrovascular accident (stroke).

Review of an incident report dated 10/9/10, revealed the following: "pt [patient] was found sitting on the floor next to net bed. Net bed was open due to nurse trying to see if we could get rid of restraint." Review of the physician progress notes dated 10/9/10, and timed 1500 [3:00 p.m.] revealed a registered nurse had made an entry that identified the following: "pt [patient] slept in net bed. While it was open for restraint reduction pt was found on floor at 1430 [2:30 p.m.] sitting next to bed pt. was assessed by nurse & house doctor."

The manufacturers recommendations for the use of the net bed titled Posey Canopy Bed Use were reviewed and it was noted in the section "Instructions for use section" that "Always close the zipper when a patient is in the bed".

The Clinical Nurse Specialist (CNS-H) was interviewed on 1/12/11 at 11:40 a.m. during which she stated that the facility did not have a specific hospital policy for the use of a canopy net bed but that they followed the manufacturers recommendations for use. The CNS-H confirmed that the canopy bed had not been used according to manufacturers instructions when doing the restraint reduction on 10/9/10 for P9. The CNS-H clarified the net bed should not have been used without the zipper being closed per manufacturers instructions.


Patient (P)-8 was observed to be in a restraint (canopy net bed) on 1/11/2011 at 2:30 p.m. and that it was not used according to manufacturer's recommendation to ensure a safe environment for the patient.

Registered nurse (RN)-G was interviewed on 1/11/2011 at 2:30 p.m. RN-G stated that all four rails need to be up when a patient is in bed and a canopy net bed is in use. P8 was in bed with 3 side rails up on 1/11/2011 at 2:30 p.m.

The manufacturers recommendations for the use of the net bed titled Posey Canopy Bed Use were reviewed and it was noted in the section "Instructions for use section" that "side rails must always be left down."

The Clinical Nurse Specialist (CNS-H) was interviewed on 1/12/11 at 11:40 a.m. during which she stated that the facility did not have a specific hospital policy for the use of a canopy net bed but that they followed the manufacturers recommendations for use.

Based upon observation and interview, the hospital did not ensure that 2 of 4 hospital employees (Clinical Director, RN-B) in the Outpatient Services department had training related to the location of a key which was necessary to unlock the restraints for 1 of 1 patients (P4) who utilized wrist and ankle restraints. Findings include:

The Clinical Director of the Outpatient Services department and a Registered Nurse (RN-B) were not aware of the location of a key which would be utilized to unlock the patient's ankle and foot restraints in the event of an emergency situation.

The patient (P4) was admitted to the hospital on 1/11/2011 with diagnoses which included dementia secondary to a ruptured cerebral aneurysm. The patient was observed on 1/12/2011 at 9:08 a.m. in a procedure room in the Outpatient Services department. The patient was beginning to undergo electroconvulsive therapy (ECT) while under general anesthesia. Restraint devices, which consisted of thick fabric, were attached to both of his wrists and to both of his ankles. The straps of the devices were attached to the side rails of the cart which were in the up position. All of the restraint devices were locked. A Registered Nurse (RN-B) and a Certified Nurse Anesthetist (CRNA-A), who was a contract employee, were assisting the physician with the ECT procedure. Physician-B, CRNA-A, RN-B and the Clinical Director of Outpatient Services were the only personnel in the procedure room.

The Clinical Director of the Outpatient Services area was interviewed on 1/12/2011 at 9:30 a.m.. When asked where the key to unlock the restraints in the event of an emergency was located, she checked her key ring and stated she did not have a key to unlock the restraints. The Director then asked RN-B, who was assisting in the procedure room, if she had a key to unlock the restraints. RN-B stated she did not have a key nor did she know where a key was located in the outpatient department. The CRNA-A, verified they did not have a key for the locked restraint.

When interviewed on 1/13/2010 at 10:50 a.m., the Clinical Director of Outpatient Services and the lead Registered Nurse in Outpatient Services were interviewed. The Clinical Director stated she assisted with ECT when necessary. They stated RN-B was a float nurse who assisted with the ECT procedures in Outpatient Services 3-4 times a month. They stated RN-B were now aware of the location of the key to unlock the restraints, which was always kept in the Lead RN's office.

A review of information from the Posey company, obtained from the manufacturer's web site, indicated "Posey keys must be readily available to staff at all times. In an emergency, it is difficult to cut the cuffs with scissors to free the patient".

A review of the hospital policy titled "Use of Restraint and Seclusion", last reviewed by the Restraint Committed on September 2009 and approved on 9/30/2009, did not identify where a key to unlock the restraint devices should be located in the event of a patient emergency when the restraint may need to be removed.

The facility lacked specific training regarding the location of the key for the locked restraints when utilizing these devices in ECT areas.

Based on policy review and interview the facility failed to develop an emergency water supply policy to determine the amount of water needed for inpatients, staff and other persons who come to the hospital in need of care during emergencies what had the potential to affect all patients in the hospital. The findings include:

The facility Utilities Emergency Management policy dated 8/22/02, revised last 2/13/10, had not identified calculations to determine the amount of water needed for not only inpatients, but also staff and other persons who come to the hospital in need of care during emergencies.

The Senior Lead Engineer was interviewed on 1/12/11, at 9:45 a.m. and stated the Utilities Emergency Management policy dated 8/22/02, revised last 2/13/10 had not identified the amount of water needed for not only inpatients, but also staff and other persons who come to the hospital in need of care during emergencies.

Based upon interview and record review, the hospital have policies that identified reporting and documentation requirements for anesthesia services for 4 of 4 patients who received electroconvulsive therapy (ECT) treatment in the Outpatient Services Department. Findings include:

P1 was admitted to the Outpatient Services department for an electroconvulsive therapy (ECT) procedure under general anesthesia as an outpatient on 1/12/2011.

The Short Stay Nursing Assessment" form, dated 1/12/2011 (no time of patient admission identified), was incomplete and did not identify patient height, weight or when they last voided. The "ECT Flowsheet", dated 1/12/2011, did not identify the time the patient's vital signs were taken prior to the ECT procedure. The last anesthetic agent was administered at 10:05 a.m., there was only one set of vital signs taken at 10:12 a.m. following anesthesia, which included the patients's blood pressure (186/91), pulse rate, electrocardiogram rhythm and oxygen saturation, before the patient was discharged home.

The flowsheet indicated the patient was awakening from the anesthesia at that time. There were no other vital signs taken and no other assessment of the patient's mental status prior to the patient's discharge at 10:30 a.m. which was twenty-five minutes after the last anesthetic agent had been administered.

The only discharge instructions from the Registered Nurse on the "Summary of Discharge Instructions" form directed the patient to do what she could tolerate and to rest when tired. The form also identified the date of the next ECT treatment. There were no discharge instructions given to the patient related to potential anesthetic complications.

P-2 was admitted to the Outpatient Services department to undergo ECT under general anesthesia on 1/12/2011. The patient's vital signs (blood pressure, pulse, respiratory rate and oxygen saturation) were documented on the "Physician Sedation Assessment" form, there was no time documented to indicate when the vital signs had been taken. The last anesthetic agent was administered at 9:39 a.m. and anesthesia had been discontinued at 9:49 a.m., and there were no other vital signs documented after anesthesia was discontinued. The notes indicated the IV was removed at 9:50 a.m., which was one minute after anesthesia had been discontinued. The patient was discharged as an outpatient at 9:50 a.m., which was 11 minutes after the last anesthetic agent had been administered, which had been a muscle-paralyzing agent.

A review of the "Summary of Discharge Instructions", dated 1/12/2011, indicated the patient could do what she could tolerate and to rest when tired. There were no instructions related to potential anesthetic complications.

P-3 was admitted to the Outpatient Services department for an ECT treatment under general anesthesia on 1/12/2011. The vital signs were documented on the "ECT Flowsheet", dated 1/12/2011, but there was no time to identify when these were completed. The flowsheet did not identify when P-3 had urinated, the area was left blank. The flowsheet indicated an IV had been inserted at 8:20 a.m. and removed at 8:49 a.m., there was no indication of the type of IV fluid which had been administered nor the amount of IV fluid which had been administered. The last anesthetic medication had been administered at 8:39 a.m., which was a muscle relaxant, and had been discontinued at 8:48 a.m.. There was only one set of vital signs documented prior to the patient's discharge as an outpatient.

The "Summary of Discharge Instructions" form did not provide any instructions related to potential anesthetic complications.

Chart review indicated P-4 had been admitted from the hospital to the Outpatient Services department on 1/12/2011 for an ECT procedure under general anesthesia. There was no indication what time the patient had been admitted to the Outpatient Services department nor the time nursing had completed the "Pre-Procedure Assessment form". The "ECT Flowsheet" indicated the last anesthetic agent had been administered at 9:14 a.m. (a muscle relaxing medication), anesthesia was discontinued at 9:29 a.m. and the IV had also been removed at that time.

During observation of the procedure on 1-12-11, a Certified Registered Nurse Anesthetist (CRNA-A) removed the patient's oral airway at 9:25 a.m. and directed RN-B to remove the patient's oxygen and blood pressure cuff because the patient was somewhat restless. The patient was transferred to an inpatient unit at approximately 9:35 which was twenty-one minutes after the last anesthetic agent had been given. There were no additional vital signs documented after 9:21 a.m.

When interviewed on 1/12/2011 at approximately 10:55 a.m., RN-B stated she though discharge criteria included patients having a specific patient evaluation score as identified on the "Post Operative" nursing notes. She stated she was unaware of any length of time the patient was to stay for observation following the administration of anesthesia.

The Clinical Director was interviewed on 1/12/2011 at approximately 10:50 a.m. She stated she had developed a process entitled "HE Bethesda ECT Process" which directed nursing care in the Outpatient Services department for patients undergoing ECT under general anesthesia. A review of the "HE Bethesda ECT Process" did not direct what nursing interventions should be completed for patients during the pre and post-procedure. The process also did not address the frequency of vital sign monitoring, patient discharge criteria and patient teaching.

The Clinical Director also stated they utilized Healtheast corporate policy entitled "Discharge Guidelines for Outpatients Phase II Recovery" which was last reviewed on August 2009. A review of the discharge guidelines indicated nursing staff were to assess vital signs, including pulse, blood pressure, respirations, oxygen saturation and pain every thirty minutes until approved discharge criteria had been met. This was not completed for any of the patients
(P-1, P-2, P-3, P-4) that were reviewed.

The Clinical Director reviewed the charts of P-1, P-2, P-3, and P-4 and verified none of the patients had remained in the Outpatient Services area for thirty minutes following anesthesia and there was no discharge criteria identified for these patients. The Discharge Guidelines also indicated patients were to receive discharge instructions related to anesthesia, which was not completed as directed by the Discharge Guidelines for P-1, P-2, P-3, and P-4.

The Clinical Director stated the hospital utilized the manual as the hospital nursing procedure manual and individual nursing departments modified procedures as needed. The ECT policy directed staff to monitor vital signs every 15 minutes until stable and to obtain vital signs one hour after treatment, which was not completed as directed by the policy for P-1, P-2, P-3, and P-4.

The Clinical Director also provided the surveyor with the Electroconvulsive Therapy (ECT) procedure related to nursing from the Lippincott Nursing Procedure Manual and the corporate hospital policy titled "Procedural Sedation and Anesthesia Care", last reviewed March 2010. The policy indicated staff were to utilize a "Sedation Pathway" for documentation pre-procedure, intra-procedure and post-procedure/discharge. The policy indicated post-procedure monitoring should be documented every thirty minutes and was to include vital signs, oxygen saturation, level of consciousness and other procedure specific monitors and could be discharged when approved discharge criteria had been met. The policy was not followed for P-1, P-2, P-3, and P-4. .

The Clinical Director stated no unit specific policies related to nursing care of the patient undergoing ECT under general anesthesia had been developed. She stated specific discharge criteria related to ECT patients had not been developed and nursing and anesthesia staff did not utilize the sedation pathway. She stated no other standards of nursing care specific to patients undergoing ECT had been developed.

A comprehensive pre-anesthesia evaluation was not documented for patients P-1, P-2, P-3 and P-4 as identified by facility policy.

P-1, P-2, P-3 and P-4 only had pre-anesthetic evaluation documented by CRNA-A which was the patients' ASA classification and the patient identification, NPO status and consent had been checked. Although the CRNA had assessed the patient's cardiac and respiratory status, there was no documentation of the findings, any potential anesthetic complications or the anesthesia plan of care.

The Pre-Op Anesthesia Orders, signed by the Physician (MD-B) did not reflect specific needs of patients having ECT procedures under general anesthesia. A review of P-1, P-2 P-3 and P-4 patient charts indicated MD-B had signed the orders on 1/12/2011. The orders indicated the patients should be added to the Anesthesiologist patient list.

The Clinical Director of Outpatient Services was interviewed on 1/12/2011 at 10:30 AM. She stated the "Pre-Op Anesthesia Orders" were a corporate hospital system-wide order set and not specific to patients receiving ECT treatment under anesthesia. She stated there are no anesthesiologists who administer anesthesia in the Outpatient Services department.

There were no specific discharge instructions for patients related to potential anesthetic complication following discharge.

A review of the "Summary of Discharge Instructions" which had been given to outpatients P-1, P-2 and P-3, only instructed the outpatients to do what they could tolerate and to rest when tired. There were no instructions related to potential anesthetic complications.

The Clinical Director of Outpatient Services was interviewed on 1/12/2011 at approximately 10:30 a.m. She stated anesthesia services was a contracted service and MD-B was the Medical Director of the service. She stated anesthesia was only administered in the OPS department in the hospital. She stated the Outpatient Services Department did not have a policy related to the components of a postanesthesia evaluation for inpatients and outpatients.

Based upon interview and record review, the hospital did not ensure a comprehensive pre-anesthesia assessment had been completed for 4 of 4 patients undergoing electroconvulsive therapy (ECT) under general anesthesia in the Outpatient Services Department (Patients P-1, P-2, P-3 and P-4). Findings include:

Patient P-1 underwent an ECT procedure under general anesthesia as an outpatient on 1/12/2011 while in the Outpatient Services Department. The pre-anesthesia evaluation indicated the patient's NPO (nothing by mouth) status, consent and identification had been verified. The chart also indicated the patient's anesthetic risk related to the American Society of Anesthesiology scale (ASA status). Although CRNA-A had reviewed the patient's chart and had listened to the patient's heart and lungs, there was no documentation of the findings in the medical record. There was no documentation of potential anesthesia risks nor documentation of the anesthesia plan of care.

Patient P-2 underwent an ECT procedure under general anesthesia as an outpatient on 1/12/2011 while in the Outpatient Services Department. The pre-anesthesia evaluation indicated the patient's NPO (nothing by mouth) status, consent and identification had been verified. The chart also indicated the patient's anesthetic risk related to the American Society of Anesthesiology scale (ASA status). Although CRNA-A had reviewed the medical record and had listened to the patient's heart and lungs, there was no documentation of the findings in the medical record. There was no documentation of potential anesthesia risks nor documentation of the anesthesia plan of care.

Patient P-3 underwent an ECT procedure under general anesthesia as an outpatient on 1/12/2011 while in the Outpatient Services Department. The pre-anesthesia evaluation indicated the patient's NPO (nothing by mouth) status, consent and identification had been verified. The chart also indicated the patient's anesthetic risk related to the American Society of Anesthesiology scale (ASA status). Although CRNA-A had reviewed the patient's chart and had listened to the patient's heart and lungs, there was no documentation of the findings in the medical record. There was no documentation of potential anesthesia risks nor documentation of the anesthesia plan of care.

Patient P-4 underwent an ECT procedure under general anesthesia while an inpatient on 1/12/2011 in the Outpatient Services Department. The pre-anesthesia evaluation indicated the patient's NPO (nothing by mouth) status, consent and identification had been verified. The chart also indicated the patient's anesthetic risk related to the American Society of Anesthesiology scale (ASA status). Although CRNA-A had reviewed the medical record and had listened to the patient's heart and lungs, there was no documentation of the findings in the medical record. There was no documentation of potential anesthesia risks nor documentation of the anesthesia plan of care.

The Clinical Director of Outpatient Services Department was interviewed on 1/12/2011 at approximately 10:30 a.m. She stated anesthesia services in the Outpatient Services Department was a contracted service. She stated anesthesia services in the hospital was only administered in the Outpatient Services Department for patients undergoing ECT under general anesthesia. She stated anesthesia services was under the direction of the MD-B who served as the Medical Director. She stated there was no specific hospital or department policy related to the components of a pre-anesthetic evaluation by the practitioner administering anesthesia in the Outpatient Services Department.

Based upon interview and record review, the hospital did not ensure a comprehensive post-anesthesia evaluation was completed for 4 of 4 patients who received a general anesthetic in the Outpatient Services Department (P-1, P-2, P-3 and P-4). Findings include:

The practitioner qualified to administer anesthesia did not complete a comprehensive postanesthesia evaluation for patients who had electroconvulsive therapy (ECT) under general anesthesia in the Outpatient Services Department.

Patient P-1 underwent ECT under general anesthesia as an outpatient on 1/12/2011. The medical record indicated the patient was awakening at 10:12 a.m. and the last blood pressure, pulse, cardiac rhythm and oxygen saturation were documented at that time. The record indicated the patient was receiving oxygen at 10:12 a.m., however there was no note which indicated when the oxygen was discontinued nor the patient's oxygen saturation without the oxygen. The postanesthesia note, completed by the CRNA-A at 10:19 a.m., indicated the vital signs were stable and the patient had tolerated the ECT procedure well. There was no documentation of the respiratory rate since anesthesia had been discontinued, no documentation of the oxygen saturation since 10:12 a.m. (when the patient had been receiving oxygen), and no documentation of any pain the patient was experiencing nor how the patient was tolerating oral fluids.

Patient P-2 underwent ECT under general anesthesia as an outpatient on 1/12/2011. The medical record indicated the patient was awakening at 9:46 a.m. and the blood pressure, pulse, cardiac rhythm and oxygen saturation were documented at that time. The record indicated the patient was receiving oxygen at that time, however, there was no documentation when the oxygen had been discontinued nor the patient's oxygen saturation after oxygen was discontinued. The postanesthesia note, completed by the CRNA-A at 9:49 a.m. indicated the patient was "arousable", respirations were spontaneous and vital signs were stable. There was no documentation of the respiratory rate since anesthesia had been discontinued, no documentation of the oxygen saturation after the oxygen had been discontinued, and no documentation of any pain the patient was experiencing nor how the patient had tolerated oral fluids.

Patient P-3 was observed as he underwent ECT under general anesthesia as an outpatient on 1/12/2011 at approximately 8:30 a.m. The medical record indicated the patient was awakening at 8:44 a.m. and the last blood pressure, pulse, cardiac rhythm and oxygen saturation were documented at 8:50 a.m. The patient was not evaluated by the CRNA prior to discharge at 9:10 a.m. Although the patient had not been evaluated by the CRNA prior to discharge, a postanesthesia note, which was completed by the CRNA-A at 8:48 a.m., indicated the patient was "drowsy" with spontaneous respirations and vital signs were stable. There was no documentation of the respiratory rate since anesthesia had been discontinued, no documentation of the oxygen saturation after the oxygen had been discontinued, and no documentation of any pain the patient was experiencing nor how the patient had tolerated oral fluids.

Patient P-4 underwent ECT under general anesthesia as an inpatient on 1/12/2011 at approximately 9:08 a.m. The medical record indicated the patient was awakening at 9:21 a.m. and had an oral airway in place. The last blood pressure, pulse, cardiac rhythm and oxygen saturation were documented at 9:21 a.m. The record indicated the patient was awake and restless at 9:21 a.m. There was no documentation of the patient's oxygen saturation after the oxygen was discontinued at 9:23 a.m. The postanesthesia note, completed by the CRNA-A at 9:29 a.m. indicated the patient was awake, vital signs were stable and the patient had tolerated the ECT well. There was no documentation of the respiratory rate after anesthesia had been discontinued, no documentation of the oxygen saturation after the oxygen had been discontinued, and no documentation of any pain the patient was experiencing nor how the patient had tolerated oral fluids.

CRNA-A was interviewed on 1/12/2011 at approximately 10:15 a.m. The CRNA stated it was not the practice of the CRNAs to complete a postanesthesia assessment prior to patient discharge from the Outpatient Services Department (OPS). The CRNA also stated that inpatients who undergo ECT under general anesthesia in the OPS are not seen by the CRNAs and a postanesthesia evaluation was not completed.

Based upon interview and record review, the hospital did not ensure the Organ Procurement Organization (OPO) had a performance improvement project for organ procurement. Findings include:

The Director of Care Manager Services was interviewed on 1/11/2011 at approximately 1:30 p.m. She stated the only quality improvement project related to organ donation was the data which was submitted to the hospital by Life Source for reporting of death cases. She stated there was no further analysis of the data submitted by Life Source related to quality improvement for the OPO.