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Based on facility document review and interview, the facility failed to ensure all physicians received a current copy of the Medical Staff Bylaws, Rules and Regulations of the Medical Staff, and the restraint policy. The facility census was 796.

Findings included:

1. Review of the facility document titled, "Medical Staff Bylaws", revised 04/06, provided the following information:6.B.2.(l). under Medical Executive Committee duties, "to review the Bylaws, policies, rules and regulations, and associated documents of the Medical Staff at least once a year and recommend such changes as may be necessary or desirable".

2. Review of the facility document titled, "Rules and Regulations of the Medical Staff", revised 04/06, provided the following information:
"Use of Restraints
The safety of the patients admitted is of utmost concern; therefore, all patients admitted to St. John's Mercy Medical Center will be cared for in a safe environment. A physician's order is necessary for the use of restraints. Generally speaking, restraints are to be utilized to enhance patient safety. Details about the use of restraints are found in the Restraints, Protective/Assistive Devices Policy located in the Appendix."

3. Review of the facility policy titled, "Restraints, Seclusion, Protective/Assistive Devices", approved 03/03/06 and located in the Appendix of the Rules and Regulations of the Medical Staff provided different guidance than a policy by the same title, revised 10/09, that had been given to the surveyors.

4. During an interview on 03/11/10 at 10:50 a.m., Director of Accreditation and Licensing, staff A, stated that the physicians are currently receiving the book containing the Medical Staff Bylaws and Rules and Regulations of the Medical Staff that were dated 04/06. Staff A stated no other training is provided to physicians regarding restraints.

5. During an interview on 03/11/10 at 1:10 p.m., staff A stated that the Medical Staff Bylaws and Rules and Regulations of the Medical Staff are not reviewed on an annual basis. He/she stated that changes get approved by the Medical Executive Committee and the board of directors. He/she stated that the book containing the Medical Staff Bylaws and the Rules and Regulations of the Medical Staff, revised 04/06, was printed and that is what is sent to new providers. Staff A provided surveyor with a cover sheet titled, "St. John's Medical Center Medical Staff Bylaws", which showed a revised dates of 2/08 and 11/09 (since the previous 04/06 version). Staff A stated that providers who have been on staff would have received an electronic version of the newer policies.

6. During an interview on 03/11/10 at 3:15 p.m., Director of Medical Staff Office, staff Y, stated that the book containing the Medical Staff Bylaws and the Rules and Regulations of the Medical Staff, revised 04/06, is given to new physicians. Staff Y stated that they do not do an annual review of these documents, only do updates as needed.

Based on interview and record review, the facility failed to ensure patients were informed of their patient rights for two patients (Patient #3 and #5) of 25 medical records reviewed. The facility census was 796.

Findings included:

1. During an interview on 03/09/10 at 2:50 p.m., current Patient #3 stated that he/she didn't remember receiving patient rights information.

Review of current Patient #3's medical record on 03/09/10 at 3:05 p.m. showed the patient was not informed of his/her patient rights. This was confirmed by Manager of Trauma Intermediate Care Unit, staff E.

2. Review of current Patient #5's medical record on 03/09/10 at 3:55 p.m. showed the patient was not informed of his/her patient rights. This was confirmed by Supervisor of Medical Intermediate Care Unit, staff F.

3. During an interview on 03/09/10 at 3:05 p.m., Manager of Trauma Intermediate Care Unit, staff E, stated that the patient rights information should be given to the patient or family within the first 24 hours after admission.

4. During an interview on 03/10/10 at 11:00 a.m., Interdisciplinary Practice Coordinator, staff K, confirmed that Patient #3 and Patient #5 did not receive information on patient rights.

Based on policy review, record review, and interview, the facility failed to ensure two patients (Patient #19 and #20) of three medical records reviewed received informed consent. The facility census was 796.
Findings Included:
1. Review of the facility policy titled, "Consent Guidelines," effective date 11/96 and last review date 8/08, states (in part), "The informed consent portion of the consent form must be signed by the surgeon."
2. Review of current Patient #19 medical record on 03/11/10 at 10:30 a.m. showed a form titled, "Consent to Surgical, Diagnostic or Medical Procedure and Anesthesia" for "Ascending Aorta Replacement with Possible Aortic Valve Replacement" (a procedure where a defective portion of the largest artery in the body is replaced, possibly including replacement of a valve that regulates blood flow within the artery). The consent was signed by the patient on 03/04/10. At the bottom of the consent form it states, "I certify that I personally explained the operation(s)/procedure(s), treatment goals, reasonable alternative methods of treatment, the risks involved, the possible consequences, and the possibility of complications to the patient or if the patient is unable to consent, to the person authorized to consent for patient." There is a place beneath that statement for the physician to sign and date. There was no physician signature on the consent form.
3. Review of current Patient #19 medical record on 03/11/10 at 10:35 a.m. showed a form titled, "Consent to Surgical, Diagnostic or Medical Procedure and Anesthesia" for "Chest Tube Insertion" (a procedure where a tube is surgically inserted into the chest wall to drain blood, fluid, or air and to allow the lungs to fully expand). The consent was signed by the patient ' s husband on 03/06/10. At the bottom of the consent form it states, "I certify that I personally explained the operation(s)/procedure(s), treatment goals, reasonable alternative methods of treatment, the risks involved, the possible consequences, and the possibility of complications to the patient or if the patient is unable to consent, to the person authorized to consent for patient." There is a place beneath that statement for the physician to sign and date. There was no physician signature on the consent form.
4. Review of current Patient #20 medical record on 03/11/10 at 11:00 a.m. showed a form titled, "Consent to Surgical, Diagnostic or Medical Procedure and Anesthesia" for Esophagoustroduodenoscopy [sic] ( an examination of the lining of the esophagus, stomach, and upper duodenum with a small camera which is inserted down the throat). The consent was signed by the patient on 02/06/10. At the bottom of the consent form it states, "I certify that I personally explained the operation(s)/procedure(s), treatment goals, reasonable alternative methods of treatment, the risks involved, the possible consequences, and the possibility of complications to the patient or if the patient is unable to consent, to the person authorized to consent for patient." There is a place beneath that statement for the physician to sign and date. There was no physician signature on the consent form.
5. Review of current Patient #20 medical record on 03/11/10 at 11:05 a.m. showed a form titled, "Consent to Surgical, Diagnostic or Medical Procedure and Anesthesia" for "Peripherally Inserted Central Catheter" (a form of intravenous access that can be used for a prolonged period of time). The consent was signed by the patient ' s wife on 02/17/10. At the bottom of the consent form it states, "I certify that I personally explained the operation(s)/procedure(s), treatment goals, reasonable alternative methods of treatment, the risks involved, the possible consequences, and the possibility of complications to the patient or if the patient is unable to consent, to the person authorized to consent for patient." There is a place beneath that statement for the physician to sign and date. There was no physician signature on the consent form.
6. During an interview on 03/11/10 at 11:30 a.m., Registered Nurse (RN) Staff L stated the surgeon is required to sign the consent form at the time of the procedure.

Based on policy review, interview and record review, the facility failed to request and document advance directive information for three current patients (Patient #3, #4, and #5) of five medical records reviewed for advance directives and failed to assess outpatients for advance directives. The facility census was 796.

Findings included:

1. Review of the facility policy titled, "Advance Directives" reviewed 10/08, gave direction, in part, to include the following:
" ...all adult patients will be asked if they have an Advance Directive at the time of their inpatient admission process."
"The patient will be asked whether he/she has an Advance Directive , and the answer will be documented on the Application for Admissions and Treatment Form. If the patient is unable to speak for himself/herself, family members or significant other will be questioned regarding their knowledge of an Advance Directive.
"At time of out-patient registration, the patient will be asked if they have an advance directive (i.e. living will or durable power of attorney for healthcare). The patient's response will be recorded (Y/N) in Star and on the Consent to Treat form."

2. Review of current Patient #3's medical record on 03/09/10 at 3:05 p.m. showed the patient and/or designated representative was not questioned to determine if the patient had an Advance Directive. This was confirmed by Manager of Trauma Intermediate Care Unit, staff E.

3. Review of current Patient #4's medical record on 03/09/10 at 3:20 p.m. showed the patient and/or designated representative was not questioned to determine if the patient had an Advance Directive. This was confirmed by staff E.

4. Review of current Patient #5's medical record on 03/09/10 at 3:55 p.m. showed the patient and/or designated representative was not questioned to determine if the patient had an Advance Directive. This was confirmed by Supervisor of Medical Intermediate Care Unit, staff F.

5. During an interview on 03/09/10 at 3:05 p.m., Manager of Trauma Intermediate Care Unit, staff E, stated that the patient or family should be asked if the patient has an Advance Directive within the first 24 hours after admission.

6. During an interview on 03/10/10 at 8:50 a.m., Director of Accreditation and Licensure, staff A, stated that they were not assessing patient for Advance Directive in their outpatient settings. Staff A stated they used to but when they went with their electronic medical record system, they stopped because the process changed. Staff A stated that he/she knew they were not following their policy.

7. During an interview on 03/10/10 at 11:00 a.m., Interdisciplinary Practice Coordinator, staff K, confirmed that Patients #3, #4, and #5 were not assessed for an Advance Directive.

Based on observation and interview, the facility failed to ensure patient's rights to privacy were protected when staff stored patient records with the patient first name and last initial visible to the general public in the Adult Behavioral Health Unit; and failed to ensure the patient and visitors were provided full disclosure of potential video monitoring in 24 patient rooms within the facility's "Heart Hospital". The census in the Adult Behavioral Health Unit at the time of the survey was thirteen (13) patients. The census for the "Heart Hospital" at the time of the survey was 85.

1. Facility Patient & Family Information, Form #3882, 1/09, provided to patients and/or families upon admission to the Behavioral Health Units states at Patient Rights and Responsibilities at number 5, "Patients have a right to personal privacy and confidentiality of information".

2. A tour of the Adult Behavioral Health Unit (fourteen bed unit) on 03/09/10 at 3:20 p.m. showed patient medical records stored in the nursing station with the patient's first name and last initial were clearly visible to anyone in the unit if near the nursing station.

3. Staff I, Registered Nurse, Executive Director of Behavioral Health verified that the patient's first name and last initial were visible to persons near the nursing station.


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4. Review of a brochure available for patients in the "Heart Hospital" showed (in part) that the video monitoring mechanism entitled "SafeWatch" is a telemedicine program that connects critical care patient rooms to a centralized intensive care unit (ICU) staffed around the clock by physicians and highly trained nurses. The facility does not have a policy regarding video monitoring.

5. Observation on 03/11/10 at 10:30 a.m. showed video cameras in twenty-four designated Electronic Intensive Care Unit (EICU) patient rooms on the 3rd and 4th floors of the facility's Heart Hospital. A demonstration of the equipment showed that two types of audio alarms are deployed prior to the camera turning away from the wall and focusing on the patient. When the system is fully operational, a two-way conversation can take place between the patient, staff in the room and the nurse or physician observing care. Video monitoring is initiated when nursing staff want a nurse and/or physician ' s assistance with observing/monitoring a critically ill patient. No signage regarding video monitoring is utilized in patient rooms.

6. During an interview on 03/11/10 at 3:00 p.m., Executive Director (ED) Staff AA stated patients are informed of the placement and purpose of the camera when they are placed in the EICU room. ED Staff AA stated monitoring is done without use of a consent form, and signage posted in visiting rooms informs patients, visitors, and the general public of the potential for video monitoring via the "SafeWatch" system. Observation of patients being monitored by the "SafeWatch" system is conducted in a secure location within the hospital. No recording is made from any camera or microphone.

7. A tour of the 3rd and 4th floor visiting areas on 03/11/10 at 03:15 p.m. showed signage regarding the "SafeWatch" video monitoring system had been removed. ED Staff AA immediately implemented a plan to replace the signage.

Based on policy review, interview, and record review, the facility failed to obtain physician orders prior to the application of physical restraints for two patients (Patient #5 and #20) of two patients found in medical restraints. The facility census was 796.

Findings included:

1. Review of the facility policy titled, "Restraints, Seclusion, Protective/Assistive Devices" revised 10/09, gave direction, in part, to include the following:
- "Written orders are required for each episode of restraint."- "Only a physician can authorize the use and continued use of restraints."
- "Twenty-four (24) hours is the time limit for orders for medical/surgical conditions."- "Continued use of restraint beyond the first 24 hours must be authorized by a physician order entered into the medical record each calendar day."- "If a patient was recently released from restraint and exhibits behavior that can only be handled by the reapplication of restraint, a new order would be required."- "Each episode of restraint use must be initiated in accordance with the order of the physician."

2. Review of current Patient #5's medical record on 03/09/10 at 3:55 p.m. showed the following:
- On 03/05/10 at 7:00 a.m., nursing documentation showed that the restraints were "discontinued. On 03/06/10 at 9:00 p.m., documentation showed bilateral soft wrist restraints were reapplied. There was no physician order for the restraints that were reapplied.
- On 03/08/10, there was no physician order for the restraints that were applied between 03/08/10 at 11:58 a.m. and 03/09/10 at 2:56 p.m.. Nursing documentation showed that restraints were used at least part of this time.

3. During an interview on 03/10/10 at 11:10 a.m., Interdisciplinary Practice Coordinator, staff K, confirmed there was no physician order for the restraints applied on 03/08/10.


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4. Review of current Patient #20 ' s medical record on 03/11/10 at 11:00 a.m. showed the following:
- Initial order for bilateral soft wrist restraints was dated 02/14/10 at 9:05 a.m. to prevent interference with medical treatment and patient remained in restraints at the time of the survey.
- Review of nursing documentation for 02/23/10, 03/07/10, and 03/08/10 showed Patient #20 was restrained, but review of the physician's orders showed no orders for restraints on these dates.

5. During an interview on 03/11/10 at approximately 11:15 a.m., Registered Nurse (RN) Manager L confirmed there was no physician order for the restraints applied on 02/23/10, 03/07/10, and 03/08/10.

Based on policy review, observation, interview, and record review, the facility failed to ensure an appropriate physician's order was obtained for restraints for two patients (Patient #5 and #20) of two patients found in medical restraints. The facility census was 796.

Findings included:

1. Review of the facility policy titled, "Restraints, Seclusion, Protective/Assistive Devices" revised 10/09, gave direction, in part, to include the following:
- "Written orders are required for each episode of restraint."- "Only a physician can authorize the use and continued use of restraints."
- "Twenty-four (24) hours is the time limit for orders for medical/surgical conditions. PRN orders are NOT acceptable."- "If a patient was recently released from restraint and exhibits behavior that can only be handled by the reapplication of restraint, a new order would be required."- "Each episode of restraint use must be initiated in accordance with the order of the physician."

2. Review of current Patient #5's medical record on 03/09/10 at 3:55 p.m. showed the following:
- On 03/09/10 at 3:00 p.m., nursing documentation showed bilateral soft wrist restraints "started". A physician's order was written on 03/09/10 at 2:56 p.m. for "wrist restraints as needed".

3. During an interview on 03/10/10 at 11:10 a.m., Interdisciplinary Practice Coordinator, staff K, stated that they do not accept PRN (as needed) restraint orders as was written on 03/09/10.


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4. Review of current Patient #20 ' s medical record on 03/11/10 at 11:00 a.m. showed the following:
- Initial order for bilateral soft wrist restraints was dated 02/14/10 at 9:05 a.m. to prevent interference with medical treatment and patient remained in restraints at the time of the survey.
- Review of nursing documentation for 02/18/10, 02/26/10, 02/28/10, and 03/01/10 showed restraints were removed for periods of approximately 12 hours and were reapplied without obtaining a new physician ' s order.

5. During an interview on 03/11/10 at approximately 3:00 p.m., Registered Nurse (RN) Manager L stated a new restraint order was necessary if restraints were removed for longer than the amount of time needed to perform range of motion exercises (approximately 15 minutes). Nurse Manager L confirmed there was no physician order for the restraints applied on 02/18/10, 02/26/10, 02/28/10, and 03/01/10.

Based on policy review, interview, and record review, the facility failed to ensure appropriate application, monitoring, and nursing documentation was completed for two patients (Patient #5 and #20) of two patients found in medical restraints. The facility census was 796.

Findings included:

1. Review of the facility policy titled, "Restraints, Seclusion, Protective/Assistive Devices" revised 10/09, gave direction, in part, to include the following:
- "Written orders are required for each episode of restraint."- "Only a physician can authorize the use and continued use of restraints."
- "Twenty-four (24) hours is the time limit for orders for medical/surgical conditions. PRN orders are NOT acceptable."- "Continued use of restraint beyond the first 24 hours must be authorized by a physician order entered into the medical record each calendar day."- "If a patient was recently released from restraint and exhibits behavior that can only be handled by the reapplication of restraint, a new order would be required."- "Each episode of restraint use must be initiated in accordance with the order of the physician."
- "Re-assessment for continued need of the restraint will be documented at least every eight hours by a licensed nurse."
- "Documentation will include care rendered such as hydration, nutrition, elimination and skin care-at a minimum of every two hours."
- "Type of restraint applied, start and end times will be documented."
- "Clinical justification for use will describe specific medical conditions, behaviors requiring restraints."
- "Staff will document observation of such things as patient clinical condition, circulation, and/or condition of limbs prior to application of device, during use and after removal of device."

2. Review of current Patient #5's medical record on 03/09/10 at 3:55 p.m. showed the following:
- On 03/04/10 at 6:00 a.m., nursing documentation showed bilateral soft wrist restraints "continued". The next nursing note, written on 03/04/10 at 11:00 a.m. showed that the restraints had been "reapplied". There was no documentation between 6:00 a.m. and 11:00 a.m. that showed when the restraints were removed.
- On 03/04/10 after the 11:00 a.m. nursing note that stated the restraints were "reapplied", there was no further restraint documentation until 8:00 p.m. when the documentation showed "start" (restraints). It is unclear from the medical record when the restraints were removed.
- On 03/05/10 at 7:00 a.m., nursing documentation showed that the restraints were "discontinued. On 03/06/10 at 9:00 p.m., documentation showed bilateral soft wrist restraints were reapplied.
- On 03/08/10 at 5:00 a.m., nursing documentation showed bilateral soft wrist restraints "continued". At 8:00 a.m. and 10:00 a.m., documentation showed the patient "off the floor". There was no restraint documentation to include safety checks between 5:00 a.m. and 12:00 noon.
- On 03/09/10 at 6:00 a.m., nursing documentation showed bilateral soft wrist restraints "continued". The next nursing note, written at 3:00 p.m. showed that bilateral wrist restraints were "started". There was no documentation to show when the restraints had been removed.

3. During an interview on 03/09/10 at 3:45 p.m., Supervisor of Medical Intermediate Care Unit, staff F, stated that current Patient #5 was in restraints due to punching anyone who comes close to him/her but had been out of restraints much of that day while in dialysis. Staff F stated that Patient #5 was confused.


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4. Review of current Patient #20 ' s medical record on 03/11/10 at 11:00 a.m. showed the following:
- Initial order for bilateral soft wrist restraints was dated 02/14/10 at 9:05 a.m. to prevent interference with medical treatment and patient remained in restraints at the time of the survey.
- Review of nursing documentation for the period of 02/14/10 - 03/11/10 showed nursing documentation was inconsistent and incomplete in regard to: Monitoring, assessing and re-evaluating at least every two hours; Monitoring patient condition, circulation, and/or condition of limbs prior to application, during use, and after removal of restraints; Re-assessment for need for continued restraints; and Notifying physician that restraint was no longer needed.

5. During an interview on 03/11/10 at approximately 3:00 p.m., Registered Nurse (RN) Manager L stated nurses were required to document patient assessments and treatments for restrained patients at least every two hours and stated current Patient #20's medical record reflected "poor documentation."

Based on record review, interview and facility policy review the facility failed to provide within one hour of the initiation of a restraint, a face to face assessment for one patient according to facility policy (Patient #7) of one record reviewed of patients receiving behavioral restraint intervention. The facility census was 796 at the time of the survey.

Findings included:

Facility policy titled "Restraints, Seclusion, and Protective/Assistive Devices", policy number 200.19, last revised 10/05/09, states in part, "A physician must conduct a face to face evaluation of the patient within one hour of the initiation of restraint or seclusion. If a patient was placed in restraint or seclusion, quickly recovers and is released before the physician conducts the face to face, the evaluation must still be completed within one hour of initiation".

1. Record review of Patient #7's Restraint/Seclusion documentation at 3:00 p.m. on 03/09/10 showed Patient #7 was placed in seclusion on 02/13/10 at 11:15 p.m. and released on 02/14/10 at 2:00 a.m.
The physician one hour assessment is dated 02/13/10, but is not timed. (There is not a way to determine if the assessment was done within one hour after initiation of seclusion).

2. Patient #8 was placed in seclusion with a waist restraint on 02/16/10 at 11:00 p.m. The physician one hour assessment is dated 02/16/10, but is not timed. (There is not a way to determine if the assessment was done within one hour after initiation of seclusion/waist restraint).

3. Staff H, Registered Nurse Manager, 5 West (Behavioral Health) confirmed the medical record had no further documentation that might show when the one hour assessments had been completed.