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Based on staff interview and record review, the hospital failed to ensure compliance with Vermont State Statutes to include Bill of Rights or Hospital Patients and the 2006 Edition of VT Fire and Building Safety Codes. Findings include:

Vermont State Statutes
Title 18: Health
Chapter 42: Bill of Rights For Hospital Patients
Section 1852 (a) (1) The patient has the right to considerate and respectful care at all times and under all circumstances with recognition of his or her personal dignity.

1. Based on record review and staff interview the hospital failed to assure that each patient had the right to make informed decisions about their care and were treated with dignity and respect in 1 applicable record reviewed. (Patient #8) Findings include:

Per record review, Patient #8, who was voluntarily admitted to Shepardson 6 inpatient psychiatric unit due to psychosis, requested Lunesta (medication for insomnia) during the evening shift on 1/18/11. Nursing notes on 1/18/11 at 8:35 PM stated "Pt requested Lunesta but when given it spit it right out. Nurses made multiple unsuccessful attempts to get pt to take Lunesta, pt continued to spit pill out and spit/spill chocolate milk on self and others. Pt continued to express that she wanted the medication, yet was unable to take it..." Per review of the hospital's internal investigation, one nurse held the medication in Patient #8's mouth while 2 other nurses physically held the patient's arm and head in an effort to force the patient to take the medication. Patient #8 refused the medication.

Per interview with Nurse #1 on 3/9/11 at 11:30 AM, three nurses were placed on administrative leave as the result of this event and staff education was provided which included the use of involuntary/emergency medication and restraint.

2. Per interview with the Assistant Fire Marshal on 3/11/11 at 2:30 pm, the hospital began laboratory functions at an outpatient facility on 3/7/11 without first obtaining an occupancy permit in violation of 2006 Edition of VT Fire and Building Safety Code: 20 VSA Chapter 73.

Based on observations, staff interviews and record review conducted throughout the days of survey, the Governing Body failed to ensure protection and promotion of Patient Rights based on the hospital's failure to prevent the use of unnecessary force resulting in injury and the use of prohibited weapons and restraints in response to patient behaviors. The Governing Body failed to ensure the safety of patients by failing to equip outpatient facilities, were surgical procedures are performed, with required emergency lighting.

Refer to Tags: A-0154, A-702

Based on record review and staff interview , the Condition of Participation for Patient's Rights was not met based on the hospital's failure to prevent the use of unnecessary force resulting in injury and the use of prohibited weapons and restraints in response to patient behaviors.

Refer to A-0154

Based upon review of information provided to patients/families at the time of admission and interview, the facility failed to provide sufficient information that clearly articulated the facilities complaint and grievance process. Evidence includes the following:

On 3/9/11 at approximately 2:00 PM, an interview was conducted with Manager of Patient & Family Advocacy related to the complaint and grievance process at the facility. At this time, a packet of information was reviewed which was confirmed to be the information presented to patients/families at the time of admission which was titled, "Guide for Inpatients". The packet contained additional information including patient rights and responsibilities.

Form #017773P dated 1/25/10 was identified during the interview as to where patients/families could find information about the complaint and grievance process. The only information in the notice pertaining to filing a complaint and/or grievance was: " If you have any questions or complaints about your stay, please contact our Office of Patient and Family Advocacy. They will listen to your concerns and work with you to address them." The form provided the name of the hospital, address and phone number but no contact person. Also provided were Vermont agencies for additional assistance with other concerns.

Review of the "Guide for Inpatients" on page 11 read, " We encourage direct feedback to any staff at the time a concern arises. In addition, a specific review process is offered through our Office of Patient and Family Advocacy. This process includes appropriate investigation and resolution at the point of service and/or referral to our Grievance Committee for review and written response. For more information, contact our Office of Patient and Family Advocacy.

Neither document clearly explained how a complaint or grievance could be filed including time frames and expectations. The interview confirmed that the information reviewed was how the patient was informed about their right to file a complaint or grievance

Based on record review and staff interview the hospital failed to assure that each patient had the right to make informed decisions about their care and were treated with dignity and respect in 1 applicable record reviewed. (Patient #8) Findings include:

1. Per record review, Patient #8, who was voluntarily admitted to Shepardson 6 inpatient psychiatric unit due to psychosis, requested Lunesta (medication for insomnia) during the evening shift on 1/18/11. Nursing notes on 1/18/11 at 8:35 PM stated "Pt requested Lunesta but when given it spit it right out. Nurses made multiple unsuccessful attempts to get pt to take Lunesta, pt continued to spit pill out and spit/spill chocolate milk on self and others. Pt continued to express that she wanted the medication, yet was unable to take it..." Per review of the hospital's internal investigation, one nurse held the medication in Patient #8's mouth while 2 other nurses physically held the patient's arm and head in an effort to force the patient to take the medication. Patient #8 refused the medication.

Per interview with Nurse #1 on 3/9/11 at 11:30 AM, three nurses were placed on administrative leave as the result of this event and staff education was provided which included the use of involuntary/emergency medication and restraint.

Based on observation and confirmed by interview, the facility failed to assure personal privacy for patients on one medical unit. Findings include;

Based on observations from 3/8/11 through 3/10/11, medical records posted with the first and last names of patients were fully visible and legible from approximately 18 inches away from where they were stored at the nursing station. Per interview on 3/8/11 at 10:45 AM, the Nurse Manager of the unit confirmed that "patients and visitors are allowed in [the] area". Per interview on 3/10/11, a staff person who works behind the nursing station stated that "occasionally people come to the nursing station via the front".

Based on observations and staff interview the hospital failed to provide an environment that would ensure safety and well being for all patients on the inpatient psychiatric units. Findings include:

1. On 3/9/11 at approximately 9:15 AM a tour was conducted on Shepardson 3 Psychiatric Unit. Five handwashing sinks with goose neck type faucets which were potentially loopable devices, were observed in the following areas: 2 in the hallways near room 335 and outside the Activity room; in the tub room; in the Activity room; and in the Activity room/kitchen.

2. Based on observations of the two inpatient psychiatric units during survey, four sinks on Shepardson 6 located in the hallways had goose neck type faucets which were potentially loopable devices. During interview on 3/9/11 at 3:30 PM, Nurse #1 said the sinks were included for evaluation during safety rounds but no concerns had been identified.

Based on record review and staff interview, the hospital failed to prevent the use of unnecessary force resulting in injury and the use of prohibited weapons and restraints in response to patient behaviors in 3 of 3 records reviewed.(Pt. # 7, 16, 17) Findings include:

Per review of security reports, record review and staff interview, hospital security personnel were equipped to use 'ASP Trifold Restraints' (used as handcuffs) and Oleoresin Capsicum (pepper spray) which are prohibited for use by hospital staff to restrain patients.

1. Per record review, Patient #7, admitted voluntarily due to suicidal ideation and opiate withdrawal, became 'verbally and physically agitated yelling, slamming the door and throwing items in his/her room' on 1/24/11 after being told h/she couldn't leave the hospital. Constant observation was initiated at 2:09 PM. Nursing notes described Patient #7 as ".. currently sitting in room and in behavioral control (although tense). Awaiting crisis team to evaluate.." Patient #7 was later described as sitting on the toilet 'staring blankly and mute' while crisis met with family members. Following the emergency evaluation, Patient #7 was described as " irate banging his head on the wall stating "I'm going to kill myself." Patient #7 refused to transfer to the locked inpatient psychiatric unit 'without a fight'. Nursing notes stated "given the volatility of the situation and potential for harm I call a Code 8."

Per interview on 3/9/11 at approximately 9:10 AM, Nurse # 1 stated ".. h/she wanted to leave... furious h/she couldn't leave.. nurse sounded the panic button.. h/she was sitting on the toilet and threatened to harm staff... Security applied plastic wrist restraints after placing h/her on the floor on stomach..security picked h/her up and placed in wheelchair..3 or 4 security personnel present .. complained of arm hurting when restraint put on wrist... patient struggling during wrist restraint application... we told h/her to stop struggling but h/she wouldn't." Per record review, Patient #7 had a surgical procedure in 2002 on the right upper arm.

Per review of the 1/24/11 Security Services Incident Report, security personnel responded to the Code 8 and stood by while nursing and medical staff spoke to Patient #7 about his options. Patient #7 said h/she would rather hurt staff and go to jail than go to Shepardson 6" (locked inpatient psychiatric unit). Patient #7 refused to take oral medication or move from the toilet. The report stated " The patient was fully clothed and after several minutes the patient was advised that if h/she did not move we would be forced to move h/her. The patient continued to refuse and it was decided to then attempt to direct the patient into the wheelchair. However, as soon as contact was made with the patient then started to resist and was placed down on the floor. The area was very small and the patient was aggressively resisting so it was decided to place the patient into ASP disposable restraint."

Per interview on 3/10/11 at 11:30 AM with Security Officer #1 and Security Officer #2, a total of four security officers and other patient support personnel responded to the Code 8. Security Officer #1 said he was informed that Patient #7 needed to be transferred to Shepardson 6 but h/she was refusing to go. Security Officer #1 said nursing and medical personnel were trying to convince Patient #7 to walk to the unit, but Patient #7 was verbally threatening stating h/she "would rather hurt staff and go to jail than go to Shepardson 6." Security Officer #1 described Patient #7 as dressed and seated on the toilet with fists clenched but no attempts were made to strike out. Security Officer #1 said he made the decision to place Patient #7 in the MOAB (Management of Aggressive Behavior) prone control position to avoid injury to his staff. (Patient placed on abdomen with each arm extended and secured at the shoulder and wrist with the wrists bent upward.) Four security officers were used for the "take down" per Security Officer #1. Security Officer #1 said Patient #7 was yelling "no restraints" stating h/she had a "bad right elbow." Security Officer #2 said he had to back into the shower due to space constraints. An ASP Trifold Restraint was applied which restrained Patient #7's hands behind his/her back. " H/she was told not to resist but h/she continued to resist.. h/she was twisting around." Security Officer #1 said after restraining Patient #7 h/she was "dragged" the length of h/her room to the wheelchair in the hallway and lifted into the chair. Patient #7 was transported, by four security officers, in wrist restraints and while holding his lower legs since h/she was trying to block movement of the wheelchair. Once arriving on Shepardson 6 and being led into seclusion, the plastic wrist restraints were removed by a device known as a 'Scarab cutter' used by security staff since the device cannot be removed with scissors. When Patient #7 refused to accept medication, Security Officer #1 said three security officers held Patient #7 down, with one on each arm and one holding h/her legs while the nurse administered injectable medications. Nursing notes on 1/24/11 stated the physician was aware of Patient #7's complaints of shoulder pain.

On 1/27/11, nursing notes for Patient #7 stated ".. c/o chest pain/sharp: 6/10 pain rating, pain has been present since when awoke in middle of the night last night." On 1/29/11, the physician ordered a chest x-ray. The inpatient psychiatry discharge summary dated 1/31/11 stated "On 1/29 a chest x-ray was obtained after pain continued, and showed a non-displaced rib fracture, possibly sustained during his struggle and restraint on Shepardson 3 at the time of transfer, for which no specific intervention was required." Per Interview on 3/9/11, Nurse #1 stated "the fracture probably occurred during or as the result of the restraint." Based on record review and staff interview, although Patient #7 was verbally threatening and agitated, h/she was not combative when the use of force was implemented.

2. Per review of Security Services Incident Reports, the form listed a selection of interventions including "FAHC Handcuffs and FAHC Mace'. During interview on 3/10/11 at 11:30 AM, Security Officer #1 confirmed that ASP Trifold Restraints and pepper spray were carried by security personnel. Security Officer #1 said " It (pepper spray) would be the last resort.. it's been used once in my 5 and 1/2 years.. it was used on a patient who weighed about 300 pounds who was using karate kicks and punches." The Vice President of Hospital Services provided documentation on 3/11/11 at 2:10 PM concerning the use of pepper spray at Patient #17 which occurred on 2/6/2008.

A. Per review of Security Services Incident Report dated 2/6/2008, pepper spray was used on Patient #17 on Shepardson 6, the locked inpatient psychiatric unit. Per documentation in the report, Patient #17 was "acting out.. walked past the nurse's station several times and performed several martial arts stances towards staff.. made an impression of a gun and made the impression of shooting us.. Security proceeded to the hallway where h/she took off his socks clenched h/her fist and took up a defensive stance towards staff. .. refused several commands to calm down and come with security towards the seclusion room.. became combative with staff and had to be placed on the floor to control him and prevent h/her from harming staff..picked up off the floor and taken to the seclusion room .. began to kick door.. nursing staff went to the nurse's station.. to get medications.. security personnel verbally commanded h/her to back away from the door..charged with clenched fists and was pushing S/O (security officer) out of the room.. continued to be combative.. Security staff and this officer deployed OC, ( Oleoresin Capsicum) spraying 1 second burst in face.. "

B. Per review of Security Services Incident Report and record review, Patient #16, who was admitted on 9/14/10 to the cardiac unit attempted to leave the hospital to smoke during the evening shift. Nursing notes stated "nurse and charge nurse went with Pt to 1st floor where he tried to exit the building. A transport member prevented h/her from exiting and the pt became violent striking out at anyone that attempted to stop h/her. Code 8 called and security restrained the pt." When security responded, one of the security officers observed the patient and two staff members involved in a 'struggle.' The report by security stated "..The patient at one point was in a standing position when I ordered the patient to lay on the ground or I would spray h/her (Patient #16). I pulled my OC (pepper spray) out and aimed it... I chose not to use the OC.. on seeing the OC canister h/she (Patient #16) appeared to pass out and go to the floor... h/she began to move around on the floor as if to appear to have a seizure... Staff holding the patient let go and I instructed them that the patient appeared to be faking. Staff again held the patient.. the patient was held to the floor on h/her back..I instructed staff to roll h/her (Patient #16) on stomach. ASP restraints were applied for his/her protection as well as staff. " Per interview on 3/11/11 at 1:50 PM, the Vice President of Hospital Services confirmed that the pepper spray container was directed at Patient #16 but was not used by security. Per record review, Patient #16 was admitted to the cardiology for recurrent chest pain and LOC (loss of consciousness) episodes. A neurology consult note stated that Patient #16 had seven episodes of loss of consciousness on 9/14/10 prior to the above event.

Per interview on 3/11/11 at 2:08 PM, the Vice President of Hospital Services stated. " we looked at the regulations and thought it (pepper spray) was okay... it was used for safety and not for therapeutic reasons."

Based upon document review and interview, the facility failed to report timely deaths associated with restraint or seclusion for 5 of 5 records reviewed. (Patients # 49, 50, 51,
52 and 53 ). Evidence includes the following.

The Regulatory Advisor for Fletcher Allen was interviewed on 3/10/11 at 2:30 PM regarding the facility process for death reporting relative to restraint and/or seclusion use. It was reported that the facility uses clinical auditors who review and look for the mandated CMS parameters required to be reported. The CMS form is completed, faxed and entered into the medical record.

Record review revealed that Patient # 49 died within 24 hours of the removal of restraint on 1/19/2011. The death was reported to CMS on 1/31/2011.
Patient # 50 died on 2/14/11 and the death was reported to CMS on 2/24/11.
Patient # 51 died on 2/15/11 and the death was reported to CMS on 3/10/11.
Patient # 52 died on 2/14/11 and the death was reported to CMS on 3/10/11.
Patient # 53 died on 2/4/11 and the death was reported to CMS on 2/14/11.
When asked to produce other death reporting actions to CMS, staff confirmed that the facility did not follow the the reporting requirement for other deaths as well.

Based on record review and staff interview the hospital failed to track adverse patient events related to the use of ASP Trifold restraints and pepper spray used by security personnel
in 3 of 3 records reviewed.(Pt. # 7, 16, 17) Findings include:

Per review of security reports, record review and staff interview, hospital security personnel were equipped to use 'ASP Trifold Restraints' (used as handcuffs) and Oleoresin Capsicum (pepper spray) which are prohibited for use by hospital staff to restrain patients.

1. Per record review, Patient #7, admitted voluntarily due to suicidal ideation and opiate withdrawal, became 'verbally and physically agitated yelling, slamming the door and throwing items in his/her room' on 1/24/11 after being told h/she couldn't leave the hospital. Constant observation was initiated at 2:09 PM. Nursing notes described Patient #7 as ".. currently sitting in room and in behavioral control (although tense). Awaiting crisis team to evaluate.." Patient #7 was later described as sitting on the toilet 'staring blankly and mute' while crisis met with family members. Following the emergency evaluation, Patient #7 was described as " irate banging his head on the wall stating "I'm going to kill myself." Patient #7 refused to transfer to the locked inpatient psychiatric unit 'without a fight'. Nursing notes stated "given the volatility of the situation and potential for harm I call a Code 8."

Per interview on 3/9/11 at approximately 9:10 AM, Nurse # 1 stated ".. h/she wanted to leave... furious h/she couldn't leave.. nurse sounded the panic button.. h/she was sitting on the toilet and threatened to harm staff... Security applied plastic wrist restraints after placing h/her on the floor on stomach..security picked h/her up and placed in wheelchair..3 or 4 security personnel present .. complained of arm hurting when restraint put on wrist... patient struggling during wrist restraint application... we told h/her to stop struggling but h/she wouldn't." Per record review, Patient #7 had a surgical procedure in 2002 on the right upper arm.

Per review of the 1/24/11 Security Services Incident Report, security personnel responded to the Code 8 and stood by while nursing and medical staff spoke to Patient #7 about his options. Patient #7 said h/she would rather hurt staff and go to jail than go to Shepardson 6" (locked inpatient psychiatric unit). Patient #7 refused to take oral medication or move from the toilet. The report stated " The patient was fully clothed and after several minutes the patient was advised that if h/she did not move we would be forced to move h/her. The patient continued to refuse and it was decided to then attempt to direct the patient into the wheelchair. However, as soon as contact was made with the patient then started to resist and was placed down on the floor. The area was very small and the patient was aggressively resisting so it was decided to place the patient into ASP disposable restraint."

Per interview on 3/10/11 at 11:30 AM with Security Officer #1 and Security Officer #2, a total of four security officers and other patient support personnel responded to the Code 8. Security Officer #1 said he was informed that Patient #7 needed to be transferred to Shepardson 6 but h/she was refusing to go. Security Officer #1 said nursing and medical personnel were trying to convince Patient #7 to walk to the unit, but Patient #7 was verbally threatening stating h/she "would rather hurt staff and go to jail than go to Shepardson 6." Security Officer #1 described Patient #7 as dressed and seated on the toilet with fists clenched but no attempts were made to strike out. Security Officer #1 said he made the decision to place Patient #7 in the MOAB (Management of Aggressive Behavior) prone control position to avoid injury to his staff. (Patient placed on abdomen with each arm extended and secured at the shoulder and wrist with the wrists bent upward.) Four security officers were used for the "take down" per Security Officer #1. Security Officer #1 said Patient #7 was yelling "no restraints" stating h/she had a "bad right elbow." Security Officer #2 said he had to back into the shower due to space constraints. An ASP Trifold Restraint was applied which restrained Patient #7's hands behind his/her back. " H/she was told not to resist but h/she continued to resist.. h/she was twisting around." Security Officer #1 said after restraining Patient #7 h/she was "dragged" the length of h/her room to the wheelchair in the hallway and lifted into the chair. Patient #7 was transported, by four security officers, in wrist restraints and while holding his lower legs since h/she was trying to block movement of the wheelchair. Once arriving on Shepardson 6 and being led into seclusion, the plastic wrist restraints were removed by a device known as a 'Scarab cutter' used by security staff since the device cannot be removed with scissors. When Patient #7 refused to accept medication, Security Officer #1 said three security officers held Patient #7 down, with one on each arm and one holding h/her legs while the nurse administered injectable medications. Nursing notes on 1/24/11 stated the physician was aware of Patient #7's complaints of shoulder pain.

On 1/27/11, nursing notes for Patient #7 stated ".. c/o chest pain/sharp: 6/10 pain rating, pain has been present since when awoke in middle of the night last night." On 1/29/11, the physician ordered a chest x-ray. The inpatient psychiatry discharge summary dated 1/31/11 stated "On 1/29 a chest x-ray was obtained after pain continued, and showed a non-displaced rib fracture, possibly sustained during his struggle and restraint on Shepardson 3 at the time of transfer, for which no specific intervention was required." Per Interview on 3/9/11, Nurse #1 stated "the fracture probably occurred during or as the result of the restraint." Based on record review and staff interview, although Patient #7 was verbally threatening and agitated, h/she was not combative when the use of force was implemented.

2. Per review of Security Services Incident Reports, the form listed a selection of interventions including "FAHC Handcuffs and FAHC Mace'. During interview on 3/10/11 at 11:30 AM, Security Officer #1 confirmed that ASP Trifold Restraints and pepper spray were carried by security personnel. Security Officer #1 said " It (pepper spray) would be the last resort.. it's been used once in my 5 and 1/2 years.. it was used on a patient who weighed about 300 pounds who was using karate kicks and punches." The Vice President of Hospital Services provided documentation on 3/11/11 at 2:10 PM concerning the use of pepper spray at Patient #17 which occurred on 2/6/2008.

A. Per review of Security Services Incident Report dated 2/6/2008, pepper spray was used on Patient #17 on Shepardson 6, the locked inpatient psychiatric unit. Per documentation in the report, Patient #17 was "acting out.. walked past the nurse's station several times and performed several martial arts stances towards staff.. made an impression of a gun and made the impression of shooting us.. Security proceeded to the hallway where h/she took off his socks clenched h/her fist and took up a defensive stance towards staff. .. refused several commands to calm down and come with security towards the seclusion room.. became combative with staff and had to be placed on the floor to control him and prevent h/her from harming staff..picked up off the floor and taken to the seclusion room .. began to kick door.. nursing staff went to the nurse's station.. to get medications.. security personnel verbally commanded h/her to back away from the door..charged with clenched fists and was pushing S/O (security officer) out of the room.. continued to be combative.. Security staff and this officer deployed OC, ( Oleoresin Capsicum) spraying 1 second burst in face.. "

B. Per review of Security Services Incident Report and record review, Patient #16, who was admitted on 9/14/10 to the cardiac unit attempted to leave the hospital to smoke during the evening shift. Nursing notes stated "nurse and charge nurse went with Pt to 1st floor where he tried to exit the building. A transport member prevented h/her from exiting and the pt became violent striking out at anyone that attempted to stop h/her. Code 8 called and security restrained the pt." When security responded, one of the security officers observed the patient and two staff members involved in a 'struggle.' The report by security stated "..The patient at one point was in a standing position when I ordered the patient to lay on the ground or I would spray h/her (Patient #16). I pulled my OC (pepper spray) out and aimed it... I chose not to use the OC.. on seeing the OC canister h/she (Patient #16) appeared to pass out and go to the floor... h/she began to move around on the floor as if to appear to have a seizure... Staff holding the patient let go and I instructed them that the patient appeared to be faking. Staff again held the patient.. the patient was held to the floor on h/her back..I instructed staff to roll h/her (Patient #16) on stomach. ASP restraints were applied for his/her protection as well as staff. " Per interview on 3/11/11 at 1:50 PM, the Vice President of Hospital Services confirmed that the pepper spray container was directed at Patient #16 but was not used by security. Per record review, Patient #16 was admitted to the cardiology for recurrent chest pain and LOC (loss of consciousness) episodes. A neurology consult note stated that Patient #16 had seven episodes of loss of consciousness on 9/14/10 prior to the above event.

4. During the afternoon of 3/10/11 when surveyors informed the hospital of the Immediate Jeopardy related to the use of ASP Trifold restraints and pepper spray, the Vice President of Quality and Operational Effectiveness was not aware that ASP Trifold restraints and pepper spray were being used by security personnel. During review of the hospital's Quality program on 3/11/11 at 11:05 AM, the Director of Patient Safety stated that no changes were implemented related to the use of ASP Trifold restraints following their use on Patient #7 on 1/24/11. Per interview on 3/11/11 at 2:08 PM, the Vice President of Hospital Services stated " we looked at the regulations and thought it (pepper spray) was okay... it was used for safety and not for therapeutic reasons."

Based on observations, record review and staff interview, the hospital failed to evaluate the use of side rails for 1 applicable record reviewed. (Patient # 3) Findings include:

1. Observations during a tour of Shepardson 6 on 3/8/11 at 11:00 AM with Nurse #1, side rails were observed on patient beds. Nurse #1 confirmed that all beds have four side rails. Nurse #1 further stated that staff don't use the side rails as restraints and patients can elevate the side rails if they choose to. Nurse #1 further stated "for a geriatric patient we might put up the top half rail but it's not considered a restraint."

On 3/8/11 at 1:45 PM, Patient #3 was observed in bed with two half- rails elevated at the head of the bed. Per record review, although Patient #3 was identified as being at high risk for falls, there was no assessment related to the use of side rails. Per interview on 3/8/11 at 4:10 PM and 3/9/11 at 9:10 AM, Nurse #1 confirmed that half-rails were used for Patient
#3. Nurse #1 said the side rails were not used as restraints and possibly were used to access the call system, but staff were concerned about Patient #3's behavior and risk for falls. Nurse #1 stated "we could improve.. maybe other areas of the hospital use an assessment we could use."

2. During the initial tour of the Shepardson 3 Unit on 3/8/11 at approximately 10:30 AM; and on 3/10/11 at approximately 9:15 AM, the following rooms were observed to be equipped with 4 side rails: Rooms 332, 333, 311, 323
On 3/10/11 at approximately 9:30 AM on Shepardson 3, Nurse #4 indicated when Housekeeping prepared the room for admission; the 2 upper rails were left in the raised position. H/she added, the patients then decided if they wanted them up or down. Nurse #4 also said patients had an assessment for Fall Risk that was completed daily and included side rails; however, there were no individualized or specific assessments for the use of side rails.

Based on observation, interview, and record review, the hospital failed to ensure that nursing staff developed a nursing care plan for 2 of 3 patients (#26, and #27), and failed to ensure a care plan included the use of a C-PAP (continuous positive airway pressure) machine for one patient (#28). The findings include:

1. Patient #26 was admitted to the Shepardson 3 Psychiatric Unit on 3/6/11 with diagnoses which included Suicide Ideation, Depression (Chronic), Substance Abuse, Dissociative Identity disorder, Bulimia, and Family Conflict.

Review of the Interdisciplinary Treatment Plan dated 3/7/11 identified Problems as: Depressive Symptoms; Suicidal Ideations with plan; Relationship Problems; and Substance Dependence (THC - tetrahydrocannabinol, the major psychoactive chemical compound in cannabis). The section for Psychological Interventions was not completed. The last page of the Care Plan was only signed by the Therapist on 3/6/11.

Observation of the Shepardson 3 Unit on 3/8/11 at approximately 10:30AM upon entrance to the unit, found the normally unlocked exit door to be locked. Interview with the Psychiatrist following the tour, revealed the locked status was due to a patient who had been attempting to leave the unit. The Psychiatrist explained he/she did not feel there was therapeudic benefit for this patient to be transferred to the Shepardson 6 Psychiatric Unit, which was locked at all times.

Interview with Nurse #4 on 3/9/11 at approximately 10:00AM revealed the Care Plan did not indicate Patient #26 was a flight risk. There was no revision to reflect the specific problem, or interventions to be implemented.

2. Patient #27 was admitted to the Shepardson 3 Psychiatric Unit on 3/2/11 to 3/8/11 with diagnoses which included Suicide Ideation, Cervical Pain, History of ETOH (alcohol), Migraine, and Mood Disorders.

Review of the Interdisciplinary Treatment Plan dated 3/3/11 identified Problems as: Suicidal Risk. The section for Psychological Interventions was not completed. The last page of the Care Plan was not signed by the Therapist. Interview with Nurse #4 on 3/9/11 at approximately 9:40AM revealed the Interdisciplinary Care Plan should be completed within 24 hours of admission.

3. Patient #28 was admitted to Shepardson 3 Psychiatric Unit on 2/16/11 with diagnoses which included Severe Anxiety, Depression, Hypertension, and Hyperlipidemia. Treatment to include ECT (Electroconvulsive therapy).

Review of the Pre-Admission Referral Summary dated 2/16/11 indicated the patient had a C-PAP (continuous positive airway pressuremachine) for apnea. Review of the Interdisciplinary Treatment Plan dated 2/17/11 did not include a reference to the use of a C-PAP machine. Review of the Inpatient Psychiatry Treatment Plan Update dated 2/24/11 revealed a Physician, Social Worker, and Therapist signature; however, there was no signature for Nursing. On 3/10/11, an interview with Nurse #3 on Shepardson 3 at approximately 9:30AM revealed Pt. #28 did not use a CPAP machine.

Based on observation and staff interview the hospital failed to ensure that all medical records were properly stored in a location that protected them from potential fire and/or water damage. Findings include:

During a tour on 3/7/11 at 3:15 PM improper storage of medical records was observed at an off campus medical records location. Active patient records were observed stored on metal shelves, however in several locations multiple records were stored without protection on top of metal shelves throughout the storage area with some stacks heights to be from 6 to 15 inches sitting in close proximity to sprinkler heads. If the sprinkler heads were prompted to disperse water, the improperly stored records would be in direct contact with water as it was expelled from the sprinkler heads and subject to destruction. The observation was confirmed by the Director for Health Information Management at the time of the tour.

Based on observation, staff interview and record review, the Director of Nutrition Services failed to assure that dietary staff implemented the policy for monitoring of refrigeration temperatures in accordance with safe food handling practices. Findings include:

Per observation during a tour of the kitchen and dietary areas with the Director of Nutrition Services and other dietary staff on 3/8/11 commencing at 10:10 AM, refrigeration temperatures and/or temperature logs revealed multiple days when temperatures exceeded the safe range for storage of perishable foods and there was no evidence of actions taken. Out of range temperatures were recorded daily for freezer #1 for all of February and daily in March, with ranges from 14 - 24 degrees F (Fahrenheit). The thermometer stated that the temperature for freezer #1 was 25.8 degrees during the tour. There were also multiple days when logs for kitchen refrigerators #2, 4, 10 & 13 were out of range at 40 - 44 degrees F for the early AM temperature check. Logs for reach-in refrigerators in the Harvest Cafe revealed multiple days when temperatures were out of range at 40 - 41 degrees. Per review, the hospital's P/P "Cooler/Freezer Temperature Chart Standards for Nutrition Services" stated "If a cooler or freezer temperature is out of compliance, ( at or below 39 degrees F for coolers and at or below 0 degrees for freezers) it will be reported immediately to the supervisor/lead on duty.(T?) the designated staff will take the following course of action and document by number in the column on the form and circle the cooler or freezer which is out of compliance." The out of range temperatures were not circled on the logs reviewed and there was no evidence of any remedial action taken per the policy. These omissions were confirmed during interview with the Director of Nutrition Services on the afternoon of 3/8/11 after policy review.

Based on observation and interview, the hospital failed to ensure the environment was maintained in a safe manner. Findings include:

Per observations made during the physical environment tour on 3/8/11 and 3/9/11 there were loose hand rails in the following locations:

1. Outside the labor and delivery lounge
2. Across from room 4-143 in the west pavilion
3. Between rooms 489-490 on Baird 4
4. Between rooms 574-575 on Shepardson 5

The above observations were confirmed by the facility Quality Assurance representative accompanying the surveyor at the time of the observations.

Based on observation and staff interview, the hospital failed to ensure emergency lighting was available at all outpatient offices where surgical procedures are performed. Findings include:

Per observation of one outpatient clinic on 3/11/11, it was observed that although there is a system to illuminate the hallways in case of a power outage, only flashlights and glow sticks are available to illuminate the procedure rooms in case of a power outage. Per review of billing codes for March 1, 2011 through March 10, 2011, surgical procedures are performed in the two procedure rooms at the outpatient clinic. Per interview on 3/11/11, at approximately 9:45 AM, one clinical staff person stated that if the lights go out "we have flashlights in the rooms". Per interview, a second clinical staff person stated that if the lights went out during a procedure, staff would "make sure the flashlights were on so they could finish the procedure".

Based on observation and confirmed by interview, the hospital failed to assure laminate hoods in the pharmacy were maintained in an acceptable level of quality and safety. Findings include:

Based on observation on 3/9/11 at 1:30 PM of the main pharmacy area, two of four laminate hoods where IV solutions are prepared had discolored and degraded paint on the outsides of the preparation area. The identified areas were tacky to the touch and although degraded to the frame in several pinpoint areas, did not appear to flake off the frame. Per interview at 1:50 PM on 3/9/11, Pharmacist # 1 confirmed that the areas were indeed degraded.

Based on observation, staff interview and record review, hospital staff failed to adhere to aseptic technique during 2 applicable observations of treatment/care provision; failed to ensure consistent monitoring of temperatures and relative humidity was conducted and monitored in Central Sterile Processing; and failed to ensure equipment in disrepair was not used in the operating rooms. Findings include:

1. Per observation of set up procedures for a hemodialysis machine on the Medical Intensive Care Unit (MICU) on 3/8/11 at 3:25 PM, the Hemodialysis Technician (HD) attached the blood chamber for the CRIT-LINE to the Optiflux dialyzer with the same gloves used to move the trash can closer to the dialysis machine. The contamination of the dialyzer/set up was immediately confirmed with the HD and the Director of Renal/Transplant Services. After the observation, the equipment was disposed of and a new set-up was initiated.

2. Per observation, on the afternoon of 3/8/11, Nurse #2 failed to maintain proper infection control and hand hygiene technique during a dressing change procedure. After sanitizing his/her hands and donning clean gloves, the nurse touched his/her face mask, adjusting the fit over the nose and contaminating the glove, and then proceeded to remove the dressing covering the catheter insertion site on the neck of Patient #40. During interview, immediately following the procedure, Nurse # stated s/he did not recall touching his/her mask during the process of changing the dressing. Per review the facility's policy titled Hemodialysis Vascular Access: Central Venous Catheter (CVC) Care and Maintenance, dated October 2010, identifies the procedure for CVC Site Assessment and Care which include; don mask and gown, perform hand hygiene and don gloves, proceed to open sterile supply packages and remove the dressing, '(be careful to avoid contaminating the insertion site)'.

3. During Environment of Care Safety Audits, which includes staff from the Infection Control department, surveillance of the Central Sterile Process (CSR):( the department within the hospital that processes, issues, and controls professional supplies and equipment, both sterile and nonsterile, for some or all patient-care areas of the facility) failed to identify the lack of policy and process for the ongoing monitoring of temperatures and relative humidity in all CSR locations. Per national standards developed by AAMI ( Association for the Advancement of Medical Instrumentation) hospitals are expected to monitor and maintain temperatures and relative humidity within recommended levels in all locations associated with Central Sterile Reprocessing (CSR) to include decontamination, preparation & packing and sterile storage.

Monitoring and maintaining temperatures and relative humidity at specific parameters is recommended to prevent microbial and bacterial growth in packaged sterilized material and instruments. Per Centers for Disease Control (CDC) and Health Care Infection Control Practice Advisory Committee (HICPAC) Guidelines for Environmental Infection Control in Health-Care Facilities 2003 states "...Relative humidity levels >60%, in addition to being perceived as uncomfortable, promote fungal growth.."
During a tour of CSR on 3/9/11 at 1:50 PM a review of the hospital's monitoring process for temperature and humidity control was reviewed. Per observations of a Dickson humidity and temperature chart recorder in the sterile stores area, the temperature reading was 69 degrees Fahrenheit (F) and the relative humidity was 15.2. (Per AAMI guidelines ST79 2006 3.3.65 relative humidity in sterile storage is not to exceed 70% and in other CSR locations humidity should be kept between 30-60 %. Optimal temperatures is 75 degrees F in sterile storage; 68 - 73 degree F in preparation & packing; and 60-65 degrees F in decontamination area) . When asked how the relative humidity and temperature levels were monitored the Director of CSR confirmed the only process presently was for staff to remove the graft chart from the monitoring device weekly, replace with a new graft sheet and place the completed graft chart in a notebook. No daily monitoring and/or review policy existed to assess if relative humidity and temperature levels met recommended parameters in all 3 locations within CSR that have Dickson humidity and temperature monitoring devices. Recommend parameters were not made available to staff for monitoring temperatures and relative humidity nor was a process developed for notification if a problem was identified. In addition, the lack of monitoring and review of relative humidity and temperatures also was performed at the Fanny Allen outpatient surgical location. This deficient practice was also confirmed on 3/10/11 at 8:30 AM by the Director of CSR.

4. Staff in the peri-operative area failed to adhere to infection control standards when an operating room table extension with torn and cracked vinyl was not removed from use. On the morning of 3/9/11 while touring the operative suite area, staff were observed preparing an operating room for the next surgical case. Utilizing the table extension with several breaks in the integrity of the vinyl surface compromised effective disinfection of the surfaces. In an addition, 2 other operating rooms table extension were noted to be stored on the floor in the operating room. These observations were confirmed by the interim nurse manager for Surgical Services to be breaches in infection control practices and a potential compromise of patient safety.

Based on observations, staff interview and record review the Condition of Participation: Surgical Services was not met as evidence by the hospitals failure to monitor temperature and humidity levels in the Central Sterile Processing locations; failure to ensure access to the operative and recovery area is limited to authorized individuals and failure to provide emergency lighting in out patient areas where surgical procedures are conducted. Findings include:

1. Per national standards developed by AAMI (Association for the Advancement of medical Instruments) hospitals are expected to monitor and maintain temperatures and relative humidity within recommended levels in all locations associated with Central Sterile Reprocessing (CSR) to include decontamination, preparation & packing and sterile storage. Monitoring and maintaining temperatures and relative humidity at specific parameters is recommended to prevent microbial and bacterial growth in packaged sterilized material and instruments. During a tour of CSR on 3/9/11 at 1:50 PM a review of the hospital's monitoring process for temperature and humidity control was reviewed. Per observations of a Dickson humidity and temperature chart recorder in the sterile stores area of CSR the temperature reading was 69 degrees Fahrenheit (F) and the relative humidity was 15.2. (Per AAMI guidelines ST79 2006 3.3.65 relative humidity in sterile storage is not to exceed 70% and in other CSR locations humidity should be kept between 30-60 %. Optimal temperatures is 75 degrees F in sterile storage; 68 - 73 degree F in preparation & packing; and 60-65 degrees F in decontamination area.) When asked how the relative humidity and temperature levels were monitored, the Director of CSR confirmed the only process presently was for staff to remove the graft chart from the monitoring device weekly, replace with a new graft sheet and place the completed graft chart in a notebook. No daily monitoring and/or review policy existed to assess if relative humidity and temperature levels met recommended parameters in all 3 locations within CSR that have Dickson humidity and temperature monitoring devices. Recommended parameters were not made available to staff for monitoring temperatures and relative humidity nor was a process developed for notification if a problem was identified. In addition, the lack of monitoring and review of relative humidity and temperatures also was noted to exist at the Fanny Allen outpatient surgical location. This deficient practice was also confirmed on 3/10/11 at 8:30 AM by the Director of CSR.

2. During a tour on the morning of 3/9/11 with the Director of Peri-Operative Services the McClure entrance to the peri-operative area was observed to be unsecured creating potential access to the operative suites and recovery areas by unauthorized individuals. Although all other entrances to the peri-operative area are secured requiring employee ID badge authorization to access the area, the McClure entrance is not equipped with a badge ID monitoring system. An unauthorized individual can press the automatic door opener, travel down a corridor where stretchers and equipment are stored and enter into the operative suites area which is also not secured. In addition, both the McClure peri-operative door entrance and the entrance leading directly into the operating suites are not distincly marked either on the floor or doors warning unauthorized individuals are not permitted to enter. These observations were confirmed by the Director of Peri-Operative services at the time of the tour.

3. Per observation of one outpatient clinic on 3/11/11, it was observed that although there is a system to illuminate the hallways in case of a power outage, only flashlights and glow sticks are available to illuminate the procedure rooms in case of a power outage. Per review of billing codes for March 1, 2011 through March 10, 2011, surgical procedures are performed in the two procedure rooms at the outpatient clinic. Per interview on 3/11/11, at approximately 9:45 AM, one clinical staff person stated that if the lights go out "we have flashlights in the rooms". Per interview, a second clinical staff person stated that if the lights went out during a procedure, staff would "make sure the flashlights were on so they could finish the procedure".

Based upon record review and interview, the facility failed to document complete post anesthesia evaluations. A review 1 of 7 patients who had received anesthesia services revealed documentation by the individual qualified to administer anesthesia did not contain qualitative elements that addressed their recovery from anesthesia and in 1 of 1 applicable anesthesia evaluations, the written evaluations were mostly identical. (Patient #28) Evidence includes the following:

1. Record review for Patient #28 revealed a procedure requiring general anesthesia was ordered initially twice a week on 2/12/11 and increased to three times a week on 3/1/11.
On 2/18/11, the first procedure was conducted. The post anesthesia evaluation conducted on 2/18/11 read: "the patient has been evaluated, assessed and discharged from anesthesia care with stable cardiorespiratory function and acceptable mental status, pain management, body temperature, fluid balance, nausea/vomiting control and Aldrete score. Additional monitoring and assessment needs have been addresses. If present, postoperative events are documented below". There was no qualitative data that indicated what "acceptable mental status" was nor "stable respiratory function or the type of anesthesia that was administered.

On 2/21/11, the post anesthesia evaluation read as: "the patient has been evaluated, assessed and discharged from anesthesia care with stable cardiorespiratory function and acceptable mental status, pain management, body temperature, fluid balance, nausea/vomiting control and Aldrete score. Additional monitoring and assessment needs have been addresses. If present, postoperative events are documented below".

On 2/25/11, the post anesthesia evaluation read as: "the patient has been evaluated, assessed and discharged from anesthesia care with stable cardiorespiratory function and acceptable mental status, pain management, body temperature, fluid balance, nausea/vomiting control and Aldrete score. Additional monitoring and assessment needs have been addresses. If present, postoperative events are documented below".

On 3/2, 3/4, 3/7, 3/9/11, the post anesthesia evaluations all read as: "the patient has been evaluated, assessed and discharged from anesthesia care with stable cardiorespiratory function and acceptable mental status, pain management, body temperature, fluid balance, nausea/vomiting control and Aldrete score. Additional monitoring and assessment needs have been addresses. If present, postoperative events are documented below".

During an interview with the Health Care Service Director in the afternoon of 3/9/11, the documentation of the post anesthesia evaluations were discussed. The "canned" language is a choice in the electronic system that the provider has an option to choose. The anesthesia providers discuss and confer with clinical staff in PACU (Post Anesthesia Care Unit) and use the clinical signs documented by PACU staff. If no issues, they choose from the drop down menu the canned language as noted above. It was confirmed that looking directly at the post anesthesia evaluations, clinical indicators are not present but the system could be changed so that all applicable clinical elements to measure anesthesia recovery could be included in their system.

Based on staff interview and record review the facility failed to establish policies and procedures governing the provision of medical care by Physician Assistant (PA) in the ED (Emergency Department). Findings include:
Per record review, Patient #55, who had been recently diagnosed with GBM (Glioblastoma muliforme, a type of brain cancer), was hospitalized for a period of 3 weeks duration for treatment of complex medical issues, including; Pneumocystis carinii pneumonia, septic shock, DVT (Deep Vein Thrombosis) of the left leg as well as bilateral Pulmonary Emboli (blockage of arteries in the lungs) and Atrial Fibrillation (condition related to heart rhythm). The patient received anticoagulant medication as part of their treatment, and was discharged from the hospital on 6/15/10. Patient #55 presented to the ED just 3 days later, on 6/18/10, complaining of left leg pain, and, despite the available information from the recent hospitalization regarding the patient's medical history, the PA did not consult with the supervising Attending physician and failed to conduct any diagnostic studies when assessing the patient's medical condition. Patient #55 was diagnosed, at that time, with Sciatica (related to irritation of the sciatic nerve) and discharged back to a SNF (Skilled Nursing Facility). Patient # returned to the ED, again, 3 days later, on 6/21/10, with ongoing pain, and the ED physician, who provided the patient's care at that time identified that the patient had a "complex medical hx (history) for GBM and chemo...." and included lab and diagnostic imaging studies as part of the assessment. The lab studies identified a significant drop in blood levels requiring blood transfusion, and a CT of the pelvis revealed retroperitoneal bleed (bleeding internally into the membrane that lines the abdominal cavity in the area of the lower back), and the patient was subsequently readmitted to the hospital for treatment.
Per interview, at 9:50 AM on 3/10/11, the Medical Clinical Leader, responsible for the oversight of quality of care provided in the ED, stated that, although there is a supervising Attending physician available in the ED at all times, there was no formal process in place for assuring ongoing/continuing assessment of the medical care provided by PAs, and no policy or guidelines that clearly defined when a PA would be required to consult the Attending physician regarding medical care of ED patients. The Clinical Leader stated there is an expectation that a PA will consult with the Attending physician when a patient presents with a "complex" case, however that determination is left solely to the individual PA's judgment. S/he also stated that although there is an expectation that PAs will consult the Attending if they are considering use of advanced imaging studies, particularly CT or MRI, there is no policy or protocol to assure consistency of that practice. In addition, the Clinical Leader stated that the process for conducting ongoing assessment of medical care provided by PAs in the ED includes: a requirement to attend at least 50% of the monthly Quality Meetings where case review is conducted; and an informal process of review of PA records, conducted by the Clinical Leader, on those PAs with whom he works, during clinical shifts that s/he is scheduled as a supervising Attending. S/he further stated that they are currently in the process of developing policies and procedures for assuring ongoing/continuing assessment of medical care provided by PAs to ED patients.