The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

CLEVELAND CLINIC 9500 EUCLID AVENUE CLEVELAND, OH 44195 Sept. 20, 2012
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on observation, medical record review, policy review, and staff interview, the hospital failed to ensure each patient was given a copy of their rights (A-117), that patient grievances were fully investigated (A-123), and restraints were applied and maintained safely for patients (A154). The cumulative effect of these systemic practices resulted in the hospital's inability to ensure the rights of all patients were administered, respected and maintained.
VIOLATION: PATIENT RIGHTS: NOTICE OF RIGHTS Tag No: A0117
Based on observation, medical record review, and interview, the facility failed to ensure each patient received a copy of their patient rights and responsibilities. This affected three (Patients #18, #20 and #21) patients of 23 sampled patients, . The patient census was 1055.

Findings:
The medical record review for Patient #18 was completed on 09/20/12. The record review revealed a history and physical, dated 09/18/12, indicating the patient was admitted to the facility for a diagnosis of right upper abdominal pain.
The patient was interviewed, on 09/18/12 at 2:30 P.M., and revealed the patient did have a complaint. When asked if the facility had given the patient a copy of the patient rights, Patient #18 confirmed the agency had not given the patient a copy of the patient's rights.
On 09/18/12 at 2:25 P.M., during an interview, Staff Y stated all patients get their rights from registration and not from the staff on the floor where they are admitted . Staff Y added the patients' rights are available at the nurses station.

The medical record review for Patient #20 was completed on 09/20/12. The record review revealed a history and physical, dated 09/13/12, that stated the patient was admitted to the facility, on 09/13/12, with a complaint of coronary artery disease and was assessed as having severe coronary artery disease and severe right internal carotid disease.
On 09/18/12 at 3:27 P.M., during an interview, Patient #20 affirmed the facility had given the patient a copy of patients' rights. The patient produced a booklet entitled "Patient Rights and Responsibilities". Review of the booklet revealed it did not contain the state agency's complaint hotline number.

The medical record review for Patient #21 was completed on 09/20/12. The record review revealed a physician's progress note, dated 09/05/12 at 11:06 A.M., revealing the patient had been nauseated and had been vomiting for four days and had complained of chest pain.
On 09/18/12 at 3:41 P.M., during an interview, Patient #21 stated a copy of the patient rights were received and presented a packet. Review of the patient rights packet revealed that packet as well did not have the state agency's complaint hotline number.
On 09/18/12 at 4:00 P.M., during an interview, Staff Y stated there were three pages missing from the packet, that those pages had the state hotline number and Staff Y did not know how that happened and wasn't sure where Patient #20 and #21's patient rights packet had came from.
On 09/18/12 at 4:20 P.M., during an interview, Staff A stated he/she wasn't sure how the three pages were missing in the patient rights packet, but he/she thought someone overheard a surveyor was coming and so they copied the patient rights but did not copy both sides of the sheets. Consequently, when they distributed the rights to the patients, the patients got copies with pages missing. He/she didn't know who "they" was.
On 09/19/12 at 10:30 A.M., during an interview, Staff AA and Staff Z confirmed that patient rights packets come from registration. They said someone on the floor where Patient #20 and #21 were staying overheard the surveyor was coming and so "they" (and not registration) made a copy of the patient rights to distribute to each patient. They said not all of the patient rights booklet got copied, including the state hotline number.
VIOLATION: PATIENT RIGHTS: NOTICE OF GRIEVANCE DECISION Tag No: A0123
Based on medical record review, and staff interview, the hospital failed to follow it's own policy regarding the investigation of a patient's complaint for one of three patients (Patient # 9) reviewed who had complained. The hospital census at the time of the survey was 1055. The total sample size was 23.

Findings include:

The medical record review for Patient # 9 was completed on 09/20/12. This patient sent a letter of complaint to the hospital, initially on 03/29/12. The complainant's letter alleged that a cardiac catheterization and stent insertion was done, on 10/20/11, without the patient's consent. The hospital first received the complaint letter from the complainant on 04/03/12. One of the nine hospital ombudsmen was assigned the case, and the investigation began. The ombudsman interviewed the four physicians involved, the physician who obtained the consent and the three involved in the catheterization procedure directly. The ombudsman also interviewed one of the two nurses in the room during the patient's catheterization. In accordance with hospital procedure, the ombudsman made two attempts to call the complainant and left voice messages due to inability to reach the complainant. Because the ombudsman could not reach the complainant by phone, a letter was sent on 04/11/12 asking the complainant to call the ombudsman.

The complainant reported in a letter dated 04/16/12 that he/she had purposely not returned the ombudsman's phone messages. The complainant reports within the letter of having tried to call the ombudsman's office and requested to speak with the director.

Review of the hospital ombudsman's notes on 09/19/12, did not reveal documentation of this phone call. Interview with the director of the ombudsman's department (Staff G) and the assistant director of the ombudsman's department (Staff H), on 09/18/12 at 2:30 PM, revealed the assistant director did attempt to call the complainant, but did not document it. This is not in accordance with the guidelines in the Ombudsman Manual which reads, "every transaction taken to investigate the concerns should be documented in the notes."

During this interview, Staff G and H were questioned as to which staff member in radiology was referenced in the letter, sent by the complainant, dated 04/16/12. Both reported they did not know as this was not investigated. This too is not in accordance with the guidelines in the Ombudsman Manual which reads, "all aspects of the concern should be investigated, not just the major issues."

Review of the Ombudsman's documentation regarding the complainant's grievance revealed the Ombudsman interviewed only one of the two nurses listed on the patient's catheterization team. This nurse was the one working in the monitor room. The other nurse and the cardiovascular technician were the other two personnel in the room that the complainant alleges were at the bedside in complainant's letter dated 05/19/12, paragraph number six.

The hospital ombudsman's last correspondence was a letter to the patient dated 05/31/12 in which the patient's most recent complaints from the letter of 05/19/12 were not addressed.

These findings were confirmed during interview with Staff A, G and H on 9/18/12 at 2:30 PM.

This deficiency substantiates the allegations contained in Complaint Number OH 649.
VIOLATION: USE OF RESTRAINT OR SECLUSION Tag No: A0154
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on medical record review, observation, interview, and policy review, the hospital failed to ensure each patient had restraints imposed upon them only to ensure their immediate safety for three (Patients #5, #19 and #3) of nine patients reviewed who were in restraints. This affected Patient #5 who was in restraints from 08/08/12 through 09/19/12, Patient #19 who was in four point restraints for the purpose of fall prevention, and Patient #3 who had bilateral wrist restraints for the purpose of fall prevention. Upon entrance on 09/17/12, there were 58 patients in restraints and the total census was 1,055 patients.

Findings included:

Review of the medical record for Patient #5 was completed on 09/17/12 at 1:35 PM. The [AGE] year old patient was admitted to the hospital 08/08/12 with diagnoses including N-methyl-D:-aspartate receptor (NMDAR) encephalitis (disease of the brain), seizures, hypertension (high blood pressure), general anxiety disorder, and major depressive disorder.

Review of the medical record revealed the patient came in through the emergency room on [DATE] and was admitted to the H22 neurosurgery unit. The medical record revealed an order was obtained for soft wrist and soft ankle restraints on 08/08/12 at 7:15 PM. The medical record revealed orders on 08/08/12 for the patient to be placed in seizure precautions (padded side rails, suction at bedside and oxygen at bedside). On 08/08/12, the medical record lacked documentation of specific interventions tried before the physical restraints were applied or that the least restrictive intervention was tried before implementing both soft wrist and soft ankle restraints. The medical record revealed a nurses note dated 08/08/12, that documented "increased agitation, patient sitting up in bed and throwing self from side to side." The medical record revealed a physician order, dated 08/08/12 at 10:00 PM, to add a vest restraint.

The medical record revealed a physician order, dated 08/10/12 at 7:00 AM, to add hand mitt restraints. The restraint orders revealed that the vest restraint was removed on 08/12/12 from 7:00 AM until 11:00 AM.

The medical record revealed a physician order, dated 08/13/12 at 7:00 AM., to add a sitter (an unlicensed person who is to sit in the room, specifically to watch the patient). The medical record lacked documentation, from 08/09/12 through 09/19/12, of any specific behaviors, exhibited by the patient, to warrant the continued use of the restraints, specific alternative methods tried, that release from the restraints were tried other than removing the vest for four hours on 08/12/12, or that less restrictive measures had been considered.

During an interview on 09/17/12 at 3:00 PM, Staff B confirmed that in addition to having a sitter in the room at all times, the patient was in soft wrist, soft ankle, vest, and hand mitt restraints.

The initial observation of Patient #5 was made on 09/17/12 at 1:35 PM, in the H22 Neurology Intensive Care Unit, it was observed that Patient #5 was resting quietly in the hospital bed with eyes closed and in addition to having a sitter in the room was restrained by soft wrist, soft ankle, vest, and hand mitt restraints.

The second observation of Patient #5 was made, on 09/18/12 at 10:30 AM, in the H22 Neurology Intensive Care Unit. Patient #5 was observed to be resting quietly in the hospital bed with eyes closed. In addition to having a sitter in the room, Patient #5 was restrained in soft wrist, soft ankle, vest, and hand mitt restraints.

The third observation of Patient #5 was attempted on 09/19/12 at 11:00 AM in the H22 Neurology Intensive Care Unit. Patient #5 had been moved to the J32 Heart Failure Intensive Care Unit. The third observation was then made, on 09/19/12 at 11:25 AM, in the J32 Heart Failure Intensive Care Unit. Patient #5 was observed to be resting quietly in the hospital bed with eyes closed, but had only the hand mitt restraints in place. There was no sitter observed in the room.

During an interview, on 09/19/12 at 11:05 AM, Staff C stated that upon assessment on 09/19/12 at 10:00 AM, in the J32 Heart Failure Intensive Care Unit, it was determined Patient #5 needed only the hand mitt restraints. The soft wrist, soft ankle, and vest restraints were removed. Staff C stated that sitters are not used on the J32 Heart Failure Intensive Care Unit.

The fourth observation of Patient #5 was made on 09/20/12 at 11:55 AM. Patient #5 was observed to be resting quietly in the hospital bed with eyes closed and had on only the hand mitt restraints, and there was no sitter in the room. It was observed that only one of the side rails on the bed was padded. This finding was verified with Staff O who stated that the other rail should be padded for seizure precautions. Staff O stated sitters are not used on the J32 Heart Failure Intensive Care Unit.







The medical record review for Patient #19 was completed on 09/20/12. The record revealed the [AGE]-year-old patient's hospital stay began at the facility, on 09/16/12, with presentation to the emergency department with a complaint of altered mental status. The record revealed an emergency department note, dated 09/16/12, that stated the patient was found in his/her own feces and emesis that morning. The note indicated this was unusual for this patient. The note stated the patient continued to defecate on himself while in the emergency department. The note stated the patient had schizoaffective disorder, and the patient moved both arms and legs appropriately. The note stated the patient's toxicology screen was positive for marijuana.
The record revealed a nursing note, dated 09/16/12 at 11:10 A.M., that stated the patient had staff in the room to protect him/her from falling or climbing out of bed.
The record revealed a nursing note, dated 09/16/12 at 11:18 A.M., that stated the patient refused to lie in bed and was being watched by a sitter, i.e. staff.
The record revealed a nursing note, dated 09/16/12 at 11:25 A.M., that stated the patient was placed in a Posey vest restraint to protect from falling.
The record revealed a physician's order, dated 09/16/12 at 11:28 A.M., to place the patient into a Posey vest for demonstrating a lack of understanding to comply with safety directions/needed precautions.
The record revealed a nursing note, dated 09/16/12 at 4:54 P.M., that stated the patient was resting in bed, comfortable, and had a sitter.
The record revealed a nursing note, dated 09/16/12 at 6:15 P.M., that stated the patient was admitted to the hospital and the Posey vest restraint was removed.
The record revealed a physician's order, dated 09/16/12 at 6:30 P.M., indicating the patient was to be placed in soft wrist and ankle restraints with four side rails up to prevent patient from removing vital equipment or lacked the ability to comply with safety directions.
On 09/17/12 at 3:07 P.M., Patient #19 was observed to be in bilateral leg and wrist restraints and was lying undisturbed in bed. The patient was observed to have a saline lock to his/her left forearm without intravenous fluids running continuously. The patient was not on a ventilator, receiving any oxygen or tube feedings.
On 09/17/12 at 3:12 PM., during an interview, Staff I said the patient had come to the floor in a vest restraint and he/she took removed the vest restraint and put the patient in a four point restraint. Staff I confirmed the patient did not have any intravenous fluids running continuously. Staff I confirmed the patient was in four point restraints because the patient pulled at an intravenous access site and tried to get out of bed.
The medical record revealed the services from a sitter, like that from the emergency department, did not continue when the patient arrived to the floor and was placed in four-point restraints.
On 09/17/12 at 3:12 P.M., during an interview, Staff I stated the patient could qualify for a sitter. (A sitter would be a less restrictive than a four-point restraints.)
On 09/17/12 at 3:12 P.M., during an interview with Staff D and Staff E, Staff D stated the patient "still would be in restraints if the patient had a sitter."
On 09/17/12 at 3:12 P.M. Staff E, a member of nursing administration, then stated, "Absolutely!"

The medical record review for Patient #3 was completed on 09/20/12. The record revealed the [AGE] year old patient's care began in the hospital on [DATE], via the emergency department with a complaint of confusion and headaches. The record revealed a history and physical, dated 09/03/12, that stated the patient became lethargic on the way to the hospital and had a subarachnoid hemorrhage (i.e., a stroke) from an aneurysm.
On 09/17/12 at 2:12 P.M., the surveyor observed Patient #3 in bed with both hands restrained to the bed and a family member sitting beside the bed. A non family member sitter was not observed.
The medical record revealed a physician's order, dated 09/17/12 at 8:30 A.M., that stated the patient was to have both wrists restrained to prevent patient from removing vital equipment or therapies.
On 09/17/12 at 2:21 P.M., during an interview, Staff P (a nurse) stated the patient picks at stuff like the intravenous access and heart leads. Staff P said, "The patient needs someone there (at the bedside) all the time."
On 09/17/12 at 2:18 P.M., during an interview, Staff Q and R both said they could not restrain just one limb. They said if one side of the body has been paralyzed it would still need to be restrained.
On 09/19/12 at 3:45 P.M., during an interview, Staff U confirmed what Staff Q and R had said, that both limbs need to be restrained. Staff U said even if one side of a patient has been weakened by stroke it would still get restrained because there might be a possibility they could still use it to flip out of the bed.
Staff Q and R said the arm without the intravenous access could be restrained while the arm with the intravenous access was unrestrained (i.e., the patient wouldn't be able to pull out the intravenous access because the opposite arm would be restrained, but Patient #3 would still have the use of the arm with the intravenous access, so only one arm would be restrained in an attempt to protect the intravenous access).
On 09/19/12 at 3:45 P.M., during the same interview, Staff A said if the patient is pulling at tubes then there's a risk they'll try to get out of bed; hence, the need for bilateral restraints.
Review of the facility's restraint application, policy number R.3, was completed on 09/20/12. The review revealed, "No patient should ever be restrained on only one side" and "Three point restraint insures the patient will be prevented from falling out of bed. "
Review of the facility's restraint and/or seclusion use policy, RI 114, revised 6/08, stated "If restraints are needed, then the least restrictive method that is effective will be used. "
VIOLATION: INFORMED CONSENT Tag No: A0955
Based on medical record review, and interview, the facility failed to ensure informed consent was documented in the patient's record for one (Patient #13) of 31 patients scheduled for the catheterization lab on 09/18/12, and the facility failed to obtain informed consent by an authorized person for one (Patient #1) of 25 medical records reviewed. The hospital census at the time of the survey was 1055.

Findings include:

The medical record review for Patient #13 was completed on 09/18/12. The facility performed a heart catheterization for the patient on 09/18/12. The patient record did not have a signed consent in his/her chart for the procedure the facility performed on 09/18/12.

The medical record review for Patient #14 was completed on 09/18/12. The facility performed a heart catheterization on Patient #14 on 09/18/12. The patient's record contained 2 signed consents for heart catheterization performed on 09/18/12. The first consent was signed by Patient #14 for a left heart catheterization with or without intervention. The second consent contained in Patient #14's chart was signed by Patient #13 for percutaneous coronary intervention of the left anterior descending coronary artery.

Staff #5 was interviewed on 09/18/12. Staff #5 stated that while obtaining consent in the morning the computer stopped working. Staff #5 stated he/she located a different computer to obtain Patient #14's consent for the procedure and pulled up the wrong patient's form for Patient #13 to sign.

The medical record review for Patient #1 was completed on 09/17/12. The patient record contained a durable power of attorney form to be effective on disability for the patient's family member, in case the family member became disabled. There was not a durable power of attorney for the patient in the medical record. The patient's record contained three signed consents for surgery. The facility's staff obtained telephone consent from the patient's father for two of the surgeries. The facility obtained a telephone consent for a gall bladder surgery from an agent who was not related to the patient nor legally authorized to give consent for the patient.
On 09/20/12, the social worker documented the patient's father wanted the patient returned to California to have the surgery. The social worker documented there were questionable power of attorney documents presented by the agent. The social worker documented the need to have ethics (the ethics department) involved due to the inadequate power of attorney documents which appeared to be only partially complete with scribbled out signatures.
On 09/20/12, the facility ' s policy #R1104 "Informed Consent" and policy #R1104b "Persons Authorized to Consent" was reviewed. The policy stated if a patient cannot provide informed consent, informed consent will be obtained from a person who is legally authorized to consent on behalf of the patient.
On 09/18/12, Staff A, stated the social worker did not involve the ethics department regarding the durable power of attorney documents in the patient's chart. Staff A stated informed consent was given to the social worker by the patient's father, but the facility failed to document the authorization on the informed consent form.