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 July 25, 2013
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on interview, policy review, and record review, the facility failed to do a comprehensive investigation prior to sending the patient a grievance resolution letter (A120) failed to obtain general consent for treatment timely (A131), failed to have the advance directive available for staff to follow and failed to ensure the patient's request for more information on advance directives was addressed timely (A132) and failed to follow its policy on restraints-using three different forms to order restraints (A154). This has the potential to affect each patient with a complaint and each restrained patient. The cumulative effect of these systemic practices resulted in the facility's inability to ensure all patients' rights were protected. The patient census was 968.

Findings:

See A120, A131, A132 and 154.
VIOLATION: PATIENT RIGHTS: TIMELY REFERRAL OF GRIEVANCES Tag No: A0120
Based on interview and record review, the facility failed to do a comprehensive investigation prior to sending the patient a grievance resolution letter. This affected one of eight patients reviewed who complained to the facility's ombudsman's department. (Patient #4)

Findings:

The clinical record review for Patient #4 was completed on 07/25/13. The record review revealed in February, 2002, the patient underwent a redo of an aortic valve replacement with replacement of the ascending aorta.

Review of the ombudsman's (Staff W) case notes for Patient #4 revealed the office had received a written complaint from the patient on 03/06/13. The complaint stated during x-rays taken in 2011 at another facility, Patient #4 was informed a needle was retained from a previous surgery. The case notes stated the patient was informed to send the records from recent imaging for this facility's staff to review. The notes state a review of the medical record was completed. The notes then state, "It was determined after all imaging files available to this office were reviewed, the presence of a suture needle was not confirmed." The notes reveal the patient was called and informed to send the outside records from recent imaging to this facility. The notes reveal a grievance letter was sent to the patient.

Review of the grievance letter sent to Patient #4 revealed the letter was dated 04/25/13. The letter stated "It was determined after all imaging files available to this office were reviewed, the presence of a suture needle was not confirmed."

In an interview with Staff V, an ombudsman manager, on 07/24/13 at 11:20 A.M., revealed the office did receive the images from the outside facility. Staff V said the images were found in Staff W's (an ombudsman) work area. Staff V could not say how long the images had been there.

Contrary to what the letter to Patient #4 stated, not all imaging files were reviewed. Staff V said in interview on 07/24/13 at 11:20 A.M. the images sent in by the patient had not yet been read by the facility's own staff until 07/24/13. Staff V said the read had confirmed the presence of the needle, and a revised letter had been sent.

On 07/25/13 at 1:15 P.M. in an interview Staff V stated he/she had no idea when the office received the images. Staff V said ombudsmen have complainants send their digital media directly to the ombudsmen's office. Staff V said the secretary then hands the digital media off to the ombudsman handling the complaint. Staff V said no record is kept of when the digital media first comes to the office, when it is given to the ombudsmen or how long the ombudsmen keep the media in their possession.
VIOLATION: PATIENT RIGHTS: INFORMED CONSENT Tag No: A0131
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and interview, the facility failed to obtain consent on admission for one of 19 patients reviewed. (Patient #19)

Findings:

1. The electronic clinical record review for Patient #19 was completed on 07/25/13. The review revealed the [AGE] year old patient was admitted to the facility on [DATE]. The history and physical stated the patient had been transferred from an outside facility for severe sepsis and suspicion of [DIAGNOSES REDACTED].

The record review revealed a paper document for general consent to treat signed by the patient's spouse on 07/13/13-four days later. The signed consent form is numbered on bottom right corner as follows: 3, Rev 12/07.

On 07/25/13 at 2:30 P.M. in an interview, Staff R, a quality manager, while acknowledging the consent was signed on the 13th, said the computer record revealed the consent as having been signed earlier.
VIOLATION: PATIENT RIGHTS: ADVANCED DIRECTIVES Tag No: A0132
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review, policy review and interview, the facility failed to have Patient #18's advance directive available for staff to follow and failed to ensure the patient's request for more information on advance directives was addressed timely. This affected two of 19 patients reviewed. (Patient #18 and Patient #16)

Findings:

1. The electronic clinical record review for Patient #18 was completed on 07/25/13. The review revealed the patient was admitted to the facility on [DATE]. The history and physical dated 07/23/13 revealed the patient was diagnosed with an acute ischemic left middle communicating artery stroke and the patient's past medical history was significant for heart disease, atrial fibrillation, and diabetes.

The record in its electronic form revealed on 07/22/13 the patient had advance directives and the facility was in possession of a copy of them.

On 07/25/13 at 1:45 P.M. in an interview, Staff R, a quality manager, stated the advance directives would be found as a hard copy on the floor, however, Staff R was unable to find the advanced directive on the floor or anywhere.

2. The electronic medical record review for patient #16 was completed 07/25/13 at 12:15 PM. Patient #16 was admitted on [DATE] with a diagnosis of cancer of the left breast. Review of the electronic medical record revealed that on 07/11/13, during pre-admission testing, the patient indicated he/she did not have an advance directive and requested more information regarding advanced directives. The electronic record stated, "Directives: Appropriate Consult Placed filed at 07/23/2013 1853." Further review of the electronic medical record revealed the consult was not placed until 07/25/13 at 12:35 PM tow days after admission and . In an interview with Staff B on 07/25/13 at 1:15 PM, Staff B confirmed this finding.

Review of the facility's advance directives policy entitled "Advance Directives Policy", as last revised on 09/21/12 was reviewed on 07/25/13. The policy review revealed upon admission the patient is asked for a copy of advance directive and if the patient desires additional advance directive information protocols are in place to provide that information.
VIOLATION: USE OF RESTRAINT OR SECLUSION Tag No: A0154
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview, policy review and record review, the facility failed to follow its own policy for writing orders for restraints, using three different restraint order forms, each from a different revision date, and failed to avoid using restraints as part of fall prevention. This affected five of 19 patients reviewed. (Patient #11, #13, #17, #18, #19)

Findings:

1.The electronic clinical record review for Patient #18 was completed on 07/25/13. The patient was admitted to the facility on [DATE] with a history and physical dated 07/23/13 that revealed the patient was diagnosed with an acute ischemic left middle communicating artery stroke. The history and physical stated the patient's past medical history was significant for heart disease, atrial fibrillation, and diabetes.

The record review revealed the physician ordered both vest and mitt restraints for attempting to remove vital medical devices on 07/24/13 at 4:00 A.M.

On 07/24/13 at 12:00 P.M. the patient's arterial line was removed, and at 3:15 P.M. although the mitts were removed, the vest remained on.

On 07/25/13 at 8:00 A.M. the vest restraint was removed. (The patient was in a vest restraint from 07/24/13 at 3:15 P.M. to 07/25/13 at 8:00 A.M.)

On 07/25/13 at 10:30 A.M. in an interview, Staff S, a staff nurse, stated the patient remained in the vest restraint because the patient was trying to get out of bed and pulling at her/his tubes. Staff S was unable to describe how the vest stopped the patient from pulling at tubes.

The record review lacked evidence a patient companion was attempted from 07/24/13 at 3:15 P.M. to 07/25/13 at 8:00 A.M. in lieu of the vest restraint to keep the patient in bed.

On 07/25/13 at 10:30 A.M. Staff S confirmed the facility does use patient companions.

2. The clinical record review for Patient #17 was completed on 07/25/13. The review revealed the [AGE] year old patient was admitted to the facility on [DATE]. The history and physical dated 07/19/13 revealed the patient was admitted complaining of vision issues and a computed tomography scan revealed a intracranial hemorrhage.

On 07/22/13 at 8:00 P.M. the physician ordered the patient placed in a vest restraint for climbing out of bed. The electronic clinical record revealed documentation the vest was applied for getting out of bed.

On 07/24/13 at 7:00 A.M. the physician ordered the patient placed in a vest restraint to prevent the patient from removing "vital equipment."

On 07/25/13 at 11:30 A.M. in an interview Staff T, a nursing manager, stated the patient had been placed in the vest as the patient was trying to get out of bed and might fall. Staff T said the medical equipment in place was a condom catheter and intravenous access.

Review of the facility's restraint policy entitled "Restraint Use Procedure for Non-Violent/Non-Self-Destructive Behavior", as last revised on 03/18/13 was reviewed on 07/25/13. The review revealed the policy directed staff to use a preprinted order sheet, # 7.

Patient #17's order sheet for restraints was on form # 7, revised on 06/11. The form contained check boxes for wrist and ankle restraints, and hand mitts, however, no space for just left, just right, or both.

3. The electronic clinical record review for Patient #19 was completed on 07/25/13. The review revealed the patient had an electronic-and not form # 7-order for mitt restraints dated 07/24/13 at 11:15 A.M.

On 07/25/13 at 11:45 A.M. in an interview, Staff U, a nurse manager, stated the order was given to use in the night in case the patient tried to pull out the nasogastric tube. Staff U stated the patient was never placed in the restraint. The order was discontinued on 07/25/13 at 10:23 A.M.

4. Review of the medical record for Patient #11 was completed on 07/25/13 at 10:30 AM. Patient #11 was admitted to the hospital 06/27/13 with diagnoses including hyperglycemia and heart failure. Review of the medical record revealed a physician's order dated 07/24/13 for Patient #11 to be restrained due to violent behavior toward the direct care staff. This physician's order was written on a paper form entitled Licensed Independent Practitioner Order for Restraints with a revision date of July 2008.


5. Review of the medical record for Patient #13 was completed on 07/25/13 at 11:45 AM. Patient #13 was admitted to the hospital 07/15/13 with a diagnosis of a right internal carotid artery dissection (stroke). Review of the medical record revealed a physician's order dated 07/17/13 for Patient #13 to have a right hand mitt restraint due to attempting to remove medical devices. This physician's order was written on a paper form entitled Licensed Independent Practitioner Order for Restraints with a revision date of June 2011.

In summary, Patient #11 had their restraint order written on a paper form revised on 07/08, Patient #13 had their restraint order written on a paper form revised 06/11, Patient #17 had their restraint order written on a form revised 06/11, and Patient #19 had their restraints ordered electronically.
VIOLATION: QAPI PERFORMANCE IMPROVEMENT PROJECTS Tag No: A0297
Based on interview, policy review, and meeting minutes, the facility failed to take appropriate actions to improve quality performance in the area of surgery counts for retained needles. This has the potential to affect all surgical patients in the facility. The patient census was 968.

Findings:

Review of the ombudsman's (Staff W) case notes for Patient #4 revealed the office had received a written complaint from the patient on 03/06/13. The complaint stated during x-rays taken in 2011 at another facility, Patient #4 was informed a needle was retained from a previous surgery. The medical record review revealed in February, 2002, Patient #4 underwent a redo of an aortic valve replacement with replacement of the ascending aorta at this facility.

Review of the surgical operations clinical quality council meeting of 4/14/13 was completed on 07/25/13. The review revealed a discussion on Code Rust which is defined as an imaging procedure that involves communication of imaging results of a suspected introspective retained foreign body from a staff radiologist to the staff surgeon. The review reveals discussion on the most frequently counted surgical item are suture needles. Discussion included the following bullets: Discrepancies are resolved with recounting and then x-rays. The surgeon should disclose missing needles to the patient and also discuss with risk management. Case reports of retained needles creating problems: Needles greater than 17 millimeters in size and in special spaces such as the eye require further assessment and most likely require x-ray. Needles less than 15 millimeter there should be no danger (except tight space like the eye) and x-rays are not required. Discussion revealed sometimes the surgeon does not request an X-ray when counts are off. X-rays should be taken following a report of incorrect count (other than the small needle less than 15 millimeter).

Review of statistics of x-rays called to rule out foreign bodies during surgery was completed on 07/25/13. The review revealed for 2012 there were 494 x-rays for suspicion or retained foreign body. The review revealed from January 2013 to June 2013 there were 242 x-rays called.

On 07/24/13 at 8:45 A.M. the Operating Rooms Medical Director, Staff M, was interviewed. Staff M revealed the reason the number of Code Rusts was running at the same rate for 2013 as it was for 2012 was due to encouraging any member of surgical team to call for a Code Rust if there is any doubt. Staff M said the number could be inflated because one surgeon always calls for an x-ray before the final skin closing. Staff M said he/she did not know what the statistic would be if that surgeon was taken out of the equation. The specific surgeon and/or type of surgeries that had the most/least Code Rust called could not be shared.

Review of the surgical operations clinical quality council meeting minutes from 08/02/12 to 06/06/13 was completed on 07/25/13. The review did not reveal any discussion of the total number of Code Rusts called, why the Code Rust were called or which surgeon and/or which types of surgery had the most/least Code Rust called.

A request was made for surgical policy regarding surgery counts for retained needles. The facility presented two policies. Policy A titled "Counts Policy" was received on 07/22/13 and Policy B titled "Counts" was received on 07/24/13 at 10:50 A.M.

Policy A was approved by the surgical affinity group on 12/01/11 and effective on 03/25/13. Review of the policy on 07/24/13 revealed if "any component" of sponge/instrument/needle or other counts of items used during a surgery were incorrect before the skin was closed, a Code Rust imaging procedure should be initiated. This policy did not address whether or not to x-ray for retained needles of a specific millimeter size.

Policy B was approved on 12/01/11 and revised on 11/28/12. Review of Policy B on 07/24/13 revealed if "any component" of sponge/instrument/needle or other counts of items used during a surgery were incorrect before the skin was closed, a Code Rust imaging procedure should be initiated. In addition, Policy B stated an x-ray for needles smaller than 17 millimeter was "optional."

On 07/24/13 at 8:45 A.M. Staff M stated in interview that Policy A (Counts Policy) should reflect the discussion of the Quality council meeting minutes of 04/04/13 and order for an x-ray of needles less than 15 millimeter suspected of being retained in the patient.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
Based on interview, policy review, and observation, the facility failed to follow its surgical counts policy on pausing and following a script of what to speak after the final count of surgical items and prior to the final closing of the surgery. This affected four of 19 patients reviewed. (Patient #5, #6, #8, and #3)

Findings:

Review of the facility's "Counts Policy" (Policy A), approved by the surgical affinity group on 12/01/11 and effective on 03/25/13, was completed on 07/24/13. The review revealed before the final skin closure of surgery, the surgical team is to stop and pause. Then, the surgeon explores the wound and verbalizes results of the search. The policy then directs the surgical team to say the following:

"Sponge, Instrument, Needle, and Other Counts are Correct" proceeded by "Team agrees."

1. On 07/22/13 at 1:10 PM, an observation was made in the operating room of Patient #5 having an open colectomy of the sigmoid colon performed (bowel surgery). When counting the surgical sponges, needles, instruments, and other sterile items the surgical team collectively failed to follow the hospital's policy entitled "Counts Policy" in regard to completing the pause before final closure and verbally stating, "Sponge, Needle and Other Counts are Correct" and "Team Agrees" as directed in the Counts Policy.

2. On 07/22/13 at 1:30 PM, an observation was made in the operating room of Patient #6 having an anterior cervical discectomy and fusion (spinal surgery). When counting the surgical sponges, needles, instruments, and other sterile items the surgical team collectively failed to follow the hospital's policy entitled "Counts Policy" in regard to completing the pause before final closure and verbally stating, "Sponge, Needle and Other Counts are Correct" and "Team Agrees" as directed in the Counts Policy.

On 7/22/13 at 3:00 PM, in an interview with Staff C and Staff D, these findings were confirmed. Staff C stated when new clinical staff are oriented and trained in the operating room, they are not taught to say the script exactly as it is written in the "Counts Policy", but rather to just verbalize the counts are correct.

3. On 07/23/13 at 9:45 AM, an observation was made in the operating room of Patient #8 having a right total hip replacement. When counting the surgical sponges, needles, instruments, and other sterile items the surgical team collectively failed to follow the hospital's policy titled "Counts Policy" in regard to completing the pause before final closure and verbally stating, "Sponge, Needle and Other Counts are Correct" and "Team Agrees" as directed in the policy.


4. On 07/23/13 at 2:50 P.M. the last half of the surgery for Patient #3 was observed with Staff Q-a member of the operating rooms' nursing management. Review of the operative record revealed the patient was undergoing an aortic valve repair. At 4:08 P.M. (preceding the final closing) the scrub nurse, Staff N verified with the circulating nurse, Staff O, that the count was correct.

At 4:10 P.M. the surgeon-Staff P-was observed to leave the bedside while the rest of the team continued to close the wound. A noticeable pause was not observed nor was the script heard as directed in policy that the count was correct.

On 07/23/13 at 4:30 P.M. in an interview immediately after the case, Staff Q stated although the script was not followed, the surgery would have stopped had the count not been correct. Staff Q said the nurses wouldn't give any more instruments to the surgeon until the count was rectified.