HospitalInspections.org

Based on observation, interview, and document review, the facility failed to ensure patient photos/records were stored and secured to prevent unauthorized access. In addition, the facility failed to ensure patients labratory information was kept confidential. This had the potential to effect all patients who had been seen at the hospital for any procedure (s) which included for plastic surgery at the facility in the last two years and for anyone who had a labratory procedure performed at the hosptial.

Findings include:

The facility provided a form titled Health Insurance Portability and Accountability Act (HIPPA) Incident Form dated 7/26/13. The form identified the following: "[physician's assistant (PA)-A], stated that [physician (MD)-B] has been taking photos of his patients for up to two years, and they have been working on a process to organize them on [PA-A] computer. Throughout the course of the discussion I learned that:
1.) [MD-B] is using his own personal camera to take the photos, which he does not use solely for work purposes.
2.) [MD-B] has photos saved to memory cards, which he takes home with him.
3.) PA-A burned all of the photos to CD's [compact disc] for [MD-B], and we are not sure where these are located or stored.
4.) [MD-B] uses his cell phone to take photos if the camera is not working."

The investigation was documented by three different individuals:
The quality director identified, "Met with [MD-B] on July 30th [2013] regarding his personal camera and told him he cannot use his own personal device to take photos of patients. He needs to leave the memory card from that camera in the building to eliminate the risk of loss or theft that could result in a privacy violation. [MD-B] was not receptive to the discussion, so I escalated to the CEO [chief executive officier ], CMO [chief managing officier], and HR [human resources]."
2.The CMO identified, "Met with [MD-B] on August 1st [2013] to review issue and coach him on process of not removing memory card from the building."
3. The CEO identified, "Met with [MD-B] on August 12th [2013] to provide coaching on privacy issue/ risk of removing memory care with patients photos from building."

The action plan on the HIPPA incident form indicated: "Follow up with [MD-B] and his [PA-A] show that the memory card is no longer being removed from the building [done]. We have obtained specs [specifics] for options to purchase a [facility] owned camera for the plastic surgery department. HIM [health information managment] and IT [information technology] have put a process in place to upload photos from camera directly into EPIC [the patient record system]."

During observation on 9/5/13, at 2:54 p.m. MD-B's office was observed in the outpatient clinic connected to the hospital. MD-B's office door was open and was shared with two other people, the PA-A and a clinic nurse.

During interview on 9/5/13, at 2:45 p.m. the quality directorstated she had spoke with MD-B but he had not been receptive to her request to leave the memory card in the building so the issue was passed on the CEO. The quality director stated she had never seen what was on the memory card and did not know what pictures had been taken and placed on the CD. The quality director stated there was no direct monitoring to ensure MD-B had been leaving the memory card in the hospital, however, PA-A had told her the MD-B had been locking it in his top drawer in his office. The quality director stated she did not talk to MD-B about the allegation of using his cell phone to take pictures of patients.

During interview on 9/5/13, at 3:00 p.m. the CEO stated he spoke to MD-B about patient privacy and leaving the memory card in the facility. The CEO stated there was no monitoring system currently in place, however, he stated PA-A had told them the MD-B was leaving the memory card in his office locked up. The CEO stated he had not spoken to MD-B about what pictures were on his cell phone, CD, or memory card on the camera; and the facility cannot "babysit" physicians. The CEO stated the facility had not ordered a camera for MD-B yet and they are trying to figure out which camera would be the best for the MD-B.

During interview on 9/5/13, at 4:20 p.m. PA-A stated she had observed MD-B lock the memory card in his top drawer before leaving the facility in the evening. PA-A stated she had been working with the physician for about nine months and had only seen him use his cell phone to take pictures of patients about six times. However, she could not remember the patient or the circumstances of what pictures were taken with the cell phone camera.PA-Astated pictures are taken of patients before surgery, during surgery once the markings are made in the operating room before incision, and after surgery when the patient comes to the office for a post operation visit.PA-Astated consents for photography are only obtained if the photos are going to be used for advertising purposes. She stated those consents are kept in MD-B's office and are not be located in the patient medical charts. PA-A was not sure where the CD was which many of the pictures from MD-B's personal camera had been transferred to.

Upon review of the policy titled Photographing/Videotaping Patients dated June 1, 2010 indicated, "It is never acceptable to use mobile camera phones as the equipment used to take photographs or film...authorization and consents to photograph/ videotape and corresponding photographs will be placed in the patients medical record and remain under the confidentiality and security guidelines, policies and procedures that govern medical record security and confidentiality of [facility]...Photographs, films, recordings, or other images may only be taken by employees with equipment provided by [facility], unless otherwise authorized by risk management..."

Although the facility was aware the physician had been taking pictures of patients with his own camera and cell phone, the facility failed to ensure these patient pictures were secure. In addition, the facility failed to ensure the CD with patient pictures on was secure and kept in the facility nor did the facility investigate what pictures were on the personal camera, cell phone, or CD.



18622

The Medical Records department failed to maintain confidentiality of clinical records.

A tour of the Medical Records department was conducted on 9/4/13, at 10:00 a.m. with the vice president of support services and the supervisor of Medical Records. During the tour, there were six carts with three shelves each filled with medical records and a seventh cart with one of three shelves filled with medical records. The names of the patients were visible on the records. There were approximately 25 medical records on each of the 19 shelves for a total of 475 medical records. The medical records were in clear view of any hospital staff who had access to the medical records area.

The vice president of support services and the supervisor of Medical Records were interviewed during the tour of the Medical Records department on 9/4/13, and confirmed that hospital, clinic, and emergency department staff, housekeeping, and engineering all had access to the Medical Records area. It was further noted and confirmed that the Medical Records department was not sure how many hospital and clinic employees had badge access to the medical records area because human resources determined employee access to the Medical Records department. It was further confirmed that after hours anyone who accessed the medical records area would have had access to the medical records on the carts starting with 7/13, when the records had first been placed on the carts in preparation for scanning into the elctronic medical record. The vice president of support services stated that they would lock up the carts with the medical records in an office in the department from now on so unauthorized personnel would not have access. When queried, it was confirmed that housekeeping had unlimited access to the medical records department after hours (4:30 p.m.) when no medical records personnel were in the department. When asked if there was a policy on who had access to the medical records it was confirmed that there was no policy on who could have access to the medical records. Access to medical records was granted by Human Resources.

A review of the Access Denial, Granted and Other Badge Events, By Reader was reviewed for the dates between 7/1/13 through 9/4/13. There were multiple times that hospital and clinic employees were granted access after 4:30 p.m. which included personnel from the emergency department, clinic, nurses - no department listed physicians, housekeeping and engineering.

A review of the variance/issue/concern report indicated that on 4/10/13, an e-mail had been received from the environmental services manager regarding the medial record storage facility located in the old O'Rielly building. The environmental services manager was over in the O'Reilly building setting up cleaning supplies and noticed that the door between the Grand Itasca Clinic and Hospital storage and Timberlakes's storage was open. On 5/16/13, a medical records person went over to the O'Reilly storage building around 1:30 p.m. and called the Supervisor of Medical Records upon arriving because the front door was unlocked and nobody was at the building. The second door was also propped open allowing anyone to be able to enter and have access to Grand Itasca medical records.

Also noted on the variance/issue/concern reports was a breach of confidentiality on 5/30/13, when a patient at the clinic reported an x-ray technician who told several family members of a patient that had lymph node cancer and now they are waiting to see what stage it was. Human resources terminated the employee. On 6/4/13, a random audit was conducted on an employee on records that were accessed by this employee. The employee had accessed medical records she did not have need to know. The employee was suspended and an improvement plan was done for inappropriately accessing information without a need. There were additional breaches of confidentiality noted in the variance report.

On 9/5/13, at 8:55 a.m. the vice president of support services and the supervisor of Medical Records revisited the concern of who had access to the medical records department. The vice president of support services and the supervisor of Medical Records had met with human resources and it was determined that numerous hospital employees had access to the medical records area that should not have access. The list of who would now be granted access was limited and they needed to eliminate all non-essential badge access users. When queried, they confirmed that the offsite storage area, located in the O'Rielly building, was indeed found unsecured on 4/10/13 and 5/16/13. The hospital did not have a system in place to monitor access to the O'Reilly building and did not have a system to monitor that the doors were secured at all times.

The hospital had a policy on Violation of Confidentiality, Policy # IM-116. It was the policy of Grand Itasca Clinic and Hospital to manage data and information with the highest degree of security and confidentiality. All efforts would be undertaken to prevent a breach of the confidentiality and security. "Any staff member who knowingly/willingly breaches confidentiality/security of data or information may receive a minimum a written disciplinary warning, at a maximum, termination."



20810

During observation of laboratory service areas in the facility on 9/5/13, at 9:30 a.m. the clinic blood draw stations in hall A-B and hall C-D each consisted of a small room with a curtain for procedures, and immediately adjacent, a short section of countertop and cupboard in the wall of the hall where specimens and the corresponding documents were placed. Specimens and corresponding documents were placed in the open on the countertop. There were patients and clinic staff walking in both hallways.

When interviewed on 9/5/13, at 9:30 a.m. the director of laboratory services stated the laboratory staff working at the clinic blood draw stations attempt to turn any documents on these countertops facing away from the hallway. She also stated she would immediately work on a plan to correct the situation.

Based on interview and document review, the facility failed to ensure 5 of 6 discharge patients with restraints, (P30, P25, P27, P29, P28) had a comprehensive assessment, consistent monitoring to ensure the least restrictive method was being used, and physician orders regarding type of restraint to be used and/or body part(s) to be restrained.

Findings include:

P30 had a physical restraint order that did not identify the type of restraint or the body part to be restrained, and there were no orders written for three of the eight days the patient was in restraints. Also, P30 had restraints with no justification regarding why P30 needed restraints for eight days, nor was the patient consistently monitored while in restraints.

P30's medical record indicated P30 was admitted to the hospital on 12/20/12, with diagnoses of alcohol withdrawal delirium and perforation/ abscess of bowel. P30's medical record indicated that, beginning on 12/21/12, at 11:00 a.m., the patient had soft left and right ankle and wrist restraints and four side rails up and was restrained until 12/29/12, at 8:46 a.m.

Document review of the eight days P30 was in restraints revealed the following: The Physician's Order dated 12/21/12, at 3:48 p.m. indicated P30 was restrained due to "Interference with medical treatment and to protect the patient from harm." The restraint type was listed as "physical device," the order did not specify which least restrictive restraints should be used for P30, nor did it identify the type of restraint or body parts which should be restrained.

12/21/13
A Physician's Note dated 12/21/12, at 11:05 a.m. indicated the patient was "noted to be anxious, agitated, diaphoretic and escalating this a.m. after not receiving ice chips. Wanting to leave without further cares and perseverating about being incarcerated and disrespected. Patient states that if he leaves he will be fine and can take care of himself and he wants to go home and no other place. Given he is acutely ill and has no insight into the degree of his illness he will be placed on hold if he tries to leave."

A Nursing Note on 12/21/12, at 11:57 a.m. indicated, "Patient behavior escalated out of control... patient medicated per physician orders... Restrained per MD [physician] order. Patient also has a sitter at bedside for safety. Patient is resting calmly in bed." However, the order to place P30 in restraints on 12/21/12, was not obtained until 3:48 p.m. four hours after P30 was restrained.

The Non-Violent Restraint flow sheet assessed P30 from 12/21/12, at 12:00 p.m. until 12/23/12, at 7:00 p.m. when the flow sheet indicated P30 was "sleeping" and "calm." There was no indication the facility attempted to remove the restraints to the least restrictive method.

12/22/13
On 12/22/12, P30 remained in bilateral wrist and ankle soft restraints, and had four side rails up until 4:00 p.m. when the facility removed the bilateral ankle restraints. However, the bilateral wrist restraints and four side rails remained in place. There was no Physician's Order for P30 to be restrained on 12/22/12. The monitoring on 12/22/12, assessed P30 as asleep at 10:59 p.m. There was no further assessment of P30 until 12/23/12, 15 hours later.

12/23/13
The Physician ' s Order dated 12/24/12, at 12:09 p.m. indicated the start date for P30 to be restrained was 12/23/12, at 8:00 a.m. The reason for restraints was "Interference with medical treatment and to protect the patient from harm." The restraint type was listed as "physical device, " the order did not specify which least restrictive restraints should be used for P30, nor did it identify the type of restraint or which body parts should be restrained. There was no physician order written on 12/23/12, for P30 to be restrained. A Physician's Note dated 12/23/12, at 4:00 p.m. identified, "Patient limited secondary to sedation... comfortable, restraints on wrists and ankles." On 12/23/12, the patient was assessed as "asleep" at 11:00 p.m. The next assessment of P30 was not completed until 12/24/12, at 8:00 a.m. nine hours later.

12/24/12:
The Physician ' s Order dated 12/24/12, at 12:08 p.m. indicated P30 was restrained due to "Interference with medical treatment and to protect the patient from harm." The restraint type was listed as "physical device, " the order did not specify which least restrictive restraints should be used for P30, nor did it identify the type of restraint or which body parts should be restrained. A Physician's Note on 12/24/12, at 4:52 p.m. indicated, "Patient limited secondary to sedation... gets agitated at times and reaches for the wound vac [vacuum] and pulls, still needs restraints on arms most of the time."

12/25/12
The Physician's Order dated 12/25/12, at 3:06 p.m. indicated P30 was restrained due to "Interference with medical treatment and to protect the patient from harm." The restraint type was listed as "physical device " the order did not specify which least restrictive restraints should be used for P30, nor did it identify the type of restraint or which body parts should be restrained.

On 12/25/12, at 1:40 a.m. the facility removed the four side rails until 6:00 a.m. when they were placed back on. There was no assessment regarding why the siderails were discontinued or why they were placed back up. 12/25/12 at 2:53 p.m.- Physician's Note: "Patient limited secondary to sedation... gets agitated at times and reaches for the wound vac and pulls, still needs restraints on arms most of the time."

12/26/12
The Physician's Order dated 12/26/12, at 12:26 p.m. indicated P30 was restrained due to "Interference with medical treatment and to protect the patient from harm." The restraint type was listed as "physical device," the order did not specify which least restrictive restraints should be used for P30, nor did it identify the type of restraint or body parts which should be restrained.

On 12/26/12, at 2:00 a.m. the side rails were removed until 6:00 p.m. at which time they were placed back up. There was no assessment regarding why the side rails were removed or why they were put back in place. A Physician's note on 12/26/12, at 9:25 a.m. indicated, "...becomes agitated if Ativan [an antianxiety medication] is backed off. He reaches for the wound vac and pulls. He also threatens to leave the hospital... restraints PRN [as needed]."

On 12/26/12, P30 was assessed as "alternative" regarding cognitive status and patient response to safety check at 6:00 a.m. The next assessment of P30 was not completed until 12/26/12, at 4:00 p.m. (10 hours later).

12/27/12:
A Physician's Note dated 12/27/12, at 9:51 a.m. indicated"...becomes agitated if Ativan is backed off. He reaches for the wound vac and pulls. He also threatens to leave the hospital... restraints PRN."

A Nursing Note on 12/27/12, at 5:26 p.m. indicated, "Patient and family requested restraints be removed for a little while, had a conference with patient and ex-wife about being compliant with cares and I would be willing to take restraints off for a few minutes and then they would have to go back on. If patient continues to be cooperative with care we may extend time off of restraints... nursing assistant is in patient's room while restraints are off."

A Nursing Note on 12/27/12, at 6:30 p.m. indicated, "Patient was cooperative while restraints were off. Skin assessed and restraints put back on after an hour, patient were also compliant with putting restraints back on and understood why we are doing this." There was no assessment regarding why P30 had the restraints placed back on. There was no Physician's Order for P30 to be restrained on 12/27/12.

12/28/12
The Physician's Order dated 12/28/12, at 11:04 a.m. indicated P30 was restrained due to "Interference with medical treatment and to protect the patient from harm." The restraint type was listed as "physical device," the order did not specify which least restrictive restraints should be used for P30, nor did it identify the type of restraint or body parts which should be restrained.

A Nursing Note on 12/28/12, at 11:10 a.m. indicated, "Patient arouses and awakens easily... Patient still does not show ability to follow commands appropriately and doesn't demonstrate good judgement, so the restraints remain on and 1:1 sitter." There was no assessment regarding what "good judgement" meant, or why the restraints had to be placed back on.

A Nursing Note on 12/28/12, at 3:15 p.m. indicated, "Patient was out of restraints for one hour, tolerated well. Patient moved around in bed, practiced coughing and deep breathing. Patient started getting restless at 3:15 p.m. Restraints reapplied and gave another 4 mg [milligrams] of IV [intravenous] morphine [a narcotic]." There was no assessment regarding if P30 still had a one-one, nor was there an assessment which identified the least restrictive method was being utilized.

12/29/12
The restraint monitoring ended on 12/29/12 at 8:46 a.m. There was no assessment regarding why the restraints were being discontinued.

During interview on 9/5/13, at 12:15 p.m. the nurse director verified P30's Physician's Orders for restraints did not included the type of restraint or the body part to be restrained, there was no physicians order to restrain P30 for three of the eight days the patient was restrained, no assessment of the least restrictive method tried, and P30 was not consistently monitored and/or assessed throughout the eight days P30 was restrained.


P25's Physician Orders for restraints did not include the restraint type or the body part to be restrained, there was not consistent monitoring while the patient was in restraints, and there was no assessment to determine the least restrictive method was utilized.

P25 was admitted to the facility on 10/15/12, for respiratory failure and acute renal failure and was restrained beginning on 10/16/12 at 8:00 a.m. until 10/20/12 at 4:00 a.m.

10/16/12
A Physician Order dated 10/16/12, at 9:15 a.m. ordered non-violent restraints for P25 for "interference with medical treatment and to protect the patient from harm. Restraint type; physical device." The order did not indicate the specific restraint type for P25 or indicated the body part to be restrained. The soft left and right wrist restraints were documented on the Restraint Flowsheet as being initiated on 10/16/12 at 8:00 a.m.

10/17/12
A Physician ' s Order dated 10/17/12, at 9:15 a.m. ordered non-violent restraints for P25 for "interference with medical treatment and to protect the patient from harm. Restraint type; physical device." The order did not indicate the specific restraint type for P25 or indicated the body part to be restrained.

The clinical justification for the restraints was listed as "pulling at lines and tubes." However, the physician note on 10/17/12, at 6:56 a.m. assessed P25 as
"sedated." There was no further assessment on 10/17/12, regarding the ongoing need for P25 to be restrained.

10/18/12
There was no Physician ' s Order written on 10/18/12, for P25 to be restrained. A Physician ' s Order dated 10/19/12, at 12:00 a.m. with a start date of 10/18/12, ordered non-violent restraints for P25 for "interference with medical treatment and to protect the patient from harm. Restraint type; physical device." The order did not indicate the specific restraint type for P25 or indicated the body part to be restrained.

.On 10/18/12, at 6:00 p.m. the patient P25 was assessed as being "calm." The next assessment was not completed until 10/19/12, at 8:00 a.m. (14 hours later). The clinical justification for the restraints was listed as "pulling at lines and tubes." However, physician note on 10/18/12, at 7:59 a.m. assessed P25 "sedated." There was no further assessment on 10/18/12, regarding the ongoing need for P25 to be restrained.

10/19/12
A Physician ' s Order dated 10/19/12, at 8:30 a.m. ordered non-violent restraints for P25 for "interference with medical treatment and to protect the patient from harm. Restraint type; physical device." The order did not indicate the specific restraint type for P25 or indicated the body part to be restrained.

The clinical justification for the restraints was listed as "pulling at lines and tubes." However, a physician note on 10/19/12 at 8:56 a.m. assessed P25 as "sedated."

On 10/19/12, at 3:00 p.m. the patient was assessed as "alternative" in cognitive status and safety check response. The next assessment of P25 was not completed until 10/19/12, at 8:00 p.m. (five hours later).

During interview on 9/5/13, at 12:15 p.m. the nurse director verified P25's physician orders had no restraint type or body part to be restrained, there was not consistent monitoring being done while the patient was in restraints, and there was no assessment identifying the least restrictive method was utilized.


P27's Physician Order for restraints did not include the restraint type or the body part to be restrained and there was not consistent assessment of the patient while in restraints.

P27 was admitted to the facility on 8/26/12, for altered mental status, seizure, and alcoholism. P27 was restrained beginning on 8/26/12, and was discontinued on 8/29/12, at 6:00 a.m.

8/26/12
A physician order dated 8/26/12, at 6:43 p.m. indicated P27 was restrained due to "interference with medical treatment and to protect the patient from harm. Restraint type; physical device." The order did not indicate the specific restraint type for P27 or which body part(s) to be restrained.

On the restraint flowsheet the documentation of soft left and right wrist restraints began on 8/26/12, at 8:00 p.m. There was no assessment regarding least restrictive method tried.

8/27/12
A physician order dated 8/27/12, at 10:06 a.m. indicated P27 was restrained due to "interference with medical treatment and to protect the patient from harm. Restraint type; physical device." The order did not indicate the specific restraint type for P27 or indicated the body part to be restrained.

On 8/27/12, P27 was assessed as sleeping at 4:00 p.m. The next assessment completed on the P27 was not until 8:00 p.m. (four hours later).

8/28/12
A physician order dated 8/28/12 at 9:17 a.m. indicated P27 was restrained due to "interference with medical treatment and to protect the patient from harm. Restraint type; physical device." The order did not indicate the specific restraint type for P27 or indicated the body part to be restrained.

The documentation of soft left and right wrist restraints ended on 8/29/12 at 6:00 a.m. There was no assessment regarding why the restraints were discontinued.

During interview on 9/5/13 at 12:15 p.m. the nurse director verified P27's Physician ' s Order for restraints did not include the type of restraint to be used or which body part(s) were assessed needing to be restrained and there was no assessment completed for P27 done at least the minimum two hour intervals while the patient was restrained.

P29 was on a 72 hour hold related to "combative behavior." The patients restraint physician order did not indicate which body part to be restrained, there was no monitoring documented for the 24 hours the patient was restrained, and the facility did not renew the physician order for the patient in the four hour time period required for the violent patient.

P29 was admitted to the facility on 7/26/13, with diagnoses of dementia and combative behavior. The patient was placed on a 72 hour hold related to threatening to leave and striking out at nurses.

The emergency room note on 7/26/13, indicated P29 was brought in related to being combative. The facility was unable to transfer P29 to the behavioral health unit until 7/30/13. The note indicated, "Dementia due to Parkinson disease with behavioral disturbance. Acutely worsened. This patient is a danger to himself and others. He is an elopement risk. He needs one to one sitter care, and 72 hour hold... we will protect the patient from self harm, sedate him as needed."

A physician order dated 7/26/13, at 12:19 p.m. indicated P29 needed restraints due to "interference with medical treatment and to protect the patient from harm. Restraint type; physical device: Soft limb and side rails, however, the order did not specify the body part to be restrained.

On the restraint flowsheet dated 7/26/13, at 12:30 p.m. identified P29 was initiated on soft left and right wrist and ankle restraints. There was no further assessment of R29's restraints, the patient ' s current condition and response, or if the restraints were released and the skin condition was assessed for the duration P29 had restraints in place, which were removed on 7/27/13, at 1:12 p.m.

A nurse note on 7/26/13, at 4:00 p.m. indicated, "soft leg restraints removed at this time... soft arm restraints continue to be in place." There was no assessment regarding why the ankle restraints were removed.

A nurses note on 7/27/13, at 3:01 a.m. indicated, "...patient is on a 72 our hold, soft wrist restraints, one to one sitter...patient continues with behavioral issues, attempting to strike staff, and wanting to leave."

A physician note on 7/27/13, at 11:19 a.m. indicated, "have not seen the hallucinations or violent behavior exhibited in the emergency room yet today. Restraints are off for now. Continued need for sitter, either daughter or nursing staff."

A nurse ' s note on 7/27/13, at 1:12 p.m. indicated, "In collaboration with registered nurse (RN) and physician it has been decided that restraints are no longer necessary and therefore discontinued."

Although P29 was documented as being restrained for 24 hours and 45 minutes, the facility obtained a physician for the restraints once on 7/26/13 at 12:30 p.m., but did not renew the order as required for the "violent restraint." (See facility policy below). In addition, the facility did not have an ongoing assessment completed for the 24 hours P29 was restrained.

During interview on 9/5/13, at 12:15 p.m. the nurse director verified P29's Physician ' s Order for restraints did not include the body part to be restrained, there was no ongoing assessment during the 24 hours the patient was restrained, and only one Physician ' s Order for restraining P29 was written during the 24 hour period.


P28's Physician Order for restraints did not include the body part to be restrained for the patient and no assessment was completed to ensure the least restrictive method was utilized and why P28 required restraints for three days.

P28 was admitted to the facility on 8/9/13, with diagnoses of perforated duodenal bulb ulcer. P28 was restrained from 8/9/13 at 11:15 p.m. until 8/11/13 at 12:15 a.m.

A Physician's Order dated 8/9/13, at 10:22 p.m. indicated P28 needed to be restrained due to "interference with medical treatment and to protect the patient from harm. Restraint type; physical device: Soft limb," however, the order did not indicated the body part to be restrained.

On the restraint monitoring sheet from 8/9/13, at 11:15 p.m. to 8/10/13 at 11:28 p.m. P28 was identified as "asleep" or "calm" and was restrained with soft left and right wrist restraints. There was no assessment completed by either the physician or nurses regarding why P28 needed to be restrained, nor was there any indication a less restrictive method was tried during the three days the patient was restrained.

A Physician's Order dated 8/10/13, at 9:51 a.m. ordered non-violent restraints for P28 for "interference with medical treatment and to protect the patient from harm. Restraint type; physical device: Soft limb," however, the order did not indicated the body part to be restrained.

A Physician's Order dated 8/11/13, at 8:12 a.m. ordered non-violent restraints for P28 for "interference with medical treatment and to protect the patient from harm. Restraint type; physical device: Soft limb," however, the order did not indicated the body part to be restrained.

During interview on 9/5/13, at 12:15 p.m. the nurse director verified P28's restraint order did not identify the body part to be restrained and there was no assessment indicating the ongoing need for P28 to be restrained for three days.

The facility policy/procedure titled Restraint Use dated 7/11, instructed, the facility "does not provide services for behavioral healthcare (violent and/ or self destructive). In the event a patient is seen in the emergency department for assessment, stabilization, or treatment awaiting transfer to a psychiatric facility the transfer will be made as rapidly as possible and appropriate assessments will occur until the transfer is complete. See Restraint Use- violent or Self destructive Patients section..." The Restraint Use- Violent or Self Destructive Patient section indicated, "Anytime a restraint is initiated for violent or self destructive behavior reasons: A physician order must be obtained...Verbal and written orders are limited to 4 hours for patients 18 years of age or older... A renewal order is needed each time restraint use extends beyond these limits...An in-person re-evaluation is completed by the physician every 8 hours for patients 18 years of age or greater..." The policy further instructed, "Release the limb restraint and perform range of motion on the affected limb every two hours..." Restraint use for non-violent or non-self destructive patients: "The use of restraints will be limited to those situations with appropriate clinical justification, to protect the patient from harming themselves or others... clinical criteria includes patients with one or more of the following conditions and attempts to pull out IV/ arterial/ central limes, NG tubes, feeding tubes, catheters, or interferes with their treatment... dementia/ Alzheimer, delirium... inability to comprehend the need for treatment... If a patient meets the above criteria, their behavior may cause them significant injury/ harm or interfere with their medical treatment, and the less restrictive measures have proven ineffective an order for restraints should be considered. The order must be provided by the patients assigned physician and include all of the following: The reason the restraint is being used; the type of the restraint; the extremity or body parts to be restrained; and the duration (time frame) for the restraint application...Assessment/ monitoring of patient by an RN to be completed every 2 hours minimum and documented on restraint record... Restraint orders need to be renewed every 24 hours."

Based on interview and document review, the facility failed to accurately assess 1 of 1 patient (P29), who was restrained related to violent and combative behavior.

Findings include:

P29 was on a 72 hour hold related to "combative behavior." The physician restraint order did not indicate which body part to be restrained, there was no monitoring documented for the 24 hours the patient was restrained, and the facility did not renew the physician order for the patient in the 4 hour time period required for the violent patient.

P29 was admitted to the facility on 7/26/13, with diagnoses of dementia and combative behavior. The patient was placed on a 72 hour hold related to threatening to leave and striking out at nurses.

The emergency room note on 7/26/13, indicated P29 was brought in related to being combative. The facility was unable to transfer P29 to the behavioral health unit until 7/30/13. The note indicated, "Dementia due to Parkinson disease with behavioral disturbance. Acutely worsened. This patient is a danger to himself and others. He is an elopement risk. He needs one to one sitter care, and a 72 hour hold... we will protect the patient from self harm, sedate him as needed."

A Physician's Order dated 7/26/13, at 12:19 p.m. indicated P29 needed restraints due to "interference with medical treatment and to protect the patient from harm. Restraint type; physical device: Soft limb and side rails, however, the order did not specify which body part(s) to be restrained.

The Restraint Flowsheet dated 7/26/13, at 12:30 p.m. assessed P29 was initiated on soft left and right wrist and ankle restraints. There was no further assessment of P29's restraints, the patients current condition and response, or if the restraints were released and the skin condition was assessed.

A Nurse ' s Note on 7/26/13, at 4:00 p.m. indicated, "Soft leg restraints removed at this time... soft arm restraints continue to be in place." There was no assessment regarding why the ankle restraints were removed and why the wrist restraints remained in place.

A Nurse's Note on 7/27/13, at 3:01 a.m. indicated, "...patient is on a 72 our hold, soft wrist restraints, one to one sitter...patient continues with behavioral issues, attempting to strike staff, and wanting to leave."

A Physician's Note on 7/27/13, at 11:19 a.m. indicated, "have not seen the hallucinations or violent behavior exhibited in the emergency room yet today. Restraints are off for now. Continued need for sitter, either daughter or nursing staff."

A Nurse's Note on 7/27/13, at 1:12 p.m. indicated, "In collaboration with registered nurse [RN] and physician it has been decided that restraints are no longer necessary and therefore discontinued."

Although P29 was documented as being restrained for 24 hours and 45 minutes, the facility obtained a physician order for the restraints on 7/26/13, at 12:30 p.m. but did not renew the order as required for the "violent restraint." (See facility policy below).

During interview on 9/5/13, at 12:15 p.m. the nurse director verified P29's physician order for restraints did not include the body part to be restrained, there was no ongoing assessment during the 24 hours the patient was restrained, and only one Physician's Order for restraining P29 was written during the 24 hour period. The nurse director also verified P29 was assessed as a non-violent restraint use, which did not reflect the documentation which was provided on P29.

The facility policy/procedure titled Restraint Use dated 7/11, instructed, the facility "does not provide services for behavioral healthcare (violent and/ or self destructive). In the event a patient is seen in the emergency department for assessment, stabilization, or treatment awaiting transfer to a psychiatric facility the transfer will be made as rapidly as possible and appropriate assessments will occur until the transfer is complete. See Restraint Use- violent or Self destructive Patients section..." The Restraint Use- Violent or Self Destructive Patient section indicated, "Anytime a restraint is initiated for violent or self destructive behavior reasons: A physician order must be obtained...Verbal and written orders are limited to 4 hours for patients 18 years of age or older... A renewal order is needed each time restraint use extends beyond these limits...An in-person re-evaluation is completed by the physician every 8 hours for patients 18 years of age or greater..." The policy further instructed, "Release the limb restraint and perform range of motion on the affected limb every two hours..."

Based on interview and record review the facility did not ensure that all departments of the hospital maintained a quality assurance and performance improvement (QAPI) program. This had the potential to affect all patients of the hospital.

Findings include:

The Medical Records department did not have QAPI program.

A tour of the Medical Records department was conducted on 9/4/14, at 10:00 a.m. with the vice president of support services and the supervisor of Medical Records. During the tour,
the vice president of support services confirmed that the Medial Records department did not have a QAPI program.

The Organ Procurement program did not have a QAPI program.

During interview on 9/4/13, at 9:20 a.m. the director overseeing organ procurement (OPO) verified there was no QAPI program for organ procurement. She stated the nurses meet and go over issues with the OPO program, however, there was no specific quality program with goals or objectives. The director also stated the OPO program did not report to the overall hospital quality program as it was not part of the hospital quality program.

The quality director was interviewed on 9/5/13, at approximately 10:30 am. She verified not all departments had an active QAPI program.

The policy titled Organizational Performance Improvement Plan read, "Collaborative and specific indicators of both processes's and outcomes of care are designed, measured and assessed by all appropriate departments/services in an effort to improve patient safety and organizational performance."

Based on observation, interview, and document review, the facility failed to ensure patient photos/records were stored and secured to ensure patient confidentiality. This had the potential to effect all patients who had been seen at the hospital and for all patients who had plastic surgery at the facility in the last two years.

Findings include:

The facility provided a form titled HIPPA Incident Form dated 7/26/13. The form identified the following:

"[PA-A], stated that [MD-B] has been taking photos of his patients for up to two years, and they have been working on a process to organize them on [PA-A] computer. Throughout the course of the discussion I learned that:
1.) [MD-B] is using his own personal camera to take the photos, which he does not use solely for work purposes. 2.) [MD-B] has photos saved to memory cards, which he takes home with him. 3.) [PA-A] burned all of the photos to CD's for [MD-B], and we are not sure where these are located or stored. 4.) [MD-B] uses his cell phone to take photos if the camera is not working."

The investigation was documented by three different individuals:
The quality director noted, "Met with [MD-B] on July 30th regarding his personal camera and told him he cannot use his own personal device to take photos of patients. He needs to leave the memory card from that camera in the building to eliminate the risk of loss or theft that could result in a privacy violation. [MD-B] was not receptive to the discussion, so I escalated to the CEO, CMO, and HR."

The CMO identified, "Met with [MD-B] on August 1st to review issue and coach him on process of not removing memory card from the building."

The CEO identified, "Met with [MD-B] on August 12th to provide coaching on privacy issue/ risk of removing memory care with patients photos from building."

The action plan on the HIPPA incident form indicated: "Follow up with [MD-B] and his [PA-A] show that the memory card is no longer being removed from the building (done). We have obtained specs for options to purchase a [facility] owned camera for the plastic surgery department. HIM [health information managment] and IT [information technology] have put a process in place to upload photos from camera directly into EPIC (the patient record system)."

During observation on 9/5/13, at 2:54 p.m. MD-B's office was observed in the outpatient clinic connected to the hospital. The MD-Bs office door was open and was shared with two other people, the PA-A and a clinic nurse.

During interview on 9/5/13, at 2:45 p.m. quality director stated she had spoken with MD-B but he had not been receptive to her request to leave the memory card in the building so the issue was passed on the CEO. The quality director stated she had never seen what was on the memory card and did not know what pictures had been taken and placed on the CD. The quality director stated there was no direct monitoring to ensure MD-B had been leaving the memory card in the hospital, however, PA-A had told her the MD-B had been locking it in his top drawer in his office. The quality director stated she did not talk to MD-B about the allegation of using his cell phone to take pictures of patients nor was she aware where and what is on the CD.

During interview on 9/5/13, at 3:00 p.m. CEO stated he spoke to [MD-B] about patient privacy and leaving the memory card in the facility. The CEO stated there is no monitoring system currently in place, however, he stated PA-A had told them the MD-B was leaving the memory card in his office locked up. CEO stated he had not spoken to MD-B about what pictures were on his cell phone, CD, or memory card on the camera; and the facility cant "babysit" physicians. The CEO stated the facility had not ordered a camera for MD-B yet and they are trying to figure out which camera would be the best for MD-B. The CEO was not aware of what patient information was on the CD or where the CD was currently located.

During interview on 9/5/13, at 4:20 p.m. PA-A stated she had observed MD-B lock the memory card in his top drawer before leaving the facility in the evening. PA-A stated she had been working with the physician for about 9 months and had only seen him use his cell phone to take pictures of patients about 6 times. However, she could not remember the patient or the circumstances of what pictures were taken with the cell phone camera. PA-A stated pictures are taken of patients before surgery, during surgery once the markings are made in the operating room before incision, and after surgery when the patient comes to the office for a post operation visit. PA-A was not sure where the CD was which many of the pictures from MD-B's personal camera had been transferred to.

Upon review of the policy titled Photographing/ Videotaping Patients dated June 1, 2010 indicated, "It is never acceptable to use mobile camera phones as the equipment used to take photographs or film...authorization and consents to photograph/ videotape and corresponding photographs will be placed in the patients medical record and remain under the confidentiality and security guidelines, policies and procedures that govern medical record security and confidentiality of [facility]...Photographs, films, recordings, or other images may only be taken by employees with equipment provided by [facility], unless otherwise authorized by risk management..."

Although the facility was aware the physician had been taking pictures of patients with his own camera and cell phone, the facility failed to ensure these patient pictures were secure to ensure patient confidentiality. In addition, the facility failed to ensure the CD with patient pictures was secure and kept in the facility; nor did the facility investigate what pictures were on the personal camera, cell phone, or CD to ensure patient confidentiality was maintained.


18622

The Medical Records department failed to maintain confidentiality of clinical records.

A tour of the Medical Records department was conducted on 9/4/14, at 10:00 a.m. with the vice president of support services and the supervisor of Medical Records. During the tour, there were six carts with three shelves each filled with medical records and a seventh cart with one of three shelves filled with medical records. The names of patients visible on each record. There were approximately 25 medical records on each of the 19 shelves for a total of 475 medical records. The medical records were in clear view of all hospital staff that had access to the medical records area.

The vice president of support services and the supervisor of Medical Records were interviewed during the tour of the Medical Records department on 9/4/13, and confirmed that hospital, clinic, and emergency department staff, housekeeping, and engineering all had access to the Medical Records area. It was further noted and confirmed that the Medical Records department was not sure how many hospital and clinic employees had badge access into the medical records area because human resources determined who had access to the Medical Records department. It was further confirmed that after hours anyone who accessed the medical records area would have had access to the medical records on the carts starting with 7/13, when the records had first been placed on the carts in prepararion for scannining into the electronic medical record. The vice president of support services stated that they would lock up the carts with the medical records in an office in the department from now on so unauthorized personnel would not have access. When asked, it was confirmed that housekeeping had unlimited access to the medical records department after hours (4:30 p.m.) when no medical records personnel were in the department. When asked if there was a policy on who had access to the medical records it was confirmed that there was no policy on who could have access to the medical records. Access to medical records was granted by human resources.

A review of the Access Denial, Granted and Other Badge Events, By Reader was reviewed for the dates between 7/1/13 through 9/4/13. There were multiple times that hospital and clinic employees were granted access after 4:30 p.m. which included personnel from the emergency department, clinic, nurses - no department listed physicians, housekeeping and engineering.

A review of the variance/issue/concern report indicated that on 4/10/13, an e-mail had been received from the environmental services manager regarding the medial record storage facility located in the old O'Rielly building. The environmental services manager was over in the O'Reilly building setting up cleaning supplies and noticed that the door between the Grand Itasca Clinic and Hospital storage and Timberlakes's storage was open. On 5/16/13, a medical records person went over to the O'Reilly storage building around 1:30 p.m. and called the supervisor of Medical Records upon arriving because the front door was unlocked and nobody was at the building. The second door was also propped open allowing anyone to enter and have access to Grand Itasca medical records.

Also noted on the variance/issue/concern reports was a breach of confidentiality on 5/30/13, when a patient at the clinic reported an x-ray technician who told several family members of a patient that had lymph node cancer and now they are waiting to see what stage it was. Human Resources terminated the employee. On 6/4/13, a random audit was conducted on an employee on records that were accessed by that employee. The employee had accessed medical records she did not have need to know. The employee was suspended and an improvement plan was done for inappropriately accessing information without a need. There were additional breaches of confidentiality noted in the variance report. The facility still did not ensure the confidentiality of the medical records as the facility's improvement plan lacked evidence of what action plans they put into place to minimze and/or to prevent unauthorized access to the records. The facility did not have quality assurance progam in place to track and trend unauthorized access to the medical records.

On 9/5/13, at 8:55 a.m. the vice president of support services and the supervisor of Medical Records revisited the concern of who had access to the medical records department. The vice president of support services and the supervisor of Medical Records had met with human resources and it was determined that numerous hospital employees had access to the medical records area that should not have access. The list of who would now be granted access was limited and they needed to eliminate all non-essential badge access users. When asked, they confirmed that the offsite storage area, located in the O'Rielly building, was indeed found unsecured on 4/10/13 and 5/16/13. The hospital did not have a system in place to monitor access to the O'Reilly building and did not have a system to monitor that the doors were secured at all times.

The hospital had a policy on Violation of Confidentiality, Policy # IM-116. It was the policy of Grand Itasca Clinic and Hospital to manage data and information with the highest degree of security and confidentiality. All efforts will be undertaken to prevent a breach of this confidentiality and security. Any staff member who knowingly/willingly breaches confidentiality/security of data or information may receive a minimum a written disciplinary warning, at a maximum, termination.

Based on observation, interview, and record review, the hospital was found to be out of compliance with the Condition of Participation related to the Physical Environment (42 CFR 482.41) related to lack of compliance with Life Safety Code requirements. These findings have the potential to affect all patients in the hospital.

Findings include

Please refer to Life Safety Code inspection tags: K-0011, K-0022; K-0049; K-0054; K-0056; K-0072; K-0147; K-0211 for additional information.

Based on observation, interview and document review, the facility failed to minimize the risk of food borne illness when they did not have a system in place to effectively monitor the water temperature during the sanitizing cycle in the dish machine, cool potentially hazardous foods properly and ensure foods reach the final internal temperatures. These food safety concerns had the ability to affect all 13 patients who resided in this facility. In addition, the facility failed to clean and sanitize the shared emergency department (ED)/Intensive Care Unit (ICU) ice machine, which had the ability to affect 4 ED patients and 3 ICU patients with oral intake.

Findings include:

Dishware sanitation:
Observation of the kitchen, following lunch on 9/3/13, at 2:58 p.m. revealed that the dish machine had been in operation for the lunch and breakfast meals. Dietary Aide (DA)-A had been in charge of running the dirty breakfast, lunch dishes and cookware through the machine. By 3:00 p.m. DA-A had run the majority of the dirty dishes and cookware through the dish machine. The dish machine during the sanitation cycle on 9/3/13, at 3:00 p.m. revealed the sanitizing water temperature had exceeded the maximum safe temperature of 194 degrees Fahrenheit (F). The temperature gauge located on the front of the machine read 200 to 210 degrees F during three separate trials.

The facility did not have a, "Dish Machine Temperature Log" to record the sanitizing water temperature.
Interview with the DA-A on 9/3/13, at 3:03 p.m. confirmed that there was no temperature log to record the sanitizing water temperature before running the dishes through the dish machine. DA-A stated "I did not know we didn't have one," and added they used to have one when the other dietary manager (DM) was there.
Interview with the DM-A on 9/3/13, at 3:30 p.m. revealed that the dish machine utilized hot water rather than chemicals to sanitize their dishware. However, DM-A stated the facility did not have a written policy and procedure relative to monitoring the sanitizing water temperature in the dish machine. When interviewed about how the facility ensured that the dishes had been sanitized effectively, given the water temperature had not been taken or recorded on this day, the DM-A was unsure.
The policy was requested on 9/5/13, at 11:19 a.m. the facility did not provide a dishwashing policy to include how often to take and record the sanitizing water temperature or what interventions would be necessary if the sanitizing water temperatures fell below or above the acceptable range of 180-194 degrees F. DM-A stated he was aware that there was a minimum temperature of 180 degrees F. for the sanitizing cycle, but he was unaware that there was a maximum water temperature of 194 degrees F.
Review of the facility provided documentation the, "Hobart Instructions for C-Line A & AW Dishwashers" revised 4/08, revealed that the temperature of the water during the sanitation cycle needed to reach a minimum of 180 degrees F. with no maximum temperature identified.
Review of the 2009 Food Code in Section 4-501.112 revealed that the, "Temperature of the hot water used for sanitation should not exceed 194 degrees F."
Review of the Hazard Analysis Critical Control Point (HACCP) "Sanitation Manual Fifth Edition" page 63 revealed that "the final rinse temperature should be less than 194 degrees F. If the final (sanitizing cycle) rinse temperature was too high, the water was atomized and thus was inadequate for sanitizing."
Observations of the dish machine during the sanitation cycle on 9/5/13, at 11:19 a.m. revealed the sanitizing after temperature had exceeded the maximum safe temperature of 194 degrees F. DM-A confirmed at this time he had not submitted a work order for maintenance to work on the temperature issue, and the facility continued to utilize the dish machine.
During review of the temperature log implemented on 9/4/13, indicated that the final rinse temperature should be 180-190 degrees F. On 9/5/13, at 11:30 a.m. the log revealed the water temperature had not been taken or recorded for the breakfast meal this a.m. and dishes had been ran through. In addition, the water temperature had exceeded a safe temperature of 194 degrees F on 9/4/13, for the breakfast meal at 200 degrees F. and at the lunch meal at 196 degrees F. No follow up was provided on the log as to what was done when the temperatures exceeded 190 degrees F.
Many food products have the ability to leave pathogenic microorganisms on dinner plates, utensils, and cookware if they are not cleaned and sanitized effectively. These microorganisms can lead to food borne illness.
Review of the preplanned menu for "Week 1 Day 1-6" the week of survey, revealed that the facility prepared a wide variety of entrees including pork, chicken, fish, braised beef, meat containing soups and gravy ' s. These food products had the ability to leave pathogenic microorganisms on un-sanitized dishes such as; Salmonella, Campylobacter, Clostridium perfringens and E. coli. All of which could cause food borne illness.

Cooling:
The facility did not have a system in place to cool left over potentially hazardous foods properly to minimize the risk of food borne illness.

During the initial brief tour of the kitchen on 9/3/13, at 2:58 p.m. revealed the walk in cooler had two full six liter (L) containers (tall round cylinder which does not allow rapid cooling) with leftover homemade chicken and pork gravy dated 8/27/13, (the day it was made). A left over pork loin roast was put in the walk-in cooler on 9/3/13, at 2:00 p.m. in a long shallow pan and was hot to the touch. DM-A had temped the pork loin at 112 degrees F.

At this time the DM-A reported the facility should be cooling potentially hazardous foods from 135°F to 70°F within two hours; from 70°F to 41°F within four hours; with the total time for cooling from 135°F to 41°F not to exceed six hours. The DM-A confirmed the facility utilizes left over foods and pre-cooks raw roasts the day before. DM-A stated the facility did not have a process in place to ensure food was properly cooled.

During a follow-up visit of the kitchen on 9/5/13, at 11:13 a.m. the leftover pork loin served on 9/3/13 was in the same long shallow pan. The DM-A stated the staff did not temp/record the potentially hazardous food to ensure it cooled from 135°F to 70°F within two hours; from 70°F to 41°F within four hours; to ensure the total time for cooling from 135°F to 41°F did not exceed six hours. There was also a cart that contained five pans of cooked braised beef roasts in the walk-in cooler, it was dated 9/4/13. The DM-A stated the product was raw. The DM-A reported the braised beef was cooked on 9/4/13, put into the freezer for a few minutes to cool rapidly and then transferred to the walk-in refrigerator. The DM-A confirmed the staff had not temped the foods to ensure it was properly cooled to the 41 degrees F within 6 hours. The walk-in in cooler also had a six L container of chicken noodle soup dated 9/4/13. The DM-A stated he was also not sure if that was properly cooled.

On 9/3/13 at 3:15 p.m. Cook (C)-A reported she did know if left over potentially hazardous foods had been cooled from 135°F to 70°F within two hours; from 70°F to 41°F within four hours; with the total time for cooling from 135°F to 41°F did not exceed six hours, as she had not taken the food temperature when cooling food in the refrigerator. C-A added she was not aware of the process to cool left over hot foods for safe storage.

The facility's Cooling Potentially Hazardous Foods policy and procedure revised 4/06, identified potentially hazardous foods must be cooled from 135°F to 70°F within two hours; from 70°F to 41°F within four hours; with the total time for cooling from 135°F to 41°F did not exceed six hours within four hours of use. The procedure identified hot foods must be cooled to 40 degrees F or lower and if a big quantity it should separated into smaller containers so it cools faster.

The infection control logs reviewed from 9/12, to 8/13, did not identify any food borne illness concerns with no resident or staff gastrointestinal illness reported.

Final Cooking Temperatures:
During observation on 9/5/13 at 10:50 a.m. C-C was working on the steam table line that was used to serve patients trays. C-C was not sure if the food had been temped but started to serve trays. C-C was asked to temp the foods. The cauliflower was 130 degrees F. C-C confirmed the cauliflower was not up to its final cooking temperature of 135 degrees F, the proper temperature for service. C-C reviewed the Hot Storage Temperature Inspection Record for September and reported the temperatures for this meal service were not filled in by the day cook who cooked these foods. C-C verified with C-B (day cook) that the final cooking temperatures had not been taken prior to meal service. C-C stated the cook that cooks the food and moves it to the steam table should temp the food at that time.

Hot Storage Temperature Inspection Record for 7/13 identified the log was not filled on 15 of the 31 days. The 8/13 log was not filled out on 9 of 31 days with most days missing at least 1-2 meal temperatures of potentially hazardous foods.

During an interview on 9/5/13, at 11:39 a.m. the DM-A stated the staff member who cooks the food should be temping it for the final cooking temperatures, and then recording on the Hot Storage Temperature Inspection Record. DM-A reported he monitors that food was cooked to the proper internal temperature by monitoring the Hot Storage Temperature Inspection Records. DM-A verified he has not had a change to look at these since assuming the new role as DM. DM-A reviewed the temperatures logs and confirmed they were incomplete.

§483.35(i) - Sanitary Conditions identifies cooking is a critical control point in preventing food borne illness. Cooking to heat all parts of food to the temperature and for the time specified below will either kill dangerous organisms or inactivate them sufficiently so that there is little risk to the resident if the food is eaten promptly after cooking. Monitoring the food ' s internal temperature for 15 seconds determines when microorganisms can no longer survive and food is safe for consumption. Fresh, frozen, or canned fruits and vegetables that are cooked do not require the same level of microorganism destruction as raw animal foods. Cooking to a hot holding temperature (135 degrees F) prevents the growth of pathogenic bacteria that may be present in or on these foods.



30951

On 9/4/13, at 9:30 a.m. during a tour of the intensive care unit (ICU) and emergency department (ED) shared kitchenette area, it was observed that the water nozzle and ice chute had a buildup of white mineral like material, which was verified by the ED director.

The weekly Preventative Maintenance Procedure form, revised 11/2010, indicated:
1. a. Wipe down dispensing areas, grill, and splash tray with de-scaler.
b. Clean dispensing area, grill and splash tray with sanitizer.
c. Pour sanitizer and hot water down drain to ensure proper drainage.
The Scotsman most recent cleaning was dated 8/30/13.

The Utility Management Program, Preventive Maintenance Procedure indicated semi-annual ice machine maintenance was performed on 4/15/13, and stated in accordance with the applicable Technical Manual.

The Scotsman Maintenance manual dated 5/2001, indicated: "Although the ice in this dispenser is completely untouched, the water and ice vending systems will need to be periodically sanitized and de-mineralized.... Schedule the sanitation, cleaning and de-mineralization on a regular basis to keep the ice clean and the machine operating efficiently.

Based on interview and document review, the facility failed to ensure timely notification was completed to the OPO (Organ Procurement Organization), for 4 of 6 patients (P31, P32, P33, P26) death records reviewed.

Findings include:

Documentation of notification to the OPO, Life source, did not include time and/or date of notification following patient death to ensure timely notification was being completed.

P31 had a date and time of death documented as 10/17/12, at 12:30 a.m. on the hospital form titled Death Checklist. The form identified Life source was notified on 10/17/12, however, the time of notification is not identified.

P32 had a date and time of death documented as 12/5/12, at 1:30 p.m. on the hospital form titled Death Checklist. The form identified Life source was notified on 12/5/12, however, the time of notification is not identified.

P33 had a date and time of death documented as 2/12/13, at 8:34 p.m. on the hospital form titled Death Checklist. The form identified Life source was notified on 2/12/13, however, the time of notification is not identified.

P26 had a date and time of death documented as 3/14/13, at 9:15 a.m. on the hospital form titled Death Checklist. The form identified Life source was notified, however, there is no date or time of when Life source was documented.

During interview on 8/5/13 at 8:50 a.m. registered nurse (RN)-D stated the nurse supervisor is responsible to notify Life source of all deaths occurring in the hospital within one hour of death and record the time and date of notification on the Death Checklist. RN-D verified there was no way to determine if life source was notified timely for P26, P33, P32, and P31 following death. RN-D stated more training would have to be provided for the nurses to ensure life source received timely notification of all deaths.

The facility policy titled Organ/ Tissue/ Eye Donation: Donation Process dated 2/12, identified, "It is the policy ...to refer all imminent brain death and cardiac deaths ... to life source. Timely referral of patients is ideally within one hour ..."

Based on observation, interview, and document review, the surgeon failed to holster the electrocautery blade for 1 of 3 patients (P17) observed having a surgical procedure and the hospital failed to ensure hair was completely contained while staff was in the surgical suite during 1 of 3 observed surgical procedure for (P17).

Findings include:

P17 was taken to the operating room suite for a surgical repair of a ventral hernia on 9/5/13 at 10:29 am. P17 was intubated and general anesthetic was administered at 10:50 am. At 10:51 a.m. the surgeon (MD)-A shaved P17's chest area, collected the loose hair with adhesive, and at 10:55 a.m. a time out with fire risk was called. After the time out, the circulating nurse (RN)-A, scrubbed the chest area and umbilicus with Hibiclens (an antiseptic antimicrobial skin cleanser) and then towel dried the area. At 11:00 a.m. CloraPrep (preoperative skin preparation) was applied and a three minute dry time was started using a timer. The manufacturing guidelines for Chloraprep indicated minimum dry time on a hairless surface was three minutes.

At 11:06 a.m. P17 was draped with the Electrocautery holster clipped to the right side of the drape at the hip area of the patient. The placement of the electrocautery was to the right of the surgeon. The cautery was used throughout the procedure and most of the time when MD-A was not using the electrocautery pencil it was placed on the drape for up to 30 seconds at a time. At other times the electrocautery pencil was placed in the holster by either the surgeons assistant (RN)-B or the scrub nurse (RN)-C. Occasionally MD-A would also holster it. On two different occasions when it was not holstered the cautery sat on the drape below the incision area for 50-70 seconds. The surgeon switched sides with his assistant twice during the procedure. When MD-A was on the left side of the patient the cautery holster remained clipped to the drape on the right side of the patient. Because the surgeon utilized the electrocautery pencil with his right hand MD-A would set the electrocautery pencil down on the drape above the chest area which was nearest the oxygen source of the incubated patient. At 11:57 a.m. the cattery pencil was placed on the drape above the chest level where it remained un-holstered for five minutes.

On 9/5/13, at 12:15 p.m. the director of surgery was interviewed. The director of surgery indicated she had observed the electrocautery pencil lying on the drape several times throughout the procedure and verified the one time it was five minutes. She further verified the electrocautery pencil should be holstered or in the surgeons hands at all times.

On 9/5/13, at 1:15 p.m. the supervisor of surgery was interviewed and indicated he was unsure as to whether the surgeons had reviewed the information on electrocautery and surgical fires, however he indicated the electrocautery pencil was to be holstered when not in use.

After leaving the surgical suite on 9/5/13, at 1:30 p.m. MD-A was interviewed. MD-A indicated he had training about surgical fires about one year ago. When asked about holstering the electrocautery pencil in between usage he agreed it should be and he thought he had done that. When asked about it being left on the drape and not holstered for five minutes, MD-A was surprised it had been that long.

The policy and procedure on, "Electrosurgery Use in the OR," reviewed and revised 5/12 indicated the electrosurgical units should be used in accordance with manufacturer's guidelines. The policy also indicated when not in use the electrocautery should be placed in the safety holder.

The current manufacturer's user guide provided from Covidien entitled, "ForceTriad Energy Platform," indicated under fire/explosion hazard: Do not place active instruments near or in contact with flammable materials such as gauze or surgical drapes. Electrosurgical instruments that are activated or not in use can cause a fire. When not in use, place the electrosurgical instruments in a safety holster or safely away from patients, the surgical team, and flammable materials.

P17 was observed during a surgical procedure on 9/5/13, at 10:29 a.m. The circulating nurse RN-A was wearing two surgical caps. One cap covered her long pulled back hair and the other covered the top of her hair. The hair at the sides by her ears was exposed. RN-B, the surgeon ' s assistant, had a cap on that did not cover the entire hair in the back. The hair was exposed about one to two inches below the bottom of the surgical cap.

RN-A adjusted her head attire however the surgical caps did not stay in place. At 11:33 a.m. RN-A's hair was again exposed and when interviewed RN-A indicated the hair needed to be completely covered. She left the surgical suite and returned at 11:37 a.m. with her hair completely covered. RN-B was assisting the surgeon and unable to leave. On 9/5/13, at 10:30 a.m. the director of surgery confirmed the hair should be completely covered.

The hospital's policy last reviewed 4/13, and entitled, "Surgical Attire," was reviewed and the policy revealed, personnel should cover head and facial hair, including sideburns and necklines when in the semi and restricted areas.