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Based on staff interview, observation, review of patients' clinical records and policies and procedures, it was determined the governing body failed to provide the operational oversight and direction necessary to ensure contracted dialysis services provided to hospital patients were safe. This resulted in immediate jeopardy to the health and safety of dialysis patients. The findings include:

1. Refer to A084 as it relates to the failure of the governing body to ensure one of two contract dialysis service providers provided care in a safe manner. The effect of this negative facility practice seriously impeded the ability of the hospital to provide care of adequate quality and placed dialysis patients at risk of serious harm or death.

Note: The facility was notified of the findings related to the immediate jeopardy on 10/18/10 starting at 4:05 PM. A Plan of Correction was reviewed and accepted on 10/19/10 at 9:00 AM. The Plan of Correction included: Obtaining and retaining 2 functioning Neo-Stats on the hospital premises in Boise, implementing a concurrent auditing process for all dialysis patients, formalizing and implementing a reporting system for dialysis equipment malfunctions, and education was provided to all dialysis and hospital staff for the concurrent audit process, equipment malfunction reporting process and quality control measures. A survey of current dialysis patients was conducted on 10/19/10. The hospital's contractor was in compliance with cares and treatment of hospital patients and the immediate jeopardy was abated.

Based on review of clinical records and policies, observations, and contract staff interviews, it was determined, the Governing Body failed to ensure 1 of 2 contract dialysis providers performed independent conductivity and pH checks prior to dialyzing one of two inpatients (#65), whose records were reviewed and were observed receiving dialysis treatments. The lack of testing had the potential to cause serious injury or death to dialysis patients. This placed the health and safety of all hospital patients who received dialysis services in immediate jeopardy. The findings include:

The hospital's Governing Body contracted all its inpatient hemo-dialysis services. This was documented in a contract with Provider A, dated 05/01/07.

On 10/18/10 during a tour of the hospital's CCU at 1:35 PM, Patient #65 was noted to be receiving hemo-dialysis by a Registered Dialysis Nurse that worked for Provider A. During the observations, it was noted that a Neo-Stat was not in the possession of the Registered Dialysis Nurse. A Neo-Stat is a hand-held, syringe-style meter used to verify the conductivity, pH and temperature of the final dialysate water and verified the accuracy of dialysis machine readings. Not verifying the machine's conductivity and temperature readings with an independent comparison could lead to the rapid development of acid/base imbalance in the patient's body, resulting in potential serious injury or death.

The FDA Quality Assurance Guidelines recommend that the conductivity, pH and temperature of the final dialysate be checked with an independent reference meter before every treatment.

Provider A's "PRESCRIPTION VERIFICATION AND SAFETY CHECKS" policy, dated 9/09, stated a manual conductivity and pH of the dialysate prior to each dialysis treatment must be completed. This policy was not followed.

On 10/18/10 starting at 1:35 PM, the Registered Dialysis Nurse who dialyzed Patient #65 was interviewed. She stated that on Friday, 10/15/10, she noticed the Neo-Stat meter was not working properly. She stated she did not report the broken equipment to Provider A's bioengineering department, and they only had one Neo-stat available at the hospital's Boise location. She stated she did not work during the weekend, but on 10/18/10 at 1:35 PM, she stated the Neo-Stat meter was not used before Patient #65 was dialyzed because the Neo-Stat meter remained broken.

On 10/18/10 starting at 2:45 PM, dialysis Provider A's Out-Patient Manager was interviewed. She stated the Registered Dialysis Nurse who dialyzed Patient #65 should have performed a manual conductivity and pH test of the dialysate water prior to dialyzing the patient. She said that by not doing a manual conductivity and pH test of the dialysate water, patients were at risk for electrolyte imbalances that could lead to injury or death.

The hospital failed to ensure contracted dialysis services were provided to hospital patients in a safe manner.

Based on observations and interview it was determined the hospital failed to ensure patient privacy of protected health information for 1 of 2 current patients (#70), whose physicians were observed discussing cares and treatments. This resulted in a violation of a patient's right to privacy. Findings include:

During a tour of the hospital's outpatient Orthopedic Surgery Center on 10/22/10 at 8:30 AM, a physician was observed discussing Patient #70's arthroscopic procedure, in the main lobby, with Patient #70's family members. The surveyor could overhear the conversation. Another patient's family member and two employees were also present within hearing distance.

An empty consultation room was observed to be present off of the lobby.

The family members of Patient #70 were interviewed on 10/22/10 starting at 8:51 AM. They stated the physician did not offer privacy before discussing Patient #70's arthroscopic procedure.

Hospital management was asked if they had a policy in place to protect patient's health information in these instances. As of 10/29/10, a policy was not provided.

The hospital failed to ensure physicians did not discuss patients' health information in common areas where other people could overhear the information.

Based on review of policies, clinical records, and staff interviews, it was determined the hospital failed to ensure that 5 of 7 patients reviewed for whom restraints were used (#22, #23, #24, #40, and #41), had a physician's order or a complete physician's order for physical restraints. This had the potential to cause a lack of appropriate physician oversight in the management of restraints. Findings include:

1. According to the hospital's policy titled, "Restraints," revised 9/21/10, "All restraints are applied and continued pursuant to an order by the physician who is responsible for the patient's ongoing care. If a physician is not available to issue an order, an RN may initiate the use of restraints based on an assessment of the patient indicating a significant change in the patient's condition. In that case, the physician managing the patient's care is notified within minutes of the initiation of restraint, and a telephone or written order is obtained from that physician and entered into the patient's medical record. A complete restraint order must include: [the] type of restraint; clinical justification for the restraints; order duration [and] signature, date, and time."

In the two examples that follow, this policy was not followed.

a. Patient #41 was an 11 month old female, who was admitted to the hospital on 9/06/10.

A "PICU Observation Record" documented RN application of bilateral soft wrist restraints beginning on 9/12/10 at 10:00 AM. There was not a valid physician's order present at the time Patient #41 was restrained. A physician's order for restraints was obtained and written on 9/12/10 at 12:00 PM, 2 hours after the application of restraints.

During an interview on 10/25/10 at 2:56 PM, the Clinical Nurse Specialist for the Medical/Surgical Units reviewed Patient #41's record and confirmed the previous order was not valid. She also confirmed the delay in obtaining a physician's order.

The hospital failed to obtain a physician's order to restrain Patient #41 within minutes of the initiation of restraints.

b. Patient #40 was a 13 year old female who was admitted to the hospital on 9/26/10. "Physical Restraint Orders," dated 9/26/10 at 3:50 PM, documented physician orders to initiate soft bilateral wrist restraints. The order failed to document the reason (clinical justification) for the use of restraints.

In an interview conducted on 10/25/10 at 3:27 PM, a Pediatric Clinical Nurse Specialist reviewed Patient #40's record and confirmed the physician's order for restraints was incomplete.

The hospital failed to ensure patients had complete restraint orders.




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2. Patient #24's medical record documented a 34 year old female who was admitted to the ED on 9/12/10 at 2:55 PM. Patient #24 was placed on an "involuntary mental health hold" at 2:57 PM on 9/12/10. The Triage note by the RN, dated 9/12/10 at 3:28 PM, stated, "Pt. arrives from home fighting and yelling that she needs to kill herself. Per significant other, off psych meds x 3 days, drank alcohol today...The patient is combative and awake with an affect that is loud and agitated." An anti-psychotic medication [Haldol 5 mg] and an anti-anxiety medication [Ativan 2 mg] were administered intramuscularly at 3:21 PM on 9/12/10. A physician order to apply 4-point restraints [wrists and ankles] to Patient #24 was written at 3:12 PM on 9/12/10. A "Progress Note" by the RN at 3:15 PM on 9/12/10, stated Patient #24 was, "...alert and oriented to person and place and agrees to be more cooperative. We discussed why we gave her Haldol and Ativan and that we would remove the restraints one by one as she was more cooperative. She agreed to this."

At 3:38 PM on 9/12/10, nursing notes documented Patient #24 was "...kicking. Patient poses a risk of injury to self or ED staff." At 3:40 PM on 9/12/10, nursing notes documented Patient #24 was sleeping. At 3:44 PM on 9/12/10, nursing notes documented, "Vital signs/weight rechecked: O2 saturation. Tolerated procedure well." At 4:05 PM on 9/12/10, nursing notes documented Patient #24 was resting. At 4:09 PM on 9/12/10, nursing notes documented Patient #24 was catheterized. Her response to this procedure was not documented. At 4:54 PM on 9/12/10, nursing notes documented Patient #24's, "Condition improved: Pt. wakes when addressed, calm, cooperative. One arm and one leg still in restraints...significant other visited and they kissed." Nursing notes did not document when the 2 limb restraints had been removed. The next nursing note was dated 9/12/10 at 5:44 PM. It stated, "At 17:40 (5:40 PM) removed left ankle restraint pt tolerated well remains compliant to safety measures." The next nursing note was dated 9/12/10 at 6:05 PM. It stated, "Pt. sleeping. Last restraints removed." Patient #24 was then admitted to a medical floor as an inpatient.

The Director of the ED was interviewed on 10/20/10 at 9:30 AM. She reviewed the medical record and confirmed the documentation.

Patient #24 had physician orders for 4-point restraints. At some point between 4:09 PM on 9/12/10 and 4:54 PM on 9/12/10, 2 of those restraints were removed and 2 were left in place. A third restraint was removed 50 minutes later. Patient #24 remained in one point restraint for another 25 minutes until that last restraint was removed. New orders were not obtained for the 2 point and 1 point restraints.

3. Patient #22's medical record documented a 14 year old female who was admitted to the ED, on 9/25/10 at 9:30 AM, for a mental health examination. A note by the RN at 5:31 PM on 9/25/10, stated, "Pt's behaviors escalated and pt began screaming at parents and staff. Pt left her room and was screaming at parents and staff in the hallway. Pt's father was able to get pt into room. Pt continues to scream, hit, and kick. Pt does not redirect well with verbal commands and after several attempts pt is placed in four point restraints and given Zyprexa [an anti-psychotic medication]." A physician order was obtained for "Soft restraints Four-point." A note by the RN at 5:47 PM on 9/25/10, 16 minutes later, stated, "pt cooperative with blood draw, tolerated well. R (right) wrist restraint removed." A note by the RN at 6:01 PM on 9/25/10, 14 minutes later, stated, "pt remains cooperative, bilateral leg restraints removed. pt thankful." A note by the RN at 6:32 PM on 9/25/10, stated, "patient was discharged via wheelchair accompanied by parent/guardian." The time the left wrist restraint was removed was not documented.

The Director of the ED was interviewed on 10/20/10 at 9:30 AM. She reviewed the medical record and confirmed the documentation.

Patient #22 had a physician order for 4-point restraints. At 5:47 PM on 9/25/10, 1 of those restraints was removed and 3 were left in place. At 6:01 PM on 9/25/10, 14 minutes later, 2 more restraints were removed and 1 was left in place. This violated the original order. New orders for restraints were not obtained.

4. Patient #23's medical record documented a 72 year old male who was admitted to the ED on 9/21/10 at 5:44 PM. At 6:06 PM on 9/21/10, the physician documented, "[Patient #23] is very confused, severely demented, and typically not verbally interactive at all. He is also trying repeatedly to get out of bed, pulling at his IV, and will not help us to maintain cervical spine immobilization." At 6:15 PM on 9/21/10, the nurse documented, "Pt is not violent, he is trying to sit up and get out of bed...Security is in to place pt in four points [restraints] until neck is cleared." An order for "Soft restraints four point" was written on 9/21/10 at 6:03 PM. A nursing note at 6:40 PM on 9/21/10, stated "Condition improved: pt is now laying on stretcher without fighting the restraints..." A nursing note at 7:01 PM on 9/21/10 stated, "Condition improved: pt returns from CT relaxed, eyes open and responding to wife verbally, leg restraints are off and pt is not fighting, [bilateral] hands are pink and warm, able to place two fingers under restraints." The nursing note at 8:34 PM, 93 minutes later, stated Patient #23 was medically cleared and the hand restraints were removed.

The Director of the ED was interviewed on 10/20/10 at 9:30 AM. She reviewed the medical record and confirmed the documentation.

Patient #23 had physician orders for 4-point restraints. At 7:01 PM on 9/21/10, 2 of those restraints were removed and 2 were left in place. This violated the original order. New orders for restraints were not obtained.

The policy "Restraints," revised 9/21/10, did not address the practice of removing restraints one limb at a time and how the practice affected the original restraint order.

The Clinical Nurse Specialist for the Medical/Surgical Units was interviewed about the policy on 11/01/10 at 9:30 AM. She stated nurses were trained to remove restraints one limb at a time. However, she said the policy did not address this practice.

The hospital did not ensure patients were restrained consistent with physician orders.

Based on staff interview and review of records and hospital policy, it was determined the hospital failed to ensure restraint orders did not constitute PRN orders for 1 of 2 pediatric patients (#41) whose records were reviewed for restraint orders. This had the potential to result in a lack of physician oversight. The hospital also failed to ensure clarity of the restraint policy. This had the potential to lead to inadvertent PRN use of restraints. Findings include:

1. A hospital policy, "Restraints," revised 9/21/10, stated, "Restraint orders must be implemented within 1 hour" (after receipt of the order).

Allowing an hour for implementation of restraints raises the question as to whether restraints were clinically justified (needed to ensure immediate physical safety of the patient). Allowing an hour for implementation also had the potential to allow staff to delay application of restraints to see if they were really needed, which would result in PRN use of restraints.

A meeting on 10/27/10 beginning at 10:25 AM included restraint focus team members (the Director of Quality and Patient Safety, the Director of Accreditation and Nursing Operations, the Chief Nursing Officer, the Administrator for Women's Services, the Vice President of Medical Affairs, and the Clinical Nurse Specialist for Medical Surgical). Team members stated it was not the intent of the policy to allow PRN use of restraints, rather it was the intent of the policy to give concrete guidelines to nursing staff. The Chief Nursing Officer expressed appreciation for surveyors' perspective and stated she could see how the policy might be misinterpreted.


2. Patient #41 was an 11 month old female admitted to PICU on 9/06/10 for respiratory distress. According to a "HISTORY AND PHYSICAL," dated 9/06/10, Patient #41 was intubated after arrival and placed on a ventilator. A "CONSULTATION REPORT," dated 9/07/10, stated Patient #41 had been intubated, paralyzed and ventilated since admission.

An initial physician's restraint order, dated 9/06/10 at 05:00 AM, for soft bilateral wrist restraints, had two boxes checked to indicate the clinical justification for restraints. The language next to the checked boxes stated the patient was unable to consistently follow directions and had a potential for unplanned removal of tubes. The restraint orders were renewed every day for 9 days (9/07/10 at 9:50 AM, 9/08/10 at 8:30 AM, 9/09/10 at 9:00 AM, 9/10/10 at 4:20 PM, 9/11/10 at 12:35 PM, 9/12/10 at 12:00 PM, 9/13/10 at 9:35 AM, 9/14/10 at 7:00 AM, 9/15/10 at 8:10 AM). The clinical justification listed on the physician's order form remained the same for each of the 10 days.

According to nursing documentation on "Restraint Observation Records," Patient #41 was not restrained between 9/07/10 at 10:00 PM and 9/12/10 at 10:00 AM. RN documentation (9/08/10 at 7:30 AM, 9/10/10 at 3:00 PM, and 9/11/10 at 8:00 PM) described Patient #41 as "paralyzed." This provided justification for not restraining Patient #41 even though physician orders for restraints were present.

Physician progress notes (9/08/10 at 8:53 AM, 9/09/10 at 8:31 AM, 9/10/10 at 4:29 PM, and 9/11/10 at 12:58 PM) similarly described Patient #41 as sedated, paralyzed and on a ventilator. The notes did not state Patient #41 had breakthrough movement from the paralysis which could have provided clinical justification for the need for restraints. A specific and individual assessment of Patient #41's need for restraints was not documented.

On 10/26/10 at 3:00 PM, the physician was interviewed who wrote restraint orders for Patient #41. When asked why he ordered restraints for a patient who was chemically paralyzed, he explained that he had seen patients in the past have breakthrough movement, even though they were chemically paralyzed. He explained this put them at risk for self-extubation. He stated he trusted the RNs who provided care for his patients and deferred to their judgment as to whether restraints were or were not needed. This explanation left the decision to restrain Patient #41 up to the RNs based on their own assessments (a PRN restraint).

Restraints were ordered based on the potential for self-extubation based on past experience with other patients rather than based on an individual assessment of Patient #41 at specific points in time to determine specific need for restraints. This constituted a PRN order.

Based on review of medical records and hospital policies and staff interview, it was determined the hospital failed to ensure restraints were discontinued at the earliest possible time for 2 of 5 restrained ED patients whose medical records were reviewed. This resulted in the potential for patients to be unnecessarily restrained longer than they needed to be. Findings include:

1. Patient #24's medical record documented a 34 year old female who was admitted to the ED on 9/12/10 at 2:55 PM. The triage note by the RN, dated 9/12/10 at 3:28 PM, stated Patient #24 was combative. An anti-psychotic medication (Haldol 5 mg) and an anti-anxiety medication (Ativan 2 mg) were administered intramuscularly at 3:01 PM. A physician order to apply 4-point restraints (wrists and ankles) to Patient #24 was written at 3:12 PM on 9/12/10. A "Progress Note" by the RN at 3:15 PM on 9/12/10, stated Patient #24 was, "...alert and oriented to person and place and agrees to be more cooperative. We discussed why we gave her Haldol and Ativan and that we would remove the restraints one by one as she was more cooperative. She agreed to this."

At 3:38 PM on 9/12/10, nursing notes documented Patient #24 was, "...kicking. Patient poses a risk of injury to self or ED staff." At 3:40 PM on 9/12/10, nursing notes documented Patient #24 was sleeping. At 3:44 PM on 9/12/10, nursing notes documented, "Vital signs/weight rechecked: O2 saturation. Tolerated procedure well." At 4:05 PM on 9/12/10, nursing notes documented Patient #24 was resting. At 4:09 PM on 9/12/10, nursing notes documented Patient #24 was catheterized. Her response to this procedure was not documented. At 4:54 PM on 9/12/10, nursing notes documented Patient #24's, "Condition improved: Pt. wakes when addressed, calm, cooperative. One arm and one leg still in restraints...significant other visited and they kissed." The next nursing note was dated 9/12/10 at 5:44 PM. It stated, "At 17:40 (5:40 PM) removed left ankle restraint pt tolerated well remains compliant to safety measures." The next nursing note was dated 9/12/10 at 6:05 PM. It stated, "Pt. sleeping. Last restraints removed." An assessment of the need for continued restraint, including specific behaviors and rationale, was not documented after they were applied.

No combative behaviors were documented after 3:38 PM on 9/12/10. An assessment of the need for continued restraint was not documented before completely removing the restraints at 6:05 PM.

The Director of the ED was interviewed on 10/20/10 at 9:30 AM. She reviewed the medical record and confirmed the documentation.

Hospital staff failed to assess Patient #24 in order to determine the earliest time when restraints could be safely discontinued.

2. Patient #22's medical record documented a 14 year old female who was admitted to the ED on 9/25/10 at 9:30 AM for a mental health examination. A note by the RN at 5:31 PM on 9/25/10, stated "Pt's behaviors escalated and pt began screaming at parents and staff. Pt left her room and was screaming at parents and staff in the hallway. Pt's father was able to get pt into room. Pt continues to scream, hit, and kick. Pt does not redirect well with verbal commands and after several attempts pt is placed in four point restraints and given Zyprexa [an anti-psychotic medication]." A physician order was obtained for "Soft restraints Four-point." A "Patient right flowsheet" documented Patient #22 was "Cooperative" at 5:22 PM, 5:46 PM, and 6:00 PM on 9/25/10. A note by the RN at 5:47 PM on 9/25/10, stated "pt cooperative with blood draw, tolerated well. R wrist restraint removed. A note by the RN at 6:01 PM on 9/25/10, stated "pt remains cooperative, bilateral leg restraints removed. pt thankful." A note by the RN at 6:32 PM on 9/25/10, stated "patient was discharged via wheelchair accompanied by parent/guardian. The time the left wrist restraint was removed was not documented.

No combative behaviors were documented after 5:31 PM on 9/25/10. An assessment of the need for continued restraint was not documented before completely removing the restraints.

The Director of the ED was interviewed on 10/20/10 at 9:30 AM. She reviewed the medical record and confirmed the documentation.

Hospital staff failed to assess Patient #24 in order to determine the earliest time when restraints could be safely discontinued.

Based on observations, record review, and staff interview, it was determined the hospital failed to ensure an RN provided sufficient supervision to ensure seizure precautions were implemented per physician orders for 1 of 1 current patient (#60), who was observed and who had orders for seizure precautions. The lack of nursing supervision and failure to follow physician orders had the potential to put a patient at risk for injury. Findings include:

Patient #60 was a 54 year old female who was admitted to the hospital on 10/18/10. A "History and Physical," dated 10/18/10 that was untimed, stated Patient #60 was found at home by her daughter, noted to have a gash on her forehead and the TV lying on the floor. Patient #60 was transported to the hospital's ED where she was observed by staff to have a 45-second generalized tonic-clonic seizure and bite her tongue. A physician's order, dated 10/18/10 at 2:00 PM, stated Patient #60 was to be admitted to the hospital's CCU unit for further observations and placed on seizure precautions.

The hospital's CCU was toured in the afternoon of 10/19/10. At 2:40 PM, the CCU's Charge Nurse was interviewed. He stated that seizure precautions included padding the rails of the patient's bed. Patient #60 was observed at this time and her bed rails were noted to be without pads.

The RN caring for Patient #60 was interviewed on 10/19/10 starting at 2:45 PM. She stated she had received a physician's order to discontinue the seizure precautions but did not write down the order.

On 10/19/10 at 3:30 PM, Patient #60's physician was interviewed. She stated that she did not discontinue Patient #60's seizure precautions.

Sufficient RN supervision was not provided to ensure seizure precautions were followed for Patient #60.

Based on observations, staff interview, and review of federal guidelines, it was determined the hospital failed to maintain food at recommended temperatures in 1 of 2 kitchens observed during a tour of the facility. Failure to maintain appropriate temperatures in food storage areas had the potential to promote bacterial growth and increase the risk of food-borne illness. Findings include:

According to the government website "FoodSafety.Gov," bacteria grow most rapidly in temperatures that range between 40 and 140 ?F. Some harmful bacteria can double in number in as little as 20 minutes.

During a tour of the hospital's kitchen on 10/27/10 at 8:45 AM, the following temperatures of food were measured in a cold holding unit: ham 48 degrees F (7 degrees too high), sausage 50 degrees F (9 degrees too high), and turkey 52 degrees F (11 degrees too high). A large container of liquid eggs on ice registered a temperature of 49 degrees F (8 degrees too high). The observations were confirmed, at the time of the tour, by a chef that worked in the kitchen.

The hospital failed to maintain temperatures of food to reduce the risk of food-borne illnesses.