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

SAINT ALPHONSUS REGIONAL MEDICAL CENTER 1055 NORTH CURTIS ROAD BOISE, ID 83706 July 31, 2012
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0168
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on staff interview and review of medical records, hospital policies, and credentials files, it was determined the hospital failed to ensure restraints were utilized in accordance with orders of physicians or authorized LIPs. This affected the care of 3 of 7 patients (#7, #37 and #40) who had been placed in restraints and whose records were reviewed. The use of restraints without proper authorization had the potential to result in the inappropriate use of restraints. Findings include:

1. Patient #37's medical record documented a [AGE] year old male who was admitted on [DATE] following a motor vehicle accident and a head injury. He was discharged to the Rehabilitation Unit on 7/18/12. A verbal order from PA A was documented on 7/15/12 at 11:04 AM for bilateral wrist restraints. The order was signed by the PA on 7/15/12 at 2:52 PM.

PAs are not independent and must work under the supervision of a physician. The Idaho Board of Medicine (IDAPA 22.01. .07) defines a PA as a person licensed to render patient services under the direction of a supervising and alternate supervising physician.

The hospital policy "Restraint and Seclusion," dated 7/03/12, stated the patient's physician or other "LIP" could order restraints. The term LIP was not defined. PAs were not specifically mentioned by the policy as being able to order restraints.

PA A's "SCOPE OF PRACTICE AND SUPERVISING PHYSICIAN REQUEST FORM," dated 6/28/11, outlined parameters the hospital placed on the PA's practice. It stated the PA could conduct History and Physical examinations and discharge summaries which must be countersigned by the supervising physician. It also stated the PA could "diagnose and manage minor illnesses or conditions" and "manage the health care of the stable chronically ill patient in accordance with the medical regimen initiated by the supervising physician." The agreement did not state the PA could evaluate the need for and order restraints.

The Regulatory Accreditation Coordinator reviewed the medical record on 7/25/12 beginning at 10:50 AM. She confirmed the order by the PA for restraints. She stated she thought PAs had privileges to order restraints but said she was not sure.

In addition, the EMR documented Patient #37 had 4 side rails up on his bed on 7/13/12 at 8:00 PM, on 7/14/12 at midnight, 3:00 PM, and 8:00 PM, and on 7/15/12 at 7:00 AM. The use of all 4 side rails prevented Patient #37 from moving his arms and legs freely which met the definition of a restraint. Orders were not present in Patient #37's medical record which authorized the use of all 4 side rails.

The Regulatory Accreditation Coordinator reviewed the medical record on 7/30/12 beginning at 3:30 PM. She confirmed the documentation and the lack of orders authorizing the use of the side rails.

Restraints were utilized for Patient #37 without orders and restraints were also ordered by a person who was not authorized to provide those orders.

2. Patient #40's medical record documented a [AGE] year old male who was admitted on [DATE] following a fall with a closed head injury. He was currently a patient as of 7/25/12. A verbal order from PA B was documented on 7/20/12 at 12:11 AM for an enclosure bed restraint.

The PA B's "SCOPE OF PRACTICE AND SUPERVISING PHYSICIAN REQUEST FORM," dated 10/28/10, stated she could conduct History and Physical examinations and discharge summaries which must be countersigned by the supervising physician. It also stated the PA could "diagnose and manage minor illnesses or conditions" and "manage the health care of the stable chronically ill patient in accordance with the medical regimen initiated by the supervising physician." The agreement did not state the PA could evaluate the need for and order restraints.

The Regulatory Accreditation Coordinator reviewed the medical record on 7/25/12 beginning at 10:50 AM. She stated she thought PAs were authorized to order restraints.

Restraints were ordered for Patient #40 by a person who was not authorized to provide those orders.





3. Patient #7's medical record documented a [AGE] year old male who was admitted on [DATE] at 12:36 AM for care related to respiratory failure. According to the "History and Physical," dictated on 7/19/12 at 2:01 AM, respiratory failure was secondary to severe COPD, interstitial lung disease (a group of disorders that cause progressive scarring of lung tissue, affecting the ability to move adequate oxygen into the bloodstream) and a higher than normal carbon dioxide level in the blood. The "History and Physical," also documented Patient #7 was transported by paramedics and admitted through the ED, where he was intubated and transferred to CCU for continued treatment.

An order from the physician was documented on 7/19/12 at 12:34 AM for soft, bilateral wrist restraints. The "Restraint Non-Violent Form," dated 7/19/12 at 1:12 AM documented Patient #7 was reaching for his intubation tube and IV lines. Documentation in the section of the form titled, "Type of Restraints," included the use of soft bilateral wrist restraints and all side rails raised. Orders were not found in Patient #7's medical record that authorized the use of side rails as a restraint.

The Regulatory Accreditation Coordinator was interviewed on 7/26/12, beginning at 2:00 PM. She reviewed Patient #7's medical record and confirmed there was no order for the use of side rails as a restraint.

Restraints were used for Patient #7 without an order.
VIOLATION: FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE Tag No: A0724
Based on observation and staff interviews, it was determined the hospital failed to ensure 1 of 1 kitchen evaluated for environmental issues was maintained in such a manner as to ensure the safety and well-being of patients. Failure to maintain a clean food storage and preparation environment had the potential to result in negative outcomes for patients, staff, and visitors. Findings include:

1. During a tour of the hospital's kitchen, on 7/23/12 from 10:45 AM to 11:45 AM, accompanied by the Regulatory Accreditation Coordinator and Senior Food Service Director, the following concerns were noted:

a. In the produce cooler, foods were not labeled with expiration date and were not disposed of after expiring as follows:

i. There were buckets of blueberry, poppy seed, apple cinnamon, and chocolate muffin batter, dated 7/14/12. The Senior Food Service Director stated the mixes should have had a five day expiration date sticker on them. He stated the muffin batters had expired 7/19/12, which was four days before the survey and kitchen tour.

ii. A container of citrus curry dressing was dated 7/13/12, and had no expiration date. The Senior Food Service Director stated the dressing should have had a five day expiration sticker in place and should have been discarded on 7/18/12.

iii. On a rack directly under the container of citrus curry dressing, a large stainless steel bowl was noted to have a wrinkled and soiled plastic wrap covering. There was a sticky yellow substance on the sides of the bowl and on the plastic wrap. The bowl was identified by a piece of tape as containing leeks, and had no label to indicate when the leeks were prepared and would expire.

iv. A gallon container of peeled shallots was not dated to indicate when it was opened or when it expired.

b. The walk-in freezer posed the following safety issues:

i. Packages of food were open and undated, including, pasta sheets, hash brown cubes and apple strudel.

ii. The floor of the freezer had an area where an unidentified liquid had spilled and frozen over, this posed a safety hazard for kitchen staff. The Senior Food Service Director acknowledged the frozen spill. He did not offer an explaination how the slippery spill area could be cleaned, but stated the freezer floor could not be mopped.

c. The dishwashing room posed the following safety issues:

i. The floor was wet due to pooled water under the sink which extended beyond the rubber mats used for staff while working at the sink, posing a fall risk.

The Senior Food Service Director confirmed the presence of pooled water in this location during the tour on 7/23/12.

ii. The kitchen workers were observed rinsing the cooking utensils and stacking them on the floor. The dirty rinsed cookware was stacked resting against a rack which stored clean cookware and dishes.

The Senior Food Service Director stated the dirty utensils were placed on the floor as there was insufficient counter space while waiting for the dishwasher. He confirmed the dirty utensils were resting against the clean cookware rack, and told a kitchen worker to move the wet soiled utensils.

d. The fluorescent lights over the grill area were covered with a clear panel. The panels had a thick brown layer of grease.

The Senior Food Service Director stated the panels were wiped down nightly, but confirmed the grease had not been removed during the cleaning process.

e. The catering pantry had the following food storage and safety concerns:

i. A pipe anchored to a wall had condensation dripping into a receiving drain on the floor. The drain was not covered or screened to prevent insect and or rodent entry.

ii. The catering pantry had a counter with personal coffee cups, food, office supplies, a radio and personal hand lotion. The food and personal items were directly over a rack which held clean glasses and stemware.

The Senior Food Service Director described the counter as an employee work area and requested a kitchen worker remove the rack with clean stemware.

f. Sections of the kitchen floor had areas of residual from dried spills of food and/or liquid items. Small pieces of food and dust debris littered the floor behind the grill and oven unit, as well as, the pantry for dry food storage and clean cooking utensil racks.

During the tour on 7/23/12, the Senior Food Service Director stated housekeeping was responsible for cleaning the department after the kitchen was closed. The nightly cleaning included scrubbing and hosing down the floors and behind the equipment.

The physical environment of the dietary department was not adequately maintained to ensure the safety and well-being of patients.
VIOLATION: MEDICAL RECORD SERVICES Tag No: A0450
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and review of medical records it was determined the facility failed to ensure that all medical record entries were complete for 7 of 39 inpatients (#11, #37, #38, #39, #45, #49 and #50) whose records were reviewed. Failure to ensure complete documentation resulted in lack of clarity of the course of hospital events and incomplete medical records. Findings include:

1. Patient #45 was a [AGE] year old female admitted on [DATE] for a total laparoscopic hysterectomy. Her medical record contained the following discrepancies resulting in incomplete documentation:

a. Patient #45's medical record contained documentation of an anesthesia preoperative assessment, completed and signed by the anesthesiologist on 7/25/12 at 8:53 AM. The assessment contained documentation that indicated the surgeon's H&P had been reviewed and anything different from that H&P would be documented in the anesthesia evaluation. The past medical history indicated Patient #45 was a smoker with occasional use of inhalers for asthma. The assessment contained a list of Patient #45's allergies and medications. The section of the assessment dedicated to the physical examination contained documentation of the initial set of vital signs, a description of Patient #45's mouth and airway and documentation that Patient #45 was oriented to person, place, time, and situation. In addition the anesthesiologist documented that Patient #45's breath sounds were equal bilaterally with no wheezing, rhonci, or rales and that her cardiac sounds indicated a regular rhythm without murmurs or gallops. The remainder of the assessment documentation included laboratory values, the anesthesia risk classification for Patient #45, and documentation of the discussion of the anesthesia plan with Patient #45.

However, the documentation in the anesthesia preoperative assessment was not consistent with information presented upon interview with Patient #45 and the anesthesiologist.

Patient #45 and her spouse were interviewed on 7/25/12 at 9:15 AM. She stated she met with her surgeon on the Friday prior to surgery. She explained that the surgeon reviewed the procedure, risks and benefits, but did not do a physical examination at that appointment. She confirmed that her surgeon had not been in to see her on 7/25/12 as of 9:15 AM. She stated the anesthesiologist had visited her that morning and explained the details of her anesthesia plan and reassured her of the safety of the anesthesia. She confirmed that the anesthesiologist did evaluate her mouth and oral cavity but did not listen to her heart or lungs with a stethoscope.

The Anesthesiologist was interviewed on 7/25/12 at 9:20 AM. He stated it was the anesthesiologist's responsibility to update the H&P in the medical record. He stated the anesthesiologist does not redo the physical examination portion. He stated if the patient had any concerning symptoms, such as new symptoms since the history was completed by the surgeon, he completed a focused examination. He stated he may listen to the patient's heart and lungs with a stethoscope if they had any cardiopulmonary diagnoses. He did state that the RN's always completed the physical examination.

A second surveyor interviewed the Anesthesiologist on 7/25/12, beginning at 9:25 AM. He stated there was a new, anesthesia-specific section of the hospital's EMR that went into effect recently. As he demonstrated the use of the new section of the EMR, the Anesthesiologist reviewed Patient #45's medical record. He stated he met with Patient #45 earlier that morning and explained the risks and benefits related to the use of general anesthesia. He said he performed a focused assessment, which consisted of an oral/airway examination. When asked if he assessed the heart and lungs, the Anesthesiologist stated the pre-operative nurse listened to the heart and lungs that morning during her physical examination of Patient #45. He went on to explain he would not listen to heart and lungs unless a condition change was reported after the physical assessment was completed by the surgeon. He then said he would listen to the patient's heart and lungs if they had any cardiopulmonary diagnoses. As the Anesthesiologist continued to review Patient #45's EMR, he read aloud that she had a significant history of smoking cigarettes and was diagnosed with [DIAGNOSES REDACTED]. He said based on the conversation he had with her that morning, Patient #45's condition was unchanged. He then said she was instructed to use her inhaler before arriving at the hospital, which was a typical practice for patients' with histories of asthma undergoing surgery.

The medical record did not clearly reflect the anesthesia assessment of Patient #45's care.

b. Patient #45's EMR contained a documented titled, "History & Physical." At the bottom of the form, beneath the name of the surgeon who dictated the report, was documentation which indicated the report was dictated on 7/25/12 at 12:35 AM, transcribed at 2:28 AM, and the date of service was 7/25/12. The H&P contained information regarding Patient #45's past medical and surgical history, a review of systems, and a physical examination which indicated Patient #45's lung sounds were "Clear to auscultation (listening with a stethoscope)," her heart rate was a regular rhythm, and the results of a pelvic examination.

However, Patient #45 and her spouse were interviewed on 7/25/12 at 9:15 AM. She stated she met with her surgeon on Friday prior to surgery (7/20/12). She explained that the surgeon reviewed the procedure, risks and benefits, but did not do a physical examination at that appointment. She confirmed that her surgeon had not been in to see her on 7/25/12 as of 9:15 AM.

The Preop RN was interviewed on 7/25/12 at 9:20 AM. She reviewed the electronic documentation in Patient #45's record. She reviewed the H&P for Patient #45. She stated she was unable to determine exactly when the H&P had been performed and confirmed that while the surgeon may have dictated the report after midnight on 7/25/12, the report did not clearly document when the physical examination had been conducted.

The medical record did not clearly document the course of events of Patient #45's care.

2. Patient #49 was a [AGE] year old female admitted on [DATE] for care of a post-operative infection following a hip joint replacement. Her medical record contained a document titled, "Post Operative Note." Documentation at the top of the form indicated it was a "Final Report." The "Post Operative Note" was completed and signed by the surgeon on 7/23/12 at 8:07 PM. The report indicated surgery was completed on 7/23/12 at 6:35 PM. Patient #49's record also contained an "Operative Report." The documentation indicated this was a "New version to correct visit, 7/24/12," and that this was a "Final Report." The "DATE OF PROCEDURE" was documented as 7/24/12.

The Charge Nurse for the Orthopedic unit reviewed Patient #49's medical record on 7/25/12 at 2:45 PM. She confirmed that the surgical procedure was performed on 7/23/12 at 6:35 PM which is consistent with the "Post Operative Note." She confirmed that the dictated operative report indicated the surgery was completed on 7/24/12, which was not correct. She agreed the medical record did not correctly or consistently document the course of events for Patient #49.

The medical record did not clearly reflect events of Patient #49's care.





3. Patient #38 was a [AGE] year old female, admitted on [DATE] with pregnancy complicated by [DIAGNOSES REDACTED]] disorder), and heart failure. Patient #38's record indicated she had a Caesarean Section on 7/21/12. An "Anesthesia Preoperative Assessment," dated 7/21/12 at 7:27 AM, included notation by the Anesthesiologist that a consent was signed, and the procedure was discussed with the patient. However, Patient #38's record indicated she was intubated and chemically paralyzed and therefore would have been unable to participate in the decision or the consent for anesthesia.

During an interview with on 7/24/12 beginning at 2:00 PM, the Anesthesiologist who provided the anethesia reviewed Patient #38's medical record and confirmed she did not sign a consent, and she was unable to participate in a discussion regarding anesthesia. He stated he had been in error regarding his documentation that Patient #38 had signed a consent. The Anesthesiologist stated the EMR contained a formatted screen for the Anesthesia Preoperative Assessment and included prompts, as well as, personalized preferences for each practitioner. He stated his personalized preferences had pre-populated data that could be modified. The sections related to the consent, including the statement "discussed with patient" were made in error.

The medical record did not clearly reflect events of Patient #38's care.

4. Patient #11 was a 7 week old male, born 5/29/12 at 30 weeks gestation (10 weeks early). His record contained the results of an umbilical cord sampling for a drug screen. The record included an order for the drug screen, however, there was no documentation to support the reasons for the test, and no documentation of parental consent.

A hospital policy titled "NEWBORN TOXICOLOGY TESTING," dated 2/22/12, indicated the RN or LIP was to document in the newborn EMR the reasons for ordering drug screening of the newborn. In addition, staff were to document notifying the mother when a drug screen was ordered.

During an interview on 7/23/12 beginning at 2:10 PM, the NICU Charge Nurse reviewed Patient #11's record and described the process for obtaining drug screens for neonatal patients. She stated certain criteria must be met before a drug screen could be ordered. She explained the criteria included such things as the mother's history of drug use, lack of prenatal visits, an abruption of the placenta, etc. She was unable to find documentation in the record that Patient #11's mother met any of the criteria for drug screening the newborn. The NICU Charge Nurse was unable to find documentation that Patient #11's mother had been informed of the drug testing of her infant.

The medical record did not contain documentation required by policy to ensure a complete medical record for Patient #11.





5. Patient #50 was a [AGE] year old male who was admitted on [DATE] at 10:45 AM for surgery related to degenerative joint disease in the left hip. The "Operative/Procedure Report," dated 7/23/12 at 6:08 PM, documented Patient #50 had a left total hip arthroscopy (procedure performed through small incisions used to insert instruments and to insert a camera to visualize the inside of a joint).

Patient #50's medical record was reviewed in the Orthopedic Unit on 7/25/12 at approximately 3:15 PM. An "Idaho Living Will and Durable Power of Attorney for Health Care" form was found in the record. The form documented that Patient #50 chose "Option 1" on the living will, which indicated he chose to receive "All treatment, Artificial Nutrition and Hydration" in the event that life sustaining measures became necessary during the hospitalization . The form also documented that Patient #50 designated an individual as his health care agent and durable power of attorney. Individuals chosen as first and second alternates were named on the document as well. The document was signed by Patient #50 and dated 7/27/12 (4 days after admission). Given that Patient #50 was admitted on [DATE], the document would not have been in effect as intended.

The Charge Nurse for the Orthopedic Unit was interviewed on 7/25/12, beginning at 3:10 PM. She stated the living will and durable power of attorney should have been issued, explained to Patient #50, and reviewed for accuracy by the pre-operative nurse. The Charge Nurse then stated she would discuss the document with Patient #50 and allow him to make corrections if he chose to do so.

The Director of Patient Safety and Regulatory Compliance was interviewed on 7/27/12, beginning at 8:10 AM. After researching the situation, she reported that a packet of pre-operative documents were mailed to Patient #50, and he brought the signed documents with him the date of surgery. She stated because the documents were already complete at the time of admission, Patient #50 did not go through the pre-operative screening process. She stated the responsibility for reviewing the admission documents then became the responsibility of the pre-operative nurse.

A RN in the pre-operative unit was interviewed on 7/27/12, beginning at 8:55 AM. The RN confirmed the pre-operative nurse assigned to the patient on the day of surgery was responsible for reviewing admission documents for accuracy, including the "Idaho Living Will and Durable Power of Attorney for Health Care."

The hospital did not ensure that the "Idaho Living Will and Durable Power of Attorney for Health Care" form was accurate in Patient #50's medical record.





6. Patient #39's medical record documented a [AGE] year old female who was admitted on [DATE] and was discharged on [DATE]. She was admitted for paranoid delusions and acute psychosis. A "Restraint/Seclusion Violent Form," dated 7/11/12 at 11:16 AM, stated hard restraints were applied to Patient #39's wrists and ankles at 10:30 AM. A "Restraint/Seclusion Violent Form," dated 7/11/12 at 11:32 AM, stated the restraints were discontinued at 11:00 AM.

The order for the above restraint was written on 7/11/12 at 4:03 PM. A progress note by the physician who wrote the order was not documented.

Patient #39's Physician was interviewed on 7/25/12 beginning at 8:45 AM. She stated she was present when Patient #39 was restrained and witnessed those behaviors. She confirmed she did not document the event or an examination of Patient #39.

Events surrounding the restraint of Patient #39 were not documented.

7. Patient #37's medical record documented a [AGE] year old male who was admitted on [DATE] following a motor vehicle accident and a head injury. He was discharged to the Rehabilitation Unit on 7/18/12.

Patient #37's record documented a "Progress Note" by the PA, dictated at 7/15/12 at 11:18 AM, which stated "The patient is severely agitated. We will do a trial of mitts with a Posey [vest] and restraints. If this does not work, we will consider getting a Vail bed."

Patient #37's record documented a verbal order from the PA was on 7/15/12 at 11:04 AM for bilateral wrist restraints. The order was signed by the PA on 7/15/12 at 2:52 PM. The order did not include mitts or a Posey restraint.

"Restraint Non-Violent Forms" for 7/15/12 and 7/16/12 were reviewed. They did not document Patient #37 was placed in mitts or in a Posey restraint.

The next progress note by the PA was dictated 7/16/12 at 5:37 PM. The note stated Patient #37 was restrained but did not mention mitts or a Posey restraint.

The Regulatory Accreditation Coordinator reviewed the medical record on 7/25/12 beginning at 10:50 AM. She confirmed the record did not document the status of the mitts or the Posey restraint.

Patient #37's record was not clear regarding the status of proposed restraint use.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, and review of policies and medical records, it was determined the facility failed to ensure implementation and monitoring of systems for mitigating potential infection control risks. This directly impacted 3 of 7 patients (#29, #45 and #57) for whom procedures were observed, 8 of 29 Departments/Units (Laboratory, Kitchen, Perioperative, Medical, Orthopedic, Telemetry, Neurology, and General Surgery) toured, and had the potential to impact all staff, visitors, and patients cared for at the facility. The failure to ensure implementation and monitoring of systems had the potential to expose patients and staff to infections. Findings include:

1. Biohazardous materials were not disposed of in a manner to minimize the risk of cross contamination as follows:

The hospital's "Exposure Control Precautions," policy, dated 5/10/12, indicated, "All Regulated Waste will be placed in a red bag. Red bag waste will be placed in a red, rigid container with a biohazard label to be transported off-site for incineration."

A housekeeper on the General Surgery Unit was interviewed on 7/23/12 at 11:10 AM. She stated that floor staff always placed biohazardous materials in the designated red biohazard bags. She explained that staff then placed the red bag on the floor next to the trash can in the patient's room and she would transport the red bag to the biohazard bin in the soiled utility room.

A housekeeper on the Telemetry Unit was interviewed on 7/24/12 at 2:30 PM. She confirmed that floor staff typically placed biohazardous materials in the red biohazard bags. She stated that she would find the bags on the floor next to the trash can in the patient's room. She stated that if the red bag had not been tied closed by nursing staff she would not remove the bag, but if it was a closed bag she would transport it to the red biohazard bin in the soiled utility room.

A housekeeper on the Neurology Unit was interviewed on 7/24/12 at 3:15 PM. She stated she did not have any concerns related to biohazardous materials placed in with the regular waste in the trash cans in patient's rooms. She stated staff placed biohazardous materials in the red biohazard bags and set the bags next to the trash can in the room. She explained that she transported the red bag to the biohazard bin in the soiled utility room.

Infection Prevention Specialists A, B, and C were interviewed jointly on 7/27/12 at 11:05 AM. All three individuals stated they believed that nursing staff were transporting the red biohazard bags to the hard-walled biohazard container in the soiled utility room. Each confirmed the expectation that the biohazard bags be disposed of immediately and not placed on the floor to await housekeeping services.

The facility failed to ensure that biohazardous materials were disposed of to minimize the risk of cross contamination.

2. Blood glucose monitors were not cleaned to minimize the risk of cross contamination as follows:

Patient #57 was a [AGE] year old female admitted on [DATE] for care of elevated blood glucose levels. An aide on the Medical Unit was observed to perform a blood glucose test on a Patient #57 on 7/24/12 at 11:20 AM. The aide removed the glucometer, inserted the test strip, and placed the glucometer on the patient's bed. She swabbed the patient's finger with alcohol and obtained the blood sample. She then placed the glucometer on a counter in the patient's room until the glucose level was read. She then removed the test strip and placed the glucometer back in the carrying case. She stated she cleaned the glucometer with Sani-wipes prior to docking it. She confirmed that she did not wipe down the glucometer between each patient use unless it was visibly soiled.

An aide on the Orthopedic Unit was interviewed on 7/25/12, beginning at 3:30 PM, about cleaning glucometers used on multiple patients. The aide stated she cleaned the machine before placing it back in the docking station. When asked to explain the hospital's policy and practice, she stated she was uncertain, but thought the machine should be cleaned once per shift. The aide confirmed she was not cleaning the glucometer after each patient use.

The hospital's "BLOOD GLUCOSE MONITORING" policy, dated 6/18/10, indicated the facility utilized the Precision Xceed Pro Glucometer for testing patients' blood glucose levels. According to the policy, the "Meter should be cleaned daily with Quality Control testing and as needed when exposed to patient blood, secretions or contaminates" and "Acceptable cleaning solutions include alcohol- and ammonia-based solutions (i.e. Sani-Cloth Plus wipes)." However, according to the CDC's website related to blood glucometer cleaning, last updated 5/02/12, "Whenever possible, blood glucose meters should not be shared. If they must be shared, the device should be cleaned and disinfected after every use, per manufacturer's instructions."

Infection Prevention Specialist B was interviewed on 7/27/12 at 11:05 AM. She confirmed that the facility's policy was to clean the blood glucometers on a daily basis.

The facility failed to ensure that blood glucose meters were cleaned between each patient use to minimize the risk of cross contamination.

3. The Perioperative area of the hospital was toured with Infection Prevention Specialist B on 7/25/12 from 9:15 AM to approximately 11:00 AM. The following infection control breaches were observed during the tour:

a. Patient #45 was admitted on [DATE] for a total laparoscopic hysterectomy. Her care was observed from 9:15 AM to 11:00 AM. At 10:47 AM the Circulating RN was observed to apply the antiseptic skin preparation to Patient #45. The RN donned sterile gloves and applied the skin prep solution to the abdominal region using sponges, beginning at the umbilicus and moving in outward circles to clean the entire abdomen. The RN then began to clean the perineal and vaginal region. He was observed to wipe down the outer thigh region before moving in toward the vagina. The RN was not observed to change gloves following the completion of prepping the skin and prior to the insertion of the urinary catheter, a sterile procedure.

The hospital's "Skin Antisepsis, Patient" policy was last reviewed 4/2012. The policy instructed staff to "Wear sterile gloves unless the antiseptic prep applicator is of sufficient length to prevent the antiseptic and patient's skin from coming in contact with the nonsterile glove." According to the policy, skin preparation of the perineum or vagina is as follows: "...Scrub the inner aspects of the thighs beginning at the labia majora and moving outward toward the knee, covering approximately the upper third of each thigh...Catheterization in conjunction with the perineal vaginal preparation...Complete the surgical prep...Remove and dispose of the prep gloves...Open the necessary catheter supplies...Don sterile gloves and insert a sterile catheter."

The Circulating RN was interviewed on 7/25/12 at 4:07 PM. He reviewed the technique for cleaning the vaginal area and inserting the urinary catheter. He stated he believed his gloves were still sterile after prepping the skin and therefore he was able to insert the urinary catheter under sterile conditions.

The Association of Surgical Technologists (AST), in an article titled, "Recommended Standards of Practice for Skin Prep of the Surgical Patient," noted the following standards of practice were "researched and authored by the AST Education and Professional Standards Committee and have been approved by the AST Board of Directors. They are effective October 20, 2008." The recommendations included, "The most important principle of skin prep is prepping always progresses from the clean to the dirty area...The paint solution should be applied with prep stick sponges, using the no-touch technique in order to avoid contamination from the gloves that came into contact with the prep-solution soaked sponges." In addition, "Abdominal-perineal and abdominal-vaginal procedures require separate skin preps since the perineal and vaginal areas are considered contaminated. The perineal or vaginal prep should be performed first in order to avoid splashing and contaminating the abdomen if it were to be prepped first."

During an interview on 7/27/12 at 11:05, Infection Prevention Specialist B explained that when the above policy was written staff were not using sterile gloves to apply skin prep. She stated the facility changed practices to using sterile gloves with the application of the skin prep and, therefore, the urinary catheter was instered under sterile conditions. She confirmed the hospital's "Skin Antisepsis, Patient" policy did not reflect this current practice. She also confirmed that the appropriate method to prep the vaginal area was to work from the vagina outward to the thighs.

b. On 7/25/12 at 11:00 AM, instruments were observed being removed from an OR after a completed operation. The equipment was loaded onto a cart with one side open, and much of the equipment was blood stained. One surveyor accompanied the OR Assistant as he transported the cart to the elevator designated for soiled equipment. The hallway through which the cart was transported had several clean hospital beds lined up against the wall. The open side of the cart faced these clean beds. The OR Assistant confirmed that the doors to the cart were not always closed to ensure containment, but that usually the open side of the cart faced away from the clean equipment occasionally stored in the hall way.

According to the hospital's "Environmental Sanitation in Perioperative Areas" policy, dated 10/04/10, "Contaminated articles leaving the operating room will be contained or covered..."

The facility failed to ensure infection control practices were followed to mitigate the risks of cross contamination in the Perioperative area.





4. The Laboratory was toured on 7/24/12 from 9:40 AM to 10:45 AM with the Lab Director and the Regulatory Accreditation Coordinator. The following infection control breaches were observed during the tour:

a. The sinks in the lab area each had multiple bottles of personal hand lotion.

A hospital policy, titled "HAND HYGIENE IN THE PREVENTION OF INFECTION," dated 2/16/12, stated "The hospital will supply hand lotion to employees," and "only hospital-approved lotions may be used by staff on nursing units."

b. Each sink, as well as, some of the work areas in the lab, had small plastic wash bottles containing a pale pink liquid. Some of the bottles were labeled, the dates on the bottles ranged from 12/2010 to 2011 and were written on faded tape. There was no indication if the date was a refill date or an expiration date, and the potency of the solution could not be determined.

During the tour, the Lab Director explained the bottles contained a disinfectant solution that was used to clean the counters and work areas in the lab. She stated the solution was mixed and stored in the autoclave room and the wash bottles were refilled as needed.

At 10:00 AM in the autoclave room, the Lab Director brought forth a plastic gallon container with "Isopropyl Alcohol" printed by the factory, and "Amphyl" written with a permanent marker. In addition, a line had been placed on the bottle to indicate a fill level. The Lab Director confirmed the bottle originally contained isopropyl alcohol. She was unsure of the amount, dilution, or contact time required for the Amphyl to be effective in cleaning of laboratory surfaces.

The facility failed to ensure the environment in the laboratory was maintained to mitigate risks of cross contamination.

5. During a tour of the hospital's kitchen, on 7/23/12 from 10:45 AM to 11:45 AM, accompanied by the Regulatory Accreditation Coordinator and Senior Food Service Director, the following infection control concerns were noted:

a. In the produce cooler, foods were not labeled with expiration date and were not disposed of after expiring as follows:

i. There were buckets of blueberry, poppy seed, apple cinnamon, and chocolate muffin batter, dated 7/14/12. The Senior Food Service Director stated the mix should have had a five day expiration date sticker on them. He stated the muffin batters had expired 7/19/12, which was four days before the survey and kitchen tour.

ii. A container of citrus curry dressing was dated 7/13/12, and had no expiration date. The Senior Food Service Director stated the dressing should have had a five day expiration sticker in place and should have been discarded on 7/18/12.

iii. On a rack directly under the container of citrus curry dressing, a large stainless steel bowl was noted to have a wrinkled and soiled plastic wrap covering. There was a sticky yellow substance on the sides of the bowl and on the plastic wrap. The bowl was identified by a piece of tape as containing leeks, and had no label to indicate when the leeks were prepared and would expire.

iv. A gallon container of peeled shallots was not dated to indicate when it was opened or when it expired.

b. In the walk in freezer packages of food were open and undated, including, pasta sheets, hash brown cubes and apple strudel.

c. In the dishwashing room the kitchen workers were observed rinsing the cooking utensils and stacking them on the floor. The dirty rinsed cookware was stacked resting against a rack which stored clean cookware and dishes.

The Senior Food Service Director stated the dirty utensils were placed on the floor as there was insufficient counter space while waiting for the dishwasher. He confirmed the dirty utensils were resting against the clean cookware rack, and told a kitchen worker to move the wet soiled utensils.

e. The catering pantry had the following infection control concerns:

i. A pipe anchored to a wall had condensation dripping into a receiving drain on the floor. The drain was not covered or screened to prevent insect and or rodent entry.

ii. The catering pantry had a counter with personal coffee cups, food, office supplies, a radio and personal hand lotion. The food and personal items were directly over a rack which held clean glasses and stemware.

The Senior Food Service Director described the counter as an employee work area and requested a kitchen worker remove the rack with clean stemware.

f. Small pieces of food and dust debris littered the kitchen floor behind the grill and oven unit, as well as, the pantry for dry food storage and clean cooking utensil racks.

During the tour on 7/23/12, the Senior Food Service Director stated housekeeping was responsible for cleaning the department after the kitchen was closed. The nightly cleaning included scrubbing and hosing down the floors and behind the equipment.

The physical environment of the dietary department was not adequately maintained to ensure the safety and well-being of patients.

6. Hand hygiene was not performed in accordance with policy to mitigate the risk of cross contamination as follows:

a. During a tour of the Outpatient Lab area, from 10:10 to 10:30 AM, two phlebotomy procedures were observed. The first procedure was observed at 10:15 AM. The phlebotomist cleansed the patient's arm with alcohol, then palpated the site and performed the puncture without re-cleansing the site. After obtaining the sample, still wearing soiled gloves, she opened a drawer and removed the phlebotomy tubes for the sample. The phlebotomist removed her gloves and did not perform hand hygiene. She took the specimen tubes to a location in the lab area that had a computer and typed on the keyboard. After she entered information on the computer, the phlebotomist was observed to perform hand hygiene using hand sanitizer. The phlebotomist did not wipe down the computer keyboard or work area after she finished.

The Lab Director confirmed the above observations during the tour. She stated she did not see fault when observing the phlebotomist wear gloves during the procedure, removing them, not performing hand hygiene then touching the computer and work areas.





b. Patient #29 was a [AGE] year old male who was admitted on [DATE], for treatment related to altered mental status and a recent history of a sacral (base of the spine) decubitus ulcer.

Two RNs were observed while performing a dressing change of the decubitus ulcer, on 7/24/12 at 10:15 AM. The RNs reviewed the orders for the dressing change and assembled supplies for the dressing. After washing their hands and donning gloves, the RNs explained the procedure to Patient #29 and turned him on his left side in order to access the wound. There was no dressing found to be in place when Patient #29 was turned, but he was found to be soiled with feces. This required the nurses to clean the area before proceeding with the dressing change. Both RNs were observed to have exposed their gloved hands to the soiled area. The RNs then noticed they had failed to assemble supplies for cleaning the perineal area. While RN A remained with Patient #29, and assisted him to maintain positioning, RN B obtained additional supplies from the closet in Patient #29's room. RN B was not observed to change her gloves prior to obtaining additional supplies, and therefore touched the closed doors and supplies inside the closet with soiled gloves. After cleaning Patient #29, both RNs' disposed of soiled materials, performed hand hygiene, and put on clean gloves before performing the dressing change.

RN A and RN B were interviewed immediately after completing the dressing change. Both confirmed the hospital's practice was to remove the potentially soiled gloves and dispose of them prior to touching surfaces in the room.

Infection Prevention Specialist C was interviewed on 7/27/12, beginning at 11:05 AM. She stated the facility has been working with the nursing staff to improve the practice of assembling all necessary supplies prior to beginning a treatment or procedure.

The hospital's "Exposure Control Precautions" policy, dated 5/10/12, indicated hand hygiene was to be performed, "Before and after patient contact, after contact with the patient's environment, and after removing personal protective equipment (PPE) including gloves." In addition, "Hand hygiene is required after removal of gloves. Gloves must be removed immediately after completing procedure and hand hygiene performed prior to continuing other activities, for example, charting, use of telephone, computers, etc, and before leaving the work area."

The facility failed to ensure the implementation and monitoring of systems for mitigating potential infection control risks throughout the hospital.
VIOLATION: PATIENT RIGHTS: INFORMED CONSENT Tag No: A0131
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on medical record review, staff interview and review of hospital policies, it was determined the hospital failed to ensure 6 of 39 inpatients (#7, #10, #11, #38, #47 and #48) whose records were reviewed, had the opportunity to make informed decisions about his or her health status. This also had the potential to impact all new born patients. This failure had the potential to result in procedures being performed without fully executed informed consents. Findings include:

The hospital's "CONSENT FOR MEDICAL TREATMENT" policy, dated 1/19/11, stated "It is the policy of [the facility] that a patient or patient representative shall give voluntary and informed consent for all care, treatment and services involving material risk." The policy also included "L.I.P. must document through a fully executed, timed and dated Consent Form that he or she has obtained Informed Consent from Patient prior to any Procedure..." Additionally, the policy documented "If a patient is unable to sign his or her name and is unable to make even a mark, such Patient must ask another person to sign his or her name. The Medical Employee must witness the execution of the Consent Form by such other person on behalf of Patient and must indicate on the Consent Form that he or she witnessed the third party sign at Patient's request."

The "MEDICAL RECORDS" policy, undated, indicated each medical record would contain evidence of properly executed informed consents.

Informed consents were incomplete as follows:

1. Patient #7's medical record documented a [AGE] year old male who was admitted on [DATE] at 12:36 AM for care related to respiratory failure. According to the "History and Physical," dictated on 7/19/12 at 2:01 AM, respiratory failure was secondary to severe COPD, interstitial lung disease (a group of disorders that cause progressive scarring of lung tissue, affecting the ability to move adequate oxygen into the bloodstream) and a higher than normal carbon dioxide level in the blood. The "History and Physical," also documented Patient #7 was transported by paramedics and admitted through the ED, where he was intubated and transferred to CCU for continued treatment.

A "Critical Care Progress" note, dictated 7/20/12 at 11:38 AM, documented the physician planned a bronchoscopy (procedure that allows a physician to look at a patient's airway through a thin viewing instrument called a bronchoscope) for Patient #7. The note specifically stated, "I was able to arouse [the patient] and talk to him. I told him I needed to do a bronchoscopy through his tube. He has had these procedures before, and in fact, I have performed them on him before." The physician's progress note further stated Patient #7 was being maintained on a mechanical ventilator. A "Bedside Procedure Form," dated 7/19/12 at 11:21 AM, indicated Patient #7 underwent a bronchoscopy. An operative consent form signed by Patient #7 or Patient #7's designee could not be found in the medical record.

The RN caring for Patient #7 at the time of the bronchoscopy was interviewed on 7/26/12, beginning at 8:30 AM. The RN stated she witnessed the physician obtaining a verbal consent for the procedure from Patient #7. She also stated Patient #7 was coherent and able to understand the situation. When asked to explain the hospital's process related to patients' who are unable to sign a surgical consent and do not have a representative present, the RN stated the hospital's practice was 2 RNs witnessed and signed the surgical consent form with the patient's verbal permission. The RN confirmed a surgical consent form was not reviewed and signed for Patient #7.

The hospital failed to ensure a signed surgical consent form was in Patient #7's record for a bedside bronchoscopy.





2. Patient #10 was a male admitted to the NICU, born 7/21/12 at 28 weeks gestation (12 weeks early). Patient #10 required required mechanical ventilation to assist with his breathing and multiple central lines. The medical record documented a UAC for monitoring purposes, a UVC for blood sampling and medication delivery, and a percutaneous CVL for medication administration when the umbilical lines were discontinued.

The "CONSENT FOR TREATMENT AND PATIENT SERVICE AGREEMENT" dated 7/21/12, was signed by Patient #10's father. The consent stated "...no substantial medical procedure will be performed without my informed consent as required by law." Patient #10's record did not have consents for the intubation, UAC, UVC, or percutaneous CVL.

A policy, titled "CONSENT FOR MEDICAL TREATMENT," dated 1/19/12, included types of procedures requiring informed consent that must be evidenced by a separate consent form. Examples of procedures requiring informed consent included central line insertion, intubation, and invasive monitoring such as an arterial line.

During an interview on 7/23/12 beginning at 2:10 PM, the NICU Charge Nurse reviewed Patient #10's record and confirmed there were no consents for the central lines, intubation and invasive monitoring.

Informed consents for invasive procedures were not obtained for Patient #10.

3. Patient #11 was a 7 week old male, born 5/29/12 at 30 weeks gestation (10 weeks early). According to the medical record Patient #11 required donor breast milk to meet nutrition needs.

The "Donor Breast Milk" policy, dated 3/24/11, indicated in order to use donor breast milk, a signed hospital admission consent was required. However, the "CONSENT FOR TREATMENT AND PATIENT SERVICE AGREEMENT," was signed by Patient #11's mother but was not timed or dated. The consent was incomplete.

During an interview on 7/23/12 beginning at 2:10 PM, the NICU Charge Nurse reviewed Patient #11's record and confirmed the admission consent was incomplete. The NICU Charge Nurse stated premature infants often needed breast milk, and if the mother was unable to provide an adequate supply, the baby would get donor breast milk. She stated use of donor breast milk was implied in the admission consent and there was not another specific consent obtained when donor breast milk was used.

A complete admission consent was not obtained for Patient #11.

4. Patient #47 was a [AGE] year old female admitted to the facility on [DATE] for a scheduled induction of labor. Her medical record contained a "CONSENT FOR INDUCTION OF LABOR," signed by the Midwife and Patient #47 on 7/03/12 at 1:45 PM, prior to the admission for delivery. The consent was lacking a signature, date and time for the witness portion of the consent.

Patient #47 required a cesarean section to deliver her baby. A form, "ANESTHESIA EVALUATION," was completed by the anesthesiologist on 7/23/12 at 8:55 AM. The anesthesiologist noted Patient #47 was Russian speaking and the anesthesia consent was obtained with an interpreter. However, the "ANESTHESIA CONSENT," signed by both anesthesiologist and Patient #47 on 7/23/12 at 8:56 AM, was lacking a signature, date and time for the witness portion of the consent. There was no documentation on the consent that an interpreter was present while the consent was obtained.

A policy titled "CONSENT FOR MEDICAL TREATMENT," dated 1/19/12, included "If a Patient cannot understand English, the LIP must convey the Required Information (and answer any questions of Patient) through a translator speaking Patient's language." Additionally, the policy stated "A Medical Employee must witness the execution of the Consent Form by Patient and confirm that Patient has no further questions regarding the Required Information or the Procedure."

During an interview on 7/25/12 beginning at 3:00 PM, the Charge Nurse of the Family Maternity Center reviewed Patient #47's record and confirmed the consents were incomplete. The Charge Nurse stated she was unaware Patient #47 required the services of a translator.

Informed consents were not complete for Patient #47.

5. Patient #38 was a [AGE] year old female, admitted on [DATE] with pregnancy complicated by [DIAGNOSES REDACTED]] disorder), and heart failure. Patient #38's medical record indicated she had a Caesarean Section on 7/21/12. An "Anesthesia Preoperative Assessment," dated 7/21/12 at 7:27 AM, included notation by the anesthesiologist that a consent was signed, and the procedure was discussed with the patient. However, Patient #38's medical record indicated she was intubated, and chemically paralyzed and therefore would have been unable to participate in the decision or the consent for anesthesia. The medical record did not contain an anesthesia consent.

During an interview with on 7/24/12 beginning at 2:00 PM, the Anesthesiologist who provided the anesthesia, reviewed Patient #38's medical record and confirmed there was no anesthesia consent. He stated he had been in error regarding his documentation that Patient #38 had signed a consent.

6. Patient #48 was a newborn male, born 7/24/12. His medical record did not include a "CONSENT FOR TREATMENT AND PATIENT SERVICE AGREEMENT."

According to the "CONSENT FOR MEDICAL TREATMENT" policy, dated 1/19/11, "A patient or patient representative shall give voluntary and informed consent for all care, treatment and services." In addition, the policy specified that an admission to the medical facility required an informed consent. The "MEDICAL RECORDS" policy, undated, indicated each medical record would contain evidence of properly executed informed consents.

During an interview on 7/25/12 beginning at 3:00 PM, the Charge Nurse of the Family Maternity Center reviewed Patient #48's record and confirmed there was no consent. She stated the facility did not obtain a consent for treatment for newborn patients. She confirmed an admission consent would not be found in any of the newborns' records.

The facility failed to ensure that medical records contained properly executed informed consents.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0178
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on staff interview and review of medical records, it was determined the hospital failed to ensure 1 of 2 patients (#39), who were restrained for violent behavior, received a face to face examination by a qualified person. This resulted in a lack of assessment to determine causes for the behavior and determination as to the appropriateness of the restraint. Findings include:

Patient #39's medical record documented a [AGE] year old female who was admitted on [DATE] and was discharged on [DATE]. She was admitted for paranoid delusions and acute psychosis. A "Restraint/Seclusion Violent Form," dated 7/11/12 at 11:16 AM, stated hard restraints were applied to Patient #39's wrists and ankles at 10:30 AM. The form stated Patient #39 was "Attempting to strike out at others..." The restraints were discontinued at 11:00 AM that same day. Documentation of a face to face evaluation was not present in the medical record.

The Regulatory Accreditation Coordinator reviewed the medical record on 7/24/12 beginning at 11:10 AM. She confirmed evidence of a face to face evaluation of Patient #39 within 1 hour of the time of restraint was not present in the medical record.

A face to face evaluation of Patient #39 was not conducted.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, staff interview, and review of medical records and user manuals, it was determined the hospital failed to ensure 1 of 2 patients in net bed restraints (#56), whose records were reviewed, was restrained in a safe manner. The use of unsafe restraint techniques had the potential to cause serious injury or death. Findings include:

Patient #56's medical record documented a [AGE] year old male who was admitted on [DATE] and was discharged on [DATE]. Diagnoses included stroke and bipolar disorder. Physician orders, dated 7/13/12 at 5:33 PM, 7/14/12 at 3:46 PM, and 7/15/12 at 3:26 PM, all included "All Side Rails Up, Enclosure Bed/Net Bed, Soft Limb X2 [wrist restraints]." Nursing notes documented these restraints were utilized in accordance with the orders.

The hospital utilized the same model of enclosure bed for all patients who needed one. The Regulatory Accreditation Coordinator accompanied the surveyor to the Rehabilitation Unit to observe an enclosure bed on 7/25/12 at 4:10 PM. A sign on the side of the bed contained a warning which stated to leave the side rails down in order "...to prevent side rail entrapment." The Regulatory Accreditation Coordinator provided a copy of the bed's user manual, not dated. The manual stated "Never leave side rails in the up position when the patient compartment is closed. A failure to follow this warning may result in serious injury or death from entrapment in the side rails, or between the mattress and the side rails."

RN C was interviewed on 7/25/12 beginning at 4:35 PM. She stated she cared for Patient #56 while he was in the net bed. She stated the side rails were up when the bed was enclosed with the net. She stated she was not aware of the warning to avoid using side rails in conjunction with the enclosed bed.

The hospital put Patient #56 at risk for injury by placing him in an enclosure bed with the side rails up.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0169
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on staff interview and review of medical records and hospital policies, it was determined the hospital failed to ensure orders for the use of restraints were not written on an a prn basis for 1 of 7 restrained patients (Patient #40) whose records were reviewed. The use of restraints on a prn basis had the potential to result in the unnecessary use of restraints. Findings include:

Patient #40's medical record documented a [AGE] year old male who was admitted on [DATE] following a fall with a closed head injury. He was currently a patient as of 7/25/12. Daily orders for "Enclosure Bed/Net Bed" restraints were documented beginning on 7/18/12 at 11:50 PM, 7/19/12, 7/20/12, 7/21/12, 7/22/12, and 7/23/12. The order dated 7/18/12 at 11:50 PM, stated to release Patient #40 "When awake and out of bed." The order dated 7/20/12 at 12:11 AM stated to release Patient #40 "When awake and out of bed, or when sitter available to be with patient."

Patient #40's medical record contained a nursing "Handoff Form," dated 7/18/12 at 6:41 PM. The form stated "Sitter dc'd at NOC from 2300 to 0700, enclosure bed ordered, only to be zipped up during these times, not when sitter is present. Will need to initiate restraint orders at 2300 when enclosure bed zipped. Can order restraint as a verbal order per Dr...Pt calm and cooperative today."

The Regulatory Accreditation Coordinator reviewed the medical record on 7/24/12 beginning at 2:00 PM. She confirmed the orders for the enclosure bed. She stated the restraint had been used for Patient #40 from 7/18/12 through 7/23/12. She stated the restraint had been used instead of a sitter from 11:00 PM until 7:00 AM.

The hospital policy "Restraint and Seclusion," dated 7/03/12, stated "...as needed (PRN) restraint orders are not acceptable unless the patient is in and out of restraint as a normal part of daily treatment. Examples include...If a patient's status requires...an enclosure bed is used while the patient is in bed, a standing order or prn is permitted." The Regulatory Accreditation Coordinator, interviewed on 7/24/12 beginning at 2:00 PM, confirmed the hospital allowed the use of enclosure beds on a prn basis.

The use of an enclosure bed for Patient #40 was based on the availability of sitters and staff to supervise the patient. It was not based on the behavior of the patient or on staff assessment of the need for restraint. The enclosure bed was used prn when staff were not available to supervise Patient #40.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0164
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on staff interview and review of medical records, it was determined the hospital failed to ensure restraints were used only when less restrictive interventions had been determined to be ineffective. This affected the care of 2 of 7 restrained patients (#37 and #40) whose records were reviewed. The lack of patient assessment, including the evaluation of less restrictive interventions, had the potential to result in the unnecessary use of restraints. Findings include:

1. Patient #40's medical record documented a [AGE] year old male who was admitted on [DATE] following a fall which resulted in a closed head injury. He was currently a patient as of 7/25/12.

Patient #40's medical record contained a nursing "Handoff Form," dated 7/18/12 at 6:41 PM. The form stated "Sitter dc'd at NOC from 2300 to 0700, enclosure bed ordered, only to be zipped up during these times, not when sitter is present. Will need to initiate restraint orders at 2300 when enclosure bed zipped. Can order restraint as a verbal order per Dr...Pt calm and cooperative today."
"Restraint Non-Violent Forms" documented Patient #40 was placed in an enclosure bed restraint at 11:30 PM on 7/18/12 and remained restrained through 6:00 AM on 7/19/12. The section labeled "Alternatives to Restraints Attempted," at midnight on 7/19/12 (the first note), stated "Bed Alarm, Frequent toileting, Increased observation, Moved closer to nurses' station, Promoted normal sleep pattern, Verbal reminders." The note stated Patient #40 was currently sleeping. The note did not explain the alternatives or state how they had been ineffective. For example, the note did not document when the last time was the bed alarm had been used or why it had not been effective. It appeared a sitter had been an effective alternative but this was not mentioned in the "Alternatives." The note did not define frequent toileting, increased observation, promoted normal sleep pattern, or verbal reminders. The note did not say how these related to the need for restraint for Patient #40. "Restraint Non-Violent Forms" documented Patient #40 was again placed in an enclosure bed restraint at 11:00 PM on 7/19/12 and remained restrained through 4:00 AM on 7/20/12. The section labeled "Alternatives to Restraints Attempted," at 11:00 PM on 7/19/12 stated "Bed Alarm, Environmental modification, Increased observation, Visually supervised, Other: close observation." Again, the medical record did not define these terms or explain how they had been ineffective.

The Regulatory Accreditation Coordinator reviewed Patient #40's medical record with the surveyor on 7/24/12 beginning at 2:00 PM. She confirmed the medical record did not document an assessment of the need for restraints that included less restrictive interventions that had been tried and found ineffective.

The hospital did not comprehensively assess the need for restraint for Patient #40 including the effectiveness of less restrictive interventions.

2. Patient #37's medical record documented a [AGE] year old male who was admitted on [DATE] following a motor vehicle accident and a head injury. He was discharged to the Rehabilitation Unit on 7/18/12. Physician orders on 7/13/12, 7/14/12, and 7/15/12 called for the use of bilateral wrist restraints. "Restraint Non-Violent Forms" documented Patient #37 was restrained during those days. None of the forms stated what type of restraints were being used, although the "Restraint Non-Violent Form," dated 7/13/12 at 4:00 AM, documented "pt able to unclip right restraint and then left restraint." An assessment of the need for restraints including less restrictive interventions that had been attempted and that had been ineffective was not documented on 7/13/12, 7/14/12 and 7/15/12.

Physician orders for restraints, dated 7/13/12 at 8:10 AM, 7/14/12 at 7:49 AM, and 7/15/12 at 11:04 AM, stated "Alternatives Tried: Counseling." No details were documented and no other less restrictive measures were documented.

The Regulatory Accreditation Coordinator reviewed Patient #37's medical record with the surveyor on 7/25/12 beginning at 10:22 AM. She confirmed the medical record did not document an assessment of the need for restraints that included less restrictive interventions that had been tried and found ineffective.

The hospital did not comprehensively assess the need for restraint for Patient #37 including the effectiveness of less restrictive interventions.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0166
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on staff interview and review of medical records, it was determined the hospital failed to ensure plans of care were modified to provide direction to staff for 3 of 7 restrained patients (#37, #40 and #56) whose records were reviewed. The lack of care planning had the potential to interfere with a consistent approach in the care of patients who were restrained. Findings include:

1. Patient #40's medical record documented a [AGE] year old male who was admitted on [DATE] following a fall which resulted in a closed head injury. He was currently a patient as of 7/25/12.

"Restraint Non-Violent Forms" documented Patient #40 was placed in an enclosure bed restraint at 11:30 PM on 7/18/12 and remained restrained through 6:00 AM on 7/19/12. "Restraint Non-Violent Forms" documented Patient #40 was again placed in an enclosure bed restraint at 11:00 PM on 7/19/12 and remained restrained through 4:00 AM on 7/20/12.

The nursing "Care Plans" document for Patient #40 contained a section dated 7/18/12 at 11:53 PM labeled "IPOC Risk of Injury to Self/Others: with/without restraints-risk for Inj: Restraint Non-Beh [behavioral] (Initiated)." The plan listed "Outcomes" such as "Absence of Inadvertent Self Injury-Achieved or Progressing" and "Med interventions no longer necessary-Achieved or Progressing." "Achieved" or "Progressing" was then documented daily after the outcomes. No explanation of the terms achieved or progressing was listed. No direction to staff regarding caring for Patient #40 was included in the plan.

The Regulatory Accreditation Coordinator reviewed Patient #40's medical record with the surveyor on 7/24/12 beginning at 2:00 PM. She confirmed the lack of a specific care plan.

The hospital did not develop a specific POC for Patient #40.

2. Patient #37's medical record documented a [AGE] year old male who was admitted on [DATE] following a motor vehicle accident and a head injury. He was discharged to the Rehabilitation Unit on 7/18/12. Physician orders on 7/13/12, 7/14/12, and 7/15/12 called for the use of bilateral wrist restraints. "Restraint Non-Violent Forms" documented Patient #37 was restrained during those days. None of the forms stated what type of restraints were being used, although the "Restraint Non-Violent Form," dated 7/13/12 at 4:00 AM, documented "pt able to unclip right restraint and then left restraint."

The nursing "Care Plans" document for Patient #37 contained a section dated 7/06/12 at 6:53 PM labeled "IPOC Risk of Injury to Self/Others: with/without restraints-risk for Inj: Restraint Non-Beh (Initiated)." The plan listed "Outcomes" such as "Absence of Inadvertent Self Injury-Achieved or Progressing" and "Med interventions no longer necessary-Achieved or Progressing." "Unchanged" or "Progressing" was then documented daily after the outcomes. No explanation of the terms achieved or progressing was listed. No direction to staff regarding caring for Patient #37 was included in the plan.

The Regulatory Accreditation Coordinator reviewed Patient #37's medical record with the surveyor on 7/25/12 beginning at 10:22 AM. She confirmed the lack of a specific care plan.

The hospital did not develop a specific POC for Patient #37.

3. Patient #56's medical record documented a [AGE] year old male who was admitted on [DATE] and was discharged on [DATE]. Diagnoses included stroke and bipolar disorder. Physician orders, dated 7/13/12 at 5:33 PM, 7/14/12 at 3:46 PM, and 7/15/12 at 3:26 PM, all included "All Side Rails Up, Enclosure Bed/Net Bed, Soft Limb X2 [wrist restraints]." Nursing notes documented these restraints were utilized in accordance with the orders.

The nursing "Care Plans" document for Patient #56 contained a section dated 7/11/12 at 8:08 PM labeled "IPOC Risk of Injury to Self/Others: with/without restraints-risk for Harm to Self/Others." The plan listed "Outcomes" such as "Absence of Harm to Self and/or Others-Achieved or Progressing" and "Absence of Inadvertent Self Injury-Achieved or Progressing." "Unchanged" or "Progressing" was then documented daily after the outcomes. No explanation of the terms achieved or progressing was listed. No direction to staff regarding caring for Patient #56 was included in the plan.

The Regulatory Accreditation Coordinator reviewed Patient #56's medical record with the surveyor on 7/25/12 beginning at 3:20 PM. She confirmed the lack of a specific care plan.

The hospital did not develop a specific POC for Patient #56.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0185
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on staff interview and review of medical records, it was determined the hospital failed to ensure a description of behavior was documented for 2 of 7 restrained patients (#40 and #56) whose records were reviewed. The lack of documentation interfered with the hospital's ability to justify care provided to patients. Findings include:

1. Patient #40's medical record documented a [AGE] year old male who was admitted on [DATE] following a fall which resulted in a closed head injury. He was currently a patient as of 7/25/12.

"Restraint Non-Violent Forms" documented Patient #40 was placed in an enclosure bed restraint at 11:30 PM on 7/18/12 and remained restrained through 6:00 AM on 7/19/12. "Restraint Non-Violent Forms" documented Patient #40 was again placed in an enclosure bed restraint at 11:00 PM on 7/19/12 and remained restrained through 4:00 AM on 7/20/12. "Restraint Non-Violent Forms" documented Patient #40 was placed in an enclosure bed restraint at 8:00 PM on 7/21/12 and remained restrained through 6:00 AM on 7/21/12. "Restraint Non-Violent Forms" documented Patient #40 was placed in an enclosure bed restraint at 10:00 AM on 7/21/12 and documented he was not restrained at 12:00 noon on 7/21/12. "Restraint Non-Violent Forms" documented Patient #40 was placed in an enclosure bed restraint at 2:00 PM on 7/21/12 and documented he was not restrained at 4:00 PM on 7/21/12. The times Patient #40 was released from restraints was not documented.

The "Restraint Non-Violent Forms" did not include a description of Patient #40's specific behavior at the time he was restrained except 7/19/12 at midnight, 7/19/12 at 2:00 AM, 7/19/12 at 6:00 AM, 7/19/12 at 11:00 PM, 7/20/12 at 2:00 AM, and 7/21/12 at 6:00 AM, when it was documented Patient #40 was sleeping.

The Regulatory Accreditation Coordinator reviewed Patient #40's medical record with the surveyor on 7/24/12 beginning at 2:00 PM. She confirmed the lack of documentation related to specific behaviors Patient #40 exhibited that may have warranted the use of restraint.

The hospital did not document specific behaviors while Patient #40 was restrained.

2. Patient #56's medical record documented a [AGE] year old male who was admitted on [DATE] and was discharged on [DATE]. Diagnoses included stroke and bipolar disorder. Physician orders, dated 7/13/12 at 5:33 PM, 7/14/12 at 3:46 PM, and 7/15/12 at 3:26 PM, all included "All Side Rails Up, Enclosure Bed/Net Bed, Soft Limb X2 [wrist restraints]." Nursing notes documented these restraints were utilized in accordance with the orders.

The nursing "Restraint Non-Violent Forms," which contained the restraint assessments, did not document Patient #56's behavior from 7/13/12 at 6:00 AM to 7/14/12 at 10:00 AM (28 hours) except to state when he was asleep. From 7/14/12 at noon through 7/15/12 at 11:59 PM, the "Restraint Non-Violent Forms" did not document Patient #56's behavior.

The Regulatory Accreditation Coordinator reviewed Patient #56's medical record with the surveyor on 7/25/12 beginning at 3:20 PM. She confirmed specific behaviors warranting the use of restrain for Patient #56 were not documented.

The hospital did not document specific behaviors while Patient #40 was restrained.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0188
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on staff interview and review of medical records, it was determined the hospital failed to ensure the response to restraint interventions used, including the rationale for continued use of the intervention, was documented for 2 of 7 restrained patients (#40 and #56) whose records were reviewed. The lack of documentation interfered with the hospital's ability to justify the continued use of restraints. Findings include:

1. Patient #40's medical record documented a [AGE] year old male who was admitted on [DATE] following a fall which resulted in a closed head injury. He was currently a patient as of 7/25/12.

"Restraint Non-Violent Forms" documented Patient #40 was placed in an enclosure bed restraint at 11:30 PM on 7/18/12 and remained restrained through 6:00 AM on 7/19/12. "Restraint Non-Violent Forms" documented Patient #40 was again placed in an enclosure bed restraint at 11:00 PM on 7/19/12 and remained restrained through 4:00 AM on 7/20/12. "Restraint Non-Violent Forms" documented Patient #40 was restrained in the enclosure bed at 8:00 PM on 7/20/12 and remained restrained through 6:00 AM on 7/21/12. "Restraint Non-Violent Forms" documented Patient #40 was restrained in the enclosure bed at 10:00 AM on 7/21/12 and documented he was not restrained at 12:00 noon on 7/21/12. "Restraint Non-Violent Forms" documented Patient #40 was restrained in the enclosure bed at 2:00 PM on 7/21/12 and documented he was not restrained at 4:00 PM on 7/21/12. The times the restraints were discontinued were not documented.

The "Restraint Non-Violent Form," dated 7/19/12 at midnight, stated Patient #40 was sleeping when the restraint was applied. The "Restraint Non-Violent Forms," dated 7/19/12 at 2:00 AM and 7/19/12 at 6:00 AM, also documented Patient #40 was sleeping. The form, dated 7/19/12 at 4:00 AM, did not document Patient #40's behavior. The form, dated 7/19/12 at 4:00 AM, stated Patient #40's "Behavior for restraining continues" but it did not specify what that behavior was. The "Restraint Non-Violent Form," dated 7/19/12 at 11:00PM, stated Patient #40 was sleeping when the restraint was applied. The next "Restraint Non-Violent Form," dated 7/20/12 at 2:00 AM, also stated Patient #40 was sleeping. The next form, dated 7/20/12 at 4:00 AM, stated "Behavior for restraining continues" but it did not specify what that behavior was. The next form, dated 7/19/12 at 8:00 AM, stated Patient #40 was not restrained. The next "Restraint Non-Violent Form" that documented Patient #40 was restrained was dated 7/20/12 at 8:00 PM. It stated Patient #40's "Behavior for restraining continues" but it did not specify what that behavior was. The "Restraint Non-Violent Forms," dated 7/20/12 at 10:00 PM, as well as, 7/21 at midnight and 2:00 AM, stated "Behavior for restraining continues." The "Restraint Non-Violent Form," dated 7/21/12 at 4:00 AM, stated Patient #40 was released from restraint to have a snack in the dining room. The form stated he was placed back in the restraint at 3:15 PM. No behavior was documented. "Restraint Non-Violent Forms" stated Patient #40 was sleeping at 6:00 AM on 7/21/10 and was not restrained at 8:00 AM.

The Regulatory Accreditation Coordinator reviewed Patient #40's medical record with the surveyor on 7/24/12 beginning at 2:00 PM. She confirmed the lack of documentation related to Patient #40's response to the restraints.

The hospital did not document Patient #40's response to restraints.

2. Patient #56's medical record documented a [AGE] year old male who was admitted on [DATE] and was discharged on [DATE]. Diagnoses included stroke and bipolar disorder. Physician orders, dated 7/13/12 at 5:33 PM, 7/14/12 at 3:46 PM, and 7/15/12 at 3:26 PM, all included "All Side Rails Up, Enclosure Bed/Net Bed, Soft Limb X2 [wrist restraints]." Nursing notes documented these restraints were utilized in accordance with the orders.

The nursing "Restraint Non-Violent Forms," which contained the restraint assessments, did not document Patient #56's response to the restraints from 7/13/12 at 6:00 AM to 7/14/12 at 10:00 AM (28 hours) except to state when he was asleep. From 7/14/12 at noon through 7/15/12 at 11:59 PM, the "Restraint Non-Violent Forms" did not document Patient #56's response to the restraints.

The Regulatory Accreditation Coordinator reviewed Patient #56's medical record with the surveyor on 7/25/12 beginning at 3:20 PM. She confirmed specific responses related to Patient #56's being restrained were not documented.
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on staff interviews and review of medical records, hospital policies, and credentials files, it was determined the hospital failed to protect and promote patients' rights. This compromised the hospital's ability to keep patients safe and prevented staff from utilizing restraints in a consistent manner. Findings include:

1. Refer to A131 as it relates to the facility's failure to ensure patients were afforded the opportunity to make informed decisions.

2. Refer to A144 as it relates to the facility's failure to ensure patients were restrained in a safe manner.

3. Refer to A164 as it relates to the facility's failure to ensure restraints were used only when less restrictive interventions were determined to be ineffective.

4. Refer to A166 as it relates to the facility's failure to ensure patients' plans of care were modified to reflect the use of restraints.

5. Refer to A168 as it relates to the facility's failure to ensure restraints were utilized in accordance with orders of physicians or authorized LIPs.

6. Refer to A178 as it relates to the facility's failure to ensure patients who were restrained for violent behavior received a face to face examination by a qualified person.

7. Refer to A185 as it relates to the facility's failure to ensure a description of behavior was documented for restrained patients.

8. Refer to A188 as it relates to the facility's failure to ensure the response to restraint interventions used, including the rationale for continued use of the intervention, was documented.

The cumulative effect of these negative systemic practices resulted in the inability of the hospital to promote and protect the rights of patients.