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Based on record review, policy review, and staff interview, the Hospital staff failed to determine when the use of an antipsychotic drug should be considered a chemical restraint, and, the Hospital staff failed to prohibit the use of drugs or medications used to manage a behavior that was not a standard treatment for the patient's condition for 1 patient (#43), out of a total sample of 43 patients, and 2 (NS #B and NS #C) out of 5 non-sampled patients.

Findings included:

Review of the Hospital's policies and procedures for Restraint and Seclusion indicated that the purpose of the policy was to ensure the appropriate use of restraint and seclusion. The policy applied to all patient care areas. The policy's requirements outlined were specific to the patient behavior(s) that the restraint or seclusion intervention was being used to address and was not based on the patient's behavior diagnosis or physical location within the hospital. The policy indicated that the hospital was committed to the goal of reducing and ultimately eliminating the use of restraint and seclusion and the following circumstances would utilize, as a last resort, the use of some form of a restraint:

*management of violent or self destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others
*ensuring the physical safety of the non-violent or self-destructive patient

The Hospital's policy defined a medication restraint as a drug or medication when used as restriction to manage the patient's behavior or restrict the patient's freedom of movement and is not a standard treatment or dosage for the patient's condition.

In addition to the restraint policy, the Hospital developed a policy and procedure for "Code Safe." The Code Safe is a rapid response team approach to provide for the best possible care and treatment of an escalating individual. The Code Safe protocol adds an early clinical response and is called after every attempt to de-escalate the situation was made by offering/ including, but not limited to, the following:

*A quiet space/environmental modification
*PRN (as needed) medication
*Time for ventilation of feelings
*An activity change, asking patient what might help him/her calm down

On 12/13/13, the Hospital's restraint log was reviewed by the surveyor. The restraint log was dated 4/23/13-12/10/13. The restraint log included the date, patient name, unit, type of restraint, physician name and the duration of the restraint. The restraint log did not include all the patient care areas, and excluded the intensive care unit, the emergency unit and the psychiatric unit. Those areas monitor and tracked the use of restraints separately. The restraint log indicated that a drug, as defined under the Hospital's restraint policy, had not been used as a restraint intervention.

However, a separate log was maintained for the Code Safety responses. A review of the Code Safety log from 1/10/13-12/1/13 indicated that the Hospital tracked these responses separately (hospital, intensive care, emergency care and psychiatric care). These hospital areas did include interventions utilized during the response. The Code Safety log included the date, staff manager name, unit, patient name, critique, restraint/hands on, injury to patient or staff, narrative, outcome and minutes. The Code Safety log indicated that medication and restraints had been used during the Code Safety responses.


During interview on 12/16/13 at 8:30 A.M., the Clinical Risk Manager said the hospital did not use chemical restraints.

1. Patient #43 presented to the hospital in October 2013 with changes in mental status and diagnoses that included dementia, cerebral vascular accident and atrial fibrillation.

On 10/22/13 at 11:00 P.M., a physician's telephone order was obtained for the antipsychotic medication Zyprexa 5 mg (milligrams), IM (intramuscularly), one time, and a Posey vest. A nurse's assessment dated 10/22/13 at 11:30 P.M. indicated the resident was crying, yelling, restless and agitated. The note did not indicate that a restraint assessment had been completed to determine if the patient had met the criteria for restraints. In addition, there was no clinical evidence that the patient was monitored following the I.M. injection of the Zyprexa.

On 10/23/13 at 4:07 A.M., a second physician's telephone order was obtained for the antipsychotic medication Zyprexa 5 mg, IM, one time and a Posey vest. The orders did not indicate that the patient had met the criteria for restraints. A restraint assessment was initiated on 10/23/13 at 5:34 A.M. The assessment indicated the resident was confused, disoriented, restless and agitated. The assessment did not include a conclusion or identify that a restraint was implemented. A monitoring tool was initiated. However, the monitoring tool was used to monitor the Posey restraint and did not include monitoring the patient following the I.M. Zyprexa.

On 10/23/13 at 12:34 P.M., a third physician's telephone order was obtained to continue with the antipsychotic medication Zyprexa at 12.5 mg daily and Zyprexa 5 mg, IV (intravenously) every 4 fours as needed for agitation, hold for sedation. The Posey vest and the restraint monitoring assessments were discontinued.

2. NS # B presented to the Hospital in October 2013 with diagnoses that included pneumonia, respiratory failure, kidney failure, and dementia. On 11/4/13 at
3:00 P.M., a physician's telephone order for a Posey vest was obtained by the nurse. A restraint assessment was initiated for the Posey vest.

On 11/5/13 at 3:00 P.M., a telephone order for the antipsychotic medication Zyprexa, 5 mg, I.M., one time was obtained. At 7:30 P.M. on the same day, a telephone order to continue the Posey vest was given. At 11:00 P.M. on 11/5/13 and at 5:00 A.M. on 11/16/13, two additional doses of the antipsychotic medication Zyprexa 5 mg, I.M., were ordered. Further review of the physician's orders indicated that the use of I.M. Zyprexa was ordered and administered on 11/9/13 at 5:50 A.M., and again, on 11/10/13 at 7:27 A.M. The orders failed to indicate that the resident had met the criteria for a medication restraint.

3. NS #C was admitted to the hospital in August 2013, after a fall and sustained a head laceration. The clinical record indicated the resident had gone through alcohol withdrawal from 8/23/13 through 8/28/13, but had remained agitated.

On 8/28/13 at 5:20 A.M., 8:00 A.M. and 12:45 P.M., the nursing staff obtained physician orders for the antipsychotic medication Haldol 2.5 mg, I.M., one time, and every 6 hours as needed IV, and a Posey vest. The orders indicated that the Posey vest should be applied until the physician saw the resident in the morning. There was no documentation to justify the use of the antipsychotic medication. A monitoring flow sheet was implemented for the Posey vest. On 8/31/13, the orders for the antipsychotic medication Haldol and the Posey vest were renewed. A restraint monitoring tool was implemented for the Posey but there was no evidence that the Haldol was being monitored as a restraint.

During interview with UM #3 (Unit Manager #3) on 12/17/13 at 10:45 A.M., and record review of the clinical records for Patients #43 and NS #'s B and C, UM #3 said that the orders for the antipsychotic medications administered to these patients failed to indicate their intended use. UM #3 said the antipsychotic medications were ordered during the implementation of a physical restraint and that the patients demonstrated high risk of harming themselves. UM #3 said that the use of the antipsychotic medication was not considered a restraint. He/She said that the focus of the restraint assessment was directed toward the Posey vest. UM #3 also said that the medications were probably administered to sedate the patient. He/she agreed that if the physician's orders had included the intent of the medication use at the time it was ordered, along with administrative guidelines for their use, treatment and monitoring would have included assessment of a patient receiving chemical restraints.

Based on record review and staff interview, it was determined that the Hospital failed to implement the use of restraints in accordance with the Hospital policy for restraints for 1, (#43), of 43 sampled patients, and 2 (NS #B and NS #C), of 5 non-sampled patients reviewed.

Findings included:

The Hospital's restraint policy was reviewed. The policy stated that a written order was required in all cases for the use of restraint or seclusion. All orders for restraint/seclusion were to have the following written elements: Reason for restraints, type of restraint device, maximum duration of order, date and time and physician/LIP (licensed independent practitioner) signature, nurse documents in the patient's medical record the following: type of restraint device, ordering physician name, time and date.

1. Review of Patient #43's clinical record indicated Patient #43 was restless and agitated. On 10/22/13 at 11:00 P.M., a physician's telephone order was obtained for the antipsychotic medication Zyprexa 5 mg (milligrams), I.M. (intramuscularly) one time and a Posey vest. However, documentation did not indicate the reason for the restraints, the maximum duration of order. The order was not signed or dated by the physician until 11/11/13 at 12:50 P.M. and the documentation failed to indicate the restraints were ever applied and/or administered. The documentation did not follow the Hospital's restraint policy.

2. Review of NS #B's medical record indicated that an order was written 11/4/13 to place NS #B in a Posey vest on 11/5/13, 11/6/13, 11/9/13, and 11/10/13, and to administer the antipsychotic medication Zyprexa, 5 mg, I.M. However, documentation did not indicate the reason for the restraints and/or the maximum duration of the orders.

3. Review of NS #C's medical record indicated an order was written on 8/28/13 at 5:20 A.M., 8:00 A.M. and 12:45 P.M., to administer the antipsychotic medication Haldol and a Posey vest. The orders did not include the reason for the restraints and failed to include the maximum duration of the orders.

4. During interview on 12/17/13 at 10:45 A.M., the UM #3 (Unit Manager #3) said the restraint policy was not followed.

Based on medical record review and interview, the Hospital failed to ensure that all surgical records contained documentation of an updated examination of the patient, including any changes in the patient's condition, within 24 hours after admission but prior to surgery or a procedure requiring anesthesia services, when the medical history and physical examination were completed within 30 days before admission for 3 (#30, #31 and #32) of 5 surgical outpatients' records, from a total of 10 outpatients reviewed. Findings included:

1. For Patients #30, #31,and #32, medical record reviews on 12/11/13 indicated that each record contained a form that read, "I have reviewed the history and physical, examined the patient. At this time there are no changes in condition."

However, review of each of the above records indicated that no examinations of the patients were documented.

2. During interview on 12/12/13 at 3:00 P.M., the Director of Perioperative Services confirmed that an updated examination of Surgical Patients #30, #31 and #32, was not documented as performed.

3. During interview on 12/13/13 at 7:15 A.M., the Chief Medical Officer confirmed that updated patient examinations, before surgeries requiring anesthesia, were not consistently performed.

Based on observation and staff interview, the hospital failed to consistently maintain equipment in a manner to ensure an acceptable level of safety and quality.

Findings include:
1. Observation in the Intensive Care Unit at 10:00 A.M. on 12/10/13 revealed difficult airway equipment in the clean storage room. The equipment included an endoscope (devices consisting of a tube and optical system that allows the practitioner to visualize the structures of a patient's respiratory system). The reprocessed endoscope was coiled up and stored in a plastic bin until needed.
Guidelines and recommendations from multiple professional societies indicate that a clean endoscope be suspended vertically to promote ventilation and reduce the potential for trapped residual moisture and the risk of microbacterial growth.


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2. Observations during the tour of the Emergency Department (ED) on 12/10/13 from 10:30 A.M. to 12:00 P.M. revealed the following;

a. The door openers at the Ambulance Entrance and the entrance to the ED Blue Zone were loose and didn't consistently work. During the observation, the ED Nurse Manager (NM) said that the door openers needed to be repaired and had malfunctioned for some time.

b. At 10:40 A.M. on 12/10/13, the Surveyor tested the Nurse Call system in the ED Blue Zone patient bathroom. After approximately three minutes ED Technician #1 responded to the call. ED Technician #1 said she would have come sooner but she had to check all the bathrooms because the call system didn't identify which bathroom call was sounding.

During interview on 12/10/13 at 10:45 A.M., the ED NM said that the Nurse Call System's alarm was soft and could not always be heard by Nursing Staff at the Blue Zone Nurses' Station. The ED NM also said hat he system was old and was installed when the ED was built in the year 1950, and had not been updated since then. The NM confirmed that the malfunctioning Nurse Call System created a safety risk for patients.

3. Observations in Operating Room (OR) #7 on 12/11/13 at 10:45 A.M., revealed that a two foot strip of base cover, behind the OR entry door, was broken and taped together with duct tape, creating a risk for cross-contamination as the base cover behind the door was uncleanable.

4. On 12/17/13 at 8:35 A.M., the MB 5 Unit, Medication Room A was inspected. A plastic yellow container labeled " Patient Meds/Pneumovax " was observed at the bottom of the medication refrigerator. The container was observed to have an unidentifiable, pinkish-colored sticky substance on the bottom surface. The container had an unopened vial of pneumovax vaccine inside of it.

On 12/17/13 at 9:05 A.M., the MB 5 Unit, Medication Room B was inspected. This medication rooms' refrigerator also had a plastic yellow container labeled " Patient Meds/Pneumovax " on the bottom shelf. The container was coated with a sticky, unidentifiable substance.

CL #1 (Clinical Leader #1) was interviewed on 12/17/13 at 9:05. He/She said that both of the plastic containers in the two medication refrigerators on MB 5 required cleaning.

Based on observations, interviews, and review of the Hospital's policies/procedures, employee health files, and manufacturer's directions for use (MDFU), the Hospital failed to consistently ensure an acceptable level of infection prevention practice related to adherence to infection control policies and procedures, medication administration, hand hygiene, and effective disinfection of equipment for 5 Patients (#9, #14, #15, #28, and #29) from a total sample of 43 patients (33 inpatients and 10 outpatients).

Findings included:

1. Observations in the Emergency Department (ED) Triage Area at 10:30 A.M. on 12/10/13, revealed the following:

a. The Dinemap machine (records and displays patients heart rate, blood pressure, blood oxygen levels) was dirty with dust and tape residue. The Biomedical Department's inspection sticker was loose and had been taped to the Dinemap.

During the observation the ED Nurse Manager (NM) said that the Dinemap was supposed to be cleaned at least once per eight hour staff shift.

b. The area around the hand washing sink was cluttered with stored equipment and supplies (e.g., ice machine, multiple paper cups, and disinfectant wipes). Infection Control Standards of practice requires sink counters to be free of equipment supplies due to the risk of cross-contamination from water spray.

2. Observation in the ED Blue Zone patient bathroom at 10:55 A.M. on 12/10/13, revealed that an opening in the wall mounted paper towel dispenser unit, (intended for paper towel disposal), had been taped-off with approximately eight pieces of medical tape, rendering the paper towel dispenser unit uncleanable and a potential source for cross-contamination.

During the observation, the ED NM said the opening was taped so that patients/visitors would not throw paper towels into it and so that patients/visitors would use the waste receptacle. The NM said it should have been removed.

3. Observations of the ED Pediatric Code Cart at 11:30 A.M. on 12/10/13, revealed that the top, sides and the drawers of the cart were dirty with spillage, tape residue and built-up layers of dust. Multiple reference charts (e.g., Tylenol dose chart, a Pediatric Trauma Center's emergency reference chart, Pediatric policy), were taped to the top and side of the cart, rendering it uncleanable.

4. Observation of the ED Suture Cart at 11:40 A.M. on 12/10/13, revealed the inside of the cart drawers, where the clean and sterile supplies were stored (local anesthetizing medication, suture, sponge), were stained black with dirt and spillage and were held together with duck tape.

5. For Patient #9, observations in the Emergency Department on 12/10/13 at 10:45 A.M., revealed that Registered Nurse (RN) #4 failed to adhere to Infection Control Standards of Practice for Hand Hygiene during medication administration as follows:

a. After touching the keyboard of the medication dispensing unit with both hands, RN #4 removed pain relief and anti nausea medications for patient administration. RN #4 failed to perform hand hygiene before handling the medications.

b. RN #4 then opened the clean/sterile supply cart and removed a sterile needle and syringe, alcohol prep pads and a sterile 2x2 sponge. RN #4 failed to perform hand hygiene before opening the clean/sterile supply cart and remove the above supplies.

c. RN #4 then removed the packaging from the sterile syringe and needle and drew the pain medication into the syringe, without first performing hand hygiene, as required.

d. RN #4 then removed gloves from the clean glove box and donned the gloves, without first performing hand hygiene.

e. RN #4 then administered the medications to Patient #9.

6. Observations in the Pre-operative holding Area at 9:10 A.M. on 12/11/13, revealed that Clinical Associate (CA) #1 disinfected the stretcher, blood pressure cuff, and monitor wires in Pre-op Bay #1. However, CA #1 failed to follow the disinfectant wipes manufacturer's directions for use (MDFU), which required the equipment surfaces to remain visibly wet for two minutes and then allowed to air dry. The surfaces only remained visibly wet between 30 and 60 seconds.

7. For Patient #28, observations in the Pre-operative holding Area at 9:15 A.M. on 12/11/13, revealed that RN #3 failed to perform hand hygiene before donning a pair of gloves to insert an intravenous line. Infection Control Standards of Practice for Hand Hygiene and Hospital policy require hand hygiene to be performed prior to donning gloves.

8. For Patient #29, observations in operating room (OR) #1 on 12/11/13 from 11:00 A.M. to 12:00 P.M. revealed that RN #7 failed to adhere to Infection Control Standards of Practice and the Association of periOperative Registered Nurse (AORN) Standards and Recommended Practices as follows:

a. RN #7 failed to perform hand hygiene before preparing and administering local anesthesia medications to the sterile surgical table.

b. RN #7 failed to perform hand hygiene before donning sterile gloves to perform Patient #29's surgical skin prep.

c. RN #7 reached directly over the sterile table while dispensing suture to the sterile field [AORN Standards and Recommended Practices prohibit unsterile (not wearing a sterile gown and gloves) staff from reaching over a sterile field].

d. RN #7 reached directly over the sterile table while dispensing additional local anesthesia medication to the sterile field.



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9. The Hospital failed to provide adequate protective personnel equipment (PPE) to prevent transmission of infections and communicable diseases.

Observations in the Intensive Care Unit (ICU) at 9:50 A.M. on 12/10/13, indicated Personal Protective Equipment (PPE) was easily accessible to each patient room. The PPE consisted of cover gowns, gloves and masks. According to the Occupational Safety and Health Administration (OSHA) requirement, PPE will be considered "appropriate" only if it does not permit blood or other potentially infectious materials to pass through or reach the employee's work clothes, street clothes, undergarments, skin, eyes, mouth, or mucous membranes under normal conditions of use, and for the duration of time which the protective equipment will be used. The Surveyor interviewed the Resource Nurse during the tour of the ICU. The Resource Nurse said the yellow cover gowns were the only gowns available to staff. The available PPE did not meet the OSHA requirement of providing accessible impermeable cover gowns for procedures involving blood or other potentially infectious materials as the yellow gowns were only fluid resistant.


10. The Hospital failed to position two (2) of three (3) ventilated patients to meet a standard of care in reducing ventilator-associated pneumonia.
Findings included.

According to the CDC publication "Guidelines for Preventing Health Care Associated Pneumonia, 2003", in the absence of medical contraindication(s), elevate at an angle of 30-45 degrees the head of the bed of a patient at high risk for aspiration (e.g., a person receiving mechanically assisted ventilation and/or who has an enteral tube in place).

a. Observations in the ICU, and interview with RN #1 at 10:55 A.M. on 12/10/13 revealed Patient #15 was mechanically ventilated. RN #1 said Patient #15 should be positioned with the head-of-the-bed (HoB) at a minimum of 30 degrees elevation. Patient #15 was positioned at 25 degrees.

b. Observations in the ICU, and interview with RN #2 at 11:35 A.M. on 12/10/13 revealed Patient #14 was mechanically ventilated. RN #2 said Patient #14 should be positioned with the head-of-the-bed (HoB) at a minimum of 30 degrees elevation. Patient #14 was positioned at 25 degrees.

11. The Hospital failed to ensure hand-hygiene practices were consistently followed by a student nurse.

Observations in the Mugar 3 Building (MB3), a General Medical Unit, at 8:45 A.M. on 12/11/13 revealed a staff member with a splint on her hand. The student nurse was observed exiting a patient room.

The Surveyor interviewed the Chief Nursing Officer (CNO) during the tour of MB 3 at 8:45 A.M. on 12/11/13. The CNO said Hospital staff were not allowed to work wearing hand splints because it interfered with adequate hand hygiene practices.

The Surveyor interviewed the Clinical Facilitator at 9:00 A.M. on 12/11/13, The Clinical Facilitator said the student had been cleared by the Director of the Nursing program to return to clinical duty.


12. The hospital failed to comply with the Occupational Safety and Health Administration (OSHA) general industry standard for respiratory protection for the healthcare worker.

Review of the written Respiratory Protection Program indicated employees who had been fit tested (a procedure to ensure correct fit of an employees respirator/mask) to wear an N95 respirator, would have annual fit testing. A respirator/mask is used to protect the healthcare worker against diseases spread through the air, e.g., tuberculosis.


The Surveyor reviewed Employee Health Records of 10 Hospital Staff. Four (4) of the ten (10) staff had not been fit tested annually as required. The (4) Hospital staff who were not compliant were fit tested in 2005, 2007, 2011, and 2012.


13. The hospital failed to minimize the risk of cross-contamination while using a hand held mobile patient laboratory identification device.

Observation and interview with Phlebotomist #1 (Phleb #1) on the Intensive Care Unit on 12/10/13 at 11:10 A.M., revealed a hand held laboratory computer was used. According to Phleb #1, this mobile system was used to identify the patient by scanning a bar code bracelet, and created patient labels for the blood tubes. Observation of the phlebotomy procedure revealed the device was handled by Phleb #1 after she touched (direct contact) the patient and again after the blood-drawing procedure (wearing the gloves used during the phlebotomy procedure). According to Phleb #1 the device was cleaned at the beginning and end of the shift and when exiting an Isolation/Precaution room.

According to the Hospital policy Equipment Disinfection, and verified with the Infection Preventionist on 12/11/13, the policy indicated the device was to be cleaned all mobile devices used from patient to patient are to be cleaned between each use.



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14. For Patient #23, observations in the Cesarean Section Room on 12/11/13 at 9:30 A.M., revealed that Certified Nurse Midwife (CNM) #1 failed to adhere to Infection Control Standards of Practice and the Association of periOperative Registered Nurse (AORN) Standards and Recommended Practices.

CNM #1 reached directly over the sterile table while dispensing a sterile bovi (cautery machine) tip sponge to the sterile field [AORN Standards and Recommended Practices prohibit unsterile (not wearing a sterile gown and gloves) staff from reaching over a sterile field].

Based on medical record review and interview, the Hospital failed to ensure that all brief operative reports described the techniques, findings, and tissues removed or altered, for 3 (#30, #31 and #33) of 5 surgical outpatients' records, from a total of 10 outpatients reviewed. Findings included:

1. For Patient #30, For Patient #30, medical record review on 12/12/13 indicated that under "findings" on the Brief Operative Note, Surgeon #1 only wrote, "See note." Surgeon #1 failed to document the techniques, findings, and tissues removed or altered under "findings".

2. For Patient #31, medical record review on 12/12/13 indicated that under "findings" on the Brief Operative Note, Surgeon #2 only wrote, "Dictated." Surgeon #2 failed to document the techniques, findings, and tissues removed or altered under "findings".

3. For Patient #33, medical record review on 12/12/13 indicated that under "findings" on the Brief Operative Note, Surgeon #3 only wrote, "See dictation." Surgeon #3 failed to document the techniques, findings, and tissues removed or altered under "findings".

4. During interview on 12/12/13 at 3:00 P.M., the Director of Perioperative Services confirmed that the above Brief Operative Notes did not describe the techniques, findings, and tissues removed or altered during surgery.