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.

ST ELIZABETH EDGEWOOD 1 MEDICAL VILLAGE DRIVE EDGEWOOD, KY 41017 April 5, 2012
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on observations, interviews, review of the server reports for operating rooms (graphs & values), surgical site infection log, and review of the 2012 Edition of Association of Operating Room Nurses (AORN) Preoperative Standards and Recommended Practices for Inpatient and Ambulatory Settings, it was determined the facility failed to monitor and maintain the humidity levels in four (4) of twenty (20) Operating Rooms (OR) # 9, #10, #11, and #12 to ensure patients received care in a safe environment.

Observation of Operating Rooms #9, #10, #11, and #12 revealed no mechanism to monitor humidity levels. Upon investigation of the system for monitoring humidity, it was found the humidity levels are monitored electronically outside the OR by engineering. The computer program was to monitor the OR humidity levels and alarms would activate if humidity was outside the set parameters. However, interview with the Director of Plant Operation, revealed the parameters were set at the 30-65 range, not the recommended 30-60 range according to AORN standards. In addition, there was no policy in place to direct staff. Further investigation of the system revealed the chiller for OR suites #9, #10, #11, and #12 did not have the capacity to reduce the humidity to acceptable levels.

Review of the server report, printed on 04/05/12 for the dates March 12, 2012 through April 5, 2012, revealed a total of four (4) of twenty (20) operating rooms (OR #9,10,11,and 12) with humidity levels ranging from 62% to 78.92%, greater than the acceptable high limit of 60% relative humidity (RH). Review of a graphical representation provided by the facility, with the report print date of 04/05/12, revealed from 03/12/12 through 04/05/12 four (4) OR's (Rooms #9, #10, #11, & #12) had humidity levels that dropped below 30% RH and 20% RH routinely for numerous days. The minimum value =21.08 and maximum value =78.92. In addition, the facility did not have a policy to monitor the RH or the temperatures in the OR rooms.

Review of the surgery performed list for the dates of March 6, 2012-March 30, 2012, revealed surgeries were performed on those days high humidity levels were noted. Review of the surgical site infection log from October 2010 through February 2012 revealed nineteen (19) infections were identified from OR #9 and OR#11.

The facility's failure to ensure humidity levels were monitored and maintained at appropriate levels placed patients at risk for serious harm, injury or death. Immediate Jeopardy was identified under the Condition of Participation for Surgical Services. The facility was notified of the Immediate Jeopardy on 04/05/12. The jeopardy was removed prior to exit on 04/05/12; however, a Condition level deficiency remains.

Validation of the Immediate Jeopardy removal:
The facility closed OR #9, #10, #11, and #12 effective at 6:00 PM, April 5, 2012, and will remain so until issues related to humidity levels are resolved.

Refer to A 0951
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
Based on observations, interviews, review of the server reports for operating rooms (graphs & values), surgical site infection log, and review of the 2012 Edition of Association of Operating Room Nurses (AORN) Preoperative Standards and Recommended Practices for Inpatient and Ambulatory Settings, it was determined the facility failed to monitor and maintain the humidity levels in four (4) of twenty (20) Operating Rooms (OR) # 9, #10, #11, and #12 to ensure patients received care in a safe environment.

Observation of Operating Rooms #9, #10, #11, and #12 revealed no mechanism to read humidity
levels. Upon investigation, it was found the humidity levels are monitored electronically outside the OR by engineering. The computer program was to monitor the OR humidity levels and alarms would activate if humidity was outside the set parameters. However, interview with the Director of Plant Operation, revealed the parameters were set at the 30-65 range, not the recommended 30-60 range according to AORN standards. In addition, there was no policy in place to direct staff. Further investigation of the system revealed the chiller for OR suites #9, 10, 11, and #12 did not have the capacity to reduce the humidity to acceptable levels.

Review of the server report, printed on 04/05/12 for the dates March 12, 2012 through April 5, 2012, revealed a total of four (4) of twenty (20) operating rooms (OR #9,10,11,and 12) with humidity levels ranging from 62% to 78.92%, greater than the acceptable high limit of 60% relative humidity (RH). Review of a graphical representation provided by the facility, with the report print date of 04/05/12, revealed from 03/12/12 through 04/05/12 four (4) OR's (Rooms #9, 10, 11, & 12) had humidity levels that dropped below 30% RH (seven (7) of the twenty-five (25) days. The minimum value =21.08 and maximum value =78.92. In addition, the facility did not have a policy to monitor the RH or the temperatures in the OR rooms.

Review of the surgery performed list for the dates of March 6, 2012-March 30, 2012, revealed surgeries were performed on those days high humidity levels were noted. Review of the surgical site infection log from October 2010 through February 2012 revealed nineteen (19) infections were identified from OR #9 and OR#11.

The findings include:

Review of the 2012 edition of the Association of Operating Room Nurses (AORN) revealed established recommended practices to reflect the acceptable relative humidity (RH) ranges of 30-60% and temperature ranges of 68-73 Degrees Fahrenheit (F). The 2012 edition of AORN revealed low humidity levels increased the risk of electrostatic charges, which pose a fire hazard in the oxygen-enriched environment or when flammable agents are in use and increases the potential for dust. High humidity levels increased the risk for microbial growth in areas where surgery or procedures are performed.
The facility had no policy for environmental safety regarding monitoring humidity levels and
temperatures. The facility stated they used the AORN guidelines and American Institute of Architecture(AIA).

Observation of OR suites #9, #10, #11, and #12, on 04/04/12 at 4:00 PM, revealed there was no mechanism in any of the rooms that would show the humidity level. There were sensors in each OR suite used to monitor the humidity levels and temperatures which were transmitted to a server in Plant Engineering Department.
Review of the server report, printed on 04/05/12 for the dates March 12, 2012 through April 5, 2012, revealed a total of four (4) of twenty (20) operating rooms with humidity levels ranging from 62% to 78.92%, greater than the acceptable high limit of 60% relative humidity (RH). Review of a graphical representation provided by the facility, with the report print date of 04/05/12, revealed from 03/12/12 through 04/05/12 four (4) OR's (Rooms #9, 10, 11, & 12) had humidity levels that dropped below 30% RH seven (7) of the twenty-five (25) days. The minimum value =21.08 and maximum value =78.92. In addition, the facility did not have a policy to monitor the RH or the temperatures in these OR rooms.

Interview, on 04/04/12 at 4:00 PM, with the Assistant Director of Engineering (mechanical) revealed the OR suites did not have a specific mechanism in the rooms to reveal humidity readings. The humidity levels and temperatures for the OR suites are monitored with an automatic system that records hourly readings. He stated the facility had an automated alarm system which alert engineering when the humidity and/or temperature levels were out-of-safe ranges. He identified the safe humidity range to be thirty (30) to sixty (60) %. He stated whenever the humidity levels are outside that range, the system would activate the alarm in the facility and it would also go to his pager. The OR department should be notified.

Interview with the HVAC Mechanic, on 04/04/12 at 4:00 PM, revealed OR suites #9, #10, #11, and #12 are controlled by air handler #20. He revealed the air units are not set up to de-humidify and there was no means to decrease the humidity levels or even control the humidity. He said the OR team should be called whenever the humidity levels are outside the acceptable range.

Interview with the OR Nurse Manager, on 04/04/12 at 4:35 PM, revealed the facility followed AORN guidelines in developing policies and procedures. She further revealed that it was the responsibility of Plant Engineering to monitor the OR's temperature, humidity level, and air flow exchanges. She stated she did not recall receiving any messages from that department stating there was a problem with any of the three measurements.

Observation, on 04/04/12 at 4:55 PM, revealed OR #9 had a thermostat mounted on the wall that controlled the temperature; however, no mechanism to read humidity levels.

Interview, on 04/04/12 at 5:15 PM, with a registered nurse (RN) that works in the OR revealed she was not aware of any concerns with the humidity levels in the OR's. She stated she had never received a call from the engineering department notifying her of any out-of-range humidity levels.

Interview with the Director of Plant Engineering, on 04/05/12 at 2:30 PM and 3:15 PM, revealed the humidity alarms are set at 30-65% because of fluctuation limits. If the alarms were set at 60% as recommended, it would constantly go into alarm as it adjusts itself. There was no de-humidifier on the system. The system (air handler #20) did not have the means to drop the humidity immediately. The chillers are the only means to reduce humidity level; however, the chillers do not have enough coils to keep the humidity down when the outside air/humidity are high. The Director stated the facility had no policy regarding temperatures and humidity levels in the OR.

Continued interview with the Director, on 04/05/12 at 4:00 PM and 5:05 PM, revealed he did not know if any surgeries had been cancelled on the days high humidity levels was noted. He stated it was the engineering department's responsibility to inform the OR staff if the humidity levels were outside the acceptable range. He stated the days the humidity levels were elevated, the alarms were activated, and notification to the OR department was completed. However, there was no documented evidence the notification had occurred. He stated he had not documented or kept a log of date, time, and whom he notified of the high humidity levels. He indicated there was no follow up when humidity levels were outside the acceptable range of 30-60%. He stated he had relied on the automatic monitoring system to alert him whenever there was a problem.

Interview with the Vice-President of Nursing, on 04/05/12 at 5:30 PM, revealed the OR staff had not receive notification from engineering regarding humidity levels greater than 60% or lower than 30%. She stated she had interviewed the OR nurse manager and other nursing staff and she was told no notification had been given. She stated the OR suites with humidity level outside the acceptable levels could have been closed and surgeries would have been moved to another OR suite or cancelled. She stated high humidity levels placed patients at risk for infections.

Interview with The President and CEO, on 04/05/12 at 5:30 PM, revealed he was unaware of the problem with air handler #20 and the inability to reduce humidity levels in OR# 9, #10, #11, and #12. He stated he relied on those department directors to inform him of any serious problems. He identified the seriousness of the problem and indicated that he would take immediate corrective action. He gave instructions to close OR suites #9, #10, #11, and #12 until the ability to control humidity levels could be corrected. Air handler #20 would be replaced and QAPI would monitor the progress.


Review of the surgery performed list for the dates of March 6, 2012-March 30, 2012, revealed multiple surgeries were performed on those days high humidity levels were noted. Example: OR #9, on 03/19/12 the automatic humidity reading was 73.04 at 9:00 AM with surgery in progress. The surgery log revealed from 03/12/12-03/30/12, humidity levels were over the 60% RH for twelve (12) of the fifteen (15) days surgeries were performed, reaching as high as 78.92%. This was in OR #9. The surgical log revealed 388 surgeries were performed in OR #9, #10, #11, and #12 from 03/06/12-03/30/12 when the humidity levels were recorded high. Review of the surgical site infection log from October 2010 through February 2012 revealed nineteen (19) infections were identified from OR #9 and OR #11.


Interview with Director of Infection Control, on 04/05/12 at 5:30 PM, revealed she looks at trends for OR related infections. When asked if the humidity levels had been integrated into the track and trend of OR infections, she replied in the past. However, she was unaware there was a problem with humidity levels in those OR suites, therefore, she had not included that component in her infection control data.
VIOLATION: PATIENT RIGHTS: NOTICE OF RIGHTS Tag No: A0117
Based on observation, interview, and review of the facility's policy Patient's Rights and Responsibilities and the Emergency Department pamphlet titled Patient's Rights and Responsibilities, it was determined the facility failed to notify two (2) of seven (7) sampled patients treated in the Emergency Department of their rights.

The findings include:

Review of the facility's policy regarding Patient's Rights and Responsibilities revealed each patient would receive a printed statement or have access to a statement of their rights and responsibilities as a patient of the facility. In addition, the policy stated attempts would be made to communicate to patients the content of their rights and responsibilities in a manner in which the patient would understand.

Review of the Emergency Department (ED) pamphlet titled Patient Rights and Responsibilities listed the thirty-five (35) rights the patients have as a patient within the ED.

Observation, on 04/03/12 at 11:05 AM, revealed Patient #34 signing admission papers in ED Room #2 and was not given the pamphlet on his/her rights or offered information on their rights as a patient of the facility.

Interview, on 04/03/12 at 11:05 AM, with Patient #34 revealed he/she was not told of his/her rights as a patient in the ED.

Interview, on 04/03/12 at 11:10 AM, with Patient #33 in ED Room #22 revealed he/she was not given or offered information on his/her rights.

Interview, on 04/03/12 at 11:15 AM, with the Registration Clerk (staff #12) revealed the patient rights pamphlets are located on the desk of admissions in the ED and patients were given the pamphlet if they asked for it. She stated the pamphlets were not given to the patients without a request. It was revealed the standard for signing in as a patient to the ER did not include patient rights.

Interview, on 04/04/12 at 11:45 AM, with the Vice-President of Nursing revealed patients in the ED are informed of their rights by being given a copy of the patient rights brochure (pamphlet) as they entered the door to the hospital as a patient. She stated it was to be given to all patients. She indicated all hospital staff were trained with a computer based training course to give the patients the information. She said all staff received annual training related to informing patients of their rights and new employees received this training as well. This would include both clinical and non-clinical employees.

Interview, on 04/04/12 at 11:50 AM, with ED Registration Clerk (staff #13) revealed the practice to provide the pamphlet to the patients in the ED was not being followed because the pamphlets were being thrown in the trash or "piled up" in the waiting room. She stated she had received direction from her manager to not give the patient rights pamphlets unless the patient asked for them.

Interview, on 04/04/12 at 4:25 PM, with the ED Registration Manager revealed all ED patients were to be given a copy of their rights. She revealed no knowledge of how this was monitored. She stated registration was responsible to provide the information to the patients. It was revealed the registration staff was in-serviced on giving patients the patient rights information.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observation, interview, and review of the facility's policy, it was determined the facility failed to consistently implement the infection control program to prevent the development and transmission of disease and infections in regard to cleaning of blood glucose meters. Observation of a blood glucose (capillary) finger stick testing for three (3) of three (3) sampled patients (with orders for blood glucose checks) out of total sample of thirty (30) patients, revealed the glucose meter was not cleaned between patient use. (Patients #28, #29, and #30)

The findings include:

Review of the facility's infection control system revealed the facility incorporates infection prevention practices into all aspect of delivery of care in the facility. The Infection control committee meets monthly and distributes newsletters regarding infection control prevention practices monthly. Review of the February 2012 newsletter revealed information on "equipment cleaning and disinfection" was provided. The newsletter instructed staff to clean shared durable medical equipment (e.g. glucose meters, etc) between patient use according to manufacturer's recommendations. The facility used Precision Xceed Pro machine with policy and procedures titled, "Whole Blood Glucose using Precision Xceed Pro", with a revision date of September 29, 2011. Under XIV. Cleaning the Precision Xceed Pro Glucose meter the procedure instructs staff to use Sani-cloth to wipe the exterior of the meter. The policy stated it is important to keep the meter clean to prevent the spread of infection and to only use the following products to clean the exterior of the meter and port protector: Sani-cloth HB or Sani-cloth Plus or Super Sani-cloth. Additional information regarding cleaning of the glucose meter stated to clean meter between each patient using only Sani-wipes. "Do not use Alcohol wipes, peroxide, or bleach.

Observation, on 04/03/12 at 11:30 AM on the 2-B1 unit, revealed CNA #1 was collecting a blood sample by fingerstick for blood glucose monitor (capillary). The CNA took the Precision Xceed Pro glucose meter into Patient #28's room. The CNA applied gloves and performed a fingerstick and placed the blood onto a test strip inserted into the meter. She obtained the glucose reading and disposed of the blood strip into the trash. She removed her gloves and washed her hands. She took the glucose meter out of the room and placed the meter into a portable case. The CNA did not clean the meter.

Continued observation revealed CNA #1 then went to Patient #29's room to collect a blood sample for a blood glucose reading at 11:46 AM. The CNA removed the meter from the portable case, took the meter into Patient #29's room and followed the same procedures as before. Once a blood glucose reading was obtained, the CNA removed her gloves, washed her hands, and removed the meter from the room. She did not clean the glucose meter and placed the meter back into the case. The CNA then went into Patient #30's room at 11:52 AM and proceed to perform a fingerstick and obtain a blood glucose reading. She obtained the glucose reading, removed her gloves, washed her hands, and took the glucometer outside the patient's room. Observation revealed a nurse was outside the room and she cued CNA #1 to clean the glucose meter. The CNA used some type of wipe.

Interview with CNA #1, on 04/03/12 at 11:55 AM, revealed she had not cleaned the glucose meter between Patient #28, #29, and #30. She stated she was suppose to clean the meter after each patient use but she had forgotten. When asked what she cleaned the meter with this time, the CNA obtained a red top container with label from Office Supply that read for electronic wipes. Further interview with the CNA confirmed that was where she obtained the wipe that she cleaned the glucose meter. Observation of the portable docking station where the meter was stored revealed small packets of alcohol wipes.

Interview with the Unit Manager (Staff # 22) for 2-B1, on 04/03/12 at 12:15 PM, revealed she had observed CNA #1 had not cleaned the glucose meter between patients. She stated CNAs are allowed to perform fingerstick for blood glucose testing using the capillary method only. The CNAs have been trained on how to use this meter and cleaning of the meter was included in the training. She stated only Sani-wipes are used to clean glucose meters. She stated she observed the CNA did not use the correct cleaning wipe. She stated re-training with the CNA was needed.

Interview with Infection Control Committee (Director and 3 Coordinators), on 04/04/12 at 10:10 AM, revealed the committee meets monthly. The committee tracks and trends infections and training was computer based mostly. A point of care education program was developed with infection control modules that included handwashing, isolation, PPE (patient protection equipment), organisms, and other infection control issues. The Director revealed training for the glucose meters are completed with modules. During orientation, procedures are taught and competency test are required. Annually, training was mandatory through point of care modules. She stated the staff are taught to clean the meters with whatever was recommended by the manufacturer. She stated Staff Development would provide the training. She revealed the infection control committee had not performed any type of audits related to cleaning of the glucose meters.

Interview with the Staff Development, Education Specialist, on 04/4/12 at 11:30 AM, revealed the CNAs are trained on the glucose meters through computer-based learning modules. The CNAs must perform precision test and skills competency check demonstrating High and Low controls and pass a test. Review of the learning module revealed cleaning and precautions are included in the learning module. The module instructs staff to clean the external surface of the meter between each patient use with Sani-cloth wipes.

Observation, on 04/04/12 at 4:45 PM, revealed CNA #1 performed a blood glucose test for Patient #30. The CNA cleaned the glucose meter after use with a Sani-wipe. She stated the facility provided packets of Sani-wipes to the staff today. The CNA stated she had received retraining on how to clean the meters.

Interview with the Unit Manager for 2-B1, on 04/04/12 at 5;00 PM, revealed CNA #1 had been retrained on the correct method to clean the glucose meters. The manager revealed the Sani-wipe packets were received and disturbed today. She indicated she had begun re-training the staff today; however, she had no documented evidence of the training and then stated it was provided by verbal, on-the-spot training. She revealed only 3 CNAs had been trained so far.
VIOLATION: USE OF RESTRAINT OR SECLUSION Tag No: A0154
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, review of the clinical record and facility restraint policy, it was determined the facility failed to ensure all patients were free from restraints except for immediate physical safety of the patient, staff, or others for five (5) of twelve (12) restrained patients. (Patients #12, #15, #16, #18 and #31) Patient #31 was observed in four (4) point wrist and ankle restraints, four (4) raised side rails, and a soft lap belt restraint restricting the patient's access to the body. The facility failed to utilize the least restrictive devices and failed to discontinue the restraints at the earliest possible time.

Patients #12, #15, #16, #18 and #31 physician's restraint orders failed to indicate what type of restraint was to be used and the reason for the physical restraint. The facility failed to obtain a new restraint order once a restraint was discontinued and then reapplied.

In addition, the facility failed to obtain physician orders for the use of restraints for Patient #31 on 03/23/12 and Patient #16 on 04/01/12.

The findings include:

Review of the facility's policy regarding Restraints used for medical management reasons, revised on 06/06/11, revealed restraints may only be used when less restrictive interventions have been determined to be ineffective. Alternatives should be considered before using restraints on any patient and particularly on vulnerable patients such as cognitively limited patients. Restraint orders for medical management reasons are time-limited for no longer than 24 hours. Orders must include the reason for the use of the restraint. If restraint use continues beyond 24 hours, the patient should receive a face-face assessment by a physician for continuation of the use of the restraint. Continuation orders are to be obtained each calendar day thereafter.

1. Record review revealed Patient #31 presented to the emergency department (ED) with symptoms of a fever (103 F) and mental status changes on 03/12/12. The patient was admitted to the ICU unit for treatment of spontaneous bacterial peritonitis. On 03/13/12, a consultation for the patient's confusion was conducted with findings of Delirium with the "majority of the patient's issues most likely to be infectious in origin." The patient had a recent admission to the behavioral health unit with psychiatric medications used. The physician noted the patient was showing improvement and could follow some directions. The patient was transferred to a Med/Surg floor on 03/16/12.

Observation during a tour of 2-AO (oncology), on 04/03/12 at 3:00 PM, revealed Patient #31 lying in bed with bilateral wrist and ankle restraints applied, four (4) side rails raised, and a soft belt restraint around the patient's waist, tied to the bed frame. A sensor pad was noted to be on the bed. There were no Intravenous (IV) lines, tubes, or equipment attached to the patient. No one was in the room with the patient.

Interview with RN #1, on 04/03/12 at 3:10 PM, revealed the patient was restrained due to risk of falling. When asked if the patient had any falls since admission, the nurse replied, " No." A skin assessment was completed during incontinent care, on 04/03/12 at 3:20 PM, with RN #1 that revealed when the right ankle and wrist restraints were released, redness was noted that resolved after 10 minutes. RN #1 stated the patient tried to get out of bed without assist and would throw her/his legs over the side rails. Ankle restraints were reapplied after ten minutes.

Interview with Patient #31, during the above observation, revealed the ankle/wrist restraints are used to keep her/him from getting out of bed. The patient stated he/she did not like the restraints and he/she could not reach water or the phone without assistance.

Observation of Patient #31, on 04/04/12 at 5:00 PM, revealed the wrist and ankle restraints had been removed. The lap belt was applied and four (4) side rails were raised.

Interview with RN #5, on 04/04/12 at 5:20 PM, revealed the least restrictive devices are to be tried prior to applying a physical restraint. She indicated the patient was already restrained upon admission to the unit. She acknowledged the restraint forms did not indicate what type of restraint was to be used nor how many. She stated the nurse would document in the computer which type of restraints had been used.

Review of the clinical record revealed bilateral wrist restraints were ordered on [DATE] upon the patient's admission to the ICU unit due to agitated, restlessness, confused and the patient was pulling at tubes. The patient had IVs and an indwelling catheter at that time. On 03/14/12, the four (4) side rails and bilateral ankle restraints were added with justification of high risk for falling. On 03/15/12 at 9:53 PM, the record revealed the first notation of a lap belt restraint was applied.

Review of the restraint orders, utilized by the facility, revealed a section for the medical management reason for a physical restraint was either high risk for falling or high risk for removing lines, tubes, equipment or dressings. Review of Patient #31's clinical record revealed from March 12, 2012 through April 5, 2012, the reason for the physical restraint on the restraint order was never indicated. In addition, telephone orders were obtained for continued restraint orders for ten (10) days with two days only the physician's name placed in the signature space by the nurse and not signed by the physician. There was no documented evidence a physician order was obtained for the restraints on 03/23/12. Later, the nurse manager provided a telephone order for the restraint use on 03/23/12; however, the physician had not signed the order.

Interview with a member of the hospital's restraint committee (staff #20), on 04/05/12 at 2:00 PM, revealed the physician should circle the reason for the restraint use when ordering the restraint. Subsequent and continued restraint orders are to be obtained each calendar day thereafter. She stated the physician should indicate what type of restraint was to be ordered. She indicated the committee chose this restraint form and was not aware the physician or nursing was not indicating what type of restraint was to be used on the restraint orders.

Interview with the Unit Manager for 2-AO, on 04/05/12 at 3:00 PM, revealed the restraint orders did not indicate the reason why the restraints were used. She reviewed the computerized documentation completed by the nurses to determine what restraints were being used and the reason why.

Review of the computerized documentation revealed, on 03/16/12 at 5:31 PM, a nurse documented the patient was restrained for safety and aggressive behavior. On 3/18/12 at 2:01 AM, documentation revealed the patient was trying to get out of bed and was becoming more aggressive towards staff. Soft restraints were applied to the patient's feet. On 03/24/12 and 03/26/12 the nurse documented the patient had become combative toward staff and had to be restrained. However, there was no evidence a behavioral management assessment was conducted with a face to face evaluation completed. The nurse manager confirmed no behavior assessment was conducted after the patient started exhibiting behaviors. Refer to A-178.

Continued review of the computerized nurses flowsheet for medical restraints revealed the staff discontinued certain restraints and reapplied later without a physician's order. This occurred on multiple days.

Interview with RN #18, on 04/05/12 at 11:45 PM, revealed the nurses inform the physician what restraints are being used. When the physician signed the restraint order, they do not always look at the restraints but go on what the nurse tells them. She said the restraint orders for Patient #31 was not specific to what restraints are used. In addition, she revealed if several restraints are used for one patient and one was discontinued and reapplied the staff do not have to get a new physician restraint order because a restraint order had already been signed that day. Example: if side rails are discontinued for greater than four hours and then reapplied, no new restraint order would be obtained because the patient was still restrained with a lap belt restraint.

Interview with a physician, on 04/05/12 at 12:00 PM, revealed nurses tell the physicians what restraints are being used. The physicians do not normally review the restraints, just sign.

2. Observation of Resident #12, on 04/03/12 at 10:00 AM, revealed the patient sitting up in a recliner with a family member at bedside. The restraints were observed to be off at the present time.

Review of the clinical record revealed Patient #12 was admitted to the hospital with diagnoses of Seizures, Pneumonia, and Mental Retardation. Record review revealed restraint orders were written daily for Patient #12 since the admission date of [DATE]. Review of the physician's orders revealed the reason for the restraint use was not indicated, nor was there indication of the type of restraints to be used.

Interview with the 3rd floor Medical Surgical RN #19, on 04/03/12 at 3:20 PM, revealed nurses make the decision for the justification of restraints, and notify the physician of what was needed. They always initiate the least restrictive restraint, and the orders allow the restraint. The type of restraint was documented on the Medical Restraint flowsheet, not on the restraint orders. She stated, "We don't document the reason for the restraint on the physician orders "

3. Patient #15 was observed in bed, at 10:00 AM on 04/03/12, with bilateral wrist restraints applied. The patient was on a ventilator, with a diagnosis of Respiratory Failure. Patient #15 had been admitted on [DATE] with physician orders for restraints.

Review of the physician restraint orders revealed the choice for restraint use was high risk of falling or high risk of removing lines, tubes, equipment or dressings; however, neither was circled or indicated. In addition, the restraint order did not indicate what type of restraint was to be used.

Interview with RN #7, Unit Manager 3rd floor Medical Intensive Care Unit, on 04/03/12 at 3:10 PM, revealed the nurse taking care of the patient that day was responsible for obtaining the restraint orders, and revealed the two criteria areas should be checked for which one the restraint was being used; however review of the orders revealed all reasons listed were blank. The manager stated there was no place to list the type of restraint and revealed the restraints were viewed as a general comment on the physician's orders.

4. Patient #16 was admitted to the facility on [DATE] with diagnoses of Respiratory Failure, Fever and Possible Sepsis. The patient was observed, on 04/03/12 at 3:00 PM, to have bilateral wrist restraints applied . Review of the clinical record revealed the patient had restraints applied since the admitted ,d+[DATE]-[DATE], and 4/1-to present.

Continued review of the clinical record for Patient #16 revealed no documented evidence a restraint order had been obtained on 04/01/12 for the use of the wrist restraints. In addition, review of the physician's orders for restraints revealed the reason for the restraint use was not indicated nor the type of restraint being used.

Interview with RN #7, on 04/05/12 at 2:10 PM, revealed the nurses tell the physician what type of restraints are used but they do not document on the physician's orders. The restraint orders are generalized so everything is covered; we do not document the reason. In addition interview with RN #7 revealed the orders for 04/01/12 must have been missed, since that date was on a weekend.

5. The facility admitted Patient #18 on 03/14/12 and the patient was observed to have bilateral wrist restraints applied on 04/03/12 at 3:25 PM. The patient was ventilator dependent.

Review of the restraint orders revealed no indication why the restraint was ordered, nor was the type of restraints to be used listed.

Interview with the RN Critical Care Director of MICU (medical intensive care unit), on 04/5/12 at 2:30 PM, revealed the reason for restraints are documented in the computerized medical justification notes, which was located in the computer EPIC system for each patient. She stated the Nurse determined what type of restraint was needed and documents this on the flow sheet of that system. RN #7 stated specific reasons and types of restraints are not listed on the physician's orders.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0178
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, and review of the clinical record and Restraints used for Behavioral Management Reasons policy, it was determined the facility failed to obtain a face-to-face behavioral assessment as indicated by the guidelines for one (1) of twelve (12) sampled patients that were restrained. The clinical record revealed Patient #31 exhibited aggressive behaviors toward staff for several days without the benefit of a face-to-face assessment.

The findings include:

Review of the facility's policy titled: Restraints and/or Seclusion used for Behavioral Management Reasons, with a revision date of 06/06/11, revealed restraints are only used for the immediate physical safety of a patient, staff, and others and must be discontinued at the earliest possible time. a physician, practitioner, or qualified registered nurse (RN) on one of the Behavioral Health units are to see the patient within one hour of initiation of restraint or seclusion. Only one evaluation needs to be completed within one hour. The purposed evaluation by the physician or qualified RN was to work with the individual and staff to identify ways to help the individual regain control and make any necessary revisions to the individuals treatment plan.


Record review revealed the facility admitted Patient #31 to an ICU bed on 03/12/12 with symptoms of a fever (103 F) and a mental status changes with a diagnosis of Spontaneous Bacterial Peritonitis. On 03/13/12, a consultation for the patient's confusion was conducted with findings of Delirium with the "majority of the patient's issues most likely to be infectious in origin." The patient had a recent admission to the behavioral health unit with psychiatric medications used. The physician noted the patient was showing improvement and could follow some directions. The patient was transferred to a Med/Surg floor on 03/16/12.

Observation during a tour of 2-AO (oncology), on 04/03/12 at 3:00 PM, revealed Patient #31 lying in bed with bilateral wrist and ankle restraints applied, four (4) side rails raised, and a soft belt restraint applied around the patient's waist. A sensor pad was noted to be on the bed. There were no Intravenous (IV) lines, tubes, or equipment attached to the patient.

Interview with RN #1, on 04/03/12 at 3:10 PM, revealed the patient was restrained due to risk of falling. When asked if the patient had any falls since admission, the nurse replied, " No."

Review of the clinical record revealed bilateral wrist restraints were ordered on [DATE] upon the patient's admission to the ICU unit due to agitation, restlessness, confusion and the patient was pulling at tubes. On 03/14/12, the four (4) side rails and bilateral ankle restraints were added with justification of high risk for falling. On 03/15/12 at 9:53 PM, the record revealed the first notation of a lap belt restraint had been applied.

Continued review of the clinical record (progress notes) revealed on 03/17/12 the patient was kicking at staff with soft ankle restraints applied and then remove at 9:04 PM. On 03/18/12, documentation revealed the patient was becoming more aggressive towards staff. "Applied soft restraints to feet." On 03/24/12 at 4:52 AM, the patient became combative toward a nurse, wrist restraints were applied. 03/26/12 just after midnight, the record revealed the patient became increasingly agitated and became combative. Wrist and ankle restraints started along with a lap belt "for patient safety." The record revealed no face-to-face evaluation was conducted in one hour after the patient exhibited these behaviors.

Interview with the Behavioral Unit Manager, on 04/05/12 at 2:00 PM, revealed Patient #31 had been treated in the unit prior to this hospital admission but the physician and staff did not feel the patient required admission to the behavioral unit. Review, on 03/25/12 at 6:30 AM, revealed a physician's note stated the patient wasn't appropriate for transfer to the behavioral unit. The manager was not aware of the aggressive behaviors noted on the above dates.

Interview with the Unit Manager for 2-AO, on 04/05/12 at 3:00 PM, revealed the restraint orders did not indicate the reason why the restraints were used. She reviewed the computerized documentation completed by the nurses to determine what restraints were being used and the reason why. Review of the documentation revealed, on 03/16/12 at 5:31 PM, a nurse documented the patient was restrained for safety and aggressive behavior. On 3/18/12 at 2:01 AM, documentation revealed the patient was trying to get out of bed and was becoming more aggressive towards staff. Soft restraints were applied to the patient's feet. On 03/24/12 and 03/26/12 the nurse documented the patient had become combative toward staff and had to be restrained. However, there was no evidence a behavioral management assessment was conducted with a face to face evaluation completed. The nurse manager confirmed no behavior assessment was conducted after the patient started exhibiting behaviors within the one hour timeframe.