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Based on observation, interview, record review, review of the facility's education, and review of the facility's policy Restraints and Seclusion, it was determined the facility failed to ensure the use of restraints, for two (2) of the thirty-two (32) sampled patients (#3 and #25), was in accordance with the patient's plan of care. Interview revealed the patients were restrained to prevent extubation; however, staff failed to ensure each patient's plan of care had been developed to include the use of the physical restraint.

The findings include:

Review of the facility's policy Restraints and Seclusion, effective 03/01/12, revealed the patient's plan of care shall be modified to indicate the use of a restraint or seclusion within twenty-four (24) hours.

1. Review of Patient #3's medical record revealed the facility admitted the patient on 11/03/12 with respiratory distress. On 11/04/12, the patient required intubation (insertion of a breathing tube) for mechanical ventilation and subsequently was placed in bilateral wrist restraints on 11/05/12. Review of the physician's order for restraints, dated 11/05/12, revealed the patient was experiencing lack of awareness of potential harm to self. Alternatives attempted prior to restraints included reorienting, familiarizing with surroundings, placement near nurses' station, relieve pain, and relaxation techniques. Further review of Patient #3's medical record revealed the facility did not develop a comprehensive plan of care for the use of a physical restraint.

Observation of Patient #3, on 11/07/12 at 1:12 PM, revealed the patient lying in the bed with an oral endotracheal tube in place attached to a ventilator. The patient was observed raising their arms off the bed approximately 30 degrees and stop at the resistance of the bilateral wrist restraints in place.

Interview with Registered Nurse (RN) #2, on 11/07/12 at 1:12 PM, revealed the patient was able to reach the endotracheal tube (breathing tube required for mechanical ventilation) and required the bilateral wrist restraints to prevent accidental removal of the tube.

2. Review of Patient #25's medical record revealed the facility admitted the patient on 11/07/12 with chest pain and was diagnosed with an acute myocardial infarction (heart attack). The patient was transferred to the cardiac cath lab and went into cardiac arrest requiring intubation and mechanical ventilation. Further review of Patient #25's medical record revealed the facility did not develop a comprehensive plan of care for the use of a physical restraint.

Observation of Patient #25, on 11/08/12 at 3:27 PM, in the cardiac cath lab revealed the patient lying on the table with a heart pump, an oral endotracheal tube in place and bilateral wrist restraints.

Interview with RN #2, on 11/08/12 at 3:45 PM, revealed the patient required physical restraints to prevent the patient from pulling on the intravenous lines and breathing tube.

Interview with the Intensive Care Unit (ICU) Clinical Supervisor after reviewing Patient #3's and Patient #25's medical record , on 11/09/12 at 3:25 PM, revealed the facility should have developed a care plan to reflect physical restraints. The Clinical Supervisor revealed the facility did provide training, and she knew the facility had a policy regarding restraints, but did not know if the policy discussed care planning of the restraint.

Interview with RN #3, on 11/09/12 at 3:30 PM, revealed she had just completed the required critical care training and confirmed restraints were discussed and all staff were required to demonstrate tying a restraint. However, the RN revealed the facility did not provide training on the facility policy or care planning of the restraints.

Interview with RN #22, on 11/09/12 at 5:00 PM, revealed he was trained on the new computer system to assist staff during the conversion. The RN revealed a mandatory reading on initiation of a care plan was started on 11/01/12, and a reading on restraint charting was sent out on 07/06/12.

Interview with the Critical Care Unit (CCU) Clinical Supervisor, on 11/09/12 at 3:40 PM, revealed critical care training was provided November through December. The CCU Clinical Manager revealed the Critical Care Educator was out of the building and not available for interview. Continued interview, on 11/09/12 at 4:00 PM, revealed she was not sure who monitored to ensure care plans were initiated. The Supervisor revealed, prior to the initialization of the computer charting system, someone in the quality department would call each unit to obtain the number of patients in restraints. The Supervisor revealed the Quality Manager was out of the building and not available for interview.

Review of the facility's education "Initiating a Care Plan", not dated, revealed restraints were not discussed nor was the requirement for initiating a care plan on patients in physical restraints. Review of the facility's training "Non-Violent Restraining Charting", not dated, revealed initiation of a care plan was not discussed. In addition, the training explained a restraint checklist would be audited daily by quality and management, but did not mention the auditing or monitoring of the care plan.

Interview with the Critical Care Unit Manager, on 11/09/12 at 3:56 PM, revealed nurses were responsible to initiate and document on the care plan. The Unit Manager revealed initiation of the care plans were monitored during shift to shift report, and all care plans were monitored every 24 hours to ensure they were revised and updated. The Unit Manager revealed, because the nursing staff filled out a restraint checklist, they do not know, or understand that a checklist does not take the place of a care plan. The Unit Manager revealed a checklist does not have goals and was not measurable. Further interview, on 11/09/12 at 4:52 PM, revealed care plans had been a problem for everyone, not just the restraints. The Unit Manager revealed adjusting to the new computerized medical record caused confusion, as it does not automatically generate a care plan and must be done manually.

Based on observation, interview, review of the facility's policy, 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 have an effective system to monitor and maintain temperatures and relative humidity (RH) levels in all fourteen (14) operating rooms (OR) and two (2) cysto rooms to ensure patients received care in a safe environment.

On 11/08/12, observation of OR #16 revealed no working mechanism to monitor humidity levels. In addition, the temperature was 64 degrees Fahrenheit, four degrees below the AORN recommended 68-72 degrees Fahrenheit. Interview revealed the OR staff did not check nor record the RH levels or air temperatures. The RH and temperatures were to be monitored electronically outside the OR by the Plant Operation Department. Upon investigation of the system for monitoring humidity and air temperatures, it was found the thermostats in the OR rooms were free standing and the computerized HVAC system could not read the humidity levels and temperatures inside the OR rooms. The computer system did monitor the air and humidity levels going into the OR rooms and the return air. The computer system had alarms that would activate if humidity levels were outside the set parameters. However, interview with the person who was assigned to oversee the Plant Operation Department, revealed the RH parameters were set at 30-75 range, not the recommended 30-60 range according to AORN standards. In addition, the HVAC computer system did not have the capacity to monitor OR #12 and Cysto rooms #1 and #2 due to an older system.

Based on the survey findings it was determined the Condition of Participation for Surgical Services 482.51 was not met. Refer to A-951

Based on observation, staff interview, review of the facility's policy, 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 have an effective system to monitor relative humidity (RH) levels and air temperatures in all fourteen (14) OR rooms and two (2) cysto rooms to ensure patients received care in a safe environment.

On 11/08/12, observation of OR #16 revealed no working mechanism to monitor humidity levels. In addition, the temperature was 64 degrees Fahrenheit (F), four degrees below the AORN recommended 68-72 degrees F. Interview revealed the OR staff did not check nor record the humidity levels and air temperatures inside the OR rooms prior to surgery. Interview revealed the RH and temperatures were to be monitored electronically outside the OR by the Plant Operation Department. Upon investigation of the system for monitoring humidity and air temperatures, it was found the thermostats in the OR rooms were free standing and were not connected to the computerized HVAC system. Therefore, the computer could not read the humidity levels and temperatures inside the OR rooms. The HVAC system monitored the air going into the OR rooms and the return air. The HVAC computer system had alarms that would activate if humidity levels were outside the set parameters. However, interview with the person who was assigned to oversee the Plant Operation Department, revealed the humidity parameters were set at 30-75 range, not the recommended 30-60 range according to AORN standards. In addition, the HVAC computer system did not have the capacity to monitor OR #12 and Cysto rooms #1 and #2 due to an older system.

The findings include:

Review of the 2012 edition of the AORN standards revealed established recommended practices to reflect the acceptable relative humidity ranges of 30-60% and temperature ranges of 68-73 degrees F. The 2012 edition of AORN revealed low RH levels increased the risk of electrostatic charges, which pose a fire hazard in the oxygen-enriched environment and high humidity levels increase the risk for microbial growth in areas where surgery or procedures are performed.

Review of the facility's policy for air environment of the OR, revised 06/14/10 with reference to AORN Standards 2010, revealed RH is maintained between 30-60%. Sterile storage areas are to be maintained less than 70%. The temperature is maintained at 68-72 degrees F. The Plant Operations Department and the Director of Preoperative Services would be responsible for ensuring this policy was implemented.

Observation of OR #16, on 11/08/12 at 8:30 AM, revealed no working mechanism to monitor humidity levels. In addition, the temperature was 64 degrees F. Interview with the Director of Surgical Services and the OR Manager,who were present during the observation, revealed the OR staff did not check nor record the humidity levels or temperatures in the OR suites. The Director of the OR stated the RH and temperatures are electronically monitored by the Plant Operation Department. The OR staff did not know what the humidity level was in OR#16. The Director stated if the RH got too high it would create a moist environment that could promote bacteria growth. If the air was too low, could cause a fire. The OR Director revealed the surgeons like the OR to be cool and the OR staff would turn the thermostat down for the comfort level of the surgeon.

Observation of OR #1, on 11/08/12 at 8:35 AM, revealed the RH was 43% and the temperature was 53.1 degrees F. Continued observation of OR suites revealed OR #15 had a RH reading of 37.5% and a temperature was 66 degrees F.

After the tour on 11/08/12 at 8:40 AM, a request for present RH and temperature readings in all OR and cysto rooms was made to the OR Director. These finding revealed humidity levels to be between 38.8 and 56.1%. However, the air temperatures were below the recommended 68-73 degrees F. The following readings were obtained: OR #2= 64.7 degrees F, OR #3= 64.6 degrees F, OR #6= 63.6 degrees F, OR #10= 61.8 degrees F, and cysto rooms= 66.7 degrees F.

Interview with the person responsible for the Plant Operation Department, on 11/08/12 at 1:30 PM, revealed the air exchange system had three (3) separate air handlers that supplied the OR suites. The computer did not communicate with the thermostats in the OR suites. Therefore, the computer could not electronically monitor the RH and temperatures in each OR suite. He said the computer monitored only the air going into the OR suite and the return air. However, the system could not monitor OR #12 and the cysto rooms air flow because the computer system did not communicate with those rooms. The set point was 35% with air from the chiller at 55 degrees F. He said the OR staff would adjust the thermostat for comfort and the computer could not detect those changes. He revealed the computer system had an alarm that would activate when out of range and send a message to the technician phone. However, further interview revealed the humidity level parameters were set at 30-75 range, not the AORN recommended 30-60 range. Therefore, an alarm would not activate until the humidity level reached a reading of 75. He could not say who had set those parameters.

Interview with the Infection Control Preventatives, on 11/09/12 at 3;15 PM, revealed they looked for trends for surgery site infections. When asked if the humidity levels and temperatures were integrated into the tracking and trending of OR infections, they replied, "yes". However, when the Plant Operation Department was interviewed again, on 11/09/12 at 4:50 PM, he revealed the older computer system could only trend ten (10) days at a time; the present date backward ten (10) days. Once those days had passed, you could not get a computer read out.

Interview with the Manager of Accreditation Services, on 11/09/12 at 5:15 PM, revealed the Director of Plant Operation left recently and the facility was in the process of interviewing for a new director. The person who was responsible for that department during the survey was not trained on specifics and was only trying to help the department until a new director could be hired. She revealed the policy for monitoring the air environment of the OR should not have been delegated to the Plant Operation Department. She stated she had tried to remove any old policy which had another department monitoring a particular department. Per interview, each department should implement and monitor their own environment.