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Due to the nature of the deficiencies, the facility failed to comply with the Condition of Governing Body. The governing body of the hospital failed to ensure that conditions and environment in the Emergency Department protected the privacy and dignity of patients and ensured the safety of patients, visitors and staff in the department.

The facility failed to meet the following standard under the Condition of Governing Body:

A 083 - Governing Body - Contracted Services
The Governing Body failed to ensure that contracted services for hotel-based sleep study units complied with the Condition of Participation of Outpatient Services and the Standard of Integration of Outpatient Services.

A 084 - Governing Body - Contracted Services
The Governing Body failed to ensure that contracted services for leased space in 2 hotels for outpatient sleep study units were provided in a safe and effective manner, as required.

A 085 - Governing Body - Contracted Services
The Governing Body failed to ensure that the hospital maintained a complete and accurate list of all contracted services, which included the scope and nature of the contracted services provided.

A 093 - Governing Body - Emergency Services
The Governing Body failed to ensure that the hospital had a comprehensive plan for appraisal of emergencies, provision of initial emergency treatment and referral of the patient for a higher level of emergency care, when appropriate.

Based on tours/observations, staff interviews and review of facility documents, the governing body failed to ensure that services provided under contract were in compliance with all applicable conditions of participation and standards for the contracted services.

Findings:

Reference Tags A 1076 Condition of Participation of Outpatient Services and A 1077 Integration of Outpatient Services for findings related the failure of leased commercial hotel space in 2 hotels, utilized for outpatient sleep studies, to comply with the Condition (A 1076) and Standard (A 1077).

Based on tours/observations, staff interviews and review of facility documents, the Governing Body failed to ensure that all services provided under a contract were provided in a safe and effective manner.

Findings:

1. The hospital failed to ensure that environmental and fire safety inspections and oversight/review of inspections and safety processes were comprehensively addressed at the hotel-based sleep study units that were housed in leased commercial space in 2 hotels.

a. Reference Tag A 1077 - Out Patient Services - Integration of Services for findings related to the hospital's failure to ensure that the hotel-based sites for the Sleep Services sleep study observation units were integrated into the inpatient resources for review of the environmental safety condition and processes. In addition, the tag (A 1077) contained findings related to the hospital's failure to ensure that the hotel-based sites for the Sleep Services sleep study observation units conducted emergency fire, emergency medical and emergency evacuation drills to ensure that the limited staff were adequately trained to handle emergency situations without the additional manpower, leadership, expertise and structures available at the main campus of the hospital to respond to emergencies.

Based on tours/observations, staff interviews and review of facility documents, the governing body failed to ensure that the hospital maintained a complete and accurate list of all contracted services, which included the scope and nature of the contracted services provided.

Findings:

The hospital failed to have a complete and accurate list of all contracted services, as required.

a. During a tour of one of the off-site sleep study units on 05/08/13 at approximately 11:00 a.m., it was determined that the site was located on a third floor wing of a hotel in a suburban community. It was also determined that the hospital had a similar contractual arrangement with another hotel in another suburban community to accommodate another sleep study unit.

b. During the tour, the Sleep Center Director stated that some of the sleep study monitoring equipment was leased equipment and s/he provided the name of the companies that provided the equipment.

c. Review of the complete list of contracts requested at the entrance conference on 05/07/13 revealed that the hotels that leased space for the 2 off-site sleep study labs and the companies that leased sleep study equipment were not listed on the contract list. In addition, it was noted that the organ procurement organizations (OPO's), with which the hospital was required to maintain a contract to comply with another Condition of Participation, were not listed on the contract list, despite the fact that the Compliance Officer confirmed that the facility did have a contractual agreement . The Compliance Officer confirmed that the contract list that had been reviewed was the most complete list that the facility had available. S/he acknowledged that the list did not contain the previously described contracts for hotels, leased sleep monitoring equipment and OPO's.

Based on tours/observations, staff interviews and review of facility documents, the governing body fled to ensure that the hospital had a comprehensive plan for appraisal of emergencies, provision of initial emergency treatment and referral of the patient for a higher level of emergency care, when appropriate.

Findings:

The hospital failed to have a comprehensive plan for provision of emergency services that addressed the needs of all areas of the main campus and all off-campus locations. The plan for provision of assessment and initial treatment of an emergency prior to Emergency Medical Services (EMS) response through use of the Rapid Response Team and Code Blue Team was not available to address the needs of the two off-campus sleep study units, located in hotels in two suburban communities.

a. Review on 05/09/13 of the Institutional policy/procedure entitled "Hospital Scope of Services" revealed no that the document contained no plan for provision of emergencies services. On 05/10/13, the Chief Nursing Officer and the Compliance Officer both reviewed the document and confirmed that the"Hospital Scope of Services" did not contain a plan for provision of emergency services.

b. Review on 05/08/13 of Institutional policies/procedures entitled "Code Blue Procedures" and "Rapid Response Team" revealed that these two medical emergency intervention teams/processes were only available at the main campus location.

c. Multiple requests were made during the survey for the comprehensive plan for provision of emergency care that addressed the needs of the main campus, as well as all off-campus locations. The Chief Nursing Officer and the Compliance Officer were unable to find a policy or plan that addressed the emergency needs, including all of the off-campus locations.

d. Review on 05/08/13 of the Sleep Services policy/procedure entitled "Medical and Environmental Emergencies and Responses" revealed the following, in parts:
"POLICY STATEMENT
The Sleep Technologist will follow established guidelines for emergencies during a sleep study to ensure safety and appropriate medical care for all patients.
SCOPE
This policy applies to all Sleep Center technologist and physicians. Technologists are primarily responsible for patients under their specific care, and should be the one to take appropriate actions as defined below, or according to BLS training. Alternately, all staff should assist as is appropriate to the situation, assessing axillary care or assisting with patient care and safety measures. All patients must be adequately attended to with safety insured during emergency incidents involving limited individuals or the facility as a whole.
PROCEDURE
For Medical Emergency
- Call the on-call Sleep Physician with questions regarding patient safety.
- For clarification regarding patient medication, oxygen requirements, CPAP pressures, sleep lab procedures, or a chronic patient conditions, the technologist should call, in this order:
- Lab (sleep) Manager
- Lead Technologist
- On-call sleep fellow or physician
- Sleep Center Medical Director
- Call 5555(Code Blue) for in house emergencies/911 for emergencies occurring in satellite lab locations as instructed by on-call Sleep Physician.
- Polysomnographic (sleep study) recording should continue to run uninterrupted during the emergency.
- Prior to defibrillation: disconnect the headbox immediately from the cradle.
- Oximeter must be disconnected from patient and headbox
- EKG leads must be removed from patient.
- All other leads/sensors should be unplugged from headbox if times allows.
-Technologist will call the patient's emergency contact with information regarding any transport to another facility for emergency medical care.
- 'Patient/Visitor Occurrence Report' must be completed by the technologist and turned in to Sleep Center supervisor prior to end of shift of incident occurrence.
- At satellite locations, the Sleep Center staff member involved in the occurrence must complete this report and fax it to (the facility) for immediate attention. The original Patient /Visitor Occurrence Report must be given to the lab manager for review, signature and appropriate action.
- For incidents in which patients are transported out, the Sleep Center Director of Operations or Lab Manager must be notified in the morning of the occurrence."
The document provided some parameters/guidelines for technologist responses to various medical emergency situations. The highest level of intervention for serious medical conditions, including possible neurological events, low oxygen levels, and cardiac-related emergencies, the direction was "call on-call Sleep Physician or 911 if applicable."

e. On 05/09/13, at 2:37 p.m., the Sleep Center Director acknowledged that no drills had been conducted at the two hotel-based sleep study locations to teach the technologists to respond medical emergencies. S/he also confirmed that there were no emergency call lights in the bathrooms at the two hotel-based sleep study sites.

Due to the nature of the deficiencies, the facility failed to comply with the Condition of Outpatient Services. The hospital failed to ensure that the services provided in the outpatient, off-campus sleep study sites were organized, in accordance with acceptable standards of practice, to meet the needs of the patients.

The facility failed to meet the following standard under the Condition of Outpatient Services:

A 1077 - Outpatient Services - Integration of Outpatient Services
The hospital failed to ensure that the care environment in the three outpatient sleep study units was organized and integrated with inpatient services to addressed the safety and infection control needs of their patients.

Based on tours/observations, staff interviews and review of facility documents, the hospital failed to ensure that the outpatient services were appropriately organized and integrated with inpatient services. The failure created the potential for negative outcomes for patients.

Findings:

1. The hospital failed to ensure that the outpatient Sleep Services clinics and sleep study observation units were integrated into the inpatient infection control structure, including prevention, surveillance and access to infection control consultation/expertise.

a. On 05/10/13 at 9:40 a.m., a tour of the main campus sleep observation units was conducted. The unit consisted of a large 6 sleep room unit with 3 observation desks located in the central hallway, each with two monitors to observe patients and their sleep study readings. A second area of the sleep observation unit was on the same floor at the end of an inpatient adult medical unit. The second unit contained four sleep rooms and a separate staff observation room with 2 observation desks, each with two monitors to observe patients and their sleep study readings. The main sleep unit also had equipment storage closets, containing masks, chin straps, leads, and plastic hoses and tubing for re-use with patients during the sleep testing. There was also an alcove with a sink and cabinets above and below the sink. The director stated that the re-usable sleep equipment was washed, soaked and disinfected there. There were hanging/drying racks for equipment in the storage closets. When asked how the various equipment was washed, the director produced a spray bottle with one anti-bacterial agent and stated that it was use to clean hoses and that chin straps were soaked in the anti-bacterial agent and then hung up to dry without rinsing. S/he was by the surveyor referred to the contents of the Sleep Services Policy entitled "Equipment Cleaning and Maintenance Policy," which stated that CPAP hoses were to be washed weekly in warm, soapy water, sprayed with the anti-bacterial agent, rinsed thoroughly and air dried. When asked about the exact methods for doing that, such as how the long hoses were effectively sprayed with the anti-bacterial agent, s/he stated that they only sprayed the outside of the tubing close to the CPAP mask, because the inside of the tubing was not dirty and did not need to be disinfected. When asked about the length of soaking time for chin straps for the anti-bacterial agent to be effective, the director and staff repeatedly stated "according to manufacturer's instructions." The director also displayed another anti-bacterial agent that was used for soaking equipment under the sink in a large covered plastic multiple gallon container. There were not fill lines for accurately measuring the amount of dilution of the agent with water. Another staff member showed the surveyor the measuring cup for the agent, which was a plastic cup similar to a 30 cc medication administration cup for dispensing a liquid medication. There were no posted detailed instructions for how to use the various anti-bacterial agents to clean/spray/soak different pieces of equipment. The soaking bin under the sink did not have a label stating when the last batch of the soaking solution had been prepared, although the director stated that each batch was good for a week. The cleaning instructions in the policy/procedure "Equipment Cleaning and Maintenance Policy" did not address the cleaning of chin straps and did not appear to reflect what the staff were actually doing when cleaning equipment was described. It also did not state how to clean the lead wires used in the sleep studies. The instructions contained no specific instructions about soaking times, contact times or how long a soak batch could be kept, or that batches should be labeled when prepared.

b. On 05/10/13 at 2:45 p.m., the hospital's Infection Preventionist was interviewed about training of staff and his/her role in review/observing their cleaning disinfecting practices in the sleep study units. S/he stated that s/he had never been to the hotel-based sleep study units to assess their cleaning practice and to assess for any infection control policy or training needs or risks. S/he stated that she also did not go to the main campus sleep study unit to evaluate any infection control issues and that s/he had not specifically reviewed the anti-bacterial agents used, or the washing techniques utilized by staff to clean the equipment. S/he stated that s/he had provided a module on use of cleaning/anti-bacterial agents in an annual competency for the staff. S/he stated that s/he usually referred staff to the manufacturers labels and did not review the agents and processes used to ensure that their processes for cleaning were effective and appropriate.

In addition, the infection control nurse was asked about an observation that the surveyor had made during the tour of the 4 bed sleep unit on the medical unit. During the tour, the surveyor had observed that the walls behind the patient beds were made of a fabric that appeared very texture and not waterproof or impervious to soil, bacteria, dust and other contaminates. The patient beds were placed right up against these fabric walls with no headboard or other solid, washable surface to prevent contamination between the bedding and the fabric walls. When asked his/her opinion of the situation described, s/he stated that it sounded like a potential infection control risk situation. S/he stated that s/he would look at the wall/bed placement and materials and assess the situation for risk. When asked if s/he routinely visited the main campus sleep unit to assess infection control risk and staff training and policy/procedure needs, s/he stated that s/he did not.


2. The hospital failed to ensure that the hotel-based sites for the Sleep Services sleep study observation units were integrated into the inpatient resources for review of the environmental safety condition and processes.

a. On 05/08/13 at 11:00 a.m. a tour was conducted a one of the hotel- based sleep observation units. During the tour, one of the lead technologists was present to be interviewed. S/he was asked if s/he had ever been present at the hotel locations when a fire drill had occurred and s/he stated that s/he had never been present when a fire drill occurred.
During the tour, the Director of the Sleep Center was asked to provide reports from the hotel about the fire-drills that they conducted. S/he stated that they received reports from the hotel about fire drills on a quarterly basis. S/he provided the fire drill reports back to January, 2012 with the most recent report being 12/13/12. S/he stated they had not received the most recent quarter's reports. Review of the reports for 01/12, 04/12, 07/12 and 10/12 for both hotel sight revealed that all fire drills were conducted between 10:00 a.m. and 2:00 p.m.

b. On 05/09/13 at 11:20 a.m., the Director of Facilities was briefly interviewed about the hotel-based sleep study units. The director was asked if there had been previous CMS life safety code inspections of those 2 locations. The director stated that s/he had never been to either of those locations. S/he stated that a state life safety inspector for CMS had inspected the offsite locations for all of the other clinics, but had not inspected the hotel-based sites, which had been in use since 2007. S/he stated that the surveyor had toured the other off-campus and on-campus sites during a 7-day life safety survey as part of a validation survey conducted in 2009. S/he stated that s/he did not go to those locations much because they are leased spaces. S/he stated that they relied on the property owners/managers to conduct fire and maintenance inspections for those locations.

c. On 05/09/13 at 2:45 p.m., the safety officer was interviewed was interviewed about environmental and safety inspections that were conducted at the hotel-based sleep units. When asked about environment/safety rounds, s/he stated that the staff at the location were asked to fill out an environmental inspection sheet. S/he stated that s/he did not go to those locations to conducted environmental inspections. When asked about whether they received elevator inspections and fire department inspections that they could review to ensure patient safety, s/he stated that the hotels were responsible for that and there was no process in place to provide those reports to the hospital. S/he stated that they could ask for them from the hotels, but acknowledged that no system was currently in place to receive and review those reports from the other facility, to ensure safe conditions for patients and staff.

3. The hospital failed to ensure that the hotel-based sites for the Sleep Services sleep study observation units conducted emergency fire, emergency medical and emergency evacuation drills to ensure that the limited staff were adequately trained to handle emergency situations without the additional manpower, leadership, expertise and structures available at the main campus of the hospital to respond to emergencies.

a. On 05/09/13, at 2:37 p.m., the Sleep Center Director acknowledged that no drills had been conducted at the two hotel-based sleep study locations to teach the technologists to respond medical emergencies. S/he also confirmed that there were no emergency call lights in the bathrooms at the two hotel-based sleep study sites. In addition, s/he acknowledged that there had been no fire drills or emergency evacuation drills conducted by the hospital, at the 2 hotel-based sleep study units.

b. Refer to A 093 - Governing Body - Emergency Services for additional findings related to a lack of integration of the hotel-based sleep study units into the emergency support plans available on the main campus.