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Based on observation, staff interviews, review of facility documents, it was determined that the facility's governing body had failed to assure two off-campus outpatient sleep studies met the physical space requirements for participation in the Medicare program.

Findings:

1. Layout of Northern Off-campus Sleep Lab:
On 01/30/14 at 9:10 a.m., a tour was conducted at the northern off-campus outpatient sleep study lab. The outpatient lab was located at the far end of the 4th floor of the hotel. The lab consisted of a 2-bedroom suite utilized as the monitoring area and equipment storage area for the sleep center. One bedroom was furnished as a monitoring area with 2 monitors and consoles to observe up to two patients. Another two rooms along the same side of the hallway were sleep study rooms as well. During the tour, signage was observed at the entrance of the hotel lobby and outside each room under the control of the sleep study lab. All rooms used for the lab were locked and the keys were under the control of the sleep study staff. The other rooms on the floor were utilized by the hotel as guest rooms.
During the tour, the director of the sleep study program and the compliance officer were interviewed. They stated that the sleep study rooms were locked with key access by the sleep study staff, which maintained their separation from the hotel guest rooms. They both stated that the local municipality had directed a door could not placed across the common hallway in order to segregate the sleep lab from the rest of that hallway because of fire safety regulations.
The staff provided a floor plan, which identified the rooms utilized by the outpatient lab along with photographs of the common use hallway and entry doors to the sleep lab rooms.
2. Layout of Southern Off-campus Sleep Lab:
On 01/30/14 at 10:45 a.m., a tour was conducted at the southern off-campus sleep study lab located within a hotel. The sleep lab was located at the far end of the 3rd floor of Building A. A two bedroom suite was utilized as the monitoring area and equipment storage area for the sleep center location. One of the bedrooms was furnished as a monitoring area with four monitors and consoles to observe up to four patients. The outpatient sleep lab also consisted of four additional rooms that were being utilized for patients.
There was a hotel guestroom located next to a sleep study patient room and directly across the common hallway from the other sleep lab rooms.
During the tour, the director of the sleep study program and the compliance officer for the hospital were interviewed during the tour and stated that the sleep study patient rooms were locked with key access by the sleep study staff, which maintained their separation from the hotel guest rooms.
They provided a floor plan which identified the sleep study rooms and those that were hotel facility or hotel guest rooms. They also took reference photographs at the request of the surveyors to more clearly depict the layout and proximity of the sleep lab rooms and hotel guest rooms.
During the tour of the location, signage was observed at the entrance of the hotel lobby, outside the patient rooms and the monitoring area identifying that it was part of the Sleep Center at (facility).
Mid-way down the hall was a glass door with a sign identifying the sleep center. On the opposite side of the glass door, there were 3 hotel guest rooms on each side of the hall.
3. Flow of Patients at two Off-Campus Locations:
The Lead Polysomnography Technician was interviewed by telephone on 02/3/14 at 2:35 p.m. S/he explained that patients were instructed to go the front desk of the hotel to tell them they were there for the Sleep Center. Patients then waited in the lobby for the technician to come and escort them to the sleep lab. S/he explained that the routine was that technicians would take their assigned patients to their rooms and leave them to dress for bed. They later return to each patient individually to orient the patients in their rooms and begin the sleep study process. The patients did not get room keys. The electronic keycards were made for each room and were good for 365 days. Those patient room keys remained in the monitoring area. The room key for each individual patient room was kept at the corresponding monitor/console for that patient room. The lead technician stated that the front desk staff were never given the names of expected patients for the evening.
S/he stated that in the morning, patients were awakened, disconnected from the monitoring equipment and asked to fill out a patient questionnaire. The patients were then free to leave. S/he stated that the patients were expected to leave the rooms, once they were dressed, and were told they could wait in the lobby if they were waiting for a ride.
4. The hospital contracts for the sleep labs were reviewed on 01/31/14. The contracts stated " Arriving patients will be asked to wait in the lobby until a Sleep Center staff member arrives to escort them to the designated rooms. "
5. The patient fact sheet " Sleep Study Test Facts " was reviewed on 01/31/14. The fact sheet stated, in part: " What to expect during your sleep study: Please arrive by 8:30 p.m. A sleep technologist will show you to your private room ...You can shower and get ready for departure from the sleep lab by 6:30 a.m., at the latest. If you are having someone pick you up, you can wait in the lobby. "
6. CMS requires that a hospital must participate in its entirety. The definition of a hospital under the social security act does not allow partial participation. The hospital has commingled space with the hotel. There are hotel rooms within the same area as defined hospital space. The hospital is comprised of both the physical facility, the personnel and equipment for the service.

The northern location for sleep studies is 3 rooms at the end of the hall. Opposite the 3 rooms are hotel guest rooms. There is no separation between the corridor for hospital rooms and the hotel guest room as well no separate patient waiting area. This is commingled space with the hotel.

The southern location for sleep studies is 5 rooms at the end of a hall. There is a glass door separating the 5 sleep study rooms from the other 6 hotel guest rooms, however, there is one hotel guest room behind the glass door. This is co-mingled space with the hotel.

For both locations arriving patients are asked to wait in the lobby until a sleep center staff member arrives to escort them to the sleep study rooms. The patient waiting area is the hotel lobby.
The governing body for both outpatient as well as inpatient areas must assure that compliance is achieved with participation requirements.

An unannounced onsite recertification survey was conducted (see event ID #9YSH21) April 8 through April 11, 2014 by one (1) Life Safety Code Inspector and included an inspection for compliance with the fire safety requirements of NFPA (National Fire Protection Association) 101, Life Safety Code, (2000 edition) and NFPA 99 Health Care Facilities (1999 Edition). The facility failed to comply with the regulations set forth. Deficiencies were cited under Life Safety Code tags K0020, K0029, K0046, K0052, K0056, K0062, K0067, K0073, K00143, K0146, and K0147.

See survey event ID #9YSH21 for full details of the cited deficiencies.