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.

HILLCREST HOSPITAL CLAREMORE 1202 N MUSKOGEE PLACE CLAREMORE, OK 74017 Aug. 15, 2014
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on observation, staff interview and document review, it was determined that the hospital failed to protect patient rights to privacy, dignity and comfort, and failed to provide care in a safe setting in the mobile cardiac cath lab.

Observations and interviews revealed that cardiac catheterization patients were not afforded personal privacy, comfort and dignity during transportation from inside the hospital to the mobile cardiac cath lab located outside of the hospital building. Patients were exposed to all types of weather conditions without adequate protection. See Tag A-0142 and A-0143.

Observations and interviews also revealed that the hospital failed to ensure patient safety, security and environmental infection control related to the mobile cath lab. See Tag A-0144.

The failed practices pose an Immediate Jeopardy to the health and safety of patients which could lead to harm or potential for harm, serious injury or death. These failed practices had the potential to affect all cardiac catheterization patients admitted to the hospital.
VIOLATION: PATIENT RIGHTS: PRIVACY AND SAFETY Tag No: A0142
Based on observations and interviews, it was determined that the hospital failed to ensure patient safety and privacy during cardiac cath procedures performed in the mobile cardiac cath lab located outside the hospital building.

Findings:

On 08/15/14, at 10:00 a.m., the surveyors observed a temporary trailer on wheels set up in the hospital's public parking lot. The staff stated this mobile unit was used for cardiac catheterization while the hospital's permanent cardiac cath lab was being relocated to another area within the hospital.

The surveyors observed that the pop-out portions of the mobile unit were supported by thin metal posts. When inside the cath lab, the surveyors noted that walking caused the unit to shake. A drop down staircase used by staff to enter the mobile cath lab did not sit level and the staff had to walk up steps that were set at a backward angle.

The unit had an open platform patient lift that was enclosed by only two small diameter side rails. The lift platform was barely large enough to accommodate a stretcher and one staff person.

The staff was asked if there were any special safety features in place for the mobile lab. The staff stated that barriers were in place to prevent cars from running into it.

The location of the mobile unit afforded no personal privacy for patients. Cardiac cath patients en route to and from the mobile cath lab could be seen by persons in the hospital's public parking lot and could be seen from one hospital public entrance, as well as from an adjacent medical office building.

The staff were asked how patients' privacy could be maintained when they could be seen by the public coming and going from the cath lab. They stated, "Patient privacy is a problem."
VIOLATION: PATIENT RIGHTS: PERSONAL PRIVACY Tag No: A0143
Based on observation and staff interview, it was determined the hospital failed to maintain patient rights to dignity and comfort during cardiac cath procedures.

Findings:

On 08/15/14, the surveyors asked the staff to describe how patients were transported from inside the hospital to the mobile cardiac cath lab. The staff stated patients were transported on stretchers in patient gowns and covered with sheets or blankets.

The staff showed the surveyors the route from the preparation area within the hospital to the mobile cath lab. The route took the patients through an outdoor maintenance/service area and then out into an open space until they reached the mobile unit. The maintenance area housed a golf car, various pieces of equipment and maintenance items. This area was not clean and was partially exposed to the elements.

Depending on the weather conditions, when the patients were transported through the maintenance area they could be exposed to bright sunlight, windy conditions, precipitation and/or extreme temperatures. The cardiac cath patients took the same route back into the hospital.

The surveyors observed that the mobile unit was uncovered and the patient and staff entrances offered no protection from wind, rain or extreme temperatures. The staff were asked how patients were protected from the weather during transport to and from the cath lab. They stated the patients were "covered with a tarp" and if needed, "a golf umbrella" was used to protect the patient's head and face.

The staff was asked if this was a comfortable and dignified way to transport a patient. No reply was made.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on observation, document review and staff interview, it was determined that the hospital failed to address safety, security and environmental exposure issues in order to provide a safe care environment for patients who had procedures performed in the mobile cardiac cath lab.

Findings:

On 08/15/14, the surveyors observed that the mobile cardiac cath lab was located in the hospital parking lot. Because it was a temporary unit (one that could be transported by pulling it with a truck), the staff was asked if the hospital had any special policies and procedures that addressed plans for severe weather. The staff stated there were no written policies for this. The staff was asked what they would do in the event of severe weather. They stated they would "just wait until it passed and then start or finish the procedure."

The staff was asked if there had been any security concerns with the mobile cath lab. The staff stated there had been no problems. It was observed by the surveyors and it was confirmed by staff that when the unit was in use, the staff door was not locked. There was no deterrent that prohibited unauthorized persons from entering the mobile cath lab when it was occupied by patients and staff.

The surveyors also observed that the mobile unit's power source, water supply and cable connections were not protected and could be vulnerable to tampering or disabling by vandals.

Because cardiac cath patients were transported through a dirty outdoor maintenance and mechanical area, the patients and their stretchers were exposed to environmental contaminants that were ultimately transported by the patients, staff and stretchers into the surgical environment of the cardiac cath lab.

The surveyors observed that the staff and patient entrances into the mobile lab were not protected from environmental exposure and allowed immediate contamination when either door was opened. Inside the mobile lab, the surveyors observed there was evidence of environmental contamination such as dirty, dusty floors, dusty surfaces and dirty air filters.

The staff was asked if there were any mobile unit specific policies and procedures that addressed safety, security and environmental infection control issues. The staff stated there were none.

An unsigned hospital cath lab policy and procedure titled, "Security Management Plan Cath Lab" had no reference or specific information related to security for the mobile cath lab.
VIOLATION: RADIOLOGIC SERVICES Tag No: A0528
Based on observation, staff interview and document review, it was determined the hospital failed to ensure:

a. all radiologic services were organized to meet the needs of cardiac catheterization patients. See Tag A-0529;

b. the mobile cath lab was prepared for safe patient use according to the manufacturer's recommendations. See Tag A-0535;

c. radiology equipment in the mobile cath lab received periodic inspections according to the manufacturer's instructions. See Tag A-0537; and

d. the hospital failed to ensure a qualified radiologist supervised the radiology services in the cardiac cath mobile lab. See Tag A-0546.

The failed practices posed an Immediate Jeopardy to the health and safety of patients which could lead to harm or potential for harm, serious injury or death. These failed practices had the potential to affect all patients admitted to the hospital who required cardiac catheterization services.
VIOLATION: SCOPE OF RADIOLOGIC SERVICES Tag No: A0529
Based on staff interview and document review, it was determined the hospital failed to ensure all radiologic services were organized to meet the needs of the patients. The hospital also failed to determine, approve, and implement a written scope of services for the mobile cath lab.

Findings:

On 08/15/14, the cardiac catheterization lab manager was asked if the cath lab was organized under the hospital's radiology services. She stated it was not. She stated she believed it was a part of cardiology services.

She was asked if the chief of radiology had any responsibilities related to the cath lab. She said he did not. She was asked who oversaw radiology safety for the mobile lab. She stated she was not sure.

She was asked how the lab interfaced with the radiology department. She stated the cath lab had some similar procedures.

There were no cardiac catheterization policies and procedures found in the radiology department policies and procedures. The cardiac cath department policies and procedures had some limited radiology policies, but none of them referred to the mobile cath lab.

The hospital provided a cath lab scope of services policy that did not include the scope of services for the mobile cath lab.
VIOLATION: SAFETY POLICY AND PROCEDURES Tag No: A0535
Based on document review and staff interview, it was determined the hospital failed to ensure the mobile cath lab was prepared and evaluated for safe patient and staff use according to the manufacturer's recommendations.

Findings:

On 08/15/14, the hospital provided a cath lab policy titled, "Radiation Safety Program." The policy documented, "...Environmental radiation surveys shall be made of any new installations and remodeled areas to assess any changes in radiation hazard. The structural shielding requirements of any new installation will be discussed with the RSO/Radiology Director..."

The plant manager was asked if the hospital had any documentation this process had been carried out. He stated they did not.

The manufacturer's site planning guide for the mobile cath lab documented, "...Radiation Shielding: Care should be taken when determining a site location for a mobile lab. Factors such as shielding, proximity to buildings and occupancy of surrounding buildings must be considered... Some states/localities may require physicist reports be done locally, in which case it is the responsibility of the customer to perform a proper radiation survey/physicist report if required..."

The hospital staff was asked if the hospital had consulted with an onsite certified medical physicist, working on behalf of the hospital, to evaluate the location and shielding of the mobile cath lab. They stated they had not.

The site planning guide further documented, "...Power Source Monitoring (Facility Only) Note: Perform a power audit first. A power analyzer should be used to check the proposed Mobile Lab facility site power for average line voltage, surges, sags, reclosures, impulses, frequency and microcuts. A period that includes two weekends should be used to simulate several days of normal use. Analysis of the data and site history of any previous power problems with other x-ray systems or computer installations should be reviewed with your power and ground representative. Verify "brown-out" (low voltage) conditions, which may occur during summer months, will not exceed the allowable range..."

The hospital was asked if the hospital experienced any power problems in the past six months. They stated they had some power interruptions and had limited low voltage events. They were asked if the hospital had performed the power audit on the mobile cath lab as recommended by the manufacturer. They stated they had not.
VIOLATION: PERIODIC EQUIPMENT MAINTENANCE Tag No: A0537
Based on observation and staff interview, it was determined the hospital failed to ensure the radiology equipment in the mobile cath lab received periodic inspections according to the manufacturer's instructions.

Findings:

A hospital cath lab policy titled, "Patient Protection" documented, "...The Cath Lab Department will have all radiation-producing equipment used on patients surveyed by a certified radiation physicist at least once a year to determine compliance of state standards and equipment performance. The survey shall address, as a minimum, acceptable criterion entrance exposure rates and adequate filtration..."

The hospital was asked to provide documentation from the physicist that an evaluation of the mobile cath lab hd been done. None was provided.

During a tour of the mobile cath lab on 08/15/14, the surveyors observed there were no current inspection stickers on any of the radiology equipment. The staff was asked if this equipment was included in the hospital's preventive maintenance program. They stated it was not.
VIOLATION: RADIOLOGIST RESPONSIBIITIES Tag No: A0546
Based on document review and staff interview, it was determined the hospital failed to ensure a qualified radiologist supervised the radiology services in the cardiac cath mobile lab.

Findings:

On 08/15/14, the cath lab manager stated a cardiologist supervised all the services in the cardiac cath lab. She was asked if a staff radiologist supervised or consulted on the radiology services provided in the cath lab. She stated, "No."

A review of the cath lab policies and procedures had limited ionizing radiation policies and were not specific to cardiac cath lab. The few that were provided had not been signed as approved by the hospital's chief of radiology. There was no documentation of involvement in the cardiac cath lab services by the hospital's chief of radiology.
VIOLATION: DISPOSAL OF TRASH Tag No: A0713
Based on observation and staff interview, it was determined the hospital failed to implement procedures for the proper collection and prompt disposal of trash in the mobile cath lab.

Findings:

On 08/15/14 at 11:00 a.m., the surveyors toured the mobile cardiac cath lab. The staff stated the cases scheduled for the day were finished. At the time of the tour, trash (including biohazardous waste and sharps) had not been removed from the cath lab. Trash cans were full and a red biohazard bag was tied up and stored on the floor in a corner of the surgical suite. Several empty shipping boxes were stacked on a surgical back table.

The staff was asked if trash was collected and stored in a soiled workroom between cases. They stated it was not, and that it was allowed to collect in the containers in the room because the mobile unit did not have a soiled holding room. The staff stated the housekeeping department terminally cleaned the cath lab at the end of the day and this was when trash was removed.
VIOLATION: PHYSICAL ENVIRONMENT Tag No: A0700
Based on observation, document review and staff interview, it was determined the hospital failed to:

a. implement a preventive maintenance program for the equipment in the mobile cath lab and failed to develop emergency procedures specific to the mobile cath lab. See Tag A-0701;

b. implement procedures for the proper collection and prompt disposal of trash in the mobile cath lab. See Tag A-0713;

c. provide cardiac catheterization services in an area designed and maintained to meet accepted standards of practice. See Tag A-0722;

d. provide cardiac catheterization services in a safe location. See Tag A-0723;

e. ensure mobile cath lab supplies were stored and maintained to ensure safety and quality. See Tag A-0724;

f. ensure cardiac catheterization was performed in an area large enough to provide the service according to the accepted standards of practice. See Tag A-0725; and

g. the hospital failed to ensure proper ventilation, humidity and temperature controls were maintained in the mobile cardiac catheterization lab. See Tag A-0726.

The failed practices posed an Immediate Jeopardy to the health and safety of patients which could lead to harm or potential for harm, serious injury or death. These failed practices had the potential to affect all patients admitted to the hospital who required cardiac catheterization services.
VIOLATION: MAINTENANCE OF PHYSICAL PLANT Tag No: A0701
Based on observation, record review and staff interview, it was determined the hospital failed to implement a preventive maintenance program for the equipment in the mobile cath lab and failed to develop emergency procedures specific to the mobile cath lab.

Findings:

A hospital policy titled, "Equipment Preventive Maintenance" documented, "...Testing of all electrical equipment will be performed by the engineering Department/BioMedical Services and the results documented. All equipment should be checked a minimum of monthly for current PM..."

On 08/15/14, hospital staff was asked if the mobile cath lab was included in the equipment preventive maintenance program. They stated it was not.

The staff was also asked if the hospital had developed emergency preparedness procedures specific to the mobile cath lab. They stated they had not.

The staff was asked if the hospital performed emergent cardiac catheterization procedures. The cath lab manager stated they did within certain limits. She was asked to provide policies and procedures that described the capabilities and availability of the mobile cath lab for emergent cases. None was provided.

At the time of the tour of the cath lab, the suite was dirty, trash had not been removed and the room was not prepared for an emergent case. The manager was asked when the suite would be terminally cleaned. She stated it was usually cleaned at the end of the day by the housekeeping department.
VIOLATION: FACILITIES Tag No: A0722
Based on observation, document review and staff interview, it was determined the hospital failed to provide cardiac catheterization in an area designed and maintained to meet accepted standards of practice for this service.

Findings:

On 08/15/14, the surveyors conducted a tour of the mobile cardiac catheterization lab. The hospital's original in-house cardiac catheterization lab was closed to be relocated to another area of the hospital.

The following deficiencies were observed in the mobile cath unit:

1. There was not enough space for the equipment and supplies necessary to support cardiac cath procedures. The manufacturer's floor plan for the mobile cath lab documented there was less than 220 square feet of space in the cath lab. Because there no place for it, the emergency suction machine was stored unplugged on top of a high cabinet. All types of supplies were stored in various areas of the lab, including outside the surgical area and on the floor.

2. The staff stated the hospital had not engaged a certified medical physicist, working on behalf of the hospital, to evaluate the mobile unit's radiation protection capabilities.

3. The surgical scrub sink was not large enough to allow for a thorough surgical scrub. In addition, this sink was located within the surgical suite. Because the sink was narrow and shallow, there was likely splash contamination of personnel and the surrounding surfaces that held clean supplies and equipment. There was no separate hand washing sink for staff located in the mobile unit.

4. The mobile unit had no patient holding area and no way for patients to move from the preparation area into a semi-restricted and then into the restricted surgical environment of the cath lab.

5. There was no storage for portable equipment and supplies not needed during the procedure. The patient stretcher was stored on the patient lift outdoors (subjected to sun, rain, etc.) until the cardiac cath procedure was completed.

6. There was no provision for a staff changing area that ensured staff could change into clean scrub attire and then move directly into the surgical environment. The staff wore surgical scrub attire and traveled back and forth from the hospital building, through the outdoors and then into the surgical environment of the cath lab.

7. There were no clean and soiled workrooms provided within the mobile cath lab.

8. There was no provision for separate storage of sterile supplies within the suite. Sterile packs were stored in a cabinet outside of the surgical procedure area in the control room. Other sterile supplies were stored in various places with non-sterile supplies.

9. The unit had no dedicated janitor's closet.

10. The hospital had no documentation the hospital leadership evaluated the mobile cath lab's design and features before it was entered into service.
VIOLATION: LOCATION OF FACILITIES Tag No: A0723
Based on observation and staff interview, it was determined the hospital failed to provide cardiac catheterization services in a safe location.

Findings:

On 08/15/14, the surveyors observed and were told by staff the mobile cardiac cath lab was located in a wheeled trailer in the hospital parking lot. The mobile unit was not a part of the physical plant of the hospital. No provision had been made to attach it and shelter it to an appropriate area of the hospital.

The mobile lab's manufacturer's user information provided by the hospital titled, "Mobile Lab #190 Site Requirements Planning Guide" documented, "... This guide is intended to provide an overview of the Site Requirements needed for preparing your site for delivery and installation of a Mobile Lab... Attachment to Facility: Various connection system options are available. The physical connection between the land based facility and the mobile lab can be as simple or complex as desired. In appropriate climates, awning type enclosures seem to work best. More permanent structures can be also be built. Please contact us for examples of what prior customers have done to physically connect a mobile lab to a hospital..."

The surveyors observed there was no structural connection between the hospital and the mobile cath lab. The hospital made no modifications to ensure patients were protected from the weather, were provided with visual privacy and were provided any measure of security by restricting access to the unit.
VIOLATION: FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE Tag No: A0724
Based on observation and staff interview, it was determined the hospital failed to ensure mobile cath lab supplies were stored and maintained to ensure safety and quality.

Findings:

On 08/15/14, the mobile cath lab was toured with hospital staff. There was inadequate storage space for supplies. Some sterile supplies were stored on the floor. Sterile supplies were stored with unsterile supplies.

Drawers and cabinets were overstocked with items so that the first items received in were not guaranteed to be the first supplies taken out.

Some sterile and non-sterile supplies needed within the surgical suite were stored in the control room.

Supplies in the emergency cart appeared old, with discolored and wrinkled packaging. Some packages were stained and had debris attached to the outside.

There was no organization to the storage of supplies. IV fluids and many other items were stored in various areas throughout the lab.
VIOLATION: COMPLEXITY OF FACILITIES Tag No: A0725
Based on observation and staff interview, it was determined the hospital failed to ensure cardiac catheterization was performed in an area large enough to provide the service according to the accepted standards of practice.

Findings:

On 08/15/14, the surveyors conducted a tour of the mobile cath lab. The cath lab consisted on three areas: the control room, the surgical suite and a mechanical room. The surgical suite was so small that staff could not walk completely around the procedure table without running into equipment or inadvertently knocking over supplies. The mechanical room was so small that only one person could stand in it at a time.

The small size of the surgical suite made it likely that staff would accidentally contaminate a sterile field during the procedure. It was unlikely staff could pass safely around one another without contaminating their sterile gowns.

The staff stated they had no space to collect soiled materials, equipment or linen. They also stated there was no clean workroom.

Because the lab was so small, there was no designated space to park the patient stretcher during the procedure. The staff stated they parked the stretcher outside the mobile lab on the patient lift that was exposed at all times to the elements.

The staff acknowledged the area was difficult to work in.
VIOLATION: VENTILATION, LIGHT, TEMPERATURE CONTROLS Tag No: A0726
Based on observation, record review and staff interview, it was determined the hospital failed to ensure proper ventilation, humidity and temperature controls were maintained in the mobile cardiac catheterization lab.

Findings:

On 08/15/14, a tour of the mobile cath lab was conducted. Staff was asked if they could verify the required 15 room air exchanges per hour for the cath lab. They stated they could not. The staff had no knowledge of the monitors for the HEPA air filters and no knowledge of the pre-filters (required upstream from the HEPA filters) and where they were located. The staff had no knowledge of where the fresh air intakes were located. It appeared the mobile lab did not take in fresh air, but simply re-circulated air.

The staff stated they did not monitor and document humidity and temperature levels in the lab. The hospital had no documentation to verify humidity and temperature ranges were within acceptable parameters for the provision of cardiac catheterization procedures in the mobile lab.

See also Life Safety Code survey.
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on observation, document review and staff interview, it was determined the hospital failed to:

a. limit access to the mobile cardiac catheterization surgical suite;

b. ensure conformity to aseptic and sterile conditions in the mobile cardiac cath lab;

c. provide proper cleaning between cases and ensure appropriate terminal cleaning;

d. enforce the use of clean surgical attire;

e. monitor, inspect, test and maintain biomedical equipment in the mobile cath lab;

f. store sterile supplies in a manner to ensure integrity and sterility;

g. monitor and maintain temperature and humidity within acceptable surgical parameters;

h. develop and implement all the required surgical policies and procedures related to the cath lab. See Tag A-0951; and

i. the hospital failed to maintain a procedure log with all the required elements. See Tag A-0958.

Findings:

On 08/15/14, the surveyors toured the hospital's mobile cath lab located in the hospital's public parking lot. The following observations were made:

1. The mobile cath lab (a stand-alone, unattached trailer) had no provision to limit traffic via semi-restricted and restricted corridors and when in use, allowed unrestricted access by unauthorized persons. In addition, the patient entrance door to the cath lab sterile area opened directly from the outside.

2. The cath lab was very small (approx. 220 square feet) and had inadequate space to accommodate the types and amount of equipment, supplies and materials required for the procedures. The surgical area was so small that walking paths were restricted and the space around the draped patient was likely to be inadvertently contaminated by staff or equipment contact. It was unlikely that sterile fields could be set up and maintained without contamination.

3. The surgical scrub sink was located inside the sterile area, rather than outside the suite as required. The scrub sink was the size and depth of a sink found in a travel trailer. It was not possible to perform a surgical scrub without splashing the staff's surgical attire. The very small counter space around the surgical scrub sink held an open box of non-sterile gloves, surgical clippers and various other items that were in the contaminated splash zone around the sink.

4. A very large oxygen tank was chained to a dolly in the surgical area. The tank and the dolly were dirty and appeared to have come directly from a delivery truck. The mobile unit had no other oxygen delivery system.

5. Empty shipping boxes were stacked on a surgical back table in the sterile procedure area.

6. At the time of the tour, the surgical area had a red biohazard bag tied up on the floor. A large plastic 50 gallon trash can still had trash in it that had accumulated from the cases performed that day. Trash was on the floor. It was apparent that the procedure table and other equipment had not been cleaned. There was so much equipment, materials and supplies in the room that all surfaces and floor space could not be terminally cleaned. The entire suite appeared it had never had adequate terminal cleaning.

7. The emergency cart was dusty and dirty.

8. A rubber cushioning-type mat was found on the floor next to the procedure table. When it was lifted, dirt, dust and debris were evident on the floor.

9. Even though the day's cases ended before 10:00 a.m., the staff stated terminal cleaning was done near the end of the work day by the housekeeping department. At the time of the survey, the staff stated the cath lab was available for emergent cases. However, the staff did not ensure terminal cleaning was done immediately after the last scheduled case of the day.

When staff was asked how the suite was cleaned, the staff stated the housekeeping staff rolled a mop cart out of the hospital to the parking lot and cleaned the cath lab with it. The cath lab had no dedicated janitor's cleaning equipment.

The staff was asked if the housekeeping staff had been trained in terminally cleaning a surgical environment. The cath lab manager stated they were. She was asked to provide the policies and procedures that governed the terminally cleaning process. None were provided.

10. A hospital cath lab policy titled, "Dress Code" documented, "...Lab Coats: All personnel exiting the suite who intend to return to the suite to perform procedures or services are required to wear a lab coat over their scrub suit... Shoe covers are optional..." The policy did not address all the surgical attire requirements for a surgical area, such as hair covers.

When the surveyors arrived at the hospital, a staff person dressed in scrub attire was seen walking across the open outdoor space between the hospital building and the mobile cath lab. The staff person was not wearing a lab coat.

11. The biomedical equipment used in the mobile cath lab had no documentation of routine inspection and maintenance.

12. Sterile supplies were stacked on the floor in the surgical area. Sterile supplies were stored with non-sterile supplies. Sterile supplies were also stored outside the surgical area in the radiology control room. Supplies were stuffed into every drawer and cabinet in manner to potentially compromise the integrity of the packaging.

13. Temperature and humidity were not monitored and the hospital had no documentation these were maintained within acceptable parameters for a surgical procedure area.

The failed practices posed an Immediate Jeopardy to the health and safety of patients which could lead to harm or potential for harm, serious injury or death. These failed practices had the potential to affect all patients admitted to the hospital who required cardiac catheterization services.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
Based on policy and procedure review and staff interview, it was determined the hospital failed to develop and implement all the policies necessary to govern the surgical care provided in the mobile cardiac cath lab.

Findings:

On 08/15/14, the surveyors requested and reviewed all the policies for the mobile cardiac cath lab. The majority of the policies were not specific to the unique needs of the mobile unit. Other policies were vague or incomplete and did not give staff enough information to perform their duties according to accepted standards of practice.

The following policies were not found:

aseptic and sterile surveillance and practices
scrub techniques
identification of infected and non-infected cases
housekeeping requirements and procedures
clinical procedures (such as required documentation on the procedure register, among others)
surgical counts
scheduling of patients
protocols for all surgical procedures performed, including a list of equipment, supplies,
materials necessary to carry out each assignment
disinfection practices
handling infectious and medical waste
outpatient surgery post-operative care planning and coordination and provision for follow-up care

The hospital had no policy that addressed whether or not the mobile cath lab was designated as an anesthetizing location.

The staff was asked if there were any other policies available for the mobile cath lab. None were provided.
VIOLATION: OPERATING ROOM REGISTER Tag No: A0958
Based on record review and staff interview, it was determined the hospital failed to provide a procedure register for the mobile cardiac cath lab that contained all the required elements.

Findings:

On 08/15/14, the cardiac cath lab manager was asked to provide the surgical procedure register for the cath lab. The register used by the department did not document the following information:

patient identification number
total procedure time
complete name and title of the surgeon
complete names, titles and job assignments of all staff present
type of sedation or anesthesia and who administered it with a
complete staff name and title
the exact procedure(s) performed
pre and post procedure diagnosis
patient age
implanted devices

The cath lab manager stated she was not aware the requirements for surgery applied to the cardiac cath lab.
VIOLATION: OUTPATIENT SERVICES Tag No: A1076
Based on observation, document review and staff interview, it was determined the hospital failed to provide outpatient cardiac catheterization services in a manner consistent with inpatient services.

Findings:

On 08/15/14, observations were made of the hospital's mobile cardiac cath unit. The unit had been in service since April 2014. The hospital staff stated the mobile unit had served approximately 90 patients.

The mobile unit did not provide all the required facilities and features that were provided in a permanent cardiac cath lab. The patients who received services in this mobile lab did not receive the same care environment and level of service as patients who received cardiac catheterization in the hospital's in-house cath lab. This was verified through staff interview.

Patients who received care in the mobile cath lab were not provided the care and services that preserved the patients' rights to privacy, dignity and comfort as those provided for inpatients. This verified through observation and staff interview.

The support services manager stated the mobile unit's biomedical equipment was not included in the hospital's preventive maintenance program and the mobile unit's systems for ventilation, temperature and humidity were not included in the hospital's maintenance program. Staff working in the cath lab were not familiar with the alarms and emergency power systems in the mobile unit. The physical plant for the mobile cath lab was not treated as the physical facilities within the hospital.

The cardiac cath lab manager stated this service was not integrated with the radiology or surgery departments. The mobile cath lab service did not meet the same standards as those found in radiology and surgery within the hospital.

Through observation of the condition of the mobile lab and through interview with staff, standards of practice for the provision of a surgical environment and for adherence to aseptic and sterile technique was not provided in the cath lab as was provided in other surgical areas.

Hospital medical records documented the patients who received care in the mobile unit were not afforded the same level of staff as comparable services found elsewhere in the hospital. The RN cath lab manager was routinely responsible for patient sedation during the procedure and was responsible for circulating duties at the same time. The same RN manager many times was also responsible for the pre-procedure preparation of the patients and post-procedure recovery of the patient.

This staffing pattern did not allow the nurse manager who provided conscious sedation to solely focus on that task. It also did not allow the manager time to oversee the function and staff performance in the cath lab. Because the nurse also had pre-op and post-op patient care responsibilities, it was not possible for the nurse to provide adequate RN oversight of the surgical suite cleaning, disinfection and procedure preparation of the suite. It also did not allow adequate time for the nurse to provide appropriate preparation for RN circulating responsibilities and to ensure patient safety.

According to staff interview, this type of staffing pattern and associated nurse responsibilities was not found elsewhere in the hospital.

The failed practices posed an Immediate Jeopardy to the health and safety of patients which could lead to harm or potential for harm, serious injury or death. These failed practices had the potential to affect all patients admitted to the hospital who required cardiac catheterization services.