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Based on the onsite inspection, completed July 19 through August 2, 2011, the facility failed to comply with the regulations set forth for Life Safety and, therefore, deficiencies were cited under Life Safety Code tags K0018, K0020, K0027, K0029, K0038, K0050, K0052, K0056, K0062, K0063, K0072, K0074, K0076, K0130, K0143, K0144, and K0145. See survey event ID #6MET21 for full details of the cited deficiencies.

Based on tours/observations, staff interviews and review of facility documents, the hospital failed to ensure that facilities, supplies and equipment, including infusion pumps and portable cardiac monitors were maintained to ensure acceptable level of safety and quality. In addition, the facility failed to remove non-working equipment from the laboratory area and ensure that all work areas in the laboratory were kept clean, orderly and in good repair. The findings created the potential for negative outcomes for patients.

The findings were:

1. Preventive Maintenance Inspections:

A tour of the Oncology Patient Care Unit was conducted with the hospital's Chief Nursing Officer (CNO) and the Department's Manager on 11/1/2011 at approximately 8:15 a.m. It was observed that in a patient room that an intravenous infusion pump was available for patient use that did not have current biomedical engineering inspection tags. The tag on the pump stated that the equipment was due for inspection and preventative maintenance since August 2011. The hospital's CNO and the Department's Manager confirmed that the equipment did not have any indication of a more recent inspection than August 2010. S/he removed the pumps from the room at that time to allow inspection by the facility's biomedical technicians.

A tour of the Cardiac/Telemetry Patient Care Unit was conducted with the hospital's CNO and the Department's Manager on 11/1/2011 at approximately 10:00 a.m. It was observed that in a room that contained supplies for patient care as well as equipment for patient use that two portable cardiac monitors to be used for patient transports were available for patient care did not have current biomedical engineering inspection tags. The tags on each monitor stated that the monitors were due for inspection and preventative maintenance since January 2011. The hospital's CNO and the Department's Manager confirmed that the equipment did not have any indication of a more recent inspection than January 2010. S/he removed the pumps from the room at that time to allow inspection by the facility's biomedical technicians.

An interview with the hospital's Director of Clinical Engineering on 11/1/2011 at approximately 11:10 a.m., revealed that the one infusion pump and the two cardiac monitors that had not been inspected that were found on 11/1/2011 had not been inspected by the biomedical engineering service when they were due because his/her staff were unable to locate the pieces of equipment. S/he stated that the missing equipment was reported to the Safety Committee as well as to the department where the equipment belongs to. S/he presented work orders for the three pieces of equipment that the facility could not locate previously.

A review of the work orders that were provided on 11/1/2011 at approximately 11:10 a.m., revealed that the facility could not locate the infusion pump on 8/30/2011 and on 8/31/2011. There was no further documentation of attempts to locate the equipment on the provided documentation. The work orders for the cardiac monitors reflected that the facility had not been able to locate the monitors on 1/31/2011 and 2/1/2011. There was no further documentation of attempts to locate the equipment on the provided documentation.

2. Laboratory Equipment and Work Environment:

On 10/31/11 at approximately 11 a.m., a tour/observations of the hospital's laboratory services area was conducted. During the tour of a storage/work room off the main lab area revealed the following findings:

The room was a small room with three large refrigerators/freezers with a sink and stainless steel work counter and open and glass-doored shelving above, a corner cabinet with shelving beside it. The staff member conducting the tour stated that the refrigerators/freezers contained blood specimens that were being held for a week or two in case additional analysis tests were needed. In addition, two of the freezers contained packaged boxes of chemicals/reagents utilized in the laboratory. On the corner shelf was a piece of equipment that the staff member stated was an old non-working incubator. There was no sign saying that it was non-working, but there was a sticker on the front of the incubator that stated "Remove from service," dated 9/2010. The incubator and the cabinet were dirty/dusty and the lower corner cabinet had what appeared to be rust or chemical corrosion along the side of the cabinet. The cabinet contained old dirty equipment, including a clear plastic shield mask, assorted tools and parts of tool, scattered on both shelves. The contents appeared very dirty/dusty and in disarray. The shelf/ledge beside the corner cabinet contained several empty and discolored and very dusty beakers or containers for liquids. There were two empty containers that stated that they had previously contained hydrochloric acid. On the stainless steel sink/counter, the sink held some additional plastic containers and tubing that was attached to a large plastic cylinder on the counter. The rest of the counter was clutter with several metal and plastic racks and some other containers. The contents of the sink and the counter appeared dirty/discolored and in disarray.

The laboratory storage/work room was toured again on 11/1/11 at approximately 1:50 p.m., with the director of the laboratory services. S/he confirmed that the incubator was non-working, had been replaced and should have been removed from the lab/discarded. S/he also acknowledged the dusty/dirty/cluttered appearance of the work area and the presence of additional items that needed to be discarded, including the empty bottles that had previously contained hydrochloric acid. S/he stated that the room needed to be cleaned up.

The laboratory storage/work room was toured a third time on 11/2/11 with the laboratory director, the plant operations and environmental services managers and the infection control officer to observe the condition of the room and the equipment in the room. The plant operations manager confirmed that the non-working incubator should have been removed from the area and discarded. The environmental services director confirmed that housekeeping staff cleaned floors and empty trash containers in rooms such a that one, but that laboratory staff were expected to keep the other work surfaces and equipment clean and in order. All present during the tour viewed the conditions in the room and acknowledged that it was not being properly maintained in a clean and orderly condition. All present committed to correcting various aspects of the problems in the room such as to clean/organize the area and to repair/paint damaged cabinetry. They all committed to correct/manage the situation going forward.

Based on observations, staff interview and review of the facility's policies and procedures, the facility failed to ensure that a sanitary environment was maintained in the food and dietary area, laboratory phlebotomy room, and operating rooms areas. Specifically, the facility was not following their policies and procedures and/or the proper techniques for maintaining food sanitation. The facility failed to institute a policy/procedure to clean the phlebotomy chair in the main laboratory outpatient blood draw room after each patient use. In addition, the facility routinely flash sterilized surgical eye instruments and did not maintain a proper flow during the decontamination and pre-cleaning of instruments.

The findings were:

1. Food and Dietary Area:

The facility's policy and procedure entitled, "Storage of Foods," stated the following in pertinent part: "To assure the keeping of all supplies in a manner to prevent spoilage and bacterial contamination...
All leftover cold food for storage in refrigerator is put into storage containers and completely covered with plastic or foil wrap. These are marked with the name of the item and dated. The date used is the date of disposal.
All leftover hot food for storage is refrigerated in shallow pans. The food is first cooled then covered, marked and dated."

A tour of the food and dietary preparation area was conducted on 10/31/11 at approximately 1:00 p.m. with the Dietary Manager. The refrigerators contained many trays of individual servings of desserts and salads that had been prepared in advance. However, there were a number of trays that were not dated appropriately and/or not dated at all. On the items that were not dated appropriately there appeared to be an effort to date with a pen that was not properly working and only one number of the date was visible. The observation of the dry storage area revealed that a plastic scoop for dipping was laying in the container of graham cracker crumbs. The scoop was removed during the tour; however, the crumbs were not discarded.

The observations regarding the discrepancies were shared with the Dietary Manager during the tour. The Manager stated that there were date stickers that dietary staff should be using to place on the prepared servings and leftovers that would indicate when they had been prepared so it could be appropriately discarded if not used in the allotted time frame.


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2. Laboratory:

On 10/31/11 at approximately 11 a.m., a tour/observations of the hospital's laboratory services area was conducted. During the tour of a suite of rooms utilized for outpatient blood draws, the laboratory staff member accompanying the surveyors on the tour was asked about any routine for cleaning/disinfecting the large recliner utilized for patients while having blood drawn. S/he stated that s/he believed someone from housekeeping cleaned the chair once or twice a day as part of the routine cleaning of the room. S/he stated that there was no routine for cleaning the chair between each patient. S/he stated that a phlebotomist would clean the chair if there was blood seen on the chair.

On 11/1/11 at approximately 1:50 p.m., during an interview with the director of the laboratory services area, s/he asked about the issues that were raised the previous day with the other staff member regarding a routine to clean the phlebotomy chair between patients. S/he asked if there was a laboratory requirement to routinely clean/disinfect that chair between patients if there was no evidence of blood spills. The surveyor referred him/her to the infection control officer of the facility to evaluate for appropriate routine/procedures for cleaning/disinfecting the chair as an infection control measure.

On 11/1/11 at approximately 3:30 p.m., the surveyor was approached by the infection control officer, who had become aware of the questions about cleaning/disinfecting the phlebotomy chair in the laboratory. S/he referred to a cleaning/disinfecting protocol that was in place in the phlebotomy area for pre-admission screening for surgical patients. S/he stated that the staff in that area had been instructed to clean the phlebotomy chair with "Sani-Cloths" at the beginning and end of the day and after a patient with a know infection such as MRSA (methicillin-resistant staphylococcus aureus) and VRE (vancomycin-resistant enterococci). S/he suggested that the same standard was appropriate for the laboratory phlebotomy chair. S/he was asked to follow-up with the laboratory to determine if the staff were provided with information about patient whether or not a patient had an infection, such as MRSA or VRE, when a patient presented to the laboratory for an outpatient blood draw.

Review on 11/1/11 of a staff education handout titled "Standard Precautions," which was provided by the infection control officer, revealed the following, in pertinent parts:
"Standard Precautions - Also includes proper - Cleaning of Equipment and Patient Rooms - Any items used for multiple patients must be disinfected between patients..."

On 11/1/11 at approximately 4 p.m., the infection control officer approached the surveyor again, stating that s/he had consulted with the laboratory staff and had determined the staff were not provided with information about an existing infection when a patient presented for an outpatient blood draw. S/he stated that since the staff had no way of determining which patient had a transmittable serious infection, they were going to institute a procedure of cleaning/disinfecting the phlebotomy chair ever day, at the beginning and end of the day and after each patient, with the "Sani-Cloths" that were in use in other areas of the hospital. S/he stated that s/he would prepare a policy/procedure for the laboratory to guide them to correct the situation.


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3. Flash Sterilization:

The facility's policy titled, "Infection Prevention - Operating Room," last revised 10/7/2010, stated the following, in pertinent part: "VIII. Sterilization of surgical instruments... B. Sterilize all surgical instruments according to published guidelines. C. Perform flash sterilization only for patient care items that will be used immediately (e.g., to reprocess an inadvertently dropped instrument). Do not use flash sterilization for reasons of convenience, as an alternative to purchasing additional instrument sets, or to save time..."

A tour of the Operating area was started on 10/31/11 at approximately 10:00 a.m. Tour of the Operating Room suite was conducted with the Charge Nurse and Operating Room (OR) Manager. When asked how eye instruments were sterilized, the OR Manager stated, "We don't have enough [sets] and we are flashing." A review of the flash log for the autoclave nearest the designated eye operating room revealed that two sets had been flashed already on that day, 10/31. Each set was flashed for 10 minutes at 270 degrees. The OR Manager stated that surgeries conducted at the facility were usually vitrectomies. When asked how many instruments sets the facility had for vitrectomies, s/he stated, "I believe we have two sets... It is the routine, not preferred, practice [to flash]. It is on our budge to get more vitrectomy sets." When asked the date these sets would be obtained, s/he stated, "Hopefully within the next calender year."

Upon exit, an interview was conducted with the facility's Director of Nursing. When asked how frequently eye surgeries were conducted at the facility, s/he stated, "Our overflow from [the surgical center attached to the hospital] go there and so I think what happens in a concentration of cases on a day."

The 2011 Edition Perioperative Standards and Recommended Practices for Inpatient and Ambulatory Setting by the Association of periOperative Registered Nurses stated the following within "Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment," pages 441 and 442, in pertinent part: "Special precautions should be taken for reprocessing ophthalmic surgical instruments: ...An adequate inventory of instruments should be provided to allow for thorough instrument cleaning and sterilization. An adequate inventory of instruments facilitates compliance with proper decontamination and sterilization processes... Adequate time should be provided for thorough instrument cleaning and sterilization. Time constraints may create a disincentive for personnel to adhere to decontamination procedures and may result in noncompliance."

4. Decontamination and Cleaning of Surgical Instruments:

The facility's policy titled, "Infection Prevention - Operating Room," last revised 10/7/2010, stated the following, in pertinent part:
"XI. Procedure for Decontamination of Instruments
A. Procedure for decontamination in the OR:
1. All soiled instruments will be sprayed with enzymatic cleaner before leaving the operative area.
B. Procedure for decontamination in the SPD department:
1. All soiled instruments are:
a. Soaked in enzyme bath then rinsed off by hand wearing gloves and appropriate PPE.
b. Processed through ultrasonic washer
C. Processed through washer/sterilizer unit
d. Inspected
e. Placed in proper instrument set or
f. Hung on instrument racks or
g. Wrapped for steam or gas sterilization, placed on a cart for transport to sterile supply room..."

An interview with the Director of Infection Control on 11/2/11 at approximately 8:05 a.m., s/he confirmed there was not a policy and procedure on the decontamination and pre-cleaning of instruments not in SPD.

A tour of the Women's Surgical Services department was conducted on 10/31/11 at approximately 3:00 p.m. with the Manager. Staff passed through two double doors to enter into the operating room (OR) suite area, which contained three operating room and two phases of recovery rooms. Upon entering the area directly to the left, a room deemed the decontamination room was observed in the "unrestricted space." Directly outside that room was a rack that had blue sterile wrappings setting atop of it. The Manager and current Instrument Tech were asked the process for decontaminating instruments in that area. They stated the instruments were decontaminated and pre-cleaned using a detergent and water mixture. The instruments were then placed in the washer, located in that decontamination room. After removal from the washer, the instruments were taken outside the room to and wrapped in the hallway next to the OR suite entrance door. The Instrument Tech stated, "...or I take them downstairs on a cart, cover with a clean sheet and they wrap them..." When asked where the instruments were stored after wrapping and prior to transportation to the sterile processing area, the Instrument Tech stated they would be stored in the hall or in the decontamination room on a cart. Observations revealed wrapped packs of instruments stored on a cart at the end of the decontamination room. There was not wall or physical barrier to separate the area in which dirty instruments had gross decontamination processing conducted and where clean and wrapped instruments were stored. Additionally, staff in street clothes routinely walked past clean instruments in the hall prior to and after wrapping.

A tour was conducted of the Gastrointestinal Laboratory/Minor Procedures area on 11/1/11 at approximately 12:45 p.m. The Manager and Charge Nurse were interviewed in regards to the decontamination and pre-cleaning of surgical instruments in that area. They stated that they use a detergent and water mixture, scrub every instrument, wipe down the tray the instruments were on with a disinfectant disposable cloth, and then take the instruments down to sterile processing after every case. They stated all the sterile wrapping was conducted within the sterile processing department.

Several interviews were conducted with facility's Director of Infection Control throughout the survey in regards to the cleaning and storage processes within Women's Surgery and the GI/Minor areas. On 11/2/11 at approximately 9:50 a.m., s/he was asked if there was any current procedure or flow guideline for the GYN and GI areas. S/he stated there was not. S/he explained that s/he had previously made a process for cleaning the GI scopes and posted it on the wall in their decontamination room. "We just talked about Women's Services doing the same thing, rather than making an actual policy about it." S/he stated that the GI staff covered their instruments with clean linen and carried them immediately down to sterile processing. S/he continued that Women's Services placed their instruments on a cart "but we can put a sheet on it." S/he described possible remedies to the cross-contamination issue in the Women's Services decontamination room, such as placing a shower curtain in the room to "prevent any splashing to get on the wrapped items." When asked why both areas didn't allow sterile processing conduct their cleaning, s/he stated that the GYN area liked their instruments organized and packed a certain way.

Later that day, at approximately 10:25 a.m., the Director of Infection Control stated, "I talked with sterile processing and they said after cleaning [the instruments] to put them in this plastic bag, seal it up, and mark them as unsterile until they are taken down." The Director stated s/he planned to write up that process and place it in the GYN and GI decontamination areas.

The 2011 Edition Perioperative Standards and Recommended Practices for Inpatient and Ambulatory Setting by the Association of periOperative Registered Nurses stated the following within "Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment," in pertinent part: "Contaminated instruments must be contained during transport and should be transported in a timely manner to a location designed for decontamination... Transport of soiled instruments should be separated from the delivery of clean and sterile supplies to the operating or procedure room. Separation of soiled instruments from clean supplies minimizes the risk of cross-contamination... Instruments should be decontaminated in an area separated from locations where clean activities are performed... The decontamination area should be physically separate from clean areas and include a door... The design of the decontamination area facilitates the appropriate decontamination of instruments. Having equipment and utilities in place facilitates desired infection control practices. Keeping the door closes exhausts aerosols out of the building... Instrument should be thoroughly dried..." The section titled "Recommended Practices for Selection and Use of Packaging Systems for Sterilization" stated the following, in pertinent part: "Package contents should be assembled, handled, and wrapped in a manner that provides for an aseptic presentation of package contents..."

In summary, the facility failed to identify possibly cross-contamination concerns in the GYN decontamination area as well as failed to properly assess and monitor the pre-cleaning, storage, and transportation of instruments in the GI/Minor area and GYN Surgery area. Concerns of the latter were identified upon survey and only then did the Director of Infection Control begin to assess and implement improved processes for instrument care. Care should be taken to assess for and follow current recommended standards of practice within surgical areas.

Based on review of the facility's policies and procedures and staff interview, the facility failed to ensure discharge planning policies and procedures were specified in writing. Specifically, the facility did not have policies which stated the procedure for providing patients with a list of available Skilled Nursing Facilities and post-hospital extended care facilities, when applicable. This failure did not ensure staff who provided discharge planning were informed and aware of the appropriate procedure and requirements and created the potential for a negative outcome. The facility was not in compliance with the Condition for Discharge Planning.

The findings were:

Review of the policy titled, "Case Management and Utilization Review Discharge Planning," last revised September 2011, stated the following, in pertinent part:
"I. The home care coordinator is responsible for arranging any home care needs and/or hospice needs...
K. For patients being sent to a SNF (skilled nursing facility), the sending unit must communicate all necessary information to appropriate personnel..."
The policy, and all other Case Management policies, did not address providing a list of aftercare options, except in the case of Home Care, wherein the "home care coordinator" would provide the list.

An interview was conducted with the Director of Case Management on 11/2/11 at approximately 9:45 a.m. When asked if the practice of providing a list of post-hospital/aftercare options was defined in policy, s/he stated, "You are right. It is not spelled out in a policy and procedure." S/he explained what the Case Managers do, however, there was not guidance in text for this practice.

Based on review of medical record, facility policies/procedures, and staff interview, the facility failed to ensure that the development of a discharge plan was demonstrated in the medical record in one (#17) of 30 medical records. This failure created the potential for a negative outcome.

The findings were:

The facility's policy titled, "Case Management and Utilization Review Discharge Planning," last revised September 2011, stated the following, in pertinent part: "...The case manager, in conjunction with the multidisciplinary team, verifies and documents the final disposition plan in the Case Management DC Assessment/Plan Intervention in MEDITECH. If needed, the staff RN gives a verbal report to the accepting facility and completes the nursing discharge summary at the time of discharge..."

Review of sample #17's medical record revealed that the patient was admitted on 10/13/11 through the Emergency Department and discharged on 10/19/11. The patient's electronic medical record on MEDITECH contained four entries in the discharge planning intervention. They stated the following, in pertinent part:
-dated 10/14/11 and timed 11:10; "Discharge Plan Comment: SW Note: Pt given signed copy of Important Message from Medicare Letter."
-dated 10/14/11 and timed 13:54; "Discharge needs: No Skilled DC Needs Iden, Support System: Intermit Support Avail, Support System Comment: [The patient] is an inpatient. [S/he] lives alone in a condo... [S/he] is very indept. in spite of not being able to drive. [S/he] has a cart that [s/he] takes to... [S/he] plans to go back home, indept at discharge. [Family member] lives locally and is able to assist prn."
-dated 10/18/11 and timed 15:21; "Discharge Plan Comment: CM continue to follow. Transferred to 5E for closer observation in [heart and electrolyte issues. S/he] is very independent. No needs anticipated."
-dated 10/19/11 and timed 10:18; "Discharge Plan Comment: MSW CM: Copy of Important Medicare Rights Notice given to pt/family/representative."

Further review of the medical record revealed that the Discharge Summary stated the patient was discharged with Home Health for Physical Therapy, Occupational Therapy, and Nursing needs. There was no documentation found by Case Management as to why the patient had been discharged home with home health services.

After request for documentation explaining why the patient was discharged with home health, the Director of Quality Improvement had the home health service fax over their "FACE-TO-FACE ENCOUNTER DOCUMENTATION" form. The form stated that a face to face encounter had occurred with the patient on 10/19/11 and that nursing and physical therapy home health services were necessary because the patient "requires close systems assessment, medication teaching, evaluation for gait/imbalance, safety issues."

Based on tour/observations of the facility, staff interview, and review of facility policy and procedure, the facility failed to ensure its practice was consistent with policy/procedure and standards of medical practice. Specifically, the Operating Room's Malignant Hyperthermia cart was not checked routinely, contained expired dantrolene medication as well as expired supplies. These failures created the potential for a negative patient outcome.

The findings were:

A tour of the Operating area was started on 10/31/11 at approximately 10:00 a.m. Tour of the Operating Room suite was conducted with the Charge Nurse and Operating Room (OR) Manager. When asked how many vials of Dantrolene, a medication used to treat malignant hyperthermia, was kept in the Malignant Hyperthermia Cart, the two staff members did not answer and instead looked in the reference manual on top of the cart, which stated six 60 ml syringes would be on hand. When asked if intravenous fluids were kept cooled, as the cart did not contain refrigeration capabilities, the OR Manager stated that the fluids were kept out and always on the cart, but not cooled.

Review of the clipboard on top of the cart, which contained documentation of when the cart had been checked revealed the last two times it was checked were the months of June and July. Those two months stated that the Dantrolene's date of expiration was "8/11/" Neither indicated the year of expiration. The months of August, September, and October contained no documentation that the cart had been checked. When asked who was responsible for checking the cart monthly, as was the practice, the Charge Nurse said daily assignments were made to staff and one staff member would be assigned the task of checking it. The Charge Nurse and Manager did not have knowledge as to why the checks had not been done the past three months.

The Malignant Hyperthermia cart was then unlocked and opened. Inside revealed six total boxes of Dantrolene, each with six 20 mg vials. One box, six total vials, of Dantrolene had expired in August of 2011. In addition, several supplies were expired, including an arterial line placement kit (expired August 2011), a triple lumen central line kit (expired July 2011), and a stat lock, which was kept in the arterial line kit bag (expired July 2007).

The facility's policy titled Malignant Hyperthermia, dated 2/5/2010, stated the following, in pertinent part: "POLICY: I... G. malignant hyperthermia usually manifests about 10 to 20 minutes after induction of anesthesia... II... A. The MH Cart is stored in the Operating Room in the Sterile Core near the Anesthesia workroom... C. Cold saline for infusion is stored in the OR Sterile Core just outside the Conference Room...
PROCEDURE: III... Call for Help... B. Obtain MH Cart and Code Blue Cart... G. Insert large bore IV, if possible. H. Prepare Dantrolene sodium (Dantrium) IV as ordered (each vial with 60 cc bacteriostatic sterile water, preservative-free-shake vigorously)... Note: MHAUS recommends an initial Dantrium dosage of 2.5 mg/kg by bolus rapidly. Repeat every 5 minutes. Dosing can increase up to 10 mg/kg or more as treatment continues in the crisis... K. Insert, assist in inserting and monitor as appropriate... 4. Arterial pressure line. 5. Central Venous pressure or pulmonary artery pressure line, if needed..."

The 2011 Edition of Perioperative Standards and Recommended Practices For Inpatient and Ambulatory Settings by the Association of periOperative Registered Nurses stated the following in the section titled "AORN Malignant Hyperthermia Guideline," page 554-555, in pertinent part: "Suggested Contents For A Malignant Hyperthermia (MH) Cart... Dantrolene sodium: 20 mg vials - 36 vials... Arterial line monitoring kit - 1... Central venous pressure line kit - 1... These supplies need to be readily available on the anesthesia cart or separately stocked on the MH cart."

Based on staff interviews and review of the facility's Medical Staff Bylaws and Rules/Regulations, the facility failed to ensure clear oversight of Certified Registered Nurse Anesthetists (CRNAs) existed as well as immediate availability of a supervisor. This failure created the potential for a negative patient outcome.

The findings were:

An interview was conducted with the Medical Director of Anesthesia on 11/1/11 at approximately 1:55 p.m. When asked about the oversight of CRNAs, s/he stated that there were three anesthesia groups that worked within the hospital and that her/his group did not have CRNAs but that the group who worked in the Women's/Gynecology area did. S/he stated the oversight was "done per the Anesthesiologist that day in the Women's Surgical Services." The Medical Director stated s/he did not communicate much with the CRNAs and only dealt with them when s/he talked with the physicians of the group that used CRNAs. When asked again about oversight, the Medical Director stated s/he thought the anesthesiologist would be present during induction and emergencies and "should" sign off on the medical record, however, the Medical Director referred specifics of the oversight to the physician director of that anesthesia group.

An interview was conducted with the physician Director of the Anesthesia group who worked in GYN Surgery on 11/2/11 at approximately 10:55 a.m. When asked about CRNA oversight, s/he stated, "We function as a MD CRNA team. Some surgeons prefer CRNAs, some prefer MDs. It's really surgeon preference... The anesthesiologist calls all the patients the night before... We always have an anesthesiologist onsite... The anesthesiologist is the resource if there is trouble... We work as a team for a second pair of hands." When asked how a physician would be immediately available for a CRNA, s/he stated, "All the rooms are connected by just a couple steps... If only one physician is present, the rooms are so close that all they have to do is poke their head out..." When asked if the anesthesiologists were consistently present during inductions or at any other time of the CRNA provided care, s/he stated, "No. We have non-medically directed CRNAs: we don't bill that way." When asked who specifically was conducting the oversight of the CRNAs, s/he stated, "The Anesthesiologist that is around that day would have the oversight. We sign the PACU record." When asked if the Anesthesiologists routinely signs the CRNA's operating room record, s/he stated, "We sign the OR record if we participate in the care, otherwise not necessarily." S/he stated the latter was the practice at another facility the group worked at, however that was not required at this facility. The physician was asked again about the immediate availability of physician's and s/he stated, "There was a time when a CRNA couldn't intubate and the Anesthesiologist and CRNA just switched rooms."

The facility's "Rules and Regulations of the Medical Staff" last reviewed and amended on 10/21/10, were reviewed and stated the following, in pertinent part: "17.6 Administration of any anesthesia shall be limited to individuals qualified in accordance with the Medical Staff By-Laws and credentialing policies... Certified Registered Nurse Anesthetists shall function under the supervision and direction of an anesthesiologist or a physician... Physician members of the Medical Staff who are not Board Eligible or Board Certified in Anesthesia but are granted Class I, II, or III privileges shall be responsible for the anesthesia care rendered... Procedures performed within Classes II or III may be subject to an audit or review and required documentation in the patient's medical record."

Appendix 2 of the facility's Medical Staff Bylaws, titled "Allied Health Professionals Policy" was reviewed and stated the following, in pertinent part:
"2.B.2. Category II - Advance Licensed Dependent Practitioners
The composition of Category II shall consist of... Certified Registered Nurse Anesthetist...
5.A. OVERSIGHT BY SUPERVISING/SPONSORING PHYSICIAN
(1) Category II and Category III practitioners may function in the Hospital only so long as they have a Supervising/Sponsoring Physician.
(2) Any activities permitted to be performed at the Hospital by a Category II and Category III practitioner shall be performed only under the supervision or direction of the Supervising/Sponsoring Physician.
(3) If the Medical Staff appointment or clinical privileges of a Supervising/Sponsoring Physician are resigned, revoked or terminated, the Category II practitioner's scope of practice or Category II practitioner's clinical privileges shall be automatically relinquished...
5.C. RESPONSIBILITIES OF SUPERVISING/SPONSORING PHYSICIAN
(1) The Supervising/Sponsoring Physician shall remain responsible for all care provided by the Category II and Category II practitioner in the Hospital..."

An interview with the Director of the Medical Staff Office was conducted on 11/2/11 at approximately 12:35 p.m. S/he was asked about the appendix of the Medical Staff Bylaws, which pertained to Allied Health as well as credentialing of CRNAs. S/he stated, "CRNAs have to have a physician sponsor. We have a physician sign a sponsor statement for every category of allied health professionals." When asked which physician signs the form, s/he stated, "Their sponsoring physician signs the form... That physician is not necessarily present when the CRNA is working." It was pointed out to the Director of the Medical Staff Office that the Medical Staff Bylaws stated the "sponsor/supervising" physician was responsible for all the care provided by the CRNA in the hospital. S/he acknowledged and stated, "The physician is responsible for all the care provided by that CRNA." When asked about signing off of documents, s/he stated, "A CRNA's orders and notes are not signed off by the anesthesiologist." When asked why, s/he did not know specifics but stated that the practice for Physician Assistants was for the MDs to sign off on all their documents." The Director later stated, "I did confirm that the CRNA practice act doesn't require them to sign off." S/he was asked who the "sponsor" for the CRNAs was and s/he stated it was the physician Medical Director of that group. S/he stated that the group only had two CRNAs they used.

The Director of the Medical Staff Office provided the CRNA clinical privileges form that the sponsor was required to sign. The "SPONSOR STATEMENT" stated the following: "I hereby certify that the above applicant is duly qualified to perform the privileges requested on this form. I understand that the privileges for an Allied Health Professional, if granted, will be dependent on my certification that the applicant is employed and/or sponsored by me. In the event such employment terminates, or if I withdraw my sponsorship, I agree to immediately notify the [facility's] Medical Staff Office."

An interview with the facility's Chief Medical Officer (CMO) was conducted on 11/2/11 at approximately 12:45 p.m. The CMO was asked the difference between the "supervisor" and the "sponsor," as the Medical Staff Bylaws made no differentiation. S/he stated, "The sponsor is not the supervising physician. The sponsor is who signs how you get on staff. The supervisor is who supervises the CRNA that day. The supervisor may be the doctor or may be one of the other doctors..." When asked who conducts the oversight of the CRNAs, s/he stated, "We would look at the schedule and see who the physician on that day was to see the supervisor." When asked how a physician would be immediately available for assistance to the CRNA, s/he stated, "I'm an internist and would have to ask [the director of that anesthesia group] and get back to you on how that would happen." The CMO was informed that the Director was already asked that question, however, the CMO wished to clarify with the Director.

An hour later, at approximately 1:45 p.m., the CMO and the physician Director of the anesthesia group that worked in GYN met with the surveyor. The Director stated, "You have some additional questions?" The Director was informed that the CMO had wanted clarification. The Director then stated that oversight was "the anesthesiologist on duty" and for immediate availability "the surgeon would step in." When asked how the oversight would be evidenced, s/he stated, "Because we have our schedule." S/he continued, "The expectation for my group is that we do co-sign, but we are not perfect. I know that there are charts that have slipped through." The CMO then stated, "Our CRNA privileges do not require it. Statue says the surgeon can step in." The Director stated, "The sponsor doesn't work everyday... The supervisor can be the surgeon or the anesthesiologist... Back-up can be the surgeon." When asked if the surgeons are willing to be the CRNA supervisor, s/he stated, "The [surgeons] that use a CRNA request a CRNA and are ok with supervising." When asked how one would know who the CRNA's supervisor was that day, s/he stated, "By looking at the schedule and seeing who the anesthesiologist is and who the surgeon is."

In summary, the facility's Medical Staff Bylaws stated the "Supervising/Sponsoring" physician was responsible for all the care provided in the facility by a CRNA. Per interview, the facility's CRNAs were sponsored by the physician Director of their group, however that physician did not work everyday and would, therefore, not be physical present to provide oversight. The facility stated that oversight would be evident by "looking at the schedule" to see what physicians were working that day, as that would be who was providing oversight. The facility also stated that the surgeon could provide immediate assistance if the anesthesiologist could not. However, none of these processes were clearly evident upon initial interview with the physician director of the group that employs CRNAs and the processes were not know by the Medical Director of Anesthesia, who is responsible for all anesthesia care within the facility. Additionally, documentation of CRNA oversight within the medical records would not necessarily be present, as that was not the practice, and the oversight would instead need to be found on a working staffing schedule.