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Based on personnel record review and interview, the facility failed to complete criminal background studies prior to the provision of patient care for 4 of 17 (P1, P2, P3, P4) physicians that provided care at the facility. Findings include:

During review of the physician personnel records on 2/11/10, at 1:00 p.m. the following criminal background studies were not completed prior to the physicians providing patient care at the hospital.

P1 who was providing anesthesia services at the hospital did not have a criminal background study request submitted by the facility until 2/11/10. Review of the physician's schedule at the facility indicated P1 began providing services at the hospital on 12/30/09.

P2 who was providing obstetric services at the hospital did not have a criminal background study completed (was in the application process only) prior to providing patient care at the facility. Review of the physician's schedule indicated P2 began providing services at the hospital on 12/31/09.

P3 who was providing gastroenterology services at the hospital had temporary privileges authorized by the Governing Board dated 1/8/10, however, did not have a criminal background study request submitted until 2/6/10. P3 was providing patient care at the hospital and the criminal background study had not yet been received by the hospital.

P4 who was authorized by the Governing Board of the hospital with temporary privileges on 1/25/10 to 5/25/10, had a criminal background study request submitted on 1/26/10. The criminal background study had not yet been received by the facility.

When interviewed on 2/11/10, at 4:00 p.m. the director of human services confirmed the criminal background studies were to be completed on all physicians prior to the provision of patient care.

Based on interview, record review and policy review, the hospital was found not to be in compliance with the Conditions of Participation for Surgical Services (CFR 482.51) due to failure to follow acceptable standards of practice related to surgical instrument counts. The hospital lacked policy/procedures to ensure surgical instruments were counted at specified timeframes when the possibility exists that an instrument could be unintentionally retained. In addition, the hospital failed to ensure proper procedures were followed related to use of alcohol based skin preparation in anesthetizing locations to prevent the risk of surgical fires. Findings include:


Refer to findings at A- 0951 regarding lack of surgical instrument counts and use of alcohol skin prep solution.

SURGICAL INSTRUMENTS
On 2/11/10, at 1:45 p.m. the Interim OR (operating room) manager stated the hospital performs counts on the following surgical items: sponges, needles, blades, detachable items (bull dogs and acorns), and microvascular instruments. She verified that surgical instruments were not part of the surgical count, even in cases where an instrument could be unintentionally retained.

The Association of Operating Room Nurses (AORN) is a nationally recognized professional organization who recommends standards of practice governing surgical services. AORN's current recommendation regarding surgical counts indicates instruments should be counted on all procedures in which there is a likelihood that an instrument could be retained. Instruments counts protect the patient and are a proactive injury-prevention strategy.

ALCOHOL BASED SKIN PREPARATION
The hospital did not implement policies and procedures to ensure compliance with applicable federal regulations and guidelines related to the use of alcohol based skin preparations in the surgical department. CMS (Centers for Medicare and Medicaid Services) issued a Survey and Certification Memo on 1/12/07, addressing risk reduction techniques to permit safe use of alcohol based skin preparation in inpatient anesthetizing locations in hospitals. The use of an alcohol based skin preparations in inpatient or outpatient anesthetizing locations in not considered safe, unless appropriate fire risk reduction measure are taken, preferably as part of a systemic approach by the hospital to preventing surgery related fires.

On 2/11/10, at 11:30 a.m., an interview was conducted with the Interim OR manager and the Director of Family Services regarding policy/procedure for use of alcohol based skin preparations. They verified that the hospital is using alcohol based skin preps in surgical cases, and it is the surgeons' preference on what type of skin prep is used. The Director of Family Services stated that the hospital has implemented policies and procedures regarding use of alcohol based skin preparation in the operating room to prevent the risk of fires.
However, she added that the hospital does not document in the patient record verifying that appropriate procedures were followed ensuring the proper use of the alcohol based skin preparation prior to the surgical procedure.

Based on observation, interview, record review and policy review, the hospital failed to ensure safe surgical practices were followed in accordance with acceptable standards of practice related to instrument counts when the possibility exists that an instrument could be unintentionally retained for 3 of 3 patients (P1, P2, P3) in the sample who underwent a surgical procedure requiring instrument counts. In addition, the hospital failed to ensure proper procedures were followed related to use of alcohol based skin preparation in anesthetizing locations to prevent the risk of surgical fires. Findings include:


SURGICAL INSTRUMENTS
P1 was admitted to the hospital on 2/11/10 for a vaginal hysterectomy. The surgical procedure was observed at 8:10 a.m. and a whiteboard was on the wall which included surgical count information. The counts documented included sponges and sharps, but no instruments.

P2 was admitted to the hospital on 1/21/10 for a sigmoid colectomy (removal of the sigmoid colon). The patient record lacked indication an instrument count was performed as part of the surgical counts.

P3 was admitted to the hospital on 2/2/10 for an open appendectomy (removal of the appendix through incision). The patient record lacked indication an instrument count was performed as part of the surgical counts.


Surgical patient electronic records were reviewed on 2/11/10, at 11:30 a.m. with OR (operating room) staff present. The circulating nurse (CN-1) who was present in the surgical case observed for P1, was interviewed regarding surgical counts. P1's record was reviewed and documentation indicating the surgical counts were completed and correct was located. She stated that the counts include: sponges, sharps/blades, but does not include instruments. The Interim OR Manager was present and verified the hospital's policy does not direct staff to count instruments, even if there is a possibility of a retained instrument. She added that the larger hospitals in the Metro area that their organization is affiliated with has not been counting instruments as part of the surgical counts. At 1:45 p.m. the Interim OR manager was again interviewed and stated the hospital counts the following surgical items: sponges, needles, blades, detachable items (bull dogs and acorns), and microvascular instruments. She verified that surgical instruments were not part of the surgical count.

The hospitals's policy/procedure Surgical Counts in the Operating Room, dated 12/30/09, documented:
II. Policy: A mechanism by which sponges, sharps, and designated instruments are counted for each procedure to account for these items and ensure that the patient is not injured as a result of a retained foreign body.
III. Procedure: Supplies and Instruments - Including but not limited to: bull dogs, serraphins, wecks, mayfield points, aneurysm clips, coronary occluders, acorns, vessel loops, suture boots, shoe strings, fogerty insects, and bone markers. The policy did not address other surgical instruments that could be retained during a surgical procedure.

The Association of Operating Room Nurses (AORN) is a nationally recognized professional organization who recommends standards of practice governing surgical services. AORN's current recommendation regarding surgical counts indicates instruments should be counted on all procedures in which there is a likelihood that an instrument could be retained. Instruments counts protect the patient and are a proactive injury-prevention strategy.



ALCOHOL BASED SKIN PREPARATION
The hospital did not implement policies and procedures to ensure compliance with applicable federal regulations and guidelines related to the use of alcohol based skin preparations in the surgical department. CMS (Centers for Medicare and Medicaid Services) issued a Survey and Certification Memo on 1/12/07, addressing risk reduction techniques to permit safe use of alcohol based skin preparation in inpatient anesthetizing locations in hospitals. The use of an alcohol based skin preparations in inpatient or outpatient anesthetizing locations in not considered safe, unless appropriate fire risk reduction measure are taken, preferably as part of a systemic approach by the hospital to preventing surgery related fires.

On 2/11/10, at 11:30 a.m., an interview was conducted with the CN-1, Interim OR manager and the Director of Family Services regarding policy/procedure for use of alcohol based skin preparations. They verified that the hospital is using alcohol based skin preps in surgical cases, and it is the surgeons' preference on what type of skin prep is used. The Director of Family Services stated that the hospital has implemented policies and procedures to ensure safe use of alcohol based skin preparation. However, she added that the hospital does not document in the patient record verifying that appropriate procedures were followed ensuring the proper use of the alcohol based skin preparation prior to the surgical procedure.

At the time of the licensure survey conducted by the State Agency in 10/09 (prior to patients admitted for services), the Surgical Services Conditions of Participation (CoP) was reviewed and there was discussion regarding the use of alcohol based skin preparations in anesthetizing locations. The hospital did not have a policy/procedure at that time that specifically addressed the use of the alcohol based skin preparations and the appropriate fire risk reduction measures to be taken to prevent surgical fires per recommendations of the S&C Memo 07-11. At that time there was discussion regarding the need to document the implementation of the procedures in the patient record in order to be in compliance with the federal regulations. The Director of Family Services stated she did not feel it was necessary to document the OR staff followed the Fire Prevention and Plan for Surgical Services policy/procedure related to use of the alcohol based skin preparation. She also verified this was not addressed as part of the pre-operative "time out" which is used to verify other essential information to minimize the risk of medical errors during the procedure.

The CN-1 stated she does document the type of skin prep used and follows the manufacturer's recommendation for dry time. She verified that the circulating nurse (responsible for application of the skin preparation) does not document in the medical record that he/she verified the alcohol based skin prep was dry and other appropriate interventions were taken. The Director of Family Services stated that the electronic medical record system (EPIC) used by their hospital (also shared with several other larger hospitals they are affiliated with) does not require such documentation. However, the hospital policy titled Procedure Site Skin Preparation, dated 12/09, does direct staff to document this information using EPIC.

The hospital policy titled: Fire Prevention and Plan for Surgical Services, undated, documents:
II. Policy
B. Surgeon, scrub tech and RN will visually verify that the skin prep solution has been applied properly and has had adequate time to dry (see Procedure Site Skin Preparation Policy and Procedure).

The policy titled: Procedure Site Skin Preparation, dated 12/09, documents:

IV. Procedure: Intra-operative antiseptic skin preparation
18. The surgical team will perform the final "Pause for the Cause," including verification that the skin prep solution has been applied and is dry. (This is not included on the Site Verification Form used for "Pause for the Cause".
19. In EPIC, document the solution used, that it was applied, the area of use, and that it was dry. (Not being completed).

V. Reference
Use of Alcohol-based Skin Preparations in Anesthetizing Locations. CMS Memorandum Summery. 01/12/2007.

Based on record review, policy review and staff interview, the hospital failed to ensure a doctor of medicine or osteopathy had been appointed to supervise the respiratory services activities provided by the hospital. Findings include:

A review of the respiratory therapy department was completed on 2/11/10, at 1:15 p.m. The therapy manager indicated the hospital provided routine respiratory services (such as oxygen administration, nebulizer treatments) and had serviced three ventilator (vents) patients. Two of the patients were off their vents within twelve hours of admission and the third patient was transferred to another acute care hospital. The manager acknowledged the department has ten staff in the respiratory department and the hospital staffs the department twenty-four hours a day/seven days a week.

The organizational chart for the respiratory care department was reviewed and depicted a therapy manager who was responsible to the director of acute care, who was under the director of patient care services, who was under the chief executive officer. None of the positions held a doctor of medicine or osteopathy license to supervise and administer the respiratory care service properly.

A review of the job descriptions for the therapy manager, director of acute care and the director of patient care services was reviewed. None of the job descriptions indicated the positions required a doctor of medicine or osteopathy license for authority and to delegate responsibility for the oversight of the respiratory services provided at the hospital.

The hospital policy and procedure for medical consultant utilization for respiratory care was reviewed. The policy indicated the consultant was contracted on an annual basis and was available 24 hours a day for necessary patient-centered communications concerning appropriateness of care, medical ethics, advisory and recommendations of intervention. The indications of use for respiratory consultant read: "Due to time commitments placed upon the consultant by the contracted functions with the medical center, private practice, and other duties, a procedural method should be followed in order to minimize unneeded or frivolous communications." The policy directed staff to follow the organizational chart for recommendations and problem solving. The staff who held the positions in the organizational were not a doctor of medicine or osteopathy to provide respiratory services.

The policy did direct the staff to contact the consultant, "When response time is critical, the Medical Consultant may be contacted directly in matters of: A. Orders for service for which the department or medical center has no written policies, procedures or protocols, B. Degenerating respiratory status in a patient that is unresponsive to all interventions by the attending physician and the assigned respiratory care practitioner, and C. Questions regarding suboptimal medical care or ethical dilemmas." The policy of the consultant role did not delineate the responsibility of supervision for the administration of respiratory services.

The credentials for the medical director were requested to determine if the medical director had the knowledge, experience and capabilities to supervise and administer the service properly and the hospital did not provide the credentials.

The therapy manager on 2/11/10, at 1:20 p.m. provided a list of two pulmonologists from another acute care hospital that had been in contact with the respiratory department. However, upon interview with the therapy manager on 2/11/10, at 1:20 p.m. revealed neither physician had physically been in the building to oversee and supervise the activities of the respiratory department. The director of acute care was interviewed on 2/11/10, at 4:00 p.m. and the director also revealed the physicians had been in contact via telephone and e-mails for reading bedside spirometry off site via fax to the consultant group, equipment purchasing and planning but they were not physically in the building to supervise and oversee the respiratory department for the administration of respiratory services.