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Based on interview and record review the facility failed to ensure emergency services were under the direction of a member of the medical staff. Not having the oversight and direction of medical staff personnel created a risk for not meeting the needs of emergency department patients. This resulted in the hospital's noncompliance with the following Condition of Participation: 485.618 Emergency Services. Findings:

Review of the "CAH Key Facility Personnel" sheet from 9/11-13/12, provided by the survey team and completed by the facility's Director of Nursing, revealed "Emergency Services Director" was blank.

During an interview on 9/12/12 at 10:30 am, the Director of Nursing was asked who the physician responsible for the emergency department was. She replied they did not have one.

An interview was conducted with the Chief of Staff on 9/12/12 at 1:30 pm. When asked if the facility had a physician that oversaw the emergency department, she replied they did not.

During an interview on 9/13/12 at 8:15 am, the Acting Chief Executive Officer was asked what physician was responsible for the emergency department. She replied that there was no doctor assigned to the emergency department. She added that she spoke with the Medical Director for Wrangell Medical Center and he confirmed that the facility did not have a physician who was responsible for oversight of the emergency department.



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Based on observation and interview the facility failed to ensure the temperature and humidity in the operating/procedure room and sterile processing areas were maintained at acceptable parameters. This failed practice created a risk for microbial growth and/or infections (e.g. wound, respiratory). Findings:


During an observation in operating/procedure room on 9/11/12 at 8:15 am the humidity monitor in the room read 70 percent and the thermometer in the room read 62 degrees.

During an interview on 9/11/12 at 9:45 am the Clinical Services Director stated she was responsible for oversight of the surgical services area. When asked about temperature and humidity, she replied that the facility did not monitor or record either the humidity or temperature in the surgical services area . When asked for a facility policy, she stated there was no policy for temperature and humidity monitoring in the surgical services area.


Per the AORN (Association of PeriOperative Registered Nurses) "Perioperative Standards and Recommended Practices", "Relative humidity should be maintained between 30% and 55%, within the perioperative suite, including operating rooms..., endoscopy rooms, instrument processing areas, and sterilizing areas", and "High humidity increases the risk of microbial growth in areas where sterile supplies are stored or procedures are performed. Temperature should be maintained between 68-73 degrees in within the operating room suite and general work areas in sterile processing."




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Based on record review and interview the hospital failed to ensure credentialing was completed according to the facility's medical staff bylaws for 4 physicians (#s 1; 2; 3; and 4) of 8 physicians whose credentialing files were reviewed. Specifically, the hospital failed to ensure: 1) 4 physicians (#s 1; 2; 3; and 4) were not provided with the facility's medical staff bylaws; 2) one physician (#1) had a current certification of liability coverage; and 3) one physician (#4) had references of competence. In addition, the facility failed to ensure the Medical Director was credentialed. Findings:

Medical Director

On 9/12/12 at 8:45 am the Surveyor gave the completed "Medical Staff Credentialing Worksheet" to the Administrative Assistant, who was responsible for the facility's medical staff credentialing. Included on the list of physician names for review was the Medical Director (MD). The Administrative Assistant said the Medical Director was not credentialed. She further stated the physician signed his name on all the "WRANGELL MEDICAL CENTER PHYSICIAN/ALLIED HEALTH PROFESSIONAL (AHP) DOCUMENTATION CHECKLIST" in the area for "WMC Medical Director Signature/Date."

Review on 9/12-13/12 of an e-mail from the Medical Director to the Acting Chief Executive Officer revealed the MD's list of what he has been doing for Wrangell Medical Center included the following:
? Medical Staff Meeting and worked with physicians on issues that came from the meetings;
? Peer review meeting with Physicians and Physician #5. Signed peer review letters to physicians. Completed chart reviews for peer review with Physician #5;
? Wrote a Peer Review policy and worked on credentialing/recredentialing form. Worked on getting Bartlett Regional Hospital to do help with credentialing process and reviewed all the applicants application at Bartlett;
? Reviewed charts for Credentialing;
? Reviewed incident reports, with head nurse, related to physician care; and
? Worked with CEO on some hospital issues.

Review on 9/12-13/12 of the "MEDICAL DIRECTOR EMPLOYMENT AGREEMENT" revealed "The required duties include...Assist in clinical functions as needed to carry out any of the tasks described above..."

During an interview on 9/12/12 at 9:55 am, the Acting Chief Executive Officer confirmed the Medical Director was not credentialed at Wrangell Medical Center.

On 9/12-13/12 the Administrative Assistant, who was responsible for credentialing at Wrangell Medical Center, provided credentialing files for the following physicians and confirmed they contained all the documentation the hospital had received for credentialing. Review of the credentialing files revealed:

Physician #1
? no documentation that Physician #1 had received the Wrangell Medical Staff Bylaws.
? the most current "Certificate of Liability Insurance" expired 7/1/2012.

Physician #2
? no documentation that Physician #2 had received the Wrangell Medical Staff Bylaws.

Physician #3
? no documentation that Physician #3 had received the Wrangell Medical Staff Bylaws.

Physician #4
? no documentation that Physician #4 had received the Wrangell Medical Staff Bylaws.
? no documentation references of competence was done.

Review on 9/11-13/12 of the most current Medical Staff Bylaws revealed each credentialing file must include "...A statement that the applicant has received the Bylaws...A statement that the applicant carries professional liability insurance coverage..."



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Based on interview the facility failed to ensure a physician had input in the development of all policies. Findings:


An interview was conducted on 9/16/12 at 3:35 pm with the Quality Director via phone and the Director of Nursing. They stated the Nursing Department Directors were responsible for reviewing and approving the policies specific to their departments.

When asked about physician input, they stated there was no physician involvement in either developing or approving facility policies.







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Based on observation and interview the facility failed to ensure medications in the surgical services and emergency departments were stored securely. This failed practice created a risk for access to medications by unauthorized personnel and the public. Findings:

Emergency Department

Observations in the emergency department on 9/11/12 at 8:05 am revealed one of the emergency room doors was wide open and the other was partially open. Further observation revealed multiple unsecured medications located in the department, in both emergency rooms.

During an interview on 9/11/12 at 8:15 am, when asked about access to the emergency department, the Maintenance Supervisor stated the doors into the emergency rooms were never locked.

Surgical Services Department

During observations on 9/11/12 at 8:15 am during a facility tour with the Maintenance Supervisor the door between the storage room, off the recovery room, that leads into the surgery ante/clean room was unlocked. In addition, access to the operating room/procedure room was unsecured, accessible to the staff, and public.

Observations on 9/11/12 at 8:15 am in the surgical services area with the Maintenance Supervisor revealed the door from the hallway and the door into the anteroom leading to the operating room were unlocked.


Further observations in the anteroom and the operating room revealed multiple medications in both rooms and in the anesthesia medication cart located in the operating room. None of the medications were secured.

During an interview on 9/11/12 at 8:15 am, the Maintenance Supervisor stated the surgical services department should have been locked.

During an interview on 9/11/12 at 9:00 am, when asked about access to the surgical services department, the Director of Nursing stated the doors should always be locked.

During an interview on 9/11/12 at 10:30 am a facility policy regarding medication security in the surgical services and emergency department was regquested from the Clinical Nurse Supervisor. The Clinical Nurse Supervisor stated there was no facility policy.






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Based on observation, record review, and interview the hospital failed to ensure sterilization processes and procedures were consistent with accepted standards of practice. This failed practice created a potential for disease transmission. Findings:

Overview of current professional standards for sterilization:

Sterilization, as defined by Dr. William Rutala Ph.D,, M.S., M.P.H. during an April 2008 AORN (Association of Perioperative Registered Nurses) presentation titled "Disinfection and Sterilization: Meeting the CDC Guideline", is "the complete elimination or destruction of all forms of microbial life".

Per "Guideline for Disinfection and Sterilization in Healthcare Facilities", 2008. William Rutala, Ph.D., M.P.H. and David Weber, M.D., M.P.H. and the Healthcare Infection Control Advisory Practices:

The delivery of sterile products depends not only on the effectiveness of the sterilization process but also on monitoring of the entire process.

Periodic infection control rounds to areas using sterilizers...may identify correctable variances in ...documentation of sterilization records...These rounds also may identify improvement activities to ensure that operators are adhering to established standards.


Additional References:

AORN (Association of Perioperative Registered Nurses) 2008 "Standards, Recommended Practices & Guidelines"

AAMI (Association for the Advancement of Medical Instrumentation) 2006 "Comprehensive guide to steam sterilization and sterility assurance in health care facilities"

CDC (Centers for disease control and prevention) 2008 "Guideline for Disinfection and Sterilization in Healthcare Facilities"


Sterilization

Observations in the surgical services department on 9/11/12 at 10:30 am revealed an autoclave sterilizer and a Steris automated processor that sterilizes endoscopes.

Per the Steris processor manufacturer's website, , accessed 9/21/12, documentation should include:
? Items Processed;
? Patient Identification;
? Chemical Indicator Results; and
? the Technician releasing it for use.

Review of the Steris endoscope sterilizer print-outs revealed none of the above items was documented.

Review of the autoclave sterilizer documentation revealed "instruments" was written in the spaces for "Item Run"; there was no documentation that identified the specific instruments included in each load.

During an interview on 9/11/12 at 10:30 am the Clinical Services Director and Staff #1 stated they had no other documentation regarding sterilization.

High Level Disinfection

Observations in the surgical services department on 9/11/12 at 10:30 am revealed a gallon container of Cidex OPA (a high level liquid disinfectant) under the counter. The container was half empty and 7/27/12 was written as the date the container had been opened.

However, review of the facility's most recent "Cidex OPA Minimum Effective Concentration (MEC) Test Log" revealed the last time the disinfectant was documented as having been used was on 8/31/11, eleven months prior to the date the Cidex OPA container was opened.

Per the website for Cidex OPA, , accessed on 9/21/12, "It is important to record the date the solution was poured from the original container and the date its reuse life ends (not to exceed 14 days)." Additional documentation should include:
? Date Solution Expires;
? Date Solution Tested;
? Time Solution Tested; and
? Temp in ?F Before Use.

Further review of the facility's MEC log revealed none of the above was documented.

Review of the facility policy "Cidex OPA Use", dated 8/7/09, revealed it did not meet current manufacturer's guidelines.

During an interview on 9/11/12 at 10:30 am with the Clinical Services Director for surgical services and Staff #1, they stated they did not know which instruments were disinfected with the Cidex OPA that was opened on 7/27/12. They confirmed nothing had been documented on the MEC test log since 8/31/11. When asked if they had documentation of the high level disinfection process, including identification of which instrument was disinfected, the length of disinfection time, and the patient for whom the instrument or endoscope was used, they said they did not record that information.

During the same interview, the Clinical Services Director for surgical services and Staff #1 were asked about linking instruments or endoscopes back to the patient, in the event of an outbreak or problem during the sterilization process. They confirmed the facility would not be able to trace a specific instrument or endoscope back to the patient for whom it had been used.

Per AORN's (Association of Operating Room Nurses) 2008 "Standards, Recommended Practices, and Guidelines", "Documentation should be maintained to allow for traceability of every load to the patient for whom the instruments were used."

Enzol Enzymatic Cleaner

Per the manufacturer's website, , accessed on 9/21/12, Enzol helps "reduce bacterial burden before instruments are disinfected or sterilized."

Observations in the surgical services department on 9/11/12 at 8:40 am revealed an opened gallon container of Enzol enzymatic cleaner. The Enzol's expiration date was 12/2011.

During an interview on 9/11/12 at 10:35 am Staff #2 was asked about the Enzol enzymatic cleaner. She stated they used it to clean instruments and confirmed it expired on 12/2011.


As a result of these failed practices, there was no assurance that hospital sterilization practices followed current professional standards and guidelines.





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Based on record review and interview the facility failed to ensure policies for the Emergency Room, Acute Care Nursing, and Central Supply were reviewed annually. Findings:

Review on 9/12/12 of the policy notebooks revealed the following:

? Emergency Room policies: most recent review date was 10/28/08,
? Acute Care Nursing policies: most recent review date was 8/2/11, and
? Central Supply policies: most recent review date was 4/1/10.

During an interview on 9/12/12 at 2:30 pm the Director of Nursing confirmed the Emergency Room, Acute Care Nursing, and Central Supply policies were overdue for anannual review.

Review of the facility policy; "POLICY AND PROCEDURE MANUAL REVIEW" dated 8/11, revealed, "All Department Policy and Procedure Manuals shall be reviewed annually by the Administrator or his/her designee: the Administrative Assistant."





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Based on record review and interview the facility failed to ensure a discharge summary was completed for 1 patient (#2) out of 22 patients whose medical records were reviewed. Findings:

Record review from 9/11-13/12 revealed Patient #2 was admitted to the facility 3/8/12 and discharged 3/12/12. Closed record review revealed no discharge summary was done.

When questioned by the Surveyor on 9/13/12 at 8:05 am, the Medical Records Supervisor confirmed there was no discharge summary for Patient #2.

Review on 9/11-13/12 of the most recent Medical Staff Bylaws Rules and Regulations revealed "6. The attending physician shall be held responsible for the preparation of a completed record for each patient. This record shall include...discharge note."

Review of the most current policy "Discharge Summary/Acute Care", dated July 2, 2002, revealed "A discharge summary shall be dictated on all stays which exceed 48 hours..."




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Based on interview and policy review the facility failed to have policies and procedures in place regarding inpatient and outpatient visitation rights. This deficient practice created the potential for unnecessarily restricting visitors due to staff not knowing which restrictions or limitations the facility deemed to be clinically necessary. Findings:

Review of the policies and procedures on 9/11-13/12 revealed no policy or procedure that addressed patient visitation rights.

During an interview on 9/12/12 at 8:00 am the Director of Nursing confirmed there was no policy or procedure on patient visitation rights and confirmed no staff education had been done.






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Based on interview and policy review the facility failed to have written policies and procedures in place regarding inpatient and outpatient visitation rights, including: 1) informing each patient of his/her visitation rights, including any clinical restrictions; and 2) informing each patient of their right, subject to their consent, to have whomever they wish visit. Without these policies, patients and their visitors lacked information regarding any clinical restrictions that would contraindicate visits. Findings:

Review of the policies and procedures on 9/11-13/12 revealed no policy and procedure that addressed patient visitation rights.

During an interview on 9/12/12 at 8:00 am the Director of Nursing confirmed there was no policy and procedure on patient visitation rights.




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Based on interview and policy review the facility failed to have policies and procedures in place regarding visitation rights, including any restriction or limitation in place and the reason for the restrictions. Not having these policies created the potential for patients having unequal and inconsistent visiting rights. Findings:

Review of the policies and procedures on 9/11-13/12 revealed no policy or procedure that addressed patient visitation rights.

During an interview on 9/12/12 at 8:00 am the Director of Nursing confirmed there was no policy or procedure on patient visitation rights.



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