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SEARHC WRANGELL MEDICAL CENTER-CAH
No Description Available
Tag No.: C0241
Based on observation, record review and interview the hospital failed to ensure patient safety during the provision of surgical services. Specifically, the hospital failed to ensure: 1) a visiting surgeon, who performed 6 surgical procedures on 11/3/11, was credentialed by the governing body according to the facility's medical staff bylaws, and 2) completion of a correct time out prior to surgery, according to current professional standards of practice. Due to the hospital's failure to complete the credentialing process, the visiting surgeon's professional qualifications and performance were not verified, and the hospital was unable to ensure patient safety. The hospital's failure to complete a time out prior to surgery resulted in a patient having a different surgical procedure than the one for which the patient consented. Findings:
Record review revealed Patient #1 was scheduled for a first dorsal compartment release on the left wrist, a tendon surgery, to be performed by Surgeon #1 on 11/3/11. Review of the Patient's surgical record revealed that instead of the scheduled tendon operation, a left wrist carpal tunnel release, a ligament surgery, was performed.
Credentialing
During an interview on 11/15/11at 11:15 am the Director of Nursing was asked how many times Surgeon #1 had performed surgeries at Wrangell Medical Center. She stated he had been there once, on 11/3/11, and she provided that day's surgery schedule. The schedule showed there were 6 surgeries scheduled on 11/3/11.
During an interview on 11/15/11 at 3:08 pm, the Director of Development and Quality stated that Wrangell Medical Center (WMC) "outsourced" its credentialing to Bartlett Regional Hospital (BRH) in Juneau.
Review of the Memorandum of Understanding for Credentialing of Practitioners, dated 11/19/08, between BRH and WMC revealed "Whereas Bartlett Regional Hospital is willing to enter into a networking relationship with Wrangell Medical Center for the purpose of reviewing Wrangell Medical Center's process for the credentialing of qualified practitioners; It is therefore mutually agreed under this memorandum of understanding that Bartlett Regional Hospital and Wrangell Medical Center will engage in joint activities for the credentialing of qualified practitioners for Wrangell Medical Center." Further review of the memorandum of understanding revealed no documentation that clearly defined each hospital's responsibilities regarding credentialing WMC practitioners.
On 11/15/11 at 3:45 pm the Director of Development and Quality provided Surgeon #1's credentialing file and confirmed it contained all the documentation the hospital had received for credentialing.
Review of Surgeon #1's credentialing file revealed a blank application form for surgical privileges at Wrangell Medical Center. Further review of the credentialing file revealed the following:
? an email, dated 6/17/11, from the CEO's Executive Assistant at WMC to the Medical Staff Coordinator at Bartlett Regional Hospital stating that "[Staff Name] at Ketchikan Orthopedics contacted me and they have a new doctor coming in who wants privileges at Wrangell Medical Center. His name is [Surgeon #1 Name] and his Alaska license # is [License #]."
? an email, dated 6/29/11, from the CEO's Executive Assistant at WMC to the Medical Staff Coordinator at Bartlett Regional Hospital stating that Surgeon #1 "wants privileges at Wrangell Medical Center ". The Surgeon was identified as "based out of Ketchikan (Peace Health)".
? an email, dated 11/3/11, from the Medical Staff Coordinator at BRH to WMC's Director of Development and Quality and the CEO's Executive Assistant, advising them that "I do not have an application for [Surgeon #1]".
Although the 11/3/11 email confirmed there was no application for surgical privileges for Surgeon #1, he was allowed to perform 6 surgeries at WMC that same day, 11/3/11. In addition, the 6/17/11 email confirmed Surgeon #1's credentialing process was initiated over 4 months prior to his performing surgery on 11/3/11.
During an interview on 11/16/11 at 9:20 am, the Director of Development and Quality provided WMC's Medical Staff Bylaws and confirmed they were currently in use.
Review of these undated Medical Staff Bylaws revealed Clinical Privileges was defined as "the permission granted by the Governing Body to an individual to render specific diagnostic, therapeutic, medical, dental, and/or surgical services", and "Each application for appointment to the Medical Staff and/or for initial Clinical Privileges shall be in writing, submitted on a prescribed form, shall be legible and signed by the applicant."
As a result of not having a completed application from Surgeon #1, there was no documented evidence that, prior to Surgeon #1's performing surgery on 11/3/11, the following WMC Medical Staff Bylaw's minimum requirements for clinical privileges were met:
? A statement that the applicant had received and read the Bylaws and the Rules and Regulations of the Medical Staff and that the applicant agreed to be bound by the terms;
? Detailed information concerning the applicant's qualifications;
? Specific requests stating the Medical Staff category and/or Clinical Privileges for which the applicant wished to be considered;
? The names of at least four persons including at least 3 practicing Physicians or Osteopaths who have worked with the applicant and observed the applicant's professional performance and who could provide meaningful information as to the applicant's clinical ability, ethical and moral character, ability to effectively work with others and physical and emotional status;
? Information concerning errors or omissions (malpractice) claims during the past five years;
? Information as to whether the applicant's membership status and/or Clinical privileges had ever been revoked, suspended, reduced or not renewed at any other hospital, health care institution or health care facility of any kind, and as to whether any of the following had ever been suspended, revoked, denied or not renewed:
(1) Membership/Fellowship or equivalent in any local, state, national or foreign professional organization or association;
(2) Specialty board certification or equivalent;
(3) License or certification to practice any profession in any jurisdiction;
(4) United States Drug Enforcement Administration Prescription Authority (DEA) or equivalent; and
(5) Medicare/Medicaid provider status or equivalent
? A statement that the applicant carried professional liability insurance in a sufficient amount;
? Statements notifying the applicant of the scope and extent of the authorization for release of information provisions of the Bylaws; and
? A statement whereby the Practitioner agreed that, if an adverse ruling was made with respect to his application for Medical Staff membership and/or clinical privileges, he/she would exhaust the administrative remedies offered by these bylaws before resorting to any formal legal action or proceeding.
Review of the facility's job description for the Director of Development and Quality revealed "Provides oversight for provider WMC's credentialing and privileging process."
Temporary Privileges
During an interview on 11/15/11 at 3:08 pm, the Director of Development and Quality stated that Surgeon #1 "has temporary privileging". She explained that since Surgeon #1 was from Ketchikan, Wrangell Medical Center's CEO had called a physician and hospital staff from Ketchikan General Hospital and talked to them about Surgeon #1.
Further review of Surgeon #1's credentialing file revealed 2 letters.
The first letter, dated 7/31/11, was written to Surgeon #1 and included "You have been granted temporary privileges at Wrangell Medical Center pending the completion of your credentialing process. This temporary privileging will be from July 25, 2011 to October 25, 2011." The letter was signed by WMC's CEO.
The second letter, dated October 31, 2011, was addressed "To Whom It May Concern", and was signed by the Director of Nursing, as Acting Administrator for the CEO. This letter stated "The following physicians are granted temporary privileges at Wrangell Medical Center pending the completion of their credentialing process", with Surgeon #1's name listed.
However, further review of the Medical Staff Bylaws revealed the CEO or Acting Administrator may grant temporary privileges only in the following circumstances:
1. Pendency of Application - "upon receipt of an application for Medical Staff appointment, including a request for specific Temporary Clinical Privileges and which conforms in all respects with the conditions specified in these Bylaws",
2. Care of Specific Patients - "upon receipt of a written request from a Medical Staff member, an appropriately licensed Practitioner who is not an applicant for Medical Staff membership or Clinical Privileges, may be granted Temporary Clinical Privileges for the care of one or more specific patients", and
3. Locum Tenens - "upon receipt of a written request, received at least two weeks (unless such notice is not reasonably possible) before the rendering of service is proposed to commence, a Practitioner who is proposed to serve as Locum Tenens for a member of the Medical Staff may, without applying for the membership on the Medical Staff, be granted Temporary Clinical Privileges for an initial period of the anticipated length of services as Locum Tenens not to exceed the maximum allowed by the Practitioner's license".
The section on granting Temporary Clinical Privileges continued with "Temporary Clinical Privileges shall be granted only when the information available reasonably supports a favorable determination regarding the requesting Practitioner's qualifications, ability and judgment to exercise the Clinical Privileges requested, and only after the Practitioner has satisfied the requirements of these Bylaws regarding professional liability insurance."
Further review of Surgeon #1's credentialing file revealed no documented evidence of any of the Medical Staff Bylaw's requirements for temporary privileging.
Surgical Time Out
AHRQ (Agency for Healthcare Research and Quality, a Federal agency charged with improving patient safety), www.ahrq.gov
According to an article in Medical News Today, www.medicalnewtoday.com
Per the AORN's Comprehensive Surgical Checklist, www.aorn.org, accessed 11/28/11, Time Out includes all team members confirming the procedure to be performed.
The "AORN Position Statement on Preventing Wrong-Patient, Wrong-Site, Wrong-Procedure Events", www.aorn.org
The American College of Surgeons "Statement on ensuring correct patient, correct site, and correct procedure surgery" , www.facs.org
During an interview on 11/15/11 at 1:20 pm, when the operating room (OR) Coordinator was asked what time out meant, she replied that "everyone stopped", and the person in charge of the time out got everyone's attention and the patient and procedure were reviewed. When asked about the time out prior to Patient #1's surgery, the OR Coordinator said that when the nurse" got to the point where she'd say the procedure" she had to look through the chart in order to find the name of the surgery on the consent, but before the consent was found, Surgeon #1 stated it was a carpal tunnel surgery. Then the time out ended and the carpal tunnel surgery, not the scheduled surgery, was performed.
Observation in the surgical area with RN #1 on 11/16/11 at 1:15 pm revealed a bulletin board note located in a central location in the operating room. There was a note on the bulletin board titled "Time Out" which listed Procedure, in addition to patient name, date of birth, surgeon, allergies, and other pertinent information.
Review of the hospital's policy titled "Time Out Procedure", dated 8/7/09, revealed "If time out occurs in the operating room, it must involve the entire operative team" and "agreement on the procedure to be done" was identified as one of the "elements to be addressed" in the time out. In addition, the policy stated "Wrangell Medical Center care providers are required to follow the Universal Protocol for Preventing Wrong Site, Wrong Procedure/Surgery, Wrong Person at all times."
Per the "Universal Protocol For Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery", www.acep.org