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Based on review of credential files, review of Medical Staff Bylaws, Rules and Regulations, review of the Medical Staff QI (Quality Improvement)/Peer Review Policy and staff interview, the governing body of the CAH (Critical Access Hospital) failed to ensure that the Medical Staff Bylaws, Rules and Regulations were followed in the appointment and/or reappointment of 2 of 12 medical staff physicians (Physicians H and J) reviewed and for 2 of 4 allied health professionals (Certified Registered Nurse Anesthetists O and P) reviewed and failed to ensure that the Medical Staff QI/Peer Review Policy for external peer review was followed. This failed practice has the potential to affect all patients treated by physicians or allied health professionals at the CAH. The roster of Medical Staff provided by the CAH listed 7 Active Staff, 75 Consulting Staff and 19 Affiliate Staff. On the first day of survey patient census was 4 acute inpatients and 1 skilled inpatient.

Findings are:

A. Review of the Medical Staff Bylaws approved by the governing body on 4/27/11, under Article V Procedures for Appointment, Reappointment, and Resignation revealed the following concerning appointment to the Medical Staff:
1. Section 1 Appointment Requirements, subsection A - Application Form, number ii: "Detailed information concerning the practitioner's professional qualifications and letter of reference from at least two (2) practitioners who have had sufficient experience in observing and working with the practitioner to enable them to render an opinion on his or her professional competence and ethical character".
2. Section 1 Appointment Requirements, subsection D - Conditions of Application, number ii: "Authorizes the Hospital to consult with members of the medical staffs of other hospitals with which the practitioner has been associated and with others who may have information bearing on his or her competence, character, and ethical qualifications".
3. Section 2 Appointment Process, subsection A - Verification of Completeness: "The Chief Executive Officer must determine whether the application and supporting materials are completed, including letters of reference...."

B. Review of the credential file for Physician H revealed the physician was initially granted privileges and appointment to the Medical Staff - Consulting category by the Governing Body on 5/25/11 and Physician J was initially granted privileges and appointment to the Medical Staff - consulting category by the Governing Body on 5/30/12. Review of both credential files revealed there were no references from other hospitals where these physicians worked or from personal references. Interview with the Director of Human Resources (duties included credentialing) on 1/30/13 at 1:30 PM and 3:10 PM revealed they usually get reference for initial applications but not for reappointments and confirmed these 2 credential files for initial appointment lacked any references.

C. Review of the Rules and Regulations of the Medical Staff approved by the governing body on 4/27/11 revealed the following under Section C - Allied Health Professions:
- "Examples of individuals who qualify as Allied Health Professionals include, but are not limited to Certified Registered Nurse Anesthetists ("CRNAs"), nurse practitioners, physician assistants....."; and
- Biennial Review: "The allied Health Professional shall submit written information regarding his or her....Cooperation with Hospital and Medical Staff personnel, use of the Hospital facilities, and relationship with other practitioners...General attitude towards patients, the Hospital, and the public".

Review of the credential files for CRNAs - O and P revealed none of the above information was available at the time of reappointment by the governing body on 9/26/12.

D. Review of the policy and procedure titled Medical Staff QI/Peer Review Policy dated 5/3/04 revealed a process for internal peer review and external peer review. The definitions section of the policy contained the following:
1. "Internal Physician Peer Reviewer: For the purposes of this program, an internal physician peer review shall be defined as an active member of the medical staff, in good standing, licensed in the same medical specialty as the individual whose case is under review (exception:when external review is required). An individual functioning as an internal peer reviewer should not have been immediately involved in any of the medical management under review; however, opinions and information may be obtained from participants who were involved in the patient's care."
2. "External Physician Reviewer: An external physician shall be an active member of the [Network Hospital's name] medical staff, in good standing, licensed in a medical specialty appropriate to the type of case reviewed."

The External Physician Review section contained the following directions "Circumstances in which external physician review may be obtained include, but are not limited to...." The 6th listing under this statement was "5 (five) charts will be sent quarterly to [Network Hospital's name] for review by [name of a physician]. The charts will be chosen randomly, by request, or as a result of a Level 3 assignment." The level 3 assignment listed on the Medical Staff QI/Peer Review Worksheet was "Major deviation from practice standards or impact on patient outcome. Issue referred to Medical Staff QI/Peer Review Committee for remedial action and follow-up."

(Peer review is the process by which a committee and/or another physician examines the work of a peer and determines whether the physician under review has met accepted standards of care in rendering medical services.)

Review of the External Peer Review information for 2012 revealed 1 record was sent to the Network Hospital on 5/29/12 and 1 record was sent on 11/5/12. Interview with the Quality Improvement Coordinator on 1/29/13 from 3:30 PM to 5:00 PM confirmed 2 records were sent for external review in 2012 and revealed 1 record was sent for external review in 2011. According to this policy 20 records should be sent for external peer review every year.

Based on review of credential files, review of Medical Staff Bylaw, Rules and Regulations, review of Medical Staff QI [Quality Improvement]/Peer Review Policy, review of external peer review information and staff interview, the CAH (Critical Access Hospital) failed to ensure the Medical Staff Bylaws, Rules and Regulations were followed in the appointment and/or reappointment of medical staff physicians and allied health professionals and failed to follow the policy and procedure for external peer review. The roster of Medical Staff provided by the CAH listed 7 Active Staff, 75 Consulting Staff and 19 Allied Health Staff. On the first day of survey patient census was 4 acute inpatients and 1 skilled inpatient.

I. The Medical Staff Bylaws were not followed for the following appointments/reappointments:
- Initial appointment for 2 of 5 consulting medical staff reviewed (Physician H and J);
- Reappointment every 2 Medical Staff years for 3 of 7 active medical staff reviewed (Physicians A, C and D);
- Reappointment and continued privileges for 2 of 4 allied health professionals reviewed (Certified Registered Nurse Anesthetists O and P); and
- Reappointment every 2 years for 1 of 4 allied health professionals reviewed (Physician Assistant - M).

Findings are:

A. Review of the Medical Staff Bylaws approved by the governing body on 4/27/11 under Article V Procedures for Appointment, Reappointment, and Resignation revealed the following concerning appointment to the Medical Staff:
1. Section 1 Appointment Requirements, subsection A - Application Form, number ii: "Detailed information concerning the practitioner's professional qualifications and letter of reference from at least two (2) practitioners who have had sufficient experience in observing and working with the practitioner to enable them to render an opinion on his or her professional competence and ethical character".
2. Section 1 Appointment Requirements, subsection D - Conditions of Application, number ii: "Authorizes the Hospital to consult with members of the medical staffs of other hospitals with which the practitioner has been associated and with others who may have information bearing on his or her competence, character, and ethical qualifications".
3. Section 2 Appointment Process, subsection A - Verification of Completeness: "The Chief Executive Officer must determine whether the application and supporting materials are completed, including letters of reference...."
4. Section 2 Appointment Process, subsection C - Verification of Information: "The Hospital Administration shall inquire to the Nebraska Health and Human Services Department of Regulations and Licensure and the National Practitioner Data Bank concerning the practitioner making application."
(Review of the Medical Staff Bylaws that were approved in 2006 revealed the above Articles, Sections, Subsections and numbers were the same as listed above.)

B. Review of the credential file for Physician H revealed the physician was initially granted privileges and appointment to the Medical Staff - Consulting category by the Governing Body on 5/25/11. The credential file contained: a completed application, completed privilege form, Certificate of Insurance letter (dated 12/12/12), letter from Nebraska Excess Liability Fund (dated 12/28/12), copy of physician license with expiration date of 10/1/14, copy of the Controlled Substance Registration Certificate with expiration date of 5/31/13, copy of a completion certificate for Educational Commission for Foreign Medical Graduates and a query of the NPDB (National Practitioner Data Bank - repository of all payments made on behalf of physicians in connection with medical liability settlements or judgements as well as adverse peer review actions against licenses, clinical privileges and professional society membership). The file also contained a checklist with the physician's name with date of 5/6/11. This checklist included a section titled "References" with "Facilities where applicant has worked" and "Personal" listed. The column titled "YES" was checked for both "Facilities" and "Personal". However, review of the entire credential file revealed no reference letters. Interview with the Director of Human Resources (duties included credentialing) on 1/30/13 at 1:30 PM and 3:10 PM revealed the following:
- Indicated that they usually get reference for initial applications but not for reappointments; and,
- Confirmed that at the time of appointment the only documents available in Physician H's credential file was the complete application along with copies mentioned above and a query of the NPDB and did not contain any references or information from the Nebraska Health and Human Services Department of Regulations and Licensure.

C. Review of the credential file for Physician J revealed the physician was initially granted privileges and appointment to the Medical Staff - Consulting category by the Governing Body on 5/30/12. Review of the entire credential file revealed there were no references from hospitals where Physician J had worked or from personal references. Interview with the Director of Human Resources on 1/30/13 at 3:10 PM confirmed the lack of references in this files.

D. Review of the Medical Staff Bylaws approved by the governing body on 4/27/11 revealed the following under Article III Medical Staff Membership, Section 4 Duration of Appointment: "Initial appointments shall be for a period of time of not more than two Medical Staff years. For purposes of these Bylaws, the Medical Staff year commences on the first day of January and ends on the 31st day of December of each year." Review of the credential files for Physician A, C and D revealed they were last reappointed to the Active Medical Staff by the Governing Body on 11/17/10 . Interview with the CEO (Chief Executive Officer) on 1/30/13 at 2:15 PM indicated that these 3 physicians should have been reappointed to the Medical Staff by December 31, 2012.

E. Review of the Rules and Regulations of the Medical Staff approved by the governing body on 4/27/11 revealed the following under Section C - Allied Health Professions:
- Definitions: "Examples of individuals who qualify as Allied Health Professionals include, but are not limited to Certified Registered Nurse Anesthetists ("CRNAs"), nurse practitioners, physician assistants....."; and
- "Biennial Review. After the initial appointment period, each Allied Health Professional authorized to perform health care services or to exercise clinical privileges at the Hospital shall be reviewed biennially [every 2 years]..."

Review of the credential file for Physician Assistant - M revealed the most recent reappointment by the Governing Body was 11/17/10 . Interview with the CEO on 1/30/13 at 2:15 PM confirmed this reappointment failed to follow the Rules and Regulations for reappointment every 2 years.

F. Review of the Rules and Regulations of the Medical Staff approved by the governing body on 4/27/11 revealed the following under Section C - Allied Health Professions, 9 - Biennial Review:
"The allied Health Professional shall submit written information regarding his or her..Cooperation with Hospital and Medical Staff personnel, use of the Hospital facilities, and relationship with other practitioners...General attitude towards patients, the Hospital, and the public".

Review of the credential files for CRNAs - O and P revealed none of the above information was available at the time of reappointment by the governing body on 9/26/12.

II. Review of the policy and procedure titled Medical Staff QI/Peer Review Policy dated 5/3/04 revealed a process for internal peer review and external peer review. The definitions section of the policy contained the following:
1. "Internal Physician Peer Reviewer: For the purposes of this program, an internal physician peer review shall be defined as an active member of the medical staff, in good standing, licensed in the same medical specialty as the individual whose case is under review (exception:when external review is required). An individual functioning as an internal peer reviewer should not have been immediately involved in any of the medical management under review; however, opinions and information may be obtained from participants who were involved in the patient's care."
2. "External Physician Reviewer: An external physician shall be an active member of the [Network Hospital's name] medical staff, in good standing, licensed in a medical specialty appropriate to the type of case reviewed."

The External Physician Review section contained the following directions "Circumstances in which external physician review may be obtained include, but are not limited to". The 6th listing under this statement was "5 (five) charts will be sent quarterly to [Network Hospital's name] for review by [name of a physician]. The charts will be chosen randomly, by request, or as a result of a Level 3 assignment". The level 3 assignment listed on the Medical Staff QI/Peer Review Worksheet was "Major deviation from practice standards or impact on patient outcome. Issue referred to Medical Staff QI/Peer Review Committee for remedial action and follow-up."

(Peer review is the process by which a committee and/or another physician examines the work of a peer and determines whether the physician under review has met accepted standards of care in rendering medical services.)

Review of the External Peer Review information for 2012 revealed 1 record was sent to the Network Hospital on 5/29/12 and 1 record was sent on 11/5/12. Interview with the Quality Improvement Coordinator on 1/29/13 from 3:30 PM to 5:00 PM confirmed that only those 2 records were sent for external review in 2012 and indicated that only 1 record was sent for external review in 2011.

Based on review of the Policy and Procedure committee meeting minutes, review of the Policy and Procedure Review Form dated 2012, review of policies and procedures and staff interviews, the CAH (Critical Access Hospital) failed to ensure that the group of professional personnel reviewed 7 of 7 required types of policies and procedures in the last year. The policies not reviewed were:
- Description of the services the CAH furnishes directly and those furnished through agreement or arrangement;
- Polices and procedures for emergency medical services;
- Guidelines for the medical management of health problems that include the conditions requiring medical consultation and/or patient referral;
- The maintenance of health care records;
- Procedures for the periodic review and evaluation of the services furnished by the CAH;
- Rules for the storage, handling, dispensation and administration of drugs and biologicals;
- Procedures for reporting adverse drug reactions and errors in the administration of drugs;
- System for identifying, reporting, investigating and controlling infections and communicable diseases of patients and personnel; and
- Procedures that ensure that the nutritional needs of inpatients are met in accordance with recognized dietary practices.
Census on the first day of survey was 4 acute care inpatients and 1 skilled inpatient.

Findings are:

A. Review of the undated policy titled Policy and Procedure review revealed the following:
"Each department of TCHS [Thayer County Health Services] shall review the policies and procedures specific to their departments on an annual basis. Following completion of review any changes to the Policies & Procedures will be presented to the Policy & Procedure committee for an additional review. This committee shall be made up of the following job titles; Physician, Mid-Level [physician assistant or nurse practitioner], Administrator, Director of Nursing, Clinic Nurse, Policy and Procedure Coordinator and person from the community."

B. Review of a 3-ring notebook with the label Policy and Procedure revealed the last meeting minutes were dated 11/03/11. Also included in this 3-ring notebook was a document titled Policy and Procedure Review Form 2012 with the following documentation:
"The Following Policies were Reviewed and Approved by the Policy and Procedure Committee on the following dates:" This form contained no listing of policies and procedures.

C. Interview with the Director of Nursing on 1/30/13 at 3:30 PM confirmed policies and procedures had not been reviewed by the committee since December 2011.

Based on medical record review, staff interviews and review of facility policy the facility failed to ensure informed consent was obtained for 2 of 41 sampled patients (Patient 38 and 14). The total sample was 41. The facility census was 4.

Findings are:

A. Record review of the closed medical record for surgical Patient 14 revealed the patient was admitted preoperatively on 11/27/12. Review of the "History and Physical" dated 11/21/12 states the patient is scheduled for a laparoscopic cholecystectomy (removal of gall bladder) with umbilical hernia repair scheduled for next week. Review of the form titled "Preanesthesia Evaluation dated 11/27/12" notes the "Proposed Procedure: Lap chole [laparoscopic Cholecystectomy] & umbilical hernia." Review of the form titled "Operative Report" dated 11/27/12 notes the operation performed was "1. Laparoscopic Cholecystectomy 2. Open repair of the small umbilical hernia without mesh." Review of the form titled "Special Consent for Surgery or Other Diagnostic or Therapeutic Procedure" notes the patient signed the consent only for "Laparoscopic Cholecystectomy with possible intraoperative cholangiogram (x-rays taken during surgery to look for gallstones in the bile duct), possible open cholecystectomy." The planned umbilical hernia repair was not included on the consent.
Staff interview with the Director of Nursing and the Health Information Manager on 1/29/13 at 11:40 AM confirmed the surgical consent "should have included the planned umbilical hernia repair and did not." The DON related that there was a "breakdown between the surgeon and staff regarding the consent."

B. Upon request on 1/29/13 the facility Director of Nursing provided the facility policy for consent. The policy is titled "Consent-Informed and Implied". The policy is undated. The policy states that "Informed Consent: The patient will be informed of procedures, potential adverse reactions and potential outcomes: The patient shall sign a written consent outlining invasive procedures and surgery; The patient shall have all questions answered by the physician concerning the invasive procedure or surgery."


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C. Review of electronic Medical Record 38 on 1/28/13 at 4:00 PM with the Director of Rehabilitation revealed this patient has been receiving speech therapy services since 12/11/12. During this review the Director of Rehabilitation was unable to locate a signed consent form. When the Director was unable to find the signed consent in the electronic record a paper chart was pulled. This paper chart included a Consent to Hospital Clinic and Medical Treatment with Patient 38's name at the top of the page; however, the form had not been completed or signed. Further interview with the Director of Rehabilitation on 1/28/13 from 4:00 PM to 4:10 PM revealed this patient was receiving services in their home and the Speech Therapist had been given the consent form to have the patient sign it.

Interview with the Health Information Manager on 1/31/13 at 3:00 PM confirmed that this patient was a hospital patient receiving speech therapy services and could find no signed consent in the electronic record.

Based on review of the Quality Improvement Plan, review of QI (Quality Improvement) meeting minutes, review of QI Monitoring and Evaluation Forms, review of the Clinical Quality and Performance Improvement Scorecard Report and staff interview, the CAH (Critical Access Hospital) failed to include in their Quality Improvement program 2 of 20 departments (Cardiac Rehabilitation and Specialty Clinics) identified in QI Plan and 1 of 4 contracted radiology services (nuclear medicine). On the first day of survey there were 4 acute care patients and 1 skilled inpatients.

Findings are:

A. Review of the Quality Improvement Plan (revised date January 2002) revealed the following:
"In order to provide a high quality of patient care and services in a compassionate, safe and professional manner, the following Thayer County Health Services departments will participate in the TCHS [Thayer County Health Services] Quality Improvement Plan on an ongoing basis." Underneath this statement was a listing of 21 CAH specific departments/services including Outpatient Services (Specialty Clinics is and outpatient service), Cardiac Rehabilitation and Contracted Services.

B. Interview with Hospital Paramedic - Y (responsibilities include Cardiac Rehabilitation) on 1/29/13 from 2:30 PM to 2:45 PM revealed the following:
- Has done no quality assurance reviews;
- The Quality Improvement Coordinator "does this";
- Could provide no information concerning quality assurance.
Telephone interview with the Clinic Manager on 1/31/13 at 12:45 PM revealed no quality assurance activity had been completed in the last year. Interview with the Radiology Manager on 1/28/13 from 1:30 PM to 2:20 PM revealed the department contracts with 2 different providers for nuclear medicine services and indicated there was no quality assurance reports for either entity.

C. Review of all QI Committee meeting minutes since 1/1/2012 revealed no mention of QI related to Specialty Clinics, Cardiac Rehabilitation or Nuclear Medicine. Review of the Clinical Quality and Performance Improvement Scorecard Report revealed no quality information concerning Cardiac Rehabilitation, Specialty Clinics and Nuclear Medicine. (A Scorecard Report is a spreadsheet that lists the quality indicators that the CAH wants to measure with a target percentage identified. The results are then listed quarterly for each indicator.) Review of available QI Monitoring and Evaluation Forms revealed no forms completed for Cardiac Rehabilitation, Specialty Clinics and Nuclear Medicine. (The Monitoring and Evaluation Form also identifies quality indicators with target/threshold percentages, and gives the results and if the target percentage is not met gives an action plan.)

D. Interview with the Quality Improvement Coordinator on 1/29/13 from 3:30 PM to 5:00 PM revealed the following:
- The CAH had been working with the Clinical Quality and Performance Improvement Scorecard Report since 2009;
- Departments were still supposed to report information on department quality indicators; however, this was not always happening;
- Reported that Cardiac Rehabilitation was one of the areas not reporting;
- Indicated that they were going back to a quarterly reporting schedule for 2013 and provided a copy of the schedule.
Review of the schedule provided revealed the Specialty Clinic and Contracted were not included on the schedule.

Based on review of the agreement with a Nebraska hospital (Network Hospital) for Quality Assurance, review of the Medical Staff QI (Quality Improvement)/ Peer Review Policy, review of Medical Staff QI Peer Review Worksheets and staff interview, the CAH failed to follow their policy for external peer review provided by the Network Hospital. The roster of Medical Staff provided by the CAH listed 7 Active Staff and 75 Consulting Staff. On the first day of survey patient census was 4 acute inpatients and 1 skilled inpatient.

Findings are:

A. Review of the Network Agreement dated 11/3/11 under section V Quality Assurance revealed the following:
"As necessary, and upon request of QA [Quality Assurance] representatives of Thayer County Health Services Hospital, the Thayer County Health Services Hospital Medical Staff, Thayer County Health Services Hospital Administrator/CEO [Chief Executive Officer], or Thayer County Health Services Hospital governing body, peer review assistance may be provided by the network's peer review process or another service under contract by Thayer County Health Services".

E-mail communication with the CEO on 2/4/13 and 2/5/13 revealed the CAH uses the Network Hospital for "external peer review process".

(Peer review is the process by which a committee and/or another physician examines the work of a peer and determines whether the physician under review has met accepted standards of care in rendering medical services.)

B. Review of the policy and procedure titled Medical Staff QI/Peer Review Policy dated 5/3/04 revealed a process for internal peer review and external peer review. The definitions section of the policy contained the following:
1. "Internal Physician Peer Reviewer: For the purposes of this program, an internal physician peer review shall be defined as an active member of the medical staff, in good standing, licensed in the same medical specialty as the individual whose case is under review (exception:when external review is required). An individual functioning as an internal peer reviewer should not have been immediately involved in any of the medical management under review; however, opinions and information may be obtained from participants who were involved in the patient's care."
2. "External Physician Reviewer: An external physician shall be an active member of the [Network Hospital's name] medical staff, in good standing, licensed in a medical specialty appropriate to the type of case reviewed."

The External Physician Review section contained the following directions "Circumstances in which external physician review may be obtained include, but are not limited to". The 6th listing under this statement was "5 (five) charts will be sent quarterly to [Network Hospital's name] for review by [name of a physician]. The charts will be chosen randomly, by request, or as a result of a Level 3 assignment". The level 3 assignment listed on the Medical Staff QI/Peer Review Worksheet was "Major deviation from practice standards or impact on patient outcome. Issue referred to Medical Staff QI/Peer Review Committee for remedial action and follow-up."

C. Review of the External Peer Review for 2012 revealed 1 record was sent to the Network Hospital on 5/29/12 and 1 record was sent on 11/5/12. Interview with the Quality Improvement Coordinator on 1/29/13 from 3:30 PM to 5:00 PM confirmed that only those 2 records were sent for external review in 2012 and indicated that only 1 record was sent for external review in 2011.