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Based on record review, review of critical access hospital (CAH) policy and procedure, review of CAH employee files, and staff interview, the CAH failed to develop, implement, and provide to patients or their responsible parties its policies on advance directives, failed to provide education to staff for 10 of 10 staff records (Staff Member #3, #4, #5, #6, #7, #8, #9, #10, #11, and #15) reviewed regarding policies on advance directives, and failed to document if 3 of 5 closed out patient surgery records (Patient #12, #15, and #16) and 1 of 1 closed observation patient record (Patient #11) reviewed did nor did not have advance directives. Failure to develop and implement an advance directive policy and failure to provide the policy to patients or their responsible parties on admission limited the patients' and responsible parties' abilities to make informed healthcare decisions. Failure to determine on admission if patients have advance directives and failure to educate the staff regarding the CAH's policies and procedures on advance directives may result in patients receiving undesired healthcare services.

Findings include:

- Review of the advanced directive information provided to patients and their responsible parties occurred on 04/24/13. The information failed to include a CAH policy or procedure on advance directives, including: a clear and precise statement of limitation, identifying the legal authority for limitation, identifying how and where the issuance of the notice of advance directive is documented, identifying how and where the determination of an advance directive is documented, identifying the CAH will not condition the provision of care on whether or not the patient has executed an advance directive, identifying how and where individuals may file complaints concerning advance directives requirements, provision of education to CAH staff, and provision of education to community members.

- Review of closed medical records on 04/23/13 identified the following patient records failed to identify if they did or did not have an advance directive:
*Observation - Patient #11, Admitted and discharged 01/14/13.
*Outpatient Surgery - procedure, admission date
Patient #12 - Cataract, Admitted 10/23/12
Patient #15 - Colonoscopy, Admitted 03/05/13
Patient #16 - Colonoscopy, Admitted 12/04/12

- Review of ten randomly selected employee files (Staff Member #3, #4, #5, #6, #7, #8, #9, #10, #11, and #15) occurred on the morning of 04/24/13 and identified the facility failed to educate these staff members on the CAH's policies and procedures for advance directives.

During an interview on 04/24/13 at 9:45 a.m., an administrative staff member (#2) confirmed the CAH failed to educate all staff on the CAH's policies and procedures for advance directives and identified new employees do not receive education on advance directives during orientation.

During interview, on 04/24/13 at 11:00 a.m., an administrative nursing staff member (#1) reported the information provided following the entrance conference was the information provided to patients and their responsible parties on admission to the CAH. This staff member reported the CAH lacked a policy and procedure that included the requirements previously identified. This staff member also reported his expectation was CAH staff document if patients did or did not have an advance directive on admission.

Based on observation, policy review and staff interview, the Critical Access Hospital (CAH) failed to maintain the flooring and a cabinet shelf used to store dishes in 1 of 1 dietary kitchen (main kitchen). Failing to maintain the flooring and shelving has the potential to harbor bacteria and affect the health of patients served.

Findings include:

Review of a facility dietary department policy titled "Sanitation and Infection Control" occurred on 04/24/13. The policy, dated March 2007, stated, "PURPOSE: To have the Food Service Department provide a sanitation program for the protection of the health of the clientele. To assure that operations and techniques, including preparation and service to the clientele are such that food is properly protected at all times against contaminants and infected agents."

On 04/24/13, between 1:45 p.m. and 2:30 p.m., observation showed the linoleum on the floor in the kitchen to have numerous gouges, open cracks at the seams, and a strip approximately six inches wide and 12 inches long extending under a cabinet with the surface of the linoleum removed/torn off. Observation also showed shelves within a metal cabinet with a contact like surface with the protective covering ripped off. Water pitchers/dishes sat with the open rim flat against this surface.

During the observation on the afternoon of 04/24/13, a dietary staff member (#16) agreed the condition of the floor and cabinet shelving limited the ability to keep them clean.

Based on review of the North Dakota Department of Health, Division of Health Facilities provider files, review of Medical Staff bylaws and meeting minutes, review of the Medical Staff Directory, review of credentialing files, and staff interview, the governing body of the Critical Access Hospital (CAH) failed to ensure all components of credentialing/appointment occurred as identified in 10 of 10 provider files (Allied Health Professional #1 and #2 and Physician Providers #1, #2, #3, #4, #5, #6, #7 and #8) reviewed and failed to ensure the monitoring of the quality and appropriateness of patient care for 13 of 13 months (March 2012 through April 2013) reviewed. Failure to review all providers for the necessary components when making a decision for appointment has the potential to affect patient safety. Failure to monitor quality and appropriateness of patient care can affect the quality of health care provided.

Findings include:

Based on review of the North Dakota Department of Health, Division of Health Facilities provider files, this facility has not sustained correction of this issue. The requirement was found to be out of compliance during the previous survey completed in 2009.

Review of the CAH's Medical Staff Bylaws and Rules and Regulations occurred on 04/22/13. The bylaws, revised 08/31/10, stated: "PREAMBLE: The Medical Staff of [CAH], subject to the ultimate authority of the Board of Directors, is responsible for the overall quality of medical care delivered to patients of the [CAH]. . . . The Medical Staff's responsibility for the quality of medical care is a delegated responsibility from the Board of Directors, for which the Medical Staff shall be accountable. . . .
Article III - Membership . . .
Section 1. Nature of Staff Membership
Membership in the Medical Staff . . . is a privilege that shall be extended only to professionally competent . . . physician assistants and nurse practitioners who continuously meet the qualifications, standards, and requirements set forth in the bylaws. . . .
Article IV. Amended Procedure for Credentialing and Recredentialing
Section 1. Application for Appointment (Credentialing) . . .
a. All applications for appointment to the medical staff shall . . . include . . . detailed information concerning the applicant's professional qualifications, including the names of at least three persons who have had extensive experience in observing and working with applicant and who can provide adequate references pertaining to the applicant's professional competence and ethical character. . . .
c. The completed application shall be submitted to the Chief Executive Officer. After collecting the references and other materials deemed pertinent, the Chief Executive Officer shall transmit the application and all supporting materials to the Medical Executive Committee for evaluation. . . .
Section 2. Initial Appointment Process
a. . . . the Medical Executive Committee shall make a written report of its investigation to the Board of Directors, including its recommendation that the practitioner be provisionally appointed to the Medical Staff, that he/she be rejected . . . or deferred for further consideration. . . . All recommendations to appoint must also specifically recommend the clinical privileges to be granted . . .
b. Prior to making this report and recommendation, the Medical Executive Committee shall examine the evidence of the character, professional competence, qualifications and ethical standing of the practitioner and shall determine, through information contained in references given by the practitioner and from other sources available to the credentials committee, . . . to see whether the practitioner has established and meets all of the necessary qualifications for the category of staff membership and the clinical privileges requested by the applicant. Together with its report . . . the Medical Executive Committee shall transmit to the Board of Directors the completed application and all other documentation considered in arriving at its recommendation. . . .
g. . . . the Board of Directors shall act on the matter. . . .
k. A probationary period of six (6) months service is required of each Medical Staff applicant. . . .
i. During the time of probation, the quality and appropriateness of patient care will be monitored, evaluated and addressed by the Chief of the Medical Staff through peer review action, infection rate, mortality rate, surgical case review and other Quality assurance reports. The clinical documentation will become part of the physician's credential file to be submitted to the Medical Executive Committee and the Board of Directors.
n. The credentials file shall include . . . letters of reference, and notes on telephone reference checks, documentation of interviews . . . letter of appointment of provisional privileges, requested privileges . . .
Section 3. Reappointment (Recredentialing) Process . . . Reappointment to the Medical Staff shall be made for a period of not more than two (2) years. . . .
c. Each recommendation concerning the reappointment of a Medical Staff member and the clinical privileges to be granted upon reappointment shall be based upon the following: professional and clinical performance . . . including his/her patterns of practice based on the findings of quality assurance measures such as medical audits, utilization review, infection control activities, tissue review, medical record review, and pharmacy and therapeutics activities . . . timely completion of medical records; compliance with applicable hospital policies and with Medical Staff Bylaws, rules and regulations . . .
ARTICLE VIII - DIVISIONS OF THE STAFF . . .
Section 2. The Active Staff . . .
Section 6. The Allied Medical Professional Staff . . .
b. Application of specified profession personnel (anesthetist): . . .
5. They must reapply for appointment every two years as subject to review. Performance and Quality Assurance reports are part of the review. . . .
f. A member of the specific specialty should be included on the credentials committee when these particular applications are reviewed. . . .
Section 7. Physician Assistant . . .
e. Granting of Privileges: . . .
2. . . . Upon application from the physician assistant and at the request of the physician Medical Staff member, the Medical Executive Committee will review the credentials of the physician assistant and the privileges requested. Each application shall include the information required in Article IV, Section 1. The request will delineate specific privileges approved by the Medical Executive Committee and the Board of Directors. . . .
ARTICLE X - COMMITTEES
Section 1. Committee of the Whole . . .
b. Duties: . . .
3. To receive and act upon committee reports. . . .
11. To conduct a case review of all hospital deaths. . . .
c. Meetings: The Committee of the Whole shall meet quarterly and maintain a permanent record of its proceedings and actions . . ."

The Medical Staff Bylaws identified the same credentialing process for anesthetists and nurse practitioners as with physician assistants.

- Review of a current list of medical staff occurred on the afternoon of 04/22/13. The list identified Physician #6, #7 and #8 as active medical staff.

Review of governing board meeting minutes occurred on 04/23/13. The January 30, 2013 minutes showed the board approved provisional privileges to Physician #6, #7 and #8.

Review of credentialing files for Physicians #1- #8 and Allied Health Professionals #1 and #2 occurred on 04/23/13. Each file lacked a letter of appointment /reappointment, the date of effective appointment and expiration date of the appointment, and verification that the governing body granted the privileges requested on the application.

The following credentialing files also lacked:
* Allied Health Professional #1's file lacked medical staff approval date, privileges delineated and approved, and references or quality monitoring.
* Allied Health Professional #2's file lacked medical staff and governing body approval dates.
* Physician provider #3's file lacked privileges delineated and approved, and references or quality monitoring.
* Physician provider #4's file lacked two of the three references, and identified the physician requested courtesy privileges and the governing body granted provisional privileges.
* Physician provider #5's file lacked reference checks.
* Physician provider #6's file showed the physician applied for consulting privileges and the Medical Staff Directory showed the physician with active staff privileges. The Governing Board meeting minutes, dated 01/30/13, showed the governing body granted provisional privileges.
* Physician provider #7's file showed the governing body granted a provisional reappointment, whereas the Medical Staff Directory showed the physician had active medical staff privileges.
* Physician provider #8's file showed the governing body granted active medical staff privileges and the Medical Staff Directory identified the same. The Governing Board meeting minutes, dated 01/30/13, showed the governing body granted provisional privileges.

During interview on 04/24/13 at 9:45 a.m., an administrative staff member (#13) stated the credentialing files needed more attention.

- Review of Medical Staff meeting minutes from March 29, 2012 to April 2, 2013 occurred on April 22-23, 2013. Review of provider credentialing files (Allied Health Professional #1 and #2 and Physician Providers #1, #2, #3, #4, #5, #6, #7 and #8) occurred on the morning of 04/24/13. The meeting minutes and credentialing files lacked evidence the Medical Staff monitored/reviewed the quality and appropriateness of patient care for the initial appointment of providers, including references, and those granted reappointment, according to its bylaws. The Medical Staff failed to identify the specific clinical privileges granted to each provider during appointment or appointment.

The Medical Staff meeting minutes showed no evidence of reviewing quality assurance reports and meeting minutes, infection control reports and meeting minutes, pharmacy and therapeutic reports and meeting minutes, safety reports and meeting minutes, and evidence a case review occurred of all hospital deaths, as specified in the bylaws.

1. Based on review of infection control reports and meeting minutes and staff interview, the Critical Access Hospital (CAH) failed to implement a system to identify, report, investigate, and control infections and communicable diseases for inpatients and outpatients of the CAH for the past 16 of 16 months (January 2012 through April 2013) reviewed. Failure to identify and address incidents of infections among all patients has the potential for infections to go unreported, spread, or reoccur; affecting the health of all patients, personnel, and visitors of the CAH.

Findings include:

Reviewed on 04/23/13, the infection control program lacked evidence the CAH identified and recognized both nosocomial and community-acquired infections of inpatients and outpatients. The infection reports and meeting minutes from January 2012 through April 2013 failed to include information and documentation of inpatients and outpatients with known or suspected cases of infections and/or communicable diseases. The facility held three meetings (01/05/12, 07/18/12, and 01/15/13) during the 16 months reviewed.

During an interview on the afternoon of 04/23/13, an administrative nurse (#1) stated the facility does not receive or request infection control information from outpatients and confirmed the CAH did not formally document and include outpatients in infection control surveillance. The staff member (#1) identified the infection control committee met quarterly and confirmed missed meetings in 2012. During this interview, the administrative nurse (#1) confirmed the facility did not perform quality improvement audits in the area of infection control and did not perform surveillance or monitoring of staff and patients for infection control practices.

Failure to document all incidents of infection and communicable disease and perform surveillance among inpatients and outpatients of the CAH limited the staffs' ability to identify, monitor, track, control, and prevent infections.

2. Based on observation, review of professional literature, and staff interview, the Critical Access Hospital (CAH) failed to ensure staff followed acceptable surgical standards of practice regarding the temperature and humidity of 1 of 1 Operating Room (OR). Failure to document, monitor, and ensure the temperature and humidity of the OR are within the recommended ranges may result in the growth of bacteria and an increase in patient infections.

Findings include:

An article from the Association of Perioperative Registered Nurses (AORN), updated 06/30/09, stated, ". . . The recommended temperature range in an operating room is between 68 [degrees] F [Fahrenheit] and 73 [degrees] F . . . The recommended humidity range in an operating room is between 30% [percent] to 60%. Both the temperature and humidity should be monitored and recorded daily using a log or electronic documentation of the heating, ventilation, and air conditioning (HVAC) system. . . . Low humidity also increases the potential for dust in the operating room. The potential risk of microbial growth increases in areas where sterile supplies are stored when the humidity is too high. . . ."

Observation of the OR occurred on 04/23/13 at 10:40 a.m. with a nurse (#10). A thermometer located in the OR identified a temperature of 66 degrees F and humidity of 26%. The nurse (#10) stated the facility failed to monitor and document the temperature and humidity of the OR and stated she did not realize the specific range of each. The nurse (#10) stated both the ophthalmologist and podiatrist performed surgeries in the OR and confirmed the ophthalmologist scheduled eye surgeries at noon that day.

Based on record review and staff interview, the critical access hospital (CAH) failed to ensure accurate and complete medical records for 3 of 5 ambulatory surgical patient records reviewed (Patient #14, #15, and #16) and 2 of 7 Emergency Department (ED) patient records reviewed (Patient #17 and #21) who were transferred to tertiary care facilities. Failure of the CAH to maintain complete and accurate medical records limits the CAHs ability to ensure the continuity and quality of care provided.

Findings include:

- Review of closed ambulatory surgical patient records occurred on 04/23/13. The records identified the following, including the procedure:
*Patient #14 - admitted 08/28/12, colonoscopy. Pre- and post-anesthesia evaluations dated 08/28/12, no time documented for either evaluation.
*Patient #15 - admitted 03/05/13, colonoscopy. Pre-anesthesia evaluation dated 03/05/13 had no time documented. The post-anesthesia lacked a date and time.
*Patient #16 - admitted 12/04/12, colonoscopy. Pre- and post-anesthesia evaluation dated 12/04/12 at 8:00 a.m. Patient #16's medical record identified the procedure ended at 9:17 a.m.

- Review of Patient #21's medical record identified Patient #21 presented to the ED for treatment on 09/28/12 at 8:00 p.m. related to face and neck swelling. The medical record identified the patient's sibling who lived out of the area as the patient's medical decision maker. The medical record identified the provider contacted and received permission from the decision maker for transfer of Patient #21 to a tertiary care center. The CAH's transfer form lacked the patient's signature or witnessed telephone consent of the decision maker.

- Review of Patient #17's closed ED record occurred on 04/23/13. The patient presented to the ED for treatment of an open wound to the shoulder on 10/25/12 at 12:30 a.m. The medical record identified the CAH contacted a tertiary care facility for transfer. The transfer form lacked the receiving facility name and the patient or significant other's signature consenting to the transfer.

During interview, on 04/24/13 at 11:00 a.m., an administrative nursing staff member (#1) reported the CRNA should document, date, and time the pre and post-anesthesia evaluations on the appropriate form and confirmed the CAH staff did not complete the transfer forms.

Based on record review, review of the critical access hospital's (CAH's) Rules and Regulations of the Medical Staff, and staff interview, the CAH failed to ensure completion of a history and physical no more than seven days before admission for 3 of 5 closed ambulatory surgery patient records (Patient #12, #15, and #16) reviewed. Failure to ensure the completion of a history and physical within seven days of admission placed these patients at risk of complications related to other medical conditions.

Findings include:

Review of the CAH's Rules and Regulations of the Medical Staff, approved 08/31/10, occurred on 04/22/13. This document stated ". . . 17. A complete history and physical examination shall in all cases be written by a member of the active Medical Staff no more than seven (7) days before . . . admission of the patient. If a complete history has been recorded and a physical examination performed prior to the patient's admission to the hospital . . . an interval admission note that included all additions to the history and any subsequent changes in the physical findings must be recorded. . . ."

Review of closed ambulatory surgery patient records occurred on 04/23/13 and identified the following:
*Patient #12 - admitted 10/23/12, history and physical (H&P) dated 10/12/12 (11 days earlier)
*Patient #15 - admitted 03/05/13, H&P dated 02/18/13 (15 days earlier)
*Patient #16 - admitted 12/04/12, H&P dated 11/14/12 (20 days earlier)
The patients' medical records lacked interval admission notes after the H&P and before each patient's admission.

Following interview, on 04/24/13 at 8:20 a.m., a medical records supervisory staff member (#14) reported no additional information available regarding these patients' H&Ps. During interview, on 04/24/13 at 11:00 a.m., an administrative nursing staff member (#1) confirmed a member of the Medical Staff should have completed an interval H&P for Patient #12, #15, and #16 before their surgical procedures.

Based on record review, review of the critical access hospital's (CAH's) Rules and Regulations of the Medical Staff, and staff interview, the CAH failed to ensure admission and discharge physician orders for 3 of 5 closed ambulatory surgical patient records (Patient #14, #15, and #16). Failure to ensure physician orders for admission and discharge limited the CAH's and medical staff's ability to ensure the quality and appropriateness of care.

Findings include:

Review of the CAH's Rules and Regulations of the Medical Staff occurred on 04/22/13. This document, approved on 08/31/10, stated ". . . 7. Standing orders shall be formulated by conference between Medical Staff and Director of Nursing . . . . These routine drugs . . . shall be signed by the attending physician within twenty-four (24) hours. 8. All orders for treatment shall be in writing. . . . 11. Each patient admitted to the hospital shall have only those tests and procedures ordered by the attending physician. . . . 15. Patients shall be discharged only on a written order of the attending physician. . . . "

Review of closed ambulatory surgical patient records occurred on 04/23/13. The following patient records, including surgical procedure, lacked physician admission and discharge orders:
*Patient #14 - admitted 08/28/12, colonoscopy.
*Patient #15 - admitted 03/05/13, colonoscopy.
*Patient #16 - admitted 12/02/12, colonoscopy.

During interview, on 04/24/13 at 11:00 a.m., an administrative nursing staff member (#1) agreed physicians should provide admission and discharge orders for patients.

Based on observation and staff interview, the Critical Access Hospital (CAH) failed to ensure the confidentiality of record information and failed to provide safeguards against potential loss, destruction, or unauthorized use of patient x-ray films in 1 of 1 radiology department. Failure to secure x-ray films limited the CAH's ability to maintain the confidentiality and security of the record information and prevent the risk of unauthorized use.

Findings include:

On 04/23/13 between 8:15 a.m. and 8:50 a.m., observation of the radiology department identified an open/unlocked room/door storing x-ray films.

During interview, on the morning of 04/23/13, a supervisory radiology staff member (#4) stated radiology department staff do not ensure these films remained locked when not within the department during the work hours and overnight.

On the morning of 04/24/13, an administrative staff member (#18) stated the CAH had no policy regarding the secure storage of x-ray films in the radiology department.

Based on review of Medical Staff bylaws, meeting minutes, credentialing files, quality improvement plan and reports, infection control meeting minutes, and staff interview, the Critical Access Hospital (CAH) failed to maintain an effective quality improvement (QI) program during 13 of 13 months (March 2012-April 2013). Failure to maintain an active QI program has the potential to affect patient health and safety.

Findings include:

The CAH failed to ensure a functioning quality improvement committee to evaluate all patient care services and other services affecting CAH patient health and safety for 13 months (March 2012-April 2013) (refer to C337); failed to ensure the quality improvement program evaluated nosocomial infections for 11 months reviewed (June 2012-April 2013) (refer to C338); failed to evaluate the quality and appropriateness of the treatment furnished by three Allied Health Professions (Refer to C339); and failed to have a network hospital or a quality improvement organization or equivalent evaluate the quality and appropriateness of the diagnosis and treatment furnished by three physicians (Refer to C340).

Based on review of Medical Staff bylaws, meeting minutes, credentialing files, quality improvement plan and reports, infection control meeting minutes, and staff interview, the Critical Access Hospital (CAH) failed to maintain an effective quality improvement program to evaluate the quality and appropriateness of diagnosis and treatment of the CAH's patients for 13 of 13 months (March 2012-April 2013) reviewed. Failure to maintain an effective quality improvement program limits the CAH's ability to identify risk factors affecting patient diagnosis and treatment and to develop and implement corrective action if necessary.

Findings include:

Based on review of the North Dakota Department of Health, Division of Health Facilities provider files, this facility has not sustained correction of this issue. The requirements of C337, C338, and C340 were found to be out of compliance during the previous survey completed in 2009.

The CAH failed to ensure a functioning quality assurance/improvement committee to evaluate all patient care services and other services affecting CAH patient health and safety for 13 months (March 2012-April 2013) (refer to C337); failed to ensure the quality improvement program evaluated nosocomial infections for 11 months reviewed (June 2012-April 2013) (refer to C338); and failed to evaluate the quality and appropriateness of the treatment furnished by three Allied Health Professions (Refer to C339); and failed to have a network hospital or a quality improvement organization or equivalent evaluate the quality and appropriateness of the diagnosis and treatment furnished by three physicians (Refer to C340).

Based on review of the North Dakota Department of Health, Division of Health Facilities provider files, review of medical staff bylaws, quality improvement (QI) plan and reports and meeting minutes, Medical Staff and infection control meeting minutes, and staff interview, the Critical Access Hospital (CAH) failed to ensure the QI program evaluated all patient care services and other services affecting patient health and safety for 13 of 13 months reviewed (March 2012-April 2013). The CAH's failure to ensure the QI program evaluated all patient care services and services affecting patient health and safety limits the CAH's ability to identify risk factors affecting patient care and implement corrective action if necessary.

Findings include:

Based on review of the North Dakota Department of Health, Division of Health Facilities provider files, this facility has not sustained correction of this issue. This requirement was found to be out of compliance during the previous survey completed in 2009.

Review of the CAH's Medical Staff Bylaws and Rules and Regulations occurred on 04/22/13. The bylaws, revised 08/31/10, stated: ". . . The Medical Staff of [CAH] . . . is responsible for the overall quality of medical care delivered to patients of the [CAH]. . . . the quality and appropriateness of patient care will be monitored, evaluated and addressed . . . Reappointment (Recredentialing) Process . . . Each recommendation concerning the reappointment of a Medical Staff member . . . shall be based upon the following . . . findings of quality assurance measures such as medical audits, utilization review, infection control activities, tissue review, medical record review, and pharmacy and therapeutics activities . . . timely completion of medical records; compliance with applicable hospital policies and with Medical Staff Bylaws, rules and regulations . . . ARTICLE IX - CLINICAL SERVICES . . .
Section 6. Duties of Officers . . .
14. Assure that the quality and appropriateness of patient care provided within the department are monitored and evaluated.
ARTICLES X - COMMITTEES . . .
Section 1. Committee of the Whole . . .
b. Duties: . . .
3. To receive and act upon committee reports. . . .
11. To conduct a case review of all hospital deaths. . . .
c. Meetings: The Committee of the Whole shall meet quarterly and maintain a permanent record of its proceedings and actions . . ." "
Section 4. Medical Staff Quality Assurance/Improvement Committee . . .
b. Duties: To monitor and evaluate the quality and appropriateness of care and treatment of patients . . . which shall be reviewed by the Committee and reported to the Board of Directors quarterly.
1. Surgical Case Review Subcommittee . . . meets and reports quarterly.
2. Pharmacy and Therapeutics Subcommittee: . . . meets and reports quarterly. . . .
3. Infection Control Subcommittee: . . . Meetings will be held quarterly. Minutes will be in writing and a report made to the Medical Staff.
4. Utilization Review/Medical Records Subcommittee: . . . submits a written report to the Medical Staff quarterly. . . ."

Review of the "Rules and Regulations of the Medical Staff" occurred on 04/22/13. The rules and regulations, dated 08/31/10, stated, ". . . The Medical Staff discussions at meetings shall constitute a thorough review and analysis of the clinical reports from each department and reports of committees of the active Medical Staff."

Review of the CAH's "Organizational Quality Improvement Plan" occurred on 04/22/13. The plan, undated, stated,
". . . Goals and Objectives: . . . maintain an effective Quality Improvement (QI) Program that systematically monitors and evaluates opportunities for improving the care and services provided by the organization. The primary goal of the program will be to improve the quality of care and services provided by the organization by creating optimal outcomes with continuous incremental improvements. . . . Authority and Responsibility: Governing Body . . . Medical Staff . . . The Medical Staff is also responsible for receiving and reviewing information from the QI program that directly or indirectly affects the delivery of medical care and, ultimately, outcomes in patient/resident and services. . . . CEO [Chief Executive Officer] . . . Executive Team . . . QI Program Coordinator . . . Department Managers: Individual department managers are responsible for and accountable to their specific department's QI activities . . ."

- Review of the QI meeting minutes occurred on 04/23/13. The minutes showed the committee met in June 2012, December 2012, and February, March and April 2013. The minutes lacked evidence of reporting from departments including: dietary, housekeeping, laundry, medical records, maintenance, radiology, nursing services, social services, and patient satisfaction. The QI schedule failed to require reporting from anesthesia, contracted services, infection control, risk management and patient safety.

Review of Medical Staff meeting minutes, dated from 03/29/12 through 04/02/13, occurred on 04/23/13. The minutes lacked evidence of quarterly reporting from the Surgical Case Review Subcommittee, Pharmacy and Therapeutics Subcommittee, Infection Control Subcommittee and Utilization Review/Medical Records Subcommittee, tissue reviews and a review of all hospital deaths.

17256

Based on review of the North Dakota Department of Health, Division of Health Facilities provider files, review of the Critical Access Hospital (CAH) quality improvement (QI) plan, meeting minutes, Medical Staff bylaws, infection control meeting minutes, and staff interview, the CAH failed to ensure the QI program evaluated nosocomial infections for 11 of 11 months reviewed (June 2012-April 2013). Failure to ensure identification, investigation and implementation and evaluation of protective measures for nosocomial infections places all patients at risk for harm.

Findings include:

Based on review of the North Dakota Department of Health, Division of Health Facilities provider files, this facility has not sustained correction of this issue. This requirement was found to be out of compliance during the previous survey completed in 2009.

Review of the CAH's Medical Staff Bylaws and Rules and Regulations occurred on 04/22/13. The bylaws, revised 08/31/10, stated: ". . . The Medical Staff of [CAH] . . . is responsible for the overall quality of medical care delivered to patients of the [CAH]. . . . the quality and appropriateness of patient care will be monitored, evaluated and addressed . . .
ARTICLES X - COMMITTEES . . .
Section 4. Medical Staff Quality Assurance/Improvement Committee . . .
b. Duties: To monitor and evaluate . . .
3. Infection Control Subcommittee: . . . Meetings will be held quarterly. Minutes will be in writing and a report made to the Medical Staff. . . ."

Review of the "Rules and Regulations of the Medical Staff" occurred on 04/22/13. The rules and regulations, dated 08/31/10, stated, ". . . The Medical Staff discussions at meetings shall constitute a thorough review and analysis of the clinical reports from each department and reports of committees of the active Medical Staff."

Review of the CAH's "Organizational Quality Improvement Plan" occurred on 04/22/13. The plan, undated, stated,
". . . Goals and Objectives: . . . maintain an effective Quality Improvement (QI) Program . . . to improve the quality of care and services provided by the organization . . ."

- Review of QI meeting minutes occurred on 04/23/13. The minutes showed the committee met in June 2012, December 2012, and February, March and April 2013. The minutes lacked reporting from the infection control committee.

Review of Medical Staff meeting minutes occurred on 04/23/13. The minutes lacked evidence of quarterly reporting from the Infection Control Subcommittee.

- Reviewed on 04/23/13, the infection control meeting minutes requested from January 2012 to April 2013 identified the facility held infection control meetings on 01/05/12, 07/18/12, and 01/15/13, not quarterly as specified in the Medical Staff bylaws.

During an interview on the afternoon of 04/23/13, an administrative nurse (#1) confirmed the facility had not performed quality improvement audits in the area of infection control.

Based on a review of Allied Health Professional (AHP) credentialing files, review of Medical Staff bylaws, review of the Quality Improvement (QI) plan, and staff interview, the Critical Access Hospital (CAH) failed to evaluate the quality and appropriateness of the treatment furnished by 2 of 2 Family Nurse Practitioners (FNP) (AHP #1 and #3) and 1 of 1 Certified Registered Nurse Anesthetist (CRNA) (AHP #2) files reviewed providing care to the CAH's patients within the past year. Failure to evaluate the quality and appropriateness of the treatment furnished has the potential to affect patient outcomes involving care provided to the CAHs patients and care provided during surgical procedures requiring anesthesia services.

Findings include:

Review of the CAH's Medical Staff Bylaws and Rules and Regulations occurred on 04/22/13. The bylaws, revised 08/31/10, stated: "PREAMBLE: The Medical Staff of [CAH] . . . is responsible for the overall quality of medical care delivered to patients of the [CAH]. . . .
ARTICLE VIII - DIVISIONS OF THE STAFF . . .
Section 5. The Allied Medical Professional Staff . . .
a. The Allied Professional staff shall consist of those persons whose professions are closely allied to the medical profession . . . and shall be under the jurisdiction of the attending physician at all times. . . . specified professional personnel (anesthetist): . . .
Section 7. Physician Assistant
a. [CAH] recognizes that the services of highly trained physician assistants may be utilized by members of the Medical Staff to help provide medical care for patients. . . .
d. . . . The physician preceptor or supervising physician shall direct and review the work, records and practice of the . . . physician assistant on a continuous basis to ensure that appropriate, safe and quality treatment is rendered. . . .
Section 8. Nurse Practitioners
a. [CAH] recognizes that the services of highly trained nurse practitioners may be utilized by members of the Medical Staff to help provide medical care for patients. . . .
d. . . . A physician member of the Medical Staff shall direct and review the work, records and practice of the nurse practitioner on a continuous basis to ensure that appropriate, safe and quality treatment is rendered. . . ."

The Medical Staff Bylaws did not address the review of the work, records and practice of a CRNA.

Review of the CAH's "Organizational Quality Improvement Plan" occurred on 04/22/13. The plan, undated, did not include a process for reviewing the work, records and practice of the AHP.

- Review of the CAH's current Medical Staff Directory (listing of all providers) occurred on the afternoon of 04/22/13. Upon request on 04/24/13, the CAH failed to provide evidence of reviews of the quality and appropriateness of treatment furnished by AHP #1, #2 and #3.

During interview on 04/24/13 at 10:50 a.m., an administrative staff member (#13) stated the CAH lacked documented evidence the quality and appropriateness of treatment furnished by AHP #1, #2 and #3 occurred within the last year.

Based on review of the North Dakota Department of Health, Division of Health Facilities provider files, review of Medical Staff bylaws, and staff interview, the Critical Access Hospital (CAH) failed to have a network hospital or a quality improvement organization (QIO) or equivalent evaluate the quality and appropriateness of the treatment furnished in the last year by 3 of 3 active physicians (Physicians #6, #7 and #8) providing care to the CAH's patients. Failure to have a network hospital or a QIO or equivalent evaluate the quality and appropriateness of the treatment furnished by the physicians limits the CAH's ability to ensure the physicians furnished quality and appropriate care to the CAH's patients.

Findings include:

Based on review of the North Dakota Department of Health, Division of Health Facilities provider files, this facility has not sustained correction of this issue. This requirement was found to be out of compliance during the previous survey completed in 2009.

Review of the CAH's Medical Staff Bylaws occurred on 04/22/13. The bylaws, revised 08/31/10, stated: ". . . The Medical Staff of [CAH] . . . is responsible for the overall quality of medical care delivered to patients of the [CAH]. . . . the quality and appropriateness of patient care will be monitored, evaluated and addressed by the Chief of the Medical Staff through peer review action . . . and other Quality assurance reports. . . .
ARTICLES X - COMMITTEES . . .
Section 4. Medical Staff Quality Assurance/Improvement Committee . . . In addition to the review conducted by the Medical Staff Quality Assurance/Improvement Committee, the quality and appropriateness of the diagnosis and treatment furnished by physicians shall be evaluated periodically by (i) one appropriate and qualified entity identified in the state rural health care plan; or (ii) one peer review organization (PRO) or equivalent entity. . . ."

- The CAH failed to provide evidence a network hospital or a QIO or equivalent evaluated the quality and appropriateness of the treatment furnished by Physicians #6, #7, and #8 in the last year.

During interview on 04/24/13 at 10:50 a.m., an administrative staff member (#13) stated the CAH did not have a network hospital or QIO or equivalent evaluate the quality and appropriateness of the diagnosis and treatment furnished by Physicians #6, #7, and #8.

Based on record review, professional reference review, policy and procedure review, and staff interview, the Critical Access Hospital (CAH) failed to develop a comprehensive care plan that included measurable objectives and timetables to meet the medical, nursing, mental, and psychosocial needs for 3 of 3 active swing bed (Patient #1, #2, and #3) records and for 1 of 1 closed swing bed (Patient #9) record reviewed. Failure to develop the comprehensive care plan limited the CAH's ability to manage patient needs, communicate treatment approaches, and ensure continuity of care.

Findings include:

Berman, Snyder, Kozier, and Erb, "Fundamentals of Nursing, Concepts, Process, and Practice," 8th ed., Pearson Education Inc., Upper Saddle River, New Jersey, 2008, pages 212-215, stated, ". . . A formal nursing care plan is a written or computerized guide that organizes information about the client's care. The most obvious benefit of a formal written care plan is that it provides for continuity of care. . . . When nurses use the client's nursing diagnoses to develop goals and nursing interventions, the result is a holistic, individualized plan of care that will meet the client's unique needs. . . . Care plans include the actions nurses must take to address the client's nursing diagnoses and produce the desired outcomes. The nurse begins the plan when the client is admitted to the agency and constantly updates it throughout the client's stay in response to changes in the client's condition and evaluations of goal achievement. . . . Regardless of whether care plans are handwritten, computerized, or standardized, nursing care must be individualized to fit the unique needs of each client. . . ."

Page 215-216 stated, ". . . Multidisciplinary (Collaborative) Care Plans: A multidisciplinary care plan is a standardized plan that outlines the care required for clients with common, predictable - usually medical - conditions. . . . Like the traditional nursing care plan, a multidisciplinary care plan can specify outcomes and nursing interventions to address client problems (including nursing diagnoses). However, it includes medical treatments to be performed by other health care providers as well. . . . Multidisciplinary care plans do not include detailed nursing activities. They should be drawn from but do not replace standards of care and standardized care plans. . . ."

Review of the facility policy titled "Standards of Nursing Practice" occurred on 04/24/13. This policy, dated March 2008, stated, ". . . STANDARD I: . . . C. Continuous collection of data is evident by updating of the nursing care plan, recording of changes in health status on the medical record . . . STANDARD III: The nursing care plan includes nursing goals derived from the nursing diagnosis. A. The nursing plan of care will be initiated by the RN [Registered Nurse] in charge or within 24 hours of admission. The plan will be initialed and dated by the RN . . . B. The plan will be appropriate for the patient and individualized as needed. C. Goals are stated in realistic and measurable terms. D. The plan of care will be reviewed and revised by the nursing staff whenever the status of the patient changes and/or new information becomes available. E. The nursing plan of care will be devised giving consideration to the individual needs including physical, physiological, psychosocial spiritual needs, environmental and patient/family teaching . . . F. The discharge assessment and needs will be initiated upon admission of the patient and updated as necessary . . . STANDARD V: . . . A. Nursing actions are consistent with the plan of care based on scientific principles and individualized to the specific situation."

- Patient #1's active swing bed record, reviewed April 23-24, 2013, identified the CAH admitted the patient on 04/19/13 with diagnoses of pneumonia, congestive heart failure (CHF), and exacerbation of chronic obstructive pulmonary disease (COPD).

Review of multidisciplinary progress notes throughout Patient #1's swing bed stay identified the patient experienced weakness, shortness of breath, received skilled physical therapy, and had a reddened area on the coccyx with a dressing in place for protection.

Review of Patient #1's undated care plan identified the problem of "Impaired gas exchange" and lacked a measurable objective, timetable, and individualized interventions for this problem. The care plan failed to include the patient's diagnoses of CHF and pneumonia, participation in physical therapy, weakness/risk of falls, impaired skin integrity, and anticipated discharge plan.

- Patient #2's active swing bed record, reviewed 04/24/13, identified the CAH admitted the patient on 04/20/13 with diagnoses of diarrhea, dehydration, and weakness.

Review of Patient #2's history and physical (H&P), dated 04/20/13, identified a past medical history which included the following: a history of septic left knee joint following left knee replacement in November 2012 which required recent removal of the joint and a spacer to be placed, severe rheumatoid arthritis, type II diabetes, chronic anemia, hypertension, stage III chronic kidney disease, and aortic valve replacement.

Review of the multidisciplinary progress notes and physician's orders during the patient's swing bed stay identified contractures to bilateral hands and feet, generalized weakness, decreased appetite, sliding scale insulin, diabetic and non-dairy diet with protein supplements, dressing changes to cover left knee incision, reddened coccyx, open area on the patient's buttock, and skilled physical therapy.

Patient #2's undated care plan identified the problem of "Diarrhea" and lacked a measurable objective, timetable, and individualized interventions for this problem. The care plan failed to include the patient's diagnoses of recent left knee sepsis with current incision, type II diabetes, rheumatoid arthritis, chronic kidney disease, hypertension, anemia, aortic valve replacement, decreased appetite, therapeutic diet, contractures, generalized weakness, sliding scale insulin, impaired skin integrity, skilled physical therapy, and anticipated discharge plan.

- Patient #3's active swing bed record, reviewed April 23-24, 2013, identified the CAH admitted the patient on 04/20/13 with diagnoses of right foot cellulitis and pneumonia. Observations during survey identified the patient required continuous oxygen via nasal cannula.

Review of Patient #3's H&P, dated 04/20/13, identified the following diagnoses: history of coronary artery disease, history of a massive myocardial infarction in 2011, and history of severe peripheral arterial disease with stent placement and amputation of five digits of the left foot.

Patient #3's undated care plan identified the problem of "Impaired gas exchange" and lacked a measurable objective, timetable, and individualized interventions for this problem. The care plan failed to include the patient's diagnoses of pneumonia, cellulitis of the right foot, peripheral arterial disease, amputation of five digits of left foot, cardiac history, and anticipated discharge plan.

- Review of Patient #9's closed swing bed record occurred on 04/23/13. The CAH admitted the patient to swing bed status on 04/23/13 with diagnoses including congestive heart failure and end stage chronic obstructive pulmonary disease. The patient expired 02/26/13.

The CAH staff implemented end of life cares for the patient. The patient's care plan identified one approach limited to difficulty breathing. Patient #9's care plan lacked approaches regarding end of life cares which the CAH staff implemented.

Failure to include approaches for Patient #9's end of life care limited the CAH staff's ability to ensure the quality and continuity of care provided.

During an interview on the afternoon of 04/24/13, an administrative nurse (#1) confirmed the incomplete swing bed careplans. He stated he expected staff to initiate a care plan on admission in accordance with the patient's medical condition(s) and staff must review, add or revise, and update the care plan as the patient's condition warrants.