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Based on bylaws review, record review, and staff interview, the Critical Access Hospital's (CAH's) governing body failed to approve the appointment/privileges for 2 of 2 telemedicine entities (Entity #1 and #2) providing services to the CAH through telemedicine agreements. Failure to approve appointments/privileges of telemedicine medical staff members placed the CAH's patients at risk of receiving services from unqualified practitioners.

Findings include:

Review of the governing board's "Corporate Bylaws of the Nelson County Health System" occurred on 10/31/16 at 1:35 p.m. These bylaws, effective 05/06/03, stated,
". . . Article 6. . . .
Section 9(a). Medical Staff. Appointments to the medical staff shall be made by the Board of Directors of the Corporation. . . . The board delegates to the medical staff the authority to recommend and evaluate regarding professional competence, appointments, re-appointments and staff privileges generally. . . ."

Review of the "Medical Staff By-Laws of the Nelson County Health System" occurred on 10/31/16 at 2:05 p.m. These bylaws, adopted 11/18/03, stated,
". . . Article IV Procedures for Appointment and Reappointment . . .
Section 2.
Appointment Process
Subsection 1. . . . the Medical Staff shall . . . make a recommendation to the governing body that the applicant be either appointed to the Medical Staff or rejected for medical staff membership . . .
Subsection 2. The governing body . . . shall, with the recommendations of the Medical Staff and administrator, render a decision concerning the appointment of the applicant. . . .
Section 3.
Reappointment Process.
Subsection 4. . . . the Medical Staff shall review the information for reappointment and make written recommendations to the governing body through the administrator, concerning the reappointment, non-reappointment and/or clinical privileges of each practitioner . . ."

Reviewed on 11/01/16, the CAH's agreements included credentialing agreements for Telemedicine Entity #1 and Telemedicine Entity #2 along with lists of providers.

Upon request on 11/01/16, the CAH failed to provide evidence the governing body approved appointment/reappointment/privileges for providers with Telemedicine Entity #1 and #2.

During an interview on 11/02/16 at 8:40 a.m., an administrative staff member (#1) confirmed the CAH did not have evidence the governing body approved appointment/reappointment/privileges for providers with Telemedicine Entity #1 and #2.

APPOINTMENT/REAPPOINTMENT TO MEDICAL STAFF

1. Based on bylaws review, record review, and staff interview, the Critical Access Hospital's (CAH's) governing board failed to ensure reappointment to medical staff for 1 of 1 allied health professional (Provider #3) and appointment to the medical staff for 3 of 3 physicians (Physicians #4, #5, and #6) providing radiological and sleep study interpretation services. Failure to appoint/reappoint practitioners to the medical staff placed the CAH's patients at risk of receiving services from unqualified practitioners.

Findings include:

Review of the governing board's "Corporate Bylaws of the Nelson County Health System" occurred on 10/31/16 at 1:35 p.m. These bylaws, effective 05/06/03, stated,
". . . Article 6. . . .
Section 9(a). Medical Staff. Appointments to the medical staff shall be made by the Board of Directors of the Corporation. . . . The board delegates to the medical staff the authority to recommend and evaluate regarding professional competence, appointments, re-appointments and staff privileges generally. . . ."

Review of the "Medical Staff By-Laws of the Nelson County Health System" occurred on 10/31/16 at 2:05 p.m. These bylaws, adopted 11/18/03, stated,
". . . Article III. Medical Staff Membership
Section 1.
Qualifications
a. Only practitioner's or AHP's who are licensed to practice in the State of North Dakota, who can document their background experience, training, and demonstrate their competence, their adherence to the ethics of their profession, their good reputation, and their ability to work with others, and can assure the Medical Staff and the governing body that any patient/resident treated by them at NCHS [Nelson County Health System] will be given the highest level of patient/resident care, shall be qualified for membership on the Medical Staff . . .
Article IV Procedures for Appointment and Reappointment
Section 3.
Reappointment Process.
Subsection 4. . . .
Reappointments shall be for two (2) years. . . ."

Reviewed on 11/01/16, Provider #3's credentialing file indicated the previous reappointment to medical staff ended on 02/23/16. The file did not include evidence of reappointment since 02/23/16.

Reviewed on 11/01/16, the CAH's 2016 emergency department patient logbook indicated Provider #3 treated patients at the CAH after 02/23/16.

Upon request on 11/01/16, the CAH failed to provide evidence the governing body approved reappointment to the medical staff for Provider #3 as an allied health professional and appointment to medical staff for Physician #4 providing radiological interpretation and Physicians #5 and #6 providing sleep study interpretation services.

During an interview on 11/01/16 at 4:15 p.m., an administrative staff member (#1) confirmed the CAH's governing body had not reappointed Provider #3 in the required timeframe and the CAH had not credentialed Physicians #4, #5, and #6 who provided services to the CAH's patients.


APPROVAL OF PRIVILEGES FOR MEDICAL STAFF

2. Based on bylaws review, record review, and staff interview, the Critical Access Hospital's (CAH's) governing body failed to ensure the approval of clinical privileges for 3 of 3 active medical staff members (Physician #1, Physician #2, and Provider #3). Failure to approve clinical privileges of medical staff members placed the CAH's patients at risk of receiving services from unqualified practitioners.

Findings include:

Review of the governing board's "Corporate Bylaws of the Nelson County Health System" occurred on 10/31/16 at 1:35 p.m. These bylaws, effective 05/06/03, stated,
". . . Article 6. . . .
Section 9(a). Medical Staff. Appointments to the medical staff shall be made by the Board of Directors of the Corporation. . . . The board delegates to the medical staff the authority to recommend . . . staff privileges . . ."

Review of the "Medical Staff By-Laws of the Nelson County Health System" occurred on 10/31/16 at 2:05 p.m. These bylaws, adopted 11/18/03, stated,
". . . Article IV Procedures for Appointment and Reappointment
Section 3.
Reappointment Process.
Subsection 4. . . . the Medical Staff shall review the information for reappointment and make written recommendations to the governing body through the administrator, concerning the . . . clinical privileges of each practitioner and AHP [Allied Health Professional]
. . ."

Reviewed on 11/01/16, the most current credentialing files for Physician #1, Physician #2, and Provider #3 lacked evidence the medical staff recommended and the governing body approved specific clinical privileges.

Upon request on 11/01/16, the CAH failed to provide evidence the medical staff recommended and the governing body approved specific clinical privileges for Physician #1, Physician #2, and Provider #3.

During an interview on 11/02/16 at 8:40 a.m., an administrative staff member (#1) confirmed the CAH did not have evidence medical staff recommended and governing body approved specific clinical privileges for Physician #1, Physician #2, and Provider #3 for their last reappointments.

Based on policy and procedure manual review and staff interview, the Critical Access Hospital (CAH) failed to have the required members of a group of professional personnel annually review the CAH's health care policies and procedures in 2015 for 10 of 10 policy and procedure manuals (Nursing, Infection Control, Cardiac Rehabilitation, Emergency Room, Quality Assurance, Organ Procurement, Medical Records, Respiratory Therapy, Laboratory, and Radiology) reviewed. Failure to have the required group of professional personnel annually review the policies and procedures limited the CAH's ability to ensure the policies and procedures were current and followed regulations and standards of practice.

Findings include:

Review of the CAH's policy and procedure manuals occurred on all days of the survey. The following manuals lacked evidence of annual review in 2015 by the required members of a group of professional personnel (a physician and a physician assistant/nurse practitioner/clinical nurse specialist): Cardiac Rehabilitation, Emergency Room, Quality Assurance, Organ Procurement, Medical Records, Respiratory Therapy, and Laboratory. The following manuals lacked evidence of annual review in 2015 by a physician assistant/nurse practitioner/clinical nurse specialist: Nursing, Infection Control, and Radiology.

During interview on 11/01/16 at 1:20 p.m., an administrative staff member (#1) confirmed the CAH had failed to have the required group of professional personnel annually review the CAH's health care policies and procedures.

Upon request on 11/02/16, the CAH failed to provide a policy requiring annual review of their health care policies and procedures by the required group of professional personnel.

Based on observation, policy review, professional reference review, and staff interview, the Critical Access Hospital (CAH) failed to ensure the removal of outdated medications from 1 of 1 room with medication in the emergency department (ED). Failure to remove outdated medications may result in patients receiving expired and ineffective medications.

Findings include:

Review of the policy titled "HANDLING OF OUTDATED INJECTABLE DRUGS" occurred on 11/02/16. This undated policy stated, ". . . Nursing administration will pull outdated medications on a routine monthly basis. . . ."

Review of the policy titled "MEDICATION STORAGE AND COMPLIANCE MONITORING" occurred on 11/02/16. This undated policy stated, "All medications throughout the hospital will be properly, safely and securely stored in accordance with the hospital's policies and State and Federal laws and regulations. . . . Nursing staff will inspect all medications storage areas on a monthly basis to ensure compliance with this and to monitor expiration dates. . . ."

Review of an article titled "Questions about Multi-dose vials" found on the Centers for Disease Control and Prevention (CDC) website, revised February 2011, stated ". . . If a multi-dose has been opened or accessed (e.g., [example given] needle-punctured) the vial should be dated and discarded within 28 days . . ."

Observation of the emergency department occurred on 10/31/16 at 3:00 p.m. and identified the following:
* Two 250 milliliter (ml) bags of 5% Dextrose, both expired October 1, 2016, in a bin on the counter
* One 10 ml vial of 1% Lidocaine Hydrochloride marked as opened on 09/04/16
* One vial of Bacteriostatic .9% Sodium Chloride marked as opened on 09/24/16
* One 20 ml vial of 2% Lidocaine 20 milligrams/ml marked as opened on 08/25/16

During the above observation, a supervisory nurse (#2) stated the above medications had expired, and staff should have removed the medications from current use.

Based on review of professional literature, record review, and staff interview, the Critical Access Hospital (CAH) failed to assess and document the effectiveness of medications given to patients on an as needed (PRN) basis for 5 of 16 patients reviewed in closed records (Patient #2, #3, #4, #10, and #14). Failure to evaluate the patient's response to PRN pain medications limited the nursing staffs' ability to assess whether the medication achieved the desired effect or if the patient experienced any side effects or adverse reactions from the medication.

Findings include:

Review of the facility policy titled "PAIN MANAGEMENT" occurred on 11/01/16. This undated policy stated, ". . . The pain assessment scale shall be used in conjunction with the PRN medication sheet each time a resident receives a PRN medication at the time of administration as well as follow-up to evaluate the effectiveness of the medication given. . . ."

Berman and Snyder, "Kozier & Erb's Fundamentals of Nursing: Concepts, Process, and Practice," 9th ed., Pearson Education, Inc., New Jersey, page 862-870, states, ". . . Process of Administering Medications: When administering any drug, regardless of the route of administration, the nurse must do the following: . . . 6. Evaluate the client's response to the drug. . . . In all nursing activities, nurses need to be aware of the medications that a client is taking and record their effectiveness as assessed by the client and the nurse on the client's chart. . . . Skill 35-1 Administering Oral Medications: . . . Evaluation: Return to the client when the medication is expected to take effect (usually 30 minutes) to evaluate the effects of the medication on the client. . . ."

- Review of Patient #2's closed inpatient medical record occurred on 11/01/16 and identified the CAH admitted the patient on 07/18/16 after a fall for pain in the right wrist, finger, knee, and head. The record indicated an order for Roxicodone IR [immediate release] 5 milligrams (mg) every 4 hours PRN for moderate pain and changed to 5-10 mg every 6 hours.

Patient #2's eMAR, chart notes, and flowsheet showed the following administration times and patient responses for the PRN medication:
* 07/20/16 at 6:02 p.m. 5 mg administered - no response documented within 1 hour
* 07/23/16 at 1:15 p.m. and at 4:54 p.m. 5 mg administered - no response documented within 1 hour
* 07/24/16 at 6:48 p.m. 5 mg administered - response documented at 8:48 p.m. (2 hours later) with pain still at a level 4, and no further interventions documented
* 07/27/16 at 2:45 p.m. 5 mg administered - no response documented within 1 hour
* 07/28/16 at 6:29 p.m. 10 mg administered - response documented at 10:46 p.m. (4 hours later) with pain still at a level 4, and no further interventions documented
* 07/29/16 at 5:15 p.m. 5 mg administered - no response documented within 1 hour

- Review of Patient #3's closed inpatient medical record occurred on 11/01/16 and identified the CAH admitted the patient on 06/10/16 for right flank pain. The record identified an order for morphine sulfate 2 mg every 4 hours PRN intravenously (IV) for severe pain.

Patient #3's eMAR, chart notes, and flowsheet showed the following administration times and patient responses for the PRN medication:
* 06/10/16 at 4:39 a.m., 8:55 a.m., and 1:30 a.m. - no response documented within 1 hour

- Review of Patient #4's closed inpatient medical record occurred on November 1-2, 2016 and identified the CAH admitted the patient on 09/01/16 with a wound infection complicating hardware. The record identified an order for Aleve 440 mg PRN nightly for pain.

Patient #4's eMAR, chart notes, and flowsheet showed the following administration times and patient responses for the PRN medication:
* 09/05/16 at 9:37 p.m. - no pre-medication pain assessment completed and no response documented within 1 hour
* 09/07/16 at 9:37 p.m. - no pre-medication pain assessment completed and no response documented within 1 hour
* 09/08/16 at 9:00 p.m. - no pre-medication pain assessment completed and no response documented within 1 hour


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- Review of Patient #14's closed inpatient medical record occurred on all days of survey and identified the CAH admitted the patient into Swingbed (SB) on 04/13/16. The record indicated an order for Ultram (tramadol) 50-100 mg every six hours PRN and Tylenol 650 mg every six hours PRN for pain. Between 04/13/16 and 04/21/16, nursing staff administered 11 doses of the Tylenol and seven doses of the Ultram. On two occasions the nursing staff administered both medications at the same time.

Patient #14's eMAR, chart notes, and flowsheet showed the following administration times and patient responses for the PRN medication:
* 04/13/16 at 7:00 p.m. the flow sheet identified the patient experienced pain to the mid coccyx and described the pain as a #3 "(bothersome)" on a scale of 1-10. The eMAR showed nursing staff administered the patient a dose of Tylenol 650 mg and Ultram 50 mg at 11:52 p.m. Staff documented the next follow-up/assessment of the pain at 5:32 a.m. on the flowsheet.
* 04/14/16 at 2:50 p.m. the flow sheet identified the patient experienced pain to the mid sacrum and described the pain as a #6 "(distressing)". The flow sheet failed to identify the nursing intervention. The next follow-up on pain occurred at 7:00 p.m. and 8:26 p.m., again the patient describing the pain as a #6 "(distressing)" to the mid sacrum and left foot. The eMAR identified nursing staff administered the patient pain medication 1.5 hours after the 7:00 p.m. "distressing" pain which included a dose of both Tylenol 650 mg at 8:26 p.m. and Ultram 50 mg and 8:27 p.m. Nursing staff did not reassess the patients pain until 11:00 p.m., 2.5 hours later, at which time the patient experienced pain of #5 "(moderate)" to the left leg (repositioning occurred).
* 04/15/16 at 2:34 p.m. the flow sheet identified the patient experienced a #6 pain ("distressing") of the right and left knee. Nursing staff administered Ultram at 2:34 p.m. and did not re-assess the patient's pain until 7:00 p.m. at which time it was rated at a 4 "(discomforting)." The flow sheet identified nursing staff reassessed the resident's pain next on 04/16/16 at 7:00 a.m.
* 04/16/16 at 11:01 p.m. the flow sheet identified the next assessed pain as a #5 "(moderate) to the right rib cage. The eMAR showed nursing staff administered Tylenol on the 04/16/16 at 8:42 p.m. and Ultram at 11:01 p.m.

- Review of Patient #10's closed medical record occurred on all days of survey and identified the CAH admitted the patient into SB on 07/08/16. Admission orders included Percocet every 6 hours PRN for moderate pain. The eMAR identified nursing staff administered the Percocet on 15 occasions between 07/09/16 and 07/20/16. The eMAR and flow sheets identified the following:
* 07/09/16, nursing administered Percocet at 11:04 a.m. for "distressing" pain (location not identified), and did not reassess the pain until 6:35 p.m., over seven hours later. A "shift summary" note, timed 5:48 p.m., identified the patient received relief from the morning PRN medication.
* 07/12/16 at 1:00 p.m. nursing identified the patient experienced "distressing" pain to the right knee and did not offer or provide any measures nor identify if the patient refused anything for the pain, including repositioning.

During interview on 11/01/16 at 10:50 a.m. an administrative nurse (#2) stated to refer to the nurses' notes to determine if a patient's pain is resolved with the administration of pain medications.

Review of the medical record identified nursing staff not reassessing the patients' response to measures implemented to relieve pain. With the possibility of an entry regarding the pain in three different locations in the electronic medical record, following the effectiveness of measures, including pain medications administered, does not ensure that a timely reassessment occurs. This may result in the patient receiving inadequate pain relief and staff not assessing when a change in the pain relieving measures, including ordered pain medication, is needed for each patient.

Review of Patient #2, #3, #4, #10, and #14's records failed to include evidence nursing staff assessed and documented the pre-medication pain and/or the effectiveness of the PRN medication in a timely manner.

Based on meeting minutes review and staff interview, the Critical Access Hospital (CAH) failed as part of an annual program evaluation to review a representative sample of active and closed clinical records for 1 of 1 year (2015). Failure to review clinical records as part of the annual program evaluation limited the CAH's ability to determine if the utilization of services was appropriate and whether staff followed the CAH's policies.

Findings include:

Reviewed on all days of survey, the 2015-2016 medical staff, governing body, and quality assurance meeting minutes lacked evidence the CAH reviewed a representative sample of active and closed clinical records as part of an annual program evaluation for 2015.

Upon request on 11/01/16, the CAH failed to provide evidence the CAH reviewed a representative sample of active and closed clinical records as part of an annual program evaluation for 2015.

During interview on 11/01/16 in the afternoon, an administrative staff member (#1) confirmed the CAH had not reviewed active and closed clinical records as part of an annual program evaluation for 2015.

Upon request on 11/02/16, the CAH failed to provide a policy requiring an annual program evaluation.

Based on record review, meeting minutes review, staff interview, and policy manual review, the Critical Access Hospital (CAH) failed as part of an annual program evaluation to annually review the CAH's health care policies for 1 of 1 year (2015). Failure to annually review the CAH's health care policies as part of the annual program evaluation limited the CAH's ability to determine whether staff followed the CAH's policies and whether the CAH needed to revise policies.

Findings include:

Reviewed on all days of survey, the 2015-2016 medical staff, governing body, and quality assurance meeting minutes lacked evidence the CAH reviewed its health care policies as part of an annual program evaluation for 2015.

Upon request on 11/01/16, the CAH failed to provide evidence staff reviewed their health care policies as part of an annual program evaluation for 2015.

During interview on 11/01/16 in the afternoon, an administrative staff member (#1) confirmed the CAH had not reviewed their health care policies as part of an annual program evaluation for 2015.

Upon request on 11/02/16, the CAH failed to provide a policy requiring an annual program evaluation.

Based on meeting minutes review and staff interview, the Critical Access Hospital (CAH) failed as part of an annual program evaluation to determine whether the utilization of services was appropriate, staff followed their health care policies, and if the CAH needed to make changes for 1 of 1 year (2015). Failure to perform an annual program evaluation limited the CAH's ability to determine if the CAH needed to make changes.

Findings include:

Reviewed on all days of survey, the 2015-2016 medical staff, governing body, and quality assurance meeting minutes lacked evidence the CAH determined whether the utilization of services was appropriate, staff followed their health care policies, and if the CAH needed to make changes as part of an annual program evaluation for 2015.

Upon request on 11/01/16, the CAH failed to provide evidence the CAH determined whether the utilization of services was appropriate, staff followed their health care policies, and if the CAH needed to make changes as part of an annual program evaluation for 2015.

During interview on 11/01/16 in the afternoon, an administrative staff member (#1) confirmed the CAH had not determined whether the utilization of services was appropriate, staff followed their health care policies, and if the CAH needed to make changes as part of an annual program evaluation for 2015.

Upon request on 11/02/16, the CAH failed to provide a policy requiring an annual program evaluation.

Based on policy review, record review, meeting minutes review, and staff interview, the Critical Access Hospital (CAH) failed to ensure the Quality Assurance (QA) program evaluated all patient care services and other services affecting patient health and safety for 12 of 15 months reviewed (October 2015 - September 2016). Failure to ensure departments report to the QA Committee limited the CAH's ability to identify risk factors affecting patient care and implement corrective action if necessary.

Findings include:

Review of the policy titled "NCHS [Nelson County Health System] QA [Quality Assurance]/QI [Quality Improvement] Plan" occurred on 11/01/16. This undated policy stated,
"1) It is the expectation that each department identify and evaluate the Quality Assurance/
Quality Improvement plan for their department.
. . .
At a minimum, all monitors need to be reported monthly as designated by the reporting calendar, or as often as needed to indicate compliance and review. . . .
A written summary report should be completed with copies made to provide to the QA committee/
COW [Committee of the Whole]-Med. [Medical] Staff/Board of Directors for their review - meaning a monthly summary, or a quarterly summary - depending on your reporting timeline.
Noncompliance with developing/monitoring/
providing reports as scheduled will result in disciplinary action - this is not an optional task!
. . ."

Review of the document titled "CAH MONITORS" occurred on 11/01/16. This undated document stated, "All reports are due at a minimum QUARTERLY . . ."

Review of the "NCHS Quality Improvement Reporting Schedule 2015-2016" occurred on 11/01/16. This schedule stated, ". . .
October 2015 Quarterly report on
July/Aug/Sept monitors from . . . all CAH departments
January 2016 Quarterly report on
Oct/Nov/Dec monitors from . . . all CAH departments
April 2016 Quarterly report on
Jan/Feb/Mar monitors from . . . all CAH departments
July 2016 Quarterly report on
April/May/June monitors from . . . all CAH departments
October 2015 Quarterly report on
July/Aug/Sept monitors from . . . all CAH departments"

Reviewed on 11/01/16, the November 2015-October 2016 (including the months of July 2015 - September 2016) quality assurance committee's quarterly meeting minutes lacked evidence the health information services department submitted reports from October 2015 - September 2016.

During interview on 11/01/16 at 2:25 p.m., an administrative QA staff member (#2) confirmed the health information services department had failed to submit monitoring reports to the QA Committee for the past year.

Based on bylaws review, policy review, record review, credentialing files review, 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 for 2 of 2 active staff physicians' (Physicians #1 and #2) credentialing records reviewed. Failure to have a network hospital or a QIO or equivalent evaluate the quality and appropriateness of the treatment furnished by the physicians limited the CAH's ability to ensure the physicians furnished quality and appropriate care to the CAH's patients.

Findings include:

Review of the medical staff's bylaws titled "Medical Staff By-Laws of the Nelson County Health System" occurred on 10/31/16. These bylaws, adopted 11/18/03, stated, ". . .
Article IV Procedures for Appointment and Reappointment . . .
Section 3.
Reappointment Process. . . .
Subsection 2.
Each recommendation concerning the reappointment of a medical staff member and the clinical privileges to be granted upon reappointment shall be based upon such member's professional competence and clinical judgment in the treatment of patients . . ."

Review of the policy titled "Nelson County Health System Peer Review Guidelines" occurred on 11/01/16. This undated policy failed to require a network hospital or a quality improvement organization (QIO) or equivalent evaluate the quality and appropriateness of the treatment furnished by physicians.

Reviewed on 11/01/16, the 2014-2016 peer review records failed to include evidence a network hospital or a QIO or equivalent evaluated the quality and appropriateness of the treatment furnished by Physicians #1 and #2.

Upon request on 11/01/16, 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 #1 and #2.

Review of the 2014 credentialing files for Physician #1 and #2 occurred on November 1-2, 2016 and failed to include evidence of peer review performed by a network hospital or a quality improvement organization (QIO) or equivalent.

During interview on 11/01/16 at approximately 11:15 a.m., an administrative staff member responsible for peer review (#3) confirmed Physicians #1 and #2 provided services to the CAH's patients, and the CAH did not have a network hospital or QIO or equivalent evaluate the quality and appropriateness of the diagnosis and treatment furnished by these physicians.