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THIS IS A REPEAT DEFICIENCY FROM THE SURVEY COMPLETED ON 11/02/16.
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 4 of 4 quarters reviewed (Quarters 1, 2, 3, and 4) in 2019. 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 "Quality Assurance Performance Improvement Committee" occurred on 2/25/20. This undated policy stated, ". . . Goal: To establish, implement, support, maintain, monitor and document evidence, that review and evaluation of the quality and appropriateness of patient\resident care methods, are constantly in progress, facility wide, and within all departments and services of NCHS [Nelson County Health System]. . . ."

Review of the "Quality Assurance Reporting Schedule 2019-2020" occurred on 2/25/20. This schedule stated, ". . .
April 2019 Quarterly report on Jan/Feb/Mar 2019 monitors from . . . all CAH departments . . .
July 2019 Quarterly report on April/May/June 2019 monitors from . . . all CAH departments . . .
October 2019 Quarterly report on July/Aug/Sept 2019 monitors from . . . all CAH departments . . .
January 2020 Quarterly report on Oct/Nov/Dec 2019 monitors from . . . all CAH departments . . ."

Reviewed on 2/25/20, the April 2019 through January 2020 (including the months of January 2019 through December 2019) QA committee's quarterly meeting minutes lacked evidence the respiratory therapy department submitted reports and lacked evidence the activities department reported hospital patient monitoring.

During interview on 2/25/20 at 4:45 p.m., an administrative staff member (#1) confirmed the respiratory therapy department had failed to submit monitoring reports to the QA Committee in 2019.

During interview on 2/26/20 at 9:25 a.m., an administrative staff member (#2) confirmed the activities department monitoring submitted to the QA committee failed to include hospital patients.

THIS IS A REPEAT DEFICIENCY FROM THE SURVEY COMPLETED ON 11/02/16.
Based on bylaws review, agreement review, and staff interview, the Critical Access Hospital's (CAH's) medical staff failed to recommend and the governing body failed to approve the reappointment/privileges for 2 of 2 telemedicine physicians (Physicians #1 and #2) files reviewed who provided services to the CAH through telemedicine agreements. Failure of the medical staff to recommend and the governing body to approve reappointments/privileges of telemedicine medical staff members placed the CAH's patients at risk of receiving services from unqualified practitioners.

Findings include:

Review of the "Medical Staff Bylaws of the Nelson County Health System" occurred on 02/24/20. These bylaws, effective 06/24/19, 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 reappointment, non-reappointment and/or clinical privileges of each practitioner . . .
Addendum H
Article VIII Medical Staff Categories
Section 6 Telemedicine Staff . . . Individuals providing telemedicine services from a 'distance site' must be appointed to the Telemedicine Staff . . ."

Review of the governing body's "Corporate Bylaws of the Nelson County Health System" occurred on 02/24/20 at 3:30 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. . . ."

Reviewed on 02/25/20, the CAH's agreement with Telemedicine Entity #1, dated 6/01/11, stated, ". . . 3. Nelson County Health Systems [NCHS] Responsibilities. . . . A. NCHS will accept . . . [Name of Telemedicine Entity #1] standard privileging/delineation documentation . . . The parties understand and agree that NCHS maintains complete and final authority and control over credentialing and privileging of providers practicing at NCHS. . . ." The list of providers from Telemedicine Entity #1, dated 8/07/19, included Physician #1.

Reviewed on 02/25/20, the CAH's agreement with Telemedicine Entity #2, dated 07/05/11, stated, ". . . 5. Responsibilities. . . . The governing body of Nelson County Health System may grant privileges to Providers and practitioners employed by [Name of Telemedicine Entity #2] based upon recommendation of Nelson County Health System's medical staff which may base its recommendations on information provided by [Name of Telemedicine Entity #2]. . . ." The list of providers from Telemedicine Entity #2, dated 06/21/19, included Physician #2.

Upon request on 02/25/20 and 02/26/20, the CAH failed to provide evidence the medical staff recommended and the governing body approved reappointment/privileges for Telemedicine Physicians #1 and #2.

During an interview on 02/26/20 at 11:45 a.m., a staff member (#5) confirmed the CAH did not have evidence the medical staff recommended and the governing body approved reappointment/privileges for Telemedicine Physicians #1 and #2.

ALLIED HEALTH PROFESSIONALS' ADMITTING PRIVILEGES
1. Based on bylaws review, record review, and staff interview, the Critical Access Hospital's (CAH's) governing body failed to ensure the CAH followed the medical staff bylaws for 12 of 20 (Patients #1, #2, #3, #5, #8, #9, #10, #11, #12, #13, #15, and #17) patients' admission records reviewed. Failure to ensure the medical staff followed the bylaws for patient admission requirements limited the CAH's ability to ensure proper care of the CAH's patients.

Findings include:

Review of the "Medical Staff Bylaws of the Nelson County Health System" occurred on 02/24/20. These bylaws, effective 06/24/19, stated, ". . . Definitions . . . 5. 'Allied Health Professional' or AHP means an individual, who is either a licensed nurse practitioner, physician assistant, or an advanced practice nurse . . . Addendum G Article VIII Medical Staff Categories Section 4 Allied Health Professionals (AHP) Subsection 4. Allied health professionals shall be allowed to vote and hold Medical Staff office. They shall not have admitting privileges. . . ."

Review of patient medical records occurred on all days of survey. The following records indicated a nurse practitioner or physician's assistant (AHPs) admitted the following patients: Patients #1, #2, #3, #5, #8, #9, #10, #11, #12, #13, #15, and #17.

During interview on 2/24/20 at 3:25 p.m., an administrative staff member (#4) confirmed AHPs admit patients at the CAH and the Medical Staff Bylaws stated AHPs shall not have admitting privileges.

THIS IS A REPEAT DEFICIENCY FROM THE SURVEY COMPLETED ON 11/02/16.
APPOINTMENT/REAPPOINTMENT TO MEDICAL STAFF
2. Based on bylaws review, record review, and staff interview, the Critical Access Hospital's (CAH's) governing board failed to ensure appointment/reappointment to medical staff and granting privileges followed the bylaws for 5 of 7 providers' files reviewed (Providers #3, #4, #5, #6, and #7). Failure to follow the bylaws when appointing/reappointing practitioners to the medical staff and granting privileges 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 02/24/20 at 3:30 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 02/24/20 at 2:00 p.m. These bylaws, adopted 06/24/19, stated,
". . . Article III. Medical Staff Membership
Section 1. Qualifications a. Only practitioner's [sic] or AHP's [Allied Health Professionals] [sic] 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 1 . . . the Medical Staff shall review all pertinent information available on each practitioner and AHP [allied health professional] scheduled for periodic appraisal for the purpose of determining its recommendations for reappointment to the Medical Staff and for the granting of clinical privileges for the ensuing period. . . . Subsection 3 The Medical Staff shall at least 90 days prior to the expiration date of the present staff reappointment for each medical staff member, provide such staff member with reappointment form for use in considering his/her reappointment. Each staff member who desires reappointment shall return the form to NCHS administrator . . . 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 and AHP . . .
Addendum E Article V Clinical Privileges . . . Section 4 Temporary Privileges Subsection 4 Locum tenens (temporary replacement physicians) shall be appointed as courtesy staff. . . . An abbreviated credentialing format may be used for locum tenens . . . At a minimum . . . NCHS query the National Physician's Data Bank . . ."

Review of the providers' 2018-2019 credentialing files occurred on 4/25/20 at 1:20 p.m. and indicated the following:
- Provider #3: no evidence of NCHS medical staff's recommendation and NCHS governing body's approval of reappointment and privileges in 2018.
- Provider #4: no evidence of an application for reappointment; and no evidence of NCHS medical staff's recommendation and NCHS governing body's approval of reappointment and privileges in 2018-2019.
- Provider #5: no evidence of NCHS medical staff's recommendation and NCHS governing body's approval of reappointment and privileges in 2018.
- Provider #6: no evidence of NCHS medical staff's recommendation and NCHS governing body's approval of reappointment and privileges in 2018.
- Provider #7: no evidence NCHS queried the National Physician's Data Bank (NPDB) before approving temporary appointment in August 2019.

Upon request on 02/25/20, the CAH failed to provide evidence NCHS medical staff recommended and NCHS governing body approved appointment/reappointment to the medical staff and privileges for Providers #3, #4, #5, #6, and #7.

Reviewed on 02/25/20, the CAH's 2019-2020 emergency department patient logbook indicated Providers #3, #6, and #7 provided treatment to the CAH's patients.

During interview on 02/25/20 at 1:20 p.m., a radiology staff member (#6) confirmed Provider #4 provided radiological interpretation services for the CAH.

During interview on 02/25/20 in the afternoon, an administrative staff member (#1) confirmed Provider #5 provided sleep study interpretation services for the CAH.

During interview on 02/26/20 at 11:45 p.m., a staff member (#5) confirmed the CAH did not have evidence the medical staff had recommended and the governing body approved the appointment/reappointment and granting of privileges for Providers #3, #4, #5, and #6; and the CAH did not have evidence they queried the NPDB before appointing Provider #7.

THIS IS A REPEAT DEFICIENCY FROM THE SURVEY COMPLETED ON 11/02/16.
Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) failed to ensure the removal of outdated medication and sterile supplies from 1 of 1 medication room, and 1 of 1 clean utility room on the medical/surgical floor. Failure to remove outdated medications and sterile equipment may result in patients receiving expired and ineffective medications and supplies.

Findings include:

Review of the policy titled, "Handing of Outdated Injectable Drugs" occurred on 02/26/20. This undated policy stated, ". . .1. Nursing administration will pull outdated medications on a routine monthly basis. . . ."

Review of the policy titled, "Medication Storage and Compliance Monitoring" occurred on 02/26/20. This policy, dated 05/19/15, stated, ". . .Nursing staff will inspect all medication storage areas on a monthly basis to ensure compliance with this and to monitor expiration dates. . . ."

Review of the policy titled "Outdated Materials" occurred on 02/26/20. This undated policy stated, ". . . will assure that all products that have expiration dates will be monitored. . . . All outdated products are removed on a monthly basis and replaced with current dated products. . . ."

Observation of the medication room on 02/24/20 at 1:44 p.m. with an administrative nurse (#1) showed a box of 16 vials of Cleocin Phosphate (Antibiotic) 600 mg(milligram)/4 ml(milliliter) with an expiration date of 01/2020.

Observation of the clean utility room on 02/24/20 at 2:30 p.m. with a staff nurse (#3) showed Foley catheters with an expiration date of 7/2018, 1/2019, and 11/2019.

During an interview on 02/26/20 at 11:20 a.m., an administrative nurse (#1) stated she expected staff to check outdates on medications and supplies on a routine monthly basis.

Based on record review, professional literature review, policy review, and staff interview, the Critical Access Hospital (CAH) failed to evaluate the safe use of side rails, failed to assess a patient individually prior to utilizing side rails, failed to consider side rails as a potential entrapment hazard, and failed to provide education to the patient and responsible party regarding the hazards of side rail use for 1 of 1 patient (Patient #2) record reviewed utilizing side rails. Failure to assess and evaluate the use of side rails, to consider side rails as a potential entrapment hazard, and to educate patients and responsible parties regarding the hazards of using side rails, restrict a patient's movement and increased the risk of entrapment or injury.

Findings include:

The Hospital Bed Safety Workgroup (HBSW) publication titled, "Clinical Guidance for the Assessment and Implementation of Bed Rails in Hospitals, Long Term Care Facilities, and Home Care Settings, dated April 2003, stated, ". . . bed rails may pose increased risk to patient safety. . . . pose a risk of entrapment . . . as well as falls that occur when patients climb over the rails or footboards when the rails are in use. . . . CMS [Centers for Medicare and Medicaid Services] issued guidance in June 2000 . . . One section of the guidance states, 'It is important to note that side rails present an inherent safety risk, particularly when the patient is elderly or disoriented. Even when a side rail is not intentionally used as a restraint, patients may become trapped between the mattress or bed frame and the side rail. Disoriented patients may view a raised side rail as a barrier to climb over, may slide between raised, segmented side rails, or may scoot to the end of the bed to get around a raised side rail. When attempting to exit the bed . . . the patient is at risk for entrapment, entanglement, or falling from a greater height posed by the raised side rail, with a possibility for sustaining greater injury or death than if he/she had fallen from the height of a lowered bed without raised siderails. . . . The population at risk for entrapment are patients who are frail or elderly or those who have conditions such as agitation, delirium, confusion, pain . . . 3. Use of bed rails should be based on patients' assessed medical needs and should be documented clearly . . . The patient's chart should include a risk-benefit assessment that identifies why other care interventions are not appropriate or not effective if they were previously attempted . . . The care plan should include educating the patient about possible bed rail danger to enable the patient to make an informed decision . . . If a bed rail has been determined to be necessary, steps should be taken to reduce the known risks associated with its use. . . . Assessment of risk should be part of the individual patient's assessment, and steps to address the risk should be incorporated into the patient's care plan. . . ."

Review of the facility policy titled "Restraints, Safety mechanisms, Protective Devices, Side Rails" occurred on 02/25/20. This undated policy stated, "[Facility name] will limit the use of restraints to emergencies in which there is imminent risk of the patient physically harming him/her self or others. Non-physical interventions are the preferred interventions. . . . Assessment or Screening Tools: These are to be done if restraints are being considered. *Mental status assessment such as the Mini-Cog *Confusion Assessment *Fall Risk Assessment *Pain Assessment *Pain Assessment in persons with dementia *Determination on undetected medical problems. Risk factors for physical restraint use include: . . . *Fall-injury risk . . . Alternatives to physical restraints to prevent falls and injury: *Eliminate use of full side rails *Use of 1/2 length top side rails to promote bed mobility as needed *Keep bed in low, locked position with mats at bedside . . . *Attend to unmet physical needs: toileting, food, fluids, sleep, comfort, pain relief. . . ."

Review of Patient #2's medical record occurred on all days of survey. Review of admission assessments and progress notes identified high risk for falls and up with one assist. During the afternoon and evening shift on 01/22/20, the nurses' notes indicated the patient's restlessness, agitation, and attempt to get out of bed per self without notifying staff for assistance. At 9:00 p.m. documentation on the Flowsheet and progress notes showed the nurse utilized all four side rails to ensure the patient did not attempt to exit the bed. Documentation continued to show all four side rails utilized through the remaining hospitalization.

During interview on 02/25/20 at 10:50 a.m., an administrative nurse (#1) verified the following:
* Staff had not assessed, identified, or careplanned the use of four side rails as a restraint
* The patient had attempted to get out of bed without staff assistance, and at the time the nurse utilized all four side rails, the patient continued to be physically able to get out of bed without assist
* Staff utilized the side rails to keep the patient from attempting to self transfer
* Staff had not educated the patient or notified the family regarding the side rail use

During interview on the morning of 02/26/20, an administrative nurse (#1) confirmed staff failed to identify and assess the four side rails as a restraint for Patient #2 per facility policy.

THIS IS A REPEAT DEFICIENCY FROM THE SURVEY COMPLETED ON 11/02/16.

Based on record review, review of facility policy, and staff interview, the Critical Access Hospital (CAH) failed to assess the effectiveness of medications given to patients on an as needed (PRN) basis within the expected timeframe for 5 of 8 patient records reviewed (Patients #5, #12, #14, #17, and #19) who received PRN medications. Failure to evaluate the patients' responses to PRN medications within the expected timeframe limited the nursing staffs' ability to assess whether the medications achieved the desired effect.

Findings include:

Review of the CAH's policy titled, "Pain Management" occurred on 02/25/20. This policy, revised November 2016, stated, ". . . Re-assessment to evaluate the effectiveness and to assess for side effects or adverse reactions will be completed and documented within 1 hour of medication administration. . . ."

Reviewed February 24-26, 2020, the following records indicated CAH staff failed to assess the efficacy of PRN pain medications within the expected one hour after administration for the following patients:
* Patient #5 received hydrocodone 5-325 milligrams (mg) during a four day hospitalization in February 2020. Staff failed to complete a follow-up assessment within one hour during four of the following six times:
- 02/10/20 administered at 5:53 a.m. with follow-up at 7:25 a.m. (1 1/2 hours)
- 02/10/20 administered at 4:00 p.m. with follow-up at 9:33 p.m. (5 1/2 hours)
- 02/11/20 administered at 5:16 a.m. with follow-up at 2:30 p.m. (7 1/4 hours)
- 02/11/20 administered at 2:30 p.m. with follow-up at 6:15 p.m. (3 3/4 hours)

* Patient #12 received Tylenol 650 mg and sumatriptan 100 mg during a four day hospitalization in October 2019. Staff failed to complete a follow-up assessment within one hour during three of five Tylenol administrations and two of two sumatriptan administrations.
Tylenol:
- 10/08/19 administered at 4:05 p.m. with follow-up at 7:11 p.m. (3 hours)
- 10/10/19 administered at 11:45 p.m. with follow-up at 8:00 a.m. the next day (8 hours)
- 10/12/19 administered at 3:00 a.m. with follow-up at 8:51 a.m. (5 3/4 hours)
Sumatriptan:
- 10/08/19 administered at 5:50 p.m. with follow-up at 9:00 p.m. (3 hours)
- 10/11/19 administered at 12:37 a.m. with follow-up at 8:00 a.m. (7 1/2 hours)

* Patient #14 received Toradol 15 mg intravenously (IV), Tylenol 500-1000 mg, and Flexeril 5-10 mg during a three day hospitalization in December 2019. Staff failed to complete a follow-up assessment within one hour after five of six Toradol administrations, four of eight Tylenol administrations, and four of four Flexeril administrations.
Toradol:
- 12/02/19 administered at 11:21 a.m. with follow-up at 3:05 p.m. (3 1/2 hours)
- 12/02/19 administered at 5:05 p.m. with follow-up at 9:00 p.m. (3 hours)
- 12/02/19 administered at 11:08 p.m. with follow-up at 5:56 a.m. (7 hours)
- 12/03/19 administered at 9:00 a.m. with follow-up at 12:41 p.m. (3 1/2 hours)
- 12/03/19 administered at 8:40 p.m. with follow-up at 11:01 p.m. (2 1/4 hours)
Tylenol:
- 12/02/19 administered at 12:03 a.m. with follow-up at 7:21 a.m. (7 1/4 hours)
- 12/02/19 administered at 3:05 p.m. with follow-up at 5:05 p.m. (2 hours)
- 12/02/19 administered at 9:00 p.m. with follow-up at 11:08 p.m. (2 hours)
- 12/03/19 administered at 5:56 a.m. with follow-up at 7:30 a.m. (1 1/2 hours)
Flexeril:
- 12/02/19 administered at 5:05 p.m. with follow-up at 9:00 p.m. (4 hours)
- 12/02/19 administered at 11:07 p.m. with follow-up at 5:56 a.m. (6 3/4 hours)
- 12/03/19 administered at 9:00 a.m. with follow-up at 12:41 p.m. (3 1/2 hours)
- 12/03/19 administered at 6:39 p.m. with follow-up at 8:40 p.m. (2 hours)

* Patient #17 received Toradol 30 mg IV during a two day hospitalization in September 2019. Staff failed to complete a follow-up assessment within one hour after four of four administrations.
- 09/11/19 administered at 5:59 p.m. with follow-up at 10:18 p.m. (4 1/4 hours)
- 09/12/19 administered at 11:03 a.m. with follow-up at 2:45 p.m. (3 3/4 hours)
- 09/12/19 administered at 5:00 p.m. with follow-up at 6:46 p.m. (1 3/4 hours)
- 09/13/19 administered at 1:00 a.m. with follow-up at 5:20 a.m. (4 1/4 hours)

* Patient #19 received Tylenol 650 mg during a two day hospitalization in November 2019. Staff failed to complete a follow-up assessment within one hour after two of six administrations.
- 11/17/19 administered at 1:29 p.m. with follow-up at 5:00 p.m. (3 1/2 hours)
- 11/19/19 administered at 3:54 a.m. with follow-up at 7:30 a.m. (3 1/2 hours)

During interview on 02/26/20 at 8:00 a.m., an administrative nurse (#1) verified staff failed to complete a follow-up assessment within one hour after PRN medications administered.