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Based on record review, policy review, and staff interview, the Critical Access Hospital (CAH) failed to ensure staff documented in the patient's medical record whether or not the patient executed an advance directive for 10 of 20 (Patient #1, #6, #8, #9, #10, #12, #15, #17, #18, and #19) records reviewed. This failure limits the CAH's ability to determine whether the patient had an advance directive.

Findings include:

The policy "Advanced Medical Directives," dated 12/13/2005, stated, "POLICY: It is the policy of McKenzie County Healthcare Systems Hospital to abide by the provision of the Patient Self-Determination Act of 1991. This includes the patient's right to make his/her own health care decisions, and the right to make an advanced directive. . . . Nursing personnel shall query the patient or family member upon admission, if at all possible, as to whether the patient has executed an advance directive. This shall be done as part of the nursing assessment. The existence or non-existence of an advanced directive shall be documented in the patient's medical record. . . ."

During an interview on the afternoon of 08/09/16, an administrative staff member (#1) stated business office personnel document whether each patient has an advance directive upon admission to the hospital, and if staff admit a patient after the business office closes, nursing staff document this information.

Review of Patient #1, #6, #8, #9, #10, #12, #15, #17, #18, and #19's medical records occurred on August 08-10, 2016. The records failed to include evidence staff documented whether the patient executed an advance directive.

Based on bylaws review, review of provider credentialing files, review of an agreement, and staff interview, the Critical Access Hospital's (CAH's) governing board failed to recognize the same medical staff member requested re-appointment and provided the approval for that re-appointment; failed to ensure credentialing occurred for all practitioners providing services as a telemedicine/contracted entity; and failed to recognize practitioners provided treatment/services not delineated during credentialing by the medical staff and governing body. Failure to ensure the governing body appointed and credentialed medical staff according to the governing body and medical staff bylaws does not ensure the delivery of care by qualified providers. Refer to C 241.

ACTIVE STAFF APPOINTMENT TO MEDICAL STAFF

1. Based on bylaws review, provider credentialing files, and staff interview, the Critical Access Hospital's (CAH's) governing board failed to recognize the same medical staff member requested re-appointment and provided the approval for that re-appointment for 1 of 1 active medical staff provider (Physician #1). This resulted in Physician #1 practicing without proper credentialing for two appointment periods and placed the CAH's patients at risk of receiving treatment/services from an unqualified practitioner.

Findings include:

Review of the "MEDICAL STAFF BY-LAWS" occurred on 08/08/16. These bylaws, adopted 10/20/14, stated, ". . . DEFINITIONS: . . . The term "PRACTITIONER" means an appropriately licensed, doctor of medicine or osteopathy, family nurse practitioner, certified physician assistant . . . ARTICLE II. . . . The purpose of this organization shall be: . . . 2. To strive for a high level of professional performance of all practitioners and allied health practitioners authorized to practice in the hospital through on-going review, analysis, and evaluation of the clinical work of the members of the medical staff. . . . ARTICLE III. MEDICAL STAFF MEMBERSHIP . . . SECTION 1. . . . shall be extended only to professionally competent practitioners who continuously meet the qualifications, standards and requirements set forth in these by-laws. . . . SECTION 4. Term . . . Appointment to the medical staff shall be for a two-year period. . . . ARTICLE IV. CATEGORIES OF THE MEDICAL STAFF: . . . Section 2. The Active Medical Staff: . . . shall be required to maintain medical staff privileges . . . ARTICLE V. PROCEDURE FOR APPOINTMENT AND RE-APPOINTMENT . . . SECTION 2. Re-appointment Process: Every two (2) years the practitioner must complete re-appointment application . . . The medical staff shall review and investigate all the information . . . any privilege changes . . . ARTICLE VI. CLINICAL PRIVILEGES . . . Every practitioner . . . by virtue of medical staff membership or otherwise, shall in connection with such practice, be entitled to exercise only those clinical privileges specifically granted to him or her by the medical staff and approved by the Board of Directors . . ."

Review of the governing body's bylaws occurred on 08/08/16. These bylaws, dated 10/29/12, stated, ". . . Article VIII - Medical Staff; Section 1. The Bylaws of the Medical Staff . . . govern the relationship between the Medical Staff and the Board of Trustees . . . Section 3. . . . c. The Medical Staff shall make recommendations to the Board of Trustees concerning: i. Appointments, reappointments . . . ii. Granting of clinical privileges . . ."

Review of a random sample of provider credentialing files occurred on 08/09/16. The listing of the medical staff members included one active medical staff, a family practice physician. Review of this physician's file (Physician #1) identified the physician himself signed for the medical staff approval for re-appointment, and review of the clinical privileges. The re-appointment approval occurred on 12/17/14, for the two year period of 2015 and 2016, and the governing body approved the reappointment on 12/29/14. In addition, Physician #1 signed for the medical staff approval in 11/2012 for the previous reappointment for the two year period of 2013 and 2014. The credentialing file identified governing body approval based on this medical staff approval.

On 08/10/16 at 11:00 a.m., a staff member (#9) stated Physician #1 should not be providing the medical staff approval for his re-appointment and delineation of privileges.

APPOINTMENT OF TELEMEDICINE PROVIDERS

2. Based on bylaws review, agreements review, and staff interview, the CAH failed to ensure credentialing occurred for practitioners providing services for 1 of 2 current telemedicine/contracted entities (Entity #1). Failure to develop an agreement for credentialing and/or appoint/reappoint practitioners providing telemedicine services for CAH's patients placed the patients at risk of receiving treatment from unqualified providers.

Findings include:

Review of the "MEDICAL STAFF BY-LAWS" occurred on 08/08/16. These bylaws, adopted 10/20/14, did not specify "Telemedicine Staff" as a category of the medical staff. The bylaws stated, ". . ARTICLE V. PROCEDURE FOR APPOINTMENT AND RE-APPOINTMENT . . . SECTION 3. Outside Credentialing: The medical staff may accept credentialing information from any hospital or entity with whom it has contracted for such information. . . ."

Review of the CAH's agreement with a sleep laboratory services contractor occurred on 08/09/16. The agreement, dated 03/07, stated, ". . . STATEMENT OF BACKGROUND INFORMATION . . . B. Hospital desires that [name of contractor], as an independent contractor, provide certain sleep testing services to address the Hospital's needs with respect to sleep study services. C. [Name of contractor] is willing to furnish the sleep testing services to satisfy the Hospital's needs and the community's needs for quality sleep testing. . . . represents that it is qualified to provide the services . . . ARTICLE 2: RESPONSIBILITIES OF [name of contractor] 2.1 Compliance with Regulations . . . [name of contractor] shall comply with . . . rules and regulations of Hospital [CAH]. . . . ARTICLE 5: INDEPENDENT CONTRACTOR RELATIONSHIP . . . Hospital shall not exercise and shall have no right to exercise control over [name of contractor] provision of Services hereunder. . . ."

Review of the governing board's bylaws occurred on 08/08/16. These bylaws, adopted 10/29/12, stated, ". . . ARTICLE VIII - MEDICAL STAFF Section 1. The Bylaws of the Medical Staff of this Corporation . . . govern the relationship between the Medical Staff and the Board of Trustees . . . Section 2 . . . b. All applications for appointment to the Medical Staff shall be in writing . . . which information shall be verified through the credentialing process. . . ."

On 08/10/16 at 11:00 a.m., a staff member (#9) stated no appointment or re-appointment occurs for the physicians providing services through the agreement/contract.

DELINEATION OF PRIVILEGES

3. Based on bylaws review, review of credentialing files and staff interview, the CAH failed to ensure 2 of 2 practitioners (Physician #2 and allied health professional #3) identified in an event report did not provide treatment/services not delineated during credentialing by the medical staff and governing body. Both practitioners performed a procedure not given privileges for which placed this patient at risk of significant injury due to receiving treatment from unqualified providers.

Findings include:

Review of the "MEDICAL STAFF BY-LAWS" occurred on 08/08/16. These bylaws, adopted 10/20/14, stated "The term "CLINICAL PRIVILEGES" means the rights granted to a licensed medical professional to render specific diagnostic, therapeutic, medical, dental, or surgical services specifically delineated to him. . . ." and ". . . ARTICLE V. PROCEDURE FOR APPOINTMENT AND RE-APPOINTMENT . . . SECTION 2. . . . The medical staff shall review and investigate all the information . . . any privilege changes . . . ARTICLE VI. CLINICAL PRIVILEGES . . . (a) Every practitioner . . . by virtue of medical staff membership or otherwise, shall in connection with such practice, be entitled to exercise only those clinical privileges specifically granted to him or her by the medical staff and approved by the Board of Directors . . . (b) Every initial written application for staff appointment must contain a request for the specific clinical privileges desired within the applicant's speciality. . . . The applicant shall have the burden of establishing his or her qualifications and competency in the clinical privileges requested. . . ."

Review of event reports within the past six months occurred on 08/08/16. An event report, dated 04/24/16, identified an incident where a physician (#2) attempted a shoulder reduction and was "unsuccessful." Internal review of the incident identified the family consented to allowing a FNP [family nurse practitioner (#3)] attempt to reduce the shoulder "which he did without any incident. . . ."

Review of Physician #2's credentialing file showed medical staff approval for appointment on 02/18/15 and the governing body approval on 02/26/15 for the years 2015 and 2016. The "DELINEATION OF MEDICAL PRIVILEGES DESIRED" did not include any orthopedic privileges including shoulder dislocations.

Review of an affiliate staff member's, FNP #3, credentialing file showed an application submitted on 10/02/15 for the practitioner's appointment along with a list of privileges requested. The file showed medical staff approval for appointment and delineation of privileges occurred on 12/16/15, and the governing body approval for the same on 12/21/15. The "DELINEATION OF MEDICAL PRIVILEGES DESIRED" did not include privileges for shoulder dislocations.

During interview on 08/10/16 at 11:25 a.m., a physician (#1) stated practitioners need to request specific privileges with appointment/ reappointment applications that they are competent to perform.

Based on observation, record review, review of professional reference, personnel files, policy and procedure review, review of North Dakota Board of Nursing practice statements, and staff interview, the Critical Access Hospital (CAH) failed to ensure the provision of services by failing to ensure staff followed professional standards regarding injectable medications, failing to ensure removal of outdated medications and intravenous fluids, failing to ensure secure storage of medications, and failing to have a system in place to accurately document the removal of medications from the pharmacy in absence of the pharmacist (Refer to C276); failing to ensure staff followed appropriate infection control practices in the Operating Suite and the patient tub room (Refer to C278); and failing to ensure nursing staff administered conscious sedation in accordance with facility policy and the North Dakota Board of Nursing requirements (Refer to C297). Failure to ensure the provision of services placed patients at risk of receiving improper care and could result in the patients experiencing adverse consequences.

MULTI-DOSE VIALS

1. Based on observation, review of professional references, and staff interview, the Critical Access Hospital (CAH) failed to ensure staff followed professional standards regarding injectable medications in the Physical Therapy Department (PT) and Emergency Rooms (ERs) on 2 of 3 days of survey (08/08/16 and 08/10/16). Failure to utilize proper technique when accessing multi-dose vials (PT) and failure to dedicate multi-dose vials accessed in the immediate patient care environment to one patient (ERs) placed patients receiving injections at risk of contracting an infection.

Findings include:

The Centers for Disease Control and Prevention document "Frequently Asked Questions (FAQs) regarding Safe Practices for Medical Injections," updated 02/09/11, stated, ". . . A multi-dose is a vial of liquid medication intended for parenteral administration (injection or infusion) that contains more than one dose of medication . . . Multi-dose vials should be dedicated to a single patient whenever possible. If multi-dose vials must be used for more than one patient, they should only be kept and accessed in a dedicated medication preparation area (e.g. [such as], nurses station), away from immediate patient treatment areas. This is to prevent inadvertent contamination of the vial through direct or indirect contact with potentially contaminated surfaces or equipment that could then lead to infections in subsequent patients. If a multi-dose vial enters an immediate patient treatment area, it should be dedicated for single-patient use. . . . Examples of immediate patient treatment areas include operating and procedure room, anesthesia and procedure carts, and patient rooms or bays. . . ."

The APIC (Association of Professionals in Infection Control and Epidemiology) Position Paper: Safe Injection, Infusion, and Medication Vial Practices in Health Care (2016), stated, ". . . MEDICATION VIALS . . . * Disinfect the rubber septum on all vials prior to each entry, even after initially removing the cap of a new, unused vial. * Always use a new sterile syringe and new needle/cannula when entering any vial. Never enter a vial with a syringe or needle/cannula that has been previously used. . . . * Use multidose medication vials for one patient whenever possible. . . . * Store and access multidose vials away from the immediate patient care environment and always use a sterile syringe and needle/cannula each time the vial is accessed. . . ."

- Observation of the Emergency Rooms (ERs) occurred on 08/08/16 at 1:55 p.m. with an administrative nurse (#1) and showed two punctured multi-dose vials of Lidocaine (used for local anesthesia) available for use in ER 102. The nurse (#1) stated staff use the multi-dose vials for more than one patient and do access the vials in the immediate patient care areas.

- Observation of the Outpatient Physical Therapy department occurred on 08/10/16 at 9:10 a.m. with a physical therapist (PT) (#15) and showed a punctured multi-dose vial of dexamethasone (cortisone) and a syringe with a needle attached on the shelf near the vial in the PT office. When asked, the PT stated he used the dexamethasone for Iontophoresis treatments (delivery of medication through the skin by electrical stimulation). The PT stated he used the same needle and syringe to access the vial for more than one patient and does not disinfect the septum prior to accessing the vial. Observation also showed the vial not dated when opened.

OUTDATED MEDICATIONS AND INTRAVENOUS FLUIDS

2. Based on observation, record review, review of facility policy, and staff interview, the Critical Access Hospital (CAH) failed to ensure removal of outdated medications and intravenous (IV) fluids in 3 of 3 areas where staff store medications and IV fluids (Medication room, Emergency Room [ER], and the Operating Room [OR]). Failure to remove outdated medications and fluids may result in patients receiving expired and ineffective medications.

Findings include:

Review of the policy "Outdated Medications" occurred on 08/10/16. The policy, dated August 2011, stated, "POLICY: to outline the inventory management system that ensures outdated drugs and biologicals are not available for patient use. PROCEDURE: 1. Every month an inventory will be done by the Director of Nursing/Assistant Director of Nursing or their designee from the nursing staff to check the medications and biologicals for outdates. . . . 3. the outdated medications will be removed from the shelves where they are located and shall be returned to the Consulting Pharmacist for removal . . ."

- Observation of the ERs occurred on 08/08/16 and 1:55 p.m. with an administrative nurse (#1). The crash cart in the Main ER showed five 50 milliliter (ml) bags of IV dextrose 5% with an expiration date of 07/31/16.

- Observation of the OR occurred on 08/08/16 at 3 p.m. with two administrative nurses (#1 and #2). A cart in the OR showed one 1000 ml bag of IV Lactated Ringers Solution with an expiration date of April 2016.

- Observation of the medication room occurred on 08/09/16 at 8:51 a.m. with an administrative nurse (#2) and identified the following expired medications:
* Bacitracin Zinc ointment: 28 tubes - expired September 2015
* Lidocaine Cream - 3 unopened and 1 opened tube - expired May 2016
* Flu vaccine - 8 tubexes (pre-filled syringes) - expired June 2016
* Omega 3 vitamins - 1 bottle of 30 tablets - expired April 2016
* Sodium Chloride 0.9% for injection on the IV tray - 1 vial expired July 2015

During an interview on the morning of 08/09/16 the nurse (#2) stated the CAH does not have a system to routinely check for outdated medications. She stated the nurses "do it on their down time" and the CAH does not keep a log.


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SECURE STORAGE OF DRUGS AND BIOLOGICALS

3. Based on policy review, observation, and staff interview, the Critical Access Hospital (CAH) failed to ensure secure storage of drugs and biologicals in 1 of 2 radiology departments (computerized tomography (CT)). Failure of the CAH to adequately secure drugs and biologicals created an opportunity for unsafe and unauthorized use.

Findings include:

Review of the policy "Proper storage of drugs and chemicals" occurred on 08/10/16. This policy, effective 06/20/13, stated,
"Applies to: Hospitalwide
Policy: To define the need for proper storage of drugs and biologicals. . . ."
The policy failed to address secure storage of drugs and biologicals in the CT department.

Observation of the CT department, on 08/09/16 at approximately 2:30 p.m., revealed an unlocked portable case on the counter. The case contained medications for use in emergencies. The CT department was unlocked and located in a hallway accessible to the public.

During an interview on 08/09/16 at approximately 2:35 p.m., an administrative radiology staff member (#4) confirmed the facility stored unlocked, unsecured medications in the CT department.


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REMOVAL OF MEDICATIONS FROM THE PHARMACY WHEN THE PHARMACIST IS NOT AVAILABLE

4. Based on observation, review of the North Dakota Century Code, policy and procedure review, and staff interview, the Critical Access Hospital (CAH) failed to have a system in place to accurately document the removal of medications from the pharmacy in the absence of the pharmacist. This failure has the potential to create insufficient distribution, control, and accountability of medications in the CAH.

Findings include:

The North Dakota Century Code, Chapter 61-07-01 "Hospital Pharmacy" stated, ". . . 61-07-01-05. Absence of pharmacist. . . . 1. General. During such times as a hospital pharmacy may be unattended by a pharmacist, arrangements must be made in advance . . . for the provision of drugs . . . in emergency circumstances, by access to the pharmacy. . . . 3. Access to pharmacy. Whenever any drug is not available from floor supplies or night cabinets, and such drug is required to treat the immediate needs of a patient whose health would otherwise be jeopardized, such drug may be obtained from the pharmacy in accordance with the requirements of this section. One supervisory registered professional nurse and only one in any given eight-hour shift is responsible for removing drugs therefrom. . . . a. Removal of any drug from the pharmacy by an authorized nurse must be recorded on a suitable form showing patient name, room number, name of drug, strength, amount, date, time, and signature of nurse. b. Such form must be left with the container from which the drug was removed, both placed conspicuously so that it will be found by a pharmacist and checked properly and promptly; or, in the case of a unit dose, place an additional dose of the drug, or the box, on the form. . . ."

Review of the policy "Removal of drugs and biological from the Pharmacy" occurred on 08/09/16. This policy, dated 06/30/16, stated, "When a pharmacist is not available, drugs and biological are to be removed from the medication room or storage area only by personnel designated to do so. Procedure: . . . 2. The staffed RN's [registered nurses] and LPN's [licensed practical nurses] who have been educated on how to remove drugs and biological from the medication room or storage area may remove drugs and biological in the amounts ordered by the medical provider to be given to individual patients in the absence of a pharmacist. . . ."

Observation of the hospital pharmacy took place on 08/09/16 at 10:30 a.m. with an administrative nurse (#1). The administrative nurse (#1) stated only she and another administrative nurse (#2) have access to the pharmacy to obtain medications for patients in the absence of pharmacy staff. The nurse (#1) explained when a staff member removed a medication from the pharmacy, the staff member placed the box/container from which the staff member took the medication into a red box on the desk counter, so the pharmacist can see what medications staff removed. The nurse (#1) stated staff may also call or talk to the pharmacist regarding removal of a medication, but staff do not document the removal.

Based on observation, review of facility policy, review of professional literature, and staff interview, the Critical Access Hospital (CAH) failed to ensure staff followed appropriate infection control practices in 1 of 1 Operating Suite (Operating Room [OR] and adjacent utility and storage rooms) and in the patient tub room. Failure to follow appropriate infection control practices may result in transmission of organisms and pathogens from equipment/instruments to 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. The requirement was found to be out of compliance during the previous survey on 09/19/12.

- Review of the policy "Cleaning Protocol for the OR" occurred on 08/10/16. The policy, dated 06/05/08, stated, "POLICY: When there are procedures scheduled in the OR, it will be cleaned."

Review of the Association of Perioperative Registered Nurses (AORN) clinical practice guideline "Anesthetic Equipment," updated January 28, 2013, stated, ". . . Laryngoscope blades should be . . . protected from contamination until used. . . . blades should be stored in packages . . . to ensure the blade is protected from contamination. The storage of unpackaged laryngoscope blades is unreliable and leads to questions regarding the safe use of the blades. . . ."

During an interview on the afternoon of 08/08/16, an administrative nurse (#1) stated a physician performs colonoscopies and esophagogastroduodenoscopy (EGD [a scope exam of the gastro-intestinal tract]) once a month. The nurse (#1) stated the physician performs the procedures in the OR.

Observation of the Operating Suite occurred on 08/08/16 at 3 p.m. with two administrative nurses (#1 and #2) and showed the suite consisted of the following rooms:
* An anteroom where staff perform hand hygiene prior to entering the OR
* The OR with an attached soiled utility room
* A clean utility room off the anteroom which included a Steris machine - used to process scopes
* A supply room adjacent and connecting to the anteroom which staff can also access from the main hallway.

Observation in the OR showed a suction canister next to the operating table partially filled with cloudy liquid and an uncovered Yankauer (a large bore suction catheter) attached. The nurses (#1 and #2) stated staff used the suction apparatus during an EGD on 08/04/16 and should have disposed of the apparatus and replaced it with clean supplies when cleaning the OR following the procedure.

Observation of a cart in the OR revealed a drawer with a laryngoscope handle and several unwrapped blades lying loose in the drawer. When asked, an administrative nurse (#1) stated it was not the CAH's practice to sterilize and wrap the laryngoscope blades and/or the handle.

Observation in the supply room adjacent to the OR occurred on 08/08/16 at 3:30 p.m. with a staff member (#22) in charge of sterilizing and showed sterile supplies and equipment stored in the room with a small sterilizer on a table. When asked where staff clean instruments (such as those used in the emergency room and for procedures) prior to sterilization, the staff member (#22) pointed out a sink in the room and stated staff wash the instruments, in the sink and let them dry on a towel on the counter prior to sterilization. Observation showed the sink located next to the door leading into the anteroom. The opposite side of the sink included open shelves on which staff stored cloth towels and unwrapped gauze pads. Staff also stored other supplies on shelves near the sink.

A telephone interview with the staff member (#18) responsible for cleaning the scopes occurred on 08/09/16 at 9:52 a.m. The staff member stated she performs initial cleaning of debris from the scope in the soiled utility room off the OR. The staff member (#18) stated she then takes the scope to the supply room adjacent to the anteroom and does a more thorough cleaning there. Following that, she takes the scope to the Steris in the clean utility room for processing.

Staff cleaning soiled endoscopes and instruments in the supply room sink adjacent to open shelves containing clean supplies may result in contamination of the clean supplies.


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- Review of the policy "Bath, Tub with Whirlpool" occurred on 08/10/16. This policy, dated 02/13/05, stated, ". . .Whirlpool Tub Cleaning: Clean and disinfect the tub after every bath. Procedure: . . . 4. Press and hold the disinfect button . . . 5. . . . thoroughly scrub all interior surfaces of the tub . . ."

Review of the manufacturer's instructions for "Penner Patient Care Whirlpool Disinfectant Cleaner" occurred on 08/10/16. The instructions stated, ". . . Directions for use . . . For Cleaning Fiberglass Bath and Therapy Equipment: . . . Product to surface contact time must be at least 10 minutes for proper disinfection. . . ."

An interview with a nurse aide (#10) regarding cleaning the whirlpool tub occurred on 08/09/16 at 5:45 p.m. When asked how long the disinfectant should remain in the whirlpool tub, the nurse aide (#10) stated "about 5 minutes."

On 08/10/16 at 11:00 a.m., a nurse aide (#6) demonstrated the cleaning of the whirlpool tub after bathing a patient. The staff member mechanically raised the chair from inside the tub and positioned it on the outside edge of the tub, sprayed clean water from the hose onto the inside tub surface, pushed a button on the tub to release disinfectant into the tub, used a sponge type brush to scrub the entire inside surface of the tub, including across the controls, rinsed off and squeezed the liquid out of the scrub brush, and re-sprayed the tub with the water hose. This entire procedure took no longer than three minutes. The staff member then moved the chair over the top of the tub, obtained the squeezed out scrub brush, brushed over the surfaces of the chair, lowered the chair into the tub and immediately rinsed the chair with water. The scrubbing of the surfaces of the chair took no longer than two minutes.


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The CAH's failure to ensure staff thoroughly cleaned the OR after use, properly stored and disinfected the laryngoscope blades and handle, cleaned the scopes and soiled instruments in an area separate from clean supplies, and properly cleaned the whirlpool tub placed patients at risk of contracting an infection.

Based on record review, review of the North Dakota Board of Nursing (NDBON) practice statements, review of facility policy, personnel files, and staff interview, the Critical Access Hospital (CAH) failed to ensure nursing staff administered conscious sedation in accordance with facility policy and the North Dakota Board of Nursing (NDBON) requirements for 1 of 1 closed patient (Patient #5) record reviewed who received conscious sedation from three unqualified nurses (Nurse #19, #20, and #21). Failure to ensure staff administering conscious sedation possessed the necessary qualifications placed patients at risk of an adverse event while receiving conscious sedation.

Findings include:

Review of the NDBON Practice Statement "Role of Registered Nurse (RN) in the Management of Patients Receiving Moderate Sedation/Analgesia for Therapeutic, Diagnostic, or Surgical Procedures" occurred on 08/09/16. The practice statement, revised October 2012, stated, ". . .
B. Qualifications . . . 6. The institution or practice setting has in place an educational/competency validation mechanism that includes a process for evaluating and documenting the individuals' demonstration of the knowledge, skills, and abilities related to the management of patients receiving sedation/analgesia. Evaluation and documentation of competence occurs on a periodic basis according to institutional policy. . . ."

The NDBON practice statement "Role of the RN in Administration of Anesthetic Agents" occurred on 08/09/16. The practice statement, revised July 2013, stated, "Administration or management of patients receiving anesthetic agents used for the purpose of sedation is outside of the scope of practice of the LPN [Licensed Practical Nurse]."

Review of the facility policy "Conscious Sedation" occurred on 08/09/16. The policy, dated August 2013, stated, ". . . 9. RNs should have Advanced Cardiac Life Support (ACLS) training and to be able to follow the directions of the attending provider for the general nursing floor and Emergency Room. RNs that do conscious sedation in the OR will be certified in ACLS and have the training completed for administering and monitoring patients receiving conscious sedation per MCHS' [McKenzie County Healthcare Systems'] guidelines. . . . Nursing Competency 1. RNs will meet the following requirements prior to administering and monitoring conscious sedation/analgesia: * Validated ACLS training * For the OR validated current competency in the administration and monitoring of conscious sedation/analgesia. Validation is achieved by successfully completing a learning module and post-test. Additionally, the RN will be able to demonstrate satisfactory performance in the operation of any equipment that is or may be used to administer conscious sedation/analgesia and manage its side effects and complications. The RN will be required to review annually . . ."

Review of Patient #5's closed emergency room record occurred on August 9-10, 2016. The record identified Patient #5 presented to the emergency room on 04/24/16 at 5:55 p.m. with a dislocated right shoulder. The record showed, during attempts to relocate the shoulder, three nurses (#19, #20, and #21) administered the following medications used for conscious sedation to Patient #5:
* 6:53 p.m. - Ketamine 100 milligrams (mg) by Nurse #20 (an RN)
* 6:54 p.m. - Fentanyl 150 micrograms (mcg) by Nurse #20
* 7:12 p.m. - Versed 2 mg by Nurse #19 (an RN)
* 7:15 p.m. - Versed 2 mg by Nurse #19
* 7:21 p.m. - Versed 2 mg by Nurse #19
* 7:26 p.m. - Versed 2 mg by Nurse #21 (an LPN)
* 7:37 p.m. - Versed 1 mg by Nurse #19
* 7:38 p.m. - Versed 1 mg by Nurse #21

An interview with an administrative nurse (#1) occurred during observations of the Surgical Suite on 08/08/16 at 3:00 p.m. When asked which nurses were qualified to administer conscious sedation, the nurse (#1) stated the CAH had only one nurse qualified to administer conscious sedation, an administrative nurse (#2).

Review of personnel files occurred on 08/10/16 at 1:55 p.m. with a Human Resources staff member (#5) regarding Nurse #20's qualifications. The staff member identified Nurse #20 as an agency nurse and stated because of this, she had no record of the nurse's qualifications. The staff member (#5) stated, "[Name Travel Agency] has that information," and stated the CAH does not receive the information from the travel agency. The facility provided no evidence of conscious sedation education for the nurses (#19, #20, and #21).

The CAH's failure to ensure only qualified nurses administered conscious sedation placed patient's receiving sedation at risk of an adverse event or complications related to the medication administration.

Based on record review, review of the Medical Staff Rules and Regulations, and staff interview, the Critical Access Hospital (CAH) failed to obtain a properly executed informed consent for 1 of 1 closed patient (Patient #5) record who received conscious sedation in the emergency room (ER). Failure to obtain informed consent did not allow the patient to be fully informed of the procedure including the type of anesthesia used and the risks/benefits of the procedure.

Findings include:

Review of the medical staff "Rules and Regulations" occurred on 08/10/16. The Rules and Regulations stated, "C. GENERAL CONDUCT OF CARE . . . 8. Informed Consent: It is the sole responsibility of the licensed medical professional [sic] secure the patient's competent, voluntary and understanding consent to proceed with treatment or operative procedure. . . . a) Disclosure: In order to obtain the patient's informed consent, the medical staff member who proposes to perform the procedure shall have the duty of making a reasonable disclosure of the available choices with respect to the proposed treatment or procedure. Such a disclosure must include a discussion with the patient or the legally responsible individual of the material and known risks involved; that is, the risks which are significant in terms of their seriousness and likelihood of occurrence. This disclosure must be documented in the medical record and should include the licensed medical professional's assessment of whether the individual understood the disclosure. . . ."

Patient #5's closed ER record, reviewed August 9-10, 2016, identified the patient presented to the ER on 04/24/16 at 5:55 p.m. with a dislocated right shoulder.

An emergency room report, dictated by Provider #2 on 04/24/16 at 7:16 p.m., stated, ". . . emergency department course: X-rays confirm anterior dislocation of the shoulder. The patient was placed in a supine position after signing consent for procedure with sedation was obtained . . . He initially received . . . fentanyl [for pain] . . . He received Ketamine [for sedation] . . . He was placed in twilight sleep. . . . IMPRESSION: Anterior dislocation, right shoulder, attempt at putting the shoulder back in place was unsuccessful."

A second emergency room report, dictated by Provider #3 on 04/24/16 at 8:29 p.m., stated, ". . . Patient initially given . . . Versed [for sedation] . . . The patient is well conscious sedated . . . After 3 attempts, I felt the patient's shoulder pop, and heard the patient's shoulder moved back into place. . . ."

The record showed the patient's father signed a form titled "Consent for Anesthesia Services" on 04/24/16 at 6:40 p.m. The form described several types of anesthesia, but did not include a description of conscious sedation, which staff used for Patient #5 during the procedure. The form also lacked identification of the procedure the provider planned to perform, including an explanation of the possible risks of the procedure.

The emergency room reports lacked evidence the providers (#2 and #3) made a disclosure of the available choices, including a discussion of the risks, and a statement regarding the patient's understanding of the disclosure, and documented the disclosure in the medical record as stated in the Medical Staff Rules and Regulations.

During an interview on 08/10/16 at 1:55 p.m., a quality assurance staff member (#3) confirmed the consent form used for Patient #5 was outdated and stated the CAH had not used the form for several years.

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 12 months reviewed (August 2015-July 2016). Failure to ensure departments report quality of patient care monitoring 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 Improvement Plan" occurred on 08/08/16. This policy, revised 10/2015, stated,
"I. Mission/Vision/Values of McKenzie County Healthcare Systems . . .
The purpose of the quality improvement efforts at McKenzie County Healthcare Systems is to ensure the delivery of high quality patient services, to enhance the safety of patient, visitors, and staff . . .
IV. Goals/Objectives for Quality Improvement Program . . .
Objectives: . . .
6. Integrate quality improvement into processes throughout the organization. . . ."

Reviewed on August 8-9, 2016, the CAH's 2015 and 2016 quality improvement committee reporting schedule listed housekeeping for September 2015, December 2015, March 2016, and June 2016. The schedule did not include pharmacy.

Reviewed on August 8-9, 2016, the August 2015-July 2016 quality improvement committee's monthly meeting minutes lacked evidence housekeeping and pharmacy submitted reports.

During interview on 08/09/16 at 4:15 p.m., a quality improvement staff member (#3) confirmed pharmacy and housekeeping departments had failed to submit monitoring reports to the QA Committee during the past year.

Based on bylaws review, policy 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 by 3 of 3 active and/or courtesy staff physicians (Physicians #1, #6 and #7) credentialed by the CAH. 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:

Review of the "MEDICAL STAFF BY-LAWS" occurred on 08/08/16. These bylaws, adopted 10/20/14, stated, ". . . ARTICLE VI. CLINICAL PRIVILEGES . . . (c) Periodic reappraisal of clinical privileges and the increase or curtailment of some shall be based upon the direct observation of care provided, review of records of patients treated in this or other hospitals and review of the records of the medical staff which document the evaluation of the member's participation in the delivery of medical care. . . ."

Review of the policy titled "PEER REVIEW OF PATIENT HEALTHCARE RECORDS" occurred on 08/10/16. This policy, dated 05/15/12, stated, "It is the policy of McKenzie County Healthcare Systems that we will enter an arrangement with [a named hospital] for ongoing peer review of our medical records. . . . The HIM [health information management] Department will make copies of the records . . . prior to being referred on. . . ."

Review of the "Quality Improvement Plan" occurred on 08/09/16. This policy, revised October 2015, stated, "I. Mission/Vision/Values . .. . is committed to preserving and improving the quality of health of the people we serve. . . . F. Regulatory and Accrediting Agencies . . . include North Dakota Health Care Review . . . The role of these third parties in the Quality Improvement process is to evaluate the organizations provision of care and services as well its program for assessing the quality of care and services. . . ."

During interview on 08/09/16 at 11:26 a.m., an administrative staff member (#2) stated the CAH had not requested peer review from an outside source for over a year, to evaluate the quality and appropriateness of the diagnosis and treatment furnished by the CAH's physicians.