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Based on policy and procedure review and staff interview, the Critical Access Hospital (CAH) failed to ensure one of the required members of a group of professional personnel annually reviewed the CAH's health care policies and procedures in 2015 for 12 of 12 departments (Nursing, Surgery, Anesthesia, Sterile Processing, Emergency Department, Infection Control, Health Information Management, Rehabilitation Services, Dietary, Pharmacy, Laboratory, and Radiology) reviewed. Failure to have the required group of professional personnel annually review the CAH's health care 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 policies and procedures occurred on all days of the survey. The following departments' health care policies and procedures lacked evidence of annual review in 2015 by one of the required members (a physician assistant/nurse practitioner/clinical nurse specialist) of a group of professional personnel: Nursing, Surgery, Anesthesia, Sterile Processing, Emergency Department, Infection Control, Health Information Management, Rehabilitation Services, Dietary, Pharmacy, Laboratory, and Radiology.

During interview on 11/09/16 at 9:30 a.m., an administrative staff member (#3) confirmed the CAH failed to ensure a physician assistant/nurse practitioner/clinical nurse specialist annually reviewed the CAH's health care policies and procedures.

Based on observation, review of the North Dakota Century Code, and staff interview, the Critical Access Hospital (CAH) failed to limit and prevent access by unauthorized personnel in 1 of 1 medication room located in an off-site speciality clinic. This failure allowed an opportunity for unsafe and unauthorized access and/or use of medications and had the potential to create insufficient distribution, control, and accountability of medications.

Findings include:

The North Dakota Century Code, Chapter 61-07-01 "Hospital Pharmacy" stated, ". . . 61-07-01-06. Physical requirements. . . . 3. Storage. All drugs must be stored in designated areas . . . which are sufficient to ensure proper . . . security. . . . 6. . . . so as to prevent access by unauthorized personnel. . . ."

Observation of an off-site speciality clinic took place on the morning of 11/08/16 with a supervisory nurse (#6). This nurse stated nursing staff utilize a badge to access the medication room as well as environmental services staff to empty the garbage after hours. Observation of the medication room identified unlocked cabinets with medication for three of the four disciplines providing services within the clinic specifically podiatry, orthopedics and wound care. The medications within the cabinets included, in part, injectables of Lidocaine (local anesthetic), Kenalog-10 (anti-inflammatory), Betamethasone sodium phosphate (anti-inflammatory), and Depomedrol (anti-inflammatory). Non injectable drugs included, in part, silver nitrate sticks (used for cauterization), and a Lidocaine topical product.

During an interview on 11/08/16 at 2:30 p.m. an administrative staff member (#1) stated he was unaware environmental staff had access to the clinic medication room and confirmed they should not have access.

During an interview on 11/09/16 at 9:30 a.m. an administrative staff member (#4) confirmed environmental staff should not have access to the clinic medication room.

Based on observation, review of professional literature, and staff interview, the Critical Access Hospital (CAH) failed to ensure staff followed professional standards of care related to infection control practices observed in 3 of 3 operating rooms (OR #1, #2, and #3). This failure had the potential to lead to contamination and may have allowed transmission of organisms and pathogens to patients.

Findings include:

Review of the American Association of Nurse Anesthetists (AANA) document, "Infection Control Guide for Certified Registered Nurse Anesthetists [CRNA]," revised November 2012, stated, ". . . The American Association of Nurse Anesthetists (AANA) has a long history of supporting the infection prevention and control clinical practices of its members, and as such, has a zero-tolerance for practitioner noncompliance with accepted infection prevention and control best practices. . . . CRNAs work in environments considered high-risk for exposure to pathogens via multiple routes. . . . As an imperative to improve patient . . . safety, CRNAs must make infection prevention and control a primary focus in anesthesia care. . . . These recommendations constitute minimum expected behavioral guidelines. . . . Anesthesia Machine Surfaces and Other Environmental Surfaces: The anesthesia machine does not come in direct contact with the patient. However, there is considerable potential for pathogen exposure from the machine to the patient as organisms are carried by the anesthetist's hands. . . . CRNAs should recognize that materials stored on the anesthesia machine may be inadvertently contaminated by other airborne debris . . . during the operative procedure, and therefore, should take protective measures to prevent this. . . . Heat and Moisture Exchangers, Anesthesia Circuits, and Breathing System Filters: . . . Anesthesia circuits may be manufactured as either single patient use items or multiple patient use items . . . CRNAs should pay close attention to anesthesia circuit product labeling. It is important to note that the outer surface of the circuit may have contamination when the system is not changed between patients. . . . Key Recommendations for Heat and Moisture Exchangers, Anesthesia Circuits, and Breathing System Filters: . . . Oral Airways and Suction Devices, Stylets, Bougies, Endotracheal Tubes and Connectors and Laryngoscope Blades: Most oral airways and suction devices are disposable and should be treated as clean objects. They should not be allowed to drop on the floor and they should be discarded. Stylets are most commonly supplied as sterile, disposable and for single patient use. Endotracheal tubes . . . also are commonly supplied as sterile and for single patient use. . . . Preventive Measures: Environmental . . . Infection transmission in the operating room environment can be reduced or prevented when appropriate safeguards and precautions are implemented and must be a priority in all settings where patient care is provided. . . . CRNAs shall follow universal precautions whenever caring for patients . . ."

Observation of the surgical department occurred on 11/07/16 at 5:30 p.m. with an administrative staff member (#8) after completion of surgery for the day. The staff member (#8) stated the CAH utilized three OR suites (OR #1, #2, and #3) for surgeries and procedures. Observation of each OR suite showed an anesthesia machine set up for patient use with an attached breathing circuit and anesthesia face mask contained in an open package; and a suction canister with attached tubing and a yankauer contained in an open package, except in OR #3 which showed no package covering the yankauer.

Further observation of the OR suites showed the following supplies placed on top of the anesthesia cart in each room:
*OR #2 - two unpackaged oral airways, a tongue depressor contained in an open package, and an oral/nasal tracheal tube contained in an open package with an attached syringe and stylet. The package of the tracheal tube, labeled sterile, stated, "Do not use if package is opened or damaged."
*OR #3 - four oral/nasal tracheal tubes in differing sizes, each contained in an open package with an attached syringe and stylet. The packages of the tracheal tubes, labeled sterile, stated, "Do not use if package is opened or damaged."

During this time, observation showed an environmental services staff member (#10) terminally cleaning OR #2. When asked about cleaning the anesthesia cart, the staff member (#10) stated she wiped down all outer surfaces of the cart, set any supplies contained on top of the cart aside until she finished cleaning, then placed the supplies back on top of the cart the way she found them.

During an interview at the time of the above observation, an administrative staff member (#8) identified the CRNAs as responsible for the anesthesia machine, cart, and supplies.

During an interview on the afternoon of 11/08/16, an administrative staff member (#9) stated anesthesia staff prepared the anesthesia machines and carts with supplies in advance in the event of an emergency due to the time it takes to prepare the supplies.

Staff failed to store medical supply items in a manner to prevent contamination. Attaching, opening, and placing medical supply items prior to immediate use on a patient increased the risk for contamination.

Based on review of professional literature, policy and procedure review, 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 12 of 20 sampled patients (Patients #3, #6, #7, #8, #9, #10, #11, #12, #14, #17, #18, and #19) records reviewed. Failure to evaluate the patients' responses to PRN medications limited the nursing staff's ability to assess whether the medication achieved the desired effect or if the patients experienced any side effects or adverse reactions from the medication.

Findings include:

Berman and Snyder, "Kozier & Erb's Fundamentals of Nursing: Concepts, Process, and Practice," 9th ed., Pearson Education, Inc., New Jersey, 2012, page 862-870, states, ". . . Process of Administering Medications: When administering any drug . . . 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. Observe for desired effect . . ."

Review of the Hospital's policy titled "Pain, Assessment & Management of" occurred on 11/08/16. This undated policy, stated, "PURPOSE: . . . To measure the effectiveness of treatment . . . Additional assessments of pain are done according to specific unit criteria. a. Emergency Department: Pain level is assessed at least twice within the ER encounter. . . . Methods to measure pain: a. There are 4 different mechanisms for measuring pain. 1) 0-10 numerical scale . . . Reassessment of pain level and assessment on any NEW pain is documented on the Pain Assessment Flowsheet . . . Reassessment of pain level is performed after each pain management intervention, once a sufficient time has elapsed for the treatment to reach peak effect (no longer than 60 - 90 minutes post-intervention). . . ."

- Review of Patient #18's closed inpatient medical record occurred on 11/08/16. The patient's admission occurred on 07/27/16 and diagnoses included pancreatitis. The medication administration record (MAR) identified nursing staff administered prn Zofran 4 milligrams (mg) intravenously (IV) on 07/28/16 at 12:47 a.m. for nausea and vomiting. A progress note, on 07/28/16 at 12:43 p.m. stated, "Giving Zofran and iv [intravenous] Fluids Npo [nothing by mouth] [sic]." The next nursing note entry occurred on 07/29/16 at 12:15 a.m., nearly 24 hours after the administration of the Zofran and did not include a re-assessment.

- Review of Patient #19's closed medical record occurred on 11/08/16. Diagnoses included pyelonephritis and urinary tract infection.
A nursing note on 09/29/16 at 5:30 p.m. identified the patient experienced pain, and the MAR identified nursing staff administered prn Dilaudid (used to treat moderate to severe pain) 2 mg IV on 09/29/16 at 5:31 p.m. The next documented note on 09/29/16 at 9:18 p.m. lacked evidence staff re-evaluated the patient's pain. The nursing note at 9:18 p.m., nearly four hours later, stated staff notified the physician as the Dilaudid was ineffective. The MAR also identified nursing staff administered prn Reglan, used to treat certain conditions of the stomach and intestines, on 09/30/16 at 9:11 p.m. Staff documented the next note on 10/01/16 at 4:29 a.m., over seven hours later.

- Review of Patient #14's closed medical record occurred on 11/07/16. Diagnoses included amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. On 09/10/16, the MAR identified nursing staff administered Xopenex (inhalation treatment) a one time order of 1.25 mg at 8:35 p.m.; Ativan (used for anxiety), a one time order of 1 mg at 9:30 p.m.; a prn dose of Ativan 0.5 mg and Zofran 4 mg at 11:08 p.m. The record lacked an assessment for the effectiveness of each dose administered.

- Review of Patient #6's emergency room (ER) record occurred on 11/09/16 and identified an admission to the ER on 11/07/16. Diagnoses included left arm pain and muscle spasm. The ER record identified the patient's chief complaint as having "excruciating pain when flexing arm" with the pain worsening the 48 hours before coming to the ER. The MAR identified staff administered Morphine sulfate (M.S.) (used for severe pain) 2 mg at 4:33 p.m. and 4 mg at 5:30 p.m. A nursing note, documented at 8:02 p.m., stated the patient's pain was "very controlled," two and a half hours after the last dose of M.S.

- Review of Patient #7's ER record occurred on 11/09/16 and identified admission to the ER on 11/07/16. The ER provider note stated, ". . . pt [patient] has severe 10/10 R) [right] hip pain . . ." The MAR identified staff administered M.S. 4 mg at 5:46 p.m. and reassessed the pain at 7:40 p.m., nearly two hours later; and administered Zofran 4 mg IV at 4:21 p.m. The record lacked evidence staff reassessed the symptoms warranting the Zofran.

- Review of Patient #8's ER record occurred on 11/09/16 and identified admission to the ER on 11/07/16. Diagnoses included right upper quadrant abdominal pain, rib pain, nausea and vomiting, and cough. The MAR identified the following IV medications administered on 11/07/16: Zofran 4 mg at 3:45 p.m.; Dilaudid 0.5 mg at 4:50 p.m.; and Zofran 4 mg at 5:30 p.m. The record lacked evidence of reassessment.

- Review of Patient #17's medical record occurred on 11/08/16. The record identified the patient required an exploratory laporatomy on 09/30/16. The record identified staff administered Percocet (5 mg oxycodone - 325 mg acetaminophen) (used for moderate pain) on 10/01/16 at 12:36 p.m. and did not reassess the patient's pain until 4:53 p.m., over four hours later; staff administered Percocet on 10/02/16 at 9:11 a.m. for pain of a #7 out of 10 and did not reassess the pain until 3:34 p.m., over 6 hours later.

- Review of Patient #9's inpatient medical record occurred on 11/09/16. Diagnoses included rotavirus. The record identified staff administered acetaminophen 650 mg on 11/05/16 at 4:51 p.m. for right shoulder pain, did not reassess the pain for effectiveness, and administered another dose at 10:34 p.m. On 11/06/16 at 8:02 a.m. staff noted pain of a #7 out of 10 in the abdomen, medicated the patient with acetaminophen 650 mg at 8:43 a.m., and did not reassess the pain until 7:59 p.m., over 11 hours later.

- Review of Patient #3's active patient record occurred on 11/07/16. The record showed staff administered ibuprofen on 11/07/16 at 3:35 a.m. and failed to assess the response to the medication until 8:01 a.m., over four hours later.


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- Review of Patient #12's inpatient medical record occurred on 11/09/16 and identified the CAH admitted the patient on 11/07/16 following a right total knee replacement. Prn pain medications included Percocet 1 to 2 tablets by mouth every four hours prn and Toradol 15 mg IV every six hours prn (both used to treat moderate to severe pain).

Patient #12's MAR and chart notes identified a nurse administered 2 tablets of Percocet on 11/07/16 at 8:22 p.m. for pain and reassessed the effectiveness of the medication at 10:27 p.m., over two hours later. The patient continued to exhibit signs of pain at that time so the nurse administered 15 mg of Toradol IV. The nurse reassessed the effectiveness of the medication on 11/08/16 at 1:00 a.m., over two and a half hours later. A nurse administered 2 tablets of Percocet on 11/08/16 at 6:28 a.m. for pain and reassessed the effectiveness of the medication at 8:30 a.m., two hours later.

- Review of Patient #10's inpatient medical record occurred on 11/08/16 and identified the CAH admitted the patient on 11/07/16 with respiratory distress. PRN pain medications included M.S. 1 to 2 mg every 15 minutes prn.

Patient #10's MAR and chart notes identified a nurse administered 2 mg of Morphine on 11/08/16 at 2:14 a.m. for pain and reassessed the effectiveness of the medication at 5:34 a.m., over three hours later. The patient continued to exhibit signs of pain at that time, and the nurse administered 2 mg of M.S. The nurse reassessed the effectiveness of the medication at 8:15 a.m., over two and a half hours later.

- Review of Patient #11's inpatient medical record occurred on 11/08/16 and identified the CAH admitted the patient on 11/03/16 with pneumonia. prn medications included Norco (5 mg hydrocodone - 325 mg acetaminophen) (used to treat moderate to severe pain) 1 to 2 tablets every six hours and Robitussin DM (guaifenesin - dextromethorphan) (used as a cough suppressant) 10 milliliters (ml) every four hours by mouth.

Patient #11's MAR and chart notes identified a nurse administered 2 tablets of Norco on 11/04/16 at 1:44 a.m. for pain and reassessed the effectiveness of the medication at 5:00 a.m., over three hours later. A nurse administered 10 ml of Robitussin DM on 11/04/16 at 10:13 p.m. for coughing and failed to reassess the effectiveness of the medication.

- Patient #6's inpatient medical record occurred on 11/08/16 and identified the CAH admitted the patient on 11/07/16 at 8:07 p.m. for left arm pain. prn pain medications included acetaminophen 500 to 1,000 mg every four hours.

Patient #6's MAR and chart notes identified a nurse administered 1,000 mg of acetaminophen on 11/07/16 at 10:26 p.m. and reassessed the effectiveness of the medication on 11/08/16 at 1:04 a.m., over two and a half hours later.

During interview on 11/09/16 at 9:15 a.m., an administrative staff member (#6) stated ER nurses conduct rounds in the ER every 30-60 minutes. The records from the ER lacked evidence/documentation staff re-assessed patients after the administration of prn medications given in the ER.

During interview on 11/08/16 at 8:50 a.m. an administrative staff member (#5) stated the facility expects nursing staff to chart results of prn medications and one time doses of medications given.

Based on review of bylaws, review of a professional reference, record review, and staff interview, the Critical Access Hospital (CAH) failed to ensure the timely completion of a post-operative anesthesia evaluation for 1 of 2 sampled surgical records (Patient #17) reviewed. Failure to evaluate anesthesia recovery prior to discharge from the postanesthesia care unit (PACU) limited the CAH's ability to ensure patients received proper care, staff identified complications, staff recognized complications during the post-anesthesia recovery, and staff did not discharge the patient prior to stabilization.

Findings include:

Review of the medical staff's bylaws rules and regulations titled "Jamestown Regional Medical Center Medical Staff Rules and Regulations" occurred on 11/07/16. These rules and regulations, approved 05/25/15, stated, ". . . This Rules and Regulations Manual contains the rules and guidelines for care . . . B. Medical Records . . . 7. OPERATIVE REPORTS: a. Operative reports shall be dictated or written in the medical record immediately following surgery. The operative report shall include . . . 10) disposition of the patient. 11) anesthesia used . . . b. The report shall be transcribed and filed in the medical record within 24 hours of dictation. . . . D. General Rules Regarding Surgical Care . . . 4. Requirements Prior to Anesthesia and Operation . . . b. Pre-operative evaluation and documentation . . . 15. The anesthetist shall maintain a complete anesthesia record to included evidences of preanesthetic evaluation and postanesthetic follow-up of the patient's condition. . . ."

Kozier & Erb's "Fundamentals of Nursing, Concepts, Process and Practice," 10th edition, dated 2016, page 899, states, ". . . Anesthesia may be general or regional . . . Immediate postanesthetic care focuses on assessment and monitoring parameters to prevent complications from anesthesia or surgery. . . ."

Review of Patient #17's medical record occurred on 11/08/16. The record identified the patient required an exploratory laporatomy on 09/30/16. The record included an "Anesthesia Transfer of Care Note" to the PACU at 11:36 a.m. on 09/30/16. The record included an "Anesthesia Post Procedure Evaluation" note dated/completed on 10/03/16, three days following the surgery.

During interview, a nursing staff member (#5) stated staff should complete post-procedure anesthesia evaluations the day of the surgery.

Based on review of bylaws, policy, records, and credentialing files 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 diagnosis and treatment furnished by 5 of 9 reappointed medical staff physicians' (Physicians #1, #2, #3, #4, and #5) credentialing records reviewed from 2014-2016. Failure to have a network hospital or a QIO or equivalent evaluate the quality and appropriateness of the diagnosis and treatment provided 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 "Jamestown Regional Medical Center Medical Staff Bylaws" occurred on 11/07/16. These bylaws, approved 05/25/15, stated, ". . .
Article V - Procedure for Appointment and Reappointment . . .
Section 5.4 Reappointment Process . . .
B. Each recommendation concerning the reappointment of a practitioner . . . shall be based upon the following:
1. the member's professional competence and clinical judgment in the treatment of patients . . ."

Review of the policy titled "MS [Medical Staff] 26: JH [Jamestown Hospital] Medical Staff Peer Review Process Policy and Procedure" occurred on 11/08/16. This policy, approved November 2013, stated,
"Purpose
To define the medical staff mechanism to conduct patient care review for the purpose of analyzing and evaluating the quality and appropriateness of care provided to patients at Jamestown Regional Medical Center. . . .
Policy . . .
5. All Medical Staff peer review will be carried out either through:
a) The Medical Executive Committee (MEC), or
b) An ad hoc Medical Staff Committee assigned peer review authority appointed by the MEC . . .
Definitions . . .
12. External Peer Review - In the event circumstances require peer review through an external reviewer or review panel, such external reviewer or review panel shall be considered for such external peer review . . ."

The policy failed to require evaluation of the quality and appropriateness of the diagnosis and treatment furnished by doctors of medicine or osteopathy at the CAH by a network hospital or QIO or equivalent for all physicians.

Reviewed on 11/08/16, 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 diagnosis and treatment furnished by Physicians #1, #2, #3, #4, and #5.

Reviewed on 11/08/16, the 2014-2016 credentialing files failed to include evidence of the evaluation of the quality and appropriateness of the diagnosis and treatment furnished by doctors of medicine or osteopathy at the CAH by a network hospital or QIO or equivalent before the following reappointments in 2014-2016:
- Physician #1 August 2015
- Physician #2 October 2016
- Physician #3 January 2015
- Physician #4 November 2014
- Physician #5 April 2016

Upon request on 11/08/16, the CAH failed to provide evidence a network hospital or a QIO or equivalent evaluated the quality and appropriateness of the diagnosis and treatment furnished by Physicians #1, #2, #3, #4, and #5 before reappointment in 2014-2016.

During interview on 11/08/16 at approximately 4:30 p.m., an administrative staff member (#3) confirmed Physicians #1, #2, #3, #4, and #5 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 before reappointments in 2014-2016.