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Based on record review, medical staff rules and regulation review, and staff interview, the Critical Access Hospital (CAH) failed to ensure the availability of a health care practitioner for patients presenting to the emergency department (ED) on a 24-hour a day basis for 5 of 16 closed ED records (Patient #9, #10, #13, #14, and #15) reviewed. Failure to ensure the availability of 24 hour emergency services for patients presenting to the ED placed patients seeking emergency treatment at risk of not receiving appropriate care and treatment.

Findings include:

Review of the CAH's Medical Staff Rules and Regulations occurred on August 22-24, 2011. This document, approved on 01/20/10 and 05/18/11, stated, ". . . VII. EMERGENCY SERVICES A. Cavalier County Memorial Hospital provides emergency services. The medical staff provides on-call coverage on a rotation basis. The on-call provider is available within 30 minutes. . . ."

Review of the facility's ED log occurred on 08/22/11. Information recorded on the ED log included, in part, the date and time of admission, a medical record number, age, name of health care practitioner, nature of injury, services rendered, and disposition. A random review of entries in the ED log showed "Comfort Call" listed under the heading for services rendered.

During interview on 08/22/11 at 4:35 p.m., an administrative staff nurse (#2) identified the use of the term "comfort call" meant the health care practitioner did not come into the emergency room to examine the patient.

Review of Patients #9, #10, #13, #14, and #15 closed medical records occurred on August 23-24, 2011.

- The ED log identified Patient #9, a 5 year old male, presented to the ED on 10/02/10. The log stated, "Comfort Call."

Patient #9's closed record identified the patient presented to the emergency department on 10/02/10 at 11:15 a.m. The CAH nursing staff notified/called the on-call health care practitioner and received a verbal order to administer Rocephin (an antibiotic) 1 gram intramuscular (IM) to the patient. The arrival time of the health care practitioner as documented on the CAH's "Outpatient Emergency Room Record" stated "comfort call." The nursing assessment identified Patient #9 as afebrile; with normal mental, cardiovascular, respiratory, neurological, and abdomen status; pale skin color; refusal to take oral medication; and "here for IM antibiotics." The child received an injection at 11:32 a.m., "tolerated well [with] some crying," and the CAH discharged the child with parent at 11:50 a.m.

The medical record lacked evidence the health care practitioner examined Patient #9.

- The ED log identified Patient #14, a 57 year old female, presented to the ED on 04/02/11. The log stated, "Out of meds [medications]."

Patient #14's closed record identified the patient presented on 04/02/11 at 2:00 p.m., and the CAH nursing staff notified/called the health care practitioner. The nursing assessment stated, "Metformin (a medication used to treat hyperglycemia) 500 mg [milligrams] po [orally] bid [two times a day]. Had ordered from pharmacy yesterday et [and] did not get in today's mail. 'Will be out tonight. Can I get more?'" The health care practitioner wrote an order for the nursing staff to dispense five tablets of Metformin to Patient #14.

The medical record lacked evidence the health care practitioner examined Patient #14.

- The ED log identified Patient #15, an 81 year old female, presented to the ED on 05/03/11. The log stated, "cc [Comfort Call]."

Patient #15's closed record identified the patient presented on 05/03/11 at 7:30 p.m. The time the CAH nursing staff notified the on-call health care practitioner, as documented on the CAH's "Outpatient Emergency Room Record," stated "cc." The nursing assessment stated, "Clinic F/U [follow-up] on today's CT scan. [Positive] abscess to buttock. Pt not seen." The on-call health care practitioner wrote an order for the nursing staff to "Dispense: Cephalexin (an antibiotic) 500 mg. Take 1 po bid. #2 [indicates two tablets]. [no] RF [refills]."

The medical record lacked evidence the health care practitioner examined Patient #15.

- The ED log identified Patient #13, a 53 year old female, presented to the ED on 06/13/11. The log stated "cc."

Patient #13's closed record identified the patient presented and the CAH nursing staff notified the health care practitioner on 06/13/11 at 11:48 p.m. The time of the health care practitioner arrival in the ED, as documented on the CAH's "Outpatient Emergency Room Record," stated "cc." The nursing assessment identified Patient #13's chief complaint as "[lower] abd [abdominal] pain - constipated. Had back surgery on 06/02/11. Trouble having BM [bowel movement] - states couple of BM's past 2 weeks. Taking OxyContin 10 mg BID - eating ok. BM's hard - Taking softener also. Took stool softener (4), Miralax - capful- [no] results. [complaints of] pain in back [with] straining. states 'Not too bloated.' Passing some flatus. Appetite fair. Last BM on 06/09/11 - hard. Denies feeling bloated 'It's more like a pressure.' Bowel sounds present x4 [times four]. Tender [lower] quadrant on palpation." The CAH nursing staff received a telephone order from the on-call health care practitioner to administer Fleets Enema x2 [times two] and Soap Suds Enema to Patient #13.

The medical record lacked evidence the health care practitioner examined Patient #13.

- The ED log identified Patient #10, a 6 month old infant, presented to the ED on 06/18/11. The log stated, "cc."

Patient #10's closed record identified the patient presented on 06/18/11 at 2:46 p.m. with complaints of a "rash under chin [for] 1 mo [month]." The nursing assessment stated, "Mom states rash under chin on et [and] off [times] 1 mo. To clinic . . . powder given - lost it - using baby powder. dk [dark] red - smells. [left] eye matted. [no] cough, fever, runny nose. Was given nystatin powder 05/09/11." The CAH nursing staff notified/called the on-call health care practitioner at 2:56 p.m. and received a verbal order for "Clotrimazole cream BID."

The medical record lacked evidence the health care practitioner provider examined Patient #10.

Based on record review, staff interview, and policy review, the Critical Access Hospital (CAH) failed to perform the weekly checks of the emergency generator for 12 of 16 weeks (05/13, 06/10, 06/17, 06/24, 07/01, 07/08, 07/15, 07/22, 07/29, 08/05, 08/12, and 08/19) reviewed in 2011 and failed to perform the monthly checks of the emergency lighting for 3 of 7 months (May, June, and July) reviewed in 2011. Failure to perform the generator and emergency lighting checks limits the CAH's ability to ensure the availability of power and lighting during an emergency power outage.

Findings include:

Review of the policies "Emergency Power and Lighting," "Generator (Emergency)," and "Emergency Lighting" occurred at approximately 10:30 a.m. on 08/23/11.
- The policy "Emergency Power and Lighting," undated, stated, ". . . The emergency power generator operates virtually all lighting systems and all essential power. All patient care equipment and areas are included in the emergency power generator. The generator is tested twice a month with a load and without a load. . . . Tests are documented by the maintenance department. Records are maintained in the maintenance department."
- The policy "Generator (Emergency)," undated, stated, ". . . Weekly: 1)Run Emergency Generator four (4) times per month for thirty (30) minutes per run. . . ."
- The policy "Emergency Lighting," undated, stated, ". . . Monthly: 1) Test emergency lighting for ten (10) seconds."

Reviewed at approximately 9:20 a.m. on 08/23/11, the 2011 weekly generator checks records indicated staff had not checked the generator in July and August; missed three weeks in June; and missed one week in May. Reviewed at approximately 9:20 a.m. on 08/25/11, the 2011 monthly emergency lighting checks records indicated staff had not checked the emergency lighting in May, June, and July.

During interview at approximately 9:25 a.m. on 08/23/11, an administrative plant operations staff member (#4) confirmed the CAH had not performed the weekly generator and monthly emergency lighting checks as required.

Based on bylaws review, record review, and staff interview, the Critical Access Hospital's (CAH's) governing body failed to follow the bylaws for appointment to medical staff for 5 of 12 providers' files reviewed (Providers #1, #2, #3, #4, and #5). By failing to approve privileges according to the CAH's bylaws, the governing body did not ensure the providers possessed the necessary qualifications and competency for medical staff membership.

Findings include:

Review of the BYLAWS OF THE CAVALIER COUNTY MEMORIAL HOSPITAL ASSOCIATION occurred on 08/23/11. These bylaws, approved 10/21/09 and 05/02/11, stated,
". . . Article VIII Medical Staff
Section 1. Organization, Appointments and Hearings
a. . . . The Board of Directors shall consider recommendations of the medical staff and appoint to the medical staff . . . physicians who meet the qualifications for membership . . .
c. All appointments to the medical staff shall be for two years only . . ."

Review of the CAVALIER COUNTY MEMORIAL HOSPITAL MEDICAL STAFF BYLAWS occurred on 08/22/11. These bylaws, approved 01/20/10 and 05/18/11, stated, ". . . Article III: Medical Staff Membership . . .
Section 4. Conditions and Duration of Appointment
A. . . . The Board [governing body] shall act on appointments, re-appointments, or revocation of appointments only after there has been a recommendation from the Medical Staff Committee as provided in these bylaws. . . .
B. Initial appointments shall be for a period of 6 months. This is considered a provisional appointment . . . In the event of successful provisional appointment, the appointment to the active medical staff shall be for two years, following completion of their initial 6 month appointment. All reappointments will be or a period of two years. . . .
C. Appointments . . . confer on the appointee only such professional and clinical privileges as have been recommended and granted by the medical staff committee and as approved by the Governing board in accordance with these bylaws. . . ."

Review of the providers' credentialing files occurred on 08/24/11 at approximately 7:45 a.m. and indicated the following:
- Provider #1: the governing board approved appointment on 06/16/10 before the medical staff recommended appointment on 07/09/10. Provider #1 began furnishing treatment for the CAH's patients on 06/16/10.
- Provider #2: the file lacked evidence the governing body reapproved the appointment after the six month initial provisional appointment ended on 01/18/08. Provider #2 furnished treatment for the CAH's patients after 01/18/08 without privileges until reappointment on 07/15/09.
- Provider #3: the file lacked evidence the governing body reapproved the appointment for family practice privileges after the six month initial provisional appointment ended on 10/21/10. Provider #3 furnished treatment for the CAH's patients after 10/21/10 until the present time without privileges.
- Provider #4: the governing board approved reappointment on 08/19/09 and the previous appointment ended on 06/20/09. Provider #4 furnished treatment for the CAH's patients during this approximate two month time period without privileges.
- Provider #5: the governing board approved reappointment on 06/15/11 and the previous appointment ended on 05/20/11. Provider #5 furnished services to the CAH's patients during this approximate three week time period without privileges.

During interview at approximately 11:20 a.m. on 08/24/11, an administrative staff member (#2) confirmed medical staff did not recommend appointment of Provider #1 before the governing board approved appointment and Provider #1 started treating patients on 06/16/10; the CAH did not reapprove Provider #2 and Provider #3 six months after their provisional initial appointments ended and Provider #2 and Provider #3 provided treatment to the CAH's patients after the provisional appointment ended; the CAH did not reappoint Provider #4 after the two year appointment ended on 06/20/09 and Provider #4 provided treatment to the CAH's patients without privileges; and the CAH did not reappoint Provider #5 after the two year appointment ended on 05/20/11 and Provider #5 provided treatment to the CAH's patients without privileges.

Based on observation, policy and procedure review, and staff interview, the Critical Access Hospital (CAH) failed to store medications in a manner to prevent access by unauthorized personnel in 1 of 1 medication room on the nursing unit. Failure of the CAH to adequately secure and restrict access of all medications created an opportunity for unsafe and unauthorized use of medications.

Based on review of the North Dakota Department of Health, Division of Health Facilities provider files, this facility has not sustained correction of this issue. This requirement was found to be out of compliance during the previous survey completed on 01/16/08.

Findings include:

Review of the policy "Medications - Storage, Restocking, Requisitioning, Disposal" occurred on 08/24/11. This policy, revised 07/07/10, stated, "It is the policy of Cavalier County Memorial Hospital that all medications will be stored in secured locations . . . Pharmacy as well as Nursing staff is responsible for the safe and secure storage of all medications on the nursing unit. . . . Storage: All medications shall be kept in secured locations. Medication Room - is secured with a keyless badge access lock as well as a keyed lock - Only the nursing staff will be allowed to access this room and reports of room access will be run periodically and verified by the Director of Nursing. A key to this room is kept by the Director of Nursing as well as the nurses on duty . . ."

- Observation of the medication room on the nursing unit with a nurse (#13), on 08/22/11 at 4:20 p.m., showed the room locked with a keyless badge access lock system. The nurse (#13) stated nursing staff accessed the Medication Room with their own personal badge. The badge unlocked the door to the Medication Room when staff swiped the badge across the key fab outside the door. The nurse (#13) stated the facility only allowed nurses access into the medication room and identified administration activated the badges.

- Observation on 08/23/11 at 8:33 a.m. showed the door to the medication room on the nursing unit propped open while an unidentified housekeeping staff member cleaned the room. A nurse (#9) entered the medication room, walked past the housekeeping staff member, prepared medications for administration to a patient, and left the medication room while the housekeeping staff member remained in the room unsupervised.

- Observation on 08/23/11 at 9:05 a.m., showed a ward clerk (#12) knocked on the door of the medication room while a nurse (#10) inside the room prepared medications for administration to a patient. The nurse (#10) opened the door to the medication room, letting the ward clerk (#12) into the room, and left the room to administer medications while the ward clerk (#12) remained in the room unsupervised.

- Observation on 08/23/11 at 4:15 p.m., showed the ward clerk (#12) entered the medication room per self with her personal badge. Observation showed no other CAH staff members in the medication room, close to the room, or at the nurses station located outside the medication room.

- Observation on 08/24/11 at 8:25 a.m., showed the ward clerk (#12) opened the door to the medication room per self with her personal badge.

During an interview on 08/24/11 at 9:25 a.m., one administrative nurse (#3) stated the facility allowed nursing staff and ward clerk staff access to the medication room on the nursing unit. The nurse (#3) stated administration could run a "room access report" if needed and view all staff who entered the medication room. Another administrative nurse (#2) stated housekeeping staff may access the medication room for cleaning, but needed nursing staff to open the door and stay in the room with the housekeeping staff while cleaning the room. The nurse (#2) stated she was unaware of ward clerk staff entering the medication room and agreed the facility should only allow nursing staff access.

Based on review of policy and procedure, review of infection statistics worksheets, review of the infection log, record review, and staff interview, the Critical Access Hospital (CAH) failed to implement a system to identify, report, and control infections and communicable diseases for outpatients of the CAH and failed to maintain a complete infection control log which included all incidents of infections and pertinent patient information regarding infections for the past 9 of 9 months reviewed (November 2010 through July 2011). Failure to identify and address all incidents of infections among patients has the potential for infections to go unreported, spread or reoccur, affecting the health of all patients, personnel, and visitors of the CAH.

Findings include:

Review of the policy "Patient Infection Log" occurred on 08/24/11. This policy, undated, stated, "To record all patient infections and communicable diseases to identify patterns, trends . . . The HUC [Health Unit Clerk] will take responsibility to record the patient and necessary information on the 'Infection Log' on every known or suspected patient infection. All patient infections (whether community or hospital acquired) need to be logged. The infection log will be reviewed by the Infection Control Team and reported to the QA [Quality Assurance] Committee quarterly. . . . The following patients will be included on the 'Infection Log': 1) All patients on antibiotics . . . 2) All patients with possible infectious processes, even if not currently on antibiotics. . . . 3) All patients started with a new antibiotic or identified with a newly acquired infection after admission . . ."

Review of the policy "Infection Control Team" occurred on 08/24/11. This policy, undated, stated, "To contribute to better patient care by furnishing data needed for surveillance to improve and implement prevention, control, and investigation of infections and communicable diseases of patients and personnel. The responsibilities of the infection control duties will be shared by a team consisting of at least one Infection Control Coordinator and one Infection Control Nurse. . . ."

Review of the policy "Healthcare Associated Infections (HAI)" occurred on 08/24/11. This policy, undated, stated, ". . . The infection control team shall review the Infection Log and record the information onto the Infection Statistics Worksheet. . . . Any infection suspected of being an HAI will then have a Healthcare Associated Infection Worksheet completed . . . This worksheet shall include the patient's name . . . admit date, date of infection, site of infection, list of antibiotics, and any information (such as lab results) showing support of infection diagnosis and/or antibiotic susceptibility patterns. Any required or continued action will also be recorded. . . ."

Reviewed on 08/24/11, the infection statistics worksheets (information reported to the QA Committee by the infection control coordinator) and the infection logs from November 2010 through July 2011 lacked evidence the CAH identified and recognized infections of outpatients. Further review of the infection log revealed the CAH failed to maintain a complete log with pertinent patient information related to infections which included: signs and symptoms of infection, whether staff collected cultures and the results of the cultures, whether staff administered antibiotics and the type of antibiotic, how the patient acquired the infection (HAI or community), and follow-up completed.

- Review of Patient #21's closed inpatient record occurred on 08/23/11 and identified CAH staff obtained blood cultures from the patient on 12/30/10. Patient #21's blood culture report identified "Prevotella Loescheii", a type of bacteria known to cause infection. The infection control log failed to include this patient.

- Review of Patient #7's closed Emergency Room (ER) record occurred on 08/23/11 and identified the patient presented to the ER on 02/24/11 with "leakage from abdominal wound" from a previous left hemicolectomy surgery at another facility. Record review showed CAH staff obtained a culture of the wound in the ER and administered an intravenous antibiotic to Patient #7. The infection control log failed to include this patient.

- Review of Patient #27's closed swing bed record occurred on 08/23/11 and identified CAH staff obtained a urine culture from the patient on 05/31/11. The infection control log failed to include this patient.

During an interview on 08/24/11 at 11:00 a.m., an infection control committee member (#14) stated the committee consisted of three CAH staff members including herself and mentioned the infection control committee does not have "set" meetings, adding the committee discussed policies and addressed questions or concerns as they arose. The staff member (#14) stated the ward clerk documented patients admitted with infections and patients within the CAH who developed signs and symptoms of infection into the infection control log; and stated the infection control coordinator reviewed the information from the infection control log and presented the information to the QA Committee quarterly. The infection control committee member (#14) confirmed the facility did not include Patients #7, #21, and #27 in the infection control log.

During a telephone interview on 08/24/11 at 2:24 p.m., the infection control coordinator (#8) stated she reviewed the infection log, patient records, and lab reports every two weeks to identify trends or patterns and confirmed the facility may have already discharged the patients before this review. The staff member (#8) stated she obtained further information only for patient's with HAI including lab results, antibiotics, and action taken. The infection control coordinator (#8) confirmed the process for documenting patients with infections in the infection log as identified by staff member (#14) in the above interview and stressed staff must document all patients with known or suspected incidents of infection in the infection log.

Based on observation, professional literature review, policy and procedure review, record review, and staff interview, the Critical Access Hospital (CAH) failed to evaluate the safe use of side rails, failed to assess each patient individually prior to utilizing side rails, failed to consider side rails as a potential restraint and ensure restraint use in accordance with the order of a medical provider responsible for the care of the patient, and failed to provide education to the patient and the responsible party regarding the hazards of side rail use for 4 of 4 active patients (Patient #1, #2, #3, and #4) observed with elevated side rails; and failed to recognize the risks associated with falls and implement appropriate interventions to manage or prevent falls for 1 of 2 closed inpatient records (Patient #25) reviewed who experienced a fall from the bed with elevated side rails.

Failure to assess and evaluate the use of side rails, to consider side rails as a potential restraint and ensure the use of restraints in accordance with the order of a medical provider, and to educate patients and responsible parties regarding the hazards of using side rails placed Patients #1, #2, #3, and #4 at risk of psychological harm, entrapment or injury, and restricted their movement. Failure to recognize the risks associated with falls and take action to manage or prevent falls caused an unsafe environment for Patient #25.

Findings include:

FDA (Food and Drug Administration) Safety Alert: Entrapment Hazards with Hospital Bed Side Rails, August 23, 1995, and Joint Commission on Accreditation of Healthcare Organization: Sentinel Event Alert, Issue 27, September 6, 2002, identified bed rail-related entrapment deaths and injuries can occur in the elderly population, who are often at risk due to limited mobility, psychoactive or sedative medications, confusion, sedation, restlessness, lack of muscle control, size and physical deformities. Death by asphyxiation or injuries to the resident's extremities can occur when the resident becomes caught between the mattress and the bed rail; the headboard and the bed rail; or getting his or her head/extremity stuck in the bed rail. Both split and full rails have the potential to cause fall-related injuries as well as entrapment. Additionally fall-related injuries or injuries to extremities can occur when confused/disoriented residents climb over the top of side rails or get an arm or leg entrapped.

The Hospital Bed Safety Workgroup 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. . . . evidence indicates that half-rails pose a risk of entrapment and full rails 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] . . . CMS 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 rails 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 . . . 1. Regardless of the purpose for which bed rails are being used or considered, a decision to utilize . . . those in current use should occur within the framework of an individual patient assessment. . . . 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. . . ."

The United States Department of Health and Human Services, Food and Drug Administration (FDA), and Center for Devices and Radiological Health (CDRH) publication titled, "Guidance for Industry and FDA Staff: Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment", issued on 03/12/06, stated, ". . . For 20 years, FDA has received reports in which . . . patients have become entrapped in hospital beds while undergoing care and treatment in health care facilities. . . . Patient entrapments may result in death and serious injuries. . . . The population most vulnerable to entrapment are elderly patients . . . especially those who are frail, confused, restless . . . In response to continued reports of patient entrapment, the FDA . . . formed a working group in 1999 known as the Hospital Bed Safety Workgroup (HBSW) . . . The HBSW identified 7 potential zones . . . in hospital beds. . . . FDA recommends that healthcare facilities conduct a risk-benefit analysis . . . Three key body parts at risk for life-threatening entrapment in the seven zones of a hospital bed system in this guidance are the head, neck, and chest. . . . "

The HBSW publication titled, "A Guide to Bed Safety - Bed Rails in Hospitals, Nursing Homes and Home Health Care: The Facts", revised April 2010, stated, ". . . Between 1985 and January 1, 2009, 803 incidents of patients caught, trapped, entangled, or strangled in beds with rails were reported . . . Of these reports, 480 people died . . . Most patients were frail, elderly or confused. . . . Patients who have problems with memory . . . or who get out of bed and walk unsafely without assistance, must be carefully assessed for the best ways to keep them from harm, such as falling. . . . Potential risks of bed rails may include: Strangling, suffocating, bodily injury or death when patients or part of their body are caught between rails or between the bed rails and mattress. More serious injuries from falls when patients climb over rails. Skin bruising, cuts, and scrapes. Inducing agitated behavior when bed rails are used as a restraint. . . . Preventing patients, who are able to get out of bed, from performing routine activities . . . Most patients can be in bed safely without bed rails. Consider the following: Use beds that can be raised and lowered close to the floor . . . Keep the bed in the lowest position with wheels locked. When the patient is at risk of falling out of bed, place mats next to the bed . . . Monitor patients frequently. Anticipate the reasons patients get out of bed . . . meet these needs . . . When bed rails are used, perform an on-going assessment of the patient's physical and mental status; closely monitor high-risk patients. . . . Reassess the need for using bed rails on a frequent, regular basis."

Review of the policy "Fall Risk Assessment" occurred on 08/24/11. This policy, effective March 2007, stated, "It is the policy . . . that we assure patients safety while in our facility. . . . 6. The patient's care plan will address the increased risk for falls and will reflect a plan of care specifically designed to meet the needs of that individual patient. 7. The nursing care plan is kept current by ongoing assessments of the patient's needs and the patient's response to interventions and updating the care plan in response to assessments."

Review of the policy "Sitters" occurred on 08/24/11. This policy, revised 12/14/10, stated, ". . . Patients that may benefit from a 'sitter': . . . High risk of falls, Delirium or dementia . . ."

Review of the policy "Restraints" occurred on 08/24/11. This policy, revised 08/18/09, stated, "Patients will be free from any unnecessary restraint. Restraints may only be imposed to ensure the immediate physical safety of the patient . . . Physical restraints are defined as any . . . mechanical device . . . attached or adjacent to the patient's body that the individual cannot remove easily which restricts freedom of movement or normal access to one's body. . . . 2. Patients determined to be at risk for restraint use will have alternatives attempted when ever possible prior to application of the restraint. Restraints will only be applied after all appropriate alternatives have proven ineffective in maintaining patient safety. . . . 4. A RN [Registered Nurse] will inform the provider of a patient's symptoms or concerns that warrant utilization of a restraint and obtain a provider's order . . . 14. Care plan should include: a. Type of restraint or device b. Reason for use . . ."

- Observation of Patient #4 on 08/22/11 at 4:20 p.m., while the patient rested in bed, identified four elevated half rails on the bed.

Review of Patient #4's active medical record occurred on August 22-23, 2011 and identified the CAH admitted the patient on 08/22/11 for fever, hypoxemia, and possible aspiration pneumonia. Patient #4's medical history included dementia. Record review showed a history of falls with the use of bed/chair alarms, lap tray, seat belt, and side rails as interventions for fall prevention at the long term care facility where Patient #4 resided prior to admission to the CAH. The record identified Patient #4 at risk for falls due to the patient's requirement of assistance with ambulation/transfers, confusion, incontinence, medications, and fall history.

Review of Patient #4's Patient Care Summary, dated August 22-23, 2011, showed the patient rested quietly in bed and indicated disorientation to place and time. The Summary showed side rails up times four and indicated the use of a tab alert/bed alarm in the safety section. Review of a form used by the Certified Nurses Aides (CNA) to document patient care, dated 08/22/11, indicated side rails up times four. Patient #4's Kardex, undated, identified the patient as a fall risk and showed bedrest with bed alarm in the activities section. Review of Patient #4's care plan, dated 08/22/11, included the problem "Potential for injury related to unfamiliar surroundings and a history of dementia" and included "side rails up times two or four" as a plan for follow-through.

Patient #4's medical record lacked medical or behavioral need for the four elevated side rails and showed the nursing staff used other interventions including a tab alert and bed alarm as a means to prevent falls and injury, but lacked assessment of these or other less restrictive interventions than the elevated side rails; lacked an assessment of risk and safety for the use of side rails, a provider's order for the use of four elevated side rails, and documentation of monitoring of the side rails; and lacked evidence of patient or responsible party education regarding the hazards of side rail use. The CAH staff failed to consider the side rails as a restraint and potential safety and entrapment hazard.

- Observation of Patients #1, #2, and #3 on all days of survey, while the patients rested in bed, identified two elevated half rails on the beds. Review of Patient #1, #2, and #3's active medical records occurred on August 22-23, 2011. Record review on each patient showed two elevated side rails for safety. The patient's records lacked an individualized assessment of risk and safety for the use of side rails, and lacked evidence of patient or responsible party education regarding the hazards of side rail use. The CAH staff failed to consider the side rails as a potential safety and entrapment hazard for the patients.

During an interview on 08/23/11 at 11:30 a.m., a staff nurse (#9) stated nursing staff elevate the side rails for patient repositioning and indicated safety as the reason for Patient #4's elevated side rails to prevent the patient from falling as the patient is a fall risk. The nurse (#9) stated the nursing staff rarely elevated four side rails on the patient's beds and mentioned nursing staff used tab alerts, bed/chair alarms, placed the bed in low position, and used sitters as interventions for a patient at risk for falls with confusion or a diagnosis of dementia. The staff nurse (#9) stated nursing staff does not perform or document an assessment for risk factors or safety for utilization of side rails.

During an interview on 08/24/11 at 9:25 a.m., an administrative nurse (#2) confirmed nursing staff does not perform an assessment of risk factors or safety for utilization of side rails. The nurse (#2) stated nursing staff usually elevate the side rails for patient positioning and access to bed controls/call light. The administrative nurse (#2) stated the CAH considers elevation of four side rails as a restraint and would require a provider's order, but mentioned it's not the CAH's practice to ever use four side rails. The nurse (#2) stated the nursing staff failed to consider the side rails a restraint, risk for safety, and a potential hazard for entrapment for the patients.


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- Review of Patient #25's closed medical record occurred on August 23-24, 2011, and identified the CAH admitted the patient on 05/01/11 with diagnoses of squamous cell carcinoma and end stage renal failure.

Patient #25's nursing assessment, dated 05/01/11, indicated the patient's neurologic status as "drowsy, confused, slurred speech, and hallucinating."

Patient #25's care plan, dated 05/01/11, included a nursing diagnosis of "Potential for injury R/T [related to] unfamiliar surroundings, with a goal of the patient to remain free from injury while hospitalized, and a nursing intervention of "side rails up times four."

Review of an untitled form showed facility staff elevated/ raised two one-half side rails attached to Patient #25's bed on 05/01/11 and elevated four one-half side rails on 05/02/11.

Patient #25's "24 Hour Patient Care Summary" dated 05/02/11 at 11:20 a.m. stated, "Pt [patient] found on floor - pt hosp [hospital] staff walking by - Pt laying on [right] side on floor- pt alert - ROM [range of motion] done to all extremities - No pain - Moved to blanket et [and] lifted back to bed - Tabs monitor applied et moved to room 161 [a room closer to the nurses station] . . . ."

Patient #25's record lacked an individualized assessment of risk and safety for use of side rails and lacked evidence of patient or responsible party education regarding the hazards of side rail use. Given Patient #25's history of drowsiness, confusion, and hallucinations and attempts to get up out of bed by himself, the CAH staff failed to consider the elevated side rails a safety and entrapment hazard for Patient #25.

Based on observation, review of professional literature, policy and procedure review, and staff interview, the Critical Access Hospital (CAH) failed to ensure nursing staff administered medications and performed tests according to accepted standards of practice during 2 of 5 medication administration observations (Patients #1 and #2 on 08/23/11) and 2 of 2 testing observations (Patient #1 on 08/23/11 and 08/24/11). Failure to confirm identification of a patient prior to medication administration and tests, risked patient safety and has the potential for staff to administer medication or perform tests on the wrong patient.

Findings include:

Berman, Snyder, Kozier, and Erb, "Fundamentals of Nursing, Concepts, Process, and Practice," 8th ed., Pearson Education Inc., Upper Saddle River, New Jersey, 2008, page 712 stated, ". . . Client safety problems can include a variety of errors such as . . . mistaken identity . . ."

Pages 848-849, stated, ". . . Process of Administering Medications. When administering any drug, regardless of the route of administration, the nurse must do the following: 1. Identify the client. Errors can and do occur, usually because one client gets a drug intended for another. . . . In hospitals, most clients wear some sort of identification, such as a wristband with name and hospital identification number. Before giving the client any drug, always check the client's identification band. . . . There are aspects of medication administration that are important for the nurse to check each time a medication is administered. These are referred to as the 'rights.' Traditionally there were five rights to medication administration. More rights have been added . . . with the latest being the ten rights."

Page 850, Box 35-4 stated, "Ten 'Rights' of Medication Administration . . . Right Client. Medication is given to the intended client. . . ."

Page 852-854, Skill 35-1 stated, "Administering Oral Medications . . . Prepare the client. Check the client's identification band. . . . This ensures that the right client receives the medication. . . ."

Review of the policy "Medication Administration" occurred on 08/24/11. This policy, revised 07/07/10, stated, "It is the policy of Cavalier County Memorial Hospital that each patient shall receive medications in a safe manner . . . 1. The procedure for administration of medications shall be followed by all nurses administering medication. . . . 8. When preparing and administering medications, the nurse will observe and comply with the '5 Rights' of Safe Medication Administration: 5. Right Patient - Check identification bracelet with the name on the medication sheet before administering any medication. It is always best to ask the patient their full name and date of birth to verify correct identification. This should be compared to the patient identifiers on the medication record. Whenever possible, the patient should be actively involved in the identification verification process. . . . 18. Procedure specifics: . . . e. Immediately administer . . . medications to the correct patient, double checking their identity . . ."

Review of the CAH's incident and accident reports from the last six months (February through July 2011) occurred on 08/23/11 and showed one incidence in which a staff member administered a medication (insulin) to the wrong patient.

- Observation of medication pass occurred on 08/23/11 at 8:25 a.m. A nurse (#9) prepared to administer oral medications of allopurinol (used to treat gout), furosemide (used to decrease fluid or blood pressure), metformin (used to treat diabetes), and Citracal (a supplement of calcium and vitamin D); and subcutaneous medications of heparin (used to prevent blood clots) and insulin (used to treat diabetes) to Patient #1. The nurse (#9) entered Patient #1's room, handed the oral medications to the patient to self administer, and administered the subcutaneous medications to the patient. Observation showed the nurse (#9) failed to identify the patient prior to medication administration. The nurse (#9) failed to bring the medication sheet into Patient #1's room.

- Observation of medication pass occurred on 08/23/11 at 9:05 a.m. A nurse (#10) prepared to administer oral medications of simvastatin (used to decrease cholesterol), atenolol (used to decrease blood pressure), Oxycontin (used to treat severe pain), fentanyl (used to treat severe pain), folic acid (a supplement), and docusate sodium (used to soften the stool); and a subcutaneous medication of heparin to Patient #2. The nurse (#10) entered Patient #2's room, handed the oral medications to the patient to self administer, and administered the subcutaneous medication to the patient. Observation showed the nurse (#10) failed to identify the patient prior to medication administration. The nurse (#10) failed to bring the medication sheet into Patient #2's room.

- Observation of blood glucose testing occurred on 08/23/11 at 11:40 a.m. with a certified nurse aide (CNA) (#11). The CNA (#11) picked up the blood glucose machine at the nurse station, walked down the hall and entered Patient #1's room, donned gloves, and performed a blood glucose test on the patient with the machine. The CNA (#11) failed to identify the patient prior to performing the test. The CNA (#11) failed to bring any form of identification of Patient #1 into the patient's room.

- Observation on 08/24/11 at 11:55 a.m. showed a CNA (#11) entered Patient #1's room and performed a blood glucose test on the patient with the blood glucose machine. The CNA (#11) failed to bring any form of identification of Patient #1 into the patient's room.

During an interview on 08/23/11 at 9:20 a.m., a nurse (#10) stated she did not confirm Patient #2's identity during medication pass because she knew the patient, but stated CAH policy required staff to identify patients prior to medication administration.

During an interview on 08/24/11 at 9:25 a.m., an administrative nurse (#2) stated the CAH's policy is to perform the five rights of medication administration to identify patients prior to performing medication administration or tests. The nurse (#2) stated she expected staff to obtain identification information from the patient (have the patient speak their name and birthdate), and compare the information with the patient's medical record (medication administration record or test order form) and nameband.

Based on record review, medical staff rules and regulation review, policy and procedure review, and staff interview, the Critical Access Hospital (CAH) failed to ensure completion of written or verbal discharge instructions for 5 of 16 closed emergency room (ER) records (Patients #7, #8, #10, #14, and #18); failed to ensure 1 of 16 closed ER record (Patient #7) and 1 of 2 closed swing bed charts (Patient #27) included laboratory results; and failed to ensure nursing staff completed/carried out the written orders of the health care provider for 3 of 16 closed ER patient records (Patients #7, #8, and #16) reviewed.

Failure to provide written or verbal discharge instructions to ER patients limited the patients' abilities to follow the providers' follow-up care instructions. Failure to ensure records include laboratory results limits the CAH's ability to ensure the providers reviewed the results and staff rendered the proper treatment/services. Failure to document the administration of medications and treatments limits the CAH's ability to ensure staff completed/carried out the providers' orders.

Findings include:

Review of the CAH's Medical Staff Rules and Regulations occurred on August 22-24, 2011. This document, approved on 01/20/10 and 05/18/11, stated, "I. ADMISSION AND DISCHARGE OF PATIENTS . . . H. Patients shall be discharged only on the written order of the attending practitioner . . . II. MEDICAL RECORDS A. The attending practitioner shall be responsible for the preparation of complete and legible medical record for each patient. This record shall include . . . special reports such as consultations, clinical laboratory reports, x-ray reports . . . VII. EMERGENCY SERVICES . . . D. An appropriate medical record shall be kept for every patient receiving emergency service and be incorporated in the patient's hospital record , is [sic] such exists. The record shall include: . . . 4. Description of significant clinical, laboratory, and roentgenolic [sic] findings. 5. Diagnosis. 6. Treatment given. 7. Condition of the patient on discharge or transfer. 8. Final disposition, including instructions given to the patient and/or his family relative to necessary follow-up care. . . ."

Review of the policy "Emergency Room Admission" occurred on 08/24/11. This policy, dated 04/05/10, stated, ". . . 12. A patient medication list shall be obtained and filled in on page four to allow for medication reconciliation. Medication dispensed or administered in the emergency room shall be listed on page three prior to discharge. 13. The patient shall be provided with written instructions upon discharge from the emergency room. Preprinted instructions are available for a number of frequently seen issues. Or at times hand written instructions will be given out. The patient needs to sign that they received and understand the instructions given to them. . . ."

Review of the policy "Documentation-Nursing" occurred on 08/24/11. This policy, dated 12/13/06, stated, "POLICY: All pertinent patient information and assessments relating to the diagnosis, treatment, and procedures will be documented in the medical record. SCOPE OF PRACTICE: Documentation in the medical record will be done within the scope of practice of nursing personnel. PROCEDURE: . . . Specific times of events such as pain medications and treatments, procedures, etc. should be documented in the nurse's notes. . . ."

Review of the following closed patient records occurred on August 23-24, 2011.

- Patient #8, a 40 year old female, presented to the ER on 08/29/10, following an unresponsive episode at work. Patient #8's medical diagnosis include insulin dependent diabetes mellitis. The health care practitioner examined the patient, ordered IV fluids and laboratory testing, admission to the hospital, dietary consult, and information on smoking cessation. Patient #8 refused hospital admission and signed out against medical advice (AMA).

Review of a nurse's note from 11:00 a.m. stated, ". . . Con't [continues] to want to go home. Refuses to be admitted. AMA paper signed. Risks explained to pt [patient] . . . Willing to see Dietitian. . . ." The record lacked evidence the CAH staff initiated a referral to a dietician or provided any verbal or written information regarding smoking cessation to Patient #8.

Review of the Patient #8's health care practitioner's dictated note, dated 08/29/10, stated, "ADDENDUM: . . . She does not want to stay in the hospital . . . She is ready to sign out against medical advice . . . Advised strongly to follow-up with her regular provider sometime next week. Strongly advised to control her blood sugar better with a diet consult and also strongly advised to stop smoking."

Patient #8's Discharge Instructions showed the CAH nursing staff failed to inform Patient #8 to follow-up with her regular provider, control her blood sugar, obtain a dietary consult, and information on smoking cessation. The record showed Patient #8 failed to sign/acknowledge receipt of these verbal instructions from the CAH nursing staff.

- Patient #18, a 78 year old female, presented to the ER on 01/01/11 with right sided epigastric pain and left leg/shin redness. Review of Patient #18's nursing assessment identified the patient rated the pain to her left leg a "4" on 0-10 pain scale.

The health care practitioner examined the patient and ordered Augmentin (an oral antibiotic) 875/125 milligrams (mg) one tablet two times a day for seven days, Tramadol 50 mg orally every six hours as needed for pain, and to follow-up with her regular provider in two days.

Review of Patient #18's written Discharge Medications showed the CAH staff failed to inform the patient to utilize Tramadol 50 mg every six hours as needed for pain. The record showed Patient #18 failed to sign/acknowledge receipt of these written instructions.

- Patient #7, a 61 year old male, presented to the ER on 02/24/11 with complaints of a "bleeding and warm" surgical incision. The on-call health care practitioner examined the patient and ordered Ancef 2 grams (gr) intervenously (IV) times one dose and then 1 gr IV for three additional doses. Review of Patient #7's initial ER record lacked evidence the patient received Ancef 2 gr IV.

Patient #7's health care practitioner's dictated note, dated 02/24/11, identified the following discharge instructions: "Ancef 2 grams IV now and 1 gram q [every] 8 [hours] as an outpatient. Warm pack this area . . . Recheck the wound tomorrow afternoon during 3rd dose of Ancef. He will use Tylenol for discomfort. He will alert us or return if there are any new symptoms such as fever, abdominal pain. or significant worsening of his cellulitis. Culture was taken as well . . . ." Patient #7's closed ER record lacked the results of the wound culture.

Patient #7's Discharge Instructions, dated 02/24/11, stated, "Other instructions: come to hospital 6 a.m., 2 p.m., 10 p.m. for IV antibiotics." The record showed Patient #7 failed to sign/acknowledge receipt of any verbal or written instructions. Patient #7's written discharge instructions lacked information pertaining to the use of warm packs to the incision, taking Tylenol as needed for discomfort, and specific instructions to return for development of a fever, abdominal pain, or significant worsening of the cellulites.

- Patient #14, a 57 year old female, presented to the ER on 04/02/11. The nursing assessment stated, "Metformin (a medication used to treat hyperglycemia) 500 mg [milligrams] po [orally] bid [two times a day]. Had ordered from pharmacy yesterday et [and] did not get in today's mail. 'Will be out tonight. Can I get more?'" The health care practitioner wrote an order for the nursing staff to dispense five tablets of Metformin to Patient #14.

The record showed Patient #14 failed to sign/acknowledge receipt of the written instructions to take the above medication.

- Patient #16, a 79 year old male, presented to the ED on 05/23/11, with complaints of chest pain and low blood pressure. The health care practitioner ordered sublingual nitroglycerin, intervenous fluids, baby aspirin; diagnostic studies including urinalysis, electrocardiogram, and chest x-ray; and a nitroglycerin drip prior to transfer to a tertiary facility. Review of Patient #16's record showed the patient voided 200 cubic centimeters of urine prior to transfer. The record lacked the results of the urinalysis.

- Patient #27, an 87 year old male, presented to the ED on 05/31/11, with complaints of increased weakness, cough, and the need for a urinary catheter change. The health care practitioner ordered laboratory studies including a urinalysis and urine culture. Patient's #27 record lacked the results of the urine culture.

- Patient #10, a six month year old male, presented to the ER on 06/18/11 with complaints of a "rash under chin [for] 1 mo [month]." The CAH nursing staff notified/called the on-call health care practitioner and received a verbal order for "Clotrimazole cream BID."

The record showed Patient #10's parents failed to sign/acknowledge receipt of the written instructions to use the above medication and to call the clinic in two days to see a provider if the symptoms have not resolved.

During interview on 08/23/11 at 4:30 p.m., an administrative nurse (#2) stated she expected nursing staff to write out discharge instructions for all patients discharged from the emergency room and confirmed Patients #7, #8, #10, #14, and #18's closed records failed to contain complete discharge instructions as listed above. This administrative nurse stated she expected all patients or their legal representatives to sign/acknowledge receipt of discharge instructions. This administrative nurse (#2) confirmed Patients #7 and #27's closed records lacked final culture reports/results. This administrative staff nurse (#2) stated she expected nursing staff to document the time staff administers a medication or treatment somewhere within the medical record on either a medication administration record or within the nurse's notes. This administrative nurse confirmed Patients #7, #8, and #16's medical records lacked evidence nursing staff completed/carried out the written orders as listed above.

Based on review of the facility's QA (Quality Assurance) reporting schedule, QA Committee meeting minutes, and staff interview, the Critical Access Hospital (CAH) failed to ensure all departments affecting patient health and safety report to the QA Committee as scheduled for 12 of 12 months reviewed (August 2010-July 2011). Failure to ensure all departments report to the QA Committee as scheduled, limits the CAH's ability to identify risk factors affecting patient care and implement corrective action if necessary.

Findings include:

Review of the "QA Reporting Calendar Cavalier County Memorial Hospital" occurred on 08/24/11 at 1:45 p.m. This schedule, revised 09/10, included the following reporting times:
- Plant Operations - Laundry/Housekeeping/Employee Safety: August, November, February, and May.
- Radiology: October, January, April, and July.

Reviewed at approximately 1:45 p.m. on 08/24/11, the August 2010-July 2011 monthly QA Committee meeting minutes indicated the following departments did not report as scheduled by the QA Committee:
- Plant Operations: scheduled to report four times and reported once in February.
- Laundry: scheduled to report four times and reported once in March.
- Housekeeping: scheduled to report four times and reported once in March.
- Radiology: scheduled to report four times and reported once in April.

During an interview at approximately 3:30 p.m. on 08/24/11, an administrative staff member (#1) and an administrative assistant (#5) confirmed Plant Operations, Laundry, Housekeeping, and Radiology did not report to the QA Committee in the past year as scheduled.

Based on bylaws review, policy review, and staff interview, the Critical Access Hospital (CAH) failed to evaluate the quality and appropriateness of the treatment provided by 2 of 2 nurse anesthetists (Providers #5 and #6) furnishing anesthesiology services to the CAH's patients in 2010. Failure to evaluate the quality and appropriateness of the anesthesiology services furnished has the potential to affect patient outcomes requiring anesthesia services.

Findings include:

Review of the CAVALIER COUNTY MEMORIAL HOSPITAL MEDICAL STAFF BYLAWS occurred on 08/22/11. These bylaws, approved 01/20/10 and 05/18/11, stated, ". . . Article II: Purpose
The purposes of this organization are: . . . 3. To ensure a high level of professional performance of all practitioners authorized to practice in the hospital . . . through an ongoing review and evaluation of each practitioner's performance in the hospital. . . ."

Review of the policy titled "Cavalier County Memorial Hospital Quality Assurance" occurred on 08/24/11. This undated policy, stated,
"Policy: Surgical Case Review
Purpose: To assure evaluation of appropriateness of surgical procedures performed in the outpatient or inpatient setting . . ."

Upon request, the CAH failed to provide evidence a physician with experience in anesthesiology evaluated the quality and appropriateness of the treatment provided by two nurse anesthetists (Providers #5 and #6).

During interviews at approximately 10:40 a.m. and 11:20 a.m. on 08/24/11, an administrative medical records staff member (#6) and an administrative nursing staff member (#2) confirmed the CAH did not have a physician with anesthesiology experience evaluate the quality and appropriateness of the treatment provided by the nurse anesthetists in 2010.