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Based on observation, interview, and record review, the Critical Access Hospital (CAH) was found to be out of compliance with Life Safety Code requirements. These findings have the potential to affect all patients in the hospital.

Findings include:

Please refer to Life Safety Code inspection tags: Building 1 K-0052 and Building 3 K-0076 for additional information.

Based on interview and document review, the institution failed to ensure sufficient on call Certified Registered Nurse Anesthetists (CRNA) employee (E-H, E-I & E-J) services were available 24 hours a day, seven days a week to provide essential services.

Findings include:

On 3/8/16, at 1:00 p.m. Employee (E)-H a CRNA stated the hospital CRNA's were scheduled for surgeries Monday through Friday. E-H stated the four hospital employed CRNA's shared on call status each week and one CRNA was on call at a time. E-H stated on call status included taking calls for needs in the hospital 24 hours a day, for the week they were on call. E-H stated the responsibilities/services of the on call CRNA's included; any emergency surgeries, epidural blocks and injections, all central lines, all intubations hospital wide. E-H also stated the CRNA's were part of the trauma and code blue teams and would be called in these events as well. E-H stated when a CRNA was on call, they also were were responsible for the daily surgeries that had been previously scheduled. E-H stated she would be interrupted on a daily basis for needs inside the hospital and the patient would have to wait either until the surgery was done or until another CRNA was available. E-H stated in cases when the on call CRNA was unable to leave the surgery, that CRNA would have to contact another CRNA to see if they could meet the patients needs. E-H stated the hospital did not have a 2nd call system in place for when the CRNA on call was busy and unable to leave. E-H stated there had been cases on the weekends when she/he was unable to leave the surgery suite to meet patient needs elsewhere in the hospital and the patient had to wait due to no CRNA back up. E-H stated she/he had spoken to the director of nursing services (DNS) and the vice president twice within the last 2 weeks about the CRNA call schedule concerns in not being able to meet the needs of the patients timely.

On 3/9/16, at 11:40 a.m. E-A the quality assurance designee verified CRNA's were part of the code team, responsible for epidural injections/blocks, all central intravenous lines, intubations as well as surgeries. E-A confirmed there was not a 2nd call system in place for the CRNA's even though the CRNAs had as a group developed a back up support within themselves if they happen to be available to help.

On 3/9/16, at 1:29 p.m. E-I stated during the week, each CRNA had scheduled surgeries and one of them was on call for the week. E-I stated when she/he was on call and CRNA services were needed in the hospital, the patient would have to wait until either she/he was available or one of the other CRNA's were available. E-I stated the CRNA's had developed their own system to back up each other when one was on call call, another would be on stand by and would stay home in the evenings and on the weekends in case the on call CRNA needed assistance. E-I stated the hospital did not have a 2nd call system in place and the back up was informal. E-I stated she/he had spoken to the director of nursing services and the vice president twice within the last two weeks about the CRNA on call concerns.

On 3/9/16, at 2:40 p.m. E-J stated the CRNA's carry a cell phone when on call and would be responsible for the CRNA needs of the hospital for the week on call, which included during scheduled surgery times. E-J stated the hospital did not have a 2nd call system in place and the CRNA's back up from another CRNA was informal. E-J stated there were times in the past where patients had to wait for CRNA services while the CRNA was in a scheduled or emergent surgery. E-J stated she/he had spoken to the director of nursing services and the vice president twice within the last two weeks about the CRNA on call concerns.

On 3/9/16, at 2:45 p.m. E-B the nurse manager for the surgical department who was a consultant stated she felt it was a huge safety concern having only one CRNA on call at a time. E-B stated the services provided by the CRNA's to the hospital was vast and not only included surgeries but all levels and types of patient care, especially in the emergency room and on the obstetric unit.

On 3/10/16, at 10:45 a.m. E-C the director of nursing services confirmed the CRNA's provided hospital wide services which included; surgeries both inpatient and outpatient, trauma/code teams, intubations, epidural injections and blocks, all central lines. E-C confirmed the CRNA's did not have a formal 2nd call system, though did at times permit a 2nd on call CRNA during times of peak season, December and June. E-C confirmed CRNA's had voiced concerns over having only one CRNA on call. E-C stated the hospitals volume of surgeries had increased and the hospital was doing more orthopedic surgeries which took more of the CRNA's time. E-C confirmed this could potentially cause problems if the on call CRNA was in a case, the CRNA would have to find another CRNA to fill the hospital need.

Review of the CRNA's on call schedule from September 2015, to March 2016, revealed only one CRNA was on call each week.

A policy was requested for safe staffing of CRNA's/essential services for patient care, none was provided.

Based on staff interview and document review, the Critical Access hospital failed to ensure physician orders and assessments for a medical restraint were completed for 1 of 6 patients (P8); failed to ensure face to face assessments were completed in first hour of restraint implementation for 1 of 6 patients (P3) who had restraints used during their hospital stay; the facility failed to inform a patient of the final resolution of their grievances in a letter for 1 of 3 patients (P5).

Findings include:

LACK OF A PHYSICIAN ORDER AND MONITORING DIRECTIONS WHEN A RESTRAINT FOR MEDICAL REASONS WERE USED ACCORDING TO THE HOSPITAL POLICY:

P8 was admitted on 2/23/16 with diagnoses which included: osteoarthritis right shoulder, unspecific rotator cuff tear/rupture of right shoulder, chronic obstructive pulmonary disease with acute exacerbation, pneumonitis and acute kidney failure according to the admission form.

According to the physician's progress note dated 2/24/16, P8 underwent a right shoulder replacement on 2/23/15. Following the surgical procedure he was extubated and immediately went into respiratory failure. There was some improvement and P8 went into respiratory failure again and remained intubated. The progress note indicated P8 had a low blood pressure with readings in the 80's and 90's and a creatinine level that elevated from 1.3 to 1.7. The documentation indicated P8 would be transferred to Sioux Falls South Dakota's critical care unit to, "better optimize and take care of the patient."

The nursing progress note dated 2/23/16, at 2200 listed, "Protocol" and the documentation indicated use of a soft wrist restraint applied to the left upper extremity. The indication was a boxed response: Pulls tube/dressing/line. No additional documentation was provided.

Review of the signed physician orders did not contain an order for restraints and no notation was made of the utilization of soft wrist restraints in the progress notes.

The policy titled: Restraint Intubated Protocol with no effective or revision date indicated the Purpose: to provide guideline for use of restraints for critical care patients who are intubated. Protocol: Initiation of the protocol requires a physician order at the time of restraint implementation. In addition a Policy titled Restraints/Seclusion dated 01/1994 and a revised date of 11/2015 indicated: Seclusion/Restraint must be in accordance with the order of a physician who is responsible for the care of the patient. If the patient is placed in restraints for medical-surgical reasons and not for violent and/or self-destructive behavior, the patient will be monitored in accordance to physician's orders.

During an interview on 3/9/16, at 2:00 p.m. with registered nurse (RN)-A. and RN-K it was verified neither the electronic or paper records for P-H contained signed physician orders authorizing the use of restraints. And in addition this was not in compliance with the facility policy.


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LACK OF FACE TO FACE WITHIN ONE HOUR FOR USE OF RESTRAINTS PER HOSPITAL POLICY:

P3's record was reviewed and it was noted they were a patient on the behavioral health unit and the restraint chair was utilized. Review of the medical record revealed a face to face assessment was not completed by a registered nurse or the physician within one hour of the restraint application.

On 3/9/16, during record review it was noted P3 was on the behavioral health unit on 5/22/15 and the restraint chair was utilized. Review of the medical record revealed a face to face assessment was not completed by a registered nurse or the physician within one hour of the restraint application.

On 3/10/16 at 9:03 a.m. the registered nurse (RN)-A stated the face to face assessment should be completed per the policy which is within one hour of the restraint implementation.

On 3/10/16 at 11:30 a.m. RN-A confirmed the documentation for the face to face completed for P3 was documented one hour and 9 minutes after the restraint application.

The Policy titled Restraints/Seclusion dated 01/1994 and a revised date of 11/2015 indicated: The face to face evaluation must be completed within 1h [one hour] after the initiation of intervention when seclusion/restraint is being used for violent/self-destructive behavior by either the physician or the trained nurse. If the seclusion/restraint intervention is discontinued prior to the 1h assessment the physician or trained registered nurse is still required to complete the face to face assessment within 1h after initiation of the intervention.

LACK OF GRIEVANCE RESOLUTION PER HOSPITAL POLICY:

P5's family member (FM)-A voiced a verbal grievance regarding concerns related to hospitalization for P5 during an appointment in family medicine on 9/3/15 the same day P5 was discharged from the medical/surgical floor of the hospital. Concerns shared included, intravenous antibiotic therapy, pain management, scaring P5 with a "shot for pain," "It would really hurt," P5 ended up crying herself to sleep. Additional concerns included discharge instructions and lack of teaching. These concerns were shared with the Vice President of Organizational Excellence (VPOE) in an email on 9/3/15. The VPOE confirmed in an interview on 3/10/16 with surveyor at 10:37 a.m. a response letter was not sent to FM-A who voiced the concern within seven days of the grievance to inform them the hospital was still working to resolve the grievance and verified a written notice outlining the resolution of the grievance was not sent to FM-A, as this concern was not treated as a grievance since it was not received in writing and she did not consider it to be a grievance. VPOE stated, "I believe a grievance is identified in those things that come to me in writing and stated if the concern or complaint was not in writing she did not treat the concern/complaint as a grievance." VPOE confirmed the Customer Complaint and Grievance Policy last revised 3/2016, identified a grievance as, "any formal or informal written or verbal expression (voice grievance) of dissatisfaction with care or a service that is expressed by the customer or the customer's representative that is not resolved at the time by the staff present...Any complaint that fits the grievance definition will require written response to the complaint."

On 3/8/16, at 1:00 p.m. a discussion was had with VPOE regarding potential grievances listed with incident reports. VPOE stated if she gets a call she would respond in the same day and resolve it that day. VPOE further stated she received calls everyday and was usually able to resolve on the phone.

On 3/10/16 at 9:00 a.m. VPOE stated that she had two grievances last year, and if she gets a letter she responds with a letter. VPOE stated, "I get calls everyday, most I resolve by phone that same day."

On 3/10/16 at 11:40 a.m., RN-A. stated, "We have always gone by a grievance is something in writing, but that is not what our policy states."

The Customer Complaint and Grievance Policy last revised 3/2016 indicated, "...Customers/grievances received on a patient should be filed within 30 days of occurrence. Grievances will be promptly addressed by the department director or his/her designee and response will be made to the complainant within seven (7) working days of receipt of the grievance. If the grievance is one that will take longer than seven (7) days to investigate and resolve, the director will contact the complainant within the seven (7) day timeframe and inform him/her that the grievance has been received, is being investigated, and that the director will report back to the complainant within thirty (30) days with a resolution of the grievance. In the event that the department director is not available, his/her designee is responsible for following up on the grievance within the established timeframe. Every effort will be made to review and respond to the complainant within seven (7) working days, but no longer than thirty (30) days. Customers with a grievance may receive a written notice of the investigators review, which will include the name of a contact person, steps taken to investigate the grievance, the results of the grievance process, and the date of completion. A written response may not be provided if alternative arrangements have been made, the director or his/her designee will forward the completed investigation to the quality department ..."

Based on staff interview and document review, the Critical Access hospital failed to ensure safe and secure practices were followed for delivery of medications to the nursing unit. This had the potential to affect the availability of ordered medications and had the potential to affect any patient located on the nursing unit scheduled to receive those ordered medications.

Findings include:

During observation of medication pass on 3/9/16, at 8:20 a.m. employee (E)-G was observed to exit the elevator across from the nursing station, walk over to the counter surrounding the nursing station and set a basket containing a variety of intravenous solutions and oral medications on top of the counter. E-G proceeded to turn her back to the basket and walk to room 227 which was a distance of at least 50 feet away from the counter and down the hall. E-G had her back toward the desk and basket containing the medications as she worked with the Walaroo (a locked cabinet outside each resident room). E-G was working in the Wallaroo for 3-4 minutes before turning, walking back to the desk to retrieve the basket containing medications. E-G then took the basket behind the nurses' station to the Pyxis unit where she stocked the unit with the medications.

When interviewed on 3/9/16, at 8:25 a.m. E-G agreed it was not a good practice to leave medications unattended and not within view at the nursing station.

The on-duty pharmacist, E-H was interviewed on 3/9/16, at 9:20 a.m. regarding delivery of medications to the nursing unit and indicated the expectation was medications were to be kept within sight at all times until placed into the appropriate secure location. E-H further stated it would not be acceptable practice to set the basket containing medications and intravenous fluids on the counter of the nursing station, and leave them unattended while going to place items into the individual wall units.

Review of the PolicyStat ID: 1675160 with an effective date of 08/2001 and last revised date of 07/2015, Titled: medication Security: Policy: All drugs stored in Avera Marshall Regional Medical Center shall be stored in appropriate and secure areas and be accessible only to authorized personnel. medications at nursing stations shall be in lockable storage at all times. When unattended the medicating carts and medicating rooms are to be locked.