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Based on observation, interview, and document review the critical access hospital (CAH) failed to ensure a planned maintenance program was able to track repairs (outpatient bathroom & soiled utility room) and perform maintenance on schedule per the manufacturers recommendations (ice machine) .

Findings include:

The Scotsman Ice Machine:
On 6/18/14, at 8:15 a.m. a tour of the nursing department was conducted with the director of nursing (DON). The Scotsman ice machine was in the patient nutrition room and had a build up of a white flaky substance and water stains on the chute, nozzle, and drip tray. In addition, a brown, wet appearing substance was inside and along the edges of the drip tray. The DON stated maintenance was responsible for cleaning the ice machine.

Outpatient room:
The outpatient room (not numbered) had a scratched, rusted and uncleanable heater surface.

Dirty Utility room:
The dirty utility room had a cupboard with a scratched and rusted surface exposed located next to the hopper.

The DON verified the observations and agreed the ice machine should be cleaned, and repairs should have been so the surface could be cleaned.

On 6/18/14, at 10:30 a.m. the maintenance manager (MM) stated the ice machine was cleaned internally once a year by maintenance and they only clean the external surfaces at that time as well. When asked what the manufacturers recommendations were for cleaning and sanitizing the ice machine, the MM stated "It's probably supposed to be every six months." The MM stated he would have housekeeping add the external ice machine to their cleaning list.

The manufacturers recommendations for sanitation, cleaning, and de-mineralization on a regular basis dated 11/2008, indicated "Twice per year is the standard recommendation [for the ice machine]."

During another interview on 6/19/14, at 1:50 p.m. the MM stated he did not have a system in place to tell when the dirty utility room cupboard was last repaired.

Based on observation, interview, and document review the Critical Access Hospital (CAH) failed to ensure the High Efficiency Particulate Air (HEPA) care unit (type of air filtration unit which protects against airborne disease transmission) had been properly maintained for 1 of 1 (isolation room) negative pressure room.

Findings include:

On 6/18/14, at 8:15 a.m. a tour of the nursing department was conducted with the director of nursing (DON) and a HEPA care unit was observed on the nursing unit in the isolation room. The DON stated maintenance was responsible for checking it to make sure it works.

During interview on 6/18/14, at 10:30 a.m. the maintenance manager (MM) stated he believed the HEPA filter was on the PCI (unsure of the name of the filter contract company) filter list. MM stated, "They send filters out and we replace them, but I don't think I date them [the filters]." MM stated he did run the HEPA filter to ensure it worked, but he did not keep a log of that.

The MM stated he had no documentation of when the HEPA filter unit was last tested to ensure the isolation room could be converted into a negative pressure room, if necessary, and verified the CAH did not have a routine testing schedule for the HEPA care unit.

The manufacture guidelines for the HEPA care unit was requested and not provided.

Based on interview and document review the critical access hospital (CAH) failed to ensure the medical staff and/or governing body approved physician credentials when reappointments were due for 3 of 14 providers (MD-C, MD-D, MD-E) whose credentials were reviewed.

Findings include:

On 6/18/14, at 2:05 p.m. the credentialing files were reviewed with the credentialing specialist (CS) and executive assistant (EA). The EA was unable to find documentation of MD-C, MD-D, and MD-E's reappointment recommendation for approval by the medical staff or governing body approval. Evidence was also lacking in the meeting minutes of the medical staff and governing board meeting minutes.

On 6/19/14, at 12:10 p.m. the EA verified it was an oversight that the reappointments had not been included in the medical staff and governing board meeting minutes. MD-C, MD-D, and MD-E's names for approval for recommendation and approval for reappointment by proxy from Essentia Health in Fargo were not evident. EA confirmed all three providers should have been included for reappointment in 11/2013.

The CAH's Medical Staff Bylaws approved 12/16/13, verified initial appointments and reappointments to the medical staff would be granted by the governing body on recommendation by the medical staff. The medical staff would recommend to the governing body the approval or rejection of reappointment applications.

Based on interview and document review the critical access hospital (CAH) failed to identify and record all adverse drug reactions (ADR) and failed to document pharmacy follow-up on 1 of 2 (P7) medication errors reported. In addition, the CAH failed to incorporate medication error review into the hospital wide quality program which has the potential to affect all patients admitted.

Findings include:

Patient (P)-7 had been admitted to the CAH on 11/18/13. During the first 24 hours of P7's stay, s/he received narcotic medication for complaints of pain. Following the doses of narcotic medication, P7 was noted to be hypoxic (reduction of oxygen supply) and hypotensive (low blood pressure). The provider was notified and P7 was given a bolus of intravenous (IV) solution and two doses of narcan (medication used to help reverse the effects of certain medications such as narcotics). P7's condition improved following this treatment.

On 6/19/14, at 9:45 a.m. the director of nursing (DON) verified P7 had not had an adverse drug reaction (ADR) form completed to document the episode for the need for a reversal medication. DON stated the CAH had seen a decline with staff completing the ADR forms since the facility had computerized this process. DON confirmed an ADR should have been completed to document this incident so further review could have been completed.

On 6/19/14, at 10:50 a.m. the director of pharmacy stated she was aware of only two medication error (ADR) forms being completed in the last six months. She thought she had documented her review and follow up on both of these, however, she was unable to provide this information. The pharmacy director confirmed P7 should have had an ADR completed and verified the CAH did not have a system in place which would alert the pharmacy when a "rescue medication," such as narcan, had been given. The pharmacist also stated this would be an incident pharmacy should have reviewed. The director of pharmacy confirmed medication error review was not a part of the pharmacy's quality assurance/performance improvement (QA/PI), nor was it incorporated into the hospital wide quality program.

On 6/19/14, at 2:15 p.m. the DON confirmed the CAH only had two ADR's reported over the last six months. The Event Record dated 4/13/14, (incident where patient was administered an incorrect medication) indicated follow up completed by the DON, however, lacked documentation of follow up conducted by the pharmacist. The second ADR completed was dated 5/12/14, (near miss). This ADR had documentation of follow up from the DON and the pharmacist, along with a corrective action plan identified.

The CAH's Adverse Drug Reaction policy dated 9/13, directed staff to complete and submit an electronic event tracking form when an adverse drug reaction was suspected. In addition, adverse drug reactions would be reviewed by the pharmacist and the DON.

Based on interview and document review the critical access hospital (CAH) failed to maintain a current and comprehensive list of all services furnished under agreements or arrangements. This had the potential to affect all patients receiving services at the CAH, which had an average annual census of 2.7 per day.

Findings include:

The initial list of services provided under agreements with the CAH was not current at the time of the survey. The CAH needed to revised the document titled, (not dated) Graceville Health Center Contracts so it would no longer include services for management with Benedictine Health Dimensions; use of storage buildings with Missionary Benedictine Sisters; health care services provide by Immaculata Monastery in Norfolk Nebraska; anesthesia services through Missionary Benedictine Sisters, and the credentialing and recredentialing of practitioners with Rice Memorial hospital. These agreements were no longer active.

The updated list was revised to include: professional service with Conroy Eye Care; otolaryngology with Janning ENT Center; audiology services with Madison Luther Home; ophthalmology services with Ophthalmology Associates: legal counsel with Riverview Law Office; magnetic resonance imaging services with Shared Medical Services; Diagnostic Teleradiology services with Consulting Radiologists and ultrasound services with Transmed.

During interview on 6/19/14 at 9:55 a.m. the executive assistant stated the initial list of services provided was not accurate, and required a revision to include the most current list of contracted services and agreements.

Based on interview and document review the critical access hospital (CAH) failed to ensure General Consent and Authorization (GCA) was obtained for 3 of 20 inpatients reviewed (P6, P10 & P11).

Findings includes:

P6 was provided medical assessment and was admitted to the CAH on 9/12/13, and remained in the facility until 9/14/13, for treatment and diagnostic testing. P6's daughter had signed all of the admission papers except the GCA, a release of information (provide medical records for review and payment for third party and insurance payors, authorization to disclose protected health information, acknowledgement for having received patient rights and the notice of privacy practices). On 9/14/14 on the day of discharge, P6 signed the consent.

P10 was provided medical assessment and was admitted to the CAH on 11/5/13, and remained in the facility until 11/8/13 for treatment and diagnostic testing. Although a checklist (not a permanent part of the medical record) indicated a GCA, and the Important Message from Medicare was present, the medical record lacked documentation of the GCA, or the Important Message from Medicare.

P11 was provided medical assessment and was admitted to the CAH on 5/5/14 and remained in the facility until 5/8/14, for treatment and diagnostic testing. Although a checklist (not a permanent part of the medical record) indicated a GCA was present, the medical record lacked documentation of the GCA.

The health information management (HIM) director was interviewed on 6/19/14, at 2:00 p.m. and confirmed consent for general care and treatment and notification of privacy rights had not been completed for P6, P10, and P11. HIM would expect a consent for general treatment to be present in every record, and would have expected P6's daughter to sign that consent with the rest of the admission paperwork on 9/12/14. The HIM reviewed the charts and checked the department and was not able to locate the consent forms.

The General Consent and Authorization policy dated 9/12/13, indicated, "Patients presenting at any [facility] site for services (either in person or virtually), will be asked to review in it's entirety, have their questions answered, and sign the GCA from before receiving services at [facility]. In the event of emergency circumstances, such as a major trauma, patients would be asked to sign the GCA as soon as reasonably possible."

Based on review of surgical privileges and staff interview the critical access hospital (CAH) did not ensure a current roster listing each practitioner's surgical privileges, was updated and available in the surgical suite for 2 of 4 surgeons (MD-B and MD-C) who performed surgery at the CAH. This had the potential to affect any patient who had surgery performed by MD-B and MD-C.

Findings include:

During a tour of the surgical suite on 6/16/14, at approximately 1:30 p.m., registered nurse (RN)-B verified current surgical privileges for MD-B and MD-C were not available in the surgical suite and in the area where surgery scheduling occurred. The roster of surgical privileges for MD-B was dated 3/21/2013 and the surgical privileges for MD-C were dated 10/11/2013.

A review of the medical staff by-laws, dated 2/16/2013, indicated medical staff applied for and were approved for surgical privileges every two years.

Based on interview and document review the critical access hospital (CAH) failed to ensure quality assurance/performance improvement (QA/PI) projects were developed and incorporated into the CAH's quality improvement program for the following services: dietary, physical environment/plant, surgery, anesthesia and medication errors. This had the potential to affect all current and future patients of the CAH.

Findings include:

On 6/18/14, at 10:35 a.m. the director of nursing (DON) and licensed practical nurse (LPN)-A, who oversees the CAH's QA/PI program, were interviewed. The DON and LPN-A stated the following departments did not have a strong QA/PI project identified with measurable goals, monitoring, and analysis: dietary services and physical plant and environment. LPN-A verified the surgical services and anesthesia departments did not have a current quality improvement project nor were these departments reporting anything to the hospital wide QA/PI committee. The DON stated medication error review was not currently incorporated into the hospital wide QA/PI program. Review of quarterly QA/PI meeting minutes dated 4/17/14, 1/16/14, 10/17/13 and 7/18/13 lacked any reports related to the departments noted.

On 6/19/14, at 10:50 a.m. the director of pharmacy confirmed medication error review was not a part of the pharmacy's QA/PI, nor was it incorporated into the hospital wide QA/PI program.