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Based on interview and document review, the Critical Access Hospital (CAH) failed to ensure established criteria for determining admissions/discharges to observation status.
Findings included:
On 1/31/17, at 9:00 a.m. the utilization review manager explained the CAH did not have a policy or procedure for determining criteria for placing patients on observation status or criteria for discharging patients from observation status.
On 2/2/16, at 8:30 a.m. director of nursing (DON) stated the CAH did not have a policy/procedure or a software program that would define criteria for placing or removing patients from observation status. DON stated education was provided during medical staff meetings and help was provided to physicians in determining appropriate patient status.

Based on observation, interview, and document review, the critical access hospital (CAH) failed to ensure an automatic external defibrillator (AED) located in the procedure suite was routinely inspected and tested.
Findings included:
During a tour of the procedure suite with registered nurse (RN)-J an AED machine was sitting on top of an emergency crash cart. When RN-J was asked to provide AED check log sheets and asked how often the unit was tested and checked, RN-J explained she was not aware the AED had to be routinely tested, checked, and that a log was needed.
On 2/2/16, at 11:30 a.m. director of nursing (DON) stated the outpatient procedure room did not have their own AED policy and one would need to be written. DON then explained the CAH's expectation was the AED machine be checked per the same guidelines outlined in the policy for the cardiac rehabilitation area.
CAH policy AED (Automated External Defibrillator) Check (Cardiac Rehab) last reviewed November 2004, directed the following: The AED will be checked every day that cardiac rehabilitation is performed. The AED will be checked by the RN doing Cardiac Rehab or a trained person.

Based on the Life Safety Code (LSC) survey component. A Medicare-participating Critical Access Hospital (CAH), including all component parts or facilities of the CAH, must comply with the applicable LSC requirements.

Please refer to the life safety code deficiencies cited at: K0345 - Fire Alarm System - Testing and Maintenance (building 02), for additional information.

Based on interview and document review, the critical access hospital (CAH) failed to ensure 2 of 2 patients (P22, P23) who required physical restraints while in the emergency department (ED) had been monitored appropriately and restraint orders consistently obtained. In addition, the CAH failed to ensure 1 of 2 patient grievances (P31) had been responded to in a timely manner according to CAH policy.
Findings include:
RESTRAINTS
P22's vulnerability screening dated 8/20/16, at 5:25 p.m. indicated P22 had been brought into the ED on 8/20/16, at 2:45 a.m. unresponsive following a suicide attempt. When P22 woke up at 3:00 a.m. P22 became combative and four point restraints (arms and legs were restrained) had been ordered and applied.
P22's patient care timeline from 8/20/16, at 3:00 a.m. thru 8/20/16, at 1:47 p.m. indicted the following documentation with regards to monitoring P22 while in restraints:
- 3:34 a.m. restraint check completed (4 minutes since restraints had been applied)
- 3:44 a.m. registered nurse (RN)-J communicated with R22 (10 minutes since last restraint check)
- 4:07 a.m. P22 was sleeping (23 minutes since last check)
- 4:55 a.m. restraint check completed (48 minutes since last check)
- 5:04 a.m. through 5:35 a.m. all four restraints where removed one by one for 10 minutes and then reapplied.
- 6:47 a.m. P22 was given water (1 hour and 12 minutes since last check)
- 6:58 a.m. P22's left ankle restraint was removed (11 minutes since last check)
- 7:36 a.m. P22's right ankle restraint was removed (38 minutes since last check)
- 8:15 a.m. P22's bilateral wrist restraints were removed one by one and reapplied (39 minutes since last check)
- 9:23 a.m. RN-J communicated with P22 (1 hour and 8 minutes since last check)
- 10:28 a.m. restraint check completed (1 hour and 5 minutes since last check)
- 11:28 a.m. P22's right wrist restraint was removed with left wrist restraint remained in place (1 hour since last check)
- 1:47 p.m. indicated P22's left wrist restraint had been removed at 1:21 p.m. (1 hour and 53 minutes since last check)

On 1/31/17, at 12:06 p.m. director of nursing (DON) confirmed the above documentation. DON confirmed it was the expectation that when a patient was placed in restraints that they were monitored every 15 minutes and this should be documented.

P23's ED provider note dated 1/2/17, indicated P23's reason for ED visit was for a possible overdose.

P23's patient care timeline from 1/2/17, at 7:18 p.m. thru 1/2/17, at 10:05 p.m. indicated the following:

- 7:29 p.m. RN-K placed an intervention into the electronic medical record for restraint observation every 15 minutes.
- 8:30 p.m. RN-K placed an intervention into the electronic medical record for restraint release every 2 hours.
- 8:35 p.m. ED provider had placed an order for restraints observation, release and that they could be removed and reapplied.
- 9:13 p.m. RN-K documented that P23's daughter had agreed to the application of soft restraints for P23's safety. In addition, restraints to P23's left and right lower extremities and P23's right upper extremity had been removed and reapplied.
- 10:05 p.m. P23 was prepared for transfer - with documentation that transport had arrived at 8:20 p.m.

On 1/31/17, 1:56 p.m. DON confirmed P23's medical record lacked an order for the initiation of the restraints; documentation of when the restraints had been applied; documentation of the every 15 minute restraint checks while P23 was in restraints; and when the restraints had been discontinued. In addition, DON confirmed some of the documentation noted above may have been late entries.

Restraints policy dated 5/2005, indicated restraints could be applied after a physician order was obtained, the RN had completed an assessment, restraints should be released every two hours, and documentation of restraints and releases should be charted.

Protective Procedure Plan (Suicide and Restraints: Chemical and Mechanical) policy dated 9/2004; indicated the patient's record must include documentation of the behavior events that led up to implementation of a restraint; the date, time and type of restraint that was initiated; physical restraints are only authorized by a physician; and patients whose extremities are physically restrained (cloth or leather) must be checked every 15 minutes for circulatory impairments, placement of restraints and skin condition.

GRIEVANCE

The CAH failed to follow up on P31's grievance according to CAH policy.

Through a thread of e-mails attached to P31's grievance the following information was reviewed:
- On 11/14/16, the chief financial officer (CFO) sent P31's grievance on to the business office representative (BOR) for follow up; which indicated P31 had voiced a complaint in 8/2016, and that P31's complaint had not been followed up on. The BOR forwarded the complaint information on to the DON on the same day (11/14/16).
- On 11/17/16, the DON provided some insight into the grievance back to the BOR and CFO.
- On 11/23/16, the CFO forwarded the thread of e-mails on to the PA for assistance in resolving P31's grievance. The CFO in the email indicated P31 had been communicated with twice, however, lacked documentation of when these conversations took place or a resolution to the grievance.
- On 12/1/16, CFO again forwarded the thread of e-mails on to PA.

On 12/1/16, a response letter was sent to P31 from PA, regarding P31's grievance which had been initiated in august.

On 2/1/17, at 2:00 p.m. PA verified P31's initial grievance had been brought to the CFO's attention in 8/2016, with the response letter sent to P31 on 12/1/16 (4 months later). PA stated this grievance just had been "forgotten". PA confirmed the CAH's policy was to respond to grievances within seven days. PA stated this absolutely did not happen with PA's grievance and it should have.

Grievance Procedure for Hospital Patients and Care Center Residents dated 1/2017, indicated any complainant had the right to request and receive a written response to any complaint within seven days.

Based on interview and document review, the critical access hospital (CAH) failed to ensure 9 of 21 registered nurses (RN-A, RN-B, RN-C, RN-D, RN-E, RN-F, RN-G, RN-H, RN-I) who compound intravenous (IV) admixtures, had been trained and observed to be competent to compound IV admixtures.
Findings include:
On 1/31/17, at 10:27 a.m. pharmacist (P)-A confirmed all RN's at the CAH compounded IV admixtures under the laminar flow hood (an enclosure in which air flow is directed so as to prevent contamination of sterile materials by airborne organisms) when the pharmacist was not in the building. P-A confirmed a pharmacist was on-site at the CAH Monday-Friday from 8:00 a.m. to 4:00 p.m. P-A stated she had started training the RN's in May, with the goal that all RN's would be trained and competent in compounding IV admixtures.
On 2/1/17, at 8:40 a.m. the director of nursing (DON) stated it had been difficult to get all of the RN's trained in compounding admixtures due to the varied shifts the RN's worked. DON confirmed all RN's at the CAH compound admixtures, and needed to be trained and competent with compounding. Moving forward, the DON stated she would be working with pharmacy to include this training and competency testing during the mandatory annual skills fair. DON provided an RN roster, which indicated out of the 21 RN's on staff at the CAH the following RN's had not completed training nor observed to be competent in compounding IV admixtures: RN-A, RN-B, RN-C, RN-D, RN-E, RN-F, RN-G, RN-H, RN-I. DON confirmed the Administration of Medications: Hospital policy dated 7/16, was currently under revision and DON included in this revision that all nursing staff would be orientated by the pharmacist in the preparation of IV medications upon hire and annually as a competency.
Director of Pharmacy job description indicated an essential function of the job was to identify and provide educational programs for nursing and pharmacy.

Based on interview and document review, the critical access hospital (CAH) failed to ensure appropriate investigation and follow up had been completed to minimize the reoccurrence of further medication errors for 6 of 7 patients (P34, P35, P36, P37, P38, P39) who had a medication error reported. This had the potential to affect all patients treated at the CAH.
Findings include:
Medication variance dated 12/20/16, indicated a larger dose of intravenous (IV) Ativan (anti-anxiety medication) had been administered to P34 than what had been ordered (2 milligrams given instead of 1 milligram).
Medication variance (undated), indicated a duplicate dose of IV Rocephin 1 gram (an antibiotic) had been administered to P35 on 9/26/16.
Medication variance dated 8/17/16, indicated P36's following medications had been missed: Cipro (an antibiotic), duricef (an antibiotic), florastor (a probiotic), Lipitor (a medication to treat high cholesterol), Mirapex (medication to treat Parkinson's disease), and sodium bicarbonate (antacid).
Medication variance dated 7/1/16, indicated a larger dose of versed (sedative) had been administered to P37 than what had been ordered (2 milligrams given instead of 1 milligram).
Medication variance dated 7/2/16, indicated a lesser dosage of IV heparin (blood thinner) had been used to flush a port for P38 than what had been ordered (50 units of heparin, instead of the 500 units of heparin which had been ordered).
Medication variance dated 7/5/16, indicated the wrong medication had been administered to P39 (lidocaine - an antiarrhythmic or anesthetic agent had been given instead of lidocaine with epinephrine - an anesthetic, vasoconstrictor medication).
On 2/1/17, at 2:50 p.m., pharmacist (P)-A stated the process for reporting and following up on medication errors was that the staff member who identified the error filled out the medication variance reporting form and gave the form to either P-A or the director of nursing (DON). The DON then followed up with the nurse who made the error. The DON collected the medication variance forms and then gave them to the P-A once a month. P-A stated the number of errors and any trends would be discussed at the quarterly quality assurance performance improvement (QAPI) meeting. P-A verified the above noted medication variances had occurred and the form lacked documentation of any follow up which had occurred. P-A stated she had no additional information on the above noted medication variances.
On 2/1/17, at 2:57 p.m. DON stated with each medication variance she would meet with the individual nurse who had made the error and educated them on the medication error. However, the DON confirmed the specific follow up documentation on the above noted medication variances was lacking.
Adverse Drug Reaction Report and Evaluation dated 5/2015, indicated the pharmacist and DON would review the medication variances for further follow up.

Based on interview and document review, the critical access hospital (CAH) failed to ensure peer review was conducted according to CAH policy for 3 of 3 medical doctors (MD-A, MD-B, MD-C) randomly reviewed.
Findings include:
MD-A's Medical Staff Review form dated 12/12/15, indicated the internal physician reviewer rated this case review (case #1) as a level 3: variation was questionable and the peer reviewer was uncomfortable. The action plan was for this case to be sent on for external peer review.
MD-A's Medical Staff Review form with a patient discharge date of 4/5/16, indicated the internal physician reviewer rated this case review (case #2) as a level 3: variation was questionable and the peer reviewer was uncomfortable. The action plan was for this case to be sent on for external peer review.
MD-B's Medical Staff Review form dated 10/5/15, indicated the internal physician reviewer rated this case review (case #3) as a level 3: variation was questionable and the peer reviewer was uncomfortable. The action plan was for this case to be sent on for external peer review.
MD-C's current credentials included that MD-C had privileges to perform colonoscopies and sigmoidoscopies.
On 2/2/17, at 9:18 a.m. health information manager (HIM) who coordinated the CAH's credentialing process, verified the above peer review cases (case #1, case #2, case #3) had not been sent on for external peer review as directed by the CAH's internal physician reviewer.
On 2/2/17, at 9:25 a.m. HIM stated MD-C was the only physician at the CAH who performed colonoscopies and sigmoidoscopies. HIM confirmed all of MD-C's surgical cases were reviewed by MD-D (pathologist). HIM verified MD-D had never had privileges to do colonoscopies and sigmoidoscopies and that MD-D had been reviewing MD-C's surgical cases for a long time.
On 2/2/17, at 10:47 a.m. HIM confirmed the current agreement entitled "Administrative Advisory and Support Agreement" between the CAH and St. Luke's hospital in Duluth included services to conduct external peer review for the CAH.
According to the Ancillary Annual Statistics Comparison form for 2015, 143 outpatient surgeries were performed.
Peer Review Process policy dated 5/26/15, indicated when a peer review case was rated a level 3 or 4, the case would be considered an outlier and required external review. The case would be referred on to the external peer review organization under contractual agreement with the CAH.