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Based on interview and document review, the critical access hospital (CAH) failed to ensure the supplemental nursing service agency (SNSA) utilized by the facility was properly registered with the Minnesota commissioner as required. This had the potential to affect all patients served at the CAH.


Findings include:


On 9/28/15, at 4:0 p.m. the director of nursing (DON) confirmed the facility utilized AnnLeo staffing agency to provide nursing coverage.


On 9/30/15, at 10:00 a.m. the DON verified the current Minnesota Department of Health's Directory of Registered Supplemental Nursing Services Agencies (SNSA's) revealed AnnLeo staffing agency was not one of the approved agencies listed. The DON confirmed registered nurse (RN)-E, an AnnLeo agency nurse was currently working full time at the facility.

Based on interview and document review, the critical access hospital (CAH) failed to ensure performance reviews were completed in a timely manner for 3 of 12 staff (DON, OT-A, pharmacist) whose personnel records were reviewed. In addition, 4 of 13 staff (DON, LSW, OT-A, pharmacist) had not completed annual training which included an infection control component.

Findings include:

PERFORMANCE REVIEWS
On 9/30/15, at 11:05 a.m. the personnel records were reviewed with the human resource manager (HRM). The HRM confirmed performance reviews should be completed annually on all staff. The HRM verified the performance review information on the following staff members:
- Director of Nursing's (DON) last performance review had been completed on 7/23/14
- Occupational Therapist (OT)-A's date of employment was 3/2/09, OT-A did not have a performance review on file
- Pharmacist's date of employment was 1/16/08, pharmacist did not have a performance review on file

The Job Performance Evaluation policy dated 1/29/09, indicated job performance evaluations would be conducted annually.

ANNUAL REQUIRED TRAINING
On 9/30/15, at 11:05 a.m. the personnel records were reviewed with HRM. The HRM confirmed annual required training which included general safety, emergency procedures and infection control was required annually for all staff. The HRM verified the annual required education information on the following staff members:
- DON had last completed the computerized annual training in 2013 (unsure of exact date)
- Licensed Social Worker (LSW) had reviewed A Workplace Accident and Injury Reduction Program (AWAIR) manual on 4/22/15
- OT-A had reviewed AWAIR manual on 3/30/12
- Pharmacist had reviewed AWAIR manual on 6/5/14

On 9/30/15, at 11:31 a.m. the HRM verified the CAH's AWAIR education manual lacked education on infection control.

The Orientation policy dated 1/29/09, indicated staff would complete annual orientation training every year of employment.

C5001



Based on surveyor observation, interview and document 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:

Refer to the Life Safety Code deficiencies cited at: K-0052 and K-0076, for additional information.

Based on interview and document review, the critical access hospital (CAH) was not in compliance with 485.627 Condition of Participation for Organizational Structure due to failure of the governing body to assume full legal responsibility for implementing and monitoring policies and bylaws governing the CAH's total operation.


Findings include:


See C241: The governing body failed to assume full legal responsibility for the implementation of medical staff and governing board By-Laws related to the the appointment / reappointment of medical staff to ensure all patients received quality care. This had the potential to affect all patients served by the CAH.

Based on observation, interview and document review, the critical access hospital (CAH) failed to ensure 3 of 5 medical staff (MD-B, NP-A, PA-B) had been reappointed according the medical staff by-laws.


Findings include:


Review of the By-Laws of the Warren Community Hospital, Inc. Medical Staff dated 3/14/07, indicated the appointment of medical staff would be made by the board for a period of two years, or until the appointment year of the hospital medical staff retroactive to January 1, 1994. In the eleventh month of the hospital appoint year, the medical staff would review each existing application for medical staff membership and may reappoint all members of the medical staff for a period of two years, provided licensure's were current, medical staff procedures were satisfied and changes in membership and privileges were acceptable to the medical staff. The By-Laws also indicated medical staff procedures included a review of clinical profile performance and privileges and in the final month of the hospital appointment year, the governing board would review each existing application for medical staff membership and reappoint all members of the medical staff for a further period of two years provided that licensure was current, medical staff procedures were satisfied and changes in membership and privileges were acceptable to the medical staff and governing board and the medical staff had not recommended that any specific appointment not be renewed. The By-Laws lacked specification for credentialing of allied health professionals (Nurse Practitioners and Physician Assistants).


1. Review of medical doctor (MD)-B's credentialing file revealed that a new application for privileges had not been made, and there was no evidence a review of clinical profile performance was completed. The only application for delineation of privileges was dated 11/21/08, therefore, there was no information related to knowledge and performance for the medical staff and hospital board to base a reappointment. The file lacked indication of when MD-B was last reappointed..


2. Review of nurse practitioner (NP)-A's credentialing file revealed that a new application for privileges had not been made, and there was no evidence a review of clinical profile performance was completed. The only application for delineation of privileges was dated 10/8/10, therefore, there was no information related to knowledge and performance for the medical staff and hospital board to base a reappointment. The file lacked indication of when NP-A was last reappointed.


3. Review of physician assistant (PA)-B's credentialing file revealed that an application for privileges had been made 4/21/14, however, there was no evidence a review of clinical profile performance was completed. There was no information related to PA-B's skills or performance for the medical staff and hospital board to base an appointment or reappointment. The file lacked indication of when PA-B was appointed / reappointed.


The chief executive officer (CEO) was interviewed on 9/31/15, at 1:15 p.m. and confirmed the medical staff credentialing files lacked appointment / reappointment information and were not completed according to the medical staff By-Laws. The CEO stated the CAH was currently looking at a more effective means of ensuring the medical staff were credentialed according to the CAH's medical staff by-laws.

Based on interview, the critical access hospital (CAH) failed to ensure the change in administration was reported to the State Agency (SA).

Findings include:

On 9/30/15, at 1:00 p.m. the chief executive officer (CEO) confirmed his hire date at the CAH was 3/23/15, and verified this change in administration was not reported to the SA, as required.

Based on observation, interview, and document review the critical access hospital (CAH) failed to ensure surgical time outs were performed according to their policy for 1 of 1 endoscopy patients (EP)-1 observed.


Findings include:


EP-1 was observed during the endoscopy procedure on 9/30/15, from 9:30 a.m. to 10:33 a.m. Prior to starting the endoscopy, medical doctor (MD)-A was heard to initiate a time out by stating EP-1's name, the date and time, type of procedure and had EP-1 sign the consent form for the procedure. Registered Nurse (RN)-E was in the procedure room at the time of the time out, however did not verbally repeat the time out information as stated by MD-A.


Review of the facility's policy STOP! IMMEDIATELY PRIOR TO PROCEDURE TIME OUT dated 3/10/15, indicated during the time out procedure all activity in the procedure room must stop, all of the team members must participate in the time out and the physician initiates the time out by identifying the following information: patient, procedure, informed consent, sight/side, marked and visible after prep and drape, patient position, pertinent clinical history, special medication considerations and allergies. The policy further instructed the physician/team to review pertinent information such as: critical or unexpected steps, operative duration, anticipated blood loss, deep vein thrombosis (blood clot) prophylaxis, glycemic control ( blood sugar) required, normothermia measures, beta blocker use, patient concerns, fire precautions and equipment use. The policy had not directed the RN or surgical technician to participate in the time out by verbally repeating aloud patient information verifying the patient name, procedure, date time, appropriate consent and surgical side or sight.


RN-E was interviewed following the procedure on 9/30/15, at approximately 10:43 a.m. during which she confirmed she had not repeated the time out information MD-A had verbalized during the time out for EP-1.


The director of nursing (DON) was interviewed on 9/30/15, at 10:45 a.m. during which she stated that it was her expectation the RN assisting in the procedure room verbally repeat aloud all of the aforementioned information during the surgical time out, and confirmed the facility's policy for time out was not clear on the expectations for time out.

Based on observation, interview and document review, the critical access hospital (CAH) failed to ensure the security of controlled medications.


Findings include:


On 9/29/15, at 1:30 p.m. during the tour of the pharmacy, several sized plastic containers labeled biohazard were observed in the medication room, on the floor up against the wall. One of these containers had written in black marker on the lid "DEA (Drug Enforcement Administration)-Biohazard - Narcotics." This container was about a gallon sized with a closed lid on the top and on the lid was an opening which had a yellow lid which was partially opened. On further examination of the container, the pharmacist (RPh) verified the container was not secured and was full of what appeared to be controlled medications (medications to include narcotics, that have a high potential for abuse or addiction and are under strict control). The RPh stated the medications were in the container because they needed to be destroyed. RPh confirmed this container should not have been left partially open on the medication room floor and it should have been locked up in the pharmacy.


On 9/29/15, at 3:02 p.m. the director of nursing (DON) confirmed the DEA biohazard - narcotic waste container should have been locked in the pharmacy. The DON stated all narcotics should be double locked. The DON stated the DEA biohazard - narcotic containers took about three months to fill, thus, the inventory and disposal of these medications were completed approximately every three months.


On 9/30/15, at 10:45 a.m. the DON provided an inventory list of medications which were in the DEA-biohazard - narcotic container. This list included [not an inclusive list]:

- 3 Demerol (pain medication) syringes
- 2 bottles of hydrocodone (pain medication)
- 12 hydromorphone (pain medication) tablets
- 8 ativan (antianxiety medication) syringes
- 5 methadone (pain medication) tablets
- 14 clonazepam (antianxiety medication) tablets
- 18 Fentanyl (pain medication) patches and syringes in a variety of dosages
- 31 morphine (pain medication) syringes in a variety of dosages
- 1 versed (medication used for sedation) syringe
- 5 xanax (antianxiety medication) tablets
- 17 lyrica (pain medication) tablets
- 3 morphine tablets
- 8 vials of midazolam (medication used before surgery for conscious sedation)
- 11 belladonna and opium suppositories (pain medication)


The Pharmacy Program policy dated 11/2007, indicated the pharmacist was to assist with returning and the destruction of unused medications.


The Safe Storage and Handling of Drugs policy dated 10/2010, indicated all narcotics would be double locked. In addition, all scheduled class II medications must be kept under double lock.

Based on interview and document review, the critical access hospital (CAH) failed to develop and maintain an ongoing, comprehensive infection control surveillance program related to the tracking and trending of infections.


Findings include:


On 9/29/15, at 1:00 p.m. registered nurse (RN)-C confirmed she was responsible for the infection control program. RN-C stated the facility did not have an infection control committee; rather she gathered information on infections in the hospital and presented the information at the facility's monthly quality assurance (QA) meeting. RN-C stated monthly she tracked cultures, catheter use, patients on isolation precautions and audited employee handwashing. RN-C stated she did not do infection control surveillance, which would have included infections, symptoms, antibiotic use and whether the infection was hospital or community acquired.


On 9/30/15, at 2:00 p.m. RN-C brought in the Inpatient Tracking Log which contained the patient name, admit date, onset date, date discharged, diagnosis, infection site, culture, organism, antibiotic, isolation and if the infection was hospital acquired. The Inpatient Tracking Log was completed for the months of April and May 2015. RN-C verified she had not completed the log for the months of June, July, August or September, 2015.


The facility policy and procedure on Methods of Surveillance dated 9/08, directed the infection control nurse to conduct surveillance of infections of patients, including, but not limited to, review of culture reports and other pertinent lab data, chart review, maintenance of inpatient and outpatient infection control logs, follow-up on communicable infection exposure and direct observation. The infection control committee would perform ongoing assessment of the surveillance and revise program as appropriate to facility needs and national guidelines.

Based on observation, interview and document review, the critical access hospital (CAH) failed to ensure medical records were stored in a safe environment in order to prevent damage and maintain integrity of the records at 1 of 1 medical record storage buildings.


Findings include:


On 9/29/15, at 10:45 a.m. the health information management (HIM) director stated some medical records were stored in an offsite storage building which was approximately 1/4 of a mile away from the CAH.


On 9/29/15, at 11:00 a.m. the offsite medical record storage building was toured with the HIM director and the maintenance manager (MM). The storage building was locked with only MM having a key. The storage building was 30 feet by 90 feet in size with a portion of the building (30 feet by 50 feet) partitioned off for medical record storage. The area was very dusty and unkept with boxes of medical records and financial and business office records scattered throughout. The MM confirmed there were approximately 35 boxes of stacked medical record boxes which were placed directly onto the cement floor. MM and the HIM director estimated there were about 200 boxes of medical records stored in this storage building. The MM verified the building was not sprinkled, did not have a fire detection system or alarm in place, nor a fire extinguisher in the building.


On 9/30/15, at 8:30 a.m. The HIM director confirmed medical records had been stored in the offsite storage building for several years.


The Medical Records Security policy dated 9/1/11, indicated clinical records should be kept in a secure locked storage room, however the policy did not address the safeguarding of records from ordinary hazards such as fire and water.

Based on interview and document review, the critical access hospital (CAH) failed to ensure quality assurance/performance improvement (QAPI) projects were comprehensive and incorporated into the CAH's QAPI program for pharmacy.


Findings include:


On 9/29/15, at 1:57 p.m. the consulting pharmacist (CP) stated he was unaware of any current QAPI project for pharmacy services.


On 9/30/15, at 9:16 a.m. the health information management (HIM) manager and registered nurse (RN)-B verified pharmacy services did not have a current QAPI project identified beyond the reporting of medication errors which the director of nursing (DON) was providing to the QAPI committee.


Quality Improvement Plan dated 5/2014, indicated each department would determine their own quality indicators and determine the length of time they would be monitored.


The agreement with the pharmacy consultant dated 1/16/08, indicated the hospital would assist the pharmacist with QAPI projects.

Based on interview and document review, the critical access hospital (CAH) failed to ensure nosocomial infections and medication therapy were incorporated into the CAH's quality assurance / performance improvement (QAPI) program..


Findings include:


On 9/29/15, at 1:00 p.m. registered nurse (RN)-C confirmed she was responsible for the infection control program. RN-C stated the facility did not have an infection control committee; rather she gathered information on infections in the hospital and presented the information at the facility's monthly quality assurance (QA) meeting. RN-C stated monthly she tracked cultures, catheter use, patients on isolation precautions and audited employee handwashing. RN-C stated she did not do infection control surveillance, which would have included infections, symptoms, antibiotic use and whether the infection was hospital or community acquired. RN-C stated she did not have an ongoing QAPI program for infection control which would have included nosocomial infections and medication therapy.


On 9/30/15, at 2:00 p.m. RN-C brought in the Inpatient Tracking Log which contained the patient name, admit date, onset date, date discharged, diagnosis, infection site, culture, organism, antibiotic, isolation and if the infection was hospital acquired. The Inpatient Tracking Log was completed for the months of April and May 2015. However, there were no tracking logs completed for June, July, August or September 2015. RN-C verified she had not completed the log for the months of June, July, August or September, 2015, therefore no surveillance / tracking was completed.


The facility Quality Improvement Plan dated 5/2014, indicated each department would determine their own indicators and determine the length of time they would be monitored.