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Based on observation during the survey walk-through, staff interview, and document review during the Life Safety Code portion of the Sample Validation Survey conducted on December 13, 2017, the surveyors find that the facility failed to provide and maintain a safe environment for patients and staff.

This is evidenced by the number, severity, and variety of Life Safety Code deficiencies that were found. Also see C231.

Based on observation during the survey walk-through, staff interview, and document review during the Life Safety Code portion of the Sample Validation Survey conducted on December 13, 2017, the surveyors find that the facility does not comply with the applicable provisions of the 2012 Edition of the NFPA 101 Life Safety Code.

See the Life Safety Code deficiencies identified with K-Tags.

A. Based on observation, interview, and document review, it was determined the Critical Access Hospital (CAH) failed to ensure outdated drugs and/or biologicals were not available for use. This has the potential to affect all inpatients, outpatients, visitors, and staff.

Findings include:

1. Observational tours of the CAH were conducted throughout 12/12/17. The following outdated drugs and/or biologicals were observed available for use:
a. On the Medical Surgical Unit in the crash cart: one syringe of Pediatric Sodium Bicarbonate 8.4%, expired 12/1/2017 and one Maxi Flo Looped Suction Catheter, expired 9/2017.
b. In the Dietary Department: one 50 count Aqua Check Hach Water Quality test strips, expired 11/2016; two Hydrion QT40 test tape, expired 11/15/16; four Ecolab Aerosol Foam Hand Sanitizers, expired 2/2014, 6/2014, 4/2015, and 9/2016; one Bacti-Stat hand wash, expired 11/2010.
c. In the Pulmonary/Cardiac Area: In the decontamination room, an open 2 quart bottle of bleach with the open date of 10/1/14. It was verbally confirmed by the Director of Cardiopulmonary Services (E#6), the bleach was expired and should have been thrown away.
d. In the Emergency Department: In Room #4's refrigerator, one 100 milliliter bottle of Eptifibatide (an intravenous medication used to prevent the formation of blood clots) and one 10 milliliter bottle of Eptifibatide with an expiration date of 11/2017. It was verbally confirmed by the Infection Preventionist (E #4), the medications were expired and should have been removed from the refrigerator.

2. An interview was conducted with the Chief Operating Officer (E#2) on 12/12/17 at approximately 11:45 AM. E#2 had observed the outdated drugs and/or biologicals in the Medical Surgical and Dietary areas and agreed they should not be available for use.

B. Based on observation, document review, and interview, it was determined the Critical Access Hospital (CAH) failed to ensure Pharmaceutical oversight of narcotic discrepancy resolution throughout the CAH. This has the potential to affect all inpatients and outpatients serviced by the CAH.

Findings include:

1. Observational tours of the CAH were conducted on 12/12/17. The Omnicells (automated dispensing machines) located in the Emergency Room (ER) and in the Medical Surgical unit were observed to have narcotic discrepancies, dated 12/6/17 and 12/7/17 respectively. As of 12/12/17 at 12:00 PM, the narcotic discrepancies had not been resolved.

2. The CAH policy titled "Automated Dispensing Machine" (revised 8/2017) was reviewed on 12/14/17 at approximately 9:45 AM. The policy stated "Schedule II Medications 5. Pharmacy will print a Schedule II Medication activity report weekly. This report will be audited monthly to check that the waste functions being utilized properly... Nurse Supervisors 2. In case of a discrepancy, a report may be printed that will document the activity of a particular medication. the supervisor will then investigate why the discrepancy occurred. The director of pharmacy will share this process."

3. An interview was conducted with the Pharmacy Director (E#10) on 12/12/17 at approximately 1:00 PM. E#10 stated "This one (Medical Surgical) was a typo, but it had not been resolved in the Omnicell and should have been. I had another one in the ER just now too that we hadn't resolved officially either and we should have."

4. A follow up interview was conducted with E#10 on 12/14/17 at approximately 9:45 AM. E#10 stated that the Pharmacy runs a discrepancy report once a week and that that is how the Pharmacy becomes aware of a discrepancy. E#10 verbally agreed there was not a process in place to assure the Nursing Supervisor was notified of a narcotic discrepancy when it occurs and lacked specific steps to assure the resolution of a narcotic discrepancy along with specific Pharmacy oversight.

C. Based on document review and interview, it was determined the Critical Access Hospital (CAH) failed to ensure initial and ongoing annual Quality Assurance monitoring of personnel designated to perform compounding of sterile preparations (CSP), in accordance with United States Pharmaceutical (USP) <797> Pharmaceutical Compounding Sterile Preparations. This has the potential to affect all personnel who are designated to perform compounding of CSPs for the CAH and patients serviced by the CAH.

Findings include:

1. The USP <797> Pharmaceutical CSP was reviewed on 12/15/17 at approximately 12:30 PM. USP <797>stated the following:
On page 12, "Personnel who prepare CSPs shall be trained conscientiously and skillfully by expert personnel... in achieving and maintaining ISO (International Standards Organization) Class 5 environmental condition before they begin to prepare CSPs. Compounding personnel shall perform didactic review and pass written and media-fill testing of aseptic manipulative skills initially, at least annually thereafter for low- and medium-risk level compounding."
On page 31, "Aseptic Work Practice Assessment and Evaluation via Personnel Glove Fingertip Sampling... Sterile contact agar plates shall be used to sample the gloved fingertips of compounding personnel after garbing in order to assess garbing competency and after completing the media-fill preparation... Garbing and Gloving Competency Evaluation- Compounding personnel shall be visually observed during the process of performing.... shall be documented... and maintained to provide a permanent record and long-term assessment of personnel competency. Gloved Fingertip Sampling- All compounding personnel shall successfully complete an initial competency evaluation and gloved fingertip/thumb sampling procedure... no less than three times before initially being allowed to compound CSPs for human use... re-evaluation of all compounding personnel for this competency shall occur at least annually for personnel who compound low- and medium-risk level CSPs..."

2. An interview was conducted with the Director of Pharmacy (E#10) on 12/14/17 at approximately 10:30 AM. E#10 stated the Pharmacy does not have a Quality Assurance process in place to address each of the required elements for initial and ongoing annual monitoring of competency of all personnel who compound CSPs.

D. Based on document review and interview, it was determined the Critical Access Hospital (CAH) failed to ensure staff performing compounding of intravenous medications for immediate- use, were trained and demonstrated competence initially and at least annually thereafter. This has the potential to affect all inpatients and outpatients who require the use of immediate-use compounded intravenous medications when prepared outside an ISO (International Standards Organizations) 5 environmental condition area.

Findings include:

1. The USP <797> Pharmaceutical Compounding Sterile Preparations (CSP) was reviewed on 12/15/17 at approximately 12:30 PM. It stated on page 12, "Personnel who prepare CSPs shall be trained... The immediate-use provision is intended only for those situations where there is a need for emergency or immediate patient administration of a CSP. Such situations may include... or critical therapy where the preparation of the CSP under conditions described for Low-Risk Level CSPs subjects the patient to additional risk due to delays in therapy..."

2. An interview was conducted with the Director of Pharmacy (E#10) and the Medical Surgical Registered Nurse (E#11) on 12/14/17 at approximately 10:30 AM. E#10 stated, "Nursing staff mix Pitocin when needed after a delivery. This can be done either in OB or in surgery." E#11 stated "We (the nurses) mix our IV (intravenous) meds (medications) in our Med Room (a none ISO 5 environment)." E#10 verbally agreed IV bags of fluid and the IV medication that is to be diluted and administered to the patients is sent to the Medical Surgical Unit, that the Obstetric nurses also mix Pitocin IVs for use in OB/surgery, and that the nurses have not been trained and have not demonstrated competence in immediate-use sterile compounding.

A. Based on document review and interview, it was determined for 6 of 9 (Medical Doctor (MD)#1,#2 #3, #5, #6, and #7) MDs and for 3 of 3 (E#5, E#6, and E#10) nursing employees reviewed for employee health assessment and vaccination status, the Critical Access Hospital (CAH) failed to ensure its employee health surveillance program was followed. This has the potential to affect all direct and contracted employees providing care and services at the CAH and has the potential to affect all patients and visitors of the CAH.

Findings include:

1. The CAH policy titled "Employee Health Program" (reviewed 03/2017) was reviewed on 12/14/17 at approximately 1:30 PM. The policy lacked inclusion of contracted providers (such as Emergency Room physicians and self-employed physicians). The policy stated the purpose of the program was to "4. Identifying infection risks related to employment and instituting appropriate preventative measures... Regular Employee:.." and went on to address immunization status assessment and further stated "Employees must finish all of the necessary immunizations within 12 weeks of their hire date..."

2. The CDC (Centers for Disease Control and Prevention) "Recommended Vaccines for Healthcare Workers" guidelines were presented by E#4 on 12/15/17 at approximately 10:00 AM and were reviewed. The guidelines recommended Hepatitis B (Hep B), Influenza (Flu), Tuberculosis (TB), Measles, Mumps, and Rubella (MMR), Tdap (Tetanus, Diphtherias, Pertussis) and Varicella.

3. The nursing employee's and MD employee's health files were reviewed on 12/14/17 at approximately 11:30 AM and lacked the following:
a. MD#1- TB, MMR, Flu, Tdap, Varicella
b. MD#2- TB, MMR, Flu, Tdap, Varicella
c. MD#3- TB, MMR, Flu, Tdap, Varicella, Hep B
d. MD#5- TB, MMR, Tdap, Varicella, Hep B
e. MD#6- MMR, Tdap, Varicella
f. MD#7- TB, MMR, Hep B, Tdap, Varicella
g. E#5, E#6, and E#10- Varicella

4. An interview was conducted with the Infection Preventionist (E#4) on 12/14/17 at approximately 11:30 AM. E#4 stated "We follow the CDC guidelines and recommendations for vaccinations. We only do our employees. We don't do contracted ones."
A follow up interview was conducted with E#4 on 12/15/17 at approximately 10:00 AM, after review of the CDC recommended vaccination guidelines, presented by E#4. E#4 stated "We didn't realize they (the CDC) had added Varicella to their list and we have not been doing this on any of our employees and should have been. We also, again, have not been checking contracted staff and should have been."

B. Based on document review and interview, it was determined for 3 of 3 (E#5, E#6, and E#10) employees required to wear respirators because of their exposure to high risk groups or procedures, the Critical Access Hospital (CAH) failed to ensure its initial and annual Respirator and fit testing were conducted in accordance with its policy. This has the potential to affect all staff at risk for exposure to TB.

Findings include:

1. The CAH policy titled "Policy Guidelines on TB Respirator" (reviewed 3/2017) was reviewed on 12/14/17 at approximately 1:30 PM. The policy stated "Purpose: To establish guidelines for employees required to wear respirators because of their exposure to high risk groups or procedures. This training shall include respirator selection, testing, inspection, cleaning (if necessary, maintenance, storage, and medical examination... Respirators shall not be worn by employees who have not received adequate training and education... Refresher training and refitting shall be done yearly."

2. An interview was conducted with the Infection Preventionist (E#4) on 12/14/17 at approximately 1:30 PM. E#4 stated "We have not been doing the Respirator fit testing and have nothing to show for any of the employees."

C. Based on observation, document review, and interview, it was determined for 2 of 2 (Pts #4 and #20) patients reviewed for infection control measures, the CAH failed to ensure its patient isolation and hand-off communication policies were followed to prevent the potential for cross contamination. This has the potential to affect all inpatients, outpatients, employees, and visitors.

Findings include:

1. An observational tour of the Medical Surgical unit was conducted on 12/12/17 at approximately 11:00 AM with the Chief Operating Officer (E#2) and the Emergency Department and Inpatient Department Director (E#3). The unit was observed to have no rooms marked to indicate the need for any type of isolation for its current patients.

2. The CAH policy titled "Policy Regarding Isolation" (reviewed 3/2017) was reviewed on 12/13/17 at approximately 11:35 AM. The policy stated "B. The CDC disease specific isolation/precautions table (see Addendum A, Attached) shall be utilized." The policy further stated the physician was primarily responsible to order isolation and, "under circumstances in which the above is not done, another physicians designated by him, the supervisor, nurse, or the Infection Control Nurse has authority to place the patient in isolation and may also remove from isolation." Appendix A stated patients with Clostridium Difficile were to be placed in Contact isolation for the duration of the illness and Influenza patients were to be placed in isolation based on CDC guidelines.

3. The CDC "Prevention Strategies for Seasonal Influenza in Healthcare Settings
Guidelines and Recommendations
The following guidance is current for the 2016-2017 influenza season.
5. Adhere to Droplet Precautions
Droplet precautions should be implemented for patients with suspected confirmed influenza for 7 days after illness onset or until 24 hours after the resolution of fever and respiratory symptoms, whichever is longer, while a patient is in a healthcare facility...Place patients with suspected or confirmed influenza in a private room or area...."

4. The CAH policy titled "Hand-Off Communication (revised 8/2017) was reviewed on 12/13/17 at approximately 11:35 AM. The policy stated "Standard: Clinical staff members provide accurate information concerning a patient's status when the responsibility for care is transferred from one caregiver to another, from one level of care to another, or from one unit or service to another... SBAR stands for: S- Situation B-Background A-Assessment R-Recommendation... Procedure: Hand off communication occurs between care providers in the following settings and circumstances:... When a patient is transferred from one level of internal care to another, I.e.: admission to the inpatient unit from the emergency room... The SBAR tool will be used for all hand-off communication... Documentation: Caregivers should provide documentation of significant hand-off communication outside the normal end of shift hand-offs... A summary of the hand-off information will be documented only if necessary to clarify the plan of care."

5. Pt #4 Admitted: 12/9/17 Diagnoses: Influenza A, Bronchopneumonia, and New Onset Atrial Fibrillation.
Pt #4's record was reviewed on 12/12/17 at approximately 3:00 PM. Emergency Department physician documentation stated Pt #4 "was admitted last night for respiratory distress. (Pt #4) has been ill since about the last 5 days when (Pt #4) had some chills and and (repeated twice in dictation) a productive cough... influenza A test was positive." The record lacked nursing documentation of hand-off communication related to the diagnosis of Influenza A between the emergency department and the inpatient unit. The record lacked orders for droplet isolation and lacked documentation of Pt #4 being put into droplet isolation. Medical Surgical documentation lacked documentation of Pt #4 having Influenza A. The electronic medical record lacked a "flag" to identify Pt #4 was to be in droplet isolation.

4. Pt #20 Admitted : 11/14/17 Diagnosis: Altered Mental Status Discharged: 11/17/17.
Pt #20's record was reviewed on 12/13/17 at approximately 12:30 PM. Pt #20's electronic medical record header stated "Infection: C. Difficile" (Clostridium Difficile). Pt #20's record stated the physician "added" an infection to Pt #20's EMR header. Nursing documentation stated contact isolation was maintained upon admission to the inpatient unit. The record lacked any further documentation that contact isolation was maintained for the duration of Pt #20's hospitalization.

5. An interview was conducted with the Infection Preventionist (E#4) on 12/13/17 at approximately 1:30 PM. E#4 stated the following:
a. For Pt #4: "I was off the weekend and Monday. I wasn't aware of (Pt #4) having Influenza A until now. (Pt #4) should have been put into droplet isolation and wasn't. (The Chief Operating Officer- E##2) and the Emergency Department /Inpatient Department Director- E#3) both told me that there was no isolation set up on the floor (Medical Surgical- Med/Surg) when the tour was conducted and we couldn't find any documentation of a hand-off between the ER (Emergency Room) and the Med/Surg about the Influenza A and there should have been. There wasn't an order for the isolation by either the physician or the nurse and there should have been. The record didn't have a "flag" put in the header to notify anyone who opens the record that the patient was to be in some type of isolation."
b. For Pt #20: "I can't find any documentation that the contact isolation was maintained for (Pt #20). They (staff) are expected to chart on this at least once a shift and I don't see that."

Based on document review and interview, it was determined for 1 of 3 (Medical Doctor (MD) #3) MDs reviewed for approved surgical services privileges, the Critical Access Hospital (CAH) failed to ensure a list of current approved surgical privileges was readily available to the surgical scheduling personnel. This has the potential to affect all patients receiving surgical services by the CAH, which performs a monthly average of 58 surgical procedures.

Findings include:

1. The Medical Staff Rules and Regulations (effective May 1, 2014) were reviewed on 12/13/17 at approximately 2:00 PM. The Rules and Regulations stated on page Rules 15, "VII. Surgical Care Issues A. 1) The surgical privileges approved for Medical Staff shall be on file in the surgery department. All surgeries shall be monitored against this list to assure that surgical practice complies with privileges granted.

2. Medical Doctor (MD) #3's electronic credential file was reviewed on 12/13/17 at approximately 1:00 PM with the Credentialing and Enrollment person (E#7). MD #3 was appointed to the Medical Staff with privileges in Gastroenterology on 8/1/16. The electronic file lacked a requested and/or approved privilege list.
On 12/13/17 at approximately 2:00 PM, E#8 (Director of Quality and Risk) presented a paper copy of MD#3's requested privileges, dated 7/19/16.

MD#3's Ongoing Professional Practice Evaluation and Focused Professional Practice Evaluation form stated MD#3 averaged 50 surgical procedures per quarter between October 2016 and June of 2017. Email documentation, dated 12/13/17, stated MD#3 had performed 78 surgical procedures between July 1, 2017 and present.

2. An interview was conducted with E#7 on 12/13/17 at approximately 1:00 PM. E#7 stated all privilege requests and approvals are scanned into the electronic file (CACTUS- an electronic system). E#7 stated "I don't see (MD#3's) privileges in here (the electronic file). E#7 stated "We also put them into the portal (a computer format) so that it is accessible to them (surgery), but I don't see it there either."
An interview was conducted with the Director of Surgical and Maternal Newborn Services (E#9) on 12/13/17 at approximately 1:50 PM. E#9 stated "I do much of the scheduling. We (the surgery staff) don't keep any paper privileges. We should be looking in the portal, or I call (E#8- Director of Quality and Risk or E#7) to make sure they (the surgeon) has the right privileges. I didn't realize (MD#3's) privileges weren't on the portal. They should have been. We obviously didn't check it and should have."

Based on document review and interview, it was determined the CAH (Critical Access Hospital) failed to ensure qualified employees were available and prepared to assume various roles in the event of an emergency. This has the potential to affect all patients, staff, visitors, and/or volunteers.

Findings include:

1. The "Emergency Operations Plan (EOP)" (reviewed 10/11/17) was reviewed on 12/12/17 at approximately 2:00 PM. The EOP noted on page 7, "During an emergency, the Hospital Incident Command System (HICS) should be activated."; On page 11, "3... Organizations are required to provide education that supports the NIMS compliance. The classes are as follows: IS-100... IS-200... IS-700... IS-800. 4. Individuals that may be assigned as Incident Commander have completed the above training."; On page 18, "... Hospital will maintain a list of qualified individuals that may fulfill the role of Incident Commander... After hours, the Nursing Administrative Supervisor is the initial designated Incident Commander."

2. The form titled "National Incident Management System - NIMS" (list of individuals that can act as the Incident Commander) was reviewed on 12/12/17 at approximately 3:00 PM. The list noted 19 names of staff listed who were identified to act as the Incident Commander. 17 of the 19 names listed lacked completion of all the required classes. The list lacked the names of the 5 Registered Nurse House Supervisors and lacked documentation of NIMS training for the House Supervisors.

3. During an interview on 12/12/17 at approximately 2:00 PM, E#5 (Director of Plant Operations and Materials Management) verbally agreed the NIMS training had not been completed by all the staff members noted to act as Incident Commander and they should have completed it. E#5 further agreed the Nurse Supervisors had not been placed on the list and also had not completed the required NIMS training

Based on document review and interview, it was determined the CAH (Critical Access Hospital) failed to define a process as to what patient/medical documentation would be provided to other health providers in the event of an evacuation. This has the potential to affect all patients serviced by the CAH during an emergency situation.

Findings include:

1. The "Emergency Operations Plan (EOP)" (reviewed 10/11/17) was reviewed on 12/12/17 at approximately 11:00 AM. The EOP section titled "Internal Disaster-Evacuation" (pages 37-41) noted "Nursing Supervisor... 4. Instruct the Unit Secretaries to place charts of inpatients with the patient..."

2. During an interview on 12/12/17 at approximately 2:00 PM, E#5 (Director of Plant Operations and Materials Management) and E#2 (Chief Operating Officer) verbally agreed the EOP did not note what patient/medical documentation was required to be shared with the receiving health care provider in the event of an evacuation.

Based on document review and interview, it was determined the Critical Access Hospital (CAH) failed to ensure initial training in the emergency preparedness policies and procedures to all new and existing physicians and midlevel providers providing services directly and/or under contract, consistent with their expected role. This has the potential to affect all direct and/or contracted physicians and midlevel providers who currently and/or will potentially provide emergency preparedness services to patients during a disaster at the CAH.

Findings include:

1. The CAH "Emergency Plans" (no date) was reviewed on 12/15/17 at approximately 12:00 PM. The Plan stated on page 22 "Medical Staff A. Physicians in the hospital at the time of the disaster should report to triage. B. The Physician on Call shall be notified immediately of the disaster and shall coordinate triage of incoming patients. Physicians who have been called in to assist in the treatment of patients will go directly to rooms designated by the Nursing Supervisor..." The Plan lacked inclusion of Midlevel providers, such as Physician Assistant and Certified Registered Nurse Anesthetists.

2. An interview was conducted with the Director Plant Operations (E#5) on 12/15/17 at approximately 2:30 PM. E#5 stated the physicians and midlevel providers, direct and/or contracted, were not included in the CAH training on the emergency preparedness plan policies and procedures.