Hendricks Community Hospital

“DRUG AND BIOLOGICALS CFR(s): Drugs and biologicals commonly used in life-saving procedures, including analgesics, local anesthetics, antibiotics, anticonvulsants, antidotes and emetics, serums and toxoids, antiarrythmics, cardiac glycosides, antihypertensives, diuretics, and electrolytes and replacement solutions. This Standard is not met as evidenced by: 40614 Based on observation, interview, and document review, the critical access hospital (CAH) failed to ensure appropriate reconciliation to prevent diversion of narcotic medications stored in the ambulance tackle box located in the pharmacy. Findings include: On observation and tour of the emergency department with registered nurse (RN)-C on 4/23/24 at 11:00 a.m., RN-C indicated the CAH had an emergency tackle box with supplies that were brought with when an RN accompanied patients in the ambulance for transport to another hospital. RN-C entered the pharmacy using a finger print reader and retrieved the orange emergency tackle box from a shelf underneath a counter. The emergency kit had a padlock present on the outside. Inside the tackle box was a plastic container, secured with a snap away plastic tag device with tag number 4434574. The kit contained the following medications: three vials of Fentanyl (Schedule II controlled substance, powerful synthetic opioid analgesic similar to morphine but more potent) 100 mcg/2 ml, five vials of Morphine (Schedule II controlled substance used to treat acute severe pain) 2 mg/1 ml, three vials of diazepam (Schedule IV controlled substance) 5 mg/1 ml and four vials of lorazepam (schedule IV controlled substance) 0.5 mg/ml. In addition, the emergency tackle box contained syringes, needles, Insyte (IV Needle) and multiple oral and injectable medications. An Ambulance Medication Box Checklist, last completed by RN-D on 4/20/24, was present inside the kit that included all contents of the kit with earliest expiration date present. The list did not include verification of the tag number on the plastic container that contained the narcotic medications. A 24 hour medication lock checklist in the emergency department included Ambulance Box 1, which RN-C indicated was the ambulance emergency tackle box. Review of checklists from November 2023 through April 2024, included documentation for 3/13/24, lock number was 4434572 with code A, which indicated patient use. The code was changed to 4434573. On 12/31/24, the lock number was listed as 4434571, with code B, which indicated an outdated check. Both were initialed by RN-D. The rest of the checklists were empty with no documentation present. On interview 4/23/24 at 11:30 a.m., RN-C stated she was not sure why the 24-hour medication lock checklist was not completed at least monthly on the checklist. RN-C added RN-D was responsible for checking the ambulance emergency kits monthly on the night shift. RN-C stated all RN’s had access to the code for the ambulance tackle box and access to the pharmacy. On interview 4/23/24 at 8:15 a.m., pharmacist (P)-D indicated narcotics were all stored in the automated dispensing cabinet (ADC) [computerized medicine cabinet used in hospital for controlling and tracking drug distribution] or locked in a pharmacy cabinet and not on the shelves in the pharmacy. All restocking of emergency kits was completed by signing out the medications from the ADC and was completed by nursing staff. Reports were run and reviewed on all controlled substances to ensure safe removals and receipts of controlled substances. If discrepancies were found, P-D and the DON would investigate to find any lost narcotics. P-D stated he was the only one who had access to the locked cabinet in the pharmacy and was the only one who ordered and stocked narcotic medications in the ADC. During interview on 4/24/24 at 9:40 a.m., the director of nursing (DON) indicated the process for checking emergency equipment and supplies included the ambulance kit and was in place prior to her assuming her role. DON stated she assumed it was adequate and correct. The DON stated since the ambulance tackle box was in the pharmacy and double locked, she did not believe reconciling the narcotic medications was necessary except when the kit had been used. The DON indicated the facility process was reviewing the plastic securing tag with number when restocking or using the medications and was not verified with each check of the ambulance emergency kit completed monthly. The DON stated the medications were all removed from the ADT when restocking the emergency kits. The DON indicated she was not certain how often the narcotics should have been reconciled. A policy and procedure Controlled Substances and High Risk Medication Diversion Prevention, dated 12/2019 included: - Pharmacy staff would stock controlled substances and high risk legend drugs. - For controlled drugs sent to patient care areas, two staff members must be involved. - A double check process was in place for drugs returned to the pharmacy that were not in ADT or in waste. - Discrepancies would be resolved within a maximum of 72 hours. - Monthly inventory of the ADT would be conducted by one hospital staff member (due to single pocket and audit trail). -Diversion index report was reviewed monthly for all individuals and compared to the medication administration record. The policy and procedure did not include reconciliation of narcotic medications stocked in emergency use kits. A policy and procedure on automated dispensing cabinet and narcotic reconciliation was requested however was not provided.”

“LIFE SAFETY FROM FIRE CFR(s): §485.623(c) Standard: Life Safety From Fire (1) Except as otherwise provided in this section: (i) The CAH must meet the applicable provisions and must proceed in accordance with the Life Safety Code (NFPA 101 and Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4.) (ii) Notwithstanding paragraph (d)(1)(i) of this section, corridor doors and doors to rooms containing flammable or combustible materials must be provided with positive latching hardware. Roller latches are prohibited on such doors. This Standard is not met as evidenced by: 27955 Based on 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: Please refer to the Life Safety Code inspection tag: K346.”

“PATIENT CARE POLICIES CFR(s): [The policies include the following:] (iv) Rules for the storage, handling, dispensation, and administration of drugs and biologicals. These rules must provide that there is a drug storage area that is administered in accordance with accepted professional principles, that current and accurate records are kept of the receipt and disposition of all scheduled drugs, and that outdated, mislabeled, or otherwise unusable drugs are not available for patient use. This Standard is not met as evidenced by: 40614 Based on observation, interview, and document review, the critical access hospital (CAH) failed to ensure outdated medications and supplies were not available for patient use. Findings include: On 4/23/24 at 9:30 a.m., a tour was completed of the radiology department with radiologist technician manager (RT)-B. The CT (computerized tomography) room included an emergency kit that was locked with a padlock and black numbered tag. The emergency kit contained the following: an Epinephrine injection (used in emergencies to treat serious allergic reactions), which expired March 2023, a pediatric epinephrine injection that expired 2/2022, three saline flushes that expired 11/30/20, one 20 gauge Insyte (intravenous (IV) needle expired 3/31/21, three 18 gauge Insyte expired 5/31/20 and four 12 milliliter syringes expired 12/31/22. The kit lacked a list of contents included in the emergency kit. During interview on 4/23/24 at 9:45 a.m., RT-B stated she was unsure when the emergency kit was last checked or opened. RT-B indicated she assumed nursing, ambulance staff or someone else was taking care of the emergency kit and did not realize she needed to check the emergency kit for outdates. On 4/23/24 at 11:15 a.m., registered nurse (RN)-C indicated staff checked the emergency department and patient care area for outdates however did not check for outdates in the radiology department. A policy and procedure for Emergency Medications, last reviewed 4/2019, included medication cart/kits was checked when the seal was broke with contents to be inspected and any missing medication replaced. The list of contents was to be updated as to expiration date and the cart/kit again sealed.”

“PATIENT CARE POLICIES CFR(s): [The policies include the following:] (vi) Procedures that ensure that the nutritional needs of inpatients are met in accordance with recognized dietary practices. All patient diets, including therapeutic diets, must be ordered by the practitioner responsible for the care of the patients or by a qualified dietitian or qualified nutrition professional as authorized by the medical staff in accordance with State law governing dietitians and nutrition professionals and that the requirement of § 483.25(i) of this chapter is met with respect to inpatients receiving post CAH SNF care. This Standard is not met as evidenced by: 34083 Based on observation, interview and document review, the facility failed to provide the appropriate ordered diet for 1 of 1 patient (P17) on an ordered clear liquid diet. Findings include: Review of P17’s 4/22/24, signed physician orders identified P17 was admitted Transitional status (considered out patient) due to his inability to complete his Colonoscopy (medical procedure that allows examination of the lining of the colon and rectum) preparation Moviprep (a low volume colons prep), scheduled for 4/24/24. Observation on 4/22/24 at 5:10 p.m., of tray service identified P17’s tray being set up for delivery of his supper meal. Cook-B stated to dietary aide (DA)-A that P17 was to receive a clear liquid diet. DA-A proceeded to go to the storage area and returned with orange jello, chicken broth, mixed berry Boost, (package identified a glass with a pink/red liquid), and a snack Pak container of chocolate pudding. The items were placed on the tray with DA-B who observed the process and placed the tray into the cart to be delivered and served to patients. When questioned about chocolate pudding being included on a clear liquid diet, DA-A responded he had not thought about it when he put it on the tray. Review of the binder located on the counter of the serving area for reference, contained an undated page labeled Clear Liquid Diet with a list of: broth, Jell-O, sprite, tea, apple juice, white grape/cranberry juice, coffee, fruit juices with no pulp or pieces, possible, juice enhanced supplement drinks (Breeze). There was no notification to avoid food or drink items with red dye for patients having a Colonoscopy procedure. In addition, the binder lacked any listing of pudding allowed for a clear liquid diet. Observation at 5:20 p.m., Cook- B stated chocolate pudding was not included on a clear liquid diet, and removed it from P17’s tray, however the red colored Boost liquid remained on the tray. The cart was transported to the nursing unit at 5:30 p.m. with the tray served to P17. Interview on 4/22/24 at 5:35 p.m., with registered nurse (RN)-B identified chocolate pudding was not included on a clear liquid diet and could not be included on the tray. On a subsequent interview on 4/24/24 at 10:00 a.m., RN-B stated P17 had been served the supper tray containing the red colored Boost supplement on 4/22/24, and she had not noted it when the tray was served. Interview on 4/23/24 at 8:40 a.m., with the certified dietary manager reported she had been informed about the chocolate pudding being placed on a clear liquid diet tray and it should have been caught by the cook who was responsible for overseeing the tray service. She stated the binder located at the serving area contained the various items allowed for each diet for staff to reference when setting up trays. She indicated the Boost supplement contained red dye and should not have been served to P17 or any resident having a colonoscopy. Observation/interview on 4/24/24 at 10:30 a.m., with RN-E identified P17’s lunch and supper trays were sent to the nursing unit for serving with Boost supplement containing red dye and she had replaced it with an allowed supplement prior to serving to P17. She stated the signed orders for a Moviprep identified to avoid any food/drink items containing red dye. Interview on 4/24/24 at 10:55 a.m., with the director of nursing (DON) stated her expectation for dietary orders to be followed for any restricted items due to noncompliance causing the possibility of inaccurate procedure results. Review of the 4/22 and 23, 2024, provider signed, Moviprep colonoscopy instructions from the MD identified to avoid any liquids with RED dye and/or pulp in it.”

“PATIENT CARE POLICIES CFR(s): These policies are reviewed at least biennially by the group of professional personnel required under paragraph (a)(2) of this section and updated as necessary by the CAH. This Standard is not met as evidenced by: 40614 Based on observation, interview, and document review, the critical access hospital (CAH) failed to review policies at least biannually by a group of professional personnel and updated as necessary. Findings include: Upon review of requested policies and procedures for pharmacy, social services and emergency room the following policies and procedures were received: - Authorization to Removed Medications/Biologicals from Pharmacy, last reviewed and approved 4/2020. - Controlled Substance and High Risk Medication Diversion Prevention, last reviewed and approved 12/2019. - Medication Outdates, last reviewed and approved 4/2019. - Disposition of Medications Returned to Pharmacy, last reviewed and approved 4/2019. - Self-Administration of Medications, last reviewed and approved 4/2019. - Medication Administration, last reviewed and approved 4/2019. - Medication Errors, last reviewed and approved 4/2019. - Medical Social Services, last reviewed and approved 7/2020. - Scope of Emergency Services, last reviewed and approved 12/2016. - Management of Drug Overdose, last reviewed and approved 12/2016. - Dead on Arrival Patients, last reviewed and approved 4/2018. - Restraint Policy, last reviewed and approved 1/2020. - Care of Alleged Sexual Assault, last reviewed and approved 3/2016. - Code Medical Emergency, last reviewed and approved 6/2018. - Emergency Medications, last reviewed and approved 4/2019. During interview on 4/24/24 at 10:06 a.m., the director of nursing (DON) confirmed the facility fell behind on review and approval of the facility policies and procedures and was aware many of them had not been reviewed since before the Covid-19 outbreak. The DON indicated they had a subcommittee that reviewed and approved all of their policies and they were currently reviewing pharmacy policies and the committee was aware there were other policies and procedures that needed to be reviewed. A policy on policy and procedure review was requested however was not received.”

“QAPI CFR(s): (b) Standard: QAPI Program Design and scope. The CAH’s QAPI program must: (2) Be ongoing and comprehensive. (3) Involve all departments of the CAH and services (including those services furnished under contract or arrangement). This Standard is not met as evidenced by: 34083 Based on interview and record review the Critical Access Hospital (CAH) failed to ensure Dietary services, Central Processing and Organ Procurement Organization (OPO) were evaluated through the quality assurance program. Findings include: Interview and document review on 4/23/24 at 9:57 a.m., with the certified dietary manager (CDM) stated she was aware she was expected to review, identify, and develop a Quality Assurance and Performance Improvement (QAPI) project for dietary however, indicated she had not done so. Interview on 4/24/24 at 9:00 a.m., with nursing assistant (NA)-A who worked in surgery and central processing with cleaning and processing of equipment and scopes identified she was the primary staff there. NA-A stated she completed training of other staff however had not identified any areas of concern and had not developed a QAPI project. Interview on 4/24/24 at 10:55 a.m., with the director of nursing (DON) stated she was not aware of QAPI projects in place for either the Central Processing Services or OPO, due to limited usage and not being aware of any current concerns. A policy for QAPI program was requested however was not provided.”

“FIRE SAFETY THE FACILITY’S POC WILL SERVE AS YOUR ALLEGATION OF COMPLIANCE UPON THE DEPARTMENT’S ACCEPTANCE. YOUR SIGNATURE AT THE BOTTOM OF THE FIRST PAGE OF THE CMS-2567 FORM WILL BE USED AS VERIFICATION OF COMPLIANCE. UPON RECEIPT OF AN ACCEPTABLE POC, AN ONSITE REVISIT OF YOUR FACILITY MAY BE CONDUCTED TO VALIDATE THAT SUBSTANTIAL COMPLIANCE WITH THE REGULATIONS HAS BEEN ATTAINED IN ACCORDANCE WITH YOUR VERIFICATION. An annual Life Safety recertification survey was conducted by the Minnesota Department of Public Safety, State Fire Marshal Division on 04/23/2024. At the time of this survey, Hendricks Community Hospital was found not in compliance with the requirements for participation in Medicare/Medicaid at 42 CFR, Subpart 483.70(a), Life Safety from Fire, and the 2012 edition of National Fire Protection Association (NFPA) 101, Life Safety Code (LSC), Chapter 19 Existing Health Care and the 2012 edition of NFPA 99, Health Care Facilities Code. THE FACILITY’S POC WILL SERVE AS YOUR ALLEGATION OF COMPLIANCE UPON THE DEPARTMENT’S ACCEPTANCE. YOUR SIGNATURE AT THE BOTTOM OF THE FIRST PAGE OF THE CMS-2567 FORM WILL BE USED AS VERIFICATION OF COMPLIANCE. UPON RECEIPT OF AN ACCEPTABLE POC, AN ONSITE REVISIT OF YOUR FACILITY MAY BE CONDUCTED TO VALIDATE THAT SUBSTANTIAL COMPLIANCE WITH THE REGULATIONS HAS BEEN ATTAINED IN ACCORDANCE WITH YOUR VERIFICATION. PLEASE RETURN THE PLAN OF CORRECTION FOR THE FIRE SAFETY DEFICIENCIES (K-TAGS) TO: IF PARTICIPATING IN THE E-POC PROCESS, A PAPER COPY OF THE PLAN OF CORRECTION IS NOT REQUIRED. Healthcare Fire Inspections State Fire Marshal Division 445 Minnesota St., Suite 145 St. Paul, MN 55101-5145, OR By email to: FM.HC.Inspections@state.mn.us THE PLAN OF CORRECTION FOR EACH DEFICIENCY MUST INCLUDE ALL OF THE FOLLOWING INFORMATION: 1. A detailed description of the corrective action taken or planned to correct the deficiency. 2. Address the measures that will be put in place to ensure the deficiency does not reoccur. 3. Indicate how the facility plans to monitor future performance to ensure solutions are sustained. 4. Identify who is responsible for the corrective actions and monitoring of compliance. 5. The actual or proposed date for completion of the remedy. Hendricks Community Hospital is a 1-story building with no basement. The original building was constructed in 1957 and was determined to be of Type II(111) construction. In 1970, an addition was constructed and determined to be of Type II(111) construction. Another addition was constructed in 2000 and determined to be of Type II(111) construction. A 202 addition was constructed and determined to be of Type II(111) construction. The most recent renovation and construction was completed in 2018 and determined to be Type II (111) construction. The building has a fire alarm system with full corridor smoke detection, including all spaces open to the corridors, that is monitored for automatic fire department notification. Patient rooms contain hard wired interconnected smoke detectors. The building is separated from a nursing home, an outpatient clinic and an assisted living facility, with 2-hour fire wall assemblies. All communicating openings are protected with labeled, listed 90-minute fire rated door assemblies. The facility has a capacity of 24 beds and had a census of 4 at time of the survey. The requirement at 42 CFR, Subpart 482.41(b) is NOT MET as evidenced by:”

“Fire Alarm System - Out of Service CFR(s): NFPA 101 Fire Alarm - Out of Service Where required fire alarm system is out of services for more than 4 hours in a 24-hour period, the authority having jurisdiction shall be notified, and the building shall be evacuated or an approved fire watch shall be provided for all parties left unprotected by the shutdown until the fire alarm system has been returned to service. 9.6.1.6 This Standard is not met as evidenced by: 35482 Based on a review of available documentation and staff interview, the facility failed to maintain an out of service plan for the fire alarm system per NFPA 101 (2012 edition), Life Safety Code, section 9.6.1.6. This deficient finding could have a isolated impact on the patients within the facility. Findings include: On 04/23/2024 at 12:10 PM, it was revealed by a review of available documentation that the current out of service policy for the fire alarm system states that a fire watch will be started when the fire alarm system is out of service for 10 hours instead of 4 hours. An interview with the Maintenance Director verified this deficient finding at the time of discovery.”