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Based on observation, interview, and record review, the hospital failed to ensure emergency code carts (or E-Cart, a mobile cart stored emergency medications and supplies to care for urgent medical emergency) were safely stocked with medications and supplies needed for urgent care of the patients in two out of two emergency code carts based on nationally recognized guidelines.

This failure could contribute to unsafe care of patients during urgent medical emergency care which could lead to negative clinical outcomes.


Findings:


During a concurrent interview, with Director of Nursing (DON) and inspection of the hospital's Emergency Cart #1 (E-Cart #1), on 6/9/25 at 2:30 pm, the cart did not have a medication or supply list attached to the cart for quick and ease of the use and the drawers were not marked with its content. The E-cart stocked medication and supplies for both adult and pediatric patients. The Broselow tape (The Broselow Pediatric Emergency Tape is a color-coded tape measure that is used worldwide as a quick reference for pediatric emergencies. Included on this tape are pre-calculated emergency medications, equipment sizes, and how much shock doses to give to re-start the heart) was dated for 2017, and not the most recent version with updated guidelines for emergency care. The emergency book for restarting the heart was dated for 2013, and not up to date with the most recent guidelines by American Heart Association (nationally recognized organization that promotes and publish appropriate care for heart attack or brain stroke emergency). Further inspection indicated the following unlabeled, outdated and co-mingled medication storage inside the E-cart #1:

i. Multiple bags of Sodium (salt) chloride IV solution 100 mL out of outer wrap and not dated ("IV" means "Into the Vein" a sterile solution; "mL" is milliliter, a measure of volume) in drawer 5.

ii. Co-mingled box containing naloxone (or Narcan, for reversal of opioid overdose) and metoprolol (a heart medication used to regulate heart rate) vial that had manufacturer label was torn and unrecognizable.

iii. In Drawer 6, the sealed medication tray did not have a list of medications with earliest expiration dating and no signature to assure its accuracy.

iv. Opened un-used packet of "Adult- Nasal cannula" supply and expired "lubricant jelly" (expired on 4/30/24) packets.

The DON confirmed the findings and stated the original signed copy of E-Cart checklist was kept in a binder in the pharmacy.

During a concurrent interview, with DON and inspection of the hospital's Emergency Cart #2 (E-Cart #2), on 6/9/25 at 3:32 pm, the cart was located inside a room in the Emergency Department (ED), and did not mirror the E-Cart #1 for medication and supply layout. The DON acknowledged this inconsistency and not mirroring the E-Cart #1 could contribute to confusion during an urgent medical situation. The E-Cart #2 medication and supply list was not signed, and the drawers were not marked for ease of use. The E-Cart #2 had outdated pediatric Broselow tapes, and unsafe co-mingled look alike medication in the same container (Benadryl, and Epinephrine - two emergency medication for allergic reaction). The sealed pediatric tray in one of the cart's drawers, did not have a list of medication and supplies and a notation on the outer box indicated, "Do Not Waste Precious Time With Calculations; Please Refer to Broselow Book..." The DON acknowledged these findings.

A review, of the facility's policy titled, "Emergency Department: Care of Crash Carts and Bags," dated 6/11/21, indicated that it is the policy of this hospital to provide up-to-date crash carts, crash bags, and Broselow bags to assist in care of critical patients. Emergency drugs and supplies for use in medical emergencies only shall be immediately available on crash carts located in the emergency department and acute hallway. The crash carts are portable and immediately available for the acute nursing stations. Content of carts/bags are to be approved by Medical Director, Pharmacist, and Medical Staff Committee... The inventory list will be kept on top of the crash cart/bag with the checklist documenting lot number, date checked... and RN initials.

A review, of the American Heart Association (AHA) guidelines titled, "Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care," dated 10/20, the guidelines emphasized having essential emergency equipment and medications readily available for cardiac arrest and other life-threatening emergencies. These guidelines focus on organization, accessibility, and appropriate stocking of the crash cart (same as Emergency Cart). The guidelines emphasized regular maintenance procedure helped ensure a level of consistency and readiness for cardiac emergency. The crash cart Organization and Accessibility included uniform arrangement of Crash carts in a standardized way within the facility and medication organization should be clearly labeled and arranged for quick identification. The guidelines on pediatric considerations indicated pediatric medications should be segregated and clearly labeled.

Based on observation, interview, and record reviews, the facility failed to have a system in place to ensure regularly scheduled inspections and preventive maintenance of the food services areas and equipment, contributing to unsanitary, uncleanable food services production and food storage areas.

These failures have the potential to result in foodborne illness (illnesses that result from ingesting contaminated foods) for patients and staff who receive food from the kitchen, and endangerment of food supplies and decreased lifespan of large equipment due to inadequate equipment maintenance.


Findings:


A review, of the 2022 FDA Food Code 6-101.11 indicated: Materials for indoor floor, wall, and ceiling surfaces under conditions of normal use shall be: (1) SMOOTH, durable, and EASILY CLEANABLE for areas where FOOD ESTABLISHMENT operations are conducted.

A review, of a policy titled, "Plant Operations and Maintenance," effective 11/07, indicated that the maintenance and operation of all hospital building, grounds structures, plan components, utilities... sanitary systems, refrigerator units, ventilation... plant security, internal and external lighting... are the primary responsibilities essential in the Plant Operation and Maintenance Program. A safe, clean, structurally sound environment shall be achieved in the hospital through development and implementation of the Plant Operations and Maintenance Program.

A review, of a policy titled, "Maintenance Work Request System," effective 11/07, indicated that it's purpose was to establish an effective means of requesting, coordinating and completing maintenance of a corrective nature. The procedure describes urgent, routine and deferred (based on priority) work requests. Corrective maintenance can be defined as those actions required to restore equipment, buildings and grounds to normal condition and to operate as designed.

A review, of a policy titled, "Weekly Log," revised 2/23/18, indicated a weekly log was to be maintained to create a record of significant occurrences in the Engineering Services including record of weekly routine inspection daily walkabouts and notes from the Engineering Log, and machinery inoperative or needing repair of maintenance.

During the initial tour of the kitchen on 6/9/25 from 12:50 pm to 2:30 pm, the kitchen was observed to be poorly maintained. Holes in the walls had the potential to harbor insects or microbes. The walls, wood cabinets, wood shelving, doors and trim had chipped, missing, and worn paint, rendering them uncleanable. The door from the dry storage room to the outside was rusted and missing paint. Two areas near the dish room had missing tile floor coving. One ceiling light over the cold food preparation area was not working and had a soiled light cover. In the walk-in refrigerator, the condenser fan shields and the areas above and to the sides of the fans had an accumulation of dust and grime, with potential to blow and cross contaminate (bacteria are unintentionally transferred from one substance or object to another with harmful effect) food in the refrigerator. In the walk-in freezer, icicles were accumulated on the condenser fan shields and around the door, indicators of freezer improper functioning.

During an interview, with the Dietary Manager (DM) on 6/9/25 at 12:50 pm, she stated the kitchen was in process of remodeling, and some painting had been done in the dry storage area. She stated there were plans to finish removing pegboard, patch holes, and paint the walls the kitchen. Some wood cabinets were going to be replaced, and some would be repainted.

During an interview, with the Plant Maintenance Supervisor (PM) on 6/10/25 at 9:05 am, he stated staffing and budget are challenges for the maintenance department, and the recent HVAC (heating and air conditioning) replacement project has taken up a lot of his time. PM stated, that the kitchen remodel was hard to work on because of many years of deferred maintenance, lack of money, and because the work couldn't be done when food production was in progress, so that required night-time hours.

In a continued interview, the PM stated he did not have a regular inspection process in place for the kitchen, and relied on staff to submit work orders. He did not regularly inspect or do preventive maintenance on the walk-in or reach-in refrigeration units. He stated his team cleaned the ice machine, inspected fire extinguishers, had the hood cleaned twice annually, and responded to emergent needs in the food services department. Light bulbs were replaced when staff notified them of a problem. PM stated he did not have a specific inspection checklist for the kitchen, but he had just started the trial of an electronic preventive maintenance system for the facility to assist with maintenance tracking and reporting.

A review, of requested kitchen inspection documentation from the past year, titled "F-371 Kitchen Sanitation Checklist," completed by the Certified Dietary Manager (CDM) on dates 7/23/24, 8/30/24, 9/30/24, 10/30/24, 12/4/24, 1/9/25, 3/26/25, and 5/20/25 indicated:

7/23/25 - Chipped molding and walls noted, and stating the problem would be reported to maintenance.

8/30/24 - Walls needed cleaning in multiple areas and holes needed to be patched, communication sent to Maintenance. Also talked about the sheet rock holes getting patched.

9/30/24 - Maintenance needs to finish patch job. Breakroom needed safety cover on light fixture. Communication sent to Maintenance.

10/30/24 - Light fixtures need cleaned in kitchen, dietary office, and employee breakroom. Communication sent to Maintenance.

12/4/24 - Need ceiling in breakroom and diet office repaired (cracks). Need light safety covers cleaned. Need light safety cover in employee breakroom.

1/9/25 - Reach in (refrigerator) fan needs cleaned. Walk-in freezer - ice on outside door. Dishroom back wall needs cleaned and painted. Ceiling chipped.

3/26/25 - Back walls in dishwasher area needs a wall painted to be able to clean. Light fixtures need cleaned. Missing light fixture in breakroom. Communication sent to Maintenance.

During an interview, with the Certified Dietary Manager (CDM) on 6/11/25 at 9:00 am, she stated that maintenance tried very hard to take care of things. When problems were urgent, maintenance was right on it to fix it. Non-urgent issues can take longer.

Based on observation, interview and record review the facility failed to ensure:

1. Expired supplies were removed from patient care areas in the clinic.

2. Policies were developed for expired supplies at the clinic.

This failure had the potential for inaccurate test results, increased risk of infection and negative clinical outcomes for patients.


Findings:


During an observation, and interview, with the Office Manager (OM), on 6/10/25 at 11:20 am, at the facility's clinic, a black metal box on the counter in the hallway labeled, "Emergency Supply." was observed. The box contained was alcohol prep pads (small pads with alcohol primarily used to clean and sterilize the skin) that were expired on 2/2022. OM confirmed, that the pads were expired and should have been removed.

During an observation, and interview, on 6/10/25 at 11:30 am, at the facility's clinic in the laboratory room, the following were observed:

* One Foley catheter tray (sterile kit containing a tube used to place in a patient's bladder to drain urine) with an expiration date of 2/28/25.

* Five urine specimen collection kits with an expiration date of 4/30/25.

* Two Syringes (20 milliliter (ml)) with an expiration date of 3/31/25.

* One Syringe (5 ml) with an expiration date of 11/10/24.

The OM confirmed the supplies were outdated, and should have been removed.

During an observation, and interview, on 6/10/25 at 11:45 am, at the wound care room within the facility's clinic a 250 ml bottle of sterile water used for wound care that had an expiration date of 5/9/25, was observed. OM confirmed the bottle was expired, and should have been removed.

2. During an interview, and record review, at 11:55 am, at the facility's clinic with OM, they were unable to locate in the clinic's policy binder, or a policy relating to expired patient supplies. The OM agreed, that the clinic should have a policy related to expired patient supplies.

During an interview, at 12:05 pm, with Materials Manager (MM), they confirmed the facility's clinic did not have a policy relating to expired patient supplies.

Based on observation, interview, and record review, the hospital failed to ensure a safe patient care policy and monitoring for a diabetic (blood sugar disease) patient in one out of two patients (Patient 10) based on standards of practice when:

The hospital did not have a policy, procedure and staff training for safe use, monitoring and calibration of Continuous Glucose Monitoring device (or CGM, brand name Free-Style Libre, a needleless technology that tracks glucose [sugar] levels in the body, instead of relying on finger-prick tests; CGM patch sensor applied to the skin to measures glucose levels in the interstitial fluid [the fluid between cells] and transmits sugar readings to a receiver such as "reader device," or smart phone).

This failed practice could contribute to unsafe use and monitoring of a high-risk disease and medication use.


Findings:


During a medication administration observation, and concurrent interview, with Registered Nurse 2 (RN 2), on 6/11/25 at 8:02 am, RN 2 prepared the 8 am medications for Patient 10, and went into the room to measure the blood sugar and vital signs such as heart rate and blood pressure. RN 2 used a "reader device," which displayed blood sugar from a CGM sensor attached to Patient 10's arm that continuously recorded blood sugar. The sensor showed a blood sugar of 109 mg/dL (normal fasting blood sugar concentration is between 70 mg/dL and 100 mg/dL; "mg/dL" is milligram per deciliter, a measure of concentration). RN 2 then informed the patient that she needed to administer her insulin (medication in shot form for treatment of blood sugar disease or diabetes). RN 2 then brought a syringe with insulin and Patient 10 administered it in her stomach area. RN 2 stated, that she was not totally familiar with and was not trained using CGM device. RN 2 stated, that she did not recall if hospital had a policy on the use and care of patients using their own CGM device. RN 2 stated, that the patient was using her own supplies while in the hospital and she did not perform a confirmatory blood sugar check with standard finger stick (blood from poking hand), and glucometer machine (a device that measured blood sugar) since it was not part of the orders. RN 2 later documented the blood sugar from the CGM device in the Patient 10's electronic medical record.

In an interview, with Patient 10, in her room, on 6/11/25 at 8:26 am, Patient 10 stated, that the CGM patch/sensor on her arm measured her blood sugar and the CGM patch was required to be replaced every 2 weeks, and she was not sure when it was changed last time.

During a concurrent interview, with Director of Nursing (DON) and the review of Patient 10's electronic medical record, on 6/11/25 at 3:54 pm, the record indicated there was no doctor's order to use the patient's own CGM device for blood sugar monitoring and the self-injection of insulin while in the hospital. The medical record further indicated there was no doctor order on managing low or high blood sugar values or when to contact the physician. The records did not instruct the nursing staff to perform an initial or routine quality control confirmatory blood sugar measurement using the traditional finger stick blood (poking the finger to get blood sample) and a glucometer (a machine that analyzes the blood sugar number). The DON stated the hospital had no policy in place for use of CGM. The DON stated because of ease of use, they had seen more CGM use in the community.

A review, of hospital's policy titled, "Blood Glucose Monitoring," dated 7/26/23, the policy indicated that blood glucose (sugar) monitoring is to be utilized both routinely for patients... with history of diabetes... The blood sugar glucose monitor will have quality controls every 24 hours period... Quality control will be done nightly by the night shift... The policy did not address how to manage patients using the CGM and quality control for safe use.

A review, of CGM manufacturer's brand name called, "Freestyle Libre-2," used by Patient 10, last accessed on 6/16/25, via https://www.freestyle.abbott/us-en/safety-information.html, and https://www.freestyle.abbott/us-en/safety-information.html#fsl2system, the record indicated "Taking ascorbic acid (Vitamin C) supplements while wearing the Sensor may falsely raise Sensor glucose readings... which could cause you to miss a severe low glucose event. Ascorbic acid can be found in supplements including multivitamins... Some supplements, including cold remedies..." The manufacturer indicated restrictions for safe use including patient on dialysis (kidney disease machine) or severe dehydration and inaccuracy of the system at lower glucose levels which could lead to inappropriate treatment decisions.

A review, of a published article titled, "Continuous Glucose Monitoring in the Hospital," dated 2/21, written in the Journal of Endocrinology and Metabolism, the article indicated, "Even though CGMs often appear to be reliable in the hospital, we believe regular routine POC blood glucose testing is still needed plus additional confirmatory POC (Point Of Care) tests are needed when: (1) glucose values are <85 mg/dL or >300 mg/dL; (2) hypoglycemic symptoms occur; (3) glucose readings and/or glucose trend arrows are not present on the monitor; (4) a blood drop symbol appears on the monitor; (5) hemodynamic instability occurs; and (6) a patient is in the immediate postoperative period."

Based on interview, observation, and record review, the hospital failed to ensure safe medication storage and drug disposition practices in the active storage areas with patient census of two when:

Outdated and unlabeled medications were stored in the active storage areas and disposition of the non-controlled prescription medications (drugs that are not opioid/drug of abuse) did not have co-signatories.

These unsafe storage practices could contribute to patients receiving spoiled drugs and risk of drug diversion.


Findings:


During a concurrent inspection of medication and supply storage area and interview, with Material Manager (MM), on 6/9/25 at 1:30 pm, a locked closet stored large number of IV (Into the Vein) solution bags as follow:

i.Sodium Chloride 100mL (or Normal Saline, salt solution used to mix drugs; "mL" is milliliter, a measure of volume) solutions bags were out of the protective overwrap and were not dated.

ii.One bag of Dextrose (sterile sugar solution) 1000 mL out of protective outer wrap and undated.

iii.Two bags of Normal Saline 1000 mL that were kept in the warmer cabinet for one month then put back on the storage shelf.

MM stated she was not aware of limited "beyond use date" (the date after which the product should not be given to a patient) once a sterile IV solution is out of its protective overwrap and did not know it was unsafe to re-use of IV bags that had been kept in the warmer cabinet for a month.

In an interview, with Director of Nursing (DON) on 6/9/25 at 1:59 pm, the DON stated, that the IV solution bags kept in the warmer cabinet should have been tossed out after 30-days storage.

During a concurrent inspection of medication room, accompanied with DON, on 6/9/25 at 3 pm, the Drug Room (a licensed room that medication are securely stored) storage areas were color coded for dates in which the products were expiring. The high-alert (drugs such as Neuromuscular Blocking Agents or NMBA- medications that paralyzes the body upon injection) medications were stored side by side with other medication on the shelves and in the refrigerator. Further inspection indicated the neonatal (infant age) drug tray stored four vials of expired magnesium vials (shot or injectable form of an element used to treat heart rhythm) with expiration date of 5/25. The pill cutter was unclean with white dust. Hazardous drugs (drugs that pose risk if handled by bare hand) were not marked for safe handling. The DON acknowledged the findings.

During concurrent interview, with DON and review of prescription destruction log on 6/9/25 at 3:16 pm, the log sheet listed the name and quantity of medications on 5/31/25, with no second co-signature. The DON stated she was not sure why the log sheet did not require a second co-signature.

During a concurrent interview, with DON on 6/11/25 at 9:30 am, and review of the facility's policy titled, "Drug Storage," dated 4/24/24, the policy indicated it is the policy of this hospital to ensure safe drug storage. Drugs stored in various locations. Certain principles shall be followed for all storage areas. The policy further indicated that the drug room is used for general storage of drugs. The door has a numeric keypad lock, and this number is only known by the RN, LVNs, and Pharmacist. The policy under Narcotic Cabinet, indicated that this cabinet requires a proximity card and PIN number to open. Access to this safe is limited to DON, Pharmacy, Nurse, and Administrator, and Assistant Administrator. The DON stated, that she was not sure if non-licensed leadership staff could have access to the controlled drug prescriptions. The administrator was not available to interview, on last day of the survey.

During a concurrent interview, with DON on 6/11/25 at 9:20 am, and review of the facility's policy titled, "Drug Disposition," the policy indicated to meet the federal and state requirements regarding the disposal and ultimate destruction of pharmaceuticals, including substances that become waste. The policy further indicated that the medication shall be destroyed by 2 RNs ("RN" Registered Nurse), or 1 RN and Pharmacist. The DON stated the hospital log sheet needed to be revised to include two signatures for destruction of non-controlled prescription medication.

A review, of publication by American Society of Health System Pharmacy (or ASHP, a professional organization with focus on pharmaceutical services and safe drug use in in hospitals and health systems) article on drug stability, titled "Applying stability data in sterile compounding," last accessed on 6/18/25, via https://publications.ashp.org/display/book/9781585286720/ch000.xml, the document on table 7 provided "Manufacturer Storage of Commercial IV Solutions Containers after Removal from Protective Overwrap". The document indicated the maximum storage time at room temperature for IV bag with 100mL and more than 250 mL volume was 30-days beyond use date. The article indicated once an IV bag was removed from its overwrap, the stability of the fluid and drug concentration can be affected, particularly due to potential evaporation and changes in the environment.

Based on interview, and record review, the hospital failed to ensure a consistent workflow or procedure to address, assess, and track adverse drug events and medication error reporting events based on standards of practice with patient census of two.

This failed practice could result in negative consequences affecting patients with undetected ADE's, recurrence of preventable errors and lack of the proactive safeguards for medication related harms.


Findings:


During a medication administration observation with Registered Nurse 1 (RN 1), on 6/9/25 at 9:35 am, RN 1 stated she was familiar with a paper form that was used to report medication related issues and errors, although she had not had any medication issues to report on. RN 1 stated, that she was a licensed nurse that worked for a limited time period in the hospital.

During an interview, with Director of Nursing (DON), on 6/10/25 at 3:07 pm, the DON stated she has not seen any reports of medication error, or Adverse Drug Reaction (ADR) from front line nursing staff in the past 2 years. The DON stated the hospital used a paper-based reporting system. The DON contributed lack of reporting to the low patient census for inpatient care, and emergency room visits. The DON stated the facility retrospectively reviewed Emergency Department (ED) patient charts after discharge for a set of audit criteria, but ADR, or medication error was not part of that audit for hospital or ED. The DON stated, that the hospital did not have a system of retrospective review of the reversal drug (medications used for quick reversal of drug's adverse effects) use to assess for possible ADR.

During a concurrent interview, with facility's Quality Assurance and Risk Coordinator (QR), and review of hospital's latest "Quality Report", dated July to December of 2024, the QR stated ADR and medication error reported manually on a paper format and the nurses documented it in the patient's health record. The QR stated her department would do an independent review of any incident reported. The QR stated she was not aware of tabulating medication error events and ADR in the hospital for board review. The QR was not aware of any proactive monitoring and review of patient charts to look for unreported medication errors or ADR. The QR was not aware of external patient safety and medication safety organizations (Food and Drug Administration or FDA drug warning, ISMP- Institute for Safe Medication Practices or AHRQ- Agency for Healthcare Research and Quality) that regularly inform health care organization of serious error or incidents that had harmed or potential to harm a patient. The QR acknowledged the Quality Report for the last 6 months of 2024 did not have any medication use report for the hospital.

During a concurrent interview, on 6/11/25 at 12:10 pm, with hospital's QR Coordinator and review of hospital's incident reports for the first 6 month of the 2025, the QR stated the list included all hospital patient's and the "incident type" after review. The QR could not explain the "medication" incident listed for Patient 27. The QR stated she needed to give an updated list without the "medication" incident for Patient 27. The QR did not provide another updated list to the Department.

During an interview, and concurrent review, of Patient 27's medical record from both Emergency Department (ED) visit, hospital and Skilled Nursing Facility (SNF, or long term care) stay, with date range of 1/13/25 to 2/18/25, accompanied by DON, the record indicated Patient 27 had a cancer diagnosis and was urgently admitted to ED for "mental status change with periods of lethargy and stupor." Patient 27 was treated urgently with Narcan (or naloxone, a medication used for reversal of opioid medications overuse). Further review of Patient 27 indicated she was started on fentanyl patch 25 mcg (a strong opioid medication in a skin patch format used for chronic pain, "mcg" is microgram a unit of dosage strength) on 1/13/25 and was quickly dose was increased to 75 mcg in two weeks. The DON stated she was familiar with Patient 27, as she was reluctant to take opioid pain medication and was opioid naïve (did not use opioid pain medication regularly) prior to start of fentanyl as confirmed with SNF medication use records. Patient 27's pain level documentation was mostly in the scale zero to three (on pain scale of 0-10, as zero being no pain) and occasional level of 4. The DON stated the use of Narcan in the ED was not addressed in the nursing notes for post use assessment. The DON stated with change in mental status, lethargy and dehydration, the fentanyl patch was probably removed from Patient 27 skin, and she could not locate any documentation on the patch removal from Resident 27's skin. The DON stated the ADR report would have helped the hospital to address improvement in patient care and use of high-risk medication that affect debilitated elderly population.

In a telephone interview, with hospital's Consultant Pharmacist (CP), on 6/11/25 at 12: 35 pm, the CP stated he was new to help hospital's pharmaceutical services and would want and expect the hospital review of the medication error and near miss data to help prevent future events.

A review, of the facility's policy titled, "Medication Error/Adverse Drug Reactions," dated 7/26/23, the policy indicated that all medications errors, including near misses and adverse drug reactions will be reviewed by the following personnel: Director of Nursing, Consulting Pharmacist, Quality Assurance and Risk manager, Medical staff, and Chief Executive Office. The policy further indicated how the medication error and ADR should be reported. The policy did not address retrospective review of patient charts and use of nationally recognized external resources to assess risk in the hospital.

A review, of the Institute for Safe Medication Practices (ISMP, a nationally recognized medication and patient safety organization) safety alert titled, "Targeted Medication Safety Best Practices," for hospitals, for 2024-2025, the guidelines indicated that the purpose of the ISMP Targeted Medication Safety Best Practices for Hospitals is to identify, inspire, and mobilize widespread, adoption of consensus-based Best Practices for specific medication safety issues that continue to cause fatal and harmful errors in patients...

Based on observations, interviews, and record reviews, the hospital failed to maintain a sanitary environment, and to prepare and serve food in accordance with professional standards of practice for food service safety when:

1. Multiple work areas in the kitchen were not clean to sight and/or touch.

2. Multiple pieces of equipment in the kitchen were not clean to sight and/or touch or were in poor condition, and equipment no longer in use was stored in the kitchen.

3. An effective system for maintaining kitchen sanitation was not in place, and staff did not follow professional standards of practice to clean equipment and prevent cross contamination (bacteria are unintentionally transferred from one substance or object to another with harmful effect) in the kitchen.

These failures had the potential to result in cross contamination and foodborne illnesses (illnesses that result from ingesting contaminated foods) for patients, and staff who received food from the kitchen which could lead to negative clinical outcomes.


Findings:


A review, of a facility's policy titled, "Sanitization," revised 2009, indicated that all kitchen areas and dining areas shall be kept clean; all utensils, counters and equipment shall be kept clean maintained in good repair and shall be free from breaks, corrosions, open seams, cracks and chipped areas that ay affect their use or proper cleaning.

A review, of a facility's policy titled, "Food Preparation and Service," revised 2019, indicated that appropriate measures are used to prevent cross contamination. These include sanitizing towels and cloths used for wiping surfaces in containers filled with approved sanitizing solution, cleaning and sanitizing work surfaces, and food contact equipment between uses, following food code guidelines.

A review, of the 2022 Food and Drug Administration (FDA) Food Code §4-601.11, indicated that equipment food-contact surfaces and utensils shall be clean to sight and touch. The food-contact surfaces of cooking equipment and pans shall be kept free of encrusted grease deposits and other soil accumulations. Nonfood-contact surfaces of equipment shall be kept free of an accumulation of dust, dirt, food residue and other debris.

1. Multiple work areas in the kitchen were not clean to sight and/or touch;

During the initial tour of the kitchen on 6/9/25 from 12:50 pm to 2:30 pm, the kitchen was not maintained in a cleanable and sanitary condition. There were holes in the walls that could harbor insects and microbes. Paint on walls, cabinets and shelving was chipped, worn or missing, rendering them uncleanable. Tile floor coving was missing in two locations near the dish room. One ceiling light was not functioning and the light cover was not clean. The condenser fans in the refrigerator had a buildup of dust/grime, and the condenser fans in the freezer The Dietary Manager (DM) agreed these areas were uncleanable and created a potential for cross contamination of food. The DM stated correction of these concerns were planned but had not been completed. (Cross reference C-914).

Floors in kitchen, food storage areas, and walk-in refrigerator were not clean between pieces of equipment, and around edges and corners of the floors. During an interview with the DM on 6/9/25 at 2 pm, she stated the floors were swept and mopped regularly.

2. Multiple pieces of equipment in the kitchen were not clean to sight and/or touch or were in poor condition, and equipment no longer in use was stored in the kitchen.

During the initial tour of the kitchen on 6/9/25 from 12:50 pm to 2:30 pm, multiple equipment-related concerns were observed:

Four out of four smaller bake pans (approximately 11 by 16 inches), and one out of two larger bake pans (approximately 13 by 18 inches), four out of four roasting pans, and three pots had a buildup of black and brown grime. In a concurrent interview, the Dietary Manager (DM) stated they were in process of replacing old equipment and showed 6 new larger size bake pans.

One out of three cutting boards showed severe pitting and deep cut marks that could harbor bacteria. In a concurrent interview, the DM stated, it's an infection control problem and removed it from service.

The cardboard plastic wrap dispenser in the cold food preparation area was unsanitary and uncleanable with food splatter and liquid stain marks.

The counter-top mixer in the Cook's area had thick buildup of grime over most surfaces of the machine and cord. One of the mixer's paddles had chipped paint that could be a potential source of food contamination. The blender base also had a buildup of grime. In a concurrent interview, the DM agreed they were not clean. The DM stated the one mixer paddle was not used by staff and removed it from service.

The white cutting board along the steam table (keeps food hot while assembling meal trays) had deep grooves that could harbor bacteria. In a concurrent interview, the DM agreed they were in poor condition.

The range had an accumulation of grime and food debris on range knobs and in the open space under the griddle.

The plate warmer had a buildup of black grime around its rim. The metal surfaces inside the plate compartments were degraded and beginning to rust. In a follow-up interview, with the DM on 6/11/25 at 3 pm, she stated the plate warmer had not been functioning properly for a while, did not warm plates well, and that hot plates were essential for keeping hot foods hot for patients and residents. The DM stated staff were using a work-around process by heating plates in the oven and then placing them in the plate warmer for tray line (meal assembly process) or obtaining the plates directly from the oven per Cook's preference. When asked if this process increased the risk of staff burns, she replied yes.

During an observation, in the Cook's area on 6/9/25 at 1:30 pm, a rusted food scale was on the counter, and a soiled mug containing small knives and utensils sat on the counter, including two knives with uncleanable wood handles. In a concurrent interview, with the DM, she stated that equipment was no longer used and she hadn't managed to dispose of it yet. She showed the manual food scale had been replaced with an electronic food scale.

During continued observation in the Cook's area on 6/9/25 at 2:05 pm, a white bucket and a large metal food container sat on the counter and contained Cook's cooking and serving utensils. The interior of the two containers were unsanitary with dust and food particles. Three out of three rubber spatulas had food particles and sticky surfaces. One rubber spatula was missing chunks of rubber from the edges - a potential food contaminant. Two out of two serving forks had chipped black paint and built-up grime.

During an observation in the walk-in freezer on 6/9/25 at 2:15 pm, food storage racks had dust and rust.

3. An effective system for maintaining kitchen sanitation was not in place, and staff did not follow professional standards of practice to clean equipment and prevent cross contamination (bacteria are unintentionally transferred from one substance or object to another with harmful effect) in the kitchen.

A review, of a policy titled, "Contamination Prevention," dated 5/9/05, indicated to prevent the spread of food borne illnesses and food poisonings of any type dietary employees must follow these rules: ...2. All cleaning and sanitation guides will be followed by dietary personnel ...4. Dietary personnel must be alert to the prevention of possible contamination of any foods.

During an observation, of the dry storage area on 6/9/25 at 2 pm, staff personal items, including two purses one sweater, and one personal beverage container were stored on the floor and on shelving with facility food items, a potential source for cross contamination.

A review, of requested kitchen sanitation inspection documentation from the past year titled, " F371 Kitchen Sanitation Checklist, completed by the Certified Dietary Manager (CDM) on dates; 7/23/24, 8/30/24, 9/30/24, 10/30/24, 12/4/24, 1/9/25, 3/26/25, 5/20/25, and 3/26/25, indicated that the CDM identified most things in the kitchen as clean each inspection. Intermittent deficiencies included 7/23/24, stove/oven was not clean; 8/30/24 shelves were dusty and back of range shelf was soiled; 9/30/24 red sanitizer bucket was empty - did not have sanitizer ready, and stove/oven was not clean; 10/30/24 blender was not clean; 1/9/25 Walk-in (refrigerator) floor needs cleaned;" 3/26/25 "Oven needs cleaned." "Overall everything looks very well." 5/20/25 no sanitation deficiencies were identified.

During an interview, with the DM on 6/9/25 at 1:47 pm, she stated she had just recently implemented daily cleaning assignments with the staff.

A review, of documents titled, "Dietary Cook's Cleaning Schedule," dated 12/30/24 through 5/23/25 listed AM Cook and PM Cook daily cleaning assignments. Some tasks directed equipment to be cleaned and sanitized, while others directed equipment to be wiped down. One assignment was titled Daily - AM Cook - "Clean and sanitize food contact surfaces after breakfast & lunch & dinner & between as needed." Another assignment titled Daily - PM Cook - directed, "Clean and sanitize food contact surfaces after dinner & between." Further review of weekly Cook's cleaning schedules dated 12/30/24 through 5/23/25, indicated cleaning was completed 138/210 opportunities (66%). There were comments such as "Not done," "No time," and blanks (not done) 72/210 opportunities (34%).


A review, of a document titled, "Modoc County Environmental Health Branch Food Facility Official Inspection Report," dated 4/2/25, indicated a minor infraction ("a violation that does not pose a imminent public health risk, but does warrant timely correction") for "Cross-Contamination Control - Prepare and store foods so as to be protected from contamination."


3A. Cleaning Fixed Equipment (equipment that cannot go through a dishwasher or sink):

A review, of a policy titled, "Sanitization," revised 2008, indicated that for fixed equipment or utensils that do not fit in the dishwashing machine, washing shall consist of the following steps: Equipment will be disassembled as necessary to allow access of the detergent/solution to all parts; and washed according to manual dishwashing procedures. Manual washing and sanitizing will employee a three-step process; washing, rinsing, and sanitizing.

During an interview, with Food Service Worker (FSW) 1 on 6/10/25 at 1:10 pm, she stated her training was done hands-on with another cook. She stated the department recently started a new cleaning regimen. When asked how she would clean kitchen counters or carts, FSW1 stated she got a cloth from the sanitizer bucket and wiped down the surface. She stated there were brushes and pads available for use as needed. When asked if she ever used soapy water in cleaning those surfaces she replied she did not use it regularly.

During an interview, with FSW4 on 6/12/25 at 8:05 am, he stated the process to clean the patient meal cart was to wipe it down with a quaternary ammonia (quat) sanitizer rag, inside and outside. He stated they took the racks out and wiped beneath them. That's it. He stated there was no deep cleaning process.

During an interview, with FSW3 on 6/12/25 at 8:15 am, she stated there was no specific cleaning at the end of the AM Cook shift because the PM cooks were busy starting their shift (in the cook's work area). When asked about the Cook's daily cleaning assignments, she stated, yes, I try, but I'm still new and it's difficult to get to it. She stated she didn't know what the PM Cooks did for cleaning.

During an interview, with FSW4 on 6/12/25 at 8:20 am, he stated he performed the PM Cook cleaning schedule. When asked how he cleaned the counters at the end of his shift he stated, "I wring out the quat rag really well, wipe the counter, and dry it with a dry cloth." When asked if there should be any wet time for the sanitizer, he stated it was supposed to stay wet for 30-seconds, "I think."

3B. Sanitizer cloths was not stored in sanitizer buckets

A review, of the 2022 Food and Drug Administration (FDA) Food Code §3-304.14 indicated that cloths in-use for wiping counters and other equipment surfaces shall be held between uses in a chemical sanitizer solution.

A review, of a policy titled, "Sanitization," revised 2008, indicated that between uses, cloths and towels used to wipe kitchen surfaces will be soaked in containers filled with approved sanitizing solution. For fixed equipment or utensils that do not fit in the dishwashing machine, washing shall consist of the following steps: Equipment will be disassembled as necessary to allow access of the detergent/solution to all parts; and washed according to manual dishwashing procedures. Manual washing and sanitizing will employee a three-step process; washing, rinsing, and sanitizing."

During multiple observations in the kitchen, cleaning rags were left unattended on work surfaces in all areas, creating a potential for cross contamination:

On 6/9/25 at 2:30 pm, a used rag was left on counter near cold food preparation sink and second used cloth was left on the coffee maker.

On 6/10/25 at 10:50 am, two used cloths were left on the counter by the coffee maker.

On 6/10/25 at 11:13 am, four used cloths were left on three different shelves in the dish room.

During an observation in the kitchen on 6/10/25 at 11:05 am, two cloth bins of soiled kitchen linen also were kept uncovered.

Based on interview, and record review, the hospital failed to monitor, track, trend and assess antibiotic use within the hospital with patient census of two based on nationally recognized guidelines.

This failure could contribute to ineffective use of antibiotic, risk and spread of drug resistance bugs (when drugs no longer work to eliminate infection) and patient's harm.


Findings:


During a medications administration observation, accompanied by Registered Nurse 1 (RN 1), on 6/10/25 at 9:35 am, RN 1 attempted to give Patient 23 his antibiotic called Augmentin (or Amoxicillin/Clavulanate, used to treat respiratory infection) in liquid form. Patient 23 refused the antibiotic, and RN 1 documented refusal after one attempt. RN 1 stated Resident 23 is on two antibiotics for the treatment of his pneumonia infection (respiratory lung infection) for about one week.

During a concurrent interview, with hospital Infection Preventionist (IP), and record review of the hospital Antibiotic Stewardship Program (or ASP- programs designed to optimize the use of antimicrobial medications [drugs to treat infections] to improve patient outcomes, reduce antimicrobial resistance, and minimize adverse events associated with these drugs), on 6/10/25 at 1:12 pm, the IP stated he mainly tracked the antibiotic use in the Emergency Department (ED). The IP shared the information log for tracking antibiotic use including the name of patient, the name of antibiotic and randomly included a culture and sensitivity testing (or C&S, when body tissue or fluids gets tested for infectious bug) without follow up. The information tracking log did not include duration of antibiotic use, indication and follow up on culture and sensitivity. The IP did not track antibiotic use for patients in the hospital. The IP did not know that Patient 23 had been on antibiotics for over 7-days.

During a concurrent record review, and interview, with Director of Nursing (DON), on 6/11/25 at 4:13 pm, the DON stated there needed to be a better collaboration with the nursing, pharmacy, and IP to help optimize antibiotic use in the hospital. The DON stated the tracking, monitoring of antibiotic use and follow up on C&S should have been done in addition to the ED.

A review, of hospital's document titled, "Infection Control/Antibiotic Stewardship," meeting minutes, for date range of 6/3/2024 to 4/29/24, the record did not show any ASP data that reflected the ASP activity for the hospital. The record on 6/3/2024, 8/26/2024, and 1/28/2025, indicated, "Reminder to follow CDC (Center for Disease Control, a federal agency oversees the health and safety of the people) guidelines on antibiotic stewardship... Antibiotic usage".

A review, of CDC's document titled, "Implementation of Antibiotic Stewardship Core Elements at Small and Critical Access Hospitals," dated 3/18/24, last accessed through https://www.cdc.gov/antibiotic-use/hcp/core-elements/small-and-critical-access-hospitals.html, the document indicated, this document provides guidance on practical strategies to implement antibiotic stewardship programs in small and critical access hospitals. It was developed as a collaboration between The Centers for Disease Control and Prevention, The American Hospital Association, The Federal Office of Rural Health Policy and The Pew Charitable Trusts. The suggestions provided here are based on discussions with staff in small and critical access hospitals, several of which have implemented all of the CDC Core Elements. Improving antibiotic use in hospitals is imperative to improving patient outcomes. Antibiotic use has well known unintended consequences. The guideline further provided example of implementation including approached to an effective monitoring program.

A review, of the hospital's policy titled "Antibiotic Stewardship," dated 4/24/24, indicated to establish Antibiotic Stewardship Program (ASP) at this hospital to help optimize clinical outcome and patient safety while minimizing the unintended consequences of antimicrobial use by utilizing the available resources to ensure appropriate antimicrobial drug product selection, dosing, route of administration, and duration of therapy. The policy further indicated to ensure the data collected is reported to Infection Control/Antimicrobial Steward Program Committee.

Based on interview, and record review, the facility's Governing Board, and leadership did not ensure the Quality Assurance and Performance Improvement (QAPI) program met the regulatory requirements for QAPI, when it was discovered that no QAPI acute care data existed.

This failure to ensure the QAPI program reporting quality and performance improvement data to the Governing Board, and receiving feedback from the Governing board can lead to sub-optimal care, extended illness, infections and adverse patient outcomes with pain and suffering.


Findings:


On 6/12/2025 at 8:50 am, during a concurrent interview, and record review, with the Quality Manager (QM), the QM was asked if she had any quality projects, monitoring or data for the acute patients. The QM answered, "No." When asked if the QM had any quality projects, monitoring or data for the emergency room, the QM answered, "No."

During the interview, the QM provided a document titled "Quality Report Review July 2024- December 2024," (Report) for review. The Report did not contain regulatory required specific information, data or performance indicators. Nor did the Report contain any Governing Board feedback for the acute care or the ER; no measures to improve and, no analysis or tracking data.

In the Report the section titled, "ER Patient Care Data," no quality improvement activities, or data analysis was present. When asked if there were any analysis of the ER Data on the report the QM replied, "No." The Report had a category for falls. When asked if the fall category has any data for acute care, or the ER the QM replied, "No. Not for them." The QM was asked if there is any feedback information related to the Report from any medical staff committee, or from the Board of Directors. The QM answered, "To be honest, no. There isn't anything."

On 6/12/2025 at 9:30 am, during a concurrent interview, and record review, with the Medical Staff Credentialer (MSC) who supervises oversight of Quality Management staff, the MSC was asked if there was any quality data or projects for the acute care or ER. The MSC replied, "No, only for skilled," referring to the skilled nursing portion of the facility. The MSC briefly looked at the document titled "Quality Report Review July 2024- December 2024," (Report). When asked whether the Report had data for the acute care or ER the MSC said, "No." The MSC confirmed there was no quality management feedback from other committees or Board of Directors.

On 6/12/2025 at 9:45 am, during an interview, the Director of Nursing (DON) was interviewed, regarding the document titled "Quality Report Review July 2024- December 2024," (Report). The DON confirmed "the document had no data analysis for the acute care and ER." The DON stated, that the MSC was aware of the issues of no data and analysis of the acute care and ER. The DON confirmed, that there was no quality management feedback from other committees or Board of Directors as required by regulation.