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Based on policy review, record review, and interview, the facility failed to:
- Complete a comprehensive quality of life activities assessment, which identified specific individualized, activity interest for four out of four discharged Swing Bed (Swing Bed - a Medicare program in which a patient can receive acute care services, then if needed Skilled Nursing Home Care) patients (#25, #26, #27 and #28) reviewed for a complete comprehensive quality of life activities assessment.
- Provide specific, individualized activity interests that stimulated the patient's physical and mental well-being for four out of four discharged Swing Bed (#25, #26, #27 and #28) patients reviewed for specific individualized activity interests.
- Develop a comprehensive activity care plan, which included activity interests and interventions for four out of four discharged Swing Bed (#25, #26, #27 and #28) patients reviewed for a comprehensive activity care plan.
These failed practices had the potential to affect all Swing Bed patients by failing to stimulate their minds, body, and social interests.
The facility census was five Acute Care patients, zero Swing Bed (Swing Beds - Medicare program in which a patient can receive acute care, then if needed, Skilled Nursing Care at the same facility) patients and one Observation (Observation - outpatient services provided to a patient while the patient's physician decides whether to admit the patient to Acute Care services or discharge the patient) patient for a total census of six.

Findings included:

1. Review of the facility's policy titled, "Multidisciplinary Team Plan of Care - Swing Bed Program," dated 03/23/10, showed staff directives:
- To provide a multidisciplinary individual plan of care for each Swing Bed resident.
- The facility shall provide accurate assessments and care planning to address the resident's needs through multidisciplinary interventions, accommodation of individual needs, and attention to the resident's customary routine.
- Utilizing collected data, the multidisciplinary team should identify and document resident problems with attention to individual needs and customary routine. This process shall be ongoing.
- Upon admission to the Swing Bed Program, a care plan should be developed for each resident. The care plan should be a "blueprint" for action providing a list of identified problems, specific, realistic, and measurable goals, realistic deadlines for achievement, nursing actions, medical and other orders suggested to attain the goals.
- Implementation of the plan of care shall be documented in the appropriate area of the medical record.
- The Multidisciplinary Committee should perform an ongoing evaluation of the plan of care and care plan reviewed weekly to include:
- The resident's response to the interventions.
- The effectiveness of the interventions in resolving the resident's problems.
- The degree to which the outcome criteria are met.

2. Review of Patients' Electronic Medical Health Records (EMHR) showed:
- Patient #25 was admitted to the facility's Swing Bed program on 01/19/24, with complaints of status post fall with multiple fractured ribs and pneumothorax (collapsed lung);
- Patient #26 was admitted to the facility's Swing Bed program on 06/10/24, with complaints of urine retention (difficulty in emptying the bladder);
- Patient #27 was admitted to the facility's Swing Bed program on 11/08/23, with complaints of closed hip fracture; and
- Patient #28 was admitted to the facility's Swing Bed program on 10/09/23 with complaints of a fractured pelvic rami (bones that make up the pelvis).

Patient #25's, #26's, #27's, and #28's EMHR showed staff failed to conduct a comprehensive quality of life activity assessment of the patients to assist in identifying the patients' activity interests and staff failed to develop a comprehensive activity care plan for the patients during the patients stay in the facility's Swing Bed program.

3. During an interview on 06/27/24 at 2:32 PM, Staff F, Swing Bed Coordinator, acknowledged Patient #25, #26, #27, and #28 EMHRs' did not contain an activity assessment or an activity care plan. Staff F stated facility staff attended a webinar provided by the Hospital Association and information obtained from the webinar instructed hospitals with Swing Bed Programs that activity assessments and activity care plans were no longer required because the activity requirement was no longer a regulatory requirement for a facility's Swing Bed Program. Staff F stated the facility stopped performing activity assessments and including activities in patients' care plan after staff received information from the webinar that activities were no longer a regulatory requirement for patients admitted to the facility's Swing Bed Program.

Based on observation, interview, hospital policy, and The United States Pharmacopeia (USP) for compound sterile preparations review, the hospital failed to:
-Ensure the required life-saving medication was readily accessible when administering Malignant Hyperthermia triggering medications.
- Ensure pharmacy staff followed the hospital's policy and infection control standards for Sterile Compounding. (A-501)
- Ensure pharmacy staff performed competencies for pharmacy staff responsible for Sterile Compounding. (A-501)
- Ensure pharmacy staff removed all paper products (particle shedding) from the segregated compounding area (SCA). (A-501)
- Ensure pharmacy staff maintained the quality of emergency medications in the crash carts. (A-505)

Due to the potential risk and harm to all patients this resulted in the non-compliance with
§42 CFR 482.25 Condition of Participation: Pharmaceutical Services.

Please refer to A-501 and A-505 for further details


46554

36473

Based on observation, interview, review of the Malignant Hyperthermia Association of the United States (MHAUS), review of the United States Pharmacopeia (USP) Chapter 797 and policy review, the hospital failed to:
- Ensure the required life-saving medication was readily accessible when administering Succinylcholine (a muscle relaxant/paralytic) in the Emergency Department (ED) or the Operating Room (OR) or when administering Anesthesia gases such as Desflurane, Sevoflurane, Isoflurane (medications administered as a an inhaled gas by a qualified anesthesia professional during surgical procedures) in the OR.
- Ensure pharmacy staff followed the hospital's policy and infection control standards for Sterile Compounding.
- Document education of pharmacy staff responsible for Sterile Compounding.
- Remove all paper products (particle shedding) from the segregated compounding area (SCA).
These failures had the potential to increase the risk of cross contamination with infection and increase the risk of harm to any patients who received compounded medications. The facility census was five Acute Care patients, zero Swing Bed patients, and one Observation (Observation - outpatient services provided to a patient while the patient's physician decides whether to admit the patient to Acute Care services or discharge the patient) patient for a total census of six.

Findings included:

Emergency Department
1. Observation on 06/25/24 at 9:49 AM, in the Emergency Department (ED), showed the Rapid Sequence Intubation (RSI - potent anesthetic agent, muscle relaxant and/or paralytic agents) Kit was located in the ED's automated medication dispensing system. The RSI Kit contained one 250 milligram (mg - unit of measurement) vial of Ryanodex (Dantrolene Sodium - antidote medication used to treat Malignant Hyperthermia).

2. During an interview on 06/25/24 at 10:00 AM, Staff E, ED Supervisor, stated the ED had enough Ryanodex medication to initiate treatment for Malignant Hyperthermia and if more of the medication was indicated, ED staff would retrieve addition Ryanodex from the pharmacy. Staff E stated the ED followed MHAUS guidelines.

3. Review of the facility document titled, "My Report: MED INVENTORY," dated 06/25/24 at 10:03 AM, showed the facility had one Dantrolene Kit (Ryanodex Kit) in the ED and one Dantrolene Kit (Ryanodex Kit) in the Surgery Department.

Pharmacy
4. Observation on 06/25/24 at 10:05 AM, of the showed the Pharmacy Department did not have any additional vials of Ryanodex located in the pharmacy.

5. During an interview on 06/25/24 at 10:09 AM, Staff A, Chief Nursing Officer, stated the facility followed MHAUS guidelines when Succinylcholine (muscle relaxant/paralytic) was used.

Operating Room
6. Observation on 06/25/24 beginning at 10:00 AM, showed:
- The OR automated medication dispensing system contained one Rynadex 250 mg vial.
- The OR and ED failed to have a Malignant Hyperthermia box/cart with the recommended supplies centrally located and accessible in the event of an MH crisis.
- The OR staff failed to obtain all recommened supplies in the 10 minutes needed per the MHAUS guidelines.

7. During an interview on 06/25/24 at 11:50 AM, Staff C, Certified Registered Nurse Anesthetist, stated all the recommended supplies was centrally located in the supply room for the OR. The Medications recommended were located in the anesthesia emergency kit except the insulin, that was in the OR automated medication dispensing system in the preoperative area. When asked to gather the supplies in a timely manner, Staff K was unable to locate the Charcoal filters.

8. The facility's failure to ensure the required three vials of Ryanodex were maintained in the facility increased the risk for patient safety to all patients that required any Malignant Hyperthermia triggering medications during intubation.

9. Review of the Malignant Hyperthermia Association of the United States (MHAUS - to promote optimum care and scientific understanding of Malignant Hyperthermia and related disorders) guidelines, dated 2016, showed the following medications and supplies should be centrally located and accessible in the event of a MH crisis:
-Drugs: Ryanodex, 3 vials of 250mg doses, sterile water for injection without bacteriostatic agent 5 ml of sterile water for injection, Sodium bicarbonate (8.4%) - 50 ml x 5, Dextrose 50% - 50 ml vials x 2, Calcium chloride (10%) - 10 ml vial x 2, Regular insulin - 100 units/ml x 1 (refrigerated), Lidocaine for injection (2%) - 100 mg/5 ml or 100 mg/10 ml in preloaded syringes, Amiodarone.
- General Equipment: Refrigerated cold saline solution - A minimum of 3,000 ml for IV cooling, Charcoal Filters - Two pairs of activated charcoal, syringes - 60 ml x 5, intravenous catheters - 16G, 18G, 20G, 2-inch; 22G, 1-inch; 24G, 3/4-inch, 4 each, Nasogastric tubes, Toomey irrigation syringes 60 ml x 2, with adapter for NG irrigation.
- Monitoring Equipment: Esophageal or other core temperature probes, central venous cannulation kits (sizes appropriate to your patient population), transducer kits for arterial and central venous cannulation.
- Nursing Supplies: Large sterile drape, Urine meter x 1, irrigation tray with piston syringe, plastic bags for ice x 4, bucket for ice, and test strips for urine hemoglobin.
- Laboratory Testing Supplies: Syringes (3 ml) for blood gas analysis or ABG kits x 6 or point of care monitor, blood specimen tubes, and urine collection container.

10. Review of the facility's policy titled, "Malignant Hyperthermia, Management Of," dated, 10/18/23, showed staff directives:
PURPOSE AND STANDARD
- Outline the proper procedure for the management of malignant hyperthermia.
- Malignant Hyperthermia (MH), an event triggered in susceptible individuals by various anesthetics, is a rare, inherited paramagnetic syndrome. It strikes fast and without warning and is a sudden and life threatening condition. It is strongly recommended for providers of surgical services to have the requisite drugs and supplies available as defined by the Malignant Hyperthermia Association of the United States to prevent and treat MH.
ACUTE PHASE TREATMENT
- Notify Surgeon
- Discontinue volatile agents and Succinylcholine
- Hyperventilate with 100% oxygen
- If available insert activated charcoal filters into the inspiratory and expiratory limbs of the breathing circuit
- Change all rubber goods on the anesthesia machine
- Get DANTROLENE: (one dose in Surgery Pyxis and one dose in ED Pyxis) NAME: RYANODEX
- Give Dantrolene
- Obtain blood gas (venous or arterial) to determine degree of metabolic acidosis
- Cool patient if core temperature is >39 degrees C or less if rapidly rising
SURGICAL SERVICES DEPARTMENT & PAR PERSONNEL SHALL BE AWARE OF THE FOLLOWING
- Malignant Hyperthermia, although rare, does exist and prompt recognition and intervention is needed in this crisis situation.
- Dantrolene sodium for injection is kept in the Pyxis in the Surgery Department as well as the Pyxis in the Emergency Department.

Pharmacy
11. Observation on 6/26/24 at 8:07 AM, in the Pharmacy, showed Staff M, Pharmacy Technician, failed to clean under her fingernails and clean eyeglasses prior to entering the compounding area, wear sterile gloves during compounding, wipe off medications gathered for compounding prior to entering the SCA, remove glove cardboard box (particle shedding product) from the compounding area and remove single-use vial in the laminar hood used for a prior compounding medication.

12. Although requested, the hospital failed to provide proof for 12 out of 12 staff competencies for Sterile Compounding.

13. During an interview on 06/26/24 at 12:31 PM, Staff B, Director of Pharmacy Services, stated staff was expected to follow USP Chapter 797 and they have not had any staff competency training for Sterile Compounding since 03/2023. Staff B stated they did not have any competency training for Sterile Compounding for the Nurse Supervisors that had access to the SCA. There was a total of 12 staff untrained that performed Sterile Compounding.

14. Review of the USP, Chapter 797, dated 2013, showed that:
- Staff were to clean hands with soap and water for 30 seconds and clean under fingernails with a nail pick.
- If compounder wears eyeglasses, they were to clean them prior to entering the SCA.
- Staff were to wipe down all products prior to bringing into the SCA.
- Wear sterile gloves when compounding.
- Particle shedding objects (pencils, corrugated cardboard, paper towels, and cotton items) were prohibited in the SCA.
- Gloved fingertip sampling required for initial testing and retested every six months for all compounding personnel.
- Media-fill testing required for initial testing and every six months.
- Surface sampling required every six months and monitored for further action coordinated with the infection control officer.

15. Review of the hospital's policy titled, "Sterile Compounding," dated 02/23/24, showed the direction for staff:
- To follow aseptic technique.
- Place only clean products in the hood.
- Clean glasses prior to entering the SCA.
- Media-fill testing should be performed every six months.
- Gloved fingertip and thumb sampling must be performed every 12 months.
- Surface sampling every six months.




46554

Based on policy and document review, observation and interview, the hospital failed to ensure expired medications were removed from the emergency crash carts (mobile cart which contains emergency medical supplies and medication) so the expired items were not available for staff use during an emergency and failed to ensure the appropriate supplies and medications were available in two of five emergency crash carts in the hospital.
This deficient practice had the potential to affect all patients that received care, treatments, and services at the hospital.
The hospital census was five Acute Care patients, zero Swing Bed (Swing Bed - a Medicare program in which a patient can receive acute care services, then if needed Skilled Nursing Home Care) patients and one Observation (Observation - outpatient services provided to a patient while the patient's physician decides whether to admit the patient to Acute Care services or to discharge the patient) patient for a total census of six.

Findings included:

1. Review of the hospital's policy titled, "Crash Cart: Daily Inventory," dated 01/02/24, showed:
- Pharmacy will check all medications and IV (intravenous) fluids (medications given directly in to the veins) for expiration dates monthly.
- Nursing will remove the contents of all the drawers and clean he cart with an antimicrobial cleanser each month and replace any non-pharmaceutical supplies.
- The nurse who uses the crash cart will check it after each use and reorder supplies used.
- From 0700 to 1500: pharmacy will place a red tag after replacing medication after using carts. When pharmacy is closed, the Nursing Supervisor will restock the cart from pharmacy and get a "numbered" tag from the Pyxis (an automated medication dispensing cabinet), This numbered tag will indicate to pharmacy that nursing restocked and placed the lock.
- Red locks are from pharmacy- cart will not be opened daily. Numbered lock is placed by nursing after use in a code.

2. Review of the hospital's policy titled, " Emergency Drugs and Antidotes," dated 08/09/23, showed:
- Emergency drugs, intended for the same purpose and stored in multiple locations, shall be uniformly arranged to facilitate rapid implementation of emergency care.
- Emergency drugs shall be readily available to the staff but not accessible to patients, visitors, and unauthorized personnel.
- The pharmacy shall responsible for maintaining the emergency drug contents at a predetermined level and for the inspection procedure to be used. Emergency drugs and emergency drug storage areas shall be checked by the pharmacy at least once a month and after each use to remove deteriorated and outdated drugs and assure completeness of content. The inspection shall assure that all items required for immediate availability are actually present and are in useable condition.
- Seals shall be stored in the pharmacy and shall not be available to nursing service and others who use the drugs.
- Users should check emergency drugs at least once each shift and notify pharmacy when drugs are missing, or other irregularities suspected. A determination that the seal is intact is a sufficient check for missing drugs.
- The pharmacy shall replace missing, expired, and unusable drugs as soon as possible and seal the container.

3. Review of the hospital's policy titled, "Outdated (Expired) Drugs and Unusable Drugs and Devices," dated 10/26/23, showed:
- The pharmacy shall identify outdated and other unusable drugs and devices and prevent their distribution and administration.
- Pharmacy, nursing and other personnel, who discover outdated and other unusable drugs and devices, and containers with worn, illegible, or missing labels shall return them to pharmacy for proper disposition.

4. Review of hospital document titled "Crash Cart Restock Requisition", undated, showed the medications, supplies, and inventory amounts for the crash cart.
- Amiodarone (Pacerone, a medication used to slow the heart from a deadly high rate.) 150mg/100ml bag, inventory 1.
- Atropine (a medication used to lower the heart rate.) 1mg, inventory 3.
- Epinephrine 1:10,000 (a medication used to treat low heart rates or used to treat life threatening allergic reactions.) 1mg syringe, inventory 10.
- Epinephrine 1:1,00 1mg vial, inventory 2.
- Lidocaine (a medication used to correct deadly heart rhythms.) 100mg, inventory 3.
- Sodium Bicarbonate (a medication used to correct pH levels.) 50mEq, inventory 2.
- Calcium Chloride (a medication used to correct the potassium level in the body.) 13.6mEq, Inventory 3.
- Adenosine (Adenocard, a medication used to slow the heart from a deadly high rate.) 6mg, inventory 3.
- Adenosine 12mg, inventory 1.
- Digoxin (Digitalis, a medication used to slow and strengthen the heart.) 0.5 mg vial, inventory 2
- Lasix (Furosemide, a medication used to aid in fluid management of the cardiac system) 40mg, inventory 3.
- Mag Sulfate (a medication used to treat low blood magnesium levels.) 1 gram vial and 10 cc sterile water, inventory 2.
- Lopressor (Metoprolol, a medication used to lower blood pressure.) 5mg, inventory 3.
- Pronestyl (a medication used to correct heartrate.) 1000mg vial and 20cc sterile water, inventory 2.
- Verapamil (a medication used to treat high blood pressure.) 5 mg vial, inventory 3
- Narcan (a medication used to reverse the effects of narcotic overdose.) 2mg, inventory 2.
- Amiodarone 150mg/100ml bag, inventory 2.
- Dobutamine (Dobuterx, a medication used to help strengthen the heart.) 250mg, inventory 1.
- Dopamine (Intropin, a medication used to raise blood pressure.) 400mg, inventory 1.
- Epinephrine 1mg/ml and 250cc D5W (an IV fluid made containing sugar and sterile water.), inventory 1.
- Normal Saline (NaCL Sodium Chloride, fluid used with the administration of intravenous (IV, in the vein) medication.) 1000ml, inventory 2.
- Lidocaine 2gm premixed IV bag, inventory 1.
- Mag Sulfate 1gm premixed IV bag, inventory 1.
- Sodium Nitroprusside (Nipride, a medication used to lower blood pressure.) 50mg vial and 250cc D5W, inventory 1.
- Normal Saline (NaCL Sodium Chloride, fluid used with the administration of intravenous (IV, in the vein) medication.) 1000ml, inventory 1.
- Portable suction.
- Additional non medication supplies and inventory amounts were listed separately.

5. Review of the hospital's document titled, "Cardiac Stress Lab Crash Cart Restock Requisition," undated, showed the following emergency medications to be stocked in the medication area of the emergency crash cart:
- Amiodarone 150mg/100ml bag, inventory 1.
- Atropine 1mg, inventory 1.
- Epinephrine 1mg syringe, inventory 1.
- Lidocaine 100mg, inventory 1.
- Sodium Bicarbonate 50mEq, inventory 1.
- Calcium Chloride 13.6mEq, Inventory 1.
- Lasix 40mg, inventory 3.
- Lopressor 5mg, inventory 2.
- Adenosine 6mg, inventory 3.
- Adenosine 12mg, inventory 1.
- Dobutamine 250mg, inventory 1.
- Dopamine 400mg, inventory 1.
- Normal Saline 1000ml, inventory 2.
- Portable suction.
- Arterial blood gas (ABG) collection kits, inventory 4.

6. Observation on 06/25/24 at 3:32 PM, in the Nuclear Medicine/Cardiac Stress Lab, crash cart, showed:
- The red lock out tag was un-numbered and intact at time of inspection.
- Three vials of Lasix (Furosemide, a medication used to aid in fluid management of the cardiac system) 40mg/ml expiration date 11/2023.
- The cart failed to have Epinephrine 1mg in the medication drawer.
- The cart failed to have portable suction.
- The cart failed to have ABG collection kits.
- The red lock out tag used to resecure the cart was located in the top drawer.

7. Observation 06/27/24 at 10:00 AM, of the Medical/Surgical Crash carts on the second floor showed the cart contained:
- 20 outdated lubricated jelly single use packets, expiration date 04/2024.
- One vial of Procainamide with the vial lid removed.
- Two outdated blue top blood collection tubes, expired 05/04/2024.
- Two outdate Iodine swabs, one expired 08/2023 and one expired 10/2023.

8. During an interview on 06/25/24 at 3:53 PM, Staff O, Radiology Technician, stated there was no epinephrine, ABG kits or suction on the cart. they stated the procedure was when staff opened the cart, there was a new red tag in the cart so staff could secure it until pharmacy could be contacted to come and secure it. Staff O stated they do not have numbered lock out tags.

9. During an interview on 06/25/24 at 4:43 PM, Staff A, Registered Nurse, Chief Nursing Officer, stated the nuclear medicine cart would not be used in a code, Emergency room staff would come with their cart to any code on the first floor. Staff A stated the cart was used more as a reaction cart, but Staff A would expect to see the Epinephrine medication stocked in the cart.

10. During and interview on 06/27/24 at 1:06 PM, Staff B, Director of Pharmacy Services, stated the crash carts should not contain expired medication, and should be stocked according to the inventory sheets and checked monthly. Staff B state the Medications should be removed prior the the expiration dates during the pharmacy check. Staff B stated the pharmacy was not responisble for non medication supplies, and that was the responsiblility of the departments.

Based on observation, document/record review, interview, review of nationally recognized standards, and policy review, the facility failed to ensure staff followed infection control policies and infection prevention standards when staff failed to:
- Follow and incorporate the Centers for Disease Control and Prevention (CDC) Core Elements of Hospital Antibiotic Stewardship Programs: 2019 into the facility's Antibiotic Stewardship Program when the facility's leadership failed to ensure Antibiotic Stewardship activities included an indication for use on orders located on patients' Electronic Medication Administration Record (EMAR).
This failure by the facility had the potential to affect the measurement of effectiveness of antibiotic medication as well as the transparency for staff to determine appropriateness for all patients presented to the facility that received antibiotic medication therapy.
- Performed hand hygiene (washing hands with soap and water or use of appropriate hand sanitizer) and changed gloves when indicated during a Port-a-Catheter (Port - a small medical device installed beneath a person's skin and connects the port to a vein, used to administer medications, fluids, and obtain blood samples used for long-term therapy) dressing change for one (#12) out of one dressing change observed.
- Performed hand hygiene and changed gloves when indicated during medication administration for two out of two observations conducted of staff administrating medications to patients (#12 and #24).
Staff's failure to perform hand hygiene before gloving, after glove removal, and before re-gloving increased the risk of contaminating the gloves and all objects staff touched wearing the gloves.
These failed practices had the potential to affect the measurement of antibiotic effectiveness of ordered antibiotic medication therapy, expose all patients, visitors, and staff to cross- contamination and increased the potential to spread infection.
The facility census was five Acute Care patients, zero Swing Bed (Swing Beds - Medicare program in which a patient can receive acute care, then if needed, Skilled Nursing Care at the same facility) patients and one Observation (Observation - outpatient services provided to a patient while the patient's physician decides whether to admit the patient to Acute Care services or discharge the patient) patient for a total census of six.

Findings included:

Antibiotic Stewardship
1. Observation on 06/26/24 at 8:58 AM, showed Staff P, Registered Nurse (RN), prepared medication for Patient #4. Patient #4's medication included Ciprofloxacin (antibiotic medication used to treat bacterial infections) intravenous (IV - in a vein), 500 milligrams (mg - unit of measurement), every 12 hours for seven days that failed to include an indication for use in the EMAR.

2. Review of patient #4's medical record showed an additional medication order for Metronidazole (antibiotic medication used to treat bacterial infections) IV, 500 mg every eight hours for seven days that failed to have an indication for use in the EMAR.

3. During an interview on 06/26/24 at 1:22 PM, Staff B, Director of Pharmacy Services, stated "I would not expect to see an indication listed on the order for an antibiotic."

4. Observation and concurrent interview on 06/27/24 at 9:10 AM, showed Staff J, RN, prepared medications for Patient #24. Patient #24's medications included levofloxacin (antibiotic medication used to treat bacterial infections), IV, 750 milligrams every 48 hours for five days. When Staff J was asked what the indication for the ordered antibiotic medication was for, Staff J stated they were unsure because patients' EMAR did not include the indication for the ordered antibiotic medication. Staff J stated staff would like for the indication to be included on patients' EMAR so staff administering the medication would know the indication why antibiotic therapy was ordered for the patient.

5. Review of Patient #24's EMAR and printed EMAR showed no indication for the ordered antibiotic medication was included to alert staff that administered the antibiotic medication the reason antibiotic therapy was ordered for the patient.

6. During an interview on 06/27/24 at 3:20 PM, Staff B, Director of Pharmacy Services, stated the pharmacy manager served as co-coordinator for the facility's Antibiotic Stewardship Program. Staff B stated providers included the indication for antibiotic medication therapy in the patient's History and Physical. Staff B stated antibiotic indication could be documented in progress notes or orders, but the indication was not included on patients' EMAR.

7. Review of the facility's document titled, "Antibiotic Stewardship Program," dated 09/05/23, showed staff directives:
- To achieve optimal clinical outcomes related to antimicrobial use while minimizing toxicity and other adverse events and the emergence of antimicrobial-resistant organisms.
- REFERENCES and related documentation: CDC Antibiotic Stewardship
- Definition: Antimicrobial Stewardship refers to coordinated interventions designed to improve and measure the appropriate use of antimicrobial agents by promoting the selection of the optimal antimicrobial regiment including dosing, duration of therapy, and route of administration. When used in conjunction with infection prevention and control, antimicrobial stewardship also prevents the development of antimicrobial-resistant pathogens.
- Conduct prospective audits of select antimicrobial use based on established criteria with direct feedback to the prescriber.
- Selection of target medications by the Antibiotic Stewardship Team to prompt review when ordered.
- Recommend alternatives that maintain efficacy and safety while reducing resistance liability.
- Evaluate target medications every 72 hours for de-escalation or discontinuation.
- Communicate recommendations to the prescribing provider and, as appropriate, Pharmacy and Therapeutics Committee.

9. Review of the facility's document titled, Antibiotic Stewardship Program failed to ensure the indication for antibiotic therapy was included in patients' EMAR when the provider wrote an order for a patient to receive antibiotic medication therapy.

10. Review of the CDC document titled, "The Core Elements of Hospital Antibiotic Stewardship Programs: 2019," showed:
- Prompt initiation of antibiotics to treat infections reduces morbidity and save lives, however, about 30% of all antibiotics prescribed in the U.S. acute care hospitals are either unnecessary or suboptimal.
- Patients who are unnecessarily exposed to antibiotics are placed at risk for adverse events with no benefit. The misuse of antibiotics has also contributed to antibiotic resistance, a serious threat to public health.
- Optimizing the use of antibiotics is critical to affectively treat infections, protect patients from harms caused by unnecessary antibiotic use, and combat antibiotic resistance.
- Antibiotic Stewardship Programs can help clinicians improve clinical outcomes and minimize harm by improving antibiotic prescribing.
The Core Elements of Hospital Antibiotic Stewardship Programs
- Hospital Leadership Commitment;
- Accountability;
- Pharmacy Expertise;
- Action;
- Tracking;
- Reporting; and
- Education.
Pharmacy-based Interventions
- Documentation of indications for antibiotics.
- Automatic changes from intravenous to oral antibiotic therapy.
- Dose adjustments.
- Dose optimization.
- Duplicative therapy alerts.
- Time-sensitive automatic stop orders.
- Detection and prevention of antibiotic-related drug-drug interactions.

Hand Hygiene - Gloving
Port-A-Catheter Dressing Change
11. Observation on 06/26/24 at 8:55 AM, showed Staff I, RN:
- Entered the room wearing gloves to perform a dressing change to Patient #12's port.
- Removed gloves, performed hand hygiene, and prepared Patient #12 for the dressing change to the patient's Port.
- Put on a face mask, handed the patient a face mask to wear during the dressing change, placed a barrier pad on the sink, and placed the supply packages onto the barrier pad, removed gloves, however, Staff I failed to perform hand hygiene after glove removal.
- Picked up the sterile gloves from the barrier pad and put the sterile gloves on, however, Staff I failed to perform hand hygiene before putting the sterile gloves on.
- Wearing the sterile gloves, Staff I opened the supply packages and removed the swab applicator and cleansed the port site and surrounding area with the antiseptic swab.
- Wearing the same gloves worn to cleanse the port site and surrounding area, Staff I accessed the port, applied a dressing over the port, flushed the port line and capped the line.
- At the completion of the dressing change, Staff I removed the sterile gloves, however, Staff I failed to perform hand hygiene after removal of gloves.
- Placed a blood pressure cuff on the patient's arm and placed a pulse oximeter on the patient's finger and obtained the patient's temperature.

12. Review of the facility's policy titled, "Central Venous Catheter (CVC - a long, thin, flexible tube placed in a large vein for long-term use to administer medications, fluids, blood and to obtain blood samples) Management and Maintenance," dated 11/22/23 showed staff directives:
CVC Dressing Change
- Perform hand hygiene.
- Open supplies, apply mask.
- Ask patient to either don a mask or cover patient's head with drape during entire dressing change.
- Don clean gloves and carefully remove old dressing without putting any tension on catheter or sutures.
- Examine insertions site for signs of infection and external catheter to ensure that the sutures, catheter, and hub are intact.
- Apply sterile gloves, activate the chloraprep (skin disinfectant and antiseptic) sponge pad, and clean the insertion site and surrounding skin with friction (back and forth motion) for 30 seconds.
- Allow to air dry.
- Apply transparent dressing.
- Perform hand hygiene after the procedure.

13. During an interview on 06/27/24 at approximately 4:15 PM, Staff A, RN, Chief Nursing Officer (CNO), acknowledged the CVC Management and Maintenance policy was utilized for patients with a Port.

Medication Preparation and Administration
13. Observation on 06/26/24 at 8:55 AM, showed Staff I, RN, prepared Patient #12 for an infusion of Cinrynze (medication used to treat a rare Hereditary Angioedema [a disorder that results in recurrent attacks of severe swelling] disorder) 1000 Units (U - unit of measurement) 10 milliliters (ml - unit of measurement) per port every other day. Staff I gloved, however, Staff I failed to perform hand hygiene before gloving. Staff I accessed the patient's port and connected the IV line and placed the IV line into the IV pump, programmed the IV pump and started the infusion. At the completion of starting the infusion, Staff I removed gloves, however, Staff I failed to perform hand hygiene after removal of the gloves.

14. Observation on 06/26/24 at 8:59 AM, showed Staff O, RN, prepared and administered medications to Patient #4:
- Staff O performed hand hygiene, gloved, checked the patient's ID band, and began scanning patient's medication.
- Staff O removed gloves and re-gloved, however, Staff O failed to perform hand hygiene after glove removal and before re-gloving.
- Staff O cleansed the patient's saline lock (SL - a thin flexible tube placed into a vein used to administer fluids, medications and/or nutrition through the lock and into the vein) port, flushed the line, and connected the IV tubing to the SL port.
- Wearing the same gloves, Staff O programmed the IV infusion pump and attempted to start the infusion.
- Staff O removed gloves and re-gloved, however, Staff O failed to perform hand hygiene before re-gloving.
- After the patient took the medications, Staff O removed gloves, performed hand hygiene, and left the room.

15. During an interview on 06/26/24 at 9:10 AM, Staff I, RN, stated:
- Staff received yearly competency education related to hand hygiene.
Hand Hygiene should be performed:
- Before staff touch a patient;
- Before accessing a patient's port;
- After staff completed procedures; and
- Before staff put on gloves, after staff remove gloves and before re-gloving.
Gloves should be worn:
- Before an invasive procedure;
- Before providing care, accessing medical devices, and dressing changes for CVC lines and ports; and
- Anytime staff could have possible exposure to blood, body fluids, and when indicated.

16. Observation on 06/27/24 at 9:10 AM, showed Staff J, RN, prepared and administered medications to Patient #24:
- Staff J performed hand hygiene, gloved, checked the patient's ID band, and re-checked the patient's finger stick blood sugar (FSBS) because the patient's blood sugar was 88 when checked earlier that morning.
- After Staff J re-checked the patient's FSBS, wearing the same gloves, Staff J, typed on the workstation computer's keyboard.
- Staff J removed gloves and re-gloved, however, Staff J failed to perform hand hygiene after glove removal and before re-gloving.
- Staff J removed the bar scanner from the workstation and scanned the patient's identification (ID) band and wearing the same gloves worn to scan the patient's ID band, Staff J cleansed the patient's SL port, flushed the line, and connected the IV tubing to the SL port.
- Wearing the same gloves, Staff J programmed the IV infusion pump and attempted to start the infusion, however, the IV pump would not program to infuse the medication, so Staff J removed the IV tubing from the IV pump, removed gloves and re-gloved, however, Staff J failed to perform hand hygiene after glove removal and before re-gloving.
- Wearing the same gloves, Staff J removed the bar code scanner from the workstation and scanned each medication bar codes, removed each medication from the packages, and wearing the same gloves, Staff J removed the pills from the packaging, and placed each pill touched by the gloved hands into a plastic medication cup.
- Staff J removed gloves and re-gloved, however, Staff J failed to perform hand hygiene before re-gloving to remove the nasal cannula worn to deliver oxygen therapy to the patient.
- Wearing the same gloves worn to remove the nasal cannula from the patient, Staff J handed the plastic medication cup to the patient and the patient took the medications.
- After the patient took the medications, Staff J removed gloves, performed hand hygiene, and left the room to retrieve another IV infusion pump.
- Upon re-entry into the patient's room, Staff J performed hand hygiene, gloved, placed the IV tubing into the IV infusion pump, programmed the IV infusion pump, scanned the bar code on the bag of IV antibiotic medication, and wearing the same gloves, Staff J cleansed the SL port, flushed the SL port, and connected the IV tubing into the SL, programmed the IV infusion pump and started the IV antibiotic medication.
- At the completion of starting the IV antibiotic, Staff J removed gloves and performed hand hygiene.

17. During an interview on 06/27/24 at 9:26 AM, Staff J stated:
- Staff received yearly competency education related to hand hygiene and gloving.
Hand Hygiene and Gloving should be performed:
- Before patient contact;
- In-between patients;
- When touching medications;
- Upon entry and exit of patients' rooms; and
- Before gloving, after removal of gloves and before re-gloving.


18. Review of the facility's policy titled, "Hand Hygiene," dated 09/05/23, showed staff directives:
- To promote and improve handwashing and hand antisepsis in health-care settings, thereby reducing the incidence of transmission of infectious disease and pathogenic microorganisms to patients and healthcare personnel.
Hand Hygiene shall be performed:
- Whenever hands are visibly soiled, dirty, or contaminated (with or without glove use).
Before:
- Putting on gloves;
- Touching or having contact with patients;
- Performing a procedure on a patient;
- Inserting any invasive device; and
- Manipulating an invasive device.
After:
- Removing gloves;
- Touching or having contact with a patient or patient's skin;
- Having contact with bodily fluids or excretions, non-intact skin, wound dressings, or other contaminated items;
- Performing a procedure on a patient;
- Having contact with the patient's environment; and
- Having contact with inanimate objects, contaminated items, or surfaces near a patient.
Glove Use:
- Perform hand hygiene before donning gloves, after removing gloves, and between glove changes. Wearing gloves does not replace the need to perform hand hygiene.
- Wear gloves when contact with blood or other potentially infectious materials, mucous membranes, and non-intact skin could occur.
- Change gloves during patient care if moving from a contaminated body site to a clean body site and perform hand hygiene between glove changes.
- Remove gloves after caring for a patient. Do not wear the same pair of gloves for the care of more than one patient, and do not wash gloves between uses with different patients.

19. During an interview on 06/27/24 at 3:37 PM, Staff K, Infection Control Preventionist, stated staff was expected to:
- Remove gloves after using the bar code scanner and perform hand hygiene.
- Perform hand hygiene before staff removed medication from the packages, and before placing the medications in the plastic medication cup if staff wore gloves to scan the bar codes on the medication packaging.
- Perform hand hygiene before flushing SL, IV lines and ports.
- Remove gloves and perform hand hygiene if staff touched inanimate (non-living objects, for example, computer workstation, bar code scanner, computer keyboard) objects in the patient's environment and before performing procedures, treatments, and services.
- Perform hand hygiene before gloving, after glove removal and before re-gloving.
- Follow the facility's policy related to hand hygiene.

Based on observation, interview, record review, review of nationally-recognized standards and policy review, the hospital failed to ensure policies were in place to perform verbal fire-risk assessments prior to surgical procedures.
This deficient practice had the potential to affect all patients that received surgical services and staff at an elevated fire risk.
The hospital census was five Acute Care patients, zero Swing Bed (Swing Bed - a Medicare program in which a patient can receive acute care services, then if needed Skilled Nursing Home Care) patient and one Observation (Observation - outpatient services provided to a patient while the patient's physician decides whether to admit the patient to Acute Care services or to discharge the patient) patient for a total census of six.

Findings included:

1. During an observation on 06/26/24 at 1:30 PM, of surgical Patient #18, in the Operating Room Suite, showed surgical staff failed to perform a verbal fire-risk assessment with all surgical staff involved in the case prior to a laparoscopic cholecystectomy (a closed surgical procedure to remove the gallbladder).

2. During an interview on 06/26/24 at 4:46 PM, Staff D, Director of Surgical Services, stated staff were expected to perform and document fire-risk assessments prior to surgical procedure. They do not do this verbally with the entire operative team currently. They stated they follow the current Association of PeriOperative Registered Nurses (AORN) national standards.

3. Review of Patient record #15's medical record on 06/26/24, showed documentation of a fire-risk assessment prior to a laparoscopic cholecystectomy.

4. Review of the AORN "Guideline for Fire Prevention Practices," dated 2023, showed the direction for staff to:
- Perform a fire-risk assessment as part of the preprocedural briefing process, to include ignition, fuel, and oxidizer sources present in the OR.
- Include cognitive aids (eg, algorithms, checklists).
- Collaborate on and implement interventions based on the fire-risk assessment.

5. Review of the hospital's policy titled, "Fire Safety In The Operating Room," dated 10/17/23, failed to show any directive to staff to perform a fire risk assessment as part of the preprocedural briefing process. The policy addressed how to manage hazards associated with fire safety in the practice setting.

6. Review of the hospital's policy titled, "Documentation Required for a Surgical Case," dated 10/17/23, failed to show any directive to staff to document a fire risk assessment as part of the preprocedural medical record.

Based on observation, interview, hospital policy review and review of equipment manufacturers recommendations, the hospital failed to ensure that the equipment used in the provision of care of patients was maintained to prevent potential hazard to patients in the outpatient therapy gym.
This deficient practice has the potential to affect all patients that use specialized equipment provided by the hospital.
The hospital census was five Acute Care patients, zero Swing Bed (Swing Bed - a Medicare program in which a patient can receive acute care services, then if needed Skilled Nursing Home Care) patients and one Observation (Observation - outpatient services provided to a patient while the patient's physician decides whether to admit the patient to Acute Care services or to discharge the patient) patient for a total census of six.

Findings included:

1. Observation on 06/26/2024 at 4:27 PM showed a hydrocollator (a device that consists of a thermostatically controlled water bath for placing cloth heating pads. When the pads are removed from the bath, they are placed in covers and placed on the patient) and a paraffin wax bath (hot wax used to treat pain and swelling of hands and feet.) were being used in the treatment care area.

2. During an interview at time of observation, Staff O, Director of Rehabilitation Services, stated that the hydrocollator temperature was checked weekly. The paraffin bath temperature was checked monthly, and wax was replaced when needed.

3. Review of the paraffin bath manufacturers undated maintenance and use guide stated:
- Test the temperature of the paraffin prior to use.
- The usable operating temperature is from 126-134 degrees F.

4. Review of hospital document titled "Temperature Log- Paraffin" showed:
- The temperature range for the paraffin bath should be between 125-135 degrees F.
- The staff recorded a temperature readings within range for 07/2022-10/11/2022, 02/2023-03/2023 and 07/2023-01/2024.
- The staff failed to record temperature readings for 11/2022-01/2022, 04/2023-06/2023, 02/2024-03/2024 and 06/2024.

5. Review of the hydrocollator manufacturers dated 2006 maintenance and use guide showed:
- The hydrocollator should be cleaned and maintained every two weeks.
- The recommended operating temperature is 160-166 degrees F. The temperature of the water should be checked with a thermometer after every adjustment, before using HotPacs.
- Check the water level daily as it has a natural loss due to evaporation.

6. Review of hospital document titled "Temperature Log- Hydrocollator" showed:
- Temperature range for the hydrocollator should be between 160-166 degrees F.
- Staff recorded a temperature readings monthly for 02/2023-03/202, 07/2023-01/2024 and 04/2024-05/2024.
- Staff failed to record temperature readings for 04/2023-06/2023 and 02/2024-03/2024.
- Seven of the recorded temperatures recorded were below the temperature range indicated.

7. Review of the hospital Policy titled "Cleaning of Hydrocollator," dated 10/11/2023, showed:
- The hydrocollator unit will be cleaned quarterly, or more often if needed, to maintain cleanliness of hot packs.
- Monthly temperature checks will be documented to ensure temperature is within manufacture's range.

8. Review of the hydrocollator manufacturers undated maintenance and use guide said that the hydrocollator should be regularly drained, cleaned, and maintained, and recommended the interval of this process as every two (2) weeks.