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Based on observation, interview and record review, the hospital failed to have a well-organized and effective nursing service when the hospital failed to ensure three medications were administered in accordance with the physician orders, facility policies and accepted standards of practice for three of 8 sampled patients when:

1. Patient 1 was administered 25 times the prescribed dose of nitroglycerin (a medication to relax the blood vessels and increase the supply of blood and oxygen to the heart for the management of chest pain). (Refer to A 405 Finding 1)

2. The dose of Patient 2's propofol (a medication used for the induction and maintenance of anesthesia or sedation) was not adjusted as prescribed according to Patient 2's Richmond Agitation-Sedation Scale (RASS, a medical scale used to measure the agitation or sedation level). (Refer to A 405 Finding 2)

3. Patient 3's medications were crushed and administered together through a feeding tube without properly flushing the tube. (Refer to A 405 Finding 3)

4. The facility failed to follow two of their policy and procedures titled "Medication Reconciliation," when two of seven patients sampled (Patient (Pt) 80 and 81) in the emergency department (ED), medication reconciliation (a process of comparing the licensed provider's admission, transfer, and/or discharge orders to current and home medications) process was not completed. (Refer to A 398)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality patient care in a safe environment.

Based on observation, interview, and record review, the hospital failed to have an active Infection Prevention and Control program which adhered to nationally recognized infection prevention and control guidelines for the surveillance, prevention, and control of HAIs (hospital acquired infections) and other infectious diseases, when:

1. Seventy-five of 75 patients had a rectal probe (device used to insert something into ones bottom) used on them without high level disinfection (HLD- complete elimination of all microorganisms in or on an instrument) being done on the probe before each use. The facility did not follow the Manufacture Guidelines for Use (MFU) for this rectal probe. (Refer to A 749)

2. The facility did not maintain audits for the inspection of sterilized surgical instruments; did not have a policy and procedure for inspecting surgical instruments; did not have a predetermined standard of compliance with which to measure the audits; did not report steam sterilization performance data to the facility's Quality Assurance and Performance Improvement (QAPI) Program; audits were incomplete; and an audit failed to identify damaged instruments. (Refer to A 772)

3. One of one laminate countertop around the hand sink used to feed water to the dialysis machines in South Tower Telemetry/Dialysis 5, room 5-006, had become rough and bubbled. The countertop had over ten half inch circles where the laminate was missing, and the bare wood was exposed. (Refer to A 750 finding 1)

4. Two surgical instruments called a needle holder, had etching and scratching that could be felt on the instrument were in use and passed an audit inspection for damage to instruments. (Refer to A 750 finding 2)


The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision of quality patient care in a safe and sanitary environment.

Based on observations, interviews and record review, the facility failed to follow two of their policy and procedures titled "Medication Reconciliation," when two of seven patients sampled (Patient (Pt) 80 and 81) in the emergency department (ED), medication reconciliation (a process of comparing the licensed provider's admission, transfer, and/or discharge orders to current and home medications) process was not completed. This failure placed Pt 80 and 81 at risk of having duplicate medication orders and had the potential to place these patients at risk of the wrong dosages.

Findings:

During a concurrent interview and record review on 2/28/24, at 9:30 a.m. with the ED Manager (EDM), Patient 81's electronic health records (EHR) for his ED visit on 6/26/23 was reviewed. The EHR indicated Pt 81 was a 37-year-old male who walked into the ED with chief complaint of bilateral leg swelling and redness and admitting diagnosis of septic shock (a life-threatening condition that happens when your blood pressure drops to a dangerously low level after an infection). The EDM reviewed Pt 81's EHR and stated the patients home medication list and medication reconciliation was not completed for this visit and it should have been completed in phase 2 (Triage nurse completes phase 1 (includes chief complaint, vital signs, pain, allergies and etc.) and the phase 2 triage (includes home medication list and etc.) and screenings will be completed by primary nurse in patient care areas)(what's phase 2) in the ED.

During a concurrent interview and record review on 2/28/24, at 1:50 p.m., with the EDM, Pt 80's EHR for her ED visit on 1/21/24 was reviewed. The EHR indicated, "Pt was walking in our parking lot while going to get the car to pick up her husband when she tripped and fell striking her head and right knee. Pt takes thinners for a-fib (irregular heart rhythm- places patient at higher risk of stroke). No loc (loss of consciousness). GCS (Glasgow Coma Scale/Score (GCS) estimates coma severity based on Eye (4), Verbal (5), and Motor (6) criteria) 15. Sustained laceration to forehead bleeding controlled". The EDM reviewed Pt 80's EHR and stated the patients home medication list and medication reconciliation was not completed for this visit and it should have been completed in phase 2 in the ED.

During a review of the facility's P&P titled, "Medication Reconciliation," effective date 4/15/2022, it indicated, "PURPOSE: A. To define an interdisciplinary process designed to avoid medication omissions and decrease actual or potential drug events. POLICY: Medication Reconciliation will occur for patients on admission to the hospital, a change in the level of care and at discharge a list of medications that the patient is taking prior to admission should be documented as soon as possible, within 24 hours of admission as best possible... A. Medication Reconciliation: A process of comparing the licensed provider's admission, transfer, and/or discharge orders to current and home medications. B. Medication History: A process of obtaining a complete and accurate list of prior two admission medications (including drug name, dosage, route and frequency..."

Based on observation, interview, and record review, the hospital failed to ensure medications were administered in accordance with the physician orders, facility policies and accepted standards of practice when:

1. Patient 1 was administered 25 times the prescribed dose of nitroglycerin (a medication to relax the blood vessels and increase the supply of blood and oxygen to the heart for the management of chest pain). This failure resulted in Patient 1 suffering symptoms of nitroglycerin overdose including low blood pressure, dizziness, and visual changes. Patient 1 required medical intervention including the administration of activated charcoal (a product for the management of poisoning) and intravenous norepinephrine (a medication for the management of severe low blood pressure) to regain stable condition.

2. The dose of Patient 2's propofol (a medication used for the induction and maintenance of anesthesia or sedation) was not adjusted as prescribed according to Patient 2's Richmond Agitation-Sedation Scale (RASS, a medical scale used to measure the agitation or sedation level). This failure resulted in Patient 2 to experience excessive agitation or sedation.

3. Patient 3's medications were crushed and administered together through a feeding tube without properly flushing the tube. This failure had the potential for Patient 3 to have compatibility issues between the administered medications which could result in tube occlusion.

Findings:

1. A review of Patient 1's clinical record showed that Patient 1 was a 75-year-old patient admitted to the facility for chest pain and shortness of breath at approximately 5:34 p.m. on 1/11/24. Patient 1 underwent coronary angiogram (a procedure to evaluate the heart muscles, valves, and blood vessels that carry blood and oxygen to the heart) and was admitted to the Intensive Care Unit (ICU) for chest pain and close monitoring after the procedure at approximately 4:12 p.m. on 1/12/24.

A review of Patient 1's Physician Orders dated 1/11/24 indicated an order for nitroglycerin as follow:
Nitroglycerin (NITROSTAT) SL (sublingual, under the tongue) Tab (tablet) 0.4 mg (milligram, unit of measure)
Ordered Dose: 0.4 mg
Admin (administration) Dose: 0.4 mg
Route: Sublingual
Frequency: Every 5 minutes PRN (as needed) for chest pain
Admin Instructions: Max 3 doses in 15 minutes. Call physician if patient still has chest pain.

A review of Patient 1's Medication Administration Report (MAR) showed that nitroglycerin 0.4 mg was given to Patient 1 at approximately 11:15 p.m. on 1/12/24 by Registered Nurse (RN) 2.

A review of Patient 1's clinical record showed that the Patient 1's blood pressure dropped from 137/76 mmHg (millimeters of mercury, unit of measure) at 11:15 p.m. to 74/37 mmHg at 11:30 p.m. on 1/12/24, fifteen minutes after the administration of nitroglycerin.

During an interview with Nursing Unit Manager (NUM) 1 at 11:20 a.m. on 2/28/24, NUM 1 reported that there was an incident involving Patient 1 receiving 25 tablets of nitroglycerin sublingual tablets instead of the prescribed dose of one tablet on 1/12/24. NUM 1 stated that poison control center was contacted, and Patient 1 was administered activated charcoal and norepinephrine to manage overdose symptoms and to bring up the patient's blood pressure.

During an electronic record review with ICU informatics (ICU-I) at approximately 3:05 p.m. on 2/28/24, ICU-I confirmed that Patient 1 was administered 25 tablets of nitroglycerin 0.4mg at 11:15 p.m. on 1/12/24 by RN 2. ICU-I stated that according to Patient 1's flowsheets, a nasogastric tube (a thin, flexible plastic tube that's used for temporary medical purposes) was inserted at 12 a.m. for the administration of activated charcoal and the physician was notified of patient's drop in blood pressure.

During an interview with RN 2 at 7:40 a.m. on 2/29/24, RN 2 stated that she read 0.4 mg on the bottle, not 0.4 mg per tablet and poured all the 25 tablets in a plastic cup and told Patient 1 to put them under the tongue. RN 2 acknowledged that it was a mistake and further stated that Patient 1 complained of vision changes, nausea, and dizziness shortly after receiving nitroglycerin.

An inspection of the nitroglycerin bottle with NUM 1 on 2/28/24 at 12 p.m. showed that the container was labeled with the following in the center of the label:

Nitroglycerin Sublingual Tablets
0.4mg/tablet
On the bottom of the label, it was printed:
25 Sublingual Tablets

NUM 1 confirmed the bottle used for nitroglycerin administration on 1/12/24 was made by the same manufacturer.

A review of Patient 1's provider communication dated 1/13/24 at 12:23 a.m., Physician 1 dictated, "I was informed that patient was given accidental dose of NTG [nitroglycerin] sublingually. I responded to the call."

According to the manufacturer's product labeling, nitroglycerin sublingual tablet is in a class of medication called vasodilators. It works by relaxing the blood vessels to relieve chest pain caused by heart muscle not getting enough oxygen-rich blood. Nitroglycerin 0.4mg tablets should be taken sublingually at the first sign of an acute anginal attack (chest pain). One additional tablet may be taken every 5 minutes until relief is obtained but no more than three tablets are recommended within a 15-minute period. Nitroglycerin overdosage may result in dizziness, visual changes, severe low blood pressure, heart block (when the electrical impulses that control the beating of the heart muscle are disrupted), increased intracranial (within the skull) pressure with cerebral (brain) symptoms of confusion and moderate fever, paralysis and coma followed by clonic convulsions (seizure activities characterized by jerking or twitching), and possibly death due to circulatory collapse (interruption of blood circulation).

According to an online publication on low blood pressure by the Mayo Clinic, Mayo Foundation for Medical Education and Research (a nonprofit American academic medical center focused on integrated health care, education, and research), severely low blood pressure can reduce the body's oxygen levels, which can lead to heart and brain damage, and a sudden fall in blood pressure can be dangerous. A change of just 20 mmHg - a drop from 110 mmHg systolic to 90 mmHg systolic can cause dizziness and fainting, and significant drops in blood pressure can be life-threatening.
A review of the facility's policy and procedure titled Medication Administration, last revised 1/2023, indicated healthcare professional should verify that the medication selected for administration is the correct one based on the medication order and the product label before administration. Healthcare professional should also verify that the medication is being administered at the proper time, in the prescribed dose.

2. A review of Patient 2's clinical notes showed that Patient 2 was a 65-year-old patient who presented to the ED with altered mental status and respiratory distress and was intubated (had a breathing tube placed through the mouth and down the throat into the lungs to help with breathing) on 1/31/24.

A review of Patient 2's Physician Orders dated 1/31/24, indicated an order for propofol intravenous (IV) drip with starting dose of 20 mcg/kg/min (microgram per kilogram per minute, unit of measure) to adjust by 5 mcg/kg/min every 5 minutes to maintain a RASS score of -1 to -2 (The RASS is a 10-point scale ranging from -5 to +4. Levels -1 to -5 denote 5 levels of sedation, starting with "awakens to voice" and ending with "unarousable." Levels +1 to +4 describe increasing levels of agitation. The lowest level of agitation starts with apprehension and anxiety, and peaks at combative and violent. RASS level 0 is "alert and calm).

During a concurrent interview and clinical record review with ICU-I at 10:30 a.m. on 2/29/24, ICU-I stated that Patient 2's propofol was started at 12:55 a.m. on 1/31/24, but RASS score was not documented every hour when there was no RASS documentation from 1:03 p.m. to 5:24 p.m. on 1/31/24. ICU-I stated that the propofol dose should have been reduced when Patient 2's RASS was documented at 1:51 a.m. (-4, deep sedation) on 2/1/24. ICU-I also stated that the propofol dose should have been increased when Patient 2's RASS were documented at 2 p.m. (+1, restless), 3 p.m. (+1, restless), and 4 p.m. (+1, restless) on 2/1/24.

During an interview with ICU-I at 11:09 a.m. on 2/29/24, ICU-I acknowledged that nurses did not document RASS hourly, and nurses did not follow the propofol titration order to the goal to prevent excessive sedation or agitation.

During a review of the facility's P&P titled, "Sedation and continuous Neuromuscular Blockade in the Critical Care Unit," last revised 12/2022, the P&P indicated, "General Ventilator Management Order set for guidance and direction regarding care ...nursing care: assess and document RASS hourly and with every titration while on sedation. Goal is per physician order."

3. During an observation of medication administration at 9:42 a.m. on 2/28/24, RN 1 was observed to crush and administer Patient 3's medications together through a feeding tube which included one sildenafil tablet (a medication used to treat high blood pressure that affects arteries in the lungs and in the heart) 20 mg, one apixaban tablet (a medication used to treat and prevent blood clots) 5 mg, and one-half tablet of metoprolol tartrate (medication used to treat high blood pressure) 25 mg. All crushed medications were mixed in 120 ml (milliliters, unit of measure) of water and administered with a 60 ml syringe in two parts. Each 60 ml part was pushed into the feeding tube over 3 seconds without flushing the feeding line before, in between, or after medication administration.

During an interview with RN 1 at 10:05 a.m. on 2/28/24, RN 1 stated that the line was not flushed prior, throughout, or after medication administration.

During a review and reconciliation of the medication administration observation with Patient 3's electronic orders, two Physician Orders (dated 2/11/24) indicated sildenafil 20 mg via PEG Tube (a feeding tube is passed into a patient's stomach through the abdominal wall) three times daily and apixaban 5 mg via PEG tube twice daily, and a Physician Order (dated 2/22/24) indicated metoprolol tartrate 12.5 mg via PEG tube twice daily.

During an interview with RPh 1 at 10:55 a.m. on 2/28/24, RPh 1 acknowledged the three medications should have been administered separately following the proper steps to flush the tube.

During an interview with Nursing Unit Manager (NUM) 1 at 12:25 p.m. on 2/28/24, NUM 1 stated that post flush should have been done at least since medications would still be in the line and not in the stomach.

During an interview with the facility's Clinical Coordinator (CC) at 12:30 p.m. on 2/28/24, the CC stated that the medications should be crushed and given separately to prevent clogging. The line should be flushed with 30 ml of water after checking placement, 10 to 15 ml of water per medication in between, and 30 ml of water to flush the line after the last medication.

During a review of Journal of Parenteral and Enteral Nutrition "ASPEN Safe Practices for Enteral Nutrition Therapy" dated 1/2017, " the journal indicated, "Provide appropriate tube irrigation around the timing of drug administration: a. Prior to administering medication, stop the feeding and flush the tube with at least 15 ml water. b. Administer the medication using a clean enteral syringe. c. Flush the tube again with at least 15 ml water. d. Repeat with the next medication. e. Flush the tube one final time with at least 15 ml water."

During a review of the facility's policy and procedure (P&P) titled, "Tube Feeding: Enteral Nutrition," revised 2/2022, the P&P indicated, "Medication administration: refer to Clinical Key for Nursing: How To Give Medicine Through a Feeding Tube...do not mix medicines in 1 syringe ...if giving more than 1 medicine, give each medicine separately. Flush the tube between each medicine and after the last dose of medicine. Use a clean syringe for each medicine."

During a review of the facility's P&P titled, "Medication Administration," last revised 1/2023, the P&P indicated, "Crush each medication separately ...crushed medication should be administered separately to ensure complete administration."

Based on interview and document review, the hospital pharmacy failed to ensure it had complete skills and competency records for two out of three pharmacists (RPh 5 and RPh 6). The failure had the potential for the pharmacists not having the demonstrated skills and competencies to perform the duties and responsibilities required of their position.

Findings:

1. During an interview and document review with the Director of Pharmacy on 3/1/24 at 10:05 a.m., he stated the pharmacists were required to conduct an annual skill competency, including the clinical monitoring, related to their field of practice. The training and competency records for three pharmacists were randomly selected and requested for review.

On 3/1/24 at 11:11 a.m., a review of the training and competency records for RPh 5 was conducted with the Pharmacy Clinical Supervisor (RPh 2). RPh 5 was hired in August 2023. His duties included being the floor-based pharmacist (a clinical pharmacist who, besides reviewing and verifying medication orders, also acts as direct drug therapy consultant to bedside practitioners). She stated newly hired pharmacists are given the competency checklist so they could make sure they check them off; however, she did not keep records of the checklist for each new hire. A review of the said checklist with RPh 2 indicated it included a list of therapeutic monitoring such as anticoagulation (medications to prevent blood clots that require close monitoring by the pharmacists) monitoring. When asked for evidence of completion, RPh 2 reviewed the training tracking record and stated RPh 5 had received training and been assessed for competency in therapeutic monitoring including anticoagulation monitoring; however, she did not have written evidence RPh 5 completed this training/competency.

A review of the pharmacy practice guidelines of the 2013 "ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals" by the American Society of Health System Pharmacists (ASHP, a national organization advocating and supporting the professional practice of pharmacists in hospitals, health systems, and other settings spanning the full spectrum of medication use), indicated the following under Orientation of Personnel: "There shall be an established, structured procedure for orienting new personnel to the pharmacy, the hospital, and their respective positions. Evaluation of the effectiveness of orientation programs should be done in conjunction with the competency assessment required before a new hire can assume full responsibility for the new position."

2. On 3/1/24 at 11:40 a.m., an interview and document review of RPh 6's training and competency records with RPh 2 indicated RPh 6 was hired on 6/11/2022. She stated RPh 6 works as an infusion pharmacist (one who works with patients receiving infusions, such intravenous infusion; and is responsible for accurately preparing the medication and monitoring the patient throughout the treatment). She stated RPh 6's primary role is chemotherapeutic therapy (cancer drug treatment). RPh 2 stated the electronic tracking software indicated RPh had the chemotherapy training on 8/26/22; however, there was none conducted in 2023.

During an interview with the Pharmacy Operations Supervisor (RPh 1) on 3/1/24 at 11:56 a.m., he stated the infusion pharmacists should have competency training, such as dosing and monitoring of chemotherapeutic agents, annually. He stated if it was not in the training tracking record, then he did not know where else to look.

During a follow-up interview on 3/1/24 at 1:35 p.m., RPh 1 stated RPh 6 was overdue for the annual chemotherapy training. He confirmed none was done in 2023.

A review of the hospital's policy and procedure titled "Orientation and Ongoing Education, Training and Competency Assessment of Pharmacy Personnel," effective 9/3/2021, indicated: "The initial orientation checklist will be provided to each new employee during his/her orientation period. The Pharmacy Management or designee will be responsible for ensuring that the new employee has reviewed and successfully completed the information on the checklist... Periodic skills assessment and competency testing will take place for staff employees. It will occur as often as is required to perform the duties outlined in the job description but at least yearly. Issues such as clinical knowledge and skills... will be included in the competency assessments. Pharmacy management or designee will act as the validator and will determine satisfactory performance based on... demonstrated performance skills."

Based on observation, interview, and record review, the facility failed to ensure three of 3 medication carts and one of 14 anesthesia medication carts were locked and medications were securely stored and when:

1. A medication cart on South Tower Medical/Telemetry 3 was left unlocked and unattended.

2. A medication cart on South Tower Telemetry/Dialysis 5 was left unlocked and unattended.

3. Registered Nurse (RN) 5 left a medication cart unlocked and unattended in the infusion clinic.

4. One of 14 Anesthesia carts in the facility Operating rooms (ORs- where surgery is performed) was left open and had IV medication left out on top and in a lock box that was not locked.

These failures resulted in the availability of medications to be diverted by unauthorized patients, staff and visitors.

Findings:

1. During an observation and interview on 2/27/24, 3:10 p.m., on Unit South Tower Medical/Telemetry 3, next to room 3765, there was an unlocked medication cart. A nurse walked by the medication cart and went into Room 3761 but did not attend to the medication cart. Room 3765's door was closed. For ten minutes, the cart was left unattended and unlocked with medication drawer visibly open. Medication cart locked automatically but draw was still open. Charge Nurse (CN) 1 stated, medication carts should be locked when nurses are not using them. CN 1 stated, the nurse should not have left her medication cart unattended and should have locked her medication cart.

During interview on 2/27/24, at 3:10 p.m., with Nurse Manager (NM) 2, NM 2 stated, should be kept locked when the nurse is not using the medication cart. NM 2 stated, visitors or unauthorized individuals could get into the medication cart and take medications. NM 2 stated, it is a safety issue.

2. During an observation and interview on 2/28/24, 9:55 a.m., on Unit South Tower Telemetry/Dialysis 5, next to room 5751, there was an unlocked medication cart. For ten minutes, the cart was left unattended and unlocked. Eventually, medication cart locked automatically. CN 2 stated, nurses can not leave unlocked medication carts unattended and unlocked as it is a safety issue.

During interview on 2/28/24, at 9:55 a.m., with NM 3, NM 3 stated, nurses should make sure carts are locked and medications are secure. NM 3 stated, someone could have taken medications.

3. During an observation and interview on 2/28/24, 2:10 p.m., in the Outpatient Infusion Clinic, in bay 4, there was an unlocked medication cart with no nurse using the cart. For five minutes, the cart was left unattended and unlocked. RN 5 had been using the cart. RN 5 stated, the medication cart should have been locked when she is not using it. RN 5 stated, people who are not authorized could take medications.

During an interview on 2/28/24, at 2:10 p.m., with NM 4, NM 4 stated, medication carts should be locked when not being used and it is a safety issue. NM 4 stated, we have visitors and public in this area and they could have taken medications that are needed for patients.

During a review facility's policy and procedure (P&P) titled, "Medication Procurement, Storage, and Inspection," dated 6/16/2021. The P&P indicated "... B. Medications shall be stored securely ... G. Floor Stock ... 1. All floor stock shall be secured in tamper-evident kits/boxes/carts, locked cabinets, or locked medication rooms ... 2. Only authorized personnel will have access to medications ... "

4. During a concurrent observation and interview on 2/28/24, at 3:13 p.m., while in OR 2 with the Director of Surgical Services (DSS) and the Manager of Surgical Services (MSS) , the Anesthesia cart was seen open with a full 5 ml (milliter- unit of measurement) syringe sitting on top labeled Rocuronium (Paralytic it can relax muscles during surgery and medical procedures), in the top drawer was 10 ml normal saline flush and 50 ml bag of normal saline, and in the open lock box on the side of the cart was a full vial of Succinylcholine (Paralytic it can relax the muscles during surgery or other medical procedures) 200 mg (milligrams- unit of measurement) per 10 ml with "WARNING: Paralyzing Agent" written in red on the vial. The DSS and the MSS stated it is the responsibility of the anesthesiologist to secure and waste the medications that they use. The DSS and MSS stated they have anesthesia technicians (AT) that are responsible to clean all anesthesia equipment including the cart, stock the cart and lock it so it is ready for the Anesthesiologist for the next procedure, normally the AT would have seen the medication and contacted the charge nurse to let her know so she could contact the Anesthesiologist and the secure the medication. The MSS stated no medications should be left out, they should be locked up immediately after surgery to protect them from being diverted.

During a review of the facility's P&P titled, "Medication Procurement, Storage, and Inspection" date 6/16/21, the policy indicated, "PURPOSE: A. To establish guidelines and processes for medication procurement, storage, and inspection ... POLICY: ... B. Medications shall be stored securely and under proper conditions as stated by the medication's manufacturer to ensure stability of that medication ... PROCEDURE: E. Controlled Substances ... 3. Medications are stored in a secure manner to prevent diversion, in accordance with law and regulation (TJC MM 03.01.01, EP-3). A. Controlled substances will be kept secured at all times in automated dispensing machines (e.g., Pyxis) throughout the facility ... F. Storage ... 3. Drugs are stored under the proper conditions of sanitation, temperature, light, moisture, ventilation, segregation, and security as directed by state/federal regulations and by the drugs manufacturer to assure stability of that drug or in the absence of such recommendations, according to a pharmacist's instructions ... G. Floor Stock 1. All floor stock shall be secured in tamper-evident kits/boxes/carts, locked cabinets, or locked medication rooms. 2. Only authorized personnel will have access to medications ..."

Based on observation, interview, and document review, the facility failed to ensure expired pharmaceutical products were removed and not accessible to use according to the facility's policies and procedures, as evidenced by:

Four 1 L (Litter, unit of measure) bags of cardioplegic solution (a solution used to induce arrest of the heart during heart surgery) were found expired in the operating room (OR).

This failure had the potential to compromise the potency and effectiveness of the cardioplegic solution used in heart surgeries.

Findings:

During an inspection of a medication storage area on the second floor (North) OR on 2/27/24 at approximately 3:45 p.m., four 1 L bags of cardioplegic solution were found in the medication refrigerator with expiration dates of 2/19/24 (bag #1), 2/19/24 (bag #2), 2/21/24 (bag #3), and 2/22/24 (bag #4). The label of the identified products indicated they contained the following:
Potassium chloride (KCl) (a type of electrolyte supplement) 80 mEq (milliequivalent, unit of measure)/ 8.4% (percent, unit of measure) bicarbonate solution (a buffering solution) 10 mEq.

During an interview with Registered Pharmacist 1 (RPh1) on 2/27/24 at approximately 3:48 p.m., RPh 1 acknowledged that the four 1 L cardioplegic solution bags were expired. RPh 1 stated that all expired cardioplegic bags should have been disposed of.

A review of the cardioplegic solution manufacturer's label indicated, "Store solution containing bicarbonate under refrigeration. Do not store longer than 24 hours."

A review of the facility's policy and procedure (P&P) titled, "Medication Procurement, Storage and Inspection," dated 6/2021, the P&P indicated, "expired, damaged and/or contaminated medications are removed from drug storage areas ...outdated drugs and related supplies shall not be dispensed."

Based on interview and record review the facility failed to properly monitor, inspect, and perform high level disinfection (complete elimination of all microorganisms in or on an instrument) to the 8848 [name of company] transducer (rectal probe- used to examine the prostate (small, walnut-shaped organ, it is below your bladder and in front of your rectum) or rectum (last several inches of the large intestine closest to the anus) thoroughly) that was used in Radiation/Oncology department on 75 of 75 patients (Patients 5-79).

This failure resulted in placing the 75 patients at risk for transmission of infections and diseases.

Findings:

During an interview on 2/27/24, at 2:08 p.m., with the Manager of Radiation Oncology (MRO), the MRO stated the rectal probe was brought in by an outside vendor [name] who had a contract with this facility and the last time the rectal probe was used was on 11/2/23. The MRO stated the vendor handled the cleaning of the probe and informed them that he does not perform high level disinfection on the probe after each use on a patient but does clean the probe prior to use and puts on a clean sleeve and then cleans the probe after the sleeve was removed. The MRO stated the procedures that use these rectal probes were being done once a month in the Radiation Oncology department.

During an interview on 2/29/24, at 3:45 p.m., with the Accreditation and Licensure Manager (ALM) and the Director of Quality (DQ) stated on 11/3/23 the facility was notified by their System [name of system] infection preventionist (IP) that there was the possibility that the rectal probes brought in by the vendor [name] were not being disinfected appropriately between patients. The ALM and DQ stated their IPs created a timeline and on 11/3/23 this Facility's IP reached out to the Radiation Oncology department leadership to confirm the use of this vendor and on 11/6/23 this was confirmed. On 11/9/23 the facility's IPs confirmed the cleaning process of the rectal probes by this vendor and the facility decided to stop using this vendor and these rectal probes until they could ensure high level disinfection (HLD) can be done prior to use on a patient. On 11/10/23 the Radiation Oncology department began the process of purchasing the ultrasound equipment with the rectal probes. The DQ stated when the facility spoke with the vendor and asked if they could do HLD on the rectal probes the vendor refused indicating that it took too much time, so the facility has stopped using this vendor. The ALM and DQ provided a list of 75 patients the rectal probe had been used on the earliest dated 3/4/2021 and last on 11/2/2023.

During an interview on 3/4/24, at 11:06 a.m., with the Infection Preventionist (IP) 1, the IP 1 stated she is one of three IPs that work for this facility. IP 1 stated she had reviewed the timeline put together for the rectal probes and confirmed it was accurate and she had been the IP to reach out to the Radiation Oncology department. IP 1 stated the importance of HLD is "to eliminate the organisms from the device to not transmit infections to the patient for patient safety". IP 1 stated as an infection preventionist she does environmental rounds in the radiation oncology department quarterly but will more than likely be doing them monthly or even weekly once the new probes get put into place. IP 1 stated, "Honestly, we didn't know they had a probe" in this department and if they had known they would have asked about the cleaning, storing, transporting and education on its use, like we do for the vaginal probes in the ultrasound department. The IP 1 stated the manager of the department knows what devices come into their departments and the steps to maintain the safety of the device and we are here to consult if they need us.

During an interview on 3/4/24, at 12:53 p.m., with the Radiation Officer for Radiation Oncology (RAD), the RAD stated he has been the RAD since 2012. The RAD stated he started using this rectal probe a couple of years ago, he stated it was used to place biodegradable gel between the rectum and the prostate, to provide protection from the radiation done to the prostate for prostate cancer. The RAD stated he was informed about the rectal probes not being HLD in November of 2023. The RAD stated he never saw the vendor doing the cleaning or HLD of the rectal probes, that as the doctor he would do the procedure and leave while the vendor did the rest (cleaning and prep of rectal probe for next procedure). The RAD stated he was very surprised when he was informed that the HLD was not being done in between use on patients.

During a review of the facilities Policy and Procedure (P&P) titled, "Loaned and Borrowed Instruments, Implants, Equipment, and Supplies" dated 9/14/22, the policy indicated, "PURPOSE: A. To give guidance for tracking loaned/borrowed instruments and implants to/from another medical facility. B. To assure instruments, implants, equipment, and supplies are available and sterile for scheduled cases ... POLICY: A. All incoming (borrowed) or outgoing (loaned) instruments, implants, equipment, or supplies will be documented on hospital approved LOAN/BORROW FORM ... D. Borrowed instruments will be cleaned, inspected, disinfected, and sterilized by the [name of the hospital] SPD (sterile processing department) prior to use ... SCOPE: ... B. For all instruments, implants, equipment, or supplies that are loaned or borrowed from a physician, another facility, or a sales representative ... PROCEDURE: B. Instrument trays brought in by vendors for scheduled cases will follow the protocol for sterilization of loaned instruments ... E. VENDOR TRAYS: 1. The vendor representative will bring the instruments or implant trays at least 24 hours prior to the scheduled procedure. 2. The vendor must provide an inventory sheet of instrument provided and the manufacturers' written instructions for the care, cleaning, assembly, and sterilization of the instruments ... F. RETURN OF VENDOR TRAYS: 1. Upon arrival to the decontamination area of the workroom the trays/instruments will be washed in the washer or decontaminated as per policy ... 4. The vendor representative will reassemble the instrument trays and arrange for transportation to their final destination ... 3. Physicians electing to supply their own instrumentation or implants are expected to comply with this policy. They must arrange the delivery of their instruments to the sterile processing department following the timeline mandated by this policy ..."

Review of [name of company] Care and Cleaning Information User Guide English BB1564-BF Issues 2023-06 For healthcare professional users only (Manufacturer for Use Instructions - MFU). The MFU indicated, " ... Warnings Infection control-follow established procedures WARNING Reproc-w2 Users of this equipment have an obligation responsibility to provide the highest possible degree of infection control to patients, co-workers and themselves. The instructions in this book are meant as a guide. To avoid cross- contamination, follow all infection control policies (including for reprocessing, packing and storage) for personnel and equipment that have been established from your office, department or hospital ... Chapter 2: ...Transducers ... Chapter 3: Introduction & Safety this user guide contains information about carrying form reprocessing [name of company] equipment. It includes important information about what you must do to ensure the safe and proper performance of the system, transducers and accessories. This includes information about cleaning, disinfecting and sterilization ... storing devices when not in use... Always reprocess the transducer prior to use.... General storage conditions... devices must be stored in a way that maintains the reprocessing level (e.g. Sterile, high-level disinfected), or else it must be reprocessed again prior to use for the local and national guidelines ... Chapter 4: Reprocessing Information and Methods ... levels of reprocessing the level reprocessing required depends on the type of equipment and its use the CDC in (Centers for Disease control and prevention) the US... Classify medical devices according to their use. For each classification they specify the level of disinfection sterilization processing that is required before use table 4 summarizes the information... semi critical devices contacts mucous membranes in parentheses table and the applications level of reprocessing required immediate cleaning and disinfection (in the USA, high-level disinfection or sterilization) ... STERRAD systems use low moisture and low temperature hydrogen peroxide gas plasma technology to process heat dash and moisture dash sensitive medical devices the systems are intended for terminal sterilization of properly cleaned, rinse, and thoroughly dried reusable medical devices ... Appendix: Reprocessing Information and Tables ... Endocavity ... 8848 ... Sterilization ... Sterrad 200 short cycle ..."

Based on observation, interview, and record review the facility failed to maintain a clean and sanitary environment to prevent the transmission of infection when:

1. One of one laminate countertop around the hand sink used to feed water to the dialysis machines in South Tower Telemetry/Dialysis 5, room 5-006, had become rough and bubbled. The countertop had over ten half inch circles where the laminate was missing, and the bare wood was exposed.

2. Two surgical instruments called a needle holder, had etching and scratching that could be felt on the instrument were in use and passed an audit inspection for damage to instruments.

These failures placed patients and staff in an unsafe and unsanitary environment which could potentially lead to negative outcomes such avoidable patient infection and staff injury.

Findings:

1. 2. During a concurrent observation and interview on 2/28/24, at 10:34 a.m., with NM 3, in South Tower Telemetry/Dialysis 5, room 5-006, the laminated surface around the hand sink, used to hook up water for the dialysis machine, was observed to be rough and "bubbled". The countertop was observed to have over ten half inch circles where the laminate was missing, and the bare wood was exposed. NM 3 stated the chemicals from the dialysis might be causing the bubbles on the countertops. NM 3 stated, the countertops cannot be properly cleaned, and bacteria can grow in the countertop. NM 3 stated, it is an infection control risk to the patients.

During a concurrent observation and interview on 2/29/22, at 1:10 p.m., with IP 1, in South Tower Telemetry/Dialysis 5, room 5-006, IP 1 stated, the countertops are unacceptable and need to be replaced. IP 1 stated, the countertops cannot be cleaned sufficiently to eliminate bacteria and it could cause infection.

During a review of the hospital's policy and procedure (P&P) titled, "Infection Control Plan", unknown date, the P&P indicated "... Purpose of Infection Prevention and Control ... As a resource within [ HOSPITAL] and the community, the Infection Preventionist educates other professionals as well as the public about risk of infection and measures to minimize and/or eliminate the risks, and to enhance patient safety and quality. ... Authority and Responsibilities ... All healthcare workers have responsibility for adherence to infection prevention and control processes/strategies. ... Surveillance Methodology ... When surveillance data identifies an area of concern, a specific problem or an opportunity for improvement, the Infection Control team will initiate actions appropriate to the issue. ..."

2. During a concurrent observation and interview on 2/28/24 at 9:35 a.m. with the Director of Surgical Services (DSS) and SPM, the SPM completed an audit of a processed and sterile surgical instrument tray was opened and the instruments inspected for cleanliness, functionality, and integrity. The tray contained 91 separate instruments. Two titanium needle holders were noted to have an etching and/or scratches that could be felt with the bare hand. SPM did not identify the etching and scratched and passed all 91 pieces as ready for use. The SPM stated the instruments should not have passed the audit as the etching/scratches created a space for a potential bioburden (bacteria living on a surface). The DSS requested a ST to remove the instruments from use. The SPM stated the facility follows the Association for the Advancement of Medical Instruments (AAMI) standards.

During a review of "AAMI Standards (AAMI)", dated 2021, indicated, " ...Damaged instruments should be removed from service ... Damaged instruments ... increase risk of patient harm ...".

During a review of a professional reference titled, "Surgical Instrument Inspection: Mission for zero patient harm (SI)", dated 2024, the "SI" indicated, " ... The condition of the instrument has a significant effect on how adequately it can be cleaned. Instruments subjected to rough handling will develop scratches and roughened surfaces over time, which will trap and hold dirt. Damaged surfaces not only allow dirt and bacteria to collect but can also be potentially dangerous for both medical staff and patients ...".

Based on observations, interviews, and record review, the Infection Preventionist (IP) failed to adhere to the national standards of the Association for the Advancement of Medical Instrumentation (AAMI) when audits for the inspection of sterilized surgical instruments were not developed and implemented; did not have a policy and procedure for inspecting surgical instrument prior to being sterilized and processed; did not have a predetermined standard of compliance with which to measure the audits; did not report steam sterilization performance data to the facility's Quality Assurance and Performance Improvement (QAPI) Program; audits were incomplete; and an audit failed to identify damaged instruments on 2/28/24 and white debris was found on the outside window of an instrument washer on 2/28/24.

These failures resulted in the potential for increased patient harm related to instrument malfunction and/or contamination of microorganisms.

Findings:

During a concurrent observation and interview on 2/28/24 at 9:20 a.m. with the Sterile Processing Manager (SPM), the Sterile Processing Department (SPD, an area where reusable surgical instruments and devices are cleaned, disinfected, and sterilized [made void of bacteria]) was toured. The SPM stated she audited (randomly inspected) sterile surgical trays (set of surgical instruments for a particular procedure) and the audit included a check for functionality, organization, and sterilization confirmation) monthly. The SPM stated she is the only person who performs tray audits and has no audit form (a list of items to be inspected when reviewing cleanliness and functionality of instruments) for the tray audits. The SPM stated the number of trays audited every month varies and the results of the audits are not recorded. The SPM stated they do not report the tray audit results to the Quality Assurance & Performance Improvement (QAPI) Committee, Infection Prevention nor other entities.

During a concurrent observation and interview on 2/28/24 at 9:25 a.m. with the SPM, the SPM was asked to perform a tray audit on sampled tray and to explain what she was doing along the way. The SPM opened the tray and checked the steam sterilization indicators (a small strip on the inside of the sealed tray that indicates steam sterilization took place), checked tray integrity, opened clamps and checked for debris or damaged, and alignment and function of the forceps (handheld instruments for grasping and holding objects). The SPM stopped her audit while approximately half of the clamps were still in the tray and on the stabilization bar (a bar running the length of the tray on which the clamp handles are threaded) of the tray. The SPM did not remove the clamps and open them until asked if the audit was completed.

During a concurrent observation and interview on 2/28/24 at 9:35 a.m. with the Director of Surgical Services (DSS) and SPM, the SPM completed an audit of a sterile surgical instrument tray consisting of 91 pieces for inspection of cleanliness, functionality, and integrity of the instruments suitable for surgery. SPM passed all 91 pieces. After the audit, it was brought to the SPM and DSS's attention that two titanium (type of metal) needle holders had etching and/or scratches on the side of the instrument that could be felt with the bare hand. The SPM stated the instrument should not have passed the audit as the etching/scratches created a space for a potential bioburden (bacteria living on a surface). The DSS requested a Sterile Processing Technician (ST) to remove the instruments from use. When asked what the acceptable passing rate for audits (for example 89 of 91 instruments passing, the rate would be 98%) is standard, the SPM stated there was not a set passing rate. The SPM stated a tray instrument not passing is an educational issue 1:1 (one on one, individualized education or remediation regarding mistakes) with the employee who put the tray together and the remediation was not documented.

During a concurrent observation and interview on 2/28/24 at 9:55 a.m. with the SPM in SPD Decontamination Room, dried white debris lined the windowsill of one of three washers. The SPM stated it was calcium deposits from the city's " ... hard water ...".

During an interview on 2/28/24 at 11:50 a.m. the SPM stated the facility followed the Association for the Advancement of Medical Instruments (AAMI) standards.

During an interview on 2/29/24 at 11:45 a.m. the Quality Director (QD) and the Accreditation Program Manager (APM) stated there was no policy or procedure for inspection of surgical instruments.

During an interview on 3/4/24 at 11:06 a.m. IP 1 stated she performed rounded (act of visiting an area) in SPD quarterly per year and was last there in January of 2024. IP 1 stated during rounding she looks for proper protective equipment, cleanliness of machines, floors, ceilings, expirations on devices and materials, and how staff are cleaning instruments. IP 1 stated AAMI standards required a standard pass rate for tray audits, but one could not get process improvement measure when there was no data. IP 1 stated remediation with staff 1:1 regarding tray issues should be documented to know how often and with whom tray audits fail. IP 1 stated there is a difference in doing the work (referred to audits) and improvement. IP 1 stated according to the facility's Infection Control and Prevention Plan and AAMI standards SPD tray audits should have been part of the QAPI Program and were not.

During a concurrent interview and record review on 3/4/24 at 1:55 p.m. with the SPM and DSS reviewed the instruction for use for the SPD washers titled, "Operating Instructions Decomat (OP)" (undated), the "OP" indicated, " ... Maintenance ... exterior ... The front and side walls can be cleaned and disinfected with an alcohol-based detergent, surgical spirit, or normal detergent ...". The SPM and DSS stated the calcium deposits should not have been on the window and should have been cleaned to maintain a clean environment.

During a review of the a professional reference titled, "AAMI Standards (AAMI)", dated 2021, "AAMI" indicated, " ... 8.2 Inspection of instruments ... Damaged instruments should be removed from service; damage is addressed according to organizational policy and procedure (e.g. evaluation, repair) ... 7.2 Policies and procedures ...The health care organization should establish policies and procedures for all methods of cleaning and decontamination of reusable items ... Process audits to monitor compliance with various policies and procedures should be performed on a scheduled basis, with appropriate follow-up to address problems ... Audits of the process can help identify gaps so methods can be identified to improve the process ... 8.1 General considerations ...In preparation for sterilization, devices should be ... inspected for cleanliness, flaws, and damage ... 14 Quality process improvement ... For steam sterilization CQI [continuous quality improvement] program encompasses the entire process of decontamination, preparation, and packaging, sterilization, quality control, sterile storage, ad product distribution ... The quality process should be developed in conjunction with appropriate departments and integrated into the overall quality process in the health facility ... A risk analysis should be completed for all aspects of the steam sterilization to identify any risk that could occur to personnel or patients ... There should be a planned, systematic, and ongoing process for verifying compliance with procedures. Quality processes can be enhanced by audits that are conducted on a regular basis. The information from these activities should be summarized and made available to appropriate individuals or groups/teams ... Measurements of process performance allow the steam sterilization process to be monitored against a predetermined level of quality ... Ongoing auditing provides data essential to assess the effectiveness of the process and make improvements in performance ... 14.2.3 ... Risk analysis ... Risk management should include determining which of the potential sterilization failures identified in the risk assessment process require management and selecting and implementing plans and corrective action ...Risk ...should include an interactive dialogue between SPD, user areas, and infection prevention ...".

Based on interview and record review the facility failed to obtain a History and Physical (H&P) (a term used to describe a doctor's examination of the patient) update within 24 hours of a surgery for one of six patients (Patient 90).

This failure had the potential for the surgical team not having the most up to date information prior to surgery.

Findings:

During a concurrent interview and record review, on 2/29/2024 at 10:30 a.m., with RN 6, Patient 90's medical record was reviewed. Patient 90 had surgery on 2/27/2024 for a coronary artery bypass grafting (a surgical procedure to improve blood flow to the heart). Patient 90 had a medical H&P completed on 2/24/2024. An update to the H&P was missing on 2/26/24 and 2/27/24 in the medical record.

During an interview on 2/29/24, at 11:00 a.m., with the QD, the QD stated, per the medical bylaws, an update to the H&P should be done 24 hours prior to the surgery. QD stated, it appears it was not done and it was missed for this patient.

During a review facility's policy and procedure (P&P) titled, "Medical Staff Rules and Regulations", not dated. The P&P indicated "... L. History and Physical Examinations ... A history and physical examination shall, in all cases, be recorded within 24 hours of admission of the patient by the attending, admitting practitioner, or his/her designee. ... 2. If a history and physical examination has been done within thirty (30) days prior to admission, a durable, legible copy of this report may be used in the patient's hospital medical record. An updated medical record entry documenting an examination for any change in the patient's condition must be included in the patient's medical record. This updated examination must be completed and documented within twenty-four (24) hours after admission ..."