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Based on observation, interview, and record review, the facility failed to ensure the Condition of Participation (CoP) for Pharmaceutical Services was met, as evidenced by:

1. The facility failed to ensure medications were kept securely, and/or locked, inside two (2) of two sampled medication carts (Medication Cart 1 and 20), in two (2) of two sampled rooms, in the operating room 2 (OR 2, a specialized area in a hospital where surgical procedures are performed) and in the Endoscopic Ultrasound (a procedure that combines endoscopy [a medical procedure where a thin, flexible tube with a camera and light (an endoscope) is inserted into the body to visualize internal organs and structures] and ultrasound [a medical imaging technique that uses high-frequency sound waves] to create images of the digestive tract [where food and liquids travel through as they are ingested, digested, absorbed, and eventually eliminated as waste] and nearby organs and tissues) room (EUS), in accordance with the facility's policy regarding "Operations - Operating Room/Pre-Op/Post Anesthesia Care Unit - Drug Administration."

This deficient practice had the potential for unauthorized access to dangerous medications that may or may not affect the safety of the hospital's patients, staff, and visitors. (Refer to A-0502)

2. Ensure unauthorized personnel would not have access to medications stored in the Endoscopic Ultrasound (a procedure that combines endoscopy [a medical procedure where a thin, flexible tube with a camera and light (an endoscope) is inserted into the body to visualize internal organs and structures] and ultrasound [a medical imaging technique that uses high-frequency sound waves] to create images of the digestive tract [where food and liquids travel through as they are ingested, digested, absorbed, and eventually eliminated as waste] and nearby organs and tissues) room (EUS) and in three (3) of three (3) medication refrigerators (a medical refrigerator, designed to maintain a consistent temperature range for the storage of medication and other temperature-sensitive medical supplies), located in the Operating Room department (OR or surgical department, a hospital ward where patients are cared and treated before, during and after surgery) corridor coves (Core 1 and 2, Outpatient Core), in accordance with the facility's policy regarding medication storage.

This deficient practice had the potential for unsafe storage and inappropriate access of drugs that may affect patients', staff, and visitors' safety. (Refer to A-0504)

3. Ensure nine (9) of nine sampled injectable medication syringes drawn up for a procedure, were properly labeled, and unused and/or outdated portions of one (1) of one sampled multidose vial (a container of liquid medication, intended for injection or infusion, that holds more than one dose), would be discarded after a procedure, in three (3) of three sampled areas, the Operating Room 2 (OR 2), the OR anesthesia work room, and in the Endoscopic Ultrasound (a procedure that combines endoscopy and ultrasound to create images of the digestive tract and nearby organs and tissues) unit (EUS), as per facility's policy regarding safe medication practices. The facility also failed to ensure used multiple dose vials (a small container, typically cylindrical and made of glass, used especially for holding liquid medicines) and four (4) of five (5) medications with overwrap that were removed, had proper dating to prevent using beyond manufacturer's guidance, in accordance with the facility's policy regarding medication storage.

This deficient practice had the potential for outdated or contaminated medications being available for use in the patient care areas, which may result in problems such as infection and reduced drug effectiveness. (Refer to A-0505)

4. Inspect and maintain stock drug (medication) supplies in one of two (2) sampled pediatric (branch of medicine dealing with the health and medica care of infants, children and adolescents from birth up to age of 18) anesthesia (a medical technique that involves using medications to temporarily block pain and sensation, making procedure like surgery possible without discomfort) carts (Cart 1, a supply cart stocked with medications and other supplies to be used by an anesthesiologist), on a monthly basis, in accordance with the facility's policy and procedure regarding drug administration.

This deficient practice resulted in two expired (outdated) medications observed in Cart 1 and had the potential to result in using medications with reduced drug effectiveness, thus compromising patient care. (Refer to A-0505)

The cumulative effect of these deficient practices resulted in the facility's inability to provide quality healthcare in a safe environment

Based on interview and record review, the facility failed to ensure that nurses notified the physician, in accordance with the facility's policy and procedure regarding Patient Controlled Analgesia (PCA- a type of pain management where patients administer their own pain medication through a pump by pressing a button), when one of 40 sampled patient's (Patient 10's) respiratory rate (number of breaths taken per minute) was measured at less than twelve (12) breaths per (/) minute (Normal respiratory rate is 14-22 breaths/minute for children), for nine (9) times, on 5/6/2025 between 3:15 p.m. to 7 p.m., as per order. The facility also failed to ensure the facility's policy and procedure did not have a different limit of respiratory rates for nurses to notify physicians.

This deficient practice had the potential for adverse events such as respiratory depression (where breathing becomes too slow or shallow, preventing proper gas exchange between the lungs and blood), due to a delay in notifying physicians of abnormal vital sign (clinical measurements, specifically pulse rate, temperature, respiration rate, and blood pressure, that indicate the state of a patient's essential body functions) measurements.

Findings:

During a review of Patient 10's admission record, the admission record indicated Patient 10 was an 11 years old patient admitted to the hospital on 5/6/2025 at 5:30 a.m. with diagnoses of congenital scoliosis (a condition present at birth where the spine [a series of interconnected bones that runs from the base of the skull to the tip of the tailbone] curves sideways due to abnormal vertebral [back bones] development) and a post-operative admission from posterior (back of the body) spinal fusion (a surgical procedure that joins two or more vertebrae in the spine).

During a concurrent interview and record review on 5/8/2025 at 2:41 p.m. in the presence of the Inpatient Pharmacy Supervisor (IPS 3) and the interim Director of Pediatrics Services (iDPS), Patient 10's medication orders, were reviewed. Patient 10's orders indicated the patient (Patient 10) had an order for hydromorphone (Dilaudid, a powerful opioid analgesic for the treatment of moderate to severe pain) PCA (or patient controlled analgesic device, which is a type of pain management where patients administer their own pain medication through a pump by pressing a button), dated 5/6/2025 at 12:50 p.m. and discontinued on 5/8/2025 at 9:52 a.m. IPS 3 stated the PCA order referred to a pediatric (the branch of medicine dealing with the health and medical care of infants, children, and adolescents from birth up to the age of 18) order set (a predefined, electronic collection of instructions and service requests grouped together for a specific clinical scenario or condition) for monitoring vital signs and parameters (a measurable characteristic or a fixed limit that influences or defines how something is done).

During a review of Patient 10's hydromorphone order, the order indicated, "order part of order set: PCA PEDS IP SCAL NATL (refers to Patient-Controlled Analgesia [PCA] in pediatric [PEDS] patients, within an inpatient [IP] setting, potentially involving pain scales [SCAL] and possibly referencing national guidelines or standards [NATL]). Further review of the PCA PEDS IP SCAL NATL indicated a checked box for "Measure vital signs and sedation (A state of calmness, relaxation, or sleepiness caused by certain drugs) scale" and " ... notify physician if: respiratory rate less than 12/min ..."

During a review of Patient 10's vital signs monitoring flowsheet dated 5/6/2025, the flowsheet indicated the following respiratory rates:
Respiratory rate = 10 at 3:15 p.m.
Respiratory rate = 10 at 3:30 p.m.
Respiratory rate = 11 at 4 p.m.
Respiratory rate = 10 at 4:15 p.m.
Respiratory rate = 11 at 4:30 p.m.
Respiratory rate = 8 at 5 p.m.
Respiratory rate = 10 at 5:15 p.m.
Respiratory rate = 11 at 5:30 p.m.
Respiratory rate = 9 at 7 p.m.

During a concurrent interview and record review on 5/8/2025 at 2:45 p.m. with the interim Director of Pediatrics Services (iDPS), Patient 10's nursing progress notes, were reviewed. iDPS stated there was no record indicating nurses had notified the physician of Patient 10's respiratory rates on 5/6/2025. IDPS stated nurses should have notified physicians.

During a review of the facility's policy and procedures (P&P) titled, Patient Controlled Analgesia (PCA), last reviewed in 3/2023, the P&P indicated " ... For Pediatric patients, the provider will order the following: ... Notify the provider if respiratory rate less than 12/minute ... RN responsibilities: ... RN will notify provider if ... Respiratory Rate is less than 8/minute ..."

Based on observation, interview, and record review, the hospital failed to ensure medications were kept securely, and/or locked, inside two (2) of two sampled medication carts (Medication Cart 1 and 20), in two (2) of two sampled rooms, in the operating room 2 (OR 2, a specialized area in a hospital where surgical procedures are performed) and in the Endoscopic Ultrasound (a procedure that combines endoscopy [a medical procedure where a thin, flexible tube with a camera and light (an endoscope) is inserted into the body to visualize internal organs and structures] and ultrasound [a medical imaging technique that uses high-frequency sound waves] to create images of the digestive tract [where food and liquids travel through as they are ingested, digested, absorbed, and eventually eliminated as waste] and nearby organs and tissues) room (EUS), in accordance with the facility's policy regarding "Operations - Operating Room/Pre-Op/Post Anesthesia Care Unit - Drug Administration."

This deficient practice had the potential for unauthorized access to dangerous medications that may or may not affect the safety of the hospital's patients, staff, and visitors.

Findings:

During a concurrent observation and interview on 5/7/2025 at 2:51 p.m. in the Operating Room (OR, a specialized area in a hospital where surgical procedures are performed) 2 (OR 2) with the Director of Pharmacy (DOP), the director of Perioperative Services (DIR 1), and the director of anesthesiology (DIR 2), there was a medication cart, labeled as "eye medication cart #20," wide opened and fully stocked with the medications for eye procedures. DIR 1 stated the medication cart #20 did not have locking mechanism. DIR 1 stated EVS (Environmental services, team responsible for maintaining a clean, safe, and sanitary environment for patients, staff, and visitors) and surg tech (Surgical technician, a healthcare professional who assists surgeons and other medical staff during surgical procedures) have access to the room (OR 2), where medication cart #20 was observed.

During a concurrent observation and interview on 5/8/2025 at 7:18 p.m. with the Director of Pharmacy (DOP), inside the Endoscopic Ultrasound (a procedure that combines endoscopy [a medical procedure where a thin, flexible tube with a camera and light (an endoscope) is inserted into the body to visualize internal organs and structures] and ultrasound [a medical imaging technique that uses high-frequency sound waves] to create images of the digestive tract [where food and liquids travel through as they are ingested, digested, absorbed, and eventually eliminated as waste] and nearby organs and tissues) room (EUS), located on the first floor, there was a medication cart (Medication Cart #1) that had the first drawer left open. On top of the medication cart, there was a vial (a small container, typically cylindrical and made of glass, used especially for holding liquid medicines).

During a concurrent interview on 5/8/2025 at 7:18 p.m. with the Director of Pharmacy (DOP), the DOP stated the vial was Bridion (brand name sugammadex, a medication used to reverse the effects of certain muscle relaxants used during surgery) 200 milligrams (mg, unit to measure mass) per 2 milliliters (ml, unit to measure volume). The DOP stated the medication cart (medication cart #1) was an anesthesia (brings on a sleep-like state with the use of a combination of medicines) medication cart and should be locked. A concurrent inspection of the anesthesia medication cart indicated it contained high alert meds (those that pose a heightened risk of causing significant patient harm if used incorrectly) such as propofol (generic for Diprivan, a sedative, hypnotic agent used primarily in general anesthesia) and other medications used in medical procedures.

During an interview on 5/8/2025 at 7:38 p.m. with the Director of Pharmacy (DOP), the DOP stated the anesthesia medication cart should be locked and medication should not be left on top of the cart.

During a review of the facility's policy and procedures (P&P) titled, Operations - Operating Room/Pre-Op/Post Anesthesia Care Unit - Drug Administration (PR 2370.00, dated 5/2022), the P&P indicated " ... All medications are secured in a locked cabinet or pyxis machines with accessibility by authorized personnel only ..."

Based on observation, interview, and record review, the facility failed to ensure unauthorized personnel would not have access to medications stored in the Endoscopic Ultrasound (a procedure that combines endoscopy [a medical procedure where a thin, flexible tube with a camera and light (an endoscope) is inserted into the body to visualize internal organs and structures] and ultrasound [a medical imaging technique that uses high-frequency sound waves] to create images of the digestive tract [where food and liquids travel through as they are ingested, digested, absorbed, and eventually eliminated as waste] and nearby organs and tissues) room (EUS) and in three (3) of three (3) medication refrigerators (a medical refrigerator, designed to maintain a consistent temperature range for the storage of medication and other temperature-sensitive medical supplies), located in the Operating Room department (OR or surgical department, a hospital ward where patients are cared and treated before, during and after surgery) corridor coves (Core 1 and 2, Outpatient Core), in accordance with the facility's policy regarding medication storage.

This deficient practice had the potential for unsafe storage and inappropriate access of drugs that may affect patients', staff, & visitors' safety.

Findings:

During a concurrent observation and interview on 5/7/2025 at 2:52 p.m. at the facility's operating room (OR) department corridor cove (core 2) with the charge nurse (RN 2), it was observed core 2 had access to three (3) OR suites (OR 1, 2, and 3). RN 2 stated non-clinical staff, such as central supplies and the environmental services (team responsible for maintaining a clean, safe, and sanitary environment for patients, staff, and visitors), had access to the area to restock supplies and to clean the area (core 2).
During a concurrent observation and interview on 5/7/2025 at 4:11 p.m. at OR corridor cove (core 2) with Registered Nurse (RN) 2, there was a medication fridge left unlocked. The medication fridge contained injectable medications including diltiazem (medication to treat high blood pressure), vasopressin (medication to help in blood pressure regulation), carboprost (medication to stop bleeding), and methylergonovine (medication to manage postpartum [afterbirth] bleeding). RN 2 stated he (RN 2) unlocked it (the medication fridge) in the morning so OR nurses could retrieve the medications inside throughout the day as needed.

During a concurrent observation and interview on 5/8/2025 at 9:04 a.m. with the Nurse Manager (NM) 2, in the Outpatient OR Core area, there was an unlocked medication fridge. The Outpatient Core area also housed surgical supply carts. NM 2 stated the charge nurse unlocks the fridge in the morning prior to the start of any outpatient procedures and then locks it at night; in addition to the OR clinical staff, housekeeping could access this corridor (Outpatient OR Core area where an unlocked medication fridge was observed).

During an observation on 5/8/2025 at 7:10 p.m., the director of pharmacy (DOP) and the inpatient pharmacy supervisor (IPS 3) led the surveyors on a tour to the EUS (Endoscopy Ultrasound room) on the first floor. The EUS was located inside a room labeled "Control room," in a corridor connected to the emergency department and other imaging service rooms. There was a patient sitting in a wheelchair at the end of the corridor. Upon entering through the unlocked door of the Control room, the area was empty, no staff were present. Next, the door to the EUS treatment room was open, unlocked, and there was a medication cart that had the first drawer left open. DOP stated the medication cart was an anesthesia (brings on a sleep-like state with the use of a combination of medicines) medication cart that contained high alert meds (those that pose a heightened risk of causing significant patient harm if used incorrectly) such as sedatives (drugs that slow down brain activity and reduce anxiety or tension) and hynotics (drugs that promote sleep).

During an observation on 5/9/2025 at 9:48 a.m. in the OR corridor cove (Core 2), there was a medication (med) refrigerator (fridge) located near a staff elevator. The med fridge was unlocked.

During an interview on 5/9/2025 at 9:55 a.m. with the Director of Pharmacy (DOP), the OR charge nurse, and the assistant nurse director the DOP stated medication fridges located in the corridor (such as OR Core 2) should be locked. The OR charge nurse stated he (OR charge nurse) was the only person with the key to open the medication refrigerators (in OR Core 2) and he (OR charge nurse) left them unlocked so that other nurses can access the med fridge. A concurrent interview with the assistant nurse director confirmed that other personnel, such as environmental services staff and sterile processing staff, had access to the area (OR Core 2).

During a concurrent observation and interview on 5/9/2025 at 10:15 a.m. with the Supervisor of Operating Room (SOR) 1 in Core 1, the medication fridge was found unlocked. The medication fridge contained injectable medications including Carboprost (medication used to treat sever bleeding after childbirth, Vasopressin (medication used to raise blood pressure in adults with life-threatening low blood pressure when other treatments have not worked), and Methylergonovine (Methergine, a medication that treats excessive bleeding after childbirth). SOR 1 stated that the locking mechanism was not functioning and stated that the fridge should remain locked at all times. SOR 1 also stated that efforts were underway to repair the lock.

During a review of the facility's policy and procedures (P&P) titled, Medication Storage, the P&P indicated " ... Only authorized personnel have access to medications ... All non-controlled medications ... are secured when the patient care area is not staffed. Anesthesia carts ... may remain unlocked ... as long as there are authorized OR/procedural unit personnel present ..."

During a review of the facility's policy and procedures (P&P) titled, Operations - Operating Room/Pre-Op/Post Anesthesia Care Unit - Drug Administration (PR 2370.00, dated 5/2022), the P&P indicated " ... All medications are secured in a locked cabinet or pyxis machines with accessibility by authorized personnel only ..."

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

1. Ensure nine (9) of nine sampled injectable medication syringes drawn up for a procedure, were properly labeled, unused and/or outdated portions of one (1) of one sampled multidose vial (a container of liquid medication, intended for injection or infusion, that holds more than one dose), would be discarded after a procedure, in three (3) of three sampled areas, the Operating Room 2 (OR 2), the OR anesthesia work room, and in the Endoscopic Ultrasound (a procedure that combines endoscopy and ultrasound to create images of the digestive tract and nearby organs and tissues) unit (EUS), as per facility's policy regarding safe medication practices. The facility also failed to ensure used multiple dose vials (a small container, typically cylindrical and made of glass, used especially for holding liquid medicines) and four (4) of five (5) medications with overwrap that were removed, had proper dating to prevent using beyond manufacturer's guidance, in accordance with the facility's policy regarding medication storage.

This deficient practice had the potential for outdated or contaminated medications being available for use in the patient care areas, which may result in problems such as infection and reduced drug effectiveness.

2. Inspect and maintain stock drug (medication) supplies in one of two (2) sampled pediatric (branch of medicine dealing with the health and medica care of infants, children and adolescents from birth up to age of 18) anesthesia (a medical technique that involves using medications to temporarily block pain and sensation, making procedure like surgery possible without discomfort) carts (Cart 1, a supply cart stocked with medications and other supplies to be used by an anesthesiologist), on a monthly basis, in accordance with the facility's policy and procedure regarding drug administration.
This deficient practice resulted in two expired (outdated) medications observed in Cart 1 and had the potential to result in using medications with reduced drug effectiveness, thus compromising patient care.


Findings:

1. During a concurrent observation and interview on 5/7/2025 at 2:11 p.m. with the Director of Pharmacy (DOP), the director of Perioperative Services (DIR 1), and the director of anesthesiology (DIR 2), there was an anesthesia cart observed in the Operating Room (OR) 2. The DOP confirmed that there were nine (9) syringes in the first drawer of the anesthesia cart, as follows:

-One 20 milliliters (ml, unit to measure volume) syringe filled to 20 ml. The label indicated 5/7/2025 at 6:30 a.m., propofol (generic for Diprivan, a sedative, hypnotic agent used primarily in general anesthesia) 10 milligrams (mg, unit to measure mass) per ml, no quantity, and initial: CC.
-One 10 ml syringe filled to 10 ml. The label indicated it was filled with propofol 10 mg/ml on 5/7/2025 at 7 a.m., no quantity, and initial CC.
-One 5 ml syringe filled to approximately at 2.2 ml. The label indicated it was filled with glycopyrrolate (medication used to treat a variety of conditions by reducing bodily secretions and relaxing smooth muscles) 0.2 mg on 5/7/2025, no quantity, no time, and the initial were not legible
-Two 5 ml syringes filled to 5 ml each. The label indicated the content was lidocaine 1%, datedon 5/7/2025, time was not legible time, no quantity, and the initial was CC.
-One empty syringe with a label which indicated Precedex (dexmedetomidine, a medication used for sedation during surgical or diagnostic procedure), no date/time, no strength, no quantity, and no initial.
-Two empty syringes without label.
-One 10 ml syringe filled to 10 ml. The label indicated it was filled with propofol 10 mg/ml on 5/7/2025 at 1 p.m., no quantity, and the initial was AM.

During an interview on 5/7/2025 at 2:35 p.m. with the certified registered nurse anesthetist (CRNA, advanced practice registered nurse who specializes in administering anesthesia and related care to patients undergoing surgery or medical procedures), CRNA stated nurses or the anesthesiologist would draw up syringes with anesthetic medications before a case and those syringes should be discarded after the case ended. CRNA stated the aforementioned syringes with the initial "CC" were drawn by a nurse student that she (CRNA) was precepting for a case in the morning and did not know she (nurse student) needed to initial as well. At 2:40 p.m., CRNA stated the syringe dated on 5/7/2025 at 1 p.m. was drawn by her (CRNA) in preparation for an upcoming surgery.

During an interview on 5/9/2025 at 12:50 p.m. with the Director of Pharmacy (DOP), the DOP stated that syringes drawn up in the OR before/during a case should be labeled with med (medication) names, strength, quantity , date & time drawn to determine the BUD (Beyond Use Date, the date after which a compounded [custom-made drugs created by pharmacists or physicians, tailoring drug formulations to a patient's specific needs] medication (sterile [any medication that is free from microorganisms and prepared in a sterile environment] or non-sterile) should not be used. It is determined from the date and time the medication is compounded and is different from the manufacturer's expiration date), and initials. The DOP stated syringes drawn in the OR settings had a BUD of four (4) hours.

During an observation on 5/7/2025 3:22 p.m. in the OR anesthesia work room with the DOP and a certified anesthesia Technologist or Technician (CATT), there was a procedure cart (cart #9) in the room. On top of the cart, there was a multidose vial of lidocaine (commonly used to as local anesthesia or a nerve block to numb the pain during a medical procedure) 1 percent (%) in a half-full 20 ml vial. On the vial was a blank label which indicated "Discard after 28 days. EXP. [expiration] Date (blank)." The DOP confirmed the vial had been used and should have an open date or expiration date on the label.

During an observation on 5/8/2025 at 7:18 p.m. inside the Endoscopy Ultrasound room (EUS) on the first floor, with the Director of Pharmacy (DOP), there was a medication cart that had the first drawer left open. The DOP stated it was an anesthesia cart. Upon inspection of the anesthesia cart, there were 5 syringes of succinylcholine PFS (a skeletal muscle relaxant used during surgery or medical procedures); 1 of 5 syringes had a clear over wrap (a method where a flexible material, like film or paper, is wrapped around a product or another package to create a secure seal) while the other 4 syringes did not have the over wrap.

During an interview on 5/9/2025 at 12:48 p.m. with the Director of Pharmacy (DOP), the DOP stated the medication with plastic over wrap should be kept in the overwrap until use.

During a review of the facility's policy and procedures (P&P) titled, Safe Medication Practices: Medication Labeling in the Perioperative and Procedural Settings (reviewed on 3/2023), the P&P indicated " ... Label all medications, medication containers (for examples, syringes ...) ... on and off the sterile field that are not immediately administered ... Labeling occurs when any medication or solution is transferred from the original packaging to another container ... labels include ... medication name, strength, quantity ... Remove all labeled containers on the sterile field and discard their contents at the conclusion of the procedure ... Two qualified person verification of the label's accuracy is required if two or more people participate in the preparation, labeling ..." This policy did not have the updated information regarding the BUD of 4 hours for syringes drawn up in the OR settings.

During a review of the facility's policy and procedures (P&P) titled, Safe Medication Practices: Medication Labeling in the Perioperative and Procedural Settings (reviewed on 3/2023), the P&P indicated " ... Write date on vial/bottle label when first entering or opening a multiple dose vial ..."

During a review of the facility's policy and procedures (P&P) titled, Medication Storage, the P&P indicated " ... Storage of parenteral medications outside of the overwrap ... once removed from the overwrap, products are labeled with a beyond-use date per manufacturer's recommendations ..."

2. During a concurrent observation and interview on 5/8/2025 at 3:41 p.m. with the Manager (MA) of Anesthesia (a medical technique that involves using medications to temporarily block pain and sensation, making procedure like surgery possible without discomfort), at the anesthesia workroom (storage room), there was a pediatric (branch of medicine dealing with the health and medica care of infants, children and adolescents from birth up to age of 18) anesthesia cart (Cart 1, a supply cart stocked with medications and other supplies to be used by an anesthesiologist) stocked with one (1) Phenylephrine (medication to treat nasal congestion or stuffiness) injection 1,000 micrograms (mcg, unit of measure) per 10 milliliters (ml, unit of measure) with expiration date of 4/29/2025 and one (1) Epinephrine (medication to treat severe allergic reaction, cardiac arrest [when the heart stops beating], asthma and other conditions) injection 100 mcg/10ml with expiration date of 4/22/2025. MA stated the expired medications (phenylephrine and epinephrine) should be discarded. MA further stated the anesthesiologist technician was responsible for checking the anesthesia cart regularly and discarding any expired (outdated) medication.

During an interview on 5/8/2025 at 11:34 a.m. with the Director of Pharmacy (DOP), the DOP stated the following: there was a facility approved list titled, "anesthesia department - ancillary (services that support or supplement the primary care) anesthesia cart" provided to the anesthesia department to prepare stock medications in any anesthesia cart. The pharmacy department did not keep track of how many anesthesia carts were made by the anesthesia department and what medications were stocked in the anesthesia cart. The expectation was for the anesthesia department staff to check the anesthesia carts regularly. Any expired medications should be removed from the anesthesia cart.

During an interview on 5/8/2025 at 1:58 p.m. with the Director of Anesthesiology (Dir 2), Dir 2 stated the following: there was no check list for anesthesia department staff to complete when checking the anesthesia carts. The expectation was for the anesthesia tech (technician) to check the anesthesia cart on a daily basis. It was their (anesthesia tech's) responsibility to maintain supplies and check for expiration (of medications). The potency and effectiveness would be changed in expired medications. Any expired medications found in the anesthesia cart should be removed.

During a review of the facility's policy and procedure (P&P) titled, "Drug Administration," dated 5/2022, the P&P indicated, "All drug supplies in the Operating rooms/Pre-Op/PACU are inspected monthly by the pharmacist. The pharmacy personnel check stock drug supplies, including emergency drugs, for expiration dates."

During a review of the facility's job description for certified anesthesia tech, dated 9/30/2013, the job description indicated, "Essential responsibilities ... keep sufficient stock of supplies and non scheduled drugs in anesthesia workroom, machines and carts. Reviews for outdated medications. Coordinates with Pharmacy for out of stock drugs."

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

1. Ensure surveillance and maintenance of a clean and sanitary environment in one of two sampled operating room (surgical room 2), in accordance with the facility's policy regarding infection prevention, when tape residue was found on a surgical stretcher's headrest attachment inside surgical room 2,

This deficient practice had the potential for cross- contamination (the physical movement or transfer of harmful bacteria from one person, object or place to another, potentially leading to infections) and risks of infection among surgical patients.

2. Maintain a sanitary and controlled surgical environment (in which surgery is conducted while maintaining a sterile area around the incision site, and only sterile items are permitted to come in contact with this area), when an entry alarm system was not properly functioning, intended to prevent unauthorized or unmonitored access to one of two sampled sterile (free from germs) operating room (OR, a designated space within a hospital or medical facility where surgical procedures are performed, in a controlled environment to minimize infection risk) suite, when no alarm was triggered when entry to the sterile zone without a badge used in accordance with the facility's protocol regarding infection prevention.

This deficient practice created a potential breach in infection prevention practices by allowing entry into a designated sterile area without staff awareness or contamination safeguards.

Findings:

1. During a concurrent observation and interview on 05/07/2025 at 2:08 p.m. with the Director of Peri-op (Peri-operative, encompasses the medical care provided to a patient before, during, and after a surgical procedure) Services (Dir 1), it was observed that a surgical stretcher's headrest attachment inside surgical room 2 had multiple tape residue. Dir 1 stated that surgical room 2 had been cleaned and was ready for patient use. Dir 1 added that the environmental services (EVS, also known as housekeeping, are responsible for cleaning, disinfecting in hospitals) staff and the clinical staff were responsible in ensuring cleanliness of the operating rooms and its equipment.

During the same interview on 5/07/2025 at 2:08 p.m. with the Director of Peri-op (Dir 1), Dir 1 said that the staff [EVS and the Clinical Staff] should have made sure that there was no tape residue on the head rest prior to making it (referring to the surgical stretcher) available for patient use. DIR 1 stated sticky tape residue could harbor bacteria and other microorganisms, increasing the risk of surgical site infections (SSI) and cross contamination (the physical movement or transfer of harmful bacteria from one person, object or place to another, potentially leading to infections) between patients.

During an interview on 5/9/2025 at 10:59 p.m. with the Director of Infection Prevention (Dir 3). Dir 3 stated that tape residue should be removed from all patient equipment in the OR. DIR 3 said adhesive substances could harbor bacteria, blood and pathogen, and could potentially cause surgical site infections (SSI) and cross contamination. DIR 3 stated it was the surgery department leadership's and clinical staff's responsibility to monitor, identify infection risk and implement preventive measures to minimize the risk of infection to surgical patients. They (the surgery department leadership and clinical staff) were also responsible for ensuring compliance with surgical guidelines and standards.

During a review of the facility's policy & procedure (P&P) titled, "The Infection Prevention Program," last reviewed 12/2024, the P&P indicated, " The infection prevention and control program is a plan of action designed to identify infections that occur in patients and staff that have the potential for disease transmission, identify opportunities for reduction of risk for disease transmission, recommend risk reduction practices by integrating principles of infection control into all direct and indirect standards of practice."

During a review of the facility's policy & procedure (P&P) titled, "Surgical Site Infection Prevention," last reviewed 12/2024, the P&P indicated, in cleaning and disinfection of environmental surfaces, the Environmental Services (EVS) will perform between case and end of day terminal cleaning (a comprehensive process of thoroughly cleaning and disinfecting a room after a patient has been discharged or transferred) using a hospital EPA (Environmental Protection Agency) approved disinfectant. This will ensure that all surgical patients will have a clean/disinfected environment.

2. During a concurrent observation and interview on 5/9/2025 at 9:15 a.m. with the Assistant Nursing Director of the Operating Room (ADOR), the door located in the 2 North hallway that leads directly into the OR suite, was observed. A red line (a demarcation, often a colored band on the floor, that separates the semi-restricted area from the restricted, sterile [free from germs] area. This line signals that proper surgical attire, including surgical scrubs, a cap, and mask, must be worn when crossing into the restricted area) was visibly marked on the floor to indicate the beginning of the sterile environment. When the door was pushed open without using a badge entry (a method of controlling access to an area or facility using a credential, typically an ID badge, that is presented to an access control system), the alarm did not go off. ADOR stated that the door had a delayed egress function (a security feature on a door that introduces a brief delay before the door unlocks) and was designed to alarm if the handle was pressed down for 15 seconds without badge use- alerting staff to a potential unauthorized entry into a sterile zone. However, when the door was accessed without a badge, no alarm was triggered. ADOR further stated that while the door was intended to be used in emergencies for rapid patient transport, any non-emergency access must alarm, to notify staff and maintain the integrity of the sterile field. ADOR confirmed that the alarm was critical to ensure no unmonitored or non-sterile entry occurred.

During an interview on 5/9/2025 at 9:20 a.m. with the Engineering Manager (EM), EM confirmed the door alarm was a required infection control safeguard and that it was not functioning properly at the time. The EM confirmed that the failure of this alarm could potentially allow an unauthorized person into a sterile area without alarming staff to intervene.

During an interview on 5/9/2025 at 10:30 a.m. with the Director of Infection Prevention (Dir) 3, Dir 3 stated the redline was to prevent entry without proper attire, as there was a risk for cross contamination (the physical movement or transfer of harmful bacteria from one person, object or place to another, potentially leading to infections).

During a review of the facility's policy and procedure (P&P) titled, "Infection Prevention and Control Strategic Workplan 2025," dated 2025, the P&P indicated, "The Infection Preventionists support the (name of the facility) mission of promoting the health of our members and the communities we serve. We are committed to collaborative practice and management of Infection Prevention and Control through the application of epidemiology across the continuum of care to prevent adverse outcomes, to improve patient care and safety and to minimize infectious occupational hazards associated with health care delivery ... Intervening Directly to Prevent Transmission of Infectious Diseases ..."

During a review of the facility's policy and procedure (P&P) titled, "Surgical Attire Practices," dated March 2025, the P&P indicated, "To provide guidelines for all individuals entering the semi-restricted and restricted areas including but not limited to Perioperative, Labor & Delivery, Sterile Processing, and Procedural Center (providers, staff, physicians, others) for clean surgical scrub attire, including jewelry, clothing, shoes, head coverings, masks, jackets, and other accessories worn within the semi-restricted and restricted areas of the surgical or invasive environment ... All Personnel (providers, staff, physicians, others) will dress in the prescribed manner prior to entering the semi restricted and restricted areas of the perioperative departments. All providers, staff, physicians and others must wear freshly laundered blue surgical attire intended for use within the surgical suite. Surgical attire should be made of low-linting material, contain shed skin squames, provide comfort, and promote a professional appearance ..."

Based on observation, interview, and record review, the facility failed to follow policy & procedure for supplies in the operating room (OR) department, when two (2) of two (2) plasma rollers (a surgical instrument used to stop bleeding when incisions are made during surgeries involving the prostate), were identified as expired.

This deficient practice had the potential to result in the use of expired or compromised supplies during surgical procedures, placing patients at risk for ineffective treatment and excessive bleeding during prostate surgeries.

Findings:

During a concurrent observation and interview on 5/7/2025, at 2:02 p.m. with Nurse Manager (NM) 1 and Registered Nurse (RN) 2, the OR area in the facility's "2 North" area, a separate OR department from the main OR department, was observed. RN 2 stated 2 North has three operating rooms which usually handled urology (surgeries involving the bladder, kidneys, urethra, and prostate) and gynecology (surgeries involving the female reproductive system) cases, and cases such as laparoscopic appendectomies (a minimally invasive surgical procedure to remove the appendix through small incisions, rather than one large one) and laparoscopic cholecystectomies (a minimally invasive surgical procedure where the gallbladder is removed through small incisions, rather than one large one).

During a concurrent observation and interview on 5/7/2025 at 2:51 p.m. with NM 1 and RN 2, the sterile core corridor behind the ORs in 2 North, was observed. There were multiple surgical supply shelves inside the sterile core corridor. Two plasma rollers were present in one of the supply shelves in sealed and unopened packaging. Both rollers' packaging indicated an expiration date of 10/14/2024. NM 1 confirmed that those supplies were expired and should not be present in the sterile corridor. NM 1 further stated that the plasma rollers were used during TURP surgery (transurethral resection of the prostate - a surgical procedure used to treat urinary problems caused by an enlarged prostate) to stop bleeding, and that it was the OR staff's responsibility to ensure that expired supplies were not left to be used.

During a review of the facility's policy & procedure (P&P) titled, "Equipment and Supplies - Perioperative Service," last reviewed 12/2024, the P&P indicated, "Routine disposable supplies will be replenished daily by Materials Management ... Sterile supplies are rotated from left to right and bottom to top."