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Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.13 Patient's Rights was out of compliance.

A-0144 The patient has the right to receive care in a safe setting. Based on observations, document review, and interviews the facility failed to provide care in a safe setting. Specifically, the facility failed to ensure staff used non-enzymatic (proteins that increased the speed of chemical reactions) detergent on ophthalmic (eye) surgical instruments, which increased the risk for Toxic Anterior Segment Syndrome (an acute, severe swelling in the eye that occurred within one or two days of eye surgery), in one of one observation of staff performing decontamination of ophthalmic instruments in the sterile processing department.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.25 Pharmaceutical Services was out of compliance.

A-0502 All drugs and biologicals must be kept in a secure area, and locked when appropriate. Based on observations, interviews, and document reviews, the facility failed to ensure medications in the urgent care emergency cart were securely stored to prevent unauthorized access.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.42 Infection Prevention and Control and Antibiotic Stewardship Programs was out of compliance.

A-0750 The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities. Based on observations, interviews, and document review, the facility failed to ensure a safe and sanitary environment for patient care. Specifically, the facility failed to ensure staff performed hand hygiene in the pre-operative area, patient care unit, operating room, and sterile processing department, according to facility policy and national guidelines. Also, the facility failed to ensure staff did not store items under the sinks in the sterile processing department (SPD) in two of two observations of the decontamination of surgical instruments. Additionally, the facility failed to ensure medical devices and patient care supplies were not readily available for patient use and were discarded once expired. The failure was observed in one observation of the urgent care emergency cart.

Based on observations, document review, and interviews the facility failed to provide care in a safe setting. Specifically, the facility failed to ensure staff used non-enzymatic (proteins that increased the speed of chemical reactions) detergent on ophthalmic (eye) surgical instruments, which increased the risk for Toxic Anterior Segment Syndrome (an acute, severe swelling in the eye that occurred within one or two days of eye surgery), in one of one observation of staff performing decontamination of ophthalmic instruments in the sterile processing department.

Findings include:

Facility policy:

The Sterile Processing Department (SPD): Cleaning, Disinfection and Sterilization of Instruments policy read, cleaning solutions and detergents should be measured, mixed, labeled, and discarded appropriately according to the manufacturer's instructions for use (IFU) and should be compatible with the instruments and equipment for which they are used.

References:

The Prolystica 2X Concentrate Enzymatic Presoak and Cleaner IFU read, Prolystica is a low-foaming enzymatic detergent for the removal of a broad range of soils on surgical instruments and medical devices in both the manual and automated cleaning process.

The Corza Medical/Katena Products, Inc. Ophthalmic Surgical Instruments IFU read, Katena does not recommend using toxic disinfectants or enzymatic detergents for ophthalmic surgical instruments; they add chemical burden to the cleaning process and increase the potential of causing Toxic Anterior Segment Syndrome (TASS).

The risk of contamination and infection during surgery is a significant concern for all healthcare facilities. This concern is what drives how much time and effort is expended on cleaning and sterilizing surgical instruments. Specific to cataract surgery is TASS. TASS is an acute inflammation (swelling) of the anterior (in the front) chamber of the eye following cataract surgery, resulting in toxic damage to the intraocular (in the eye) tissue.

The American National Standards Institute/Association for the Advancement of Medical Instrumentation (ANSI/AAMI) ST79:2017 & 2020 Amendments Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities read, the device manufacturer's current written IFU should be accessible, reviewed, and followed.

Rationale: The device manufacturer is responsible for ensuring that the device can be effectively cleaned and sterilized with the means and methods available in healthcare facilities. Sterilization validation of a device requires microbiological, engineering, toxicological, and sometimes clinical evaluations of the device, which are beyond the abilities of most healthcare facilities. To ensure patient safety, a reusable device needs to be capable of being thoroughly cleaned and sterilized. The device labeling describes specific methods of cleaning and sterilization that the manufacturer has validated.

1. The facility failed to ensure staff used non-enzymatic detergent when decontaminating ophthalmic surgical instruments.

a. On 4/22/24 at 3:44 p.m., SPD supervisor (Supervisor) #3 was observed decontaminating eye instruments, including instruments made by Corza Medical/Katena Products, using Prolystica 2x Concentrated Enzymatic Presoak and Cleaner. The IFU for the Prolystica read the product was a low-foaming enzymatic detergent for removing a broad range of soils on surgical instruments and medical devices.

The use of the enzymatic detergent on ophthalmic instruments was in contrast to the Corza Medical/Katena Products Ophthalmic Surgical Instruments IFU, which instructed to not use enzymatic detergents for ophthalmic surgical instruments. The IFU read enzymatic detergents added chemical burden to the cleaning process and increased the potential of causing TASS. The IFU defined TASS as an acute inflammation of the anterior chamber of the eye following cataract surgery, resulting in toxic damage to the intraocular tissue.

The use of an enzymatic detergent on ophthalmic surgical instruments was also in contrast to the facility policy SPD: Cleaning, Disinfection, and Sterilization of Instruments, which instructed to use detergents compatible with the instruments.

Finally, the use of the enzymatic detergent to decontaminate ophthalmic surgical instruments was in contrast to the ANSI/AAMI ST79:2017 & 2020 Amendments Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities which instructed to access, review, and follow the device manufacturer's current written IFU.

b. On 4/22/24 at 3:44 p.m., an interview was conducted with Supervisor #3. Supervisor #3 said they had heard about TASS but did not know much about it. They explained they heard the ophthalmic surgeons discussing the condition. Supervisor #3 was not aware of the connection between TASS and the use of enzymatic detergents when decontaminating ophthalmic surgical instruments. Supervisor #3 said the facility followed ANSI/AAMI guidelines in the SPD.

c. On 4/23/24 at 12:20 p.m., an interview was conducted with ophthalmic surgeon and chief medical officer (CMO) #4. CMO #4 described TASS as an inflammatory condition that presented as endophthalmitis (swelling of the inner layers of the eye). They said patients with TASS experienced extreme eye redness but no pain. They stated TASS potentially occurred secondary to a surgical instrument that was contaminated, perhaps by enzymatic detergents.

CMO #4 explained if TASS continued untreated the patient developed permanent vision changes and loss due to scar tissue and adhesions (a band of scar tissue that joined two internal surfaces that normally would not touch). They said the inflammation in the eye could also lead to swelling in the retina (light-sensitive tissue at the back of the eye that received images and sent them to the brain). CMO #3 said retinal swelling caused cystoid macular edema. CMO #4 explained cystoid macular edema was characterized by the loss of contrast, loss of color, micropsia (objects look smaller than objective size), and central scotoma (blind spots in the middle of vision).

Based on observations, interviews, and document reviews, the facility failed to ensure medications in the urgent care emergency cart were securely stored to prevent unauthorized access.

Findings include:

Facility policy:

According to the Medication Management policy, medications are properly and safely stored throughout the facility. Emergency medications are consistently available, controlled, and secured in the facility's patient care area. Proper storage of medications shall be adhered to at all times, including security.

1. The facility failed to ensure medications in the urgent care emergency cart were securely stored to prevent unauthorized access.

A. Observations

i. On 4/24/24 at 10:00 a.m., observations of the urgent care department revealed the emergency cart located in the patient care hallway was unlocked, which allowed for unmonitored access. At this time, licensed practical nurse (LPN) team lead (Team Lead) #1 stated this cart was always unlocked. The top drawer of the emergency cart contained a plastic box labeled "Anaphylaxis/Cardiac Medications" which contained the following medications:

a. Epinephrine (relaxes the muscles and raises blood pressure) 0.3 milligram (mg), one autoinjector
b. Epinephrine 1 mg/milliliter (mL), two vials
c. Diphenhydramine (helps with allergic reactions and causes drowsiness) 50 mg/mL, two vials
d. Diphenhydramine hydrochloride 25 mg, four capsules
e. Solumedrol (anti-inflammatory) 125 mg, one vial
f. Nitroglycerin (dilates blood vessels to relieve chest pain) 0.4 mg, one vial of 25 sublingual (under the tongue) tablets
g. Aspirin (non-steroidal anti-inflammatory and blood thinner) 81 mg, eight tablets
h. Naloxone (blocks the effects of opioids) hydrochloride 0.4 mg/ml, one vial
i. Famotidine (reduces heartburn) 20 mg, three tablets

This observation was in contrast to the Medication Management policy which read, medications were properly and safely stored. Emergency medications were consistently secured in the patient care area. Proper storage of medications was adhered to at all times.

B. Interviews

i. On 4/24/24 at 10:21 p.m., an interview was conducted with Team Lead #1. Team Lead #1 stated the medication and supply room, located across the hallway from the emergency cart, was always locked to protect patients from unauthorized medication access. However, Team Lead #1 stated the emergency cart containing emergency medications in the patient care hallway was always left unlocked which was in contrast to their earlier statement about the necessity of securing medications and the Medication Management policy which read, medications were properly and safely stored throughout the facility. Team Lead #1 stated the cart was left unlocked so the emergency medications in the top drawer and other emergency medical supplies were immediately available to staff in an emergency. They stated it was important to secure medications because if patients gained access to, and consumed medications intended for use in emergencies, they could experience drowsiness, a decrease in blood pressure, or a cardiac (heart) event.

ii. On 4/24/24 at 3:32 p.m., an interview was conducted with quality and risk director (Director) #2. Director #2 stated they were not sure where the emergency cart was located in the urgent care department and added that the emergency cart was not considered a crash cart (a self-contained, mobile unit with all of the materials, drugs, and devices necessary to perform a code (an emergency event), although it contained emergency supplies, equipment, and medications, and would not need to be tracked and secured like a crash cart would be. This statement was in contrast to the Medication Management policy which read, medications were properly and safely stored throughout the facility and emergency medications were consistently secured in the facility's patient care area.

Based on observations, interviews, and document review, the facility failed to ensure a safe and sanitary environment for patient care. Specifically, the facility failed to ensure staff performed hand hygiene in the pre-operative area, patient care unit, operating room, and sterile processing department, according to facility policy and national guidelines. Also, the facility failed to ensure staff did not store items under the sinks in the sterile processing department (SPD) in two of two observations of the decontamination of surgical instruments. Additionally, the facility failed to ensure medical devices and patient care supplies were not readily available for patient use and were discarded once expired. The failure was observed in one observation of the urgent care emergency cart.

Findings include:

Facility policies:

According to the Hand Hygiene policy, all personnel will use the appropriate hand hygiene techniques, following the Centers for Disease Control (CDC) guidelines. All personnel will wash hands when hands are contaminated with potentially infectious materials, before having direct contact with patients, after coming in contact with a patient's intact skin, after moving from a contaminated body site to a cleaned body site, after contact with inanimate objects (including medical equipment), and after removing gloves. If hands are not visibly soiled hands may be cleaned with an alcohol-based hand sanitizer for 20 seconds. Staff are also to wear gloves according to standard precautions.

The SPD: Cleaning, Disinfection and Sterilization of Instruments policy read, packaging will be considered non-sterile (compromised) when certain events occur, including contamination with moisture. Arrange storage areas in a manner that prevents splashing from personnel or housekeeping. Do not store sterile items under plumbing valves and traps.

According to the Rotation of Expired Supplies policy, all supplies maintained in the inventory must be rotated to ensure that the items are used on a first-in, first-out basis. When processed properly, the oldest supplies will be consumed first thereby reducing the possibility of supplies outdating on the storeroom shelves. All supplies must be rotated in the same fashion. The newest product must be placed to the bottom right, and the oldest product to the top left.

According to the Safety, Infection, and Quality Plan, the plan is to provide a safe, functional, and sanitary environment of care.

References:

According to the CDC Hand Hygiene in Healthcare Settings guidance, retrieved from https://www.cdc.gov/handhygiene/providers/index.html and last reviewed on 4/25/24, hand hygiene reduces the spread of potentially dangerous germs to patients. Multiple opportunities for hand hygiene occur during a single care episode. Clinical indications for hand hygiene include: immediately before touching a patient; when hands are visibly soiled; before performing an aseptic task or handling invasive medical devices; before moving from work on a soiled body site to a clean body site on the same patient; after touching the patient or the patient's immediate environment; after contact with blood, body fluids, or contaminated surfaces; and immediately after glove removal.

The American National Standards Institute/Association for the Advancement of Medical Instrumentation (ANSI/AAMI) ST79:2017 & 2020 Amendments Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities read, sterile items should not be stored next to or under sinks, beneath exposed water or sewer pipes, or in any location where they could become wet.

Rationale: Adequate space is needed around sterile materials to allow for air circulation in the room, to prevent contamination during cleaning of floors, and to prevent contact between sterile items and the condensation that might form on the interior surfaces of outside walls. Sterile items that become wet are considered contaminated because moisture brings with it microorganisms from the air and surfaces.

1. The facility failed to ensure hand hygiene was performed according to facility policy and national guidelines.

A. Observations conducted in the pre-operative area (pre-op), patient care unit (PCU), operative room (OR), and sterile processing department (SPD) revealed multiple staff failed to perform hand hygiene when indicated.

i. On 4/23/24 from 1:38 p.m. to 2:22 p.m., observations conducted in pre-op revealed a surgeon exited patient bay #5 without performing hand hygiene. Another surgeon entered patient bay #2 without performing hand hygiene. Later observations revealed a surgeon entered patient bay #2 and donned gloves without first performing hand hygiene.

Observations during this time also revealed an anesthesia assistant exited patient bay #2 without performing hand hygiene. The anesthesia assistant then pulled medicine from a vial into a syringe without donning gloves or performing hand hygiene before or after. These observations were in contrast to the Hand Hygiene policy and CDC Hand Hygiene in Healthcare Settings guidance which read, all personnel washed hands when hands were contaminated with potentially infectious materials including immediately before touching a patient, before performing an aseptic task or handling invasive medical devices, after touching the patient or the patient's immediate environment, and immediately after glove removal.

ii. On 4/23/24 at 4:27 p.m., an observation conducted in the PCU revealed a surgeon entered patient room #4 without first performing hand hygiene. Observations later revealed this same surgeon then exited patient room #4 after interacting with the patient and proceeded to enter patient room #5 without performing hand hygiene in between. These observations were in contrast to the Hand Hygiene policy and CDC Hand Hygiene in Healthcare Settings guidance which read, all personnel washed hands when hands were contaminated with potentially infectious materials including immediately before touching a patient and after touching the patient or the patient's immediate environment.

iii. On 4/24/24 at 10:59 a.m., observations conducted in the OR revealed a registered nurse (RN) cleaned the operating room with CaviWipes (a cleansing towelette that decontaminates (removes germs) and disinfectants (destroys microorganisms) while wearing gloves. The RN removed the gloves without performing hand hygiene. This RN then opened a new anesthesia (a state of controlled, temporary loss of sensation or awareness induced for medical purposes) circuit (individual patient use tubes for administering anesthetic gases during surgery) and attached these to the anesthesia machine. The RN left the operating room without performing hand hygiene and returned with sterile supplies for the next procedure, which they then opened. These observations were in contrast to the Hand Hygiene policy and CDC Hand Hygiene in Healthcare Settings guidance which read, all personnel washed hands when hands were contaminated with potentially infectious materials including immediately before performing an aseptic task or handling invasive medical devices and immediately after glove removal.

iv. On 4/25/24 at 8:25 a.m., observations conducted in the SPD revealed SPD supervisor (Supervisor) #3 did not perform hand hygiene before or after decontaminating a flexible endoscope (a medical device that looks inside the body). This observation was in contrast to the Hand Hygiene policy and CDC Hand Hygiene in Healthcare Settings guidance which read, all personnel washed hands when hands were contaminated with potentially infectious materials, before handling invasive medical devices, and immediately after glove removal.

B. Document review revealed the facility's hand hygiene goal of 90% compliance was not achieved by most of the facility staff.

i. A review of the January 2024 Peri-Operative meeting minutes revealed a chart titled "2023 Hand Hygiene Compliance by Quarter." This chart revealed the facility goal for hand hygiene in 2023 was 90% compliance but in the last quarter of 2023, anesthesia providers were 70% compliant with hand hygiene, physicians were 67% compliant, physician assistants (PAs) and nurse practitioners (NPs) were 68% compliant, physical therapists were 75%, scrub technicians were 95% compliant, diagnostic imaging was 40% compliant, and registered nurses (RNs) were 91% compliant.

C. Interviews

i. On 4/24/24 at 11:38 a.m., an interview was conducted with certified anesthesia assistant (Assistant) #7. Assistant #7 stated handwashing was important to prevent the spread of microorganisms from patient to patient, or staff to patient, and causing disease. They stated if hand hygiene was not performed, this could transmit an infection to a patient.

ii. On 4/24/24 at 3:32 p.m., an interview was conducted with quality and risk director (Director) #2. Director #2 stated hand hygiene was a facility quality improvement project. They stated observations and audits had revealed a lack of hand hygiene, especially among providers. They stated when performing patient care, for example, staff had been educated that doors and curtains were both to be perceived as barriers and hand hygiene was to be performed when entering and exiting. This statement was in contrast to multiple observations in the pre-op and PCU which revealed multiple hand hygiene opportunities. Director #2 stated all staff were to perform hand hygiene as this was important to prevent healthcare-associated infections.

2. The facility failed to ensure items in the SPD were not stored under sinks.

a. On 4/22/24 at 3:19 p.m., observations were conducted on the decontamination side of the facility's SPD while SPD supervisor (Supervisor) #3 decontaminated surgical instruments. The decontamination area was arranged with three large, metal sinks against one wall and a second set of three smaller metal sinks against another wall. The areas below the sinks were not enclosed, leaving plumbing valves and traps exposed.

Under the row of smaller metal sinks were several baskets with cleaning brushes. These were not wrapped and therefore were exposed to splashing and contaminants from the floor. Observations revealed Supervisor #3 using these brushes to decontaminate surgical instruments. Observations further revealed syringes in sterile packaging in a bucket under the smaller sinks. Supervisor #3 used the syringes to flush the inside of surgical instruments. Also under the smaller sinks was a bucket of plastic-wrapped sponges saturated with detergent and equipment to test for leaks in flexible endoscopes (cameras used to see the inside of the body).

The front of the larger sinks were labeled with a sticker that read, "do not place anything below the sink here." Multiple bottles of unopened detergent, used to decontaminate surgical instruments, were stored in a corner under that sink.

b. On 4/24/24 at 8:25 a.m., observations were conducted of Supervisor #3 while they decontaminated a flexible endoscope. Supervisor #3 used equipment stored under the smaller sinks to perform this task. Further, under the sticker labeled "do not place anything below the sink here," were two additional bottles of unopened detergent and four mesh brackets. Supervisor #3 used these mesh baskets to place surgical instruments in an automatic washer after they had been decontaminated.

The observations of items stored under the sinks were in contrast to the SPD: Cleaning, Disinfection and Sterilization of Instruments policy which instructed to consider packaging non-sterile (compromised) after contamination with moisture. The policy further instructed to arrange storage areas in a manner that prevented splashing from personnel or housekeeping. Finally, the policy instructed to not store sterile items under plumbing valves and traps.

The observations were also in contrast to ANSI/AAMI ST79:2017 & 2020 Amendments Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities which instructed to not store sterile items next to or under sinks, beneath exposed water or sewer pipes, or in any location where they could become wet. The guideline read sterile items that become wet were considered contaminated because moisture brought with it microorganisms from the air and surfaces.

c. On 4/22/24 at 3:19 p.m., an interview was conducted with Supervisor #3. Supervisor #3 said the items stored under the sink stayed dry because staff used the row of smaller sinks to decontaminate ophthalmic surgical instruments. They explained staff did not splash as much at the smaller sinks because ophthalmic instruments were smaller and more delicate.

However, Supervisor #3 said they had previously found wet items under the sinks. They explained the sinks leaked on the supplies. Supervisor #3 explained the wet supplies were ruined and had to be thrown away because they were contaminated by water, which could have led to a patient infection. Supervisor #3 said the facility used ANSI/AAMI guidelines in the SPD.

d. On 4/24/24 at 4:39 p.m., an interview was conducted with infection preventionist (IP) #5. IP #5 explained items should not have been stored under the sinks because ultimately it increased the risk of patient harm. They stated items stored under the sinks could have been contaminated. IP #5 further stated if those items were used to decontaminate surgical instruments, it increased the risk of infections.

3. The facility failed to ensure expired medical devices and patient care supplies were not readily available for patient use and were discarded once expired.

A. Observations

i. Observations conducted on 4/24/24 at 9:15 a.m. in the urgent care department revealed expired supplies in the emergency cart, including:

a. BD Insyte Autoguard BC Pro Shielded intravenous (IV) catheter (tubing), one package expired 8/31/22, and one package expired 3/31/24.

b. Medichoice IV start kit (containing two gauze sponges, one tourniquet, one 3M Transpore tape, one dressing change label, one transparent dressing, and one PDI Chlorascrub Pad), one package expired 11/20/23.

c. Sourcemark nasopharyngeal airway (tubing that bypasses airway obstructions) 24FR, expired 11/20/22.

d. Vyvaire nasal cannula (tubing to deliver oxygen), one package expired 12/30/22, and one package expired 2/15/24.

This observation of the emergency cart was in contrast to the Rotation of Expired Supplies policy and Safety, Infection, and Quality Plan which read, the plan was to provide a safe, functional, and sanitary environment of care. All supplies were rotated to ensure the items were used on a first-in, first-out basis. The oldest supplies were consumed first, reducing the possibility of outdated supplies.

B. Interviews

i. On 4/24/24 at 10:22 a.m., an interview was conducted with licensed professional nurse (LPN) team lead (Team Lead) #1. Team Lead #1 stated all of the urgent care staff checked for outdated supplies monthly, which was in contrast to the observation of expired supplies in the emergency cart. Team Lead #1 stated using current emergency patient care supplies was important to ensure patient safety and further elaborated the specific risk would depend on the nature of each supply.

ii. On 4/24/24 at 3:32 p.m., an interview was conducted with Quality and Risk Director (Director) #2. Director #2 stated they had previously found expired supplies in the urgent care department, but were informed staff had implemented a new process to audit supplies. They stated they were led to understand expired supplies had been removed from all areas of urgent care. Director #2 stated it was important not to use expired supplies to ensure the integrity of the patient care supply.