Bringing transparency to federal inspections
Tag No.: A0724
Based on observation and interview, the hospital failed to properly store, a laundry cart with reusable isolation gowns and 3 rolling racks of reusable Tyvek/Tychem® suits when not in use, they were stored in a hallway blocking doors leading to the operating rooms.
As a result, the storage blocked a path of egress into and out of the Emergency Department and the operating rooms.
Findings:
On 6/11/20 at 11:57 A.M., during a tour of the hospital's Emergency Department several forms of PPE gowns were observed. There were 3 types, a blue single use disposable gown, a yellow cloth reusable/washable gown, and a tan or brown Tyvek/Tychem® plastic reusable suit.
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There were approximately 60 tan or brown plastic reusable Tyvek/Tychem® suits on hangers stored on 3 rolling racks in a hallway blocking the double doors leading to the operating rooms, above the double doors was a lighted sign, which read "Exit". There was also a laundry cart with yellow cloth reusable/washable gowns stored in the same hallway. The storage of the PPE completely blocked the hallway and rendered the doors to the operating room unusable.
On 6/11/20 at 12:09 P.M., an interview was conducted with the Emergency Department Manager. The Emergency Department Manager stated the suits hung there because there was no other place to keep them.
On 6/11/20 at 12:11 P.M., an interview was conducted with the Director of Quality Management. The Director of Quality
The Director of Quality Management was interviewed on 6/11/20 at 12:11 P.M. The Director of Quality Management stated nurses wore the suits in rooms in which patients were either COVID-19 positive or suspected to be so. She stated each suit was cleaned by the person wearing it after exiting the room, and when not in use were stored here. The Director of Quality Management stated the doors led to the operating room, but that it was a back entrance, and the doors were never used. The Director of Quality Management stated the doors to the operating room were not part of the evacuation plan and they had no other place to store the PPE when not in use.
Tag No.: A0748
Based on observation, interview and record review, the hospital failed to ensure their infection control policy related to the Covid 19 pandemic included the following:
1. The hospital failed to ensure everyone within the hospital were screened prior to being allowed into the hospital.
2. The hospital failed to properly disinfect the provided Tyvek/Tychem® isolation suits, failed to properly store the Tyvek/Tychem® suits when not in use, and allowed the modification of the Tyvek/Tychem® suits, while continuing to use them.
As a result, there was there was a potential for a person not screened to introduce and expose Covid 19 to the hospital.
Findings:
1. On 6/11/20, during a tour of the hospital, several law enforcement personnel in uniform were seen accompanying patients.
On 6/11/20 at 11 A.M., during a tour of the Emergency Department a Deputy stated he did not get screened when entering the hospital because they did not have time.
On 6/11/20 at 12:10 P.M., an interview was conducted with Greeter 2. Greeter 2 was stationed at the emergency department entrance of the facility. Greeter 2 stated every person who entered the facility must be screened for COVID-19 symptoms before they went inside. Greeter 2 demonstrated that persons who had been screened were given colored stickers to wear.
On 6/11/20 at 12:57 P.M., a patient was observed to be brought into the emergency department via gurney. Accompanying the patient were two guards. The guards were not observed to be screened for COVID-19 prior to or immediately after their entrance into the facility. The guards did not have a colored sticker on their badge to indicate they had been screened.
On 6/11/20 at 11:18 P.M., an interview was conducted with Greeter 1. Greeter 1 was observed to be stationed at the main entrance of the facility. Greeter 1 stated it was her job to screen people for COVID-19 prior to their entry into the facility. Greeter 1 stated screening was required for every individual who entered the facility. Greeter 1 stated after someone was screened, they were given a colored sticker to wear. This sticker indicated they had been screened. Signs posted at the front door indicated that each person who entered the facility must be screened for COVID-19 symptoms.
On 6/11/20 at 1:13 P.M., an interview was conducted with Guard 1. Guard 1 stated he had not been screened for COVID-19 either prior to entrance at the facility or after he entered.
On 6/11/20 at 1:42 P.M., a patient was observed to be walked into the emergency department accompanied by a police officer. The patient was observed to be seated in a wheelchair in the hallway while the police officer stood next to him. The police officer did not have colored sticker that indicated he had been screened for COVID-19 prior to his entry into the facility. The police officer was not observed to be screened after his entrance into the facility.
The hospital could not provide a policy regarding the screening of individuals entering the facility for COVID-19.
The hospital did not limit the use of the ambulance entrance to only emergency personnel and patients.
The Emergency room ambulance entrance was not staffed to screen, due to the emergent nature of this entrance. Even though there was no screening at this hospital entrance the hospital allowed law enforcement's use of the ambulance entrance, and had no methodology to ensure law enforcement or the patients they were with, were ever screened while in the hospital.
2. On 6/11/20 at 11:57 A.M., during a tour of the hospital's Emergency Department several forms of PPE gowns were observed. There were 3 types, a blue single use disposable gown, a yellow cloth reusable/washable gown, and a tan or brown Tyvek/Tychem® plastic reusable suit.
There were approximately 60 tan or brown plastic reusable suits were on hangers outside patient rooms or stored on racks in a hallway in front of doors leading to the operating rooms. Each tan or brown plastic reusable suit, had a staff name written at the neckline. A tan suit which hung outside a patient's room was noted to have a 2-inch sized tear below the left front shoulder. The tear was covered with a clear plastic sticker or tape. Several of the tan or brown plastic reusable suits were noted to have visible wear.
On 6/11/20 at 11:58 A.M., an interview was conducted with the Director of Quality Management. She stated nurses wore the suits in rooms in which patients were either COVID-19 positive or suspected to be so. She stated each suit was cleaned by the person wearing it after exiting the room.
The Emergency Department Nurse Director was interviewed on 6/11/20 at 12:16 P.M. The Emergency Department Manager stated they were given these tan or brown plastic reusable suits by the county health department when there was a shortage in disposable PPE. The Emergency Room Manager stated they issued all staff a tan or brown plastic reusable suit, and staff could determine if and when they utilized this PPE, the staff could use any of the 3 forms of gowns at their discretion. The Emergency Department Nurse Manager stated there was no tracking measures in place to ensure proper cleaning of the tan or brown plastic reusable suit was in place, there was no log in existence to verify when the tan or brown plastic reusable suit were placed in service, how often they were used, or when they were disinfected.
There was a posted procedure for the disinfecting of the tan or brown plastic reusable suits. The disinfecting procedure was observed on 6/11/20 at 12:50 P.M. The brown plastic reusable suit the RN was observed disinfecting had a small tear on the left shoulder and the flap covering the zipper had been removed.
Emergency Department Registered Nurse 1 was interviewed on 6/11/20 at 12:58 P.M., just after she demonstrated the disinfection of the brown plastic reusable suit. Emergency Department Registered Nurse 1 stated the suits were cleaned after each use with bleach wipes. She stated the staff had been trained on the cleaning of the suits but did not of have record of what the training included. She stated there were no records of which staff members were trained.
The hospital could not provide direction related to how many times a tan or brown plastic reusable suits could be disinfected, if the tan or brown plastic reusable suits could be modified or when the tan or brown plastic reusable suits could no longer be used.
According to the hospital they have provided staff instructions for the disinfection of the Tyvek/Tychem® suits, these directions were posted throughout the emergency department. The instructions were:
"Re-Usable Isolation Suit Instructions to Don & Doff
1. Outside Pt Room: Sanitize hands & Apply Shoe Covers
2. Outside Pt Room: Apply Gloves - Don Suit - Apply Double Gloves
3. Inside Pt Room: Provide Patient Care Front Facing Patient at all times
4. Inside Pt Room: Remove Outer Glove - Sanitize Hands
a. Have a Staff/Buddy watch you wipe your suit (to make sure & coach you to wipe all areas)
b. Use 3 CLOROX wipes to disinfect your suit as follows:
i. Left Arm (flip wipe over) Right Arm
ii. Front Torso
iii. Thighs (flip wipe over) Calfs
5. Outside Pt Room: Remove Inner Glove & Wash Hands
a. You may wear the suit in the department to provide patient care or sit at nurse station.
b. You may not wear your suit to the break room, kitchen or bathroom
6. Outside Pt Room: Remove your suit after it is wiped clean with your Staff/Buddy available to assist you if needed.
a. Hang Suit on Hanger & wipe entire suit when not in use
i. Use 1 CLOROX wipe to clean the back side first then the front side."
The manufactures Cleaning Guidelines for DuPont (Trademark), Tychem® garments for COVID-19,
"COVID-19 is a biological viral contaminate, therefore, causing surface contamination; consequently, the exterior
of Tychem® garments are able to be cleaned, disinfected and reused a limited number of times for COVID-19
applications. (*)
For cleaning use warm water, mild dishwashing liquid and a soft brush to remove any dirt from exterior
surfaces.
As per CDC guidelines for disinfection, diluted household bleach solutions, alcohol solutions with at least
70% alcohol, and most common EPA-registered household disinfectants should be effective to disinfect
exterior surfaces.
Products with EPA-approved emerging viral pathogens claims are expected to be effective against
COVID-19 based on data for harder to kill viruses. Follow the manufacturer's instructions for all cleaning
and disinfection products (e.g., concentration, application method and contact time, etc.). From this list,
diluted hydrogen peroxide or sodium hypochlorite (house-hold bleach) can be used to disinfect Tychem®
garments.
Thoroughly rinse the garments with clean, fresh water and allow to air-dry.
If the interior of the garment is suspected of being contaminated, DO NOT attempt to clean, disinfect and
reuse the garment; handle and dispose of the garment according to all applicable regulations.
Retire Tychem® garment if it fails to pass inspection or the garment is altered, abraded, cut, torn, punctured or otherwise breached. Follow manufacturers instruction for storage and inspection.
Garment Inspection Steps:
1. Lay the garment on a clean, smooth surface.
2. The inspection should include all areas of the suit: body, visor (if present), and gloves (if present).
3. Use a flashlight inside the suit to examine for holes, cuts, or tears. Confirm that any suspected visual imperfection is actually a void by using a small amount of water to confirm penetration. NOTE: For taped seam garments, visible stitch holes which are covered by seam sealing tape do not constitute a defect.
4. Examine garment seams. For taped seam garments, look for areas where seam tape has lifted away from the suit or where seam tape does not fully cover stitch holes. For bound seam garments, look for areas where the binding (top) fabric piece is missing or not fully attached. For serged seam garments, look for areas where the sewing thread is missing or not fully attached.
5. Examine the entire garment for signs of damage. A breach, rupture, or hole of any component of the suit is cause for rejection. Note that for taped seam garments, the fabric, visor (if present), gloves (if present), and seam areas may have visual blemishes that do not affect barrier performance. Such blemishes can include areas adjacent to the seam tape that appear to be dull, white, or frosted...
8. Examine the garment zipper and zipper cover (if present) to make sure they are in good working order. Operate the zipper. Lubricate the zipper using paraffin wax, if needed. Engage the hook and loop tape (if present) on the zipper storm flap(s) to ensure appropriate adhesion. If the garment has double sided adhesive tape on the storm flap(s), ensure that there is tape along the length of each flap; do not remove protective tape covering until the suit is donned for use.
9. Examine any garment snaps, etc. to ensure they are in good working order.
10. Examine elastic (if present) to ensure it is not damaged.
11. Examine garment labels to ensure they are attached and are legible."
The hospitals direction for the disinfection and continued indefinate use to the Tyvek/Tychem® suits does not comply with the manufacturers direction for use/reuse.