HospitalInspections.org

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Based on observation, interview, and document review, the hospital failed to develop and implement an effective infection prevention and control program.

Failure to develop and implement an effective infection prevention and control program puts patients, staff and visitors at risk of illness from communicable diseases.

Findings included:

The hospital failed to ensure that staff followed COVID-19 symptom screening processes when reporting to their assigned shifts.

The hospital failed to ensure that staff were fit tested and utilized appropriate airborne isolation precautions for staff working with COVID-19 positive or suspect patients.

The hospital failed to ensure that staff stored respirators properly when implementing extended use protocols.

The hospital failed to ensure that staff leaving COVID-19 positive or suspect patient rooms removed personal pretective equipment properly.

The hospital failed to ensure that staff disinfected patient care equipment handled by staff leaving COVID-19 positive or suspect patient rooms.

Cross Reference: Tag A0749

Due to the scope and severity of deficiencies cited under §42 CFR 482.42, the Condition of Participation for
Infection Control was NOT MET.
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Based on observation, interview, and document review, the hospital failed to ensure staff followed procedures for screening at the beginning of their shift for fever and signs/symptoms of illness as directed by hospital policy for 10 of 27 staff reviewed (Staff #501, #502, #503, #504, #505, #506, #507, #508, #509, and #510) (Item #1), failed to ensure that staff were fit tested and utilized appropriate airborne isolation equipment for 1 of 6 staff reveiwed (Staff #511) and 6 of 7 providers reviewed (Staff #206, #207, #208, #209, #516 and #517) (Item #2), failed to ensure that staff appropriately stored personal protective equipment (PPE) between uses as directed by hospital policy for 1 of 3 observations (Staff #506) (Item #3), failed to ensure staff properly removed personal protective equipment (PPE) when leaving patient rooms placed under transmission-based precautions for 4 of 4 PPE removals observed (Staff #508, #516, #203, and #205) (Item #4), and failed to disinfect patient care equipment after handling with gloves used in patient care areas under transmission-based precautions (Item #5) related to COVID-19.

Failure to comply with policies and procedures to prevent transmission of infections puts patients, staff, and visitors at risk from communicable illnesses.

Findings included:

Item #1 Health Screening

1. Document review of the hospital's policy titled, "COVID-19 Staff & Provider Screening," no policy number, dated 04/20, showed that staff and providers are to take their temperature, answer the screening questions, and record the information on the login sheet prior to the start of their shift. If staff has a temperature greater than 100 degrees or staff check the box for either of the other symptoms they are to immediately put on an ear-loop mask, wipe down the thermometer, and notify their supervisor for further directions.

2. On 04/30/20 at 9:40 AM, Investigator #5, the Infection Preventionist (Staff #512), and the Nursing Director for 2 North (2N) and 3 North (3N) (Staff #514) reviewed the COVID-19 Staff Screening document for hospital department 2N. The review showed the following:

a. 4 of 9 Staff failed to complete the COVID-19 screening prior to the start of their shift (Staff #501, #502, #503, and #504).

b. 2 of 2 Physicians failed to complete the COVID-19 screening prior to the start of their shift (Staff #508 and #509).

3. At the time of the observation, Staff #512 stated that it was hospital policy for staff to complete and document the screening prior to the beginning of their shift.

4. On 04/30/20 at 9:50 AM, Investigator #5, the Infection Preventionist (Staff #512), and the Intensive Care Unit (ICU) Manager (Staff #505) reviewed the COVID-19 Staff Screening document for the ICU. The review showed the following:

a. 2 of 6 Staff failed to complete the COVID-19 screening prior to the start of their shift (Staff #505 and #506).

b. 1 of 1 Physicians reviewed failed to complete the COVID-19 screening prior to the start of their shift (Staff #510).

5. On 04/30/20 at 10:25 AM, Staff #508 stated that the Medical Staff did not have to complete a COVID-19 screening.

6. On 04/30/20 at 10:35 AM, Staff #509 stated that he had completed his screening in the Emergency Department (ED) before he started his shift. At 11:40 AM, during review of the ED Staff logs and Visitor/Patient logs, Surveyor #5 and Staff #512 found no evidence Staff #509 completed COVID-19 screening in the ED.

7. On 04/30/20 at 10:45 AM, Staff #510 stated that she did not complete a COVID-19 screening prior to the start of her shift and stated that there were no staff available to remind the providers to take their temperatures prior to the start of their shift.

8. On 04/30/20 at 11:40 AM, Investigator #5, the Emergency Room Manager (Staff #517), and the Infection Preventionist (Staff #512) reviewed the COVID-19 Staff Screening document for the ED. The review showed the following:

a. 1 of 9 Staff failed to complete the COVID-19 screening prior to the start of their shift (Staff #507).

9. At the time of the observation, Staff #517 confirmed the finding and asked Staff #507 to complete the screening.

Item #2 Appropriate Equipment with Fit Testing

1. Document review of the hospital's policy and procedure titled, "Respiratory Protection Plan," policy number KGH003622, reviewed 04/15, showed that:

a. Respirators are selected for use in specific applications based upon design and performance criteria and the nature of the operation in question. They should not be used for applications that have not been evaluated or for operations not intended when initially selected.

b. The process for obtaining a respirator consists of determination of proper respirator, medical evaluation of each user, training of each user, fit testing of each user on the specific models of respirator to be used, issuance of the respirators, instructions on the proper size to be used (which occurs after fit testing and medical evaluation), and further evaluation and training annually in accordance with Washington State Hospital Association (WSHA) standards.

c. Fit testing will be performed annually or in accordance with WSHA and Occupational Safety and Health Administration (OSHA) guidelines. The employee will be assigned respirators for which he/she have been successfully fit tested

d. Employees using respirators will be provided with the necessary training and education regarding proper use, storage, inspection, and cleaning of the respirator.

e. Records of fit testing will be kept in the Employee health file and contain identification of the employee tested, the type of test performed, the make, model and size of the respirator, the date of the fit test, pass/fail results of the qualitative test performed or other record of quantitative fit testing performed.

f. The Program Administrator is responsible to arrange for the necessary medical surveillance, clearance, and fit testing for pertinent employees and to ensure periodic program evaluation is completed to ensure the respiratory protection program is being implemented for all employees. Program effectiveness is determined in part by determination of proper use, maintenance, and storage of respirators, and that disposable N95 filtered masks are not reused.

g. Supervisors are responsible to ensure that employees have received appropriate testing, medical evaluations, and fit testing for the proper respirator worn.

h. Respiratory Protection Guidelines will cover procedures for inspecting, donning, removing checking the fit/seal, and actual wearing of the type of respirator to be chosen according to airborne hazards and proper cleaning, storage, and maintenance of the respirator.

2. On 04/30/20 at 10:00 AM, Surveyor #5 observed a Registered Nurse (Staff #511) exiting a COVID-19 positive patient room wearing a cartridge type mask with filters on both sides of the mask. Inspection of the mask showed that it was a 3M P100 Industrial Cartridge Mask that used 2 cartridge filters that could be replaced (a personal protective mask used for protection against oil aerosols and particulate greater than .3 microns in size).

3. During interview with Investigator #5, Staff #511 stated that she had purchased the mask herself and that it was the hospital's policy that staff could purchase and use their own masks. She stated that several staff had purchased and use their own masks. Surveyor #5 asked Staff #511 if she used this mask to care for patients with COVID-19 and if she had been fit tested to use this mask. Staff #511 stated that she used the mask to care for COVID-19 patients, but she had not been fit tested.

At this same time, Investigator #5 asked Staff #511 what the hospital's policy was for when and how often the cartridges were to be changed. Staff #511 stated that she did not know when or how often the filters needed to be changed and she would need to ask her Manager.

4. On 04/30/20 at 10:09 AM, Investigator #5 interviewed the Nurse Manager for 2N (Staff #514) related to the observation of staff using their own masks, and the hospitals process for fit testing staff for these masks. Staff #514 stated that the hospital allowed staff to bring in their own masks related to the hospital's limited N95 mask supply. She stated that as far as she knew, hospital staff were not fit tested for these masks. She stated that she did not know of the specific requirements for this mask related to changing out filters and would use the manufacturer's recommendations.

5. On 04/30/20 at 4:30 PM, the Chief Nursing Officer (Staff #515) stated that it was not the hospital's policy for staff to bring in their own personal protective equipment including masks.

6. On 04/30/20 at 11:00 AM, Investigator #5 interviewed 3 Physician Staff related to Personal Protective Equipment (PPE) and the hospital's process for fit testing for the N95 masks. The interviews showed:

a. Staff #516 stated that she had not been fit tested and that she brought in her own mask to use when in the COVID-19 patient rooms.

b. Staff #517 stated that she had been fit tested in the past, but that she did not remember what size she wears. She stated that when she is in a COVID-19 patient room, "I just use a regular size mask as it seems to fit pretty tight,"

7. On 04/30/20 at 2:00 PM, Investigator #2 reviewed the occupational health and safety records for five providers (Staff #206, #207, #208, #209, and #210) to verify that staff completed respirator fit testing. The review showed the following:

a. Staff #206 (a physician) last received fit testing on 02/27/18.

b. Staff #207 (a physician) last received fit testing on 02/27/18.

c. Staff #208 (a physician) last received fit testing on 02/26/18.

d. Staff #209 (a physician) last received a signed and completed fit testing on 03/24/16.

8. Investigator #2 confirmed the above fit testing dates with the interim employee health nurse (Staff #211) at the time of review. Staff #211 stated that employees should receive fit testing annually and the testing includes the fit testing and a training component.

9. Investigator #2 and #5 interviewed the CNO (Staff #212) and the Infection Control Practitioner (Staff #213). The CNO stated that facility staff were due for their next yearly fit testing and that there was a gap with the providers not receiving annual fit testing.


Item #3 Mask Storage between Use

1. Document review of the hospital's document titled, "Protocol for Mask Use," no date, showed that:

a. Soiled masks or those used in aerosol generating procedures such as intubation and high flow oxygen will be discarded after use.

b. Staff are to store clean masks in a paper bag when not in use (breaks and meals).

c. Clean gloves are to be used for removing and placing masks into or out of the bag and the bag is to be discared after each use.

2. On 04/30/20 at 9:50 AM, Investigator #5 observed a Registered Nurse (Staff #506) place his N95 mask in a hard plastic container with a hard plastic lid.

3. At the time of the observation the Infection Preventionist (Staff #512) stated that the hospital's policy was to store the N95 masks in a paper bag between uses.

4. On 04/30/20 at 10:05 AM, Staff #506 stated that he was storing his N95 in the plastic container between uses and had just found the masks were to be stored in a paper bag.

5. On 04/30/20 at 11:05 AM, a Registered Nurse (Staff #516) stated that a Physician had brought in the plastic "clam shells" for staff to store their N95 masks between uses.

Item #4 Doffing of Personal Protective Equipment (PPE)

Reference: PDI Super Sani-Cloth® Germicidal Disposable Wipe Label Precautionary Statement Hazard to Humans and Domestic Animals stated, "Avoid contact with Skin."

Document review of the hospital's document titled, "Protocol for Mask Use," no date, showed the following:

a. Soiled masks or those used in aerosol generating procedures such as intubation and high flow oxygen will be discarded after use.

b. Staff are to use clean gloves for removing and placing masks into or out of the bag and are to discard the bag after each use.

c. Staff are to use either a full-face shield or goggles and a loop mask over the N95 to prevent contamination.

Document review of the hospital's protocol for Doffing Personal Protective Equipment (PPE) when the N95 mask will be reused showed the following sequence and location for doffing:

a. Gloves-in room

b. Gown-in room

c. Face Shield or Goggles-outside room after performing hand hygiene and donning a clean pair of gloves. Then clean the face shield or goggles with a Sani-Wipe or bleach solution.

d. Mask-outside room as the last step after the face shield/goggles are clean.

Document review of the document, "Special Droplet/Contact Precautions," revised 03/03/20, showed that staff are to remove PPE in the following order:

a. Remove gloves

b. Remove gown

c. Perform hand hygiene

d. Remove mask and eye cover

e. Perform hand hygiene

2. On 04/30/20 at 10:20 AM, Investigator #5 observed a Physician (Staff #508) doff (remove) (PPE) after exiting a COVID-19 patient room. The observation showed the following:

a. Staff #508 removed the ear loop mask covering his N95 mask inside the patient's room.

b. On exiting the COVID-19 patient's room, Staff #508 failed to perform hand hygiene, don clean gloves, and then remove and disinfect his eye goggles as directed by the hospital's policy.

c. At 10:21 AM, Staff #508 pulled his N95 mask below his nose and chin, talked with Staff waiting in the hallway, and then pulled the mask back over his nose and chin. At 10:24 AM and again at 10:25 AM, Surveyor #5 observed Staff #508 touch his eye goggles with contaminated hands

3. At the time of the observation, the Infection Control Practitioner (Staff #513) verified the finding and discussed with Staff #508 the appropriate sequencing for doffing PPE.

4. On 04/30/20 at 11:05 AM, Investigator #5 observed a Registered Nurse (RN) (Staff #516) doffing PPE after exiting a COVID-19 patient room. The observation showed the following:

a. Staff #516 exited the room and, with ungloved hands, removed several purple top Sani Cloth Germicidal Wipes disinfection wipes from the container. Staff #516 wiped down her face shield with the wipes. Staff #516 failed to perform hand hygiene after exiting the COVID-19 patient room, don clean gloves, and then disinfect her face shield as directed by hospital policy.

5. At the time of the observation, the Infection Control Practitioner (Staff #513) verified the finding and stated that the nurse should have performed hand hygiene and donned clean gloves prior to cleaning her face shield.

6. On 04/30/20 at 10:00 AM, Investigator #2 observed the personal protective equipment (PPE) doffing procedure of an RN (Staff #203) who was working in an ICU room with a patient under airborne precautions (Room 2130). The observation showed the following:

a. The staff member removed his gown in the patient room and disposed of the outer layer of gloves.

b. The staff member then exited the room and used the inner layer of gloves to clean his goggles with a disinfectant wipe and remove a simple mask covering his respirator.

c. Staff #203 then used alcohol-based hand rub to clean the inner layer of gloves.

d. Staff #203 then removed the respirator and placed it in a paper bag.

7. At the time of the observation, Investigator #2 interviewed Staff #203, who stated that he double gloves as a safety precaution. He stated that he removes the outer gloves in the room and then finishes PPE removal and cleaning with the inner layer of gloves.

8. On 4/30/20 at 10:45 AM, Investigator #2 observed a Certified Nursing Assistant (CNA) (Staff #205) don PPE when entering a patient room under Special Droplet/Contact precautions and doff PPE when exiting the room. The observation showed the following:

a. The staff member donned two pairs of gloves prior to entering the room. Upon exit, the staff member removed her gown and outer gloves in the patient room.

b. Staff #205 went to an alcove next to the patient room, removed her face shield and mask with the inner gloves and placed them on a table.

c. Staff #205 then removed the gloves and went down the hall to grab a rolling vital signs monitor.

d. Staff #205 did not perform hand hygiene after removing the gloves.

e. Staff #205 donned new gloves and used the disinfectant wipes on the rolling cart to clean the face shield.

f. Staff #205 then returned the vitals monitor, removed the gloves, and left without performing hand hygiene.

9. At the time of the observation, Investigator #2 interviewed the Risk Manager (Staff #214) about the PPE doffing process. Staff #214 confirmed the observations of incorrect PPE removal and lack of hand hygiene.

Item #5 - Cross-Contamination of Patient Care Equipment

1. Record review of the hospital policy titled, "Transmission Based Isolation Precautions," policy number KGH003095, approved 04/17, showed that staff should clean and disinfect any shared equipment used by staff working under transmission based precautions.

2. On 4/30/20 at 10:45 AM, Investigator #2 observed a Certified Nursing Assistant (CNA) (Staff #205) doff PPE when exiting a room of a patient on Special Droplet precautions. The observation showed the following:

a. Upon exit, the staff member went to an alcove next to the patient room, removed her face shield and mask, and placed them on a table.

b. Staff #205 then removed the gloves and went down the hall to grab a rolling vital signs monitor.

c. Staff #205 did not perform hand hygiene after removing the gloves.

d. Staff #205 donned new gloves and used the disinfectant wipes on the rolling cart to clean the face shield.

e. Staff #205 then returned the vitals monitor, removed the gloves, and left without performing hand hygiene.

f. Staff #205 did not disinfect the potentially contaminated vital sign monitor or table where she placed the dirty PPE.

3. At the time of the observation, Investigator #2 interviewed the Risk Manager (Staff #214) about the PPE doffing process. Staff #214 confirmed the observations of lack of disinfection of cross-contaminated equipment.
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