HospitalInspections.org

Based on document review, observation and interview, the hospital failed to ensure that a person or persons designated as infection control officer/officers developed and implemented policies governing control of infections and communicable diseases in 1 facility by: 1. failing to implement/follow their infection control policy COVID-19 for social distancing, provision of hand sanitizer to patients, and utilization of good hand hygiene. 2. failing to follow CDC guidelines for a) hand hygiene; b) Strategies for Optimizing the Supply of Facemasks and/or N95 respirators; c) Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 by failing to: i. have a process for notifying the health department about suspected or confirmed cases of SARS-CoV-2 infection, and establish a plan in consultation with local public health authorities, for how exposures in a healthcare facility will be investigated and managed and how contact tracing will be performed; ii. ensure for limited movement of SARS-CoV-2 infected patients outside of their rooms; and iii. utilize NIOSH-approved N95 respirators; d) Implementing Filtering Facepiece Respirator (FFR) Reuse/decontamination by failing to implement contingency strategy for extended use and/or properly implement crisis capacity decontamination during reuse of FFRs; e) Discontinuation of Transmission-Based Precautions and Disposition of Patients with COVID-19 in Healthcare Settings by practitioner order for COVID positive patients to be out of isolation.

Findings include:

1. Review of the infection control policy titled COVID-19, Policy Number: IC-35, Issued 4/2020 and reviewed 11/2020, indicated the following:
Policy:
CDC (Centers for Disease Control) guidelines along with CMS (Centers for Medicare and Medicaid Services) will drive this working policy.
Employees:
Staff will continue to utilize good hand hygiene and contact precautions.
All employees will follow current PPE (personal protective equipment) use state mandate.
Patients:
Patients will be encouraged to practice social distancing by staff throughout the day.
Hand sanitizer will be provided and encouraged to patients routinely before each meal and before snacks.
Patients will be seated as far apart as space allows during meals and snacks.
COVID Positive Patients:
COVID positive patients will dine at the same table and patients who tested negative will dine together at tables away from the COVID positive patients.

2. Review of CDC guidelines indicated the following:
RE: Hand Hygiene at https://www.cdc.gov/infectioncontrol/guidelines/isolation/recommendations.html, page last reviewed: July 22, 2019:
During the delivery of healthcare, avoid unnecessary touching of surfaces in close proximity to the patient to prevent both contamination of clean hands from environmental surfaces and transmission of pathogens from contaminated hands to surfaces.
Perform hand hygiene ~ in the following clinical situations:
Before having direct contact with patients.
After contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient.
After removing gloves.
RE: Hand Hygiene in Healthcare Settings at https://www.cdc.gov/handhygiene/providers/index.html and glove use, page last reviewed: January 31, 2020:
Gloves are not a substitute for hand hygiene.
If your task requires gloves, perform hand hygiene prior to donning gloves, before touching the patient or the patient environment.
Perform hand hygiene immediately after removing gloves.
RE: Strategies for Optimizing the Supply of Facemasks at https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/face-masks.html, Updated June 28, 2020:
Contingency Capacity Strategies - Implement extended use of facemasks.
HCP (health care provider) must take care not to touch their facemask. If they touch or adjust their facemask they must immediately perform hand hygiene.
HCP should leave the patient care area if they need to remove the facemask.
Crisis Capacity Strategies - Implement limited re-use of facemasks. Limited re-use of facemasks is the practice of using the same facemask by one HCP for multiple encounters with different patients but removing it after each encounter.
HCP should leave patient care area if they need to remove the facemask.
RE: Strategies for Optimizing the Supply of N95 Respirators at https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/index.html - Optimizing N95 Respirator Supplies. Updated June 28, 2020:
Use of alternatives to N95 respirators - Use NIOSH approved alternatives to N95 respirators where feasible. These include other classes of filtering facepiece respirators, elastomeric half-mask and full facepiece air purifying respirators, powered air purifying respirators (PAPRs).
Contingency Capacity Strategies (during expected shortages):
Extended use refers to the practice of wearing the same N95 respirator for repeated close contact encounters with several different patients, without removing the respirator between patient encounters...When practicing extended use of N95 respirators, the maximum recommended extended use period is 8-12 hours. Respirators should not be worn for multiple work shifts and should not be reused after extended use. N95 respirators should be removed (doffed) and discarded before activities such as meals and restroom breaks.
Crisis Capacity Strategies (during known shortages):
Non-NIOSH-approved products developed by manufacturers who are not NIOSH approval holders, including only products approved by and received from China, should only be used in crisis situations when no other NIOSH-approved N95 respirator (or a listed device from one of the other countries identified within the FDA EAU) is available.
RE: Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic at https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html, Updated Nov. 4, 2020:
Implement Universal Source Control Measures
Patients and visitors should wear their own cloth mask (if tolerated) upon arrival to and throughout their stay in the facility. If they do not have a face covering, they should be offered a facemask or cloth mask
Patients may remove their cloth mask when in their rooms but should put it back on when around others (e.g., when visitors enter their room) or leaving their room.
Create a Process to Respond to SARS-CoV-2 Exposures Among HCP and Others:
Healthcare facilities should have a process for notifying the health department about suspected or confirmed cases of SARS-CoV-2 infection, and should establish a plan, in consultation with local public health authorities, for how exposures in a healthcare facility will be investigated and managed and how contact tracing will be performed.
Recommended infection prevention and control (IPC) practices when caring for a patient with suspected or confirmed SARS-CoV-2 infection
Patient Placement: Limit transport and movement of the patient outside of the room to medically essential purposes. Patients should wear a facemask or cloth mask to contain secretions during transport. If patients cannot tolerate a facemask or cloth mask or one is not available, they should use tissues to cover their mouth and nose while out of their room.
Personal Protective Equipment:
Any reusable PPE must be properly cleaned, decontaminated, and maintained after and between uses.
HCP should be medically cleared and fit tested if using respirators with tight-fitting facepieces (e.g., a NIOSH-approved N95 respirator)
RE: Implementing Filtering Facepiece Respirator (FFR) Reuse/decontamination at https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/decontamination-reuse-respirators.html, Updated Oct. 19, 2020:
Decontamination, When There Are Known Shortages of N95 Respirators:
Limited FFR reuse is just one of several strategies available for addressing an N95 FFR crisis capacity situation when there is a known shortage of devices after conventional and contingency capacity strategies have been implemented.
A limited reuse strategy to reduce the risk of self-contamination
One strategy to reduce the risk of contact transfer of pathogens from the FFR to the wearer during FFR reuse is to issue five N95 FFRs to each healthcare staff member who care for patients with suspected or confirmed COVID-19. The healthcare staff member can wear one N95 FFR each day and store it in a breathable paper bag at the end of each shift with a minimum of five days between each N95 FFR use, rotating the use each day between N95 FFRs. This will provide some time for pathogens on it to "die off" during storage
Decontamination and subsequent reuse of FFRs should only be practiced where FFR shortages exist. Decontamination should only be performed on NIOSH-approved FFRs without exhalation valves.
RE: Discontinuation of Transmission-Based Precautions and Disposition of Patients with COVID-19 in Healthcare Settings, page last reviewed 5/2/20, printed document per facility, indicated the following: The decision to discontinue Transmission-Based Precautions for patients with confirmed COVID-19 should be made using either a test-based strategy or a symptom-based (i.e. time-since-illness-onset and time-since-recovery strategy) or time-based strategy as described below (not all inclusive):
Patients with laboratory-confirmed COVID-19 who have not had any symptoms should remain in Transmission-Based Precautions until either: Transmission-Based Precautions have been discontinued and the patient's symptoms have resolved...

3. The following was observed on 11/9/20:
Beginning at approximately 10:45am: Six (6) patients were initially observed to be in the milieu, all without face coverings and not practicing social distancing. Recliner type chairs were lined up in front of the television (TV) each right next to the other, < 1' apart. Staff in the area were noted to have been wearing FFR type face coverings. S1, Mental Health Technician (MHT) was observed to repeatedly touch and pull at his/her face mask/covering without performing hand hygiene. The mask of S1 was noted to have been loose with open gaps at each side of the mouth. S2, CNA (Certified Nursing Assistant), was also observed touching the front of his/her mask without immediately performing hand hygiene. No hand sanitizer or tissue were noted available in the patient milieu area. Hand sanitizer was noted to be in the far corners of the desk behind the counter of the nurse's station, but was not readily available for staff or patients in the milieu. At approximately 11:15am, S1 was noted to have his/her mask under his/her nose while standing next to (< 6') S2. S2 then went to a table and pulled his/her mask down below the nose and mouth by touching the front; no hand hygiene was observed before or after putting the mask back in place.

Beginning at approximately 11:15am: Patients were observed seated in chairs <6' apart participating in an activity in which a balloon was tossed and batted/touched by different patients to keep in volley type motion. No hand hygiene was observed pre or post activity and no cleaning of the balloon was observed. Two food services persons were noted to have arrived in the area, one was noted to have touched the front of his/her mask without performing hand hygiene and the other was noted to have put his/her mask below his/her nose and then put it back up as walking toward this surveyor, without performing hand hygiene after touching the mask.

Beginning at approximately 12:00pm: Eight patients were seated side-by-side eating at the front table and one patient was at another long table behind the front table. That patient had a staff member seated with him/her for feeding assist, that staff member, S2, was wearing gloves. During meal time a new patient arrived and another was discharged. At approximately 12:20pm, a hand-held/cordless phone was taken from the nurse's station to a patient at the dining table. The patient remained on the phone talking at the table until approximately 12:35pm, at which time the phone was returned to the nurse's station by S2. The patient was then observed opening food items and eating without having performed hand hygiene. S2 was noted to have removed a glove to retrieve the phone, no hand hygiene was observed after removal of the glove. Upon return to the table, S2 was observed to apply/reapply a glove to the ungloved hand without first performing hand hygiene. The phone was placed back in its cradle without having been sanitized. During meal observation, the new patient arrived in the milieu and S1 was noted to have been taking the patient's vital signs. It was noted that items fell to the floor 2 times without having been sanitized prior to being placed back in to use. Following use, S1 transported the VS machine back to the nurse's station. The VS machine was not sanitized/cleaned prior to its return to the nurse's station.

4. The MR of patient P10, in a laboratory report dated 9/17/20, indicated COVID-19 infection was detected. The document indicated the results were reported 9/18/20 at 14:35 hours. Medical SOAP (Subjective, Objective, Assessment, Plan) Note dated 9/18/20 at 11:23 (hours) indicated the following: Objective: Patient sitting at the table in the milieu interacting with peers and reading the newspaper. He/she is very talkative...Physician's order dated 9/19/20 at 10:00 (hours), a.m./p.m. not documented, indicated the following: DC (discontinue) albuterol nebulizer. COVID +. Patient may come out of room but must wear a mask (N95) while in dayroom.

5. Review of facility documentation indicated the following:
The facility lacked documentation of a strategy for optimizing supply of PPE and lacked documentation of which level of capacity (conventional, contingency, crisis) was currently in place.

Review of COVID positive logs indicated the facility had had 2 COVID positive patients, P10 and P11 and 5 staff members between 6/12/20 and 10/23/20*.
*The facility lacked documentation of internal contact tracing for patients and/or staff and lacked documentation of positive persons having been reported to a health department. The facility lacked documentation of having had a process for notifying the health department about suspected or confirmed cases of SARS-CoV-2 infection, and establish a plan in consultation with local public health authorities, for how exposures in a healthcare facility will be investigated and managed and how contact tracing will be performed

Review of earloop face mask manufacturer, M1, package information indicated the face masks had a bacterial filtration efficiency >/= 95%. The package lacked indication of virus filtration efficiency.

Review of the KN95 Disposable Folding Mask GB2626-2006, manufacturer, M2, package information indicated the following: This product is a non-medical device. Made in China.

6. The following was indicated in interview on 11/9/20:
Between approximately 10:45am and 12:45pm:
A2, Administrator, indicated that patient care staff wear N95 masks and persons outside of patient care are to wear surgical type masks in other areas. A2 indicated the facility did try to encourage social distancing but could not make patients social distance. A2 acknowledged that having the patient chairs placed side-by-side <6' apart was not encouraging social distancing.
A3, Assistant Director of Nursing (ADON), when asked about lack of sanitizer/hand washing in the milieu for patient hand hygiene, verified no hand sanitizer or tissue was available in the milieu.

Between approximately 3:30pm and 4:30pm:
A1, Director of Nursing (DON) indicated the facility did not have a specific Infection Control Nurse/Officer, but instead utilized a person from corporate via telecommunication. A1 verified that staff were using KN95 masks for patient care (indicated the facility did not have N95 masks available) and surgical/procedure type masks for areas outside of patient care. A1 indicated that due to being a mental health facility, they cannot isolate COVID positive patients and that patient's only wear facemask if they are willing. A1 indicated the facility follows CDC guidelines including those for hand hygiene and isolations/transmissible disease. A1 verified MR findings and acknowledged that the practitioner for P10 had written an order allowing a COVID-19 positive patient to be out of isolation prior to having met CDC guidelines.

Between approximately 5:00pm and 6:00pm:
A1 verified staff are reusing the KN95 masks until dirty (an unlimited amount of times/days) and that the facility did not have a policy for reuse, nor had they determined their surge capacity. A1 indicated he/she was uncertain if the KN95 masks were NIOSH-approved N95 respirators and that staff had not been fit tested for NIOSH-approved N95 respirators.
A2 verified that the facility did not have a process for notifying the health department about suspected or confirmed cases of SARS-CoV-2 infection, with a plan for how exposures in a healthcare facility will be investigated and managed and how contact tracing will be performed, nor did they have documentation of COVID positive patients and staff having been reported to the health department. A2 indicated that incident reports were not completed for any COVID positive persons (patients nor personnel).