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§483.80 Infection Control
The facility must establish and maintain an infection prevention and control program designed to provide a safe, sanitary and comfortable environment and to help prevent the development and transmission of communicable diseases and infections.
§483.80(a) Infection prevention and control program.
The facility must establish an infection prevention and control program (IPCP) that must include, at a minimum, the following elements:
§483.80(a)(1) A system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals providing services under a contractual arrangement based upon the facility assessment conducted according to §483.70(e) and following accepted national standards;
§483.80(a)(2) Written standards, policies, and procedures for the program, which must include, but are not limited to:
(ii) When and to whom possible incidents of communicable disease or infections should be reported;
(iii) Standard and transmission-based precautions to be followed to prevent spread of infections;
(iv)When and how isolation should be used for a resident; including but not limited to:
(A) The type and duration of the isolation, depending upon the infectious agent or organism involved, and
(vi)The hand hygiene procedures to be followed by staff involved in direct resident contact.
§483.80(a)(4) A system for recording incidents identified under the facility's IPCP and the corrective actions taken by the facility.
§483.80(f) Annual review.
The facility will conduct an annual review of its IPCP and update their program, as necessary.
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§483.80(d) (3) COVID-19 immunizations.
The LTC facility must develop and implement policies and procedures to ensure all the following:
(i) When COVID-19 vaccine is available to the facility, each resident and staff member is offered the COVID-19 vaccine unless the immunization is medically contraindicated or the resident or staff member has already been immunized;
(iii) Before offering COVID-19 vaccine, each resident or the resident representative receives education regarding the benefits and risks and potential side effects associated with the COVID-19 vaccine;
(v) The resident, resident representative, or staff member has the opportunity to accept or refuse a COVID-19 vaccine, and change their decision;
(vi) The resident's medical record includes documentation that indicates, at a minimum, the following:
(A) That the resident or resident representative was provided education regarding the benefits and potential risks associated with COVID-19 vaccine; and
(B) Each dose of COVID-19 vaccine administered to the resident; or
(C) If the resident did not receive the COVID-19 vaccine due to medical
contraindications or refusal;
§ 72523. Patient Care Policies and Procedures.
(a)Written patient care policies and procedures shall be established and implemented to ensure that patient-related goals and facility objectives are achieved.
(b) All policies and procedures required of these regulations shall be in writing, made available upon request to physicians and other involved health professionals, patients or their representatives, employees and the public shall be carried out as written. Policies and procedures shall be reviewed at least annually, revised as needed and approved in writing by the patient care policy committee.
§ 1255.9 Health and Safety Code - HSC
(a)(1) A skilled nursing facility shall have a full-time, dedicated Infection Preventionist (IP).
On 5/16/2023, the California Department of Public Health conducted a Recertification Survey at the facility.
The facility failed to implement and maintain a system to prevent and control transmission of infectious disease by failing to:
1.Provide education regarding the benefits, risks and potential side effects associated with Coronavirus Disease (COVID-19, a virus that causes respiratory illness that can spread from person to person) vaccine to Resident 14 or the responsible party, per facility policy.
2.Ensure the oxygen tubing was changed every seven days and as needed (PRN) for Resident 14, per facility policy.
3.Ensure Licensed Vocational Nurse (LVN) 1 and 2, and Certified Nursing Assistant (CNA) 3 conducted hand hygiene during specified infection control guidelines.
4.Obtain informed consent from Resident 30 or resident's responsible party (RP) before administering COVID-19 booster (an extra dose of vaccine after the original dose).
5.Review and Revise at least annually the facility’s Infection Prevention and Control Program policies and procedures (P&Ps).
6.Maintain a full-time designated Infection Control Preventionist (IP) as required by the State of California.
As a result, there was an increased risk in the spread of infections that could lead to serious harm to Resident 5, 14 and all residents and staff, and violated Resident 30's right to be fully informed of the benefits, risks, and the potential side effects prior to receiving the COVID-19 vaccine and or booster.
1.A review of the Admission Record indicated the facility admitted Resident 14 on 4/24/2023 with diagnoses including diabetes mellitus (a condition that happens when the blood sugar is too high) and lack of coordination.
A review of Resident 14's Quarterly Minimum Data Set (MDS, a standardized assessment and care screening tool) dated 4/30/2023, indicated the resident had severely impaired cognition (never/rarely made decisions) and required limited one-person physical assistance for bed mobility, transfers, toilet use, and personal hygiene.
A review of Resident 14's Vaccine Administration Record indicated the resident received the first dose of the COVID-19 vaccine on 4/26/2021.
During an interview and concurrent record review on 5/18/2023 at 8:57 AM, the Infection Preventionist (IP) stated that upon Resident 14's admission on 4/24/2023, Resident 14's family requested for the facility to administer the second dose of the COVID-19. The IP then confirmed there was no documentation regarding this matter in Resident 14's medical chart. The IP stated there was no documentation regarding offering COVID-19 vaccine to Resident 14 or the RP upon admission. The IP further stated she did not educate Resident 14 or the RP about the benefits, risks, and potential side effects of the COVID-19 vaccine. The IP stated the facility was required to offer COVID-19 vaccine to eligible residents upon admission to the facility, and stated residents had the right to accept or refuse the vaccine.
During an interview on 5/19/2023 at 11:20 AM, the Director of Nursing (DON) stated licensed staff were required to offer COVID-19 vaccination to residents or their RP upon admission. The DON further stated that before COVID-19 vaccine was offered to residents, staff were required to educate residents or their RPs regarding the benefits, risks, and potential side effects of the vaccine. The DON confirmed that the second dose of COVID-19 vaccine and necessary education was not offered to Resident 14 upon admission. The DON stated the potential outcome was contracting COVID-19 virus and becoming sick.
On 5/19/2023 at 12:25 PM, during an interview, the Administrator (ADM) stated licensed staff were required to educate and offer COVID-19 vaccination to residents or their RPs upon admission. The ADM stated the communication must be in writing.
A review of facility policy and procedure titled, "Coronavirus Disease (COVID-19) - Vaccination of Residents," revised 6/2022, indicated:
-Residents who were eligible to receive COVID-19 vaccine were strongly encouraged to do so.
-Residents must sign a consent prior receiving the vaccine.
-The resident or resident representative had the opportunity to accept or refuse the COVID-19 vaccine, and to change his/her decision.
-COVID-19 vaccine education, documentation and reporting are overseen by the Infection Preventionist. Before the COVID-19 vaccine is offered, the resident is provided with education regarding the benefits, risks and potential side effects associated with the vaccine. Information is provided to the resident in a language and format that is understood by the resident or representative.
2. During an observation on 5/16/2023 at 9:05 AM, Resident 14 received oxygen via nasal canula. During a concurrent interview, the IP stated oxygen tubing was to be changed weekly, every Wednesday night. She stated the oxygen tubing for Resident 14 did not have a date to indicate when it was last changed and stated she did not know when the oxygen tubing was last changed.
During an interview on 5/18/2023 at 11:25 AM, the DON stated there was no date on the nasal cannula for Resident 14 and that the oxygen tubing was to be changed once per week or when needed, when dirty or contaminated. The DON stated she was not sure when the oxygen tubing for Resident 14 was last changed and stated it should have a date when changed. The DON also stated the purpose of changing the oxygen tubing was for infection control purposes and that the potential outcome of not practicing infection control for the oxygen tubing was the resident would be at risk for infection.
A review of facility policy titled, "Oxygen Use," revised 11/2019, indicated oxygen equipment will be maintained in the following manner: Oxygen tubing will be changed every seven days and prn.
3.During an observation on 5/18/2023 at 8:28 AM, LVN 2 did not conduct hand hygiene before dispensing medication. During a concurrent interview, LVN 2 stated he did not conduct hand hygiene prior to dispensing medication and stated he was required to conduct hand hygiene for infection control purposes. LVN 2 then stated the potential outcome of not conducting hand hygiene was the spread of infection to the residents.
During an observation on 5/18/2023 at 10:55 AM, in the contact isolation room, CNA 3 was observed wearing Personal Protective Equipment (PPE) and assisting the resident in bed C with care. CNA 3 was then observed shaking hands and caring for the resident in bed B without doffing PPE or changing the PPE.
On 5/18/2023 at 10:57 AM, during an interview, CNA 3 stated the resident in bed C was on contact isolation for a history of Methicillin-resistant Staphylococcus Aureus (MRSA - bacteria that causes infection that is difficult to treat because of resistance to some antibiotics) in a wound. CNA 3 stated he helped and shook hands with the resident in bed B without doffing PPE and performing hand hygiene after helping the resident in bed C. CNA 3 stated when moving from one resident to another, hand hygiene should be performed, and PPE should be changed to prevent transmission of infection.
During an interview on 5/19/2023 at 9:48 AM, the DON stated when coming from a resident who was on contact isolation, staff should completely doff PPE and perform hand hygiene before working with a resident who was not on contact isolation to prevent transmission of infection.
A review of Resident 5's Admission Record indicated the resident was admitted to the facility on 4/19/2023 with diagnoses including urinary tract infection (UTI), muscle weakness, and abnormalities of gait and mobility.
A review of the MDS, dated 4/18/2023, indicated Resident 5 was severely impaired with cognitive skills for daily decision making. The MDS further indicated Resident 5 required extensive two-person physical assistance (resident involved in activity, staff provide weight bearing support) with bed mobility, toilet use, one-person physical assist on locomotion on unit, locomotion off unit, dressing, and personal hygiene.
During a medication pass observation on 5/18/2023 at 8:01 AM, LVN 1 introduced themself to Resident 5, checked Resident 5's ID band, placed six medications onto a plastic medication cap, and handed the cap to Resident 5. Resident 5 then took the six medications with water. LVN 1 did not perform hand hygiene before or after the medication administration.
During an interview on 5/19/2023 at 8:41 AM, the IP stated hand washing / hand hygiene was very important to prevent spread of infection. The IP stated staff needed to do handwashing before and after taking care of residents and when hands were visibly soiled.
During an interview, on 5/19/2023 at 12:26 PM, the DON stated hand washing was a standard precaution for infection control and important during medication pass to prevent spread of infection.
A review of a CDC documented titled, "Implementation of PPE in Nursing Homes to Precent Spread of MDROs (Multi-drug resistant organism)," updated 7/12/2022, indicated for contact precautions don (put on) required PPE before room entry, doff (take off) before room exit; change before caring for another resident).
A review of the facility policy titled, "Hand washing/ Hand hygiene," revised 8/2019, indicated the facility considered hand hygiene the primary means to prevent spread of infections, and all personnel should be trained in declaring in service on the importance of hand hygiene in preventing the transmission of healthcare associated infections.
4. A review of the Admission Record indicated the facility originally admitted Resident 30 on 1/29/2022 with diagnoses including dysphagia (difficulty or discomfort swallowing) and lack of coordination.
A review of Resident 30's COVID-19 Booster Vaccination Record dated 11/23/2022, indicated the physician ordered the administration of the COVID-19 Bivalent booster (protects against two strains of COVID-19) 0.5 milligrams, intramuscularly (a technique to deliver a medication deep into a muscle).
A review of Resident 30's Vaccination Record indicated Resident 30 received a COVID-19 Bivalent booster on 11/23/2022 at 10:25 PM.
A review of Resident 30's History and Physical dated 3/2/2023 indicated Resident 30 did not have the capacity to understand and make decisions.
A review of the MDS dated 5/4/2023, indicated Resident 30 had severely impaired cognition. The MDS indicated Resident 30 was totally dependent on staff for toilet use, transfers, and required extensive one-person physical assistance for dressing, bed mobility, and personal hygiene.
During an interview on 5/18/2023 at 9:11 AM, the IP stated that she administered the bivalent booster to Resident 30 without obtaining their informed consent. The IP stated it was required to obtain informed consent from residents or residents' responsible parties before administering any kind of vaccine. The IP further stated this conduct was inconsistent with the facility's policy and procedure to obtain informed consent from either the resident or their representatives prior to administering the COVID-19 vaccine.
During an interview on 5/19/2023 at 11:25 AM, the DON stated the licensed staff were required to obtain informed consent and permission from residents or their responsible parties before administering any vaccines. The DON stated the potential outcome of administering vaccine without informed consent was a violation of the resident's rights.
During an interview on 5/19/2023 at 12:10 PM, the ADM stated staff were required to obtain informed consent from residents or their responsible parties before administering COVID-19 vaccine or boosters. The ADM stated administering the COVID-19 booster without a consent was a deficient practice. The ADM further stated the potential outcome was not honoring a resident's rights.
A review of facility policy and procedure titled, "Coronavirus Disease (COVID-19) - Vaccination of Residents," revised 6/2022, indicated:
-Residents who were eligible to receive COVID-19 vaccine were strongly encouraged to do so.
-Residents must sign a consent prior receiving the vaccine.
-The resident or resident representative had the opportunity to accept or refuse the COVID-19 vaccine, and to change his/her decision.
5. During an interview on 5/19/2023 at 1:10 PM, the ADM stated the facility P&Ps should be reviewed or revised at least annually. The ADM confirmed that the Vaccination of Residents and the Infection Prevention and Control Program P&Ps had not been reviewed at least annually. The ADM stated this was a risk to