Other·July 11, 2023

F880 §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 patients, 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: (i) A system of surveillance designed to identify possible communicable diseases or infections before they can spread to other persons in the facility; (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 patient; including but not limited to: (A)The type and duration of the isolation, depending upon the infectious agent or organism involved, and (B) A requirement that the isolation should be the least restrictive possible for the patient under the circumstances. (v)The circumstances under which the facility must prohibit employees with a communicable disease or infected skin lesions from direct contact with patients or their food, if direct contact will transmit the disease; and (vi)The hand hygiene procedures to be followed by staff involved in direct patient 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(e) Linens. Personnel must handle, store, process, and transport linens so as to prevent the spread of infection. §483.80(f) Annual review. The facility will conduct an annual review of its IPCP T22 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. On 5/24/2023, an unannounced visit was made to the facility to investigate a complaint regarding infection control. The facility failed to implement interventions to prevent and control the spread of corona virus 19 (COVID-19, minor to severe respiratory illness caused by a new virus and spread from person to person) in accordance with the public health guidelines and the facility's policies and procedures by failing to: a. Provide documented evidence of the Infection Preventionist's (IP, staff responsible for the facility's infection prevention and control program) necessary surveillance (the collection, analysis, and dissemination of results for the purpose of prevention) of the COVID-19 outbreak with a complete line listing (a table that contains key information about each case in an outbreak) of COVID-19 positive patients and staff. b. Ensure all staff were fit-tested (a test protocol conducted to verify that a N95 respirator [a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles] is both comfortable and provides the wearer with the expected protection) for N95 respirator upon hire and/or annually. c. Establish and implement policies and procedures, including specific fit-testing procedures, related to the respiratory protection program required by The Occupational Safety and Health Administration (OSHA, a federal organization in the United Sates that ensures that employees are safe and healthy within their work environment). These failures resulted in not all staff were fit-tested for N95 respirator an had the potential to increase the spread of COVID-19 infection in the facility. a. During a concurrent interview and a review of the Line Listing for COVID Exposure (undated), on 5/24/2023, at 3:19 p.m., with the Director of Nursing (DON), "the Line Listing for COVID Exposure indicated the dates of COVID-19 testing, the names of patients who were tested, and the results of COVID-19 testing. The DON stated the Line Listing was not completed by the IP, because the IP was "new" and "just started working in the facility." During a concurrent interview and a review of a new, untitled line listing provided by the facility, on 5/26/2023, at 10:47 a.m., with the IP, . the new, untitled line listing indicated all the patient names, the dates of COVID-19 testing, and their COVID-19 results (positive or negative). The IP stated the COVID-19-line listing did not include all the pertinent data related to the outbreak, such as, names of COVID-19 positive patients on isolation, vaccination status, location in the facility, date/s of diagnostic or laboratory tests, the signs/symptoms present, and the outcome to effectively prevent further spread of COVID-19 infection. During a review of the facility's COVID-19 Mitigation Plan (undated), it indicated the following: 1. The facility must ensure the IP reviews guidance and recommendations provided by the Centers for Disease Control and Prevention (CDC, a United States federal government agency whose mission is to protect public health by preventing and controlling disease, injury, and disability), California Department of Public Health (CDPH), and/or local health department (LHD) to maintain consistent situational awareness with highly evolving nature of COVID-19. 2. The IP must maintain a line list of all patients and staff who are confirmed and suspected to be COVID-19 positive. During a review of the local public health department's guidance, titled "Coronavirus Disease 2019: Guidelines for Preventing & Managing COVID-19 in Skilled Nursing Facilities," dated 4/27/2023, it indicated the following: 1. Active symptom screening of patients and staff are the basis of infectious disease surveillance. 2. Prompt identification and management of symptomatic individuals (testing and isolation), including those with mild symptoms, can help mitigate transmission. [Source: http://publichealth.lacounty.gov/acd/ncorona2019/healthfacilities/snf/prevention/#testing] During a review of the Centers for Disease Control and Prevention (CDC) guidance, titled "Long-Term Care (LTC) Respiratory Surveillance Line List," dated 3/12/2019, indicated the following: 1. The Respiratory Surveillance Line List provides a template for data collection and active monitoring of both patients and staff during a suspected respiratory illness cluster or outbreak at a LTC facility. 2. The information in the columns of the worksheet capture data on the case demographics, location in the facility, clinical signs/symptoms, diagnostic testing results and outcomes. 3. Information gathered on the worksheet must be used to build a case definition, determine the duration of outbreak illness, support monitoring for and rapid identification of new cases, and assist with implementation of infection control measures by identifying units where cases are occurring. [Source: https://www.cdc.gov/longtermcare/pdfs/LTC-Resp-OutbreakResources-P.pdf] b. During a telephone interview on 5/30/2023, at 12:18 p.m., with Certified Nursing Assistant 7 (CNA 7), CNA 7 stated she started working in the facility about a month ago and had been assigned in the Red Zone (designated area of isolation for confirmed COVID-19 patients) during this current COVID-19 outbreak. CNA 7 stated she has not been N95 fit-tested in the facility, although she has been fit-tested at her previous job. CNA 7 was unable to state the specific make, model, style, and size of the N95 she was using at the other facility. During a telephone interview on 5/30/2023, at 4:01 p.m., with the DON, The DON stated he had "no idea" why CNA 7 was not fit-tested for N95 respirator prior to being assigned to the Red Zone. The DON stated even when facility’s staff were fit-tested at their previous job, they must still be tested at the facility upon hire and annually to ensure the protection of the staff and limit further spread of the COVID-19 infection. The DON stated the facility did not have a policy and procedure regarding N95 fit testing. During a review of the CDC guidelines titled, "Proper N95 Respirator Use for Respiratory Protection Preparedness," dated 3/16/2020, it indicated that staff who are required to use respiratory protection must undergo fit testing, medical clearance, and training, which are all required elements of a healthcare facility's written respiratory protection program required by the Occupational Safety and Health Administration (OSHA) Respiratory Protection standard (29 CFR 1910.134). [Source: https://blogs.cdc.gov/niosh-science-blog/2020/03/16/n95-preparedness/] A review of the OSHA's regulations titled, "Occupational Safety and Health Standards: Respiratory Protection (29 CFR 1910.134)," indicated the following: 1. The facility staff must be fit-tested with the same make, model, style, and size of respirator that would be used before a staff would be required to use any respirator. 2. The employer must provide a respirator that is adequate to protect the health of the employee and ensure compliance with all other OSHA statutory and regulatory requirements, under routine and reasonably foreseeable emergency situations. 3. The employer must provide a medical evaluation to determine the employee's ability to use a respirator, before the employee is fit tested or required to use the respirator in the workplace. The employer must identify a physician or other licensed health care professional to perform medical evaluations using a medical questionnaire or an initial medical examination that obtains the same information as the medical questionnaire. 4. Inadequacies in the employee's knowledge or use of the respirator indicate that the employee has not retained the requisite understanding or skill. 5. The employer must establish a record of qualitative and quantitative fit tests administered to an employee, including the name or identification of the employee tested, type of fit test performed, specific make, model, style, and size of the respirator tested, date of test, and pass/fail results for QLFTs or the fit factor and strip chart recording or other recording of the test results for QNFTs. 6. The fit test records must be retained for respirator users until the next fit test is administered. [Source: https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.134] c. During an interview on 5/26/2023, at 9:55 a.m., Occupational Therapy Assistant 1 (OTA 1) stated the DON conducted his fit testing upon hire. During a concurrent interview and a review of the fit testing records, dated 2/21/2023 of Occupational Therapist 1 (OT 1), Director of Rehab (DOR), Physical Therapy Assistant 1 (PTA 1), CNA 2, and CNA 1, and fit testing record, dated 4/25/2023, of Occupational Therapy Assistant 1 (OTA 1), on 5/26/2023, at 10:28 a.m., with the DON, the DON stated he signed the blank line on the fit testing records that indicated "Fit Test Performed By." The DON stated he did not follow any specific guidelines on how to conduct the fit-testing because the facility did not have a policy regarding fit-testing that included specific procedures on the duration of each step (normal breathing, deep breathing, head side-to-side, head up and down, talking, bending over, normal breathing, and overall fit test) and how to determine if "pass" or "fail." The DON stated if the staff "can taste a bitter taste, then it is okay as long as he/she can breathe normal, and no air is leaking out of the sides of the N95." A review of the OSHA's regulations titled, "Occupational Safety and Health Standards: Respiratory Protection (29 CFR 1910.134)," indicated the following: 1. The facility must develop and implement a written respiratory protection program with required worksite-specific procedures and elements for required respirator use. The facility must designate a program administrator who is qualified by appropriate training or experience that is commensurate with the complexity of the program to administer or oversee the respiratory protection program and conduct the required evaluations of program effectiveness. The facility must include in the program the following provisions, as applicable: a. Procedures for selecting respirators for use in the workplace. b. Medical evaluations of employees required to use respirators. c. Fit testing procedures for tight-fitting respirators. The facility failed to implement interventions to prevent and control the spread of COVID-19 in accordance with the public health guidelines and the facility's policies and procedures by failing to: a. Provide documented evidence of the IP’s necessary surveillance of the COVID-19 outbreak with a complete line listing of COVID-19 positive patients and staff. b. Ensure all staff were fit- for N95 respirator upon hire and/or annually. c. Establish and implement policies and procedures, including specific fit-testing procedures, related to the respiratory protection program required by the OSHA. These failures resulted in potentially increasing the spread of COVID-19 infection in the facility. This violation jointly, separately, or in any combination, had a direct or immediate relationship to the health, safety, or security of all patients in the facility.