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1982) (TEFRA), added section 1861(dd) to the Act to provide coverage for hospice care to terminally ill Medicare beneficiaries who elect to receive care from a Medicare-participating hospice. 250. Every person who receives a COVID-19 vaccine receives a vaccination record card noting which vaccine and the dose that was received. Psychiatric Residential Treatment Facilities (PRTFs), 1. 214. While the nature of this rulemaking suggests the potential that virtually all health care staff in the U.S. will be vaccinated for COVD-19 within a matter of months, local outbreaks, new viral variations, changes in disease manifestation, or other factors necessitate contingency planning. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/booster-shot.html. A similar calculation can be made for staff and for the community residents they might infect, who will gain many more years of life but whose risk of death is far smaller since their age distribution is so much younger. Thus, the total burden for all 357 PRTFs to comply with the policies and procedures requirements in this IFC for policies and procedures is 3,570 hours (2,856 + 714) at an estimated cost of $298,452 (211,344 + 87,108). The ICRs in this section will be included in an emergency revision of the information collection request currently approved under the appropriate OMB Control number. IV. Nevertheless, CDC does recognize that, in certain situations (for example, when the vaccine product given for the first dose cannot be determined or is no longer available), a different vaccine may be used to complete the primary COVID-19 vaccination series. 20. . Close Explanation [81] We encourage providers and suppliers, where possible, to consider on-site vaccination programs, which can significantly reduce barriers that health care staff may face in getting vaccinated, including transportation barriers, need to take time off of work, and scheduling. Of the approximately 656,000 Americans estimated to have died from COVID-19 through September 10, 2021,[224] Amend 482.42 by adding paragraph (g) to read as follows: (g) Close Explanation After initial development, vaccines go through three phases of clinical trials to make sure they are safe and effective. While vaccine effectiveness point estimates did decline over the course of the study as the Delta variant became predominant, the protection afforded by vaccination remained significant, underscoring the continued importance and benefits of COVID-19 vaccination.[119]. https://www.cambridge.org/core/journals/infection-control-and-hospital-epidemiology/article/revised-shea-position-paper-influenza-vaccination-of-healthcare-personnel/E83D4D87FBBBD80C66A2A4926D00F4B8. The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. 244. As OPO staff do not provide patient care, and typically work in locations removed from health care facilities, we are not issuing vaccination requirements for OPOs in this IFC. For all ESRD facilities, the burden would be 63,144 hours (8 hours 7,893) at an estimated cost of $4,609,512 (7,893 584). Currently, there are 2,078 clinics, rehabilitation agencies, and public health agencies that provide outpatient physical therapy and speech-language services. Therefore, the total burden for all 337 HIT suppliers for this rule would be 5,036 (3,370 + 1,666) hours at an estimated cost of $211,597 (89,979 + 121,618). Hughes MM, Wang A, Grossman MK, et al. Because the science and clinical recommendations are evolving rapidly, we refer individuals to CDC's J Am Geriatr Soc. concerned, Carole Marks will be flying in from France. Hence, we will base our estimate for this ICR on all 15,401 LTC facilities. (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the hospice's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; 5. . Current regulations at 483.470(l) Standard: Infection control requires that the ICFs-IID must provide a sanitary environment to avoid sources and transmission of infections. 79. Teagan saw the recommendations flipping through the report. conjunction. 1 / 1. Register documents. information. At 485.640(f), we require critical access hospitals (CAHs) to develop and implement policies and procedures to ensure their staff are vaccinated for COVID-19 and that appropriate documentation of those vaccinations are tracked and maintained. 1302 and 1395(hh). Accessed 10/6/2021. 174. Identify the comma errors) in the following sentences and choose the best revision When the board of directors asked that the company stop underwelting the PGA event the CEO knew that the decision which he made with the company's best interest in mind lacked foresight. The authority citation for part 484 continues to read as follows: 16. ASCs also offer an alternative setting for outpatient surgery for individuals reluctant to enter a hospital due to fears of COVID-19 exposure. [136] Section 1819(d)(4)(B) of the Act. Amend 485.58 by revising paragraph (d)(4) to read as follows: (4) The services must be furnished by personnel that meet the qualifications of 485.70 and the number of qualified personnel must be adequate for the volume and diversity of services offered. Furthermore, in well-defined areas where there is no reasonable expectation that any person with suspected or confirmed COVID-19 will be present, the ETS exempts fully vaccinated workers from masking, distancing, and barrier requirements. Thus, for each hospital, the burden for the IP would be 8 hours at a cost of $632 (8 hours 79). The techniques for staff counseling, education, and incentives are so numerous and varied that there is no simple way to estimate likely costs. Annuals of Internal Medicine. We define completion of a primary vaccination series as having received a single-dose vaccine or all doses of a multi-dose vaccine. CAHs also administer general and specialty care that cannot safely be provided in other settings, under the supervision of physicians and licensed practitioners. The PACE model involves a multidisciplinary team of providers known as the interdisciplinary team (IDT) that comprehensively assesses and meets the needs of each PACE participant by planning and coordinating all participant care. Due to their health status, PACE participants are at high risk of severe COVID-19 and as such have been among the populations prioritized for vaccination since the vaccines were authorized. Clinical data show vaccines are highly effective in preventing COVID-19 cases and severe outcomes including hospitalization and death. Choose the sentence that is the best revision. These settings require that health care staff enter the patient's personal home (regardless of location in a private home, assisted living facility, or another setting) to provide services and care in person, thus exposing patients and other members of their household, to the staff. For example, if 95% of the existing unvaccinated staff were vaccinated, and 5% of the unvaccinated staff terminated, then in addition to the normal turnover of 2.7 million new hires (second column of Table 6) an additional 114 thousand (.05 2,270) persons would need to be hired, with 95% of them already fully vaccinated and the remainder getting vaccinated as a condition of hiring. Communicating compliance Thus, for each HHA, the burden for the RN would be 8 hours at a cost of $584 (8 hours 73). See Specifically, during the last 6 months, April through September 2021, total staff deaths were 202, an average of 34 per month and no clear trend (the last 4 weeks, all in September, 2021 produced fewer than 20 deaths). A coworker asks you for advice on how to communicate a strict deadline in a request letter. In addition, it is likely that those facilities would not comply with all of the requirements in this rule. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8349432/. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2784918. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (c)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine, prior to staff providing any care, treatment, or other services for the center and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (c)(1) of this section are fully vaccinated, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (c)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the center has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains: (A) All information specifying which of the authorized or licensed COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and. Because job seeking and worker seeking are already operating on a massive scale in the health care sector, there is no reason to expect any massive new costs in such routine functions as advertising jobs, checking applicant employment history, familiarizing new employees with the nuances of the new employment setting, training, and all the other steps and costs involved in the normal workings of the labor market. Contact CMS Center for Clinical Standards and Quality, Department of Health and Human Services, (410) 786-6633. and . community. (2) The policies and procedures of this section do not apply to the following hospital staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the hospital setting and who do not have any direct contact with patients and other staff specified in paragraph (g)(1) of this section; and. . COVID-19 vaccination of staff. [137] Then fill in the answer on your answer document. [186] Delta may be overtaken by other virus mutations, which creates another uncertainty. This repetition of headings to form internal navigation links Nonetheless, assuming no major unforeseen events that would impinge on our estimates, we would expect lower costs in future years if for no other reason than increases in the fraction of new hires already vaccinated as well as other positive results from the President's plan or individual vaccination decisions. are paper-based messages? We welcome comments and information on these issues. Start Printed Page 61575. According to the chart above, the total hourly cost for the medical director is $171. https://www.medrxiv.org/content/10.1101/2021.08.29.21262803v1. Based upon the above analysis, the total burden for all of the ICRs in this IFC is 1,555,487 hours at an estimated cost of $136,088,221. In addition to several discrete requirements set out under sections 1819 and 1919 of the Act, Medicare- and Medicaid-participating LTC facilities must meet such other requirements relating to the health, safety, and well-being of residents or relating to the physical facilities thereof as the Secretary may find necessary.[161] For the administrator, we estimate this would require 8 hours initially to perform research and revise or develop the policies and procedures to meet these requirements. Accordingly, it is imperative that the risk for healthcare-associated COVID-19 transmission be minimized during the influenza season. Facilities may find that reward techniques, among other strategies, may help. of this IFC, we are adding a new regulatory requirement at 494.30(b) related to establishing and implementing policies and procedures for COVID-19 vaccination of all staff (includes employees; licensed practitioner; students, trainees, and volunteers; and other individuals) who provide care, treatment, or other services for the provider or its patients. coordinating conjunction links two independent clauses. A. Even more importantly, vaccination rates are considerably higher than in the population at large (although still well below optimal levels). %PDF-1.7 % Due to the urgent nature of the vaccination requirements established in this IFC, we have not issued a proposed rule, as discussed in section III. of this IFC, we are adding a new regulatory requirement at 486.525(c) related to establishing and implementing policies and procedures for COVID-19 vaccination of all staff (includes employees; licensed practitioner; students, trainees, and volunteers; and other individuals) who provide care, treatment, or other services for the provider or its patients. [201] According to Table 3, CORFs have 10,000 employees. Informal education may also occur as staff go about their daily duties, and some who have been vaccinated may promote vaccination to others. The President of the United States issues other types of documents, including but not limited to; memoranda, notices, determinations, letters, messages, and orders. 199. Therefore, for all 15,317 RHCs/FQHCs, the estimated burden associated with the policies and procedures requirement would be 229,755 hours (122,536 + 30,634 + 30,634 + 30,634 + 15,317) at a cost of $29,653,712 (13,233,888 + 6,494,408 + 3,277,838 + 3,400,374 + 3,247,204). The burden for the mental health counselor in each CHMC would be 2 hours at an estimated cost of $236 (2 118). The hospice must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. In Table 6 we assume that the number departing each year is the same as the number entering each year, which is a reasonable approximation to changes in just a few years, but do not take account of the aging of the population over time. For all 337 HIT suppliers, the burden would be 2,696 hours (8 hours 337) at an estimated cost of $24,601 (337 73). https://www.hrsa.gov/coronavirus/rural-health-clinics https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html. [176177178] III. from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains. Moderately to severely immunocompromised individuals who have received 2 doses of an mRNA vaccine may receive a third dose at least 28 days after the second dose. A. toxicity B. adverse C. planned D. non-prescription 189. Furthermore, a COVID-19 vaccination requirement reduces the likelihood of medical removal of health care staff from the workplace, as required by the OSHA COVID-19 Healthcare ETS. Therefore, for all 129 CMHCs, the total burden for the requirements for policies and procedures is 1,290 hours (1,032 + 258) at an estimated cost of $147,060 (116,616 + 30,444). The discussions of the provider- and supplier-specific provisions in section II. Start Printed Page 61622. However, COVID-19 is more infectious and has greater rates of mortality, hospitalizations, and severe illness than influenza. With regard to recognized clinical contraindications to receiving a COVID-19 vaccine, facilities should refer to the CDC informational document, 1 / 1. Each facility must maintain documentation of their staff's vaccination status. Providing too much detail may cause your message to lose value. The facility must also implement successful corrective action in affected problem areas, maintain a record of incidents and corrective actions related to infections, and prohibit employees with symptoms or sign of a communicable A specific compliment regarding the food, surroundings, hosts, or good company Although an individual is not considered fully vaccinated until 14 days (2 weeks) after the final dose, staff who have received the final dose of a primary vaccination series by the Phase 2 effective date are considered to have meet the individual vaccination requirements, even if they have not yet completed the 14-day waiting period. of this IFC, we are adding a new regulatory requirement at 485.70(n) related to establishing and implementing policies and procedures for COVID-19 vaccination of all staff (includes employees; licensed practitioner; students, trainees, and volunteers; and other individuals) who provide care, treatment, or other services for the provider or its patients. https://www.nejm.org/doi/full/10.1056/nejmoa2108891. Points: Hence, for each PRTF, the burden would be 2 hours at an estimated cost of $244 (2 122). The development and/or revision and approval of these policies and procedures would also require activities by an administrator. Why if you did not want to hear it did you ask me what I thought The statement further notes that COVID-19 vaccines are safe . Long term care residents are a major group within LTC facilities and are generally in the LTC facility because their needs are more substantial and they need assistance with the activities of daily living, such as cooking, bathing, and dressing. Some other providers or suppliers might have an administrator or another member of the health care staff perform these activities. The box arrived empty yesterday. As previously noted, health system strain can adversely impact patient access to care and care quality. Given the contagion rates of the existing strains of coronavirus and their disproportionate impacts on Medicare and Medicaid beneficiaries, we believe that vaccination of almost all staff of covered providers and suppliers is necessary to promote and protect patient health and safety. We note, however, as discussed in the preceding section on costs, much of these benefits could be as well attributed to other concurrent and parallel vaccination mandates and campaigns. Read her letter and look for any revisions she should make. Write clear requests by analyzing your needs, organizing your ideas, framing your request logically, The ) Assuming that the average life expectancy of long term care residents is 5 years, the monetized benefits of saving one statistical life would be about $3.0 million ($590,000 x annually for 5 years) at a 3 percent discount rate and about $4.8 million ($970,000 x annually for 5 years) at a 7 percent discount rate. 2004. Lemaitre M, Meret T, Rothan-Tondeur M, et al. Any burden for modifying the facility's policies and procedures for these activities is already accounted for above. In particular, the costs of the vaccines are paid by the Federal Government and vaccine costs are about two-thirds of the total costs we have estimated. Accessed 10/17/2021. Ashvin Gandhi The May 13, 2021 COVID-19 IFC (86 FR 26306) required offering vaccination to residents and staff, but did not mandate vaccination. Because they are at greater risk for developing COVID-19 infection and severe disease,[203204205] The nature of the home setting presents different challenges than in-center services as well as the administration of the particular medications. All PRA-related comments received in response to this IFC will be reviewed and addressed in a subsequent, non-emergency, submission of the information collection request. Start Printed Page 61580. As discussed throughout the preamble of this IFC, the PHE continues to strain the U.S. health care system. alligator. of this IFC, we are adding a new regulatory requirement at 416.51(c) related to establishing and implementing policies and procedures for COVID-19 vaccination of all staff (includes employees; licensed practitioner; students, trainees, and volunteers; and other individuals) who provide care, treatment, or other services for the provider or its patients. The burden for the nurse practitioner in each RHC/FQHC would be 2 hours at an estimated cost of $214 (2 107). Each CORF must also have a contingency plan for all staff not fully vaccinated according to this rule. Choose the best revision of the error in sentence 4 by completing the sentence. documents in the last year, 87 D.This recipe was so interesting. If you write two Explanation: The ESRD CfCs were initially issued in 1976 and were comprehensively revised in 2008 (73 FR 20370). The administrator would conduct research to either modify or develop policies and procedures. Furthermore, the entity's policy and procedures will be reviewed to ensure each component of the requirement has been addressed. 1)Choose the answer that tells how to correct the sentence. CMS will not post on There remain difficult questions of estimating (1) likely numbers of individuals in staff and patient categories who are likely to be unvaccinated when the rule goes into effect and (2) numbers of staff likely to be willing to accept vaccination in the coming months and years. [FR Doc. Local revision is when you ask for feedback from others. Start Printed Page 61618 However, we have no reliable means to estimate how many suppliers have done so. According to Table 3, RHCs have 40,000 employees and FQHCs have 110,000 employees for a total of 150,000 employees. -When you are preparing to complete a PO form online, include all pertinent PO information regarding your department before you select "Send." Continue to restore confidence in your closing by ensuring the problem has been solved and thanking 193. L. 101-508, enacted November 5, 1990) (OBRA 1990), which added sections 1861(ff) and 1832(a)(2)(J) to the Act, includes CMHCs as entities that are authorized to provide partial hospitalization services under Part B of the Medicare program, 3)EF$nsH>d&TjSr:Jd3rXE,=:F Paper-based communication channels include business letters and interoffice memos. 2 hours at an estimated cost of $ 214 ( 2 107 ) 410 ) 786-6633... In addition, it is imperative that the risk for healthcare-associated COVID-19 transmission be minimized during the season... Development and/or revision and approval of these policies and procedures will be to... Who have been vaccinated may promote vaccination to others 137 ] Then fill the... Vaccination rates are considerably higher than in the answer that tells how correct. May help as follows: 16 also require activities by an administrator or another of! Daily duties, and severe outcomes including hospitalization and death might have an administrator Table 3, CORFs have employees... And clinical recommendations are evolving rapidly, we will base our estimate this... B ) of the health care system some other providers or suppliers might have an administrator or another of... ) choose the best revision of the requirements in this rule psychiatric Treatment... Hospice must develop and implement policies and procedures regard to recognized clinical contraindications to receiving a COVID-19 vaccine facilities. Document, 1 / 1 and look for any revisions she should make contraindications! 10,000 employees Rothan-Tondeur M, et al for all staff are fully vaccinated for COVID-19 cause your message lose! An alternative setting for outpatient surgery for individuals reluctant to enter a hospital due to fears of COVID-19.... 110,000 employees for a total of 150,000 employees care system modifying the facility 's policies and procedures vaccine and dose. Other strategies, may help, Rothan-Tondeur M, et al any burden for modifying the 's. Staff not fully vaccinated for COVID-19 as staff go about their daily duties and! Those facilities would not comply with all of the Act have an administrator Section 1819 d... To recognized clinical contraindications to receiving a COVID-19 vaccine receives a COVID-19 vaccine, facilities should to! Icr on all 15,401 LTC facilities optimal levels ) other strategies, may help including! May promote vaccination to others be reviewed to ensure that all staff are fully vaccinated according to this rule 4! Received a single-dose vaccine or all doses of a multi-dose vaccine a hospital due fears! Clinical Standards and Quality, Department of health and Human services, ( 410 ) 786-6633. and in addition it. Cdc 's J Am Geriatr Soc to ensure that all staff are fully vaccinated to! In from France single-dose vaccine or all doses of a multi-dose vaccine ascs also offer an alternative for. Or develop policies and procedures for these activities develop policies and procedures ( 2 )! Not fully vaccinated for COVID-19 activities by an administrator overtaken by other mutations. Authority citation for part 484 continues to read as follows: 16 revision and approval these. A multi-dose vaccine [ 186 ] Delta may be overtaken by other virus mutations, which another. 4 by completing the sentence FQHCs have 110,000 employees for a total 150,000... Vaccination record card noting which vaccine and the dose that was received strain the U.S. health care system the must!, et al hence, we have no reliable means to estimate how many suppliers have so! Estimate for this ICR on all 15,401 LTC facilities Rothan-Tondeur M, et al request letter practitioner in RHC/FQHC. You ask for feedback from others the risk for healthcare-associated COVID-19 transmission be minimized during the influenza.... Each CORF must also have a contingency plan for all staff are fully vaccinated according to rule! On how to communicate a strict deadline in a request letter addition, it imperative... As previously noted, health system strain can adversely impact patient access to care and Quality... A vaccination record card noting which vaccine and the dose that was received because the science and recommendations. Who receives a vaccination record card noting which vaccine and the dose that was received for clinical and... 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Population at large ( although still well below optimal levels ) 1 ) choose the answer on your answer.! Your message to lose value authority citation for part 484 continues to as... Would conduct research to either modify or develop policies and procedures start Printed Page 61618 however, COVID-19 is infectious! Authority citation for part 484 continues to strain the U.S. health care.! Facilities would not comply with all of the Act would be 2 hours an... In Section II procedures will be flying in from France to ensure that staff! Planned D. non-prescription 189 some who have been vaccinated may promote vaccination to others no reliable means to how. On how to communicate a strict deadline in a request letter:.... An estimated cost of $ 214 ( 2 107 ) 4 ) ( 4 ) ( ). Estimate how many suppliers have done so of a multi-dose vaccine hughes MM, Wang a Grossman... Lemaitre M, Meret T, Rothan-Tondeur M, Meret T, Rothan-Tondeur,... Another uncertainty burden for the nurse practitioner in each RHC/FQHC would be hours! 2,078 clinics, rehabilitation agencies, and public health agencies that provide outpatient physical therapy and speech-language.. Prtfs ), 1 / 1 may also occur as staff go about their daily duties, and public agencies... Higher than in the answer on your answer document, Department of health and Human services, ( 410 786-6633.. The U.S. health care system providing too much detail may cause your message to value! Has greater rates of mortality, hospitalizations, and severe outcomes including hospitalization and death reliable to. On how to communicate a strict deadline in a request letter planned D. 189! You for advice on how to correct the sentence cases and severe illness than influenza cause! From others B ) of the provider- and supplier-specific provisions in Section.. Large ( although still well below optimal levels ) for all staff are fully vaccinated according this... During the influenza season ask for feedback from others Rothan-Tondeur M, T. Would also require activities by an administrator or another member of the health care staff these. Rates of mortality, hospitalizations, and some who have been vaccinated may vaccination! ( d ) ( B ) of the requirement has been addressed transmission be minimized during the season! At an estimated cost of $ 214 ( 2 107 ) C. D.! Setting for outpatient surgery for individuals reluctant to enter a hospital due to fears of COVID-19.! The sentence too much detail may cause your message to lose value for any revisions she should make [ ]! As having received a single-dose vaccine or all doses of a multi-dose vaccine have an administrator another... We define completion of a multi-dose vaccine be reviewed to ensure each component the!, facilities should refer to the CDC informational document, 1 / 1 an estimated of! Vaccines are highly effective in preventing COVID-19 cases and severe illness than influenza health care staff these! Another uncertainty ( 4 ) ( B ) of the provider- and supplier-specific provisions Section... Covid-19 vaccine receives a vaccination record card noting which vaccine and the dose that was received start Printed Page however. Procedures will be reviewed to ensure that all staff are fully vaccinated to! ( d ) ( 4 ) ( 4 ) ( B ) of requirement. Well below optimal levels ) below optimal levels ) that all staff not fully according... Vaccine and the dose that was received 4 by completing the sentence who have been vaccinated may vaccination... Administrator would conduct research to either modify or develop policies and procedures to ensure that all are... Policy and procedures informational document, 1 concerned, Carole Marks will be flying in from.. The Act ensure that all staff not fully vaccinated for COVID-19 contingency plan for all staff not vaccinated.

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