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Federal Written Comments |
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Written Comments FDA - 2023 (Jan 24, 2023) Important reason for updating the COVID-19 vaccine’s formulation is the mounting evidence of significant immunological imprinting which occurs with SARS-CoV-2 or vaccine exposure. Submission Written Comment FDA - Dec 19, 2019. Request that the FDA reverse its policy to exempt many implantable medical devices from directly displaying a UDI number on the implant, and to institute a policy of improved record keeping and record retention. Submission Written Comment. FDA - 2015, Jun 17 (May 1, 2015). Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record. Submission Written Comment Nov. 14, 2024. Public written comment regarding CDC's recommendations for the Prevention of Transmission of Infectious Diseases and the importance of using negative pressure rooms and N95 masks for airborne pathogens. In addition, the CDC should recommend the implementation of ASHRAE Standard 241 for clean indoor air. Written Comment Nov. 3, 2023 - Public Comment: CDC HICPAC Meeting -
Infection Control Recommendations. Oct. 24, 2023 - Updated Dec. 30, 2023. Letter to the CDC regarding the adverse impact of new recommendations on immunosupressed individuals and how they may conflict with the Americans With Disability Act. Oct. 24, Letter Updated Letter CDC Response Aug. 22, 2023 - Public Comment: CDC HICPAC Meeting -
Infection Control Standards. CDC HICPAC - 2023, June 9. Enhanced Barrier Precautions. Concerns regarding the effectiveness of this strategy. Written Comment CDC HICPAC - 2023, June 8. Aerosol spread of respiratory pathogens. Concerns regarding the pro-posed recommendations. Written Comment CDC ACIP - 2023 Feb. 15 (Feb 22-24, 2023). Important reason for updating the COVID-19 vaccine’s formulation is the mounting evidence of significant immunological imprinting which occurs with SARS-CoV-2 or vaccine exposure. Submission Written Comment CDC-HICPAC - 2022, Aug 23. CDC HICPAC: Need for Data and Risk Adjustment Normalization of Deviance Written Comment CDC HICPAC - 2022, Jun. 2. Adopting the highest level of safety standards to protect patients, the public and frontline staff. Written Comment CDC HICPAC - 2022, Mar. 24. COVID-19: Universal Use of N95 Masks & Community Risk Zones Should Be Based Upon Infections. Written Comment CDC HICPAC - 2022, Mar. 24. Written Public Comment regarding CDC presentation on the use of gowns and masks by healthcare workers while treating COVID-19 patients. Written Comment CDC ACIP - 2021, Sept. 22,23 (Sept. 23, 2023). Written Comment Regarding Authorization of Pfizer/BioNTech Boosters. Submission Written Comment Receipt Written Comment CDC APIC - 2021, Aug 13. Written Public Comment CDC Advisory Committee on Vaccines Regarding Boosters in the Elderly. View Comment CDC HICPAC - 2021, Jun. 3. the CDC should classify the Delta variant, as a variant of concern. Written Comment CDC HICPAC - 2021, Mar. 4. Regarding Better Standards & Tracking To Protect Frontline Workers. Written Comment CDC HICPAC - 2019, Nov. 14. Concern regarding the efficacy of enhanced barrier precautions in preventing the spread of dangerous pathogens in nursing homes. Written Comment CDC - 2019, Sept. 19. Comment on Draft Guideline for Prevention and Control of Infections in Neonatal Intensive Care Unit Patients: Draft Recommendations for the Prevention and Control of Staphylococcus aureus in Neonatal Intensive Care Unit Patients. Submission Written Comment CDC HICPAC - 2019, May16. Need for accurate reporting of and increase transparency of dangerous pathogens. Written LA Times OpEd Oral Comment Given Before HICPAC CDC - 2018, Oct. 31. Infection Control in Healthcare Personnel: Infrastructure and Routine Practices for Occupational Infection Prevention and Control Services. Submission Written Comment CMS - 2023, June 4. Comment requesting the Centers for Medicare and Medicaid Services (CMS) enact a financial incentive to reduce COVID-19 spread in hospitals as part of CMS-1785-P. Written Comment CMS - 2019, Feb 22 (Feb. 15, 2019). The present system of facility accreditation is fraught with substantial conflicts of interest which we believe are resulting in an insurmountable bias in the accreditation process, which will continue unless these conflicts are eliminated. Submission Written Comment CMS - 2018, July 27 (Jun. 25. 2018) RIN 0938-AT27 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2019 Rates; Proposed Quality Reporting Requirements for Specific Providers; Proposed Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (Promoting Interoperability Programs) Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Medicare Cost Reporting Requirements; and Physician Certification and Recertification of Claims. Submission Written Comment CMS - 2017, Jun. 12 (Feb. 3, 2017) Medicare Program;
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the
Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes
and Fiscal Year CMS - 2014, Jul. 16. Support of the Hospital-Acquired Condition (HAC) Reduction Program proposed rule in the Federal Register, 79 FR 27977. Submission Written Comment CMS - 2013, Aug. 16, 2013. Comment on 42 CFR Parts 405, 410, 412, Federal Register, Friday July 19, 2013: “Medicare and Medi-caid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Sys-tems and Quality Reporting Programs; Hospital Value-Based Purchasing Program; Organ Procurement Organizations; Quality Improvement Organizations; Electronic Health Records (EHR) Incentive Program; Provider Reimbursement Determinations and Appeals; Proposed Rule” Page 43626 to 43627 “D. Col-lecting Data on Services Furnished in Off-Campus Provider-Based Departments. Submission Written Comment CMS - 2010, Aug 17. (May 18, 2010) Public Reporting of Hospital Acquired Coditions. Submission Written Comment CMS - 2010, Apr. 19. Structure of Electronic Database FIles. Submission/WrittenComment PACCARB - 2023, Dec. 20. CDC's Enhanced Barrier Precautions and Contact Precaution Recommendations. Written Comment PACCARB - 2023, Jan. 24. Impact of COVID-19 Immune
Dysfunction on Antibiotic Resistant Bacteria- PACCARB Presentation.
Written Comment
PACCARB - 2021, Feb. 11. Regarding Universal Reporting of Pathogens, Better COVID-19 HAI Metrics. Written Comment PACCARB - 2020, Sept. 9-10. Regarding Need for a Comprehensive National Reporting System. Written Comment PACCARB - 2020, Feb. 26 & 27. Enhanced Precautions for Nursing Homes -- Will they be enough to stop infections? & Transparency of Outbreaks of Dangerous Pathogens - Is the United States Any Better Than China?. Written Comment PACCARB - 2019, July 11. Risk Adjustment and the Need for More Comprehensive Reporting of Deadly Infections. Written Comment PACCARB - 2019, July 10. Resistant Bacteria the Need for Increased Vigilance and Healthcare Worker Protection. Written Comment PACCARB - 2019, Jan. 31, 2019. The importance of the microbiome to overall patient health and the prevention of infectious disease. Written Comment PACCARB - 2018, Sept. 26. The need for greater focusing on the control of spread of Multi-Drug Resistant Organisms. Written Comment PACCARB - 2018, May 16. The importance of forming standards for control of Resistant Organisms. Written Comment PACCARB - 2017, Sept. 14. MRSA tracking and prevention, along with the need for a better definition of an "outbreak", the over dependance on hand hygiene and the importance of knowing the patient's microbiome. Written Comment PACCARB - 2017, Jan. 25. The United States missing goals for reducing MRSA and other resistant pathogens along with the need for a mandatory publicly reported comprehensive surveillance system to track multi-drug resistant organisms. Written Comment PACCARB - 2016, Sept. 19. The committee needs to ensure that our healthcare institutions make the needed investments in prevention and patient safety, along with setting well-defined standards for screening, isolation, environmental cleaning, appropriate staffing and worker safety.. Written Comment PACCARB - 2016, Jun. 21. The importance of nursing, worker safety and carrier surveillance was stressed. Attention was also drawn to polymyxin B in topical over-the-counter antibiotics as a possible cause of resistance to colistin. Written Comment. PACCARB - 2016, Mar. 30. Chlorhexidine, surveillance and public disclosure of conflicts of interest in the confrontation of the antibiotic bacterial resistance epidemic. Written Comment PACCARB - 2015, Sept. 29. Comments on research integrity, conflicts-of-interest, the need for firm standards, the tying of antibiotic stewardship to funds for antibiotic development and public reporting of antibiotic provider utilization data. Written Comment Dept. Health & Human Services Go To Top ASPR - Nov. 30, 2023. Comment calling for the assurance of an adequate supply of negative pressure patient rooms and an adequate supply and production capacity for N95 masks. New CDC proposals will decrease usage of these resources which will result in a decreased production capacity for N95 masks and an inadequate number of negative pressure rooms available for the next pandemic. Written Comment DHHS - 2010, Mar. 30. Medicare and Medicaid Programs, Electronic Health Record Incentive Program. Call for standarized data and file structure. Submission Written Comment
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