Monthly Archives: August 2022

8/28+ WA Only: FAQ re End of COVID CofN Waivers

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Certificates of Need and Construction Reviews for ESRD facilities in Washington State were waived to allow a faster response to the COVID-19 pandemic. On August 1, 2022, Washington DOH announced that those waivers would end, and provided a timeline for that process, as described at https://nwrnbulletins.wordpress.com/2022/08/03/8-4-wa-only-covid-cofn-waivers-to-end/. Washington DOH has added a web page of Frequently Asked Questions about the process, at https://doh.wa.gov/sites/default/files/2022-08/FAQ-COVID-19WaiverOffboarding.pdf. The timeline includes August 28 deadlines.

8/23+ Late August Events

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  • August 23-September 1, 2022: CMS National Training Program Webinars. Details and Registration at https://cmsnationaltrainingprogram.cms.gov/moodle/login/index.php:
    • August 23 – Medicare Scenarios (Casework Session)
    • August 24 – CMS and SAMHSA: Federal Partners addressing Behavioral Health
    • August 25 – Medicare Plan Finder
    • August 30 – Medicare Current Topics
    • August 31 – The Public Health Emergency (PHE) and CMS Programs
    • September 1 – Marketplace to Medicare: What You Can Expect

Class 1 Recall: Covidien HD Catheters

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The FDA has announced the Class 1 recall of specific lots of Covidien (Medtronic) Palindrome and Mahurkar HD Catheters because of hub defects which can cause leakage and other problems leading to inadequate dialysis or more serious safety issues. Class 1 recalls imply risk of serious injury or death. For details see https://www.fda.gov/medical-devices/medical-device-recalls/covidien-llc-medtronic-recalls-palindrome-and-mahurkar-hemodialysis-catheters-due-catheter-hub.

8/16 EQRS New User Training and New PTH Screen

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EQRS New User Training will be held on August 16, 2022. For details and registration see https://mycrownweb.org/pcw_lems/august-2022-new-user-training/.

CMS has added new parathyroid hormone (PTH) reporting fields to EQRS. Dialysis facilities are now able to enter monthly PTH values on the Manage Clinical screen, under the Mineral Metabolism section in EQRS. The new PTH reporting fields include Parathyroid Hormone Value and date (Month, Day, Year), Parathyroid Hormone Method, and Parathyroid Hormone Upper Limit Assay Range:  

PTH values do not impact a facilities QIP, and entering them into EQRS is not required; however, facilities are required to enter N/A if a PTH value was not measured for the patient for the clinical month. The Parathyroid Hormone Method, Parathyroid Upper Limit Assay Range and date fields are required when a PTH value is entered. Reporting PTH data in EQRS allows CMS to assess bone mineral management and adverse outcomes associated with the management of PTH among the ESRD patient population; analysis will begin with PTH data for July. If your facility batch submits data or uses Health Information Exchange/Electronic Data Interchange methods for data submission, please follow the guidance provided by your organization. For more information see the PTH Reporting Frequently Asked Questions resource at https://mycrownweb.org/wp-content/uploads/2022/08/PTH-Reporting_FAQs_FINAL508.pdf. If you are having technical issues with accessing the EQRS user interface, contact the CCSQ Service Center between 5am and 5pm PT Monday-Friday at 866-288-8912, qnetsupport-esrd@cms.hhs.gov, or https://cmsqualitysupport.servicenowservices.com/ccsq_support_central.

8/4+ WA only COVID CofN Waivers to End

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Urgent information about COVID waivers: Early in the COVID-19 pandemic, Governor Inslee issued Proclamation 20-36 which waived certain certificate of need (CN), construction review (CR), and facility licensing requirements to allow health care facilities to rapidly adapt and expand to meet the demands for surge capacity. The Governor has announced his intent to rescind Proclamation 20-36 on October 27, 2022. Facilities that utilized the waivers to address surge must either revert their operations or take immediate action to move toward compliance by October 27, 2022. WA DOH will provide health care facilities a glide path to come into compliance, but you must act quickly to submit letters of intent and applications as described below. If your health care facility took advantage of the waivers in Proclamation 20-36 and you plan to maintain these changes beyond October 27, 2022, you must comply with state law applicable to your license type. This could include obtaining a certificate of need, obtaining construction review approval, and/or updating your license.

For those facilities requiring a Certificate of Need:

  1. By August 28, 2022, facilities must submit a Letter of Intent to WA DOH conforming to WAC 246-310-080. Letters of Intent must describe the increase in capacity and/or new locations the facility wants to maintain and be accompanied by a patient transition plan should DOH not approve the application. Send the Letter of Intent to COVIDwaiver@doh.wa.gov.  
  2. By October 27, 2022, facilities must submit a CN application and the appropriate fee to WA DOH following existing CN application processes and requirements. Facilities must also submit applications to modify their facility license within this same timeframe, as appropriate. If your CN application is denied, you must execute your patient transition plan and revert your operations to your previously approved CN.
  3. Exception: Health care facility types on a concurrent review cycle for CN applications (including ESRD facilities) will be required to submit a second Letter of Intent, CN application, and appropriate fee in compliance with WA DOH’s published schedule the next time the application cycle opens. Facilities must also submit applications to modify their facility license within this same timeframe, as appropriate. If your CN application is denied, you must execute your patient transition plan and revert your operations to your previously approved CN.

For those facilities requiring Construction Review:

  1. By August 28, 2022, facilities must submit a construction review application to COVIDwaiver@doh.wa.gov and appropriate fee. Applications must include a clear description of the scope of work (physical changes, additions, renovations) made to the facility.
  2. By October 27, 2022, facilities must submit formal engineering plans, functional programs, and associated documentation needed to evaluate compliance with the state licensing rules OR submit a technical assistance application to WA DOH to confirm the scope of work and establish documentation requirements. Facilities must respond quickly and in good faith to correct non-compliant construction, eliminate hazards within the environment and complete the review project.
  3. By January 25, 2023, and every 90 days after that until the project is fully approved, submit to WA DOH quarterly progress reports that address project status, updates since the last report, and planned completion date.

Following the process above will not adversely affect a facility’s CN, CR, or license application. Failure to follow the steps outlined above will be considered non-compliance and the department may take appropriate enforcement action. If you have any questions about what actions you should take now, technical assistance is available at COVIDwaiver@doh.wa.gov.

Informational Webinars: WA DOH will also host webinars about the glide path described above on the following dates:

8/8+ New EQRS Vaccination Tab and Module

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Beginning approximately August 8, 2022, EQRS users will be required to enter any new vaccination data for Hepatitis B, Influenza, and Pneumococcal vaccinations on the Manage Patient screen under the new Vaccinations tab in EQRS, shown at right.

During the new Vaccination Module rollout, the most recent vaccination records for patients will be migrated from the Manage Clinical screen and will be visible on the new screens. On approximately October 1, 2022, the vaccination fields will no longer appear on the Manage Clinical screen.

Additionally, this new EQRS reporting process for vaccinations is an event-based reporting process. This means that EQRS users must submit vaccination data when a vaccination event occurs. A vaccination event occurs when a patient:

  • Receives a vaccine dose administered by the reporting facility.
  • Receives a vaccine dose by an outside provider with documentation.
  • Receives a vaccine dose which is self-reported with or without documentation.
  • Does not receive a vaccine dose offered by the reporting facility.

In addition to reporting vaccination information when a vaccination event occurs, facilities must also review patient vaccination history and enter any confirmed vaccination information into EQRS upon each patient admission to the facility. Facilities have until approximately October 1, 2022 to fully transition their Hepatitis B, Influenza and Pneumococcal vaccination reporting process in EQRS to the new Vaccinations Module (shown below) that is located under the Vaccinations tab on the Manage Patient screen.

For more information about the new EQRS reporting process for vaccinations, please refer to the EQRS Vaccination Data Submission Requirements and Frequently Asked Questions resource at https://mycrownweb.org/wp-content/uploads/2022/07/EQRS-Vaccination-Data-Submission-Requirements-and-Frequently-Asked-Questions-FAQ_vFINAL508.pdf.

If you are having technical issues with the EQRS user interface, contact the Center for Clinical Standards and Quality (CCSQ) Service Center, Monday-Friday 5am-5pm Pacific Time, at 866-288-8912, qnetsupport-esrd@cms.hhs.gov, or https://cmsqualitysupport.servicenowservices.com/ccsq_support_central. For general EQRS questions and questions about the ESRD QIP, please use the QualityNet Q&A Tool at https://cmsqualitysupport.servicenowservices.com/qnet_qa.

The notice from EQRS does not mention COVID-19 vaccinations, which are usually considered separately from Influenza vaccinations.