Washington State Department of Health Regulatory Issues

April 17, 2017 – DOH proposes guidance on forensic blood draws by medical assistants

After a series of rules workshops, the Washington State Department of Health (DOH) has issued a CR-102 rulemaking proposal regarding forensic blood draws by medical assistants. The newly proposed medical assistant rules state that certain medical assistants may perform “forensic blood draws,” subject to supervision, delegation, and practice standards. The rules also specify that forensic blood draws are not limited to specific settings, such as hospitals or clinics. WSHA supports expanding forensic blood draw capacity in order to reduce pressure on hospital ED staff to perform these draws.

A public hearing on the proposed rules will be Tuesday, May 23, 2017, at 1:30pm in Tumwater. Information on this rulemaking and meeting locations can be found here.  The department is accepting written comments for these rules until May 23, 2017. (Zosia Stanley)

April 17, 2017 –  Blood establishment rules proposed

The Washington State Department of Health (DOH) has issued a CR-102 rulemaking proposal  to establish requirements and set fees for registration of “blood establishments” in Washington State. DOH was directed to undertake this rulemaking by SHB 2580 (enacted in 2016, codified at RCW 70.335). WSHA will be commenting on these proposed rules to make certain the rules accurately reflect the requirements of the law.

A public hearing on the proposed rules will be Tuesday, April 25, 2017, at 2:30pm in Tumwater. Information on this rulemaking and meeting locations can be found here.  The department is accepting written comments for these rules until April 25, 2017. (Zosia Stanley)

April 13, 2017 –  Follow up to Department of Health elective PCI certificate of need rulemaking meeting

The Department of Health (DOH) considered two rules petitions on elective percutaneous coronary intervention (PCI) at the rules meeting on April 11.  The first was a petition to reduce institutional and individual volume standards for elective PCI. The workgroup expressed general support for the reduced thresholds contained in the draft rules. The second was a petition to allow evaluation of elective PCI CON applications even absent numeric need. Following a request for more time to discuss the second petition, DOH has scheduled a one-hour meeting for 3-4:00 p.m., Thursday, May 11 at the  Department of Health’s Town Center 2 Building, Room 145, 111 Israel Road SE, Tumwater. The meeting will include a presentation and discussion of proposed exception language.

Additional information on the Department’s rulemaking activities is available here. (Zosia Stanley)

March 3, 2017 – Update on Department of Health certificate of need rulemaking to revise requirements for elective PCI

As noted in July, the Department of Health (DOH) is proceeding with rulemaking for elective percutaneous coronary intervention (PCI) certificate of need regulations. As a result of rulemaking petitions, DOH is considering reducing institutional and individual volume standards for safe and effective elective PCI.

Following work by a PCI data subcommittee, the rules workgroup will meet from 1-2:30 p.m., Tuesday, April 11 at the Department of Health’s Town Center 2 Building, Room 158, 111 Israel Road SE, Tumwater. The agenda, draft rules, data request, data report and analysis, and meeting summary are available for review prior to the meeting.

Additional information on the Department’s rulemaking activities is available here. (Zosia Stanley)

September 21, 2016 – Department of Health proposes to require certificate of need for expansion of operating rooms at existing ambulatory surgical facilities

The Washington State Department of Health Certificate of Need program has issued a CR-102 notice of rulemaking to require a certificate of need for the addition of operating rooms at an existing ambulatory surgical facility (ASF). The proposed change to WAC 246-310-020(1)(a) classifies the expansion of the number of operating rooms at an ASF as “the construction, development, or other establishment of a new health care facility” pursuant to RCW 70.38.150(4)(a). We encourage hospitals interested in this topic to engage in this rulemaking process. A hearing on the proposed rule is scheduled for Wednesday, October 19 at 1:00pm at the Department of Health’s Town Center 2, Room 145, 111 Israel Road SE in Tumwater. Additional information on the Department’s rulemaking activities is available here. (Zosia Stanley)

August 18, 2016 – Department of Health rulemaking to create credential for forensic phlebotomist medical assistants

The Washington State Department of Health (DOH) is in the beginning stages of rulemaking to explore creating a specific training route for law enforcement personnel to qualify for medical assistant-phlebotomist credentials. This rulemaking stems, in part, from a vetoed portion of HB 1276 (enacted in 2015) which would have created a new certificate to allow law enforcement personnel to conduct forensic blood draws on DUI suspects. WSHA supports a process to allow law enforcement to conduct forensic blood draws because it reduces pressure on hospital ED staff to conduct blood draws on potentially nonconsenting and combative patients. However, we are actively engage with this rulemaking due to liability and due process concerns regarding the location of forensic blood draws by law enforcement.

The next meeting on this rulemaking is Tuesday, August 30, 2016, from 9:00 a.m. to 12:00pm in Tumwater. Information on this rulemaking and meeting locations can be found here.

DOH has posted new FAQs to address questions related to medical assistants (MAs) performing forensic blood draws. This information was produced to address frequent concerns and questions raised regarding the ability of MAs to perform forensic (non-medical) blood draws at the request of law enforcement. The new FAQs are available on the Medical Assistant FAQ Page. (Zosia Stanley)

July 13, 2016 – DOH begins certificate of need rulemaking to revise requirements for elective PCI

The Department of Health (DOH) is in the beginning stage of rulemaking relating to the standards for elective percutaneous coronary intervention (PCI) in certificate of need regulations. According to the rulemaking statement, as a result of rulemaking petitions, DOH is considering reducing institutional and individual volume standards for safe and effective elective PCI. DOH is also considering whether to allow evaluation of elective PCI CON applications absent numeric need. The question of elective PCI volume standards, and whether the procedure should be subject to certificate of need review, was raised by stakeholders in 2015 as part of a DOH review of tertiary services subject to certificate of need.  It its review report, DOH found substantial support for retaining certificate of need requirements for elective PCI, but noted the volume question fell outside the scope of the review.

The DOH rules development meeting has been changed to Wednesday, August 3, 2016 from 9:00am to 12:00pm at the Department of Health’s Town Center 2 Building, Room 145, 111 Israel Road SE, Tumwater, WA 98501. The meeting will include discussion of the proposed revisions, explanation of the rulemaking process and timeline, and an opportunity to discuss the proposed rule. More information on the rulemaking is available on the CON elective PCI rulemaking website. WSHA will attend this meeting and strongly encourages hospitals interested in this topic to engage in this rulemaking process. (Zosia Stanley)

 September 2, 2015 – Department of Health rulemaking regarding ambulatory surgical facilities

The Washington State Department of Health Certificate of Need program is in the beginning stages of rulemaking on two important issues affecting ambulatory surgical facilities. First, the Department is considering when the expansion of a Certificate of Need-approved ambulatory surgery facility results in a new healthcare facility needing a new certificate of need. Second, the Department proposes to update the need forecasting methodology and standards for these facilities. Both rules could have substantial impacts on the way the Department regulates these facilities and could result in regulations that disadvantage hospital-based versus free-standing facilities. One suggestion under discussion is whether hospital facilities should be included in the bed need methodology for independent facilities, under the notion that hospital-based facilities are more expensive and may not be direct equivalents. WSHA would strongly oppose such a consideration. WSHA is actively engaged with the Department on this issue and strongly encourages hospital participation. The next meeting on the Ambulatory Surgical Facilities rulemaking is scheduled for Wednesday, September 16. Information on the Department’s rulemaking activities and meeting locations can be found here. (Zosia Stanley)

June 25, 2015 – Preliminary statewide imaging rules

The Washington State Department of Health recently released a draft rule for Computed Tomography. The rule aims to improve the appropriate and safe use of imaging systems. We encourage hospitals, specifically quality leaders or imaging specialists to provide feedback on this draft rule. Comments will be accepted through July 17, 2015 and should be submitted to dohephctrulemaking@doh.wa.gov.

WSHA participated on the Department’s CT Advisory Committee which developed this draft rule. We appreciate the Departments aim to improve quality while acknowledging existing quality improvement efforts and being sensitive to reporting challenges. (Ian Corbridge).

July 22, 2015 – Pharmacy investigations, a concerning trend across the state

We recently became aware of a handful of circumstances in which the Pharmacy Commission and the Washington State Department of Health have opened investigations against a hospital pharmacy license or the license of individual hospital pharmacists’. These investigations could jeopardize access to essential medications and could make it harder for hospitals to attract high-quality pharmacists.

We are extremely concerned about the approach the Pharmacy Commission is taking and the increasing number of pharmacy licenses being investigated across the state. We are working with the Department of Health to further understand its policies on investigations and the recent uptick in investigations against individual pharmacists.

May 19, 2015 – DOH Issues Proposed Rules to Protect Patient Information in CHARS Database

The Department of Health has issued proposed rules implementing ESSB6265, legislation WSHA supported to increase standards for protecting shared patient information in the Comprehensive Hospital Abstract Reporting System (CHARS). The proposed rules establish types of data files based on content and access, create a methodology for determining when indirect patient identifiers may become direct identifiers, and allow options for creating a public data file.  The Department will hold a formal hearing on the proposed regulations on June 10, 2015 at 9:30 a.m. at Town Center 2, Room 158, 111 Israel Rd. SE, Tumwater, WA 98501. (Zosia Stanley)

April 15, 2015 – DOH Final Public Meeting on Proposed Changes to Hospital Construction Standards Rules

The Department of Health (DOH) has published a CR-102 with proposed changes to hospital licensing construction standards in Chapter 246-320 WAC. This proposed final rule changes have been in the works since July 2014.  More information on the rule development process can be found here.

A public meeting to discuss the proposed changes is scheduled for May 7, 2015 from 10 am to 12 pm at 243 Israel Rd. S.E., Town Center 3, Room 224, Tumwater, WA 98501. (Zosia Stanley)

January 28, 2015 – DOH Seeking Comments on Hospital Patient Discharge Information Reporting Regulations by COB February 10

The Department of Health is seeking public comments on draft rules to amend Chapter 246-455 WAC regarding hospital patient discharge information. The rulemaking is in response to ESSB 6265, legislation WSHA supported to increase standards for protecting shared patient information in the Comprehensive Hospital Abstract Reporting System (CHARS). DOH held a stakeholder meeting on this subject October 1,  2014.

Draft rules have been proposed by DOH. The rules seek to further define direct and indirect patient identifiers and public data sets, clarify restrictions on use of the data, add requirements for data sharing agreements, and update or add definitions. The rule will also include housekeeping changes, such as updating references.

DOH is seeking public comment on the draft rule before filing the proposed rule and holding a formal hearing. If you would like to comment on the draft rule, please send your comments to vitalrecordsrules@doh.wa.gov by close of business on February 10, 2015.

DOH will also hold a webinar workshop on February 9, 2015 to take comments on the draft. You may provide comments at the webinar or by emailing DOH at vitalrecordsrules@doh.wa.gov. (Zosia Stanley)

January 14, 2015 – Certificate of Need for Tertiary Care

The Washington State Department of Health (the Department) Certificate of Need program has announced it is moving forward with review of tertiary health services that are subject to Certificate of Need. The Department will determine whether any changes are necessary to the tertiary health services list. Changes could include additions to or deletions from the list.

We want to make sure you are aware this process has started so you can participate as appropriate in the public comment period, the first phase of which is January 1, 2015 to February 28, 2015.  Read the entire WSHA bulletin here. (Zosia Stanley)

September 4, 2014 – DOH Releases Stakeholder Draft of New Hospital Construction Standards

The Department of Health (DOH) has released an initial draft of possible revisions to hospital licensing construction standards. Interested parties may submit comments by September 22, 2014.  The DOH asks that anyone proposing changes use the Rules Proposal Form from the department’s website.  You can click here for a link to this form, and for more information.  (Barbara Gorham, BarbaraG@wsha.org)

August 26, 2014 – DOH Begins Rulemaking to Protect Patient Information in CHARS

The Department of Health has begun rulemaking to implement ESSB 6265 – legislation proposed by WSHA to protect the sharing of patient information in the Comprehensive Hospital Abstract Reporting System (CHARS).  These rules will further define direct and indirect patient identifiers and public data sets, clarify restrictions on the use of the data, and add requirements for data sharing agreements.  WSHA is participating in the rulemaking process.  Interested parties wishing to participate can either send an e-mail to vitalrecordsrules@doh.wa.gov or call Kris Reichl at DOH at (360) 236-4311.

August 4, 2014 – WSHA Comments on Newborn Screening Regulations

WSHA has submitted a comment letter to the Department of Health regarding proposed rule making for newborn screening sample collection and health provider reporting.  WSHA supported the underlying legislation to ensure newborns are rapidly screened for disorders and that parents are given the result as soon as possible.  Overall, WSHA supports the proposed rule making.  However, WHSA suggests that the proposed rule be revised to more accurately reflect the data that will be published and recognize that different categories of abnormality may appropriately have different notification times. DOH staff has indicated they are receptive to our comments and will be proposing modifications in the proposed rule. (Zosia Stanley)

May 7, 2014 – Department of Health Files Notice of Proposed Rule-making for Mandatory Reporting of Clostridium difficile

The Department of Health (DOH) filed a proposed rule establishing new reporting requirements for healthcare associated infections in acute-care hospitals. Under the proposed rule, hospitals would be required to report cases of Clostridium difficile to the Centers for Disease Control and Prevention National Healthcare Safety Network (NHSN). This reporting mandate will align state and federal requirements while providing essential data to address the growing problem of Clostridium difficile infections across the state.

WSHA has been working closely with the DOH on the proposed rule and will serve on the advisory council that will provide guidance on the implementation of the final rule. This rule is expected to have minimal burden on hospitals as many already report data to the NHSN. The DOH has guaranteed technical assistance to those hospitals in need of additional support in complying with this rule.

A stakeholders meeting is set for Tuesday, May 27, 2014 at 9am. Comments on the proposed rule can be submitted here. For more detailed information on the proposed rule, contact Ian Corbridge, ianc@wsha.org or (206) 216-2514.

March 11, 2014 — WSHA Files Suit Against DOH Over Certificate of Need Rules

(Cassie Sauer)

March 11,  2014 – DOH Requires Hospitals to Submit Hospital Policies by March 25

Hospitals are required to submit policies to the Department of Health by March 25, 2014 on non-discrimination, admissions, reproductive health, and end-of-life care.  Policies should be submitted in PDF format to HospitalPolicies@doh.wa.gov and posted on the hospital’s own website.

  • WSHA’s bulletin about the requirements
  • DOH’s guidance about the requirements
  • WSHA’s bulletin on and model for non-discrimination policy

(Cassie Sauer)

February 26, 2014 – DOH Proposes New Rule to Require Statewide Reporting of Clostridium Difficile

The Washington State Department of Health (DOH) recently issued a proposed rule to require mandatory statewide reporting of Clostridium (C.) difficile. The proposed rule would align C. difficile reporting requirements with other healthcare-associated infection (HAI) reporting categories as established by the Centers for Medicare and Medicaid Services. Reporting of C. difficile would be through the National Healthcare Safety Network (NHSN), a federal tracking system for HAIs. The data reported to the NHSN will provide the DOH important information on frequency and severity of C. difficile trends. WSHA is in close communication with the DOH and is participating in the rulemaking process. More information on the proposed rule is available on the DOH website. For questions, please contact Ian Corbridge, IanC@wsha.org.

February 9, 2014 – DOH Finalizes Rule Changing Process for Appealing Administrative Orders

The Department of Health has finalized rulemaking to change the process for appealing an administrative order. The new rule specifies that if no request for administrative review of an initial order is received within 21 days, the order becomes final. The rule implements ESHB 1381, which was enacted in 2013, and which modified the DOH’s administrative adjudicative process.  Barbara Gorham, barbarag@wsha.org

November 26, 2013 – WSHA Files Final Comments on Certificate of Need and Hospital Licensing Rulemaking

The Department of Health’s final hearing on its Certificate of Need and Hospital Licensing rulemaking is being held on November 26, 2013. In addition to prior comments filed, WSHA is submitting further comments on the proposed rules. WSHA continues to object to the proposed requirement for CON review of many more transactions as contrary to law and decades of precedent, and has serious concerns about the intersection of these proposed rules with conscience clauses. WSHA also continues to have major questions about the effectiveness of the Certificate of Need program and the plan to collect hospital policies as ways to achieve the Department’s goals, and asks the Department a number of questions about its plans. Read the comments here.

November 25, 2013 – DOH Updates Draft Rules to Reduce Radiation Exposure from Computed Tomography Scanners

The Washington State Department of Health updated its proposed draft rules to regulate Computed Tomography (CT) scanners and reduce radiation overexposure.  The proposed rules establish radiation dosage limits, and require facilities using CT scanners to establish scanning protocols.  In addition, the proposed rules could potentially alter operating procedures, impose new reporting requirements, and change staffing requirements.  An advisory committee, comprised of stakeholders, will review the proposed rules and provide comments to the department.  WSHA plans to comment on the draft rules and is participating in the rulemaking process.  More information on the CT advisory committee and the proposed rules are available on the department’s website. (For more background information, please see the entry from August 23, 2013.) Vergil Cabasco, vergilc@wsha.org

September 10, 2013 – WSHA Files Further Comments on Certificate of Need and Hospital Licensing Rulemaking

WSHA has filed further, extensive comments on the Department of Health’s Certificate of Need/Hospital Licensing concept rule addressing hospital mergers and affiliations.  The comments describe why mergers and affiliations are happening, object to the proposed requirement for CON review of many more transactions as contrary to law and decades of precedent, describe the intersection of these proposed rules with conscience clauses and religious freedom, raise questions about the workability and usefulness of policy collection, and stress the role of other branches of government.  Read the comments here.

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