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DQA Quarterly Information Update

April 2010

PDF Version of this month's Quarterly Update (PDF, 74 KB)

NEW THIS ISSUE

REGULAR  FEATURES

UPCOMING  EVENTS


NEW THIS ISSUE

ALERT:  Rapamune (sirolimus) Drug 
Monitoring Recommendation
Bureau of Health Services/Clinical Laboratory Section

This alert is directed to hospital laboratory directors and transplantation and nephrology healthcare professionals.

Wyeth notified healthcare professionals of changes to the Rapamune Prescribing Information regarding changes in the performance of an immunoassay used for therapeutic drug monitoring (TDM) of sirolimus. The TDM results reported from the assay are both assay and laboratory-dependent. In addition, the results may change over time. Therefore, adjustment to the targeted therapeutic range must be made with a detailed knowledge of the site-specific assay used.

Sirolimus whole blood concentrations can be measured by either chromatographic or immunoassay methodologies. These two methodologies are not directly interchangeable and the measured sirolimus whole blood concentrations depend on the type of assay used. As such, if different assays are used in monitoring a single patient, the dose of Rapamune might be adjusted improperly with potential consequences, such as allograft rejection if drug exposure is too low or toxic side effects if exposure is too high.

Wyeth has advised healthcare providers involved in the management of patients taking Rapamune to determine (1) which assay is being used in their laboratory(ies), (2) if there is any change to the assay used, and (3) if there is a change to the laboratory's reference range and/or a subsequent change to the institution's or referring center's recommended range for sirolimus. With this information, target levels can be appropriately adjusted in order to achieve optimal clinical results.

It is critical that the clinician caring for a patient on sirolimus maintain communication with the patient's laboratory to determine whether the assay used for measuring sirolimus concentrations has been changed.

Read the complete MedWatch 2010 Safety summary, including a link to the Wyeth Dear Healthcare Professional letter, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/
SafetyAlertsforHumanMedicalProducts/ucm197059.htm

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HIPAA and Business Associate Agrements - Clarifying the
 Role of DQA
Bureau of Technology, Licensing and Education

Recently, the Division of Quality Assurance has received inquiries from several regulated providers seeking to have the Division sign HIPAA Business Associate Agreements. These requests seem to have been prompted by the recent passage of the HITECH (Health Information Technology for Economic and Clinical Health) amendments to the 2009 American Recovery and Reinvestment Act, which require "business associates" of health care entities covered by the HIPAA privacy and security rules to abide by many of the same restrictions regarding the use and disclosure of personal health information as the covered entities themselves.

This is to clarify that, for purposes of HIPAA, the Division of Quality Assurance is not a business associate of any health care provider licensed, surveyed, or otherwise regulated by the Division.  DQA is not required to, and will not, enter into a Business Associate Agreement with any provider.

In a memorandum issued after the original HIPAA regulations were implemented, the Centers for Medicare and Medicaid Services (CMS) stated that the functions performed by state survey agencies, such as DQA, constituted "health oversight" activities that were exempted from the access and use limitations regarding "personal health information" that HIPAA imposed on "covered entities."

In particular, it was made clear that state surveyors in their individual capacity and DQA as the Wisconsin state survey agency were not business associates of surveyed entities and that surveyed entities may not limit or deny access to personal health information of their residents or patients because DQA has not signed a HIPAA Business Associate Agreement with the entity being surveyed. CMS has not issued any subsequent direction that changes the status of DQA with respect to regulated providers under HIPAA or the HITECH amendments.

DQA recognizes that providers are trying to fully meet their obligations under HIPAA and subsequent federal legislation. However, executing Business Associate Agreements with DQA is not among these obligations. In addition, state resources do not permit the Division to respond to these types of inquiries.

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Grant, Iowa, Manitowoc, and Outagamie Counties to Have 
Managed Care
Administrator's Office

Effective April 1, 2010: Grant, Iowa, Manitowoc, and Outagamie Counties

On June 19, 2009, the Division of Quality Assurance issued DQA memos 09-023 (CBRFs), 09-024 (RCACs), and 09-025 (Nursing Homes) outlining the Preadmission Consultation (PAC) requirements for providers, effective July 1, 2009. The memoranda are available at:

http://www.dhs.wisconsin.gov/rl_dsl/Publications/09-023.htm

http://www.dhs.wisconsin.gov/rl_dsl/Publications/09-024.htm

http://www.dhs.wisconsin.gov/rl_dsl/Publications/09-025.htm

The memoranda identify certain information dissemination and referral responsibilities that affect facilities in counties with Managed Care/IRIS (self-directed supports waiver) and in counties where Medicaid Waiver programs are available. Currently, managed care is not available in all counties.

When managed care is made available in a county, the new PAC requirements take effect. DQA will continue to publish the Managed Care Organization (MCO) start dates in the DQA Quarterly Information Update to inform providers when the new PAC requirements go into effect.

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Registration Reminder:  Emergency Preparedness Resource Inventory (EPRI) System
Bureau of Technology, Licensing and Education

In October, via DQA Memo 09-041, the Division of Quality Assurance announced the availability of on-line registration for the Emergency Preparedness Resource Inventory (EPRI) system. This system is being developed by the Centers for Medicare and Medicaid Services to track the status of regulated health care facilities during emergencies. EPRI will also enable CMS and Wisconsin to send broadcast or targeted e-mail messages to DQA-regulated providers notifying them of emergency conditions and requesting information on their operational status.

To date, approximately 400 Wisconsin health care facilities and providers have registered for EPRI. While this is a significant number, it represents only about 10 percent of the health care providers regulated by DQA. Since CMS is expected to implement EPRI at the national level some time this year, providers are strongly encouraged to register for this system now. To do so, visit the DQA website at: http://www.dhs.wisconsin.gov/rl_dsl/bqa.htm

Select the link for Emergency Preparedness System Registration or go directly to the questionnaire at: http://4.selectsurvey.net/DHS/TakeSurvey.aspx?SurveyID=m6LLn99K

If you have questions about EPRI or completing the registration process, contact:

Richard Betz
608-264-9898
richard.betz@dhs.wisconsin.gov

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New FAQ for Hospitals
Bureau of Technology, Licensing and Education

The Division of Quality Assurance has published a "frequently asked questions" document for hospitals. The document can be accessed at:  http://www.dhs.wisconsin.gov/rl_DSL/Hospital/frequentAskQs.pdf

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MDS Updates
Bureau of Technology, Licensing and Education

New RAI/MDS Information Web Page

To assist nursing homes in finding Resident Assessment Information (RAI) and Minimum Data Set (MDS) related information that is currently available across multiple websites, DQA has developed a new RAI/MDS Information web page. This web page includes links to CMS MDS 3.0 information, technical information for obtaining software, personal logins to access the MDS System and the CASPER reporting system, quality improvement information, and many additional resources that are available online. This website will be continually updated to reflect the most current RAI/MDS resources available. The DQA RAI/MDS Information web page can be accessed at:  http://www.dhs.wisconsin.gov/rl_DSL/NHs/MDS30.htm

MDS 3.0 - No Section S for Wisconsin

MDS 3.0 will be implemented 10/1/2010 and will apply to assessments with assessment reference dates (ARD) of 10/1/2010 or later, entry records with an entry date of 10/1/2010 or later, and discharge/death in facility records with a discharge date of 10/1/2010 or later. Wisconsin will not have a state specific Section S for MDS 3.0. Nursing homes should continue completing Section S items for MDS 2.0 comprehensive assessments.

MDS Personal Login IDs

Nursing home assigned login IDs have been replaced with MDS Personal Login IDs. Personal IDs are assigned to a specific individual and are required to access the MDS System and CASPER reports. In order to acquire a new Personal Login ID, a request must be submitted to the QIES Technical Support Office (QTSO) using the MDS New User/Remove User Account Request form.

A facility is allowed to have a maximum of two Personal Login IDs. If additional personal login IDs are required, the facility can submit the MDS Additional Personal Account Request form to request additional IDs.

It is the facility's responsibility to revoke access for any users who no longer require access to the MDS System and CASPER reports. Revoking the account of a user who no longer requires access to facility data permits the facility to request a personal login ID for an additional user.

Further information and request forms are available on the QTSO website at: https://www.qtso.com/accessmds.html

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OASIS Updates
Bureau of  Technology, Licensing and Education

Home Health: WOCN OASIS-C Guidance

The Wound Ostomy Continence Nurses Society made their guidance available for answering the OASIS-C integumentary questions late in December 2009. You can obtain this eight-page WOCN document which includes pictorial pressure ulcer staging, definitions, and a glossary of terms, at:
http://www.wocn.org/

OASIS-C Q&As

In January 2010, the newest OASIS Q&As were released by the Centers for Medicare and Medicaid Services (CMS) and the OASIS Certificate and Competency Board (OCCB). These two groups collaborate to release new questions and answers each quarter. The next release is scheduled for mid-April. You can obtain any of the quarterly sets of Q&As at:  http://oasiscertificate.org/main/

The Q&As that are directly related to OASIS-C M-items begin with the October 2009 set.

CMS and the OCCB have also been re-writing the original (OASIS-B) Q&A guidance to fit the OASIS-C items. Thus far, the first four categories have been re-written, which include areas of OASIS applicability, the Comprehensive Assessment, Follow-up assessments, and several M-items. You can obtain the updated guidance sections at:  https://www.qtso.com/hhafaq.html

OASIS-C Guidance Manual

Some HHAs may be unaware that, on December 22, 2009, CMS updated the OASIS-C Guidance Manual to incorporate the 'errata' (summary of changes) they posted on December 11, 2009. The updates include some corrections to typos, but also include additional clarifications and, in some instances, new information. The following sections have been updated: Chapters 1, 3, and 5, plus Appendix C and Appendix G.

View the errata or download the updated version of the Guidance Manual (scroll down to bottom of page) at:  http://www.cms.hhs.gov/HomeHealthQualityInits/
14_HHQIOASISUserManual.asp

Note: The updated version is still labeled Sept. 2009 --- you are not accessing the wrong file.

OASIS-C Quality Measure Reports

The January 2010 DQA Quarterly carried an article that stated CMS does not plan to merge OASIS-B and OASIS-C data into HHA reports. Because of this, there will be a 'blackout period' where the CASPER OBQM/OBQI reports, along with Home Health Compare (HHC) reports, will remain static while sufficient OASIS-C data is collected and risk models are developed.

The last available OASIS B-1 reports will remain in the Casper system and on the HHC site until they are replaced with OASIS-C reports. A sufficient number of episodes are needed in order to report measures accurately; measures based on sample sizes taken over short periods of time can be misleading. OASIS-C measures will be transitioned between September 2010 and May 2011. CMS has published an OASIS-C transition projection schedule, which can be obtained on Wisconsin's DQA OASIS website (scroll down to OBQI) at: http://www.dhs.wisconsin.gov/rl_DSL/HHAs/HHAOASIS.htm

Home Health: Second HHQI Campaign

CMS has contracted with the West Virginia Medical Institute (WVMI) and Quality Insights to lead the second Home Health Quality Improvement (HHQI) Campaign. This new campaign is a grassroots movement. Under the 22-month contract, HH agencies throughout the nation will be recruited to improve two aspects of care for people with Medicare: reduction of hospital re-admissions and improvement in medication management. HH agencies are invited to register for the campaign and to "demonstrate your commitment to quality and improved patient care." Consider registering and taking advantage of the free resources and tools available.

Nearly 4,000 participants from more than 2,500 home health agencies joined this HHQI National Campaign during its first week. Agencies that have not yet registered can do so at any time during the campaign. The HHQI Campaign released its first Best Practice Intervention Package (BPIP), Introduction and Fundamentals of Reducing Avoidable Hospitalizations, on January 28th. Additional BPIPs will include Medication Management and Falls Prevention. Register or learn more about this campaign at:  http://www.homehealthquality.org/hh/default.aspx

The campaign was kicked off at a summit on January 13th at CMS headquarters in Baltimore, Maryland. Learn more about the summit or access the power point presentations and audio and videos of the meeting at: http://www.homehealthquality.org/hh/about/
2010summit/default.aspx

Home Health: The CMS CAHPS Survey

CMS would like home health agencies (HHAs) to know that the Home Healthcare Consumer Assessment of Healthcare Providers and Systems (HHCAHPS) survey began in October 2009. The CAHPS survey is designed to measure the experiences of people receiving home health care from Medicare-certified HHAs. The Home Health CAHPS survey will be conducted for HHAs by approved Home Health CAHPS survey vendors and survey results will be publicly reported.

HHAs can voluntarily participate in HHCAHPS at any time prior to July 2010. HHAs that choose to participate must conduct a dry run for at least one of the months in the third quarter of 2010 (July, August, September 2010) and, then, continuously collect HHCAHPS data every month beginning in October 2010. (Participation in the HHCAHPS will be linked to the 2012 annual payment update. Details about the HHCAHPS linkage to payment are available in the Final Home Health Payment Rule, November 10, 2009.)

All participating HHAs will need to contract with an approved HHCAHPS survey vendor. The full details and up-to-date news about the HHCAHPS survey process is available at:  https://www.homehealthcahps.org

OASIS Conversion to Personal Login IDs

CMS is changing the way HHA users log in when submitting OASIS assessments or accessing reports through the CASPER system. The changes will transition login IDs away from shared agency login IDs to individual user IDs. Agency users will be required to register for personal login IDs and will no longer be able use the shared agency ID to login to the OASIS submissions systems and CASPER reports. Each HHA or branch may apply for two separate personal logins.

Beginning in February 2010 and wrapping up in July 2010, small groups of states will transition to individual user IDs about every two weeks. Wisconsin is scheduled to start this transition beginning June 1st. Watch the OASIS Welcome page for additional information on how to register for personal login IDs.

OASIS Software: HAVEN

There have been 'issues' with HAVEN 10.0 that can now be rectified by installing the new 10.1 patch, available at:  https://www.qtso.com/havendownload.html

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Approved CBRF Training Program Website
Bureau of Assisted Living

The Division of Quality Assurance is happy to announce that UW Oshkosh has developed the department-approved curriculum and has finalized the web based application process for CBRF trainers. Anyone who wishes to be a CBRF trainer for Standard Precautions, Medication Administration and Management, Fire Safety, and First Aid and Choking after March 31, 2010, must be approved and follow the new requirements.

The Approved CBRF Training Program website is now up and running and can be accessed at:  http://www.dhs.wisconsin.gov/rl_DSL/CBRF/cbrfTrngProgms.htm

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UPCOMING EVENTS

FOCUS 2010
Bureau of Technology, Licensing and Education

Special Session - November 17
Conference - November 18

The Wisconsin Department of Health Services, Division of Quality Assurance (DQA), is pleased to announce the 10th annual conference for health care providers and DQA staff on November 18, 2010. The Focus 2010 Conference is being developed in collaboration with health care providers and associations.

This year, the theme of the conference is "Striving for Excellence in Challenging Times." The agenda for this innovative conference is designed for learning and idea exchange on multiple levels and is loaded with great presenters and topics that are applicable to day-to-day operations.

There is an impressive line-up of more than 15 presenters, including an assisted living panel, who will tackle issues of interest to all participants --- quality of life, caregiver law, falls, pain management, CMS regulations (F223-F226), hospice, and many other topics.

The FOCUS 2010 Conference will feature keynote speaker, Karyn Buxman. Karyn combined her research with the one thing that enabled her to get through an entire day without losing her sanity --- humor. She will kick off the conference with a presentation on healthcare, humor, stress management, and life balance. As an internationally recognized expert on humor, Karyn delivers an energy-charged keynote that has entertained, motivated, and educated audiences nationwide.

On November 17th, there will be an all day special session entitled "Infection Prevention and Control." This training will feature presenters from the Centers for Disease Control and Prevention (CDC), Occupational Safety and Health Administration (OSHA), and many other areas.

The conference will be held at the:

Kalahari Convention Center
1305 Kalahari Drive
Wisconsin Dells, Wisconsin
Telephone: 1-877-525-2427

When contacting the Kalahari for lodging, be sure to ask for the Focus 2010 special room rate.

More information will be included on our conference website as plans are finalized. Please visit:  http://www.dhs.wisconsin.gov/rl_dsl/training/focus10.htm

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2010 QUALITY OF LIFE TRAINING
Bureau of Assisted Living

Three spring training events have been scheduled for April, May, and June 2010. The training is a collaborative effort between state and county human service agencies and is designed for all providers in the state serving persons who are elderly or who have a disability, especially county certified adult family home providers, state licensed adult family home and CBRF providers, and social workers. Attendees will receive credit for three training hours for each event attended.

The topics and presenters are:

April 20 A Life in Community
Presenter: Mark Sweet, PhD, Trainer and Consultant
May 25
Part 1: Everybody Wants to be Loved - Healthy Relationships vs. Risky Behaviors - How do We Support and Protect?
Presenter: Pam Malin, Disabilities Coordinator, Sexual Assault Center of Family Services

Part 2: Sexual Assault Against Older Individuals
Presenter: Bonnie Coonen, Elder Abuse Coordinator, Sexual Assault Center of Family Services
June 22
Part 1: Personality Disorders
Presenter: Jeff Marcus, MD, Director of Central Wisconsin Center

Part 2: Antipsychotic Medications and Under-recognized Side Effects
Presenter: Jeff Marcus, MD, Director of Central Wisconsin Center

 The trainings will be held at:

Student Lecture Hall
Northeast Wisconsin Technical College (NWTC)
2740 W. Mason St.
Green Bay, WI

The Brown County website provides expanded information regarding the training sessions and the presenters. Fee, location, time, parking, special accommodation, smoking policy, contact, and other information is also available at: http://www.co.brown.wi.us/departments/?department=db50c2508c43

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REGULAR FEATURES

Changes in DQA Staff

Trisha Piotraschke has been hired by The Bureau of Assisted Living, Northeastern Regional Office as a Health Service Specialist. Trish started with BAL on January 3, 2010.

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DQA Numbered Memos (January, February, March)

Access the following memos at: http://www.dhs.wisconsin.gov/rl_DSL/Publications/BQAnodMems.htm http://www.dhs.wisconsin.gov/rl_DSL/ (individual providers' publications pages) 

Memo No.

Title

Summary

Providers Affected

10-001

On-line Reporting of Seclusion and Restraint Incidents for Mental Health Day Treatment Services - DHS 40

This memo provides notice of a new mechanism for reporting the use of seclusion and restraint in programs certified under Wisconsin Administrative Code Chapter DHS 40.

Mental Health Day Treatment Programs for Children

10-002

Certification of Approved Laboratories Performing Implied Consent Alcohol Testing

DQA is responsible for certifying approved laboratories performing implied consent alcohol testing under Wisconsin Statute 343.305(6)(a). This memo is to update you on information relating to this program.

CLIA

10-003

Licensing Threshold Guidelines for Assisted Living Facilities

The Bureau of Assisted Living continues to receive inquiries related to the need for licensure of community living arrangements having unique physical layouts, program services, and staffing patterns.
This memo provides a description of various scenarios that have been reviewed and BAL's determination regarding licensure.

Adult Family Homes
Community Based Residential Facilities
Residential Care Apartment Complexes

10-004

Notice of CBRF Department-Approved Training Process

UW-Oshkosh has developed the department-approved curriculum and has finalized the web based application process for CBRF trainers. Anyone who wishes to be a CBRF trainer for Standard Precautions, Medication
Administration and Management, Fire Safety
and First Aid and Choking
after March 31, 2010 must be approved and follow the requirements indicated in the memo.

Community Based
Residential Facilities

10-005

Notice of Implementation of State Only Re-visit Fee

2009 Wisconsin Act 205, created new language for home health, hospice, and hospitals authorizing a $200.00 inspection fee for DQA re-visits. Act 205 became effective June 29. 2009.

Home Health Agencies
Hospices
Hospitals

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DHS Administrative Rules Update
Administrator's Office

DHS 85 - Non-Profit Corporations as Guardians

On December 15, 2008, the Wisconsin Administrative Register published a Statement of Scope of proposed rules to amend Chapter DHS 85, Non-profit Corporations as Guardians. Through this initiative, the Department proposes to make the rule reflect current standards of practice, recognizing the increase in the number of adults in need of guardianship and the increase in the complexity of their needs.

An Advisory Committee, including advocates, providers, registers in probate, and County adult protective services staff, met and reviewed proposed rule language and made recommendations for change. The proposed rule was filed with the Clearinghouse and Legislative Reference Bureau on August 12, 2009. Public hearings on the proposed rule were held on October 8 in Waukesha and on October 14 in La Crosse.

On March 1, 2010, the Final Proposed Rulemaking Order and Report to the Legislature for Chapter DHS 85, Non-profit Corporations and Unincorporated Associations as Guardians, was posted on the Department's Administrative Rules website at the following link:  https://health.wisconsin.gov/admrules/public/Home

DHS 124 - Hospitals

During the early part of 2008, the Department of Health Services began working with hospitals, professional associations, advocates, and trade associations to revise Wisconsin Administrative Code, Chapter DHS 124, Hospitals. The Department is planning to update the code to eliminate overly prescriptive and outdated regulations, clarify the Department's enforcement authority, and make the rule more consistent with the federal Medicare requirements.

While we are continuing to work on this extensive revision to the rule, new legislation makes it necessary for the Department to move forward with a limited number of revisions to ch. DHS 124 at this time. To that end, the Department amended the Statement of Scope for ch. DHS 124, dividing the revision of the rule into two separate processes.

The Final Proposed Rulemaking Order and Report to the Legislature for Chapter DHS 124, Hospitals, relating to forfeitures, anatomical gifts, and automated external defibrillator (AED) training, was posted on the Department's Administrative Rules website on December 28, 2009. On February 19, 2010, the Final Rulemaking Order was filed and posted on the Wisconsin Administrative Rules website at: https://health.wisconsin.gov/admrules/public/Home

DHS 131 - Hospices

On December 15, 2008, the Wisconsin Administrative Rules website published a Statement of Scope of proposed rules to revise Chapter DHS 131, Hospices. The Department proposes to revise ch. DHS 131 to align the rule with revised federal Medicare regulations, to eliminate outdated regulations, and to reflect current professional standards of practice. The Department worked with the Hospice Organization and Palliative Experts (HOPE) of Wisconsin, hospices, and hospice consumers to revise ch. DHS 131.

The Proposed Rulemaking Order and Fiscal Estimate were posted on the Wisconsin Administrative Rules website on March 17, 2010. For more information, you may view the Statement of Scope on the Wisconsin Administrative Rules website at:  https://health.wisconsin.gov/admrules/public/Home

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CMS Survey & Certification Letters (January, February, March)

Listed below are Survey and Certification (S&C) Letters distributed by CMS during the last quarter. Please note that the CMS Internet site for reviewing all S&C memos is:  http://www.cms.hhs.gov/SurveyCertificationGenInfo/PMSR/list.asp

S&C No.

Title

Summary

Providers Affected

10-10

Critical Access Hospital (CAH) Regulatory Changes

On 07/31/09, the CMS issued the final FY 2010 Inpatient Prospective Payment System (IPPS) rule, effective 10/01/09, which included two changes affecting CAHs.

State Survey Agency Directors

10-11

Use of the Name of the Laboratory Director and EIN listed in the CLIA Data System

Surveyors are cautioned NOT to release the name of the laboratory director publicly, to use it carefully and only when necessary to assist with their routine regulatory and survey-related duties under the 1864 (Social Security Act) agreement.

State Survey Agency Directors

10-12

CLIA Update for Electronic Exchange of Laboratory Information

This memo offers additional guidance when surveying laboratories using Health Information Technology (HIT) for the electronic exchange of laboratory information.

State Survey Agency Directors

 

Publication Contact: Gina Bertolini
E-Mail: Gina.Bertolini@dhs.wisconsin.gov
Phone:  (608) 266-6691

E-MAIL SUBSCRIPTION SERVICES

http://www.dhs.wisconsin.gov/rl_DSL/Listserv/signup.HTM

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Last Updated: January 16, 2013