April 27, 2012
Repeal of Outdated Oregon Administrative Rules (OAR)
February 6, 2009
Clarification of Policies and Procedures for the Certification of Entities with One Certificate for Multiple Sites Under CLIA
September 5, 2008
Guidance regarding the circumstances when laboratories performing drug or alcohol screening and/or testing must be CLIA certified
November 27, 2007
Memo to Oregon Clinical Labs: New reporting poster with FAQs
August 18, 2005
Memo to Oregon Clinical Laboratories: Communicable Disease Reporting Rule Change
July 16, 2004
Memo to Oregon Clinical Laboratories (pdf) regarding release of laboratory results to authorized individuals other than the ordering physician or clinician(7K)
April 12, 2004
TO: Moderate and High Complexity Oregon Laboratories
- FROM: Rita Scheu BS MT(ASCP)
- Manager, Laboratory Compliance and Quality Assurance
SUBJECT:Laboratory Reporting of Communicable Diseases
Some laboratories have not been clear about their responsibilities related to the reporting of laboratory tests indicative of communicable diseases identified in OAR 333-018-0015(5). A sample of the poster listing these conditions and contact information for all local health departments is included.
OAR 333-018-0000(3) requires that laboratories report certain communicable disease findings to public health authorities. When more than one licensed laboratory is involved in testing a specimen, the laboratory that is responsible for reporting the test results directly to the physician caring for the patient is also responsible for reporting to public health. OAR 333-018-0005 requires that the report be made to the Local Public Health Authority (local health department) of the patient?s place of residence.
Laboratories participating in electronic laboratory reporting (ELR) through the Department of Human Services (DHS) are still required to send paper reports to the patient?s local health department until all partners (counties, state, and lab) have agreed the lab is ready to move from the Review phase to the Maintenance phase of Oregon's Quality Control Plan (find more details on this plan at www.dhs.state.or.us/publichealth/elr). Some labs have already completed the Review phase - if you're not sure of your lab's status, please contact Oregon's ELR (email@example.com). Electronic reports must include patient address information (minimal requirements are patient county or zip code).
The primary laboratory that refers testing to a second laboratory has the information on the patient?s county of residence and health care provider, which makes them best equipped to report to public health. There are times when a reference laboratory (including the Oregon State Public Health Laboratory) may itself report communicable disease findings to a Local Public Health Authority. However, this does not relieve the primary laboratory of its responsibility to report.
When more than one laboratory is involved, communication may be necessary to make sure that reports are made by the responsible laboratory. Reporting should occur within 24 hours for most tests except CD4 cell counts and blood lead testing which shall be reported within seven days. The laboratory report should indicate that a report has been made to the patient?s county of residence per Oregon rule. As with most laboratory records, documentation of disease reporting shall be kept for at least two years.
Note that OAR 333-018-015(3) calls for reporting of ?all test results indicative of and specific for the diseases, infections, microorganism, and conditions specified.? If you have any questions about whether a given test is considered to meet these criteria, please call the DHS epidemiologists at (503)731-4024.
Thank you for your attention to this matter. Your efforts are appreciated by Public Health. I can be reached at (503) 229-5855 or firstname.lastname@example.org if you have any questions.
July 10, 2003
TO: Clinical Laboratory Directors and Managers
FROM: Rita Scheu BS MT(ASCP) Manager, Laboratory Compliance and Quality Assurance
SUBJECT:Oregon State Legislative Session 2003, Laboratory issues
Please find linked below three house bills dealing with laboratory issues that were recently signed into law during the 2003 legislative session. They are HB 2309, HB 2157 and HB 2631. House Bill 2309, relating to medical blood alcohol testing, became effective on May 24, 2003, as this bill contained an emergency clause. The other two bills will become effective on January 1, 2004.
House Bill 2309 requires a health care provider taking care of an individual believed to be the operator of a motor vehicle involved in an accident, to report to law enforcement, within five calendar days, a blood alcohol level at or greater than 0.08 percent.
House Bill 2157 also relates to blood alcohol testing. Since 1987, analysis of a person?s blood for alcohol content while driving or boating, had to be by a method approved by the Department of Human Services. Effect January 1, 2003, as long as the laboratory is a CLIA laboratory certified or accredited in toxicology, or is licensed by the State under ORS 438.110 for toxicology, or is a State Police Crime laboratory accredited by a national forensic accrediting organization, the results are valid.
House Bill 2631 gives the patient a right to access their testing results directly from the laboratory. One week after the patient makes a request, the laboratory shall release the results in writing to the patient.
To view the full version of the House Bills, click on the following links: