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Medical Test Site (MTS)
TYPES OF SURVEYS (INSPECTIONS)
Initial
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Initial on-site surveys (for Category Low Volume, A-J laboratories, laboratories upgrading from waived or
PPMP testing, or laboratories changes to MTS from an accredited license category) are
performed within 6 months of the issuance of the categorized license. The date and time of
the initial survey are arranged in advance between the MTS and the laboratory surveyor.
(Refer to Survey Process).
Routine
Routine on-site surveys are conducted every two years for category low
volume, A-J laboratories. The date and time of the survey
are usually arranged in advance between the MTS and the laboratory surveyor. (Refer to
Survey Process).
Complaint
investigation
LQA investigates all complaints against clinical laboratories licensed in Washington.
Depending on the nature of the complaint, one of the following actions may be taken:
- Documentation of the complaint, with no further action
- Referral of complaint to another agency or office, if the complaint is outside the
jurisdiction of LQA
- Investigation by telephone/mail - not on-site
- An on-site complaint investigation, it is unannounced and conducted:
- Within 2 days if the complaint poses an immediate threat to patient health and safety;
or
- Within 10 days if there is no immediate threat.
If the complaint is substantiated, the MTS is charged for direct staff time involved in
the investigation and must respond to any deficiencies cited.
On-site Follow-up
A follow up is done for all deficiencies cited to determine that corrections have been
made. Typically, this verification is accomplished via phone calls, faxes and written
correspondence.
In some instances, however, the laboratory surveyor and program manager may decide that
an on-site follow up is warranted, to assure that correction of deficiencies has been
made. In determining whether an on-site follow-up survey is warranted, the following are
considered:
- The seriousness and number of deficiencies cited
- The potential effect of the deficiencies on patient care
- The degree of direct involvement by the laboratory director or supervisor
- Personnel competency
- Same deficiencies cited at the last survey
- The adequacy of the facility’s plan of correction
When an on-site follow up is conducted, the MTS is charged for direct staff time
involved.
Technical Assistance Visit
To encourage voluntary compliance and a cooperative partnership between LQA and medical
test sites, technical assistance visits may be done at the request of any MTS. Technical
assistance visits are conducted in the same manner as a routine survey, with an emphasis
on education and assistance. If "areas of concern" or deficiencies are noted, a
Findings Report is sent that describes:
- The areas not in compliance;
- The steps necessary to achieve compliance and how to provide documentation or
verification that corrections have been made;
- The date by which corrections must be made, and
- A list of training courses, consultants; manufacturers’ representatives, etc. that
may help the facility in correcting their deficiencies.
Validation Surveys
- Federal oversight of the Washington MTS program
All laboratories in Washington are licensed under a state law, rather than the federal
Clinical Laboratories Improvement Amendments of 1988 (CLIA) regulations. To assure that
Washington is carrying out a program "equivalent" to CLIA, inspectors from the Federal
Health and Human Services Centers for Medicare and Medicaid Services (CMS)
conduct validation inspections of 5% of
laboratories in Washington state. Laboratories are selected randomly and the on-site
inspections are conducted jointly (i.e., the LQA and CMS inspectors inspect the facility
at the same time). The LQA inspector conducts the survey as a routine survey and adheres
to LQA’s process for citing deficiencies and follow-up activities. Since this is a
validation of LQA’s process, the CMS inspector does not cite the testing site for
any deficiencies noted.
- Washington’s oversight of accrediting organizations
The Office of Laboratory Quality Assurance recognizes certain accrediting
organization programs as
"equivalent" to the MTS regulations and allows them to conduct oversight
activities of accredited laboratories. To assure that accrediting organizations are carrying
out a program "equivalent" to the MTS program, LQA surveyors conduct validation
inspections of 5% of the accredited laboratories in Washington. Laboratories are selected
randomly and the on-site inspections are conducted jointly (i.e., the LQA surveyor and the
accrediting organization surveyor inspect the laboratory at the same time). The accrediting
organization surveyor conducts the survey and adheres to their process for citing deficiencies
and follow-up activities. Since this is a validation of the accrediting
organization’s
process, the LQA surveyor does not cited any deficiencies noted (unless the deficiencies
pose a serious or immediate threat to patient health and safety).
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