Initial
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 six 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
The Office of Laboratory Quality Assurance (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 two 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 & Medicaid Services (CMS) conduct validation inspections of 5 percent 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 percent 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).