Medical Test Sites (MTS) Test Site Survey Process
To assist testing sites in preparing for an on-site inspection, materials are available from the MTS Program upon request or through the supplemental material and the licensing info, forms, and links webpages.
On-site Survey Process
Routine on-site surveys are typically announced with the date and time established between the laboratory surveyor and the testing site staff.
Upon arrival at the testing site, the surveyor meets with the laboratory director and other pertinent technical staff to explain the survey process and the records necessary for review. During a walk-through of the specimen collection and testing areas, the surveyor notes issues related to space, equipment, utilities, reagents and testing materials, cleanliness, and safety.
During an onsite inspection, please be prepared to share the following materials with the MTS Surveyors:
- Technical procedures, quality control/quality assurance policies, safety manual
- Personnel records (qualifications, training checklists, competency assessment documentation)
- For the previous two years:
- Patient test requisitions (or other format used to document test orders, such as charts)
- Accession logs
- Test result logs, worksheets
- Instrument printouts, tapes
- Records of quality control, calibration, equipment function checks and maintenance records, temperature records, etc.
- Documentation of quality assurance activities, problem resolution
- Proficiency testing results and corrective action documentation as indicated
- Patient test reports (or other format used to document test results, such as charts)
During the course of the survey, the surveyor points out any deficiencies as they are found and gives the staff an opportunity to clarify any misunderstanding or to provide records or documentation as needed. At the completion of the survey, the findings are shared with the director and staff. Technical assistance is provided throughout the survey and during the exit conference to help the MTS in developing a plan of action to correct their deficiencies.
If no deficiencies are found, a letter, stating that the laboratory is in compliance, is sent within 10 days to the director.
If deficiencies are cited, a deficiency statement is sent within 10 days to the director. The MTS must return a written plan of correction for each deficiency within 14 days to their surveyor. Corrections must be made no later than 60 days following the department's approval of the plan of correction. The surveyor will contact the facility requesting documentation that the correction of the deficiencies is complete and effective. When all deficiencies have been corrected, a letter stating the laboratory is in compliance is sent to the director.
MTS Survey Types
Initial on-site surveys 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.
Routine on-site surveys are conducted every two years for categorized medical test sites. The department may periodically perform routine surveys for waived MTS and PPMP MTS as well. The date and time of the survey are usually arranged in advance between the MTS and the laboratory surveyor.
- Complaint Investigation
The Office of Medical Test Sites (MTS) 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 the MTS Program
- Investigation by telephone/mail - not on-site
- On-site complaint investigations are 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 MTS Program 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 or email.
In some instances, however, the MTS Program 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.
- Repeat deficiencies cited from a previous survey.
- The adequacy of the facility's plan of correction.
When an on-site follow-up is conducted, the MTS is charged for direct MTS Program staff time involved.
- Technical Assistance Visit
To encourage voluntary compliance and a cooperative partnership between the MTS Program 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.
- 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 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 MTS Program and CMS surveyors inspect the facility at the same time). The MTS Program surveyor conducts the survey as a routine survey and adheres to our process for citing deficiencies and follow-up activities. Since this is a validation of the MTS program's process, the CMS surveyor does not cite the testing site for any deficiencies noted.
Washington's oversight of accrediting organizations
The MTS Program 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, MTS Program 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 MTS Program 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 MTS Program surveyor does not cite any deficiencies noted (unless the deficiencies pose a serious or immediate threat to patient health and safety).