01/13/2017
How Medical Source helps physicians setup POL's.
I. Regulatory Compliance (enrollment processes)
a. Source/Staff Laboratory Director
b. File CLIA application for High-Complexity Certification
c. Apply for COLA accreditation for Laboratory. (Laboratory must finance accreditation fees, Tiered based on annual testing volume)
d. Enroll Laboratory in COLA Proficiency Testing Program (Laboratory must finance accreditation fees, Tiered based on annual testing volume)
e. Source any/all required on site personnel for the laboratory
f. File all additional initial paperwork required by the regulatory bodies whose jurisdiction encompasses the location of the laboratory.
II. Regulatory Compliance (ongoing)
a. Staff the laboratories technical consultant
i. §493.1413 Standard; Technical consultant responsibilities.
1. The technical consultant is responsible for the technical and scientific oversight of the laboratory. The technical consultant is not required to be onsite at all times testing is performed; however, he or she must be available to the laboratory on an as needed basis to provide consultation, as specified in paragraph (a) of this section.
2. The technical consultant must be accessible to the laboratory to provide on-site, telephone, or electronic consultation; and
3. The technical consultant is responsible for-
a. Selection of test methodology appropriate for the clinical use of the test results;
b. Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system;
c. Enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered;
d. Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results;
e. Resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications;
f. Ensuring that patient test results are not reported until all corrective actions have been taken and the test system is functioning properly;
g. Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed;
h. Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to—
i. Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing;
ii. Monitoring the recording and reporting of test results;
iii. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records;
iv. Direct observation of performance of instrument maintenance and function checks;
v. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and
vi. Assessment of problem solving skills; and
1. Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation
ii. Technical Consultant Responsibilities (that exceed the minimum regulatory compliance)
1. Ensure that the laboratory and its staff are inspection ready on an ongoing basis.
2. Conducting surveys of the laboratory and its staff on a regular interval and documenting these surveys with the accrediting agency.
3. Preform Mach inspections to evaluate any potential deficiencies.
b. Available resources on call for additional assistance
i. Toxicologist
1. Provides assistance with the help of his team to the laboratory in the following situations
a. Questions on results or methodologies relating to toxicology (screens or confirmations)
b. Provides support and diagnosis for instrument operators when inconsistencies
c. Communicate with regulatory officials to settle any questionable differences. Very influential in the community (nationally) which makes this position very valuable to the lab.
ii. Pathologist
1. Preforms the same duties as the Toxicologist listed above but in regards to all other clinical operations outside of toxicology.
III. Installation
a. In order to maximize the efficiency of the laboratory in question we collaborate with the client and a host of resources.
i. Facility Requirements
1. Collaborate with the contractor (Physician employed, but sourced by MSI when necessary, otherwise we are pleased to work with physician chosen contractors)
a. Provide Laboratory layout and drawings
b. Define all utility requirements
c. Create punch list for contractor to ensure completed renovation serves the needs of the instrumentation and testing.
ii. Installation Requirements
1. Ensure that pathways allow for instrument delivery
2. Ensure Site requirements have been met
3. Ensure all necessary resources are available to manufacturer’s representatives to ensure success of installation (this means all ancillary’s)
4. Schedule instrument installations and eliminate any scheduling conflicts
5. Compile all necessary information and exchange with the LIS manufacturer to minimize implementation time and ensure proper function
iii. Instrument Validation and Training
1. Coordinate with training representatives and Lab personnel to develop the most appropriate training schedule.
2. Ensure that instrument validation is performed on all systems present
3. Ensure the functionality and communication of the LIS system with all instrument systems.
4. Conduct interviews with all staff post training and evaluate any issues or concerns that they may have experienced
iv. Go-Live
1. Closely monitor all aspects of the Lab’s operation for the first month with close communication with both the technical consultant and the labs personnel for the first 60 days or until the laboratory staff is proficient and confident in their ability.
IV. On-going Support from Medical Source
a. Consumables and Supplies
i. MSI will actively monitor laboratory operations and create the necessary procedures to facilitate to obtainment of supplies that the laboratory will require
ii. MSI will determine intervals for repeat purchasing, lot obtainment, batching requirements, etc. to minimize expenditures on consumables and maximize the profit on each sample.
iii. MSI will develop and save purchase lists to facilitate the ease of ordering for all authorized staff in the laboratory
b. New and emerging techniques and technologies
i. MSI will inform the laboratory staff and ownership about any new technologies that may benefit the laboratory
ii. Assist the customer in obtaining said technologies at the lowest possible price.
iii. Consult with the client if they have an interest in a new technology that was brought to their attention directly to determine if it is viable in their lab.
c. New policies, regulation and legislation
i. Medical Source will divulge any upcoming changes in legislation or regulations that will affect the market and more specifically the client’s laboratory in any way. Furthermore Medical Source will offer and suggestions on how the client can best adapt to meet the pending changes proactively.