Meeting Your Accreditation and Regulatory Standards
We comply with applicable laws and regulations such as the Clinical Laboratory Improvement Amendments (CLIA). Regulatory agencies that oversee our compliance include, but are not limited to, the Centers for Medicare & Medicaid Services (CMS), the Food and Drug Administration (FDA), and the U.S. Department of Transportation (DOT). Mayo Medical Laboratories develops, implements, and maintains policies, processes, and procedures throughout the organization that are designed to meet relevant requirements. We expect that clients utilizing our services will comply with patient confidentiality, diagnosis coding, anti-kickback statutes, professional courtesy, CPT-4 coding, CLIA proficiency testing, and other similar regulatory requirements.
Maintaining confidentiality of patient information is one of Mayo Clinic’s core values. To ensure compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the College of American Pathologists (CAP) Laboratory General Checklist (CAP GEN. 41304) for appropriate release of patient results, Mayo Medical Laboratories has adopted the following policies:
Phone Inquiry Policy
One of the following unique identifiers will be required:
- Mayo Medical Laboratories' accession ID number for specimen; or
- Client account number from Mayo Medical Laboratories along with patient name; or
- Client accession ID number interfaced to Mayo Medical Laboratories; or
- Identification by individual that he or she is, in fact, "referring physician" identified on requisition form by Mayo Medical Laboratories' client.
Health Information Portability and Accountability Act (HIPAA) Compliance
Mayo Clinic is fully committed to compliance with all privacy, security and electronic transaction code requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). All services provided by Mayo Medical Laboratories that involve joint efforts will be done in a manner which enables our clients to comply with HIPAA and the College of American Pathologists (CAP) Laboratory General Checklist (CAP GEN. 41303).
Disclosure of Results
Under federal regulations, we are only authorized to release results to ordering physicians or other health care providers responsible for the individual patient’s care. Third parties requesting results, including requests directly from the patient, are directed to the ordering facility.
Informed Consent Certification
Submission of an order for any tests contained in our test menu constitutes certification to Mayo Medical Laboratories by the ordering physician that: (1) ordering physician has obtained "Informed Consent" of subject patient as required by any applicable state or federal laws with respect to each test ordered; and (2) ordering physician has obtained from subject patient authorization permitting Mayo Medical Laboratories to report results of each test ordered directly to ordering physician. On occasion, we forward a specimen to an outside reference laboratory. The laws of the state where that reference laboratory is located may require written informed consent for certain tests. Mayo Medical Laboratories will request that the ordering physician pursue and provide such consent. Test results may be delayed or denied if consent is not provided.
Critical Values / Critical Results
Mayo Clinic's Department of Laboratory Medicine and Pathology Clinical Practice Committee, a team of laboratory directors and Mayo Clinic physicians, determines the critical values for analytical tests. These decision limits are built into our Laboratory Information System (LIS). Our call center is notified of possible critical values 24 hours a day, seven days a week by representatives in our performing laboratories in compliance with and adherence to the College of American Pathologists (CAP) Laboratory All Common Checklist (CAP COM.30000). These values apply to Mayo Clinic patients as well as the extramural practice administered through Mayo Medical Laboratories. Clients will be required to provide contact information to us to facilitate accurate and timely notification of critical values/critical results.
For up-to-date policies and lists, see Critical Values / Critical Results.
Patient Safety Goals
The Joint Commission and the College of American Pathologists patient safety goals for improving patient safety through accurate patient identification requires the use of two patient identifiers when providing laboratory services. As such, we have developed the following specimen identification policy.
Specimen Identification Policy
Mayo Medical Laboratories uses a minimum of two patient-specific identifiers to verify the correct patient is matched with the correct specimen and the correct order for testing services. As a specimen is received at Mayo Medical Laboratories, the patient’s first and last name, date of birth, medical record number, and client accession number are verified by comparing the labels on the specimen tube or container with the electronic order and any paperwork (batch sheet or form) that may accompany the specimen to be tested. When discrepancies are identified, the Mayo Laboratory Inquiry Call Center will telephone the client to verify discrepant information to assure Mayo Medical Laboratories is performing the correct testing for the correct patient. Specimens are considered mislabeled when there is a mismatch between the person-specific identifiers on the specimen and information accompanying the specimen (e.g. computer system, requisition form, additional paperwork). When insufficient or inconsistent identification is submitted, Mayo Medical Laboratories will recommend that a new specimen be obtained. In cases where an irreplaceable specimen is mislabeled, additional conditions must be met prior to testing.
In addition, Anatomic Pathology consultation services require the client pathology report. The pathology report is used to match patient name, patient age and/or date of birth and pathology case number. Since tissue blocks and slides have insufficient space to print the patient name on the block, the pathology report provides Mayo Medical Laboratories another mechanism to confirm the patient identification with the client order and labels on tissue blocks and slides.
Test Development Process
Mayo Medical Laboratories is dedicated to providing clinically useful, cost-effective testing strategies for patient care. Development, validation and implementation of new and improved laboratory methods are major components of that commitment. We have launched a standardized test life cycle process (TLCP) which includes seven specific phases of the test life cycle process (test design, development, verification, validation, launch, maintenance and test retirement). This process positively streamlines all development operations and activities and aligns with FDA test development definitions. Assays utilized at Mayo Clinic, whether laboratory developed or FDA cleared, undergo a verification, validation and performance documentation period before the test becomes available for clinical use, including:
- Specificity and interferences
- Reportable range
- Specimen stability
- Specimen type comparisons
- Urine preservative stability studies
- Comparative evaluation
- Reference values*
- Workload recording
- Limitations of the assay
- Clinical utility and interpretation
*Reference values provided by Mayo Medical Laboratories are derived from studies performed in our laboratories. If reference values are obtained from other sources, the source is indicated in the "Reference Values" field.
Analytical tests offered by Mayo Medical Laboratories are classified according to the FDA status of the test kit or reagent and to their usage. The classifications include:
- FDA approved or cleared (IVD)
- Analyte Specific Reagent (ASR)
- Investigational Use Only (IUO)
- Research Use Only (RUO)
Where appropriate, analytical test listings contain a statement regarding these classifications, test development and performance characteristics.
The Mayo Laboratory Standardization Group (MLSG) is a department-wide, multisite initiative focusing on standardizing platforms, assays, procedures and controls across all testing sites. The goal of these activities is to assure the same results are obtained at all testing sites. The group actively identifies the best method for each test and standardizes processes across testing sites to ensure high-quality and consistent results, regardless of testing location.
Turnaround Time (TAT)
Mayo Medical Laboratories' extensive test menu reflects the needs of our health care practice. We are committed to providing the most expedient turnaround time possible to improve diagnosis and treatment. We consider that laboratory services are part of the patient care continuum and the needs of the patient are paramount. Our history of service and quality metrics document our ability to deliver on all areas of service including turnaround time. Mayo Medical Laboratories defines turnaround time as the analytic test time (the time from which a specimen is received at the testing location to the time of result). Turnaround time is monitored continuously by each performing site.
Mayo Medical Laboratories, in compliance and adherence to the College of American Pathologists (CAP) Laboratory General Checklist (CAP GEN. 43900), retains all test requisitions and patient test results at a minimum for the retention period required.
Reportable Disease Notification
Mayo Medical Laboratories, in compliance with and adherence to the College of American Pathologists (CAP) Laboratory General Checklist (CAP GEN. 20374), strives to abide by laboratory reporting requirements for each state health department regarding reportable disease conditions. We report by fax, mail and/or electronically, depending upon the specific state health department regulations. Clients shall be responsible for compliance with any state-specific statutes concerning reportable conditions, including but not limited to birth defects registries or chromosomal abnormality registries. This may also include providing patient address/demographic information. Mayo Medical Laboratories reporting does not replace the client/physician responsibility to report as per specific state statutes.
Referral of Tests to Another Laboratory
We have established collaborative relationships with more than 140 laboratories within the United States. Mayo Medical Laboratories selects outside vendors on the basis of certifications, service, turnaround time, methodology, reference range and price. Laboratory qualifications are reviewed by our internal operations and quality teams. A recommendation is forwarded to our medical director for final consideration as to compliance with and adherence to College of American Pathologists (CAP) Laboratory General Checklist (CAP GEN. 41350). Once selected, each laboratory is monitored to ensure that turnaround time is prompt and certain customer service criteria are met. The referral laboratories must requalify every two years, or as their test offerings change.
Clients of Mayo Medical Laboratories receiving Mayo final reports have the responsibility in compliance with and adherence to the CAP Laboratory General Checklist (CAP GEN.48500) to validate and verify that the contents of their patient reports transmitted to their ordering physician or patient electronic medical record compares to the MayoAccess Report. The client is responsible for the transmission of patient results through the interface activities within their own system (LIS and HIS).
Paper or electronic reports of a patient’s results include all required elements and information in compliance with and adherence to the College of American Pathologists (CAP) Laboratory General Checklist (CAP GEN. 41096), with the address of the reporting laboratory on the report.
If Mayo Medical Laboratories changes a result or adds an additional comment, “revised report” will appear on the printed or electronic report under the test name. All revised reports will also be telephoned to the client. The report will show both the previous reported results and the revised or corrected results in compliance with and adherence to the CAP Laboratory General Checklist (CAP GEN. 41310).
Transportation and Handling
Mayo Medical Laboratories warrants that all in-house and contracted couriers are appropriately licensed and have received training required by OSHA regarding bloodborne pathogens. We also require training specified by the U.S. Department of Transportation regulations as detailed in 49 CFR, Parts 100-185. Personnel are trained in appropriate safety and packaging procedures suitable to specimen types and distance transported, and certified training is documented in compliance with and adherence to the College of American Pathologists (CAP) General Checklist (CAP GEN. 40515). Our couriers are also trained to adhere to any federal, state and local guidelines related to transportation of laboratory samples.
The Centers for Disease Control and Prevention (CDC), in its regulations of July 21, 1980, has listed organisms/diseases for which special packaging and labeling must be applied. Required special containers and packaging instructions can be obtained from our Supply Catalog and by using the Request for Supplies form.
Shipping regulations require that infectious substances affecting humans be shipped in a special manner. A copy of the regulations can be requested from the International Air Transport Association (IATA) by phone at 514-390-6726 or fax at 514-874-9659 or by e-mail at custserv@IATA.org.
Business Continuity and Contingency Planning
In the event of a local, regional or national disaster, Mayo Clinic and Mayo Medical Laboratories performing sites have comprehensive contingency plans in place in each location to ensure that the impact on laboratory practice is minimized. With test standardization among our performing sites and medical practice locations throughout the country, we have worked to ensure that patient care will not be compromised.