Animal Specimens

We do not accept animal specimens for laboratory testing.

Cancellation of Tests

Cancellations received prior to test setup will be honored at no charge. Requests received following test setup cannot be honored. A report will be issued automatically and charged appropriately.

Chain-of-Custody

Chain-of-custody, a record of disposition of a specimen to document who collected it, who handled it, and who performed the analysis, is necessary when results are to be used in a court of law. Mayo Medical Laboratories has developed packaging and shipping materials that satisfy legal requirements for chain-of-custody. This service is only offered for drug testing.

Clinical Trials Participation Inquiries

Specific resources and capabilities for clinical trials and research projects are available. Contact your regional representative or customer service for further information.

Compliance Policies

Mayo Medical Laboratories is committed to compliance 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 and Medicaid Services (CMS), the Food and Drug Administration (FDA), and the Department of Transportation (DOT).

Mayo Medical Laboratories develops, implements, and maintains policies, processes, and procedures throughout our organization which are designed to meet relevant requirements. In addition, we have a robust internal and external audit and assessment program to monitor ongoing compliance.

See Accreditation and Regulatory Standards for more information.

Confidentiality of Results

Mayo Medical Laboratories is committed to maintaining confidentiality of patient information. To ensure Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliance for appropriate release of patient results, the following phone inquiry policy has been adopted.

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; or
• Client accession ID number interfaced to Mayo Medical Laboratories; or
• Identification by individual that he or she is, in fact, the “referring physician” identified on requisition form

We appreciate your assistance in helping Mayo Medical Laboratories preserve patient confidentiality. Provision of appropriate identifiers will greatly assist in prompt and accurate response to result inquiries and reporting.

Disclosures 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.

Fee Changes

Fees are subject to change without notification. Specific client fees are available by calling customer service.

HIPAA Compliance

Mayo Medical Laboratories 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). Although we cannot assure that individual clients will meet their own responsibilities under HIPAA, we are committed to sharing information and coordinating efforts toward that goal. All services provided by Mayo Medical Laboratories that involve joint efforts will be done in a manner which enables our clients to be HIPAA compliant. View our HIPAA statement.

Infectious Material

The Centers for Disease Control (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 us by using the Request for Supplies form.

Shipping regulations require that infectious substances affecting humans be shipped in a special manner. See Specimen Transport for more information. A copy of the regulations can be requested from the International Air Transport Association (IATA).

Informed Consent Certification

Submission of an order for any tests contained in this catalog constitutes certification to Mayo Medical Laboratories by 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. State law where such reference laboratory is located may require written informed consent for certain tests. Mayo Medical Laboratories will request that ordering physician pursue and provide such consent. Test results may be delayed or denied if consent is not provided. Any costs incurred will remain the obligation of ordering party.

Parallel Testing

Parallel testing may be appropriate in some cases to re-establish patient baseline results when converting to a new methodology. Contact your Regional Manager or customer service for further information.

Proficiency Testing

We are a College of American Pathologists (CAP)-accredited, CLIA-licensed facility that voluntarily participates in many diverse external and internal proficiency testing programs.

Our proficiency testing includes participation in programs conducted by CAP and the Centers for Disease Control and Prevention (CDC) along with independent state, national, and international programs. See Quality for more information.

Radioactive Specimens

Specimens from patients receiving radioactive tracers or material should be labeled as such. Specimens are not routinely tested at Mayo Medical Laboratories for background radioactivity. This radioactivity may invalidate the results of radioimmunoassays (RIA).

Referral of Tests to Another Laboratory

Specimens shipped to Mayo Medical Laboratories for referral to an outside laboratory should not be sent in a glass vial(s) due to restrictions set by many of the referral laboratories. Specimens should be poured off into a plastic, screw-capped vial(s) prior to freezing. A specimen received f rozen in a glass vial(s) may be subject to cancellation at the performing laboratory’s discretion. For tests referred to another laboratory, a handling fee will be applied. Mayo Medical Laboratories invoices for all testing referred to another laboratory at the price charged to Mayo Medical Laboratories. These prices are subject to change, at the discretion of the referred to laboratory, without notification. In addition, Mayo Medical Laboratories charges a per test administrative fee.

Reflex Testing

Mayo Medical Laboratories identifies tests that reflex when medically appropriate. In many cases, we offer components of reflex tests individually as well as together. Clients should familiarize themselves with the test offerings and make a decision whether to order a reflex test or an individual component. Clients, who order a reflex test, can request to receive an “Additional Testing Notification Report” which indicates the additional testing that has been performed. This report will be faxed to the client. Clients who wish to receive the “Additional Testing Notification Report” should contact their Regional Manager or Regional Service Representative.

Reportable Disease

Mayo Medical Laboratories endeavors to comply with laboratory reporting requirements for each state health department regarding reportable diseases. We report by fax, form, or phone depending upon your individual state health department regulations. In addition, we report electronically where available. Reports are provided to the appropriate state health department based upon the state listed in the client address. We strive to cooperate with our clients so that we both comply with state regulations. Contact customer service for further information.

Request for Physician Name and Number

Mayo Medical Laboratories endeavors to provide high quality, timely results so patients are able to receive appropriate care as quickly as possible. While providing esoteric reference testing, there are times when we need to contact the ordering physician directly. The following are 2 examples:

• When necessary to the performance of a test, the ordering physician’s name and phone number are requested as part of “Specimen Required.” This information is needed to allow our physicians to make timely consultations or seek clarification of requested services. If this information is not provided at the time of specimen receipt, we will call you to obtain the information. By providing this information up front, delays in patient care are avoided.
• In some situations, additional information from ordering physician is necessary to clarify or interpret a test result. At that time, Mayo Medical Laboratories will request physician’s name and phone number so that 1 of our staff can consult with the physician.

Research Projects

Research projects will be approved on an individual basis. Please call your regional manager for details.

Specimen Identification Policy

All specimens received for testing must be correctly and adequately labeled to assure positive identification. Specimens must have 2 person-specific identifiers on the patient label. Person-specific identifiers may include:

• Accession number
• Patient’s first and last name
• Patient’s initials
• Unique identifying number (eg, medical record number)
• Date of birth

Specimens are considered mislabeled when there is a mismatch between the person-specific identifiers on the specimen and information accompanying the specimen (eg, computer system, requisition form, additional paperwork). When insufficient or inconsistent identification is submitted, we will recommend that a new specimen be obtained, if feasible.

Specimen Rejection

All tests are unique in their testing requirements. To avoid specimen rejection or delayed turnaround times, check the “Specimen Required” field within each test. You will be notified of rejected or problem specimens upon receipt. Review the following conditions prior to submitting a specimen:

• Full 24 hours for timed urine collection
• pH of urine
• Lack of hemolysis/lipemia
• Specimen type (plasma, serum, whole blood, etc.)
• Specimen volume
• Patient information requested
• Patient/specimen properly identified
• Specimen container (metal-free, separation gel, appropriate preservative, etc.)
• Transport medium
• Temperature (ambient, frozen, refrigerated)
• Transport medium
• Temperature (ambient, frozen, refrigerated)

Specimen Volume

The “Specimen Required” section of each test includes 2 volumes - preferred volume and minimum volume. Preferred volume has been established to optimize testing and allows the laboratory to quickly process specimen containers, present containers to instruments, perform test, and repeat test, if necessary.

Many of our testing processes are fully automated; and as a result, this volume allows hands-free testing and our quickest turnaround time. Since patient values are frequently abnormal, repeat testing, dilutions, or other specimen manipulations often are required to obtain a reliable, reportable result. Our preferred specimen requirements allow expeditious testing and reporting.

When venipuncture is technically difficult or the patient is at risk of complications from blood loss (eg, pediatric or intensive care patients), smaller volumes may be necessary. Specimen minimum volume is the amount required to perform an assay once, including instrument and container dead space.

We make every possible effort to successfully test your patient’s specimen. If you have concerns about submitting a specimen for testing, contact customer service. Our staff will discuss the test and specimen you have available. In some cases testing can be performed using alternative techniques.

Supplies

Shipping boxes, specimen vials, special specimen collection containers and kits, sterile vials, stool containers, and request forms are supplied without charge. Request supplies using the Supply Request form.

Test Development Process

Mayo Medical Laboratories serves patients and health-care providers from Mayo Clinic, Mayo Health System, and our reference laboratory clients worldwide. We are 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. Each assay, whether developed on site or by others, undergoes an extensive validation and performance documentation period before the test becomes available for clinical use.

Test Result Call-Backs

Results will be phoned to a client when requested from the client.

Time-Sensitive Specimens

Contact customer service prior to sending a specimen for testing of a time-sensitive nature. Relay the following information:

• Facility name
• Account number
• Patient name and/or accession number
• Shipping information (e.g. courier service)
• Date to be sent
• Test to be performed

Place specimen in a separate Mayo Medical Laboratories temperature appropriate bag. Please write “Expedite” in large print on outside of bag.

Turnaround Time (TAT)

Our extensive test menu reflects the needs of our own health-care practice. We are committed to providing the most expedient turnaround time possible to improve diagnosis and treatment. We consider laboratory services as part of the patient care continuum wherein the needs of the patient are paramount. In that context, we strive to fulfill our service obligations.

Mayo Medical Laboratories defines turnaround time as the analytical test time required. Turnaround time is monitored continuously by each performing laboratory site within Mayo’s Department of Laboratory Medicine and Pathology. Turnaround time for individual tests is available by contacting customer service.

Unlisted Tests

New procedures are developed throughout the year; therefore, some tests are not listed in our catalog. Although we do not usually accept referred tests of a more routine type, special arrangements may be made to provide your laboratory with temporary support during times of special need such as sustained instrumentation failure. For information about unlisted tests, contact customer service.

Unsatisfactory Analytic Results

If we are unable to obtain a satisfactory analytic result, there is no charge.