Policies and Procedures
Cleveland Clinic Laboratories’ policies and procedures help ensure the consistent quality testing and results that our clients and patients expect.
For questions or additional details regarding the information described here, please contact Client Services.
Cleveland Clinic Laboratories complies with all applicable laws and regulations, such as the Clinical Laboratory Improvement Amendments (CLIA), by developing, implementing, and monitoring appropriate policies, procedures, and processes.
Compliance is overseen by several regulatory agencies, including the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), and the Department of Transportation (DOT).
Analyte Specific Reagents
Analyte specific reagents (ASRs) are reagents such as chemicals or antibodies that may be purchased by clinical laboratories for use in the development of in-house tests for the diagnosis and management of various conditions. Tests which utilize these reagents undergo full analytical validation within the laboratory, and are reported with a comment identifying them as incorporating ASRs.
Ongoing advances in genetic testing and associated regulations frequently require additional patient information and/or documentation of the patient’s consent. If required information is not provided at the time of specimen submission, Cleveland Clinic Laboratories will contact the submitting facility to obtain the documentation prior to forwarding the specimen to the testing laboratory.
Health and Human Services (HHS) / Office of Inspector General (OIG) Compliance Policies
Cleveland Clinic Laboratories is committed to complete and accurate billing for all services provided to patients. Our organization actively participates in a comprehensive compliance plan that follows the regulations set forth as outlined by the Office of Inspector General (OIG).
Healthcare professionals and staff, including all ordering physicians, are required to comply with the government compliance program and requirements that include, but are not limited to the following practices, policies, and procedures:
- Physicians shall only order services and tests that are consistent with the generally accepted medical standards for diagnosis or treatment of disease and are determined by the profession to be medically necessary and appropriate.
- Patients may request services that are not covered by their benefits. Such services may be provided as long as the patient has been given advance notice and has agreed to pay for the services.
- An Advance Beneficiary Notice (ABN) must be completed by all Medicare beneficiaries when it is believed that Medicare will deny some or all of the items requested due to medical necessity or frequency limitations.
- The Centers for Medicare and Medicaid only allows screening diagnoses on a limited amount of tests. In the event that the ordering physician provides a screening diagnosis that is non-coverable, an ABN must be received with the specimen in order for the billing office to be reimbursed for these services.
- When an Organ and Disease Panel is ordered, medical necessity must be present for each test component within the panel. If all component tests within a panel do not meet the criteria of medical necessity, a physician should order individual tests or a more appropriate panel.
- A reflex test is a specific laboratory test in which an abnormal result causes one or more additional tests to be automatically ordered, resulted, and billed. Reflex tests are reviewed and approved by Cleveland Clinic’s governing administrative body each year. All tests are identified in the Cleveland Clinic Laboratories Test Directory.
Lead and Heavy Metal Testing
State Departments of Health mandate that testing laboratories report specific patient demographics and heavy metal results directly to the state. Cleveland Clinic Laboratories conforms to all such requirements and provides a separate Heavy Metals Requisition for use by the client when ordering testing for lead, cadmium, arsenic, or mercury. Clients must provide all requested information at the time of specimen submission to enable the laboratory to meet these requirements.
Specimens received with an incomplete requisition will not be tested, and the client(s) will be contacted and asked to submit any missing information. If the missing information is not received in a timely manner, testing will be subject to cancellation.
Required information for lead and heavy metal testing includes the following:
- Address (street, city, county, state, zip code)
- Primary telephone number
- Sample type: venous or capillary
- Guardian’s name (for patients 16 years old and under only)
- Referring Physician
- Address (street, city, state, zip code)
- Phone number
- Patient’s Employer (or N/A)
- Name of employer
- Address (street, city, state, zip code)
We do not accept animal specimens for laboratory testing.
Cancellation of Tests
Cancellations received prior to test setup will be honored at no charge. We cannot accommodate cancellation requests received following test setup. A report will be issued automatically and charged as indicated.
Confidentiality of Results
Cleveland Clinic Laboratories is committed to maintaining confidentiality of patient information and 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 that involve joint efforts will be done in such a way that our clients are compliant with requirements defined by HIPAA and the College of American Pathologists (CAP).
To ensure compliance with HIPAA for appropriate release of patient results, we have adopted the following policy:
- For the laboratory to release information regarding patient results by phone or email, the patient must sign the HIPAA release form.
Federal regulations permit the release of results only to ordering physicians or healthcare providers responsible for the individual patient’s care. Third-parties requesting results, including any requests directly from the patient, are directed to the ordering facility.
Critical Result Notifications
Cleveland Clinic Laboratories will immediately notify the individual who requested a test when any result indicates an imminent, life-threatening condition. This policy is compliance with CLIA regulation 493.1109 (f). Critical values of certain tests will be reported immediately by phone to the client who ordered the test, regardless of the time of day.
All specimens are handled as though they are infectious. The greatest dangers to healthcare workers exposed to blood and body fluids are the hepatitis B, hepatitis C, and HIV viruses.
Cleveland Clinic Laboratories has an extensive safety policy that adheres to guidelines provided by the Occupational Safety and Health Administration (OSHA), the Department of Labor, and the Department of Health and Human Services. Written exposure control plans are in place.
In addition, the Centers for Disease Control (CDC) has listed organisms/diseases that require the use of special packaging and labeling. Shipping regulations require that infectious substances affecting humans be shipped in a special manner. Additionally, Cleveland Clinic Laboratories has Category B Specimen Packaging Instructions available for reference.
A copy of the regulations is available through the International Air Transport Association.
Physician Name and Number Requests
Our goal is to deliver accurate, high-quality, and timely results so that diagnostic and treatment decisions can be made as quickly as possible for patient care. At times, Cleveland Clinic Laboratories needs to contact the ordering physician directly, particularly when we are conducting esoteric tests.
CCL may require the ordering physician’s name and phone number to clarify requested services, interpret a test result, or otherwise consult with the ordering physician as necessary. If the physician’s contact information was not listed on the test order where indicated, a CCL representative will call and request this information to be provided.
Cleveland Clinic Laboratories has a strict policy regarding proficiency testing (PT) to comply with CMS regulations.
Cleveland Clinic Laboratories will neither accept nor perform testing on proficiency testing material from the College of American Pathologists (CAP) or any other CLIA-approved PT provider.
If proficiency testing material is submitted to Cleveland Clinic Laboratories by a client and the proficiency testing period is in progress, the samples will be returned, and the CAP (our accreditation agency for CLIA certification) will be notified.
Samples sent for testing that appear to be proficiency survey samples will be held until the client is contacted to verify the nature of the sample.
Additionally, Cleveland Clinic Laboratories will neither communicate nor share with clients any proficiency testing survey results that are actively in progress.
Cleveland Clinic will cooperate in alternate assessment programs with other laboratories as allowed by federal regulation.
Extensive proficiency testing and quality control measures assure that each specimen is provided the full benefits of in-house quality, expertise, and knowledge.
Staff pathologists, PhDs, laboratory scientists, and technologists are all highly experienced in handling complex tests. The Medical Directors, Laboratory Director, and supervisory personnel monitor performance indicators for all laboratory services.
Performance improvement initiatives are regularly instituted and reviewed as part of an aggressive on-going quality improvement program. Client Services’ telephone calls are monitored and recorded for quality assurance.
Cleveland Clinic Laboratories does not routinely test specimens for background radioactivity. This radioactivity may interfere with the results of radioimmunoassasy; therefore, specimens from patients receiving radioactive tracers or material should be labeled as such.
Cleveland Clinic Laboratories retains all test requisitions for 15 years and patient test results are retained indefinitely. A copy of the original report can be reconstructed including reference ranges, interpretive comments, flags, and footnotes with the source system as the Pathology and Laboratory Medicine Institute’s laboratory information system.
Referral Testing Policy
Cleveland Clinic Laboratories serves our clients by selecting and using qualified, licensed reference laboratories to perform any tests not available at Cleveland Clinic. Laboratories are identified based on many factors including (but are not limited to): testing methodology, turnaround time, customer service, reporting format, and range of services offered.
Clients may, for medical reasons, request that a test be referred to a specific laboratory other than Cleveland Clinic or one which is routinely utilized by Cleveland Clinic Laboratories. Following consultation with the client regarding such requests, Cleveland Clinic Laboratories will honor the client’s request and forward the specimen.
Prices are subject to change without notice.
Some tests, under certain conditions, may result in an order for an additional test(s) placed by and at the discretion of the clinical pathologist. Please contact Client Services for information on these specific tests.
Cleveland Clinic Laboratories strives to comply with state health department requirements regarding reportable diseases. We submit our reports by fax, by phone, or electronically, depending upon the
individual state’s health department regulations. Reports are made to the state listed in the client address.
Clients are responsible for compliance with any state-specific statutes concerning reportable conditions including, but not limited to, chromosomal abnormality registries.
Specimens are only acceptable for processing when they are collected and submitted appropriately. For information on how to ship specimens to our laboratories, please refer to the following resources:
- Shipping Information
- Specimen Collection & Handling Instructions
- Category B Infectious Substance Packaging Instructions
- Instructions for Lock Box Specimens
Test Result Call-Backs
Clients may request results to be delivered by telephone. The request for a phone report may be made on the Test Request Form or by calling Client Services.
Please contact Client Services before sending a specimen for testing of a time-sensitive nature. We will ask for the following information:
- Contact name and phone number
- Facility name
- Account number / client ID or mnemonic
- 2 patient identifiers, such as the patient’s name, date of birth, MRN, or accession number
- Name of the test ordered
- Date to be sent to our laboratories
- Shipping / tracking information
To ensure specimen integrity, place the specimen in bag with a label indicating the specimen transport temperature and properly store it for pick-up.
Turnaround Time (TAT)
Cleveland Clinic Laboratories defines turnaround time as the analytical test time required.
Our laboratories’ turnaround time is monitored closely and compared to standardized laboratory metrics for continuous quality improvement.