Cleveland Clinic Laboratories policies and procedures help ensure the consistent quality testing and results that our clients expect. For questions or additional details regarding the policies and procedures described here, please contact Client Services.
Animal Specimens
We do not accept animal specimens for laboratory testing.
Back to top
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.
Back to top
Compliance Policies
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).
Our clients are responsible for their compliance with regulations related to patient confidentiality, diagnosis coding, anti-kick back statutes, professional courtesy, CPT-4 coding, CLIA proficiency testing and other similar regulatory requirements.
Analyte Specific Reagents
Analyte specific reagents (ASRs) are reagents of chemicals or antibodies that may be considered “active ingredients” of tests used to identify specific diseases or conditions. The reagents are purchased by clinical
laboratories for use in the development of in-house tests used in the diagnosis and management of various conditions. To meet FDA regulations, the laboratory provides a disclaimer on results from those in- house developed tests that incorporate ASRs.
Genetic Testing
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.
Lead and Heavy Metal Testing
State Departments of Health mandate testing laboratories to 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.
Required information includes the following:
- patient’s date of birth, race, complete address, telephone number, sample type (venous or capillary)
- guardian’s name and phone number (children only)
- name and address of patient’s place of employment
- referring physician’s name, address, telephone number and UPIN.
Specimens received without the required information will not be tested. The client will be contacted and asked to submit the missing information. If such information is not received within one week of specimen submission, the specimen will be discarded..
HHS/OIG Compliance Policies
Cleveland Clinic Laboratories participates in an active compliance plan, which follows the outline of the Health and Human Services, Office of the Inspector General (HHS/OIG) program. All ordering physicians need to be fully informed and aware of the specific activities associated with the government compliance program and the requirements that include but are not limited to the following practices, policies and procedures:
- Medicare regulations require only tests that are medically necessary for diagnosis or treatment of a patient may be billed. Each laboratory test request requires appropriate medical necessity (ICD-9 codes).
- Screening tests (with a few specifically cited exceptions) that are billed to Medicare will be denied reimbursement. Medicare may not pay for non- FDA-approved tests or tests that are identified as “research use only.”
- Each individual test component within the Organ and Disease Related Panels must meet the criteria of medical necessity.
- 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.
- When there is a likelihood that an ordered laboratory test will not be paid by Medicare, the patient should be informed and asked to sign an Advance Beneficiary Notice (ABN), Form No. CMS-R-131-L(June 2001). The signed ABN indicates to the patient the specific test(s) and charge(s) that he/she is responsible for in the event Medicare denies payment.
- 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.
- The reflex test list is reviewed and approved by Cleveland Clinic’s governing administrative bodies annually. All of these tests are also identified in this Cleveland Clinic Laboratories Test Directory.
Back to top
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 requests directly from the patient, are directed to the ordering facility.
We appreciate your assistance in helping Cleveland Clinic Laboratories preserve patient confidentiality.
Back to top
Critical Result Notification
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.
Back to top
Infectious Material
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 Reference 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.
A copy of the regulations is available on the International Air Transport Association website at www.iata.org/ps/publications/issg.htm or by calling 514-399-6770.
Back to top
Physician Name and Number Requests
Our goal is always to deliver accurate, high quality, timely results so that diagnostic and treatment decisions can be made as quickly as possible for patient care. At times, Cleveland Clinc Laboratories needs to contact the ordering physician directly, particularly when we are conducting esoteric tests.
At times we need 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 this information was not provided on the test order where indicated, Cleveland Clinic Laboratories may request this information from our client. We appreciate your rapid assistance in supplying us with the ordering physician’s name and phone number so that we may contact him or her as needed. Working together, we can provide your patients with the highest quality testing services in the shortest possible time.
Back to top
Proficiency Testing
Cleveland Clinic Laboratories has a strict policy regarding proficiency testing (PT) to comply with CMS regulations. The 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 the Cleveland Clinic Reference Laboratory 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.
Additionally, Cleveland Clinic Laboratories will neither communicate nor share with Clients 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.
Back to top
Quality Assurance
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 Quality Coordinating Team and senior management 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 call are monitored and recorded for quality assurance.
Back to top
Radioactive Specimens
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.
Back to top
Record Retention
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.
Back to top
Referral Testing Policy
Cleveland Clinic Laboratories serves its clients by selecting and using qualified, licensed reference laboratories to perform those tests not available at Cleveland Clinic. Laboratories are identified based on the quality of service provided. Such services include, but are not limited to, accuracy, reliability, turnaround time, customer service, ease of reporting 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.
In the event that Cleveland Clinic Laboratories must refer a test to another laboratory, we invoice for such testing at the price charged to Cleveland Clinic Laboratories plus an administrative fee per test. When a est is referred at the request of the client, a service fee of $30 is charged in addition to the routine administrative fee and the cost of the test.
Prices are subject to change without notice.
Back to top
Reflex Testing
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.
Back to top
Reportable Disease
Cleveland Clinic Laboratories strives to comply with state health department requirements regarding reportable diseases. We make our report electronically, by fax or phone, 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.
Back to top
Specimen Containers
In response to OSHA standards and good laboratory practices, the laboratory will not accept, transport or test any specimen contained in a syringe with a needle attached.
The use of glass tubes, especially for frozen specimens, should be avoided due to the increased risk of broken glass and biological contamination. Acceptable transport tubes are available upon request from Cleveland Clinic Laboratories (contact Client Services).
Back to top
Specimen Labeling
All specimens submitted for testing must be labeled with the patient's complete name or identifying number as written on the Test Request Form. This will assure positive identification and optimum integrity of patient specimens from the time of collection until testing has been completed and results reported. Clients will be notified of inappropriately labeled specimens, and the specimen will be returned to the client. Unlabeled or incompletely labeled specimens will not be tested (see Specimen Rejection Criteria below).
Back to top
Specimen Rejection Criteria
Specimens will be rejected and the tests and charges canceled under the following conditions:
- Unlabeled or incompletely labeled specimens
- Name on specimen does not match name on requisition or electronic order
- Leaking specimen
- Broken container
- Incorrect specimen submitted for test requested
- Insufficient volume (QNS)
- Improper specimen transport temperature
- Age of the specimen (test dependent)
- Hemolysis (test dependent)
- Specimens received with no written or electronic order
Back to top
Specimen Volume
Specific specimen requirements for each test are provided in the Test Directory. Submit the quantity specified for each test requested. Tests will be canceled as "QNS" (Quantity Not Sufficient) when the sample volume is inadequate and will be indicated as such on the report.
As a general rule, the volume of blood drawn should equal 2-1/2 times the amount of serum plasma required. For example, to obtain 4mL serum or plasma, draw at least 10mL blood. When inappropriate or insufficient specimens are submitted, the laboratory will store them and contact the requesting facility to request that the specimen be recollected. Documentation of this action will appear on the report.
If you have concerns about the volume of a specimen being submitted, please contact Client Services to discuss the test and specimen available. A staff member can advise you whether an alternative technique is available that can accommodate the lesser specimen volume.
Back to top
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 Cleveland Clinic Laboratories.
Back to top
Time-Sensitive Specimens
Please contact Client Services before sending a specimen for testing of a time-sensitive nature. We will ask for the following information:
- facility name
- account number
- patient name and/or
- Cleveland Clinic Laboratories accession number
- shipping information (i.e., courier service, FedEx®, etc.)
- date to be sent
- test ordered
Place specimen in a separate Cleveland Clinic Laboratories temperature- appropriate bag.
Back to top
Turnaround Time (TAT)
At Cleveland Clinic our “Patients First” philosophy guides every aspect of patient care activities. Through our extensive test menu and commitment to the most rapid TAT possible, Cleveland Clinic Laboratories strives to carry out this commitment to excellent patient care.
We define TAT as the analytical test time required. It is monitored closely and compared to standardized laboratory metrics for continuous quality improvement. For more information about TAT for specific tests, please refer to the Test Directory or contact Client Services.
Back to top