CMS Expectations for Laboratory Services
on 10/18/2016 10:00:00 AM
The requirements for laboratory services under the Conditions of Participation for acute care hospitals seem modest in nature. There are other regulations promulgated by CMS that provide significant oversight of clinical labs. Having said this, hospitals would be ill advised to ignore the COP for laboratory services. So what are the salient areas to be concerned about? The interpretive guidance under Appendix A of the State Operations Manual at §482.27 forms the basis for this discussion.
Your hospital must have a current CLIA certificate for all sites that provide laboratory services - even if only waived testing is performed. Depending on how services are configured, a hospital can have one certificate that covers multiple sites, or separate certificates for each site. In addition, the level of a CLIA certificate must be consistent with the scope of laboratory services offered in a given setting.
For example, suppose you have an outpatient clinic that does both waived testing and provider performed microscopy. If the CLIA certificate only permits basic waived tests, your hospital may not perform microscopy at that location. Failure to have a current and appropriate CLIA certificate is usually considered a condition-level deficiency.
Emergency Laboratory Services
Your hospital must provide emergency laboratory services 24 hours a day, seven days a week. They must be provided directly by the hospital or through onsite contracted laboratory services. This includes collection, processing and provision of results to meet a patient's emergency laboratory needs.
If your hospital has multiple hospital campuses, these emergency laboratory services must be available onsite 24/7 at each campus.
Your medical staff must determine which specific laboratory services (i.e. tests and personnel) are to be immediately available to meet the emergent needs of both inpatients as well as patients who present to your hospital in an emergent condition - usually through the emergency department.
If you have off-campus locations, then the medical staff must determine which, if any, laboratory services must be immediately available to meet the emergent needs of patients who are likely to seek care at each of those settings. These services must be available during the hours of operation of that location.
Written Description of Services
Your hospital should have a written description of the laboratory services provided, including those furnished on routine and stat basis (either directly or under an arrangement with an outside facility). Surveyors will often look at the lab's test menu and then determine if those tests are actually being performed. If a test is listed on the menu, but is not being performed at that location, then a standard-level deficiency will likely occur. Hence, it would be in your hospital's best interest to clearly identify the specific tests that are available at different campuses or off-site locations.
Processing & Examination of Tissue Specimens
CMS expects that your hospital have written instructions for the collection, preservation, transportation, receipt and reporting of tissue specimen results. Surveyors will look to see that these procedures are followed. In addition, your laboratory must have written policies, approved by the medical staff and a pathologist, stating which tissue specimens require a macroscopic examination and which tissue specimens require both macroscopic and microscopic examination.
While laboratory services may not always get a close inspection during a hospital survey, adherence to these COP requirements will assure a good survey outcome should CMS or accreditation agencies focus on this area.
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About the Author
Richard Curtis RN, MS, HACP
RN, MS, HACP
Richard (Rick) Curtis is the Chief Executive Officer for CIHQ. Rick is nationally recognized as an expert on the Medicare Conditions of Participation and the CMS Certification & Survey Process. As CEO, he successfully guided CIHQ in becoming the nation's 4th CMS approved deeming authority for acute care hospitals.
Rick's clinical background is in critical care nursing with a focus in cardiovascular and trauma service lines. He has held both clinical and executive management level positions in Quality, Risk, Education, Infection Control, and Regulatory Compliance.
Rick is a regular speaker at numerous state and national conferences on the federal regulations and accreditation standards, and is host of CIHQ's popular monthly webinars addressing key compliance challenges in today's environment.
Rick is nationally certified in healthcare accreditation, and serves as Chair of the Board of Examiners for the Healthcare Accreditation Certification Program (HACP). Rick has a degree in Nursing with a Master's Degree in Health Services Administration.