Monitoring laboratory reagents and supplies is an important aspect of maintaining an efficient laboratory. Lapses in available reagents and supplies can cause delayed test results. There are also increased costs due to expedited shipping charges. Cost savings can be realized by consolidating orders and cutting down the number of orders that have to be shipped in a given month. Delays in testing can create sample integrity problems for tests that have limited stability. Revenue can also be lost if samples need to be sent to a reference lab and are not able to be billed. For all these reasons Total Lab Care has put together a Materials Management policy and procedure that you might find helpful to control your laboratories inventory.
On January 24, 2003, the Centers for Medicare and Medicaid Services (CMS) published the final Clinical Laboratory Improvement Amendments (CLIA) regulations with an effective date of April 24, 2003. COLA revised their accreditation criteria, Criteria for Quality Laboratory Performance, with an effective date of June 1, 2007. The new CLIA and COLA regulations require that the laboratory verify the manufacturer’s performance specifications listed in their package inserts. The laboratory must verify accuracy, precision, reference range and reportable range for each non-waived test. This bulletin will address the verification of reportable range.
What is reportable range?
Reportable range is the lowest and highest result the test system can accurately report including all the values in between.
When is reportable range verification required?
Reportable range verification is required when a lab replaces a test system or instrument, adds a new test or changes the manufacturer of a test system.
NOTE: This requirement applies to all non-waived test systems put in place on or after April 24, 2003. COLA accredited labs need to meet this requirement beginning June 1, 2007. (more…)
Calibration and Calibration Verification
On January 24, 2003, the Centers for Medicare and Medicaid Services (CMS) published the final Clinical Laboratory Improvement Amendments (CLIA) regulations with an effective date of April 24, 2003. Due to the updated CLIA regulations, COLA updated their accreditation criteria, Criteria for Quality Laboratory Performance, with an effective date of June 1, 2007. Since the release of both regulations, Vital Diagnostics has received numerous questions regarding the calibration and calibration verification requirements. The intent of this Technical Bulletin is to define calibration and calibration verification, explain the requirements and provide some insight into implementation.
What is calibration?
Calibration is the process of testing and adjusting an instrument or test system to establish a correlation between the measurement of the substance being tested and the actual concentration of the substance.
The HIPAA act of 1996 required the department of Health and Human Services (HHS) to adopt national standards for health care transactions. Further additions under the Affordable Care Act of 2010 (ACA) included requirements to adopt the use of ICD-10 standards for diagnostic coding. As many of you are aware the date for implementation to switch to ICD-10 coding is set for October 1, 2015. This was after a delay by congress in 2014. The repeal of the SGR payment formula signed into law on April 16, 2014 made no reference to a delay of ICD-10 implementation for 2015. At this time it appears that the date of transition to ICD-10 coding remains October 1, 2015. (more…)
Effective January 1, 2015, CMS has introduced four new modifier subsets of the -59 Modifier in order to better define a “Distinct Procedural Service”. Currently providers can utilize modifier -59 to indicate that a CPT code is separate but distinct from another service that could be bundled. CMS feels that this modifier’s usage has been applied broadly and as such has been applied incorrectly by providers. High levels of abuse and fraud have been associated with this modifier. The primary issue with the -59 modifier is that it is defined for use in a wide variety of circumstances such as different encounters, anatomical sites and distinct services.
The four new HCPCS subsets of the -59 Modifier are:
- XE- separate encounter
- XP- separate practitioner
- XS-separate organ/structure
- XU- unusual non-overlapping service