Good news for clinical labs: The Centers for Medicare & Medicaid Services is keeping surveyors on a tight leash when it comes to handing out citations. In a May 8 letter to surveyors (Ref: S&C-03-19), CMS points out that while the new Clinical Laboratory Improvement Amendments rule it published earlier this year went into effect April 24, new survey guidelines haven't yet been issued.
"In keeping with CMS' outcome oriented approach to survey and certification, surveyors are being asked to only cite the most serious deficiencies (those that affect outcomes or potential outcomes) and to continue to offer education and training assistance until the new survey guidelines are published," the agency says. CMS says the new guidelines should be published in October. The agency notes that the new CLIA rules should ease the regulatory burden when it comes to bacteriology requirements, mycology requirements, syphilis serology and general immunology, hematology and histocompatibili-ty. And while the rule increases the burden on general quality control requirements, expanding them to all non-waived testing, CMS says surveyors "are not being asked" to survey for expanded QC until the survey guidelines are published. To see the letter, go to
http://cms.hhs.gov/reports/hcimu/hcimu_05202003.pdf. Lesson Learned: Labs may get a break on CLIA surveys in the short term - but the rules may change when CMS publishes new guidelines in October.