Long-Term Care Survey Alert

Nursing facilities that wave off those “waived”  lab testing requirements may have a new survey headache  on the horizon.

State agencies recently began surveying a  sample of skilled nursing facilities that have a certificate  of waiver (COW) under the Clinical Laboratory  Improvement Amendments. Your SNF must have such  a certificate to perform any lab testing on human specimens,  to diagnose, treat or monitor disease. Common  testing that occurs in SNFs includes blood glucose  monitoring and fecal occult blood testing.

The Centers for Medicare & Medicaid  Services insists the focus of the surveys is to assist  providers to improve their waived lab testing.

“The purpose of these surveys is to educate,  not sanction, so when surveyors discover problems,  their first effort would be to work with the lab to comply  with CLIA regulations,” a CMS official tells Eli.  CMS decided to launch the voluntary surveys  of 2 percent of waived labs annually following  studies showing widespread and serious problems  with such testing. For example, a CMS pilot  study found staff in some labs using expired test  strips or the wrong strips for an instrument. Many  labs performing waived tests didn’t have the manufacturer  instructions for performing the tests on hand  — or weren’t following them. Some were even cutting  test strips to save money, CMS reports.

Some survey experts fear the CLIA surveys  could serve as a springboard for other compliance  actions. “One would hope that education comes first,  but CMS has little if any control over state survey agencies,  which go in their own direction, as we know,”  says attorney Joseph Bianculli, with The Law Offices  of Bianculli & Impink in Arlington, VA. “And  the regional offices aren’t  exactly shy violets regarding  enforcement.”

According to the list of surveyor questions for  COW labs obtained by Eli, surveyors are instructed  to contact the regional office if the lab “performs testing  in a manner that constitutes an   imminent and serious  risk to public health.”

“The various government agencies are supposed  to communicate with each other,” agrees Andrew  Cutler, a consultant with FR&R Healthcare  Consulting in Deerfield, IL. “So if CLIA surveyors
found a facility wasn’t doing blood glucose monitoring  or another waived test correctly, I wouldn’t be surprised  if it didn’t trigger a full state survey, or at least  flag the facility in some way.

“There could also be a potential false claims  issue if the facility were found to be billing for lab tests  that it wasn’t performing appropriately.”

The CMS official agrees that CLIA regulators  might handle some situations “differently” — for  example, “if a surveyor confronted SNF staff with  serious clinical issues arising from their lab testing and  it became clear through the process that they had no  interest in compliance. Or if surveyors found a facility  purposefully doing something wrong, such  as using one blood specimen to bill four patients  — that’s different, as well. That’s not a mistake resulting from lack of knowledge.”

Target Common Problems

Meanwhile, SNFs should give themselves  a CLIA checkup to ensure surveyors will give them a  clean bill of health on their lab testing. “The primary problem SNFs make with waived testing is
where staff doesn’t sign off on each test and document  the results in the resident’s medical record,” observes  Marilyn Mines, also a consultant with FR&R.  “The facility must document the results for each test.  If the test results are abnormal, staff must report the  results to the physician and document they did that  and the outcome.”

Staff should also make sure to follow the  manufacturer’s instructions for performing tests, including  quality control, calibration and instrument maintenance.  “COW labs, including SNFs, must perform  and document quality control [as recommended by the  manufacturer] before reporting test results, even on  urine dipsticks,” according to Karla Scholl, a CLIA  compliance consultant in Palatine, IL. “As part of QC,  SNFs have to make sure the blood glucose machine is  calibrated every day,” adds Mines.

The SNF’s standard operations and procedures  manual should include the test instructions as well as  operating instructions for any instrument and any package  inserts from the controls and strips being used.

The facility’s nursing staff should also question  any waived lab results that seem way off the mark  or don’t match residents’ symptoms — for example,  very high blood sugars in the absence of other signs of  hyperglycemia. In such a case, staff should quickly  check the QC results and rerun the test. When in doubt,  always contact the physician or medical director immediately  before administering insulin based on questionable  blood glucose readings.