The U.S. Centers for Medicare and Medicaid Services lifted on Tuesday the suspension of the certification of the Commonwealth Health Center’s laboratory unit after finding that the hospital has successfully rectified all deficiencies the federal health agency identified during its September 2012 inspection.
CHCC hospital services administrator Jesse Tudela confirmed this with Saipan Tribune yesterday, saying the CMS decision was sent Tuesday in a letter to corporation management.
It will be recalled that CHCC was notified by CMS in 2012 that the laboratory is at risk of having its CLIA certification revoked.
CLIA stands for Clinical Laboratory Improvement Amendments, a federal regulatory standard that applies to all clinical lab testing performed on humans in the U.S. The objective of CLIA is to ensure the accuracy, reliability and timeliness of test results regardless of where the test was performed.
Last month, a CMS-CLIA team was on island to validate the corrective measures the corporation has implemented at the CHC laboratory.
“We’re very happy and proud of this latest decision from CMS. What this means is that our CLIA certification is no longer at risk and the unit is now allowed to perform laboratory services,” said Tudela.
CMS conducts CLIA inspections every two years. The latest decision is for the lab’s CLIA certification for 2012-2014. The next inspection—for 2014-2016—is expected this summer.
CHC’s laboratory department has 19 personnel. It has a new lab director, Dr. Phillip Dauterman, who also temporarily serves as the unit’s lab manager.
Tudela said the lack of a lab director has been a major concern for CMS. This position has been vacant for many years.
For the vacant lab manager position, the U.S. Commissioned Corps is helping look for a qualified person for the job. The group, Tudela said, is working with the Centers for Disease Control and the U.S. Human Health Services.
There are also two other unfilled positions at the unit: 2 clinical lab scientists.
Tudela said that CMS-CLIA is aware of this and has acknowledged the hospital’s efforts to fill these vacancies. Other than that, each and every concerns raised by CMS-CLIA has been resolved, he added.
Tudela praised the commitment and hard work of laboratory staff and the hospital management for making this happen for CHCC.
When CMS was on island in September, they did a separate survey of the hospital for its “Hospital Condition of Participation” and one for the Dialysis for ESRD (End Stage Renal Disease) “Facility Conditions of Participation.”
CMS has yet to render its decision on the hospital’s Condition of Participation.
Had CHC lost its CLIA certification, it would have affected the hospital’s recertification with CMS. Back in 2012, CLIA was close to revoking CHCC’s certification and that would have resulted in CHCC not being able to operate its laboratory for at least two years
As the agency responsible for the health and wellness of the people of the CNMI, it would be detrimental if CHC cannot operate a laboratory and be able to guarantee that services would be available to the hospital and its patients, including those with Medicare and Medicaid as their primary payer.