A federal district judge in Johnstown has issued a temporary restraining order that bars a medical care accreditation agency from shutting down the use of blood testing equipment at Penn Highlands DuBois Hospital.

The order issued by U.S. District Judge Stephanie L. Haines came late Thursday after a conference between attorneys representing the hospital and The Joint Commission, a not-for-profit agency with headquarters in Oakbrook Terrace, Ill., and an office in Washington, D.C.

The Joint Commission, a 71-year-old organization, is an agent for the Centers for Medicare and Medicaid Services, part of the U.S. Department of Health and Human Services.

It reviews standards and provides accreditation for medical services offered within hospitals.

In April, the agency notified Penn Highlands DuBois that the Centers for Medicare and Medicaid received reports that blood gas testing equipment used in the hospital’s clinical laboratory was not providing “desired proficiency testing results.”

The Joint Commission ordered that the testing in the hospital’s laboratory be halted for six months.

That order drew an immediate negative response from the president of Penn Highland DuBois, John S. Sutika, who submitted an affidavit reporting the hospital has replaced faulty testing equipment with new machines that have “achieved successful blood gas proficiency testing results.”

Sutika stated, “The hospital also submitted Plans of Correction and credible evidence of compliance, including written documentation and video evidence of successful proficiency testing using equipment (from a new vendor).”

The Mirror was unable to make contact with Sutika on Friday, but his affidavit submitted to the district judge indicated the clinical laboratory is utilized by clinicians “to manage oxygenation and blood chemistry of acutely ill patients that may require ventilation and/or other respiratory support.”

“Once a blood sample is taken from a patient, it must be quickly analyzed in an on-site laboratory within minutes to ensure an accurate test result,” he stated.

He reported that last December, the hospital experienced “proficiency testing issues,” but, he reported, “no patient harm resulted.”

In April, the hospital replaced the blood gas testing equipment.

Despite that move, the Joint Commission on

April 21 ordered the hospital to “immediately” cease blood gas testing.

In its communication, the commission “warned that failure to do so would result in a preliminary denial of accreditation to the hospital,” according to the affidavit.

“If TJC’s directive is upheld, it will result in substantial and irreparable harm to the hospital, its patients and the community in complete opposition to the purpose of both the hospital and TJC,” according to the Sutika affidavit.

The affidavit concluded that if the commission directive requiring it to cease blood gas testing went into effect, it would “require the hospital to withdraw ventilation from existing and future patients, including infants in the Neonatal Intensive Care Unit, patients presenting to the emergency department with COVID-19 and other ailments and patients in need of certain surgical trauma and intensive care.”

“The hospital has gone to considerable effort and expense to achieve compliance with (clinical) standards and safe practices. The hospital is committed to ensuring the continuity and availability of health care to its community,” Sutika stated.

In her order, Haines temporarily enjoined that Joint Commission from enforcing its order.

She stated, “The court finds that (the hospital) has demonstrated that irreparable harm will result if the notice to cease testing is enforced, and (the hospital) cannot continue testing.”

Haines will hold a hearing whether or not to extend the injunction on June 30.

In the meantime, she has ordered the Joint Commission to file a response to the hospital’s injunction request by June 22.

The hospital will have until June 27 to respond to the commission’s filing.

Attempts to obtain comment from the hospital’s attorney, Shannon Voll Poliziani of Pittsburgh, and the attorney for the Joint Commission, Sheila Woolson of New Jersey, were not successful.

Penn Highlands DuBois has 216 staffed beds.