Stamford Hospital Fined $55,000 For Operating Blood Draw Facility Without Approval

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Stamford Hospital has been fined $55,000 by the state for allowing a phlebotomist to draw blood at a Southington facility before obtaining a certificate of approval to operate.

A state Department of Public Health (DPH) inspection at Feel Well Health Center in Southington on or around Jan. 26 found that a phlebotomist who had contracted with Boston Heart Diagnostics in Massachusetts was conducting venipuncture, or puncturing a patient’s vein to draw blood, before Stamford Hospital obtained the necessary written certificate to operate the blood collection facility, according to a consent order signed Sept. 7 by the hospital and DPH.

Photo Stamford Hospital

Stamford Hospital was fined for operating a blood draw clinic in Southington without state approval.

The phlebotomist was collecting and sending specimens to Boston Heart for laboratory analysis and was being paid by Boston Heart to do so, the consent order said. In addition, a DPH investigation determined that between Oct. 4, 2017, and Jan. 26, 2018, Stamford Hospital paid a phlebotomist to perform venipuncture at the center prior to getting the necessary written certificate to operate the facility.

The order said the Stamford Hospital blood collection facility violated state law because it failed to: have or display a state blood collection facility certificate with a gold seal of approval, have or display emergency procedures for a distressed patient, and have a supervisor visit the facility on at least a monthly basis. The hospital also failed to maintain the blood collection area, as inspectors found rips in chair arms and noticed centrifuges that should have been calibrated annually hadn’t been calibrated since January 2016.

“The staff members who were involved in the opening of the [Southington] draw station did so without any intention of violating legal requirements,” said Ruth Cardiello, vice president of enterprise risk management and corporate compliance officer at Stamford Health. She said the company “accepts full responsibility for these actions” and reported them to DPH.

“We cooperated in every way possible with the department to rectify the situation and are complying with any resulting direction from the state,” Cardiello said. “We have already reviewed all existing blood draw stations and instituted even more stringent policies for the review of new ones by our compliance and executive teams to ensure this isolated occurrence is not repeated. This unfortunate event in no way impacted the quality of care we provide our patients at Stamford Health.”

In September, DPH received and accepted a “comprehensive plan of correction” from the hospital, which includes a plan for training all laboratory staff.

In addition to the fine, the hospital agreed to appoint a phlebotomy supervisor who has at least an associate’s degree in biological, physical or chemical science and a certificate as either a phlebotomist or medical laboratory scientist, technician or technologist.

The phlebotomy supervisor is responsible for assessing, monitoring and evaluating various aspects of patient care and protocol at the facility. Under the order, the supervisor can oversee no more than 25 blood collection facilities and must visit each one every other week for at least six months after the date the order was signed.

Also, during the first six months, DPH has sole discretion as to whether to issue any certificates and licenses to the licensee, the licensee waives its right to contest decisions, and must submit monthly reports.

In addition, facility leadership, including the clinical director of core laboratory services and the administrative director of laboratory services, must meet with DPH officials quarterly during the first six months, and at a frequency determined by DPH after that.

The order also said Stamford Hospital must ensure enough staff is available at the facility to meet the needs of patients, and policies and procedures must be reviewed and revised as needed. The hospital also has to notify DPH immediately if any of these jobs become vacant: medical director of laboratory services, administrative director of laboratory services, clinical director of core laboratory services and phlebotomy supervisor.

When asked about the fine and consent order, Christopher Stan, a DPH spokesman, said that DPH considers the nature of violations and overall situation when determining how much to fine a hospital. In this case, violations spanned nearly four months, impacted multiple patients and involved more than one licensee, he said. Licensees named in the consent order are Stamford Hospital and Stamford Hospital Laboratory and Stamford Health Laboratory.



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