Welcome! Login | Register
 

NEW: Watchdog Group Demands Answers Following RI’s $500M IT Project Rollout—NEW: Watchdog Group Demands Answers Following RI's $500M…

Guest MINDSETTER™ Steve Laffey: Providence Leaders Need Reality Check—Guest MINDSETTER™ Steve Laffey: Providence Leaders Need Reality…

Dave’s Marketplace Chooses Cranston for 10th RI Location—Dave's Marketplace Chooses Cranston for 10th RI Location

RI Ranked 10th Worst State for Teachers—RI Ranked 10th Worst State for Teachers

Cheat Sheet 59, FBI Files: Coia’s Relationship with Patriarca, FBI and the Clintons—Cheat Sheet 59, FBI Files: Coia’s Relationship with…

Moore: Catholic Church Should Focus on Charity, Not Firing Gays—Moore: Catholic Church Should Focus on Charity, Not…

G Media Studios Completes Acquisition of Local Agency—G Media Studios Completes Acquisition of Local Agency

Paiva Weed Blasted for Taking Donations from 38 Studios Defendants—Paiva Weed Blasted for Taking Donations from 38…

Smart Benefits: Received an ACA Tax Bill? Look Twice Before Paying—Smart Benefits: Received an ACA Tax Bill? Look…

Revs’ Playoff Hopes Take Hit After 2-0 Loss to Columbus—Revs' Playoff Hopes Take Hit After 2-0 Loss…

 
 

NEW: RI Nurse Violated Recall of Potential Fungal Meningitis Meds

Wednesday, December 05, 2012

 

Injectible pharmaceutical products potentially contaminated with fungal meningitis were kept in patient examing rooms by Skin Essentials Spa in North Providence, according to the RI Dept. of Health. Photo: Centers for Disease Control.

A nurse practitioner at Skin Essentials Spa in North Providence, RI, has been suspended by the Rhode Island Department of Health (HEALTH) for violations concerning pharmacy items that were recalled because of potential contamination with fungal meningitis.

Gerald Dornhecker is a Nurse Practitioner with prescriptive privileges, who worked as a nurse at Skin Essentials Medical Aesthetics and Wellness Spa on Mineral Spring Avenue, according to documents filed with HEALTH. Karen Grande, MD is the Medical Director of Skin Essentials Spa.

Recall of contaminated products in October

On October 4, 2012, New England Compounding Center (NECC) in Massachusetts issued a voluntary recall of pharmaceutical products from its Framingham, MA, facility that may be contaminated with fungal meningitis. The recall instructed customers to immediately "segregate and quarantine" the recalled materials and notify NECC for its return. According to HEALTH, Dornhecker signed the voluntary recall response form and checked a box indicating that "We do not have any of the below products in the facility."

Violations on two separate occasions

However, when the United States Food and Drug Administration conducted a Recall Audit Check 20 days later and was told by Dornhecker that Skin Essentials "did not possess any NECC products," further questioning provoked a change in the story. Dornhecker admitted that he did have possession of NECC products and produced some. "A simultaneous inspection revealed multiple NECC products, which were not quartined or segregated, and were present in exam rooms," according to HEALTH.

About a month later in late November, investigators from HEALTH conducted another examination for recalled NECC products and found multiple products that had been recalled, again in patient exam rooms and again, not quarantined or segregated.

Dornhecker's license has been suspended pending further order. Grande has been ordered to cease and desist from the use of any products recalled by NECC in the October recall and to immediately segregate and quarantine any remaining products for appropriate disposal by HEALTH, notify any and all patients who've been treated by these products.

 

Related Articles

 

Enjoy this post? Share it with others.

 
 
:!