Forty-one patients — so far — have become infected following injections to relieve knee pain at a clinic in New Jersey.
The state health department is continuing an investigation that has uncovered multiple lapses in infection control that likely led to patients developing septic arthritis. Twenty-nine of the 41 patients have required surgery as a result.
The clinic, Osteo Relief Institute Jersey Shore, in Wall Township, is still operating, though two physicians who had given injections — Mariam Rubbani, MD and Carol Skipper, MD — are no longer employed there. A medical assistant who was responsible for injectable medication preparation resigned from the clinic in early March.
All the patients identified so far were given injections at the clinic from March 1 to 6. An initial report from the New Jersey Department of Health noted that 15 of 40 patients grew bacteria from synovial fluid or knee tissue, including Staphylococcus aureus and Haemophilus parainfluenzae, but also many strains of Streptococcus that are specific to the oral cavity or teeth. "All known bacteria that have caused infections in patients likely originated from the oral or upper respiratory area," said the report.
The health department said it "is impossible to determine which specific breach might have led to transmission of microorganisms to patients," but noted that the clinic had deviated substantially from infection control guidelines. And, it said, "There is no evidence to suggest intrinsic contamination (manufacturer error) of a nationally distributed product."
John Rush, MD, the owner and medical director of Medical Offices of New Jersey Shore, which does business as the Osteo Relief Institute, said, "there has been no definitive cause identified for the adverse reactions to date, but the clinic has been working closely with state and local authorities to ensure that all necessary steps continue to be taken to avoid similar reactions in the future."
Dr Rush told Medscape Medical News by email that the clinic had voluntarily stopped treating patients temporarily and alerted "both local and state agencies" when it discovered the infections.
Since that short shutdown, "the clinic has treated over 1000 patients without incident," he said. "In fact, prior to the adverse reactions, the clinic had treated over 35,000 patients without incident since its opening," said Dr Rush, who is also president of Cenegenics, in Washington, DC.
Cenegenics is a nationwide chain of antiaging clinics that has attracted controversy for promoting use of steroids and human growth hormone.
Unsafe Environment Alleged
Knee pain patients at Osteo Relief who became infected were given injections of lidocaine 1%, and a viscosupplement (various types were recorded), delivered under fluoroscopy. The contrast agent Omnipaque 300 was used for all injections, including knee aspirations.
Joshua Kincannon, a lawyer who has sued the clinic on behalf of eight patients, says the viscosupplement injections are not effective. And, he says, the injections weren't safe, either, given the lapses found by inspectors.
The health department report "reads like a criminal indictment," Kincannon told Medscape Medical News. Kincannon, with the Lomurro firm in Freehold, NJ, said he expects to file additional suits, and noted that another firm is representing 10 other patients.
"This is not a situation where patients are treated with antibiotic pills and are ok," said Kincannon. "Most have undergone surgery," he said, adding that many of the patients have required PICC line insertion for delivery of intravenous antibiotics.
Dr Rush said neither the clinic nor its attorney "have seen any lawsuits allegedly filed against the clinic, and will not comment directly on any pending litigation except to say that the clinic will defend itself against any claims that may ultimately be made."
No Hand Washing
The state health department first heard of the infections on March 6, when the Monmouth County Regional Health Commission reported on three patients who received treatment at a local hospital for septic arthritis of their knees. The department began an investigation and on March 7 the Osteo Relief Institute voluntarily closed and sent letters to patients who had been treated at the clinic from March 1 to 6.
Dr Rush also notified the Monmouth office on March 7 of a cluster of infections.
Given the seriousness of the situation, officials from the New Jersey department of law and public safety, the Centers for Disease Control and Prevention (CDC), and the Monmouth County Regional Health Commission made an unannounced site visit on March 13.
Among the lapses found:
* Sterile needles and syringes, as well as prefilled syringes of viscosupplements, were unwrapped and opened far in advance of procedures and stored in bins under the preparation table.
* "Kits" made up of syringes, chlorhexidine wipes, and bandages — prepared in advance — sometimes would not be used until 4 days later.
* Single-dose vials of Omnipaque were used for up to 50 different knee injections.
* Multiple dose vials were not labeled with the name of the users or beyond-use dates upon opening.
* Exam table surfaces were used to prepare medications and were cleaned only once a day, at most, with Clorox wipes.
* No gloves or masks were used during preparation; staff said they used hand sanitizer, but no sanitizer was found in prep or exam rooms.
* Physicians did not generally check vital signs for patients.
* Dr Rubbani said she did not perform hand hygiene between patients because she used gloves; the gloves were not sterile.
* There were no written protocols for cleaning patient treatment rooms.
* Dr Rubbani threw leftover needles into the regular trash.
After the officials delivered their findings, the clinic promised to correct the lapses. While the clinic began using hospital grade Clorox for cleaning and hand sanitizer and gloves during preparation, and kept sterile needles and syringes inside of sterile packaging, the state and CDC investigators still found troubling practices in a second site visit on March 21.
Multiple-dose vials were still not properly labeled with the users' names or beyond-use dates. Staff questioned why syringes had to be labeled, but eventually relented. Viscosupplements were taken out of boxes and placed in plastic bins well before use, exposing them to light.
The staff did not know how to appropriately clean a centrifuge used for platelet-rich plasma procedures, according to the report.
Kits with prefilled syringes were still being prepped daily. But officials noted that predrawn, single-use medications must be discarded after an hour. The facility "then decided to prepare kits every hour for patient use," said the report.
During the visit, a physician was observed giving the wrong gel supplement injections into one of the knees of a patient. "There was no verification of chart information with the patient," according to the report.
No deaths have been reported.
But Kincannon, the attorney, said he believes more infections could be on the horizon — even in patients treated outside of the March 1 to 6 timeframe.
Medscape Medical News © 2017
Cite this: New Jersey Knee Clinic Sued After 41 Patients Infected - Medscape - May 18, 2017.