IN THE MATTER OF THE SUSPENSION OR REVOCATION OF THE LICENSE OF PARVEZ DARA, M.D., LICENSE NO. MA 33292 TO PRACTICE MEDICINE AND SURGERY IN THE STATE OF NEW JERSEY.
NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION
Argued September 16, 2013
On appeal from the Department of Law and Public Safety, Division of Consumer Affairs, New Jersey Board of Medical Examiners.
Peter L. Korn argued the cause for appellant Parvez Dara (McElroy, Deutsch, Mulvaney & Carpenter, LLP, attorneys; Mr. Korn, of counsel and on the briefs; Matthew P. Cohen, on the briefs).
Bindi Merchant, Deputy Attorney General, argued the cause for respondent New Jersey Board of Medical Examiners (John J. Hoffman, Acting Attorney General, attorney; Andrea M. Silkowitz, Assistant Attorney General, of counsel; Ms. Merchant, on the brief in A-4861-11; Siobhan B. Krier, Deputy Attorney General, on the brief in A-1110-11).
Before Judges Yannotti, Ashrafi and St. John.
Parvez Dara, M.D. appeals from the decision of the New Jersey Board of Medical Examiners (Board) revoking his medical license and ordering him to pay $30, 000 in penalties. Dara also appeals the Board's award of $372, 029.28 in fees and costs to the State. Our examination of the record satisfies us that the Board's final decisions were properly premised on facts in the record and are consonant with the applicable statutory provisions. Accordingly, we affirm.
The record discloses the following facts and procedural history leading to the administrative determinations under review.
On March 27, 2009, the Attorney General filed a complaint with the Board alleging that Dara had harmed his patients and employees by failing to implement proper infection control procedures. In the first count of the complaint, the State asserted that Dara "failed to implement adequate infection control practices" by neglecting to maintain sanitary conditions or develop proper policies and procedures, improperly handling medication and inadequately supervising staff, thereby resulting "in a risk of harm, and actual harm, to his patients." The second count alleged that Dara, despite having been on notice, repeatedly and deliberately violated Occupational Safety and Health Administration (OSHA) standards regarding toxic and hazardous substances, thus posing a danger to public health. The State sought revocation of Dara's license, as well as temporary suspension pending a final disposition.
Following a hearing of a committee of the Board on April 3, 2009, Dara's license was temporarily suspended, which was affirmed by the full Board on April 8. On April 8, we denied Dara's request to file an emergent motion. The following day, the Supreme Court denied his emergent application for a temporary stay. Dara then moved for a stay and leave to appeal at the Appellate Division, which was denied on April 22.
Having thus exhausted his emergent remedies, Dara filed an answer denying all allegations, and the matter was thereafter transferred to the Office of Administrative Law pursuant to N.J.S.A. 52:14B-1 to -15 and N.J.S.A. 52:14F-1 to -13 for adjudication as a contested case. On September 28, 2009, the State was granted leave to amend the complaint to include allegations that twenty-nine of Dara's patients had contracted Hepatitis B,  stemming from or probably linked to his practice.
After presiding over a protracted hearing between September 2010 and February 2011, the administrative law judge (ALJ) issued a lengthy written opinion and order on June 7, 2011. While finding that Dara had inadequately supervised his staff, the ALJ determined that the State failed to satisfy its burden of proof that Dara had inflicted actual harm on his patients. The ALJ recommended retroactive suspension of Dara's license, a $20, 000 fine, remuneration of State investigative costs and payment of OSHA fines. The State then filed exceptions with the Board, which heard oral argument on September 14, 2011.
On October 12, 2011, the Board issued its final decision and order, reversing the ALJ's initial decision. The Board revoked Dara's license and fined him $30, 000, having found sufficient proofs showing that Dara created an environment that risked, and actually caused, patient infections. On April 23, 2012, the Board entered a supplemental order under N.J.S.A. 45:1-25, ordering Dara to pay $328, 752.50 in investigative costs incurred by the State. Dara appeals from these two orders.
On February 24, 2009, the Ocean County Health Department (OCHD) received a report from a gastroenterologist about an unusual occurrence of Hepatitis B in two elderly, female cancer patients, who lacked the typical Hepatitis B risk factors.Robert Dosil, an administrator at Oncology Associates, also reported the cases. Although Dara first diagnosed the Hepatitis B in his patients, he failed to report at least one of the cases.
Accordingly, OCHD interviewed the two patients to determine how they had contracted Hepatitis B. OCHD then contacted the New Jersey Department of Health and Senior Services (DHSS). The agencies determined that the only identifiable risk factor at play was healthcare related, and therefore resolved to investigate the matter further. OCHD thereafter discovered two more Hepatitis B cases in elderly patients, neither of whom possessed associated risk factors. These two patients, like the gastroenterologist's infected patients, had undergone procedures at Dara's office. Investigators discerned no other commonalities.
On February 27, 2009, OCHD and DHSS sought assistance with "molecular typing of patient blood isolates" from the Center for Disease Control and Prevention (CDC). It was also decided to inspect Dara's practice as soon as possible. However, OCHD continued to conduct a widespread investigation to ascertain whether other exposure sources might explain the outbreak.
On March 3, 2009, a public health inspection team (PHIT), comprised of investigators from OCHD, DHSS, and the Board, visited Dara's Toms River facility. The investigators inspected rooms and medical waste, reviewed charts and infection control policies and procedures, and interviewed staff. A comparison of Dara's records against the CDRSS revealed a fifth infected patient.
In light of those findings, and in consultation with the CDC, the PHIT requested that Dara stop performing procedures. Dara complied and voluntarily closed the office on the same day. The local health department continued to monitor Hepatitis B cases within the county to ensure there were no other clusters outside of Dara's practice.
On March 10, 2009, investigators returned to Toms River and interviewed Dara and his staff. Except for Dara, all interviewees performed walk-through demonstrations of their delegated procedures. Consequently, the investigators discovered that staff members often failed to change their gloves after performing invasive procedures. They would then touch surfaces, syringes and other materials, thereby potentially contaminating handled items, while shifting between sterile and non-sterile procedures. Dara asserted his understanding that staff were changing their gloves as required, and maintained that he was unaware of any breaches of proper practices.
It was also discovered that Dara failed to provide policies or procedures for the proper use and storage of medications. Staff members' responses varied as to the shelf-life of medications once opened, with several staffers erroneously proclaiming that medications were fine until the manufacturer's expiration date. Moreover, with respect to medical waste, Dara did not properly decontaminate sharps containers or label them, and he failed to keep proper records regarding waste disposal.
Similarly, the office possessed neither a written infection control manual nor proper infection control policies and procedures, although the staff had, in fact, received some training. Dara's office also lacked standards regarding antiseptic use. Staffers were not trained on the use of personal protective equipment and were unsupervised when performing procedures.
For his part, Dara insisted that the substandard demonstrations did not reflect office policies, and were aberrational of how tasks were routinely performed. Had he been aware of such breaches, Dara asserted he would have stopped them and found out why they had occurred. He claimed that the staff had received bloodborne pathogen training on two separate occasions.
PHIT subsequently cautioned Dara about "significant breaches in infection control." Following the inspection, investigators continued to gather information and coordinate with Dara to resolve the problems. Barbara Montana summed up the breaches as follows:
First of all, there were no standards for infection control policies and procedures. The staff was not appropriately trained in infection control or the use of Personal Protective Equipment.
There wasn't any supervision of the staff performing these procedures. Access to catheters was not standardized. There weren't appropriate environmental controls or job assignments, so people were doing dirty procedures and clean procedures at the same time, particularly in the area of the utility room where there was blood processing and individuals drawing up medication for administration in the room next door.
There were environmental concerns, [not] thoroughly maintained sanitary conditions; the conditions in the chemotherapy room in particular; the conditions within the hood in particular as well; failure to properly handle medications and solutions appropriately; improper handling of multi-dose vials; keeping those medications out of the patient-care areas; keeping them adjacent to items that are potentially contaminated like the blood processing machine; no policies for establishing shelf life after opening of these multi-dose vials; inappropriately using bags of saline as a common source of medication for multiple patients; no labeling of syringes or prepared solutions; not adhering to aseptic techniques . . . so that staff was not engaging in inappropriate use of gloves or hand hygiene.
There was a situation where individuals were cross-contaminating items with soiled gloves that led to widespread contamination of blood within the environment. Removal of needles and syringes from sterile packages and storing those items outside of their packaging prior to the time of use, especially in an area where there was a potential for significant blood contamination adjacent to that blood analyzing machine; not using antiseptics appropriately prior to invasive procedures.
Again, not letting the alcohol dry, not letting the Betadine dry, not wiping the area with non-sterile gauze prior to performing the procedure. And . . . gauze potentially in contact with environmentally contaminated items.
Montana testified that "[e]ach of the breaches [was] significant" and had, in the past, "been associated . . . with outbreaks of diseases, bacterial and bloodborne pathogens". Since each individual breach was significant, "the totality of the situation . . . [was] egregious". Thus, Montana opined, to a reasonable degree of medical certainty, that those patients infected with Hepatitis B suffered actual harm as a result of Dara's improper practices.
The PHIT investigators were concerned for the safety of the staff and therefore contacted OSHA. They then learned that OSHA had previously inspected the Toms River facility on multiple occasions dating back to May 2002. OSHA had cited Dara for various, repeated health and safety violations, and fined him in amounts exceeding $50, 000. Accordingly, PHIT grew concerned that patients may have been exposed as early as 2002 and decided to notify those patients so that they could be tested.
Dara, hoping that corrective measures would facilitate the reopening of his practice, had hired an infection control consultant to train the staff and draft an infection control manual. PHIT again inspected Dara's office on March 23, 2009, and afterward permitted him to resume consultations and examinations only; the prohibition on invasive procedures remained.
Contemporaneous with the inspections, PHIT sustained its broad investigation to ensure there was no larger outbreak over and above Dara's practice. Investigators reviewed seventy-six regional CDRSS reports of Hepatitis B cases. They questioned Dara's patients to rule out alternative explanations, collecting information about demographics, potential exposure sources and symptoms. Consequently, investigators were able to determine the timeline of the outbreak, incubation and exposure periods, and an epidemic curve showing a significant increase of acute cases between March and May 2009.
On March 28, 2009, PHIT sent letters to Dara's patients, requesting that they be tested for Hepatitis C, Hepatitis B, and HIV. Any patients who tested positive for the Hepatitis B core antibody would then be tested for IgM, "the marker of acute infection." The acute antibody marker persists in the blood for about six months.
Of 2860 patients who were contacted, 1394 underwent testing. Of those, 103 patients were found to have markers for Hepatitis B. Thirteen had chronic Hepatitis B, nineteen had acute Hepatitis B, and sixty-eight had resolved infections. Of the thirteen chronic cases, three patients possessed lifetime risk factors. Neither those three cases nor the resolved cases were included in the CDC's subsequent molecular-typing investigation. The ...