On November 16, 2015, the Discipline Committee found that Dr. Stephen Rose James committed an act of professional misconduct in that he failed to maintain the standard of practice of the profession and he engaged in conduct or an act or omission relevant to the practice of medicine that, having regard to all the circumstances, would reasonably be regarded by members as disgraceful, dishonourable or unprofessional. The Committee also found Dr. James is incompetent.
Dr. James is an anaesthesiologist practising in pain management. His practice at the time relevant to these proceedings was at the Rothbart Centre for Pain Care (the “Clinic”).
Specifically, the findings of professional misconduct relate to his care and treatment, including his infection control practices, of: Patients A to F as well as the additional seven (Patients T to Z) identified by Toronto Public Health (TPH).
In addition, he engaged in disgraceful, dishonourable and unprofessional conduct including by:
-Providing an Interview Prep document to nursing staff at the Clinic in order to influence the nurses’ responses to the College investigation;
-Misrepresenting the purpose of the Interview Prep Document to the College;
-Misstating the steps he took when learning of Patient A and Patient B’s complications caused by his inadequate Infection Prevention and Control (IPAC) procedures; and
-Failing to make himself available, and communicating inappropriately through his nursing staff, when Patient E suffered complications.
On October 8, 2014, after allegations had been referred to the Discipline Committee, Dr. James executed an undertaking with the College agreeing to co-operate with specific infection control guidelines provided to him and to submit to unannounced inspections by the College to ensure his infection control practices were acceptable.
On about November 30, 2012 and December 10, 2012, the College received information from TPH relating to a suspected meningitis outbreak connected to Dr. James at the Clinic. On the basis of that information, the Inquiries, Complaints and Reports Committee (ICRC) commenced an investigation into Dr. James’ practice.
Toronto Public Health Investigation
In November 2012, TPH received information that three different patients were hospitalized with either staph aureus or meningitis infections from epidural injections administered by Dr. James. As a result of these infections, Dr. L, Associate Medical Officer of Health for the City of Toronto Health Unit, and Ms M, Communicable Disease Manager, TPH, attended Dr. James’ clinic. At that time, Dr. L made a verbal order requiring that Dr. James not perform any procedures and that no one change or touch anything in Room 11 or use it in any way. (Room 11 was Dr. James’ procedure room. All of his non-X-ray guided procedures were performed in that room; no other doctor used that room). In December 2012, Ms M re-attended at the Clinic to continue the TPH investigation. Dr. James was served with a written order to immediately cease performing any medical procedures that involve penetration of an instrument into a sterile site, and that he not enter Room 11.
As a result of their visits to the Clinic, TPH noted the following:
-The patient’s sterile field was not covered;
-A non-sterile gauze was used after a procedure to wipe the ooze from the patient’s back;
-Dr. James’ gloves were too big;
-Dr. James used a mask but the nose was not pinched;
-Dr. James did not always allow the Betadine, the antiseptic used to wipe the patients’ skin, to dry for long enough before he started a procedure;
-After Dr. James used an alcohol-based hand rub (“ABHR”) (Purell), and prior to donning sterile gloves, he touched many surfaces
-Dr. James opened sterile items onto a non-sterile field into a sterile container; and
-Dr. James’ wedding band was not removed during the procedure.
On December 7, 2012, at the request of TPH, Public Health Ontario attended the Clinic with a representative from TPH to conduct a review of IPAC practices within the Clinic. At that visit, Dr. James offered to provide a mock demonstration of a typical epidural procedure. The audit team observed the following issues that required immediate attention:
-Dr. James applied and removed his mask without performing hand hygiene;
-Dr. James’ hand hygiene ABHR lasted less than 5 seconds;
-Dr. James stated that he does not wait for the skin prep to dry before inserting the needle;
-Abundant supplies (including unwrapped gauze pads) stored on the counter are subject to contamination; and
-Dr. James’ mask was not adjusted at the bridge of his nose.
Based on the information obtained by TPH, and a review of the literature regarding complications following epidural steroid injections, TPH concluded that nine (9) patients developed serious infections after receiving an epidural steroid injection performed by Dr. James at the Clinic. TPH’s view regarding the cause of these infections is that Dr. James was colonized with staph aureus, and due to breaches in IPAC, transmission of staph aureus occurred from Dr. James to his patients.
The patients revealed in the TPH investigation suffered serious complications. Parts of their disease courses are described here:
i. Regarding Patient T, she received lumbar injections from Dr. James commencing in 2012. Following her last injection in October 2012, Patient T was admitted to hospital, vomiting and incoherent. She was diagnosed with bacterial meningitis.
ii. Regarding Patient U, she received lumbar injections from Dr. James commencing in 2011. In October 2012, she received 3 lumbar/thoracic epidural injections. In late October or early November, Patient U began suffering from headaches, nausea, vomiting, confusion, blurred vision, tremors. In November, she notified the Clinic that she was suffering persistent headaches. Shortly after she was admitted to hospital and diagnosed with meningitis.
iii. Regarding Patient V, she received lumbar injections from Dr. James commencing in 2010. Following a lumbar injection in July 2012, she developed fever and sought attention at the Emergency Department. She was discharged with negative blood and urine cultures. She subsequently sought treatment from her family physician complaining of pain, fever and difficulty urinating. She received additional injections from Dr. James on two occasions in August of 2012. In September 2012, she suffered a stroke and on investigation, it was discovered that many sites on her spine were infected with abscesses requiring hospitalization and the insertion of a PICC line.
iv. Regarding Patient W, he received lumbar injections from Dr. James in September and October 2012. Shortly after his injection in October 2012, Patient W experienced back pain and fever and went to the hospital, but an MRI revealed no abscesses. In November 2012 he was admitted to hospital with on-going fever and increasing weakness. A lumbar epidural abscess was found and an emergency laminectomy was performed.
v. Regarding Patient X, he received lumbar injections from Dr. James commencing in 2012. Following his last injection in November 2012, Patient X developed a fever and was hallucinating. He was admitted to hospital where he was diagnosed with an epidural abscess and staph aureus infection requiring evacuation and spinal decompression. Patient X required further surgical intervention.
vi. Regarding Patient Z, she received lumbar injections from Dr. James commencing in 2012. After her third injection in September 2012, Patient Z experienced increasing back paid and developed a fever. She was admitted to hospital with two epidural abscesses and sepsis.
The College retained Dr. N, to provide an opinion regarding Dr. James’ infection control procedures. Dr. N was asked to opine on Dr. James’ practices prior to TPH intervention largely on the basis of the information gathered by TPH. In a report dated December 20, 2013, he opined, among other things that Dr. James practices prior to their revision fell below the standard of infection control practice expected of a physician performing such procedures and concluded that these breaches were of a major nature and resulted in an uncommon serious outbreak.
The College also received several public complaints from patients who suffered serious complications:
i) Regarding Patient A, Dr. James administered lumbar steroid injections in August, September and October, 2012. At the October appointment, Patient A states that she noticed that Dr. James did not wear sterile gloves or a mask; and stated that she did not have iodine put on her back like previous times; her procedure felt rushed. She felt unwell soon after the October appointment. By November, Patient A felt extremely confused, weak, and lethargic, and had a fever. Patient A was admitted to hospital and found to have a staph aureus infection. She was diagnosed with meningitis and an epidural abscess precisely where the injection had taken place.
In addition, Dr. James made inaccurate statements to the College during their investigation about advising Patient A’s attending physician to obtain a neurological consultation.
ii) Regarding Patient B, her first consultation and treatment with Dr. James occurred in June 2012 to treat debilitating back pain. He proceeded to administer a lumbar steroid injection to Patient B that day and again in July and August 2012. In September 2012, Patient B was taken to the hospital with fever, confusion and lower back pain. Patient B spent several days in the emergency, and was ultimately admitted to as an in-patient. The working diagnosis in respect of Patient B was an epidural abscess secondary to direct skin infection from the epidural injections. It was confirmed that Patient B had a positive blood culture for staph aureus.
In addition, Dr. James made inaccurate statements to the College during their investigation about his interactions with the hospital.
Regarding both Patients A and B, the College retained Dr. O to provide an opinion in respect of the care and treatment provided by Dr. James. He opined:
In summary, it is my opinion that Dr. James has demonstrated a lack of knowledge, lack of judgment and lack of skill in providing care to [Patient B] and [Patient A]…. His non adherence to appropriate aseptic technique in the invasive procedures provided has led to significant complications and morbidity.
iii) Regarding Patient C, she was treated by Dr. James seven times between April and August 2012 for management of lower back pain. Dr. James administered epidural steroid injections to Patient C. In or around July 2012, Patient C started to experience increasing pain and decreasing stability on her feet. She reported these concerns to Dr. James, and on two occasions sought treatment at emergency. Patient C continued to see Dr. James throughout that summer. After the epidural injections failed to alleviate Patient C’s pain, Dr. James administered bilateral diagnostic lumbar facet blocks in July 2012. In August 2012, he performed a left rhizotomy on Patient C. At this appointment he provided Patient C with a note to take to her family doctor recommending a neurosurgery consult and recommending that her family physician request an MRI. He engaged in no further follow up with Patient C.
Patient C obtained was diagnosed with a serious spinal infection. A sensitive strain of staph aureus was recovered from the surgical specimen and the infection was believed to be the direct result of steroid injections.
Dr. O opined, among other things that, Dr. James failed to appreciate the patient’s progressive symptoms, failed to realize that the symptoms could be signs of an infection in a high risk patient. He also failed to adequately document the patients progressive symptoms, failed to correctly diagnosis/work up possible complications of treatments he provided, failed to adequately inquire about the patients ER visits and failed to organize appropriate timely work up of the patient’s symptoms.
iv) Regarding Patient D, she was seen by Dr. James for injections on a regular basis for treatment of chronic back pain commencing in 2010. In October 2011, Dr. James administered a lumbar epidural injection. Less than two weeks after receiving the epidural injection, Patient D began to experience symptoms of fever, increasing confusion, neck pain, nausea, vomiting and occipital headaches. She was admitted to hospital. The suspected etiology was an infection secondary to epidural injections received from Dr. James.
Patient D was readmitted to the hospital in November 2011 for a twelve day period. Her headache, nausea and vomiting continued. An MRI demonstrated an epidural fluid collection with a diagnosis of a likely enlarging epidural abscess. Patient D required extensive surgical laminectomies.
v) Regarding Patient E, Dr. James treated her for pain in her right elbow. In January 2012, Dr. James injected her elbow with cortisone and performed a caudal epidural injection the same day. Soon after the injection, Patient E’s right arm became painful and red. She began calling the Clinic to get an appointment with Dr. James so that he could look at her arm. Subsequently, Patient E attended at the clinic, and asked that someone look at her red and swollen elbow. After she waited for about an hour and a half, Dr. James saw her, told her it was likely nothing and gave her a prescription for antibiotics and told her to follow up in two weeks.
Patient E’s arm remained very painful, swollen and red. In March 2012, Dr. James immediately sent her to the Emergency Department. Patient E was found to have a post-injection abscess and a heavy growth of staph aureus and was referred for both orthopedic and plastic surgery consults.
Dr. O opined that it is below standard of care to not offer urgent follow up for a potential infection after a procedure, even if there is no fever.
vi) Regarding Patient F, in May 2012 he received a lumbar epidural injection for lower back pain from Dr. James. Less than two weeks later Patient F developed a high fever, delirium and increasing back pain while out of the country. Patient F was admitted to hospital in the United States, critically ill. He was found to have an epidural abscess and sepsis (staph aureus bacteremia), requiring ICU admission, intubation and neurosurgical evacuation together with hemi laminectomies. The likely etiology of the epidural abscess was believed to be the epidural injection.
On December 15, 2015, the Discipline Committee ordered and directed that:
- Dr. James appear before the panel to be reprimanded.
- the Registrar suspend Dr. James’ certificate of registration for a period of ten (10) months, effective immediately.
- the Registrar to impose the following terms, conditions and limitations on Dr. James’ certificate of registration:
a. Dr. James be prohibited from holding the position of Medical Director in any facility;
b. Dr. James shall perform all injections in the presence of a regulated health professional who observes each injection and who contemporaneously signs and dates the patient record confirming he/she has observed the injection. Dr. James shall provide the College with a list of regulated health professionals with whom he works and provide copies of their signatures within seven (7) days of the date of this Order, and within fourteen (14) days of employing any additional regulated health professional thereafter;
c. If Dr. James becomes aware that a patient developed an infection following a procedure that he performed, Dr. James shall, within 7 days of date on which he became aware, report the infection to the College;
d. Dr. James shall complete the next available medical record keeping course approved by the College and provide proof of successful completion within three (3) weeks thereof;
e. Dr. James shall successfully complete individualized education in communication, approved by the College at the instructor’s earliest availability and provide proof of successful completion within three (3) weeks thereof. The course will involve a series of one-on-one sessions with a College-approved instructor (the “Instructor”), incorporating principles of guided reflection, tailored feedback, and other modalities customized to the specific needs of Dr. James as assessed by the Instructor. The Instructor will make reports to the College regarding Dr. James’ progress and compliance;
f. Dr. James shall successfully complete individualized instruction in ethics approved by the College at the instructor’s earliest availability and provide proof of successful completion within three (3) weeks thereof. The instruction will involve a series of one-on-one sessions with a College-approved instructor (the “Instructor”), incorporating principles of guided reflection, tailored feedback, and other modalities customized to the specific needs of Dr. James as assessed by the Instructor. The Instructor will make reports to the College regarding Dr. James’ progress and compliance;
g. Dr. James shall retain a clinical supervisor, approved by the College, who will sign an undertaking in the form attached hereto as Schedule “A” (the “Supervisor”) no later than 30 days prior to Dr. James’ return to practice after the suspension referred to in paragraph 4 above. Dr. James shall practice under the guidance of the Supervisor for a period of period of twelve (12) months. Dr. James shall meet with the supervisor monthly to discuss any concerns arising from patient care, including infection prevention, control and treatment.
h. Dr. James shall engage a preceptor acceptable to the College to provide education in the indications and treatment for infection in Interventional Pain Medicine for a minimum period of (4) four hours. The preceptorship shall be completed within (3) months of Dr. James’ return to practice after the end of the suspension referred to in paragraph 4 above, and the preceptor shall confirm such completion in writing to the College;
i. Dr. James shall be subject to a reassessment of his practice including an observation of his sterile technique, within six (6) months of his return to practice after the end of the suspension referred to in paragraph 4 above, and shall be subject to periodic assessments (announced and/or unannounced) thereafter at the discretion of the College, including a reassessment following the completion of supervision described in paragraph g above. Dr. James shall abide by the recommendations of the assessors;
j. Dr. James shall cooperate with unannounced inspections of his practice and patient records by a College representative for the purposes of monitoring his compliance with the provisions of this Order and his infection control practices; and
k. Dr. James shall be solely responsible for payment of all fees, costs, charges, expenses, etc. arising from the implementation of any of the provisions of this Order.
- Dr. James pay costs to the College in the amount of $4,460.00 within thirty (30) days of the date of this Order.
Terms and conditions imposed on certificate by: Registration Committee
