Investigations by HSJ have identified several cases that raise questions about the current system for securing patient consent for treatment.
We have also heard concerns about the current consent process from clinical negligence lawyers.
Today HSJ revealed that the Care Quality Commission and NHS England have together raised concern about whether the current system for securing patient consent for treatment is open to abuse, amid allegations some doctors have retrospectively altered consent forms.
In one case, CQC chief executive David Behan met with a patient’s son, who believes his mother’s consent form was altered after she received treatment from Nottingham University Hospitals Trust.
John Clarke, whose mother Marlene now has terminal cancer, contacted Nottinghamshire Police, which confirmed to HSJ that detectives were working “to ascertain the facts of this allegation”.
Mr Clarke fears patients are not being offered signed copies of their consent forms, which could allow clinicians to retrospectively alter the forms after treatment.
He believes the “simple solution” to the issue is to redesign forms so they require procedures to be entered in specific boxes, with spaces removed. Patients would be asked to sign two copies of the form to show they opted not to take one.
Mr Clarke told HSJ the situation “begs the question: why hasn’t it already been implemented, given that these concerns were raised with regulators a number of years ago?”.
During a CQC inspection at the Nottingham Trust in August 2013, prompted by Mr Clarke’s concerns, inspectors found in 11 out of 13 instances they examined, the patient copy of consent forms had been retained by the trust. It was not clear whether this was due to patient preference or not.
Case study: Marlene Clarke
Marlene Clarke, aged 69, underwent surgery in 2010, by Nottingham University Hospitals Trust, to diagnose and treat suspected lung cancer.
A copy of her consent form, seen by HSJ, shows different elements of the surgery written in a mixture of uppercase and lowercase letters. Her son claims the differences show additions were made after the operation. The trust says its investigations have found his claims were unsubstantiated.
Ms Clarke was told she had a mass on the anterior, or front, of her right lung which would be biopsied in surgery and removed if cancerous. However, in post-surgery notes, seen by HSJ, surgeon Mr Antonio Martin-Ucar described making a posterior, or rear, entry and removing a mass from the back of the lung which proved not to be cancer.
He then identified a further mass on the front of the lung and without a biopsy, carried out a right upper lobectomy to remove a substantial part of the lung. Mr Clarke claims the consent form indicates surgery should have stopped unless a biopsy test diagnosed cancer.
Before surgery, the family were told Ms Clarke’s chest lymph nodes would be removed during the surgery but this did not happen and Ms Clarke was not told. She became ill in December 2010 and a few months later was diagnosed with secondary terminal cancer of the lymph glands.
Mr Clarke told HSJ: “My mum has no life anymore. She is in constant pain and this has devastated our whole family.”
A trust spokeswoman said: “We thoroughly investigated Mr Clarke’s complaints about his mother’s treatment in 2012. He alleged that she had been treated without proper consent, and that a consent document had been falsified. We found that these allegations were not substantiated.”
BMI Mount Alvernia
In another case identified by HSJ, at the BMI Mount Alvernia Hospital in Surrey, the CQC identified a series of failings on consent in 2013, including patients undergoing procedures without consent and a form being changed after a procedure, in different coloured pens.
Inspectors said the case involved a patient who was scheduled to undergo two procedures at the same time but the patient had only consented to one.
The inspectors found four patients were not given written consent for their operations, with one case having no record of any discussion taking place - in breach of GMC guidance and codes of practice.
Elsewhere, at Hinchingbrooke Hospital in January, the CQC found one patient was treated without consent, staff having carried out no assessment of the individual’s capacity to consent. A Hinchingbrooke spokesman told HSJ last week: “Following the inspection, [mental capacity assessment and deprivation of liberty] was made mandatory for all relevant staff, with the aim of 100 per cent compliance by November this year. We are currently progressing ahead of plan.”
Two clinical negligence lawyers also expressed concern.
Catherine Bell, senior lawyer with clinical negligence firm Bolt Burdon Kemp, told HSJ it was rare for clients to have a copy of their consent form and warned some patients were being asked for consent either late or on the day of surgery.
She added: “I have seen consent forms that were signed with no risks filled in and I have also seen forms that were completely illegible.”
Ms Bell said she had seen a case where a form appeared to have been altered to show a risk which the patient had not been informed about. She said: “The family did not have a copy of the form and when we were provided with a copy, the pen that was used was sufficiently different, and all the suggestions were amended after surgery.”
Nicola Wainwright, partner in clinical negligence at law firm Leigh Day, said she believed there was the potential risk of forms being altered. She said: “I see plenty of people who don’t know they should have had a had a copy and weren’t told what the consent form said they were.”
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Analysis: Investigation identifies consent form concerns