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CHAPTER2 Practicemanagement
Patientrecords
General principles Patient records should be factual, consistent,
and accurate. Ensure a logical sequence; be clear, unambiguous, and concise. Use standard coding techniques if using an electronic record— standard templates may help. Wherever possible, write notes openly while patients/ carers are present in terms they can understand. Ensure that the record is correctly dated, timed, and identiable to the person creating the record. Record:
Information on which you have based your decisions Presenting
problems; past/ family history; examination ndings and test results
Your impression of the situation How you see the problem— may
include diagnosis, dierential diagnosis, prognosis
Plan of action Negotiated between patient and doctor— may include
tests requested, prescriptions given, referrals made
Information shared and advice given Relevant worries/ concerns
voiced by the patient; information/ advice provided to the patient— especially safety netting advice and review/ follow- up arrangements
Other essential information e.g. correspondence to/ from other agencies; if consent for treatment/ examination (E p. 48) was given
0 Do not include Abbreviations (especially unconventional ones); jargon; or personal views about behaviour or temperament unless they have a bearing on the management of the patient.
Condentiality E p. 46 Electronic patient records E p. 37
Summary Care Record (SCR) Electronic medical notes summary
extracted from GP IT systems that can be viewed by healthcare sta in other NHS settings. At a minimum, the SCR holds information about cur­rent medication, and allergies/ adverse reactions to medicines. The patient can also choose to include additional information, e.g. long- term conditions, signicant medical history, or specic communication needs.
Shared electronic GP records NHS plans for healthcare organiza-
tions to work more closely together often depend on sharing patient infor­mation, including GP records. As a result, local data sharing arrangements are in place throughout the UK. However, the registered GP practice legally remains the ‘data controller’ for the record.
• Be clear on the sharing arrangements that you are part of
• Communicate and explain data sharing arrangements to patients; gain
explicit consent for data sharing where possible and record any objections. Some GP systems allow patients to view who has looked at their data
• Act on any indications of illegitimate record access
Patient Online Allows patients online access to practice systems and their
electronic GP notes to book/ cancel appointments, order repeat prescriptions, and view their GP record including test results and hospital correspondence.
Amending records Rectify errors of fact or judgement. Any alterations
or additions should be dated, timed, and signed in such a way that the ori­ginal entry can still be seen. Patients may request correction of informa­tion they believe is incorrect— you must record the patient’s view. Highlight amendments and reasons for them.
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PATIENTRECORDS
Subject access requests (SARs) Under the Data Protection Act
1998 and 2018, patients have a right of access to health records which:
• Are about them and from which they can be identied
• Consist of information relating to their health or condition
• Have been made in connection with their care
Requests should usually be written (paper or electronic). Medium in which records are supplied can be agreed between the patient and the practice and may be paper (photocopy, computer printout), electronic (e.g. USB stick), or by facilitating patient access to Patient Online.
Since May 2018, practices cannot charge a fee for this service, although may charge for repeat requests. The entire record should be provided within 1mo of the SAR unless the patient agrees to limit the request (e.g. to elec­tronic records only, or records made since a dened date).
Who can seek access?
• Any competent person may seek access to their own health records, including competent children (E p. 46)
• Any person with parental responsibility may apply for access to records of a child (<18y, or <16y in Scotland). Where >1 person has parental responsibility, each may apply independently without consent of the other parent
• Athird party authorized by a competent person may seek access to that person’s records (e.g. solicitor or insurance company), but proof of permission from the patient must be provided. If there is doubt, contact the patient to verify consent has been given
Mentally incapacitated adults Where access is sought and the individual lacks capacity to give permission, decisions must be based on the person’s best interests, taking into account the views of the person’s representative(s) and the individual’s expressed wishes and values— E p. 46.
Access todead patients’ recordsE p. 46 0 If unsure, take advice from the BMA or your defence organization.
Security of records Do not leave records (electronic or manual) un-
attended in easily accessible areas. When not in use, store paper les and port­able electronic equipment locked up. Query the status of strangers. Highlight concerns to the practice manager. Do not reveal how security systems work.
Manual records Store les closed and in logical order. Use a tracking system to monitor whereabouts of les, and return les as quickly as possible
Electronic records Do not leave terminals unattended and logged in. Do not share logins or reveal passwords to others. Change passwords regularly, and avoid using short or obvious ones. Keep smart- cards securely. Always clear the screen of a previous patient’s information before seeing another. Use a password- protected screen saver to prevent casual viewing of patient information by others
Further information
BMA M www.bma.org.uk
Access to health records:guidance for health professionals in the UK
Medical records access:GDPR changes to Subject Access Requests and
fees from 25 May 2018
GMC Guidance on good practice— condentiality. M www.gmc- uk.org
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CHAPTER2 Practicemanagement
Confidentiality
Respect for condentiality is also an essential requirement for the preser­vation of trust between patient and doctor. Failure to comply with stand­ards can lead to disciplinary proceedings and even restriction/ cessation of practice.
Caldicott Principles fordisclosure ofpatientinformation
Justify the purpose Patients may agree to identiable information
about themselves being released to specic individuals for known purposes. Implied consent applies when patients are aware that personal information may be shared and of their right to refuse but make no objection. Patients must have a realistic opportunity to refuse— and if they do refuse, clearly document that and respect their decision
Do not use patient identiable information unless it is absolutely
necessary It is not necessary to seek consent to use anonymous
information. If in doubt, seek advice from the BMA or your defence organization. Health information used for secondary purposes, e.g. planning, teaching, audit, should— when possible— be anonymous
Use the minimum patient identiable information
Access to patient- identiable information should be on a strict
‘need- to- know basis’
Everyone should be aware of their responsibilities
Understand and comply with the law
Specialcircumstances
Children (<16y) Disclosure can be authorized by a person with parental re­sponsibility. Young people, mature enough to understand the implications, can make their own decisions and have a right to refuse parental access to their health record.
Mentally incapacitated adults Assessment of capacity to consent to infor­mation disclosure is time- and decision- specic. A mentally incapacitated adult can consent to information disclosure if the person is able to:
• Understand the concept of authorizing/ prohibiting sharing of
information
• Retain that information long enough to make a decision
• Weigh up the implications of disclosure or non- disclosure
• Communicate a decision
Otherwise, decisions must be based on an evaluation of the person’s best interests, taking into account the views of the patient’s representative(s) and reecting the individual’s expressed wishes and values.
0 Except in Scotland, parents are able to consent for mentally incapaci­tated 16– 17y olds.
The deceased Legislation covering records made since 1 November 1991 permits limited disclosure in order to satisfy a claim arising from death. Where there is no claim, there is no legal right of access to information.
Breaching condentiality Only breach condentiality in exceptional cases and with appropriate justication. This includes discussing a patient with
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CONFIDENTIALITY
another health professional not involved currently with that patient’s care. Wider disclosure to people loosely associated with care (e.g. support sta in residential care settings) requires patient consent.
Situations where breach ofcondentiality may bejustied
Emergencies Where necessary, to prevent or lessen a serious and imminent threat to the life or health of the individual concerned or another person (unless previously forbidden by the patient)
Statutory requirement Ask under which legislation it is sought— check the legislation before disclosing if unsure
The public interest What is in the public interest is not dened. The BMA has produced guidance
Public health Reporting notiable diseases (statutory duty)
Required by court or tribunal
Adverse drug reactions Routine reporting to the Medicines and Healthcare products Regulatory Agency (E p. 120)
Complaints As part of GMC performance procedures involving doctors
Legalconsiderations
Human Rights Act (1998) Establishes a right to ‘respect for private and family life’ and creates a general requirement to protect the privacy of individuals and preserve condentiality of their health records. Compliance with the Data Protection Act and common law of condentiality should satisfy requirements
Common law of condentiality Built up from case law where practice has been established by individual judgements. The key principle is that information conded should not be used or disclosed further, except as originally understood by the conder, or with their subsequent permission, except in exceptional circumstances (E p. 46)
Administrative law The extent the NHS can access condential information to perform its functions is set down in statutes
Health and Social Care Act (2001) Allows for certain exceptions to condentiality laws to be made, e.g. for use in cancer registries
Freedom of Information Act (2000) Applies to all NHS bodies, including GP practices. Practices are required to produce a publication scheme detailing all information routinely published by the practice. In addition, members of the public can make written requests to see any information recorded by the practice in any format. These rights are restricted by certain exemptions, e.g. personal data
Data Protection Act (1998 and 2018) Imposes constraints on processing of personal information. Also requires personal data to be protected against unauthorized/ unlawful processing and accidental loss, destruction, or damage. Also applies to personnel records
European General Data Protection Regulation (GDPR) (2018) European legislation strengthening individual rights to control of data, to be informed of any data breaches and creating a right to ‘erasure’
Further information
BMA Condentiality and people under 16. M www.bma.org.uk GMC Guidance on good practice— condentiality. M www.gmc- uk.org Information Commissioner’s Oce Data protection. M www.ico.gov.uk
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CHAPTER2 Practicemanagement
Consent
Consent Implies willingness of a patient to undergo examination, inves-
tigation, or treatment (collectively termed ‘procedure’ in this section). It may be expressed (i.e. specically says yes or no/ signs a consent form) or implied (i.e. complies with the procedure without ever specically agreeing to it— use with care). For consent to be valid, patients:
• Must be competent to make the decision
• Have received sucient information to take it
• Not be acting under duress
Under ‘common law’, touching a patient without valid consent may consti­tute the civil or criminal oence of battery, and if the patient suers harm as a result of treatment, lack of consent may be a factor in any negligence claim. Never exceed the scope of the authority given by a patient, except in an emergency.
If you are the doctor carrying out a procedure, it is your responsibility to discuss it with the patient and seek consent. The task may be delegated, but the responsibility remains yours.
Information toinclude
• Reasons why you want to perform the procedure
• Nature, purpose, and side eects (common and serious) of proposed
procedure
• Name of the doctor with overall responsibility
• Whether students or other ‘trainees’ will be involved
• Whether part of a research programme or outside usual procedure
• Reminder that patients have a right to seek a second opinion and/ or
can change their minds about a decision at any time
And fortherapeutic procedures/ treatments
• Details of diagnosis and prognosis (including uncertainties)
• Management options— including the option not to treat and other
options that you cannot oer— and, for each option, an estimation of likely risks, benets, and probability of success
• Details of follow- up in order to monitor progress or side eects 0 Document if a patient doesn’t want to be fully informed before
consenting.
Written consent It is good practice to seek written consent if:
• The procedure is complex or involves signicant risks (‘risk’ means any
adverse outcome, including complications and side eects)
• The procedure involves general/ regional anaesthesia or sedation
• Providing clinical care is not the primary purpose of the procedure
• It has consequences for employment, social, or personal life of the
patient
• The procedure is part of a project or programme of approved research
Establishing capacity tomake decisionsE p. 96
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CONSENT
Mentally incapacitated adults The Mental Capacity Act (2005), and
equivalents in Scotland and Northern Ireland, enable patients’ advocates (usually friends, relatives, or carers) or suitable professionals (e.g. doctors, social workers) to act in patients’ best interests on their behalf. This includes provision of medical care. Before acting:
• Take all factors aecting the decision into consideration
• Involve the patient with the decision- making as far as possible
• Take the patient’s previous known wishes into consideration
• Consult everyone else involved with the patient’s care/ welfare
In situations in which there is disagreement about the patient’s best inter­ests, the decision can be referred to the Court of Protection.
Advance statementsEp. 97
Children (<16y) A competent child is able to understand the nature,
purpose, and possible consequences of a proposed procedure as well as the consequences of not undergoing that procedure. This is termed ‘Gillick competence’ after the court case in which the principle was established (Gillick v West Norfolk and Wisbech AHA [1986] AC 122).
A competent child may consent to treatment. However, if treatment is re­fused, a parent or court may authorize procedures in the child’s best inter­ests.1 Where a child is not judged competent, only a person with parental responsibility may authorize/ refuse investigations or treatment. If in doubt, seek legal advice.
Emergencies When consent cannot be obtained, you may provide
medical treatment, provided it is limited to what is immediately necessary to save life or avoid signicant deterioration in the patient’s health. Respect the terms of any advance statement/ living will you are aware of.
Further information
GMC (2008, under review) Consent:patients and doctors making deci­sions together. M www.gmc- uk.org/ ethical- guidance/ ethical- guidance- for­doctors/ consent GMC (2018) 0– 18years:guidance for all doctors. M www.gmc- uk.org/ ethical- guidance/ ethical- guidance- for- doctors/ 0- 18- years Oce of the Public Guardian Health and social care workers:Mental Capacity Act decisions. M www.gov.uk/ government/ publications/ health- and- social- care- workers- mental- capacity- act- decisions
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1 Note:in Scotland, parents do not have this power to overrule a competent child’s decision.
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CHAPTER2 Practicemanagement
Complaints
Sadly, complaints are a fact of life for most GPs. The most constructive and least stressful approach is to view them as a learning experience and a chance to improve practice risk management strategy. Always contact your local LMC ± defence organization if you are directly implicated in a com­plaint. Patients who complain generally want:
• Their complaint to be heard and investigated promptly
• Their complaint to be handled eciently and sympathetically
• To receive a genuine apology if mistakes have occurred
• To be assured that steps will be taken to prevent a recurrence
NHS complaints procedure for general practice Figure 2.1
Patient/patient’s representative wants to make a
complaint about a GP or practice service
Step 1: Local resolution
PCO
Person receiving the complaint makes a note of:
date received, contact details of the person making the complaint, and nature of the complaint
Complaints manager (usually practice manager) acknowledges the complaint within 48h and advises the complainant of right to conciliation ( p. 51)
Complaints manager investigates the complaint,
consulting all involved
Complaints manager makes a written summary of
the nature of the complaint, investigation ndings ± apology ± actions taken to remedy the situation/ prevent future recurrences. This must be completed <25d after the original date of the complaint
p. 25
Practice
Complaint resolved?
Step 2: Ombudsman
Figure2.1 The NHS complaints procedure for general practice
NO
Time limits forcomplaints NHS complaints can only be accepted:
• <1y after the incident which is the subject of the complaint, or
• <1y after the date at which the complainant became aware of the matter
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COMPLAINTS
After that time, complaints can only be accepted if there is good reason for delay and it is possible to eectively investigate.
A 3y time limit after the incident (or after the date upon which the claimant became aware that the incident might have caused harm) is placed on civil clinical negligence cases, except for children who may claim until their 21st birthday.
Conciliation Is a way of dealing with complaints that helps to avoid ad-
versarial situations. Either party can ask the local PCO for conciliation, but both parties must agree to it taking place. By bringing the two sides together with a neutral conciliator, it aims to:
• Explain and clarify matters for both parties
• Ensure both parties are really listening to each other
• Ensure the process is unthreatening and helpful
Records ofcomplaints A le on the complaint, including a copy of
all correspondence, should be kept separate from clinical records of the patient and, if the patient leaves the practice, should not be sent on with the clinical notes.
Private sector Most private sector healthcare providers have their own
complaints resolution procedures. Patients should contact the organization concerned for details.
Disciplinary procedures There is no direct connection between com-
plaints procedures and disciplinary action. If a complaints procedure reveals information indicating the need for disciplinary action, it is the responsibility of the PCO to act. If they decide there has been a breach of the terms of service, the PCO can x a penalty, if appropriate.
Further information
Risk management E p. 31 BMA M www.bma.org.uk
Medical defence organizations
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CHAPTER2 Practicemanagement
Qualityimprovement
Quality improvement (QI) comprises a set of values and tools for pro­actively setting goals and planning, implementing, and measuring change in order to improve patient care. Aculture of quality should exist throughout all healthcare organizations, and every team member should be involved in delivering and improving quality.
Steps toquality improvement Establish a quality improvement cul-
ture. Within practices there should be continuous review and appraisal of procedures and standards— RAID:
Review— gather all stakeholders together to look at a topic
Agree— a strategy to take forward. All objectives should be SMARTS
(specic, measurable, achievable, relevant, time limited, and sustainable)
Intervene— make changes decided upon
Demonstrate— the eect of changes through audit (E p. 54), patient
satisfaction questionnaires, prescribing data, etc.
Methods ofidentifying topics forQI Tools include:
• Review of new guidelines/ clinical pathways for compliance
‘Always events’— feasible care processes that patients identify should always happen when they interact with GP practices, e.g. timely appointments
• ‘Never events’ (Box 2.2)— a validated list of events known to cause severe harm that are completely preventable— could any of these events happen in your practice? How might you minimize risk?
• General Practice Safety Checklist (MoRRIS checklist)
• Trigger tool— review a sample of records of high- risk patients (e.g. patients who are designated ‘frail’) for undetected incidents
• External peer review of practice procedures and care pathways
• Signicant event reviews— E p. 54
• Criterion- based audit— E p. 54
Risk managementEp. 31
Clinical governance Dened as ‘a framework through which organ-
izations are accountable for continuously improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will ourish’.
Essential elements of clinical governance Figure 2.2
Care Quality Commission (CQC) The Health and Social Care
Act 2008 required any individual, partnership, or organization providing healthcare services in the UK to register with CQC as a service provider.
Monitoring After registration, CQC regularly inspects practices to ensure that they meet essential standards. After inspection, each practice is rated according to its performance against CQC criteria and awarded an overall rating of ‘Outstanding’, ‘Good’, or ‘Inadequate’.
0 Practices deemed inadequate by CQC usually remain registered but must ensure that they take steps to manage any risks posed by non­compliance, and must submit an action plan to explain the steps that will be taken to meet compliance with a target date for achievement.
Concerns about GP performanceEp. 11
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QUALITYIMPROVEMENT
Box 2.2 ‘Never events’ forQI
• Drug prescribed to a patient where it is recorded in the patient’s
notes as having previously caused a severe adverse reaction
• Planned referral of a patient with suspected cancer is not sent
• Prescribing a teratogenic drug to a patient known to be pregnant
(unless initiated by a specialist)
• Emergency transport is not discussed or arranged when admitting a
patient as an emergency
• Abnormal investigation result is received but not clinician reviewed
• Aspirin is prescribed for a <12y- old patient (unless recommended by
a specialist for a specic clinical condition, e.g. Kawasaki’s disease)
• Systemic oestrogen- only hormone replacement therapy is prescribed
for a patient with an intact uterus
• Methotrexate is prescribed daily rather than weekly (unless initiated
by a specialist for a specic clinical condition, e.g. leukaemia)
• Needle- stick injury is caused by a failure to dispose of ‘sharps’ in
compliance with national guidance and regulations
• Adrenaline (or equivalent) is not available when clinically indicated for
a medical emergency in the practice or GP home visit
Reproduced from de Wet etal. Developing a preliminary 'never event' list for general practice using consensus- building methods. BJGP, 64 620), e159– e167, 2014. Copyright © British Journal of General Practice 2014. Distributed under the terms of the Creative Commons Attribution
3.0 Unported (CC BY 3.0) http:// creativecommons.org/ licenses/ by/ 3.0/
p. 25)
p. 33)
CQC
Risk avoidance
Risk management
•Clear protocols
• Safe environment
• Staff training
Audit Education/training Sta
Regular review of practice against quality standards—
p. 54
Clear standards of service
Clinical governance
Infrastructure Clinical eectiveness
• Access to evidence
• Time
• Training strategies
•IT support
• Effective appraisal
• Performance feedback
• Targeted education•Teamwork
• Sharing good practice
• Significant event audit
•Evidence-based medicine
•Leadership
•Common goals
•Communication
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p. 11)
p. 56)
Figure2.2 How does clinical governance t with other QI initiatives?
Further information
Bowie P, etal. (2015) Participatory design of a preliminary safety checklist for general practice. BJGP 65(634):e330– 43.
Care Quality Commission M www.cqc.org.uk de Wet C, etal. (2014) Developing a preliminary ‘never event’ list for general practice using consensus- building methods. BJGP 64(620):e159– 67.
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