Everyone talks about it, every one hates it, but only a few really understand its importance. But what is actually a medical record? Originally meant as a series of notes taken to record and convey messages to other healthcare staff, it plays today a leading role from a documental point of view.
A MEDICAL RECORD IS A SET OF DOCUMENTS IN WHICH MEDICAL AND NURSING STAFF RECORD A SERIES OF DATA (OF A PERSONAL, HEALTHCARE, SOCIAL, ENVIRONMENTAL AND LEGAL NATURE) CONCERNING A SPECIFIC PATIENT, IN ORDER TO BE ABLE TO MAKE OUT DIAGNOSTIC/ THERAPEUTIC INFORMATION RELATING TO HIM/HER ALSO AT LATER STAGE, TO BE ABLE TO ARRANGE FOR THE REQUIRED MEDICAL ACTION AND ALSO WITH A VIEW TO SUPPORTING THE VARIOUS SCIENTIFIC, STATISTIC AND LEGAL MEDICAL SURVEYS, AND FOR TEACHING PURPOSES.
The history of medical records is lost in antiquity, in parallel with the history of medicine: in certain caves in Spain, graffiti were found, dating back to the Palaeolithic period, bearing emblematic traces of medical records; in the Pyramid era, in 3000-2000 B.C., there were people who made records of their medical activity; subsequently in Hippocrates’ times the same happened in the Asclepius hospital-temples, where columns were found bearing engravings relating patients’ names and brief reports as to their affections; lastly, in ancient Rome, Galen founded his school on case history with publications and medical accounts in the Romana Acta Diurna affixed in the forum. Therefore medical records are not recent, but have an ancient history; however today they continue to lack adequate legislation, despite the great importance they have within medical activity, especially in hospitals. In particular, even nowadays, we do not actually have a specific method for filling them in, even though there is a lot of talk about standards, normalised medical records, etc.; the old reporting system with the clinical history divided into anamnestic data relating to family, physiological situation, remote pathology and recent clinical history, as well as clinical data resulting from the examination, appears now to have been superseded. There are indeed many differences in the procedure according to which medical records are filled in, and this is due to the different personal, department or area objectives. Bad use of medical records is rather widespread and tends to worsen, possibly also owing to the limited awareness of the value that this document has, since the medical record also represents a constant certification of what is detected and what is done. A delay in filling it in or failure to do so can be judged as neglect of official duty on the part of the hospital staff, whereas failure to fill it in correctly can be judged as fraudulent misrepresentation and subsequent corrections as a substantial misrepresentation. This is why it is important for a medical record not to bear erasures, adjustments or belated additions; furthermore, a medical record should be drawn up with a clear and legible handwriting, as also prescribed by article 23 of the New Medical Code of Conduct.
Art. 23 – New Medical Code of Conduct
MEDICAL RECORDS MUST BE DRAWN UP IN A CLEAR, ACCURATE AND CAREFUL MANNER, IN COMPLIANCE WITH PROPER MEDICAL PRACTICE RULES, AND MUST CONTAIN, IN ADDITION TO ANY OBJECTIVE DATA RELATING TO THE PATHOLOGIC CONDITION AND ITS COURSE, ANY INFORMATION AS TO THE DIAGNOSTIC AND THERAPEUTIC ACTIVITIES CARRIED OUT.
The Petragnani law issued in 1938, subsequently reconfirmed by the D.P.R. (Decree of the President of the Republic) 128/69, already held the Hospital Department Consultant, in conjunction with the Senior Assistant for his own sphere of competence, responsible for the proper management and filing of medical records up to their delivery to the central archives, for which the Hospital Manager is responsible. The D.P.R. 225/74 recalls that professional nursing staff is responsible for the filing of all the clinical documentation until it is passed on to the central archives. It should also be recalled that, in the event of loss or destruction, or in any case of bad management of medical records, the liability for such circumstances is ascribable to the hospital management from a civil law point of view, whereas the individual person who is personally in charge of their storage may incur liabilities of a penal nature.
In the absence, at present, of clear regulations for the storage of medical records, from their filling in (opening) to their filing (closure), guaranteeing both documentation integrity (protection from tampering, damage or loss) and access limitation to the parties entitled to it, in line with legal provisions concerning privacy protection and sensitive data handling, the Manager of each Operating Unit, identified by the Hospital as party in charge, may delegate his cooperators (medical and nursing staff) to take care of the diligent storage of medical records and of compliance with the minimum safety measures set by article 9 point 4 of the legislative decree 318/99.
Legislative Decree 318/99, art. 9 point 4
1- In the event of personal data handling for purposes differing from those indicated under art. 3 of the law (= exclusively personal purposes), carried out through means differing from those provided for under paragraph II (= electronic or automated media), the following procedures must be complied with: in appointing in writing the staff in charge of data handling and in giving instructions in compliance with art. 8, comma 5 and 19 of the law, the manager, or, if appointed, the person in charge, are to prescribe that the appointed staff only have access to the personal data whose knowledge is strictly required to fulfil the tasks they have been assigned; the acts and documents containing the data must be stored in protected archives and, if entrusted to the staff in charge of data handling, must be stored by these and returned once the tasks have been completed.
2- In the event of data handling as per article 22 and 24 of the law, in addition to the provisions of comma I, the following procedures must be complied with: if the acts and/or documents containing the data are entrusted to the staff appointed for the data handling, they have to be stored up to their restitution in containers provided with locks; access to the archives must be controlled and the individuals admitted to such after the archives closing time must be identified and recorded.
As far as private nursing homes are concerned, the Ministerial Decree of 5 August 1977 specifies under art. 254: for each patient admitted to hospital a medical record has to be drawn up, complete with personal data and clinical-therapeutic remarks; these have to be progressively numbered; they have to be stored by the Hospital Management; in the event that the hospital is closed down, the medical records are to be put at the disposal of the town hall or of the consortium health authority.
WARNING - A medical record by a private hospital or nursing home, may have a twofold legal nature: “If it relates to medical services for which the private hospital operates within the local health unit, its legal nature is the same as that of the medical records issued by public establishments; on the other hand, for nursing homes which do not operate within the NHS, medical records therein drawn up only represent a private memorandum of the diagnostic and therapeutic activity carried out, and do not represent an official act or a certification: in order for it to be described as a certification, the medical record needs to certify facts of whose truthfulness the act is bound to provide evidence; these aspects are not recognizable in a medical record drawn up according to art. 35 of the Prime Minister’s Decree of 27 June 1986, that is by the private hospital doctor in charge as a plain internal memorandum. Therefore, from a penal law point of view, even though the professional activity carried out by a doctor within a private hospital may be viewed by the law as a service for the common good, fraudulent misrepresentation of the medical record therein drawn up, which, as mentioned, does not have the legal value of a certification, is not liable to punishment in force of art. 481 of the Penal Code (fraudulent misrepresentation by parties carrying out a service for the common good).”
But which are the issues related to proper filling in, secrecy, storage and circulation of medical records, and the conditions regulating issue of any copies?
Lastly, it should be stressed that collective professional agreements include, among the prescribed tasks of panel medical practitioners, the storage and update of individual medical files, in compliance with the prescriptions of article 48 of law no. 833/78.
In summary, medical records, having risen to the position of official acts, do not only have a clinical purpose (for assistance and evaluation of the effectiveness of treatments, or as a means of information among the various operators and for statistical or scientific purposes), but also a legal-medical purpose, and now, in addition, significant importance from an economic and administrative point of view.
Excerpt from the paper presented at the Conference “The Medical Report: a Perfect Stranger”, held at the Fatebenefratelli Ophthalmic Hospital in Milan, on 7 November 2001.
