Documentation and communication

Identification of the patient s problems, empowerment, cooperation, documentation and communication within the professions, between professions and with the patient. 

The main process (Fig. 1.1) for the care of a patient is normally the Primary care process (the patient handles their own drugs)—or the community care process (the patient gets help from community nurses at home or at a nursing home). All other processes such as hospital care (secondary/tertiary care) and the pharmacy process must support the main patient process. For improvement we must focus on patient safety and reduce drug-related problems. This means correct prescription and correct use (follow-up, documentation and communication) from the supportive process to the main process. 

Electronic support system for correct prescription, documentation and communication. 

Documentation and communication of relevant patient care aspects and medications within health care... 

The following process is applicable for changes to any component of computer technology that performs functions on regulated products, including hardware, peripheral devices, system software and utilities, application software, documentation, and communications hardware and software. These components can be either purchased from an external supplier or developed in house by the company or its designee. 

Informative FDA documents and communications related to 21 CFR Part 11 compliance are posted to public dockets on the FDA Website (currently linked at http //www.fda.gov/ohrms/dockets/dockets/dockets.htm).The relevant dockets are 00D-1538 through 00D-1543. 

Data that successfully meet the challenges posed in these questions can be said to exhibit certain distinctive characteristics—hallmarks, as we have called them in this document—that are indicative of data quality appropriateness, accuracy, integrity and transparency. Table 1 provides a brief overview of the hallmarks, their definitions and some general examples. As the summary table indicates, these four hallmarks of data quality are closely related and may in some cases overlap. In particular, the need for transparency in documentation and communication cuts across each of the other hallmarks. In the paragraphs that follow, we define each hallmark in greater detail and illustrate how implementation of the principles they embody can improve the quality of exposure assessments and the decisions that follow from them. 

Perry, J. W., Kent, Allen, Center for Documentation and Communication Research, Western Reserve Univ., Newsletter, No. 2 (August 1956). 

Management responsibility— Requires that a quahty system be defined, documented, and communicated throughout the organization, and that responsibifity for quahty be clearly defined. Top management must review the quahty system at least once a year to ensure its continuing suitability and effectiveness. 

Study personnel will have access to the study plan and appropriate Standard Operating Procedures applicable to their involvement in the study. It is their responsibility to comply with the instructions given in these documents. Any deviation from these instructions should be documented and communicated directly to the Study Director, and/or if appropriate, the Principal Investigator(s). 

Documentation and communication of information and decisions Product and system performance evaluation and improvement... 

Although the concepts of documentation are consistent irrespective of practice settings, the process by which data are collected and the tools for documentation can be quite different. Thus the training associated with documentation must be specific to the respective practice environments of pharmacists. For example, access to health care providers, medical records, laboratory data, and patients is more common in hospital pharmacy practice than in community pharmacy practice, where direct access to patients is often the only source of information. As a result, data collection, documentation, and communication with other health care providers and patients will vary based on the practice setting. However, as the use of EMRs and digital documentation becomes more common, the ability of pharmacists to interface with these systems will become less of a logistical barrier. 

The central section of Figure 19.3 shows the SEMS rule. One of its sections is paragraph 250.1913 (e)(1) which is entitled Review of and changes to the procedures must be documented and communicated to responsible personnel. On the left of Figure 19.3 is the operator s SMS. His standards to do with changes to operating procedures are under Sections abc and xyz. On the... 

Materials properties and potential hazards and operations risks are identified, documented, and communicated openly ... 

Applicable regulations, permits, codes, and workplace standards and practices are identified and conflicts are resolved. The resulting operating requirements are documented and communicated to those affected. ... 

Chemical names are usually used for documentation and communication purposes. A molecule can have several valid chemical names including computer-generated International Union of Pure and Applied Chemistry (lUPAC) names, traditional name, common name, commercial name, company assigned identifiers. Chemical Abstracts Service (CAS) Registry number, and many other synonyms. It is challenging to generate chemical stractures from the chemical names. In order to communicate effectively, line notations were developed for representing chemical struc-... 

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