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At least 19 recordsLinked to original sources

Case study: development of a forms-design guidebook.

Implementation of the approval and official format of medical record forms procedure along with the use of the forms-design guidebook will result in a forms-management program that will be efficient and effective. This program is sufficiently detailed to provide forms that are consistent and useful. The procedure will provide the necessary documentation for forms control and will facilitate an approval process that is standardized and faster than before. An overview of the steps taken to complete this project are listed in the box entitled "Steps for Revision of Forms-Control Process." The control of medical record forms will provide documents that are useful and accurate for purposes of communication and planning of quality patient care and will meet the requirements of licensing and accrediting agencies. Also, the concentration on the consideration of cost throughout this project will reduce costs by improved efficiency in the paperwork system and by reducing both the production and the usage costs of forms.

Forms and Records Control↗

Initiation of bone and amnion banking in Turkey.

There is a growing demand in Turkey for human tissue to use in surgery and wound healing. However, our country does not have facilities for local production of tissue grafts and generally depends on imported products. Under a multi-year project initiated in 1997, the International Atomic Energy Agency has provided main equipment for tissue processing and experts on Tissue Banking as well as training on tissue processing methods.In this presentation, information on various stages of the project implementation is given. Details of lay out for the process laboratories and equipment are given. Donor selection and testing criteria, processing procedures for bone and amnion, setting up product design, implementation of quality system and radiation sterilisation are described briefly. Quality procedures included preparation of quality manual, record forms, document control, non-conformance and corrective actions, training records, equipment maintenance and calibration are all in line with GMP/GLP Standards. Clinical applications of tissue grafts and medico-legal position of organ and tissue donation in Turkey are also discussed briefly.

Journal Article↗

Drug Enforcement Administration--Records and reports of registrants; central recordkeeping permits. Final rule.

This rule amends 1304.04(a) of Title 21 of the Code of Federal Regulations by eliminating Central Recordkeeping Permits but still provides a means whereby qualified registrants will be able to keep certain required records at a central location. The amendment will establish a simplified notification system in lieu of requiring a central recordkeeping permit necessary under current regulations.

Drug and Narcotic Control↗

Allowing central fill pharmacies and retail pharmacies to fill prescriptions for controlled substances on behalf of retail pharmacies. Final rule.

DEA is finalizing a Notice of Proposed Rulemaking (NPRM) defining central fill pharmacy activities and permitting central fill pharmacies to prepare controlled substances prescriptions on behalf of retail pharmacies with which the central fill pharmacies have a contractual agreement to provide such services or with which the pharmacies share a common owner. When one retail pharmacy receives a prescription and a second pharmacy prepares and subsequently delivers the controlled substance medication to the first retail pharmacy for dispensing to the patient, the second pharmacy is engaging in a "central fill activity". Records must be maintained by both the central fill pharmacy and the retail pharmacy that completely and accurately reflect the disposition of all controlled substance prescriptions dispensed. With respect to security, central fill pharmacies would be required to comply with the same security requirements applicable to retail pharmacies including the general requirement to maintain effective controls and procedures to guard against theft and diversion of controlled substances. DEA is creating an allowance for retail pharmacies that also perform central fill activities to do so without separate DEA registration, separate inventories, or separate records. This rulemaking is sought by the regulated industry and will allow for more efficient delivery of controlled substance prescriptions to patients.

Contract Services↗

Prescription and medication records.

All nurses are required to keep contemporaneous records which are unambiguous and legible. The NMC has reprinted the UKCC guidelines for records and record keeping (UKCC, 1998). The Department of Health has provided advice in its guidance on the implementation of independent nurse prescribing on the standards for prescription writing (DH, 2002).

Clinical Protocols↗

The Skaraborg hypertension project. II. Feasibility of a medical care program for hypertension.

The feasibility of a nurse-based care program for hypertension has been evaluated. The program was established in one half of the County of Skaraborg, the other half being selected as control area. Record forms from the diagnostic work-up and annual check-ups of all 3240 patients registered during five years were reviewed. Compliance with diagnostic procedures and treatment was excellent. At the end of the five-year trial period, 7% of the population studied (40-69 years old) were registered at special outpatient hypertension clinics. Random samples were drawn of patients treated at these clinics and patients taken care of in the control area. These patients were interviewed concerning their general opinion about the care, their opinion about nurses as the main deliverers of care, the continuity of care and needs for information. The comparisons favoured care at the hypertension clinics. It is concluded that the program was feasible and preferred to conventional care by the consumers.

Adult↗

The 10 essential activities of the quality assurance unit.

It is certainly my pleasure to be here today. Several months ago, Pat Pomerleau invited me to be on your program. At the time, I had no idea that I would be speaking as Paul Lepore, private citizen, rather than Paul Lepore, regulator and bureaucrat. However, the Food and Drug Administration (FDA) made me an offer I could not refuse and, upon considerable thought, I retired effective September 30, 1994. Immediately, I called Pat for advice on how to deal with my planned presentation before you. Graciously, she said that she did not believe that I would forget all I knew about Good Laboratory Practice (GLP) over 1 weekend and that the Society would love to have me anyway. Today, I intend to discuss the 10 essential activities of a properly functioning quality assurance Unit (GAU). I will summarize the importance of records and documentation to the unit and I will close with some comments on achieving regulatory compliance. My remarks are intended to emphasize that an effective, active quality assurance unit is crucial for ensuring data quality, and that attention paid to day-to-day quality assurance activities will foster regulatory compliance.

Facility Regulation and Control↗

Prospective patient-controlled analgesia quality assurance: one year's experience.

The goal of this project was to develop a prospective patient-controlled analgesia (PCA) quality assurance (QA) program and evaluate its impact on patient care. Initial elements selected for inclusion into the QA were: patient satisfaction, pain relief, clarity of instructions, respiratory rate, and nausea and vomiting. Standards were initially set at 100% with the exception of nausea and vomiting, which was 90%. Preliminary evaluation in 26 patients indicated initial standards were unrealistically high. Standards were revised to 90% for all elements except respiratory rate, which was left at 100%. Nausea and vomiting were eliminated from the QA because it was difficult to establish a cause and effect relationship with narcotic. Data were collected through patient interviews and chart reviews on a bimonthly basis. Cumulative data on 297 patients revealed standards were met in all categories. Two systematic problems identified early in the QA were that there was no recording of respiratory rate and there was a high incidence of unclear instructions. As a result of pharmacist interventions, outcomes improved. Patient outcomes with PCA therapy can be improved using a prospective PCA QA program. Pharmacy Department's without resources for daily monitoring of PCA patients should consider implementing a prospective PCA QA program.

Analgesia, Patient-Controlled↗

Development of a computerized controlled substances system.

Maintaining controlled substances records are a required and tedious task. A computerized system was developed to meet both pharmacy and nursing needs. The original system consisted of several notebook binders that were tabbed to separate different controlled substances. Pharmacy was constantly dealing with transcription errors and incorrect calculations. In the computerized program, each controlled substance was assigned its own file and mnemonic. The computer allowed for entries and maintained a running inventory. The troubleshooter pharmacist's role was redefined to oversee of the entire system, to have sole access to the entire system, and to maintain a weekly inventory. Improvements also were made in the nursing procedure, which provided a sufficient stock of controlled substances. A new, consolidated nursing form also was devised. The primary reason that the computerized system is successful is that it accommodates the needs of both nursing and pharmacy.

Adult↗

Twenty-four-hour controlled substance documentation system: the optimal way to monitor use in the nursing units.

Accountability for the use of controlled substances in the nursing units is a top priority for nursing and pharmacy administration in any health-care institution. After several discrepancies were found in inventory at the John F. Kennedy Memorial Hospital in Indio, California, the pharmacy department revised the controlled substance handling system in the hospital and implemented a 24-hour controlled substance recording system. The system provided greater accountability and allowed follow-up on any discrepancy within the next shift. The system has been highly successful. There had been six discrepancies in 12 months before implementing the system. There has been no incident of discrepancy in the last 31 months. The authors conclude that 24-hour controlled substance documentation system is very effective in providing greater accountability and control over controlled substance use in the nursing units.

California↗

Getting it right--the Australian Childhood Immunisation Register and immunisation rates in south-eastern Sydney.

OBJECTIVES: To assess the completeness of ACIR data for south-eastern Sydney children at 12 to < 15 months of age and to develop strategies to improve rates. METHODS: We surveyed children aged 12 to < 15 months listed as overdue on the ACIR011A report, December 2001, by contacting the last immunisation provider or the parents. RESULTS: From the 470 children listed as overdue, 162 children were systematically selected to form the study group. Seventeen were lost to follow-up and results are available for 145 children. Eighty children were up to date (69, encounter forms incorrect or not sent; 11, vaccinated overseas) and 11 children had moved overseas. Fifty-four children were overdue (30, provider error due to incorrect Haemophilus influenzae type b (Hib) schedule or Hib vaccine omitted; 18 did not complete schedule; 6 conscientious objectors). CONCLUSIONS: Our study indicates that between 6-9% of children on the register were likely to be overdue, whereas the ACIR011A report identified 19%. Failure of immunisation providers to correctly complete, or send encounter forms to the ACIR was the main reason for this discrepancy. Migration and failure to record overseas vaccination were also factors. IMPLICATIONS: Public health units should develop good working relationships with immunisation providers to assist and encourage immunisation and the completion and submission of encounter forms. A quarterly review, using the third dose assumption, of all children aged 12 to < 15 months identified on the ACIR011A report as overdue for immunisation may be an effective way for public health units to increase apparent rates for their area.

Bacterial Capsules↗

Check-off logs for routine equipment maintenance.

The regulatory requirement for appropriate routine instrument maintenance documentation is approached by laboratories in numerous ways. Standard operating procedures (SOPs) may refer to maintenance listed in instrument manuals, may indicate "periodic" performance of an action, or may indicate specific tasks to be performed at certain frequencies. The Quality Assurance Unit (QAU) task of assuring the performance of these indicated maintenance tasks can be extremely laborious if these records are merged with other analysis records. Further, the lack of written maintenance schedules often leads to omission of infrequently performed tasks. We recommend creation of routine maintenance check-off logs for instruments with tasks grouped by frequency of expected performance. Usage of such logs should result in better laboratory compliance with SOPs and the compliance can be readily monitored by QAU or by regulatory agencies.

Documentation↗

A reliable accounting system for controlled substances in the operating room.

BACKGROUND: Drug abuse is a leading occupational hazard for operating room personnel. Easy access to controlled substances allows drug dependence to develop and flourish. A system that accurately audits the distribution of controlled substances used in the operating room may decrease the onset of drug abuse and make it easier to identify drug addicts. A simple, inexpensive, and reliable system that improves accountability of controlled substances is described in detail. METHODS: This system involves participation by anesthesiologists, operating room nurses, and pharmacists to accurately record amount and type of drugs dispensed, used, wasted, and returned. Periodic, random, qualitative, and quantitative analyses of drugs returned for wastage are performed. RESULTS: In the first 6 months in which the system was used, 6,336 patients were treated and 7,182 ampules of controlled substances were dispensed. Thirty-seven incident reports describing deviations from the protocol occurred. In each case an explanation for the discrepancy was determined and compliance with the protocol was subsequently improved. No cases of drug diversion were discovered or suspected. CONCLUSIONS: The system described is simple and inexpensive to implement and has improved accountability for controlled substance management.

Anesthesiology↗

Unintended consequences of immigration reform: discrimination and Hispanic employment.

The record-keeping requirements of the Immigration Reform and Control Act(IRCA), and fines for illegal employment, may induce employers to discriminate against foreign-appearing workers. The General Accounting Office (GAO) reported widespread IRCA-related discrimination but did not link reported discriminatory practices to discriminatory employment behavior. We analyze the GAO's random survey and, controlling for selectivity effects, demonstrate that employers who report discriminatory practices actually employ fewer Hispanics. Although the measured reduction of Hispanic employment due to IRCA is fairly small, this finding parallels research alerting us to adverse consequences of a law that so far has achieved few of its intended effects.

Choice Behavior↗

Low cost ambulatory medical information system.

A simple, low-cost computerized minirecord system (minimal essential record) has been in operation at the Johns Hopkins Medical Clinic since mid-1975. The system has three primary components: (a) the Minirecord which contains a listing of problems and medications, plus information about visits to other clinics, (b) an appointment system used to organize materials prior to clinic encounters and assist in the follow-up of high risk special patients, and (c) an encounter data system to prepare reports used for management, quality assurance and training. This paper describes the system's operation, and reports on its utility and cost.

Computers↗

Recording, notification, compilation, and classification of statistics of occupational accidents and diseases: the Thai experience.

An International Labour Organization (ILO) project was conducted in July and August 1995 in Thailand to assist with the development of an information system on occupational accidents and diseases for the Workmen's Compensation Fund (WCF). The WCF provides cash benefits and medical care to insured workers who suffer employment injuries. The project included literature research based on the facilities of the ILO in Bangkok, and those of the Thai government, and a thorough review of the ILO Code of Practice (the Code) on recording and notification of occupational accidents and diseases, and of other international recommendations on statistics of occupational accidents and diseases. A comparative study of various notification systems of occupational accidents and diseases in Australia, Canada, the Philippines, Sweden, Thailand, and the United States was conducted. The project also included fact-finding sessions among various information suppliers and users in Thailand. The Thai notification form for collecting data for the database was redesigned and pretested. Results of the project indicated that the Code is appropriate for the recording and notification of occupational accidents and diseases in Thailand. In addition, a number of information requirements, which were included in the notification systems in the countries studied but not listed in the Code, were found to be useful for the database. A list of the baseline variables to be included in the proposed database was developed, the notification form was redesigned, and coding schemes for the information collected on the redesigned form were constructed on the basis of international standard classification systems for economic activity, employment status, occupation, nature of injury, occupational disease, body part, type of accident, and agency. A number of mechanisms were suggested for cross-checking the accuracy of data in the database. Based on the review of the Code and other international recommendations on statistical reporting, a list of baseline statistics was formulated for inclusion in the WCF annual report. Lastly, some suggestions for future statistical analysis of the database were given.

Accidents, Occupational↗

Pursuing clinical and operational improvement in an academic medical center.

BACKGROUND: An academic medical center in an increasingly competitive market, the University of California-Davis Medical Center in Sacramento started working with a consulting firm in 1995 to reduce overall operational costs and costs for the clinical processes involved in treating patients with specific conditions. ESTABLISHING THE TEAMS: Twelve operational efficiency (OE) teams and five clinical teams were commissioned, with a combined total of nearly one-half of the target cost reduction. The second wave of six clinical teams was simultaneously initiated in late spring 1996. THE IMPROVEMENT METHOD: The quality improvement process for clinical improvement teams included the review and inquiry method, which enables many pilot experiments to be conducted in parallel by work groups and coordinated by the main task team. RESULTS AND CASE STUDIES: Within six weeks of launching, the 12 OE teams achieved their goals and identified savings opportunities of more than $27 million. One OE team, medical records, had set a goal of $514,000 in cost reduction for a three-year period and achieved the first-year goal of $190,000. For a clinical team on interventional cardiology, the clinical benchmark data revealed that the cost per case of providing cardiac catheterization was greater than for all three benchmark groups. These patients, including 270 patients per year, showed a possible savings through process improvement of nearly $1.4 million. From January 1996 through March 1997, the rate of occurrence of complications decreased from 5.5% to 3%. EPILOGUE: Physicians gradually accepted more responsibility and accountability for controlling and reducing costs, while maintaining their traditional role as advocates for improved patient care.

Academic Medical Centers↗