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The Evolving Regulatory Environment and Bedside Metabolic Monitoring of the Acute Care Patient (Part 15)

The Evolving Regulatory Environment and Bedside Metabolic Monitoring of the Acute Care Patient (Part 15)Laboratory Consultant
Within each institution there is a need for a laboratory consultant who can provide both the initial training and continuing education for people doing testing outside the laboratory. The consultant should assist with technical problems. As a means of providing comparability between test systems, the laboratory consultant should provide cross-calibration of other systems with the laboratory’s analytic systems; the consultant should also conduct current competency testing of the operators by parallel analysis of patient samples using the point of care test system and the central laboratory’s test system.

The Evolving Regulatory Environment and Bedside Metabolic Monitoring of the Acute Care Patient (Part 14)

Good record keeping is essential. Most regulatory agencies require patients’ results to be recorded in a log at the point of testing. Patient results should also be clearly charted in their medical record. The documentation of patient results in both places should indicate the time and date of the test, the test result, and it should clearly identify who performed the test. Also recorded at the point of use of the instrument should be a complete record of all QC testing. Proficiency test results and records of instrument maintenance and repair should be kept. buy levaquin online
A special problem arises when the same analyte is tested by different methods in different locations for the same patient. As the patient moves from the domain of one test procedure to the domain of another, test values can change because of differences in test methodology or calibration. It is therefore important on an institution-wide basis to establish policies and procedures that will assure that test results are comparable, regardless of where the test is performed.

The Evolving Regulatory Environment and Bedside Metabolic Monitoring of the Acute Care Patient (Part 13)

The Evolving Regulatory Environment and Bedside Metabolic Monitoring of the Acute Care Patient (Part 13)Recommendations to Meet Regulatory Requirements and Reduce Malpractice Risk
Moving testing to the bedside while maintaining a high level of test reliability depends on the joint efforts of the user of the system, the manufacturer, and the medical laboratory community. In some instances, new technology and quality assurance approaches are needed. ventolin inhalers
User of the System
The user of the system performing tests on patients is held responsible by regulatory and accrediting agencies for meeting the regulatory requirements. Although not written into all regulatory rules, certain steps will help assure compliance.

The Evolving Regulatory Environment and Bedside Metabolic Monitoring of the Acute Care Patient (Part 12)

Special Problems Encountered in the Out-of-Laboratory Testing Site
Nontechnically trained individuals frequently make random, rather than systematic, errors. Sometimes the errors are due to the lack of understanding the test systems. More likely, the multiple duties and priorities of these individuals lead to errors related to distraction or inattention to detail. Their major concern is usually the immediate care of the patient. The laboratory test that they are performing is perceived as an ancillary duty of lesser importance. Because of their lack of technical training, they believe that quality is in the box that they operate. They are unaware of the variability in testing that is introduced by interaction of the analyst and the black box.

The Evolving Regulatory Environment and Bedside Metabolic Monitoring of the Acute Care Patient (Part 11)

Quality control testing and proficiency surveys, however, are relatively ineffective in detection of random errors. These measures may promote good laboratory practices by heightening awareness for quality management by the individuals doing testing. Present requirements of regulatory and accreditation agencies do little to prevent sampling or specimen handling errors except for the requirements that procedure manuals and instructions for submission of specimens be available.
Timeliness errors may actually be increased by current requirements. Quality control testing can delay the release of patient data if there are too many false alarms or if the QC results must be evaluated before patient information can be released to the care giver.

The Evolving Regulatory Environment and Bedside Metabolic Monitoring of the Acute Care Patient (Part 10)

The Evolving Regulatory Environment and Bedside Metabolic Monitoring of the Acute Care Patient (Part 10)In the laboratory, variability can arise before the test analysis (preanalytic variability), during test analysis (analytic variability), or after the analysis (post-analytic variability). Preanalytic variability may be introduced in any of the steps from the physicians ordering of the test to introduction of the patients specimen into the measuring instrument or test rea-. gents. Some important examples are as follows: failure to tell the patient that no food should be eaten before the collection of blood for triglyceride testing; keeping a tourniquet on the arm too long when obtaining a blood sample; squeezing the finger excessively when collecting a blood sample for a blood count; failure to use the correct preservative for a urine specimen for catecholamine analysis; allowing a urine specimen at room temperature for two hours prior to urinalysis; identifying a specimen with only the patients last name when there are two people with the same surname having the same test on the same day.

The Evolving Regulatory Environment and Bedside Metabolic Monitoring of the Acute Care Patient (Part 9)

Regulatory Requirements
Although there are diverse regulatory bodies with distinct philosophies, all of the regulating bodies have similar requirements for most aspects of laboratory quality management. Quality control testing is a universal requirement. The laboratory must engage in proficiency testing. This requirement, however, is applied to the laboratory itself rather than to each individual performing tests in that laboratory. Procedure manuals, detailing the specific steps of each laboratory analysis, as well as operational and administrative procedures, are required. Regulations require documentation of test results, QC testing, proficiency testing, and equipment maintenance. All of the licensing and accrediting agencies appear to permit testing outside of the clinical laboratory, provided that the criteria indicated by their regulations are met. The agencies do differ in their requirements regarding personnel qualifications and on-site inspection.

The Evolving Regulatory Environment and Bedside Metabolic Monitoring of the Acute Care Patient (Part 8)

Certain specialized laboratories performing only a few types of analyses, but not part of the central laboratory department (Special Function Laboratories), can be inspected using a generalized checklist similar to those used for inspection of the central clinical laboratory. buy asthma inhalers
A new abbreviated checklist for “ancillary testing,” such as capillary blood glucose measurements performed by nurses or blood gas analysis by cardiopulmonary perfusionists, is also available. On application, these testing activities can be included in the inspection of a hospital laboratory. The CAP, however, requires that ancillary testing be performed under the direction of the central laboratory.

The Evolving Regulatory Environment and Bedside Metabolic Monitoring of the Acute Care Patient (Part 7)

The Evolving Regulatory Environment and Bedside Metabolic Monitoring of the Acute Care Patient (Part 7)JCAHO
The JCAHO, a voluntary nongovernmental accrediting agency, has adopted standards and guidelines for testing, such as bedside capillary blood glucose testing, performed outside of the central laboratory in hospitals. Similar standards have also been adopted for its accreditation of home health services and longterm care facilities. The standards require identification of those responsible for performing, supervising, and directing such testing, policies and procedures be written, and a quality assurance program, including documentation of all results, and QC testing and proficiency testing of individuals be in place. These standards include the training, initial certification that an individual is able to properly perform the test, and competency testing requirements of individuals performing such tests. The new standards were implemented in January, 1990.

The Evolving Regulatory Environment and Bedside Metabolic Monitoring of the Acute Care Patient (Part 6)

Medicare
Clinical laboratories in Medicare-approved hospitals have been subject to regulation for many years. In an expansion of these requirements, the Department of Health and Human Services (DHHS) conditions for participation of hospitals (June 17, 1986 amendments, 42 CFR 482.57) require that blood gas determinations and other clinical laboratory tests performed by a respiratory care unit must meet the same requirements as a clinical laboratory with respect to the adequacy of facilities, proficiency testing, and QC. buy antibiotics online

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