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How accelerated regulation will affect point-of-care testing.

Isn't it interesting that as testing becomes more sophisticated and complex, it is being returned, in part, to the bedside, where it was performed many years ago? This time, however, testing at the point of patient care is bolstered by an armamentarium ar·ma·men·tar·i·um
n. pl. ar·ma·men·tar·i·ums or ar·ma·men·tar·i·a
The complete equipment of a physician or medical institution, including drugs, books, supplies, and instruments.
 of advanced technology. Also present is a heightened awareness of the importance of continuously monitoring the instruments and the professionals who operate them.

The underlying theme is improvement of patient care through more effective testing. Bedside blood glucose monitoring blood glucose monitoring Sugar monitoring Lab medicine The periodic testing of serum glucose in Pts known to have DM. See Bedside glucose monitoring, Beta cell implants, Diabetes, Glucometer, Glycosylated hemoglobin, Non-Invasive glucose monitoring.  has earned the endorsement of the American Diabetes Association The American Diabetes Association, or the ADA, is an American health organization providing diabetes research, information and advocacy. Founded in 1940, the American Diabetes Association conducts programs in all 50 states and the District of Columbia, reaching hundreds of , for example, for making results available immediately and requiring only a fingerstick to obtain specimens. In this way, the association has stated, such testing enhances patient management and may shorten hospital stay.|1~

Physicians welcome the shortened therapeutic turnaround time (1) In batch processing, the time it takes to receive finished reports after submission of documents or files for processing. In an online environment, turnaround time is the same as response time.  available through point-of-care testing point-of-care testing Lab medicine The analysis of clinical specimens as close as possible to the Pt, including bedside, ward–unit, or 'stat' regional response labs that service specified areas–eg, the ER or ICU . Results of tests performed by the central laboratory, however reliable, are of little use unless they arrive in time to contribute to therapeutic decision making.|2~

* Network. It has become clear that point-of-care testing will eventually be subject to all of the same standards that now govern testing in the central laboratory. Anticipating an increase in Government oversight, our institution established a program that would coordinate ancillary testing throughout the facility, bringing all areas into compliance with existing regulations. The network provides a mechanism for complying quickly with each new set of rules. The process also reassures the public of our commitment to high-quality medical care.

We currently monitor 17 areas of the hospital and 19 outpatient sites, offering a total of 20 different ancillary testing procedures. Our experience may be instructive for those setting up similar programs elsewhere.

* Accreditation. Voluntary accrediting agencies for laboratories and health care facilities include the Joint Commission on Accreditation of Healthcare Organizations Joint Commission on Accreditation of Healthcare Organizations,
n.pr the United States body that accredits healthcare organizations.

Joint Commission on Accreditation of Healthcare Organizations (JCAHO/TJC),
n.
 (JCAHO JCAHO Joint Commission on Accreditation of Healthcare Organizations, see there ) and the College of American Pathologists This article or section needs sources or references that appear in reliable, third-party publications. Alone, primary sources and sources affiliated with the subject of this article are not sufficient for an accurate encyclopedia article.  (CAP). In addition, HCFA HCFA
abbr.
Health Care Financing Administration


HCFA,
n.pr See Health Care Financing Administration.
 audits 5% of the Joint Commission's inspections each year. Laboratories accredited accredited

recognition by an appropriate authority that the performance of a particular institution has satisfied a prestated set of criteria.


accredited herds
cattle herds which have achieved a low level of reactors to, e.g.
 by CAP must also be approved by JCAHO before they can receive Federal certification.

JCAHO and CAP have both responded to the recent increase in the number of procedures performed outside the central laboratory by providing checklists for decentralized de·cen·tral·ize  
v. de·cen·tral·ized, de·cen·tral·iz·ing, de·cen·tral·iz·es

v.tr.
1. To distribute the administrative functions or powers of (a central authority) among several local authorities.
 testing. Decentralized laboratory testing standards developed by JCAHO went into effect Jan. 1, 1990. Guidelines vary among Federal, state, and voluntary accrediting agencies. Laboratories must be prepared to comply with the most stringent rule among these agencies in each category of oversight.

* Ramifications ramifications nplAuswirkungen pl  of CLIA CLIA Clinical Laboratory Improvement Amendments of 1988 Congressional legislation that promulgated quality assurance practices in clinical labs, and required them to measure performance at each step of the testing process from the beginning to the end-point of a . Since the 1965 Medicare Act, the Government has had the authority to certify clinical laboratories. A steamroller of regulation ever since has led to widespread confusion and concern. (For a summary of these events, see "A review of current regulations," page 50.)

Most of the hysteria in recent years has been derived from anticipation of certain dreaded implications of CLIA '88. A particular worry is the proposed assignment of each laboratory test to one of three categories: Certificate of Waiver, Level I, or Level II. A considerable body of opinion in the laboratory field and in industry holds that at least the Certificate of Waiver and Level I categories should be carefully reconsidered before the regulations appear in final form. One major complaint is that the rules do not take into account the type of instrumentation or method used in performing specific tests, although the statutory language of CLIA '88 requires HHS HHS Department of Health and Human Services.  to consider methodology when drafting the rules.

Under CLIA '88, laboratories not certified under CLIA '67 may have to apply for provisional certificates. They will then have two years to meet certain criteria, not yet final, to receive certification.

It is not certain whether ancillary sites will be defined as separate laboratories or as departments of the central laboratory. Among the many questions to be answered: Must a unit in the hospital at which bedside glucose testing glucose test See 1 Glucose, see there 2 Glucose tolerance test, see there  is performed apply for its own Level I certificate, or will point-of-care units be covered under the certificate held by the central laboratory?

However the question is resolved, certification criteria will certainly include inspections and proficiency testing proficiency test nprueba de capacitación . Under the proposed regulations, proficiency testing standards must be performed on every analyte for which proficiency materials are available. Most specialties and subspecialties would have to achieve a passing score in two consecutive testing events or in two out of three. PT standards will directly affect the training of everyone who performs laboratory tests.

Personnel standards anticipated under CLIA '88 will vary according to according to
prep.
1. As stated or indicated by; on the authority of: according to historians.

2. In keeping with: according to instructions.

3.
 the level of testing performed at each site. Precisely how this will affect point-of-care testing is not known. It may mean that formal laboratory training will become a prerequisite for performing certain procedures.

QA standards in CLIA '88 call for ongoing monitoring of virtually every step of testing: from the time the specimen is received at the testing site, through the analysis itself, to the reporting and retrieval of information.

* Path to compliance. The central laboratory has a head start in understanding the array of guidelines and regulations that govern testing. The laboratory is thus the logical source of expertise for developing and enforcing standards for point-of-care testing in its institution. There are many different paths to compliance; what works well in the central laboratory may not be immediately transferable to the patient's bedside. The best mode is persistence supported by flexibility and creativity. The spirit as well as the letter of the law should be observed.

Resistance to change is common among individuals as well as institutions. Establishing detailed rules for point-of-care testing is particularly difficult in hospitals where such testing has been performed for years without standardization or monitoring.

Enlisting the support of administration is essential as changes are made. Forming a bedside testing bedside test Lab medicine Any evaluation of analytes close to a Pt who may be a relatively critical state; devices used for BTs may be less accurate than those used in a hospital's laboratory, but have the advantage of short 'turn-around' time–eg, 2 minutes,  committee composed of nursing, physician, and laboratory representatives helps in creating protocols that everyone can understand and will follow. The committee can draft a comprehensive, cohesive standardization policy that will anticipate and prevent many potential problems.

For example, discrepancies can arise when one method is used to perform a given test in the central laboratory and another method is used at the bedside. Test results must be made comparable throughout the institution. Protocols established by the committee can accomplish this.

* Appointing a coordinator. The most effective way to administer a point-of-care testing program is to assign one person to it full time. Ideally, that person should have a laboratory background. Our institution calls that person "ancillary testing coordinator"; similar titles would be equally acceptable.

The coordinator is responsible for training personnel, monitoring and reviewing QC and maintenance records, result reporting, proficiency testing, and safety standards Safety standards are standards designed to ensure the safety of products, activities or processes, etc. They may be advisory or compulsory and are normally laid down by an advisory or regulatory body that may be either voluntary or statutory.  and for writing and reviewing procedure manuals. Other duties include installing and evaluating new instrumentation and tests and working with nurse managers and educators to set up the program. At our institution we have designated responsibilities for all individuals involved in decentralized testing.

* Training operators. To meet current regulations, all personnel--especially those who have no clinical laboratory experience--must be trained formally in the procedures performed in their areas. Records of training, which will vary according to the complexity of the analyses done, must be maintained. The program must include initial instruction, including documented evidence of training for each appropriate procedure; recertification recertification Recredentialing Graduate education A process in which a professional is periodically re-evaluated–eg, every 10 yrs by an accrediting body to assure continued provision of safe, high-quality health care ; and continuing education continuing education: see adult education.
continuing education
 or adult education

Any form of learning provided for adults. In the U.S. the University of Wisconsin was the first academic institution to offer such programs (1904).
 activities.

Although one attribute of point-of-care instrumentation is its simplicity, achieving reliable results depends on paying close attention to all details that may affect performance. Those designing the training programs must consider the importance of technique to successful completion of each procedure; any potential chemical interferences; proper storage and expiration dates Expiration Date

The day on which an options or futures contract is no longer valid and, therefore, ceases to exist.

Notes:
The expiration date for all listed stock options in the U.S.
 of reagents; and intervals at which the instruments should undergo preventive maintenance The routine checking of hardware that is performed by a field engineer on a regularly scheduled basis. See remedial maintenance.

preventive maintenance - (PM) To bring down a machine for inspection or test purposes.

See provocative maintenance, scratch monkey.
, cleaning, and service.

Certification records demonstrating continued competence must be maintained for all operators. Competence may be assured by several means. The operator may take a skill test, performing the procedure while being observed by a supervisor or other designated person. Quality control and proficiency testing protocols illustrate competence as well.

* Quality control. Accrediting agencies and HCFA mandate that a quality control material be tested daily when patient testing is being performed. For most tests, if two or more quality control levels are available, such as high and low or positive and negative, all should be run.

Patient testing may proceed only when quality control results are within acceptable ranges. Some instruments currently under development actually prevent patient testing from taking place until all QC calibrations have reached acceptable levels.

Testing procedures that do not involve an instrument must be monitored according to the institution's quality control plan. This usually involves checking reagent reagent /re·a·gent/ (re-a´jent) a substance used to produce a chemical reaction so as to detect, measure, produce, etc., other substances.

re·a·gent
n.
 expiration dates, reviewing written procedures, and providing proper training.

* Proficiency testing. Programs approved by HHS and some states may be used to test the proficiency of operators. To complement external PT, spiked samples may be prepared in-house.

The result reported by the operator should be comparable to a reference value under a preassigned limit. Corrective action A corrective action is a change implemented to address a weakness identified in a management system. Normally corrective actions are instigated in response to a customer complaint, abnormal levels if internal nonconformity, nonconformities identified during an internal audit or  must be taken when results exceed the defined limits. As it stands, CLIA '88 requires four proficiency testing events per year with five challenges each.

* Standard operating procedure standard operating procedure Medtalk A technique, method or therapy performed 'by the book,' using a standard protocol meeting internally or externally defined criteria; a formal, written procedure that describes how specific lab operations are to be performed. . Like tests performed in the central laboratory, those done at the point of patient care require written standard operating procedures. While a manufacturer's manual alone is not sufficient, it may be adapted for an institution's needs. Procedures should contain step-by-step instructions for each test. Directions for cleaning and maintenance of equipment, QC, calibration, troubleshooting, and corrective actions should be covered as well. Records of linearity, accuracy, precision, and calibration studies may also be included. All procedures must be documented and reviewed periodically.

The manual must be available at all times to everyone performing the tests it describes. If possible, each area in which testing is done should have its own copy. Storing quality control and maintenance logs nearby keeps all information in one convenient central location.

* Result reporting. Every test performed must be traceable through a permanent record or audit trail that includes the patient's name; patient identification number, if used by the institution; date, time, and result of the test; and the identity of the person who performed it. In some institutions, this process is accomplished through the normal billing procedure. Institutions that do not bill for each test need to set up an alternative method.

The laboratory can help organize files by standardizing the format used for reporting ancillary test results. The format should be easy to read and understand by everyone who may need access to those results. If all personnel performing ancillary testing have access to a computer system, they can generate a permanent record in that way. Many systems also have computer interface capabilities to automate record keeping.

In our institution, the need for documentation generates more staff complaints than any other procedural aspect of point-of-care testing. Streamlining and standardizing documentation relieves the strain somewhat. Certain point-of-care instruments provide printouts of quality control runs, calibration values, and patient information, thus lightening lightening /light·en·ing/ (lit´en-ing) the sensation of decreased abdominal distention produced by the descent of the uterus into the pelvic cavity, two to three weeks before labor begins.  the burden of manual recording.

* Safety. A chemical hygiene plan and universal precautions universal precautions,
n.pl 1. approaches to infection control designed to prevent transmission of bloodborne diseases, such as AIDS and hepatitis B in health care settings.
 must be followed according to Occupational Safety and Health Administration Occupational Safety and Health Administration (OSHA), U.S. agency established (1970) in the Dept. of Labor (see Labor, United States Department of) to develop and enforce regulations for the safety and health of workers in businesses that are engaged in interstate  (OSHA OSHA
n.
Occupational Safety and Health Administration, a branch of the US Department of Labor responsible for establishing and enforcing safety and health standards in the workplace.
) regulations. OSHA recommends that gloves be worn by any laboratorian performing a fingerstick or heelstick. Reagents must be clearly labeled and material safety data sheets (MSDS MSDS Material Safety Data Sheets, see there ) available and readily accessible. Although some OSHA requirements may seem cumbersome, they have been devised for one important reason: to reduce hazards to both patient and employee.

* Future view. Increasingly sophisticated technologies and methods of delivering patient care will call forth regulatory response in an attempt to assure the quality of health care. Cooperation will be forced to increase between disciplines within an institution. Even now, nursing, medicine, and the laboratory no longer function as separate entities.

Point-of-care testing has integrated departments into a health care team with enhanced appreciation of each other's abilities and concerns. Although responding to changing regulations can be difficult, it provides the most direct and effective means of reassuring the public that our commitment to medical care comes first.

1. American Diabetes Association. Bedside blood glucose monitoring in hospitals: Position statement. Diabetes Care 9: 89, 1986.

2. Baer, D.M., and Belsey, R.H. Managing quality and risk of bedside testing. Perspect. Healthcare Manage. 10(1): 3-7, winter 1990.

General references:

Bedside diagnostic testing Diagnostic testing
Testing performed to determine if someone is affected with a particular disease.

Mentioned in: Von Willebrand Disease
. Chest 97(5): 183S-214S May 1990.

Belsey, R.H., and Baer, D.M. The technologist's role in quality management of off-site testing; Part I: MLO MLO Mycoplasma-like organism(s)  19(9): 28-32, September 1987. Part II: 19(10): 45-53, October 1987. Part III: 19(11): 41-54, November 1987. Part IV: 19(12): 53-59, December 1987.

Belsey, R.H., and Baer, D.M. Protocols for bedside testing; Part I: MLO 20(2): 37-39, February 1988. Part II: 20(3): 63-72, March 1988. Part III: 20(4): 45-52, April 1988.

Decentralized laboratory testing standards: HAP HAP. An old word which signifies to catch; as, "to hap the rent," to hap the deed poll." Techn. Dict. h.t.  scoring guidelines. Joint Commission Perspect. 10(1): A15-A17, January/February, 1990.

"Guidelines for Ancillary Blood Glucose blood glucose Diabetology The principal sugar produced by the body from food–especially carbohydrates, but also from proteins and fats; glucose is the body's major source of energy, is transported to cells via the circulation and used by cells in the presence  Testing in Multi-Patient Settings." Milpitas, Calif., Lifescan, Inc., 1989.

Halper, H.R., and Foster, H.S. "Laboratory Regulation Manual," vol. 1, pp. 137-170. Washington, D.C., O'Connor and Hannan, 1988.

"Inspection Checklist for Ancillary Testing." Northfield, Ill., College of American Pathologists, 1989-1990.

Leroux, M.L., and Desjardins, P.R.E. Establishment and maintenance of a hospital glucose meter A glucose meter (or glucometer) is a medical device for determining the approximate concentration of glucose in the blood. It is a key element of home blood glucose monitoring (HBGM) by people with diabetes mellitus or with proneness to hypoglycemia.  program. Lab. Med. 20(2): 97-99, February 1989.

National Committee for Clinical Laboratory Standards. Ancillary (bedside) blood glucose testing in acute and chronic care facilities. Proposed guideline C30-P. Villanova, Pa., NCCLS NCCLS National Committee for Clinical Laboratory Standards , 1989.

Standards for decentralized testing in hospitals. Joint Commission Perspect. 9(2): 7-8 March April 1989.

Figure I

Assignment of responsibilities for point-of-care testing at Lovelace Medical Center

Central laboratory

Evaluates instrumentation and implements all testing procedures

With managers and educators, plans the training and certification of all personnel performing testing outside the central laboratory

With nurse education, coordinates all written procedures, designs documentation forms

Sees that each point-of-care testing area has appropriate procedures and forms

Provides proficiency testing (quarterly)

Reviews and evaluates all QC, instrument maintenance, and PT (monthly)

Issues reports to area managers on the performance of QC and PT (monthly)

Monitors compliance with all Federal, state, and local governmental regulations and voluntary standards

Area managers

Enroll all certified personnel in QC, instrument maintenance, and PT programs

Assure proper test result recording

Review area performance reports (monthly)

Take appropriate action when poor performance is noted

Operators

Perform and document QC activities (daily) Perform and document instrument maintenance (as required) Participate in PT programs Document test results according to house policy

A review of current regulations

The 1965 Medicare Act stipulates standards for certification of laboratories receiving reimbursement from the Federal government. This set of rules is administered by the Department of Health and Human Services Noun 1. Department of Health and Human Services - the United States federal department that administers all federal programs dealing with health and welfare; created in 1979
Health and Human Services, HHS
 (HHS) through its agency, the Health Care Financing Administration Health Care Financing Administration,
n.pr department in the U.S. agency of Health and Human Services responsible for the oversight of the Medicaid and Medicare benefit programs, including guidelines, payment, and coverage policies.
 (HCFA). Also enforced by HHS is the Clinical Laboratories Improvement Act of 1967, which governs laboratories that transport more than 100 specimens per year across state lines.

In 1988, HCFA attempted to reconcile the discrepancies between the Medicare Act and CLIA '67 with a comprehensive update. The revised CLIA '67 rules, mandatory for all laboratories formerly covered under both the Medicare Act and the original CLIA '67, were published in the Federal Register on March 14, 1990. All but the proficiency testing guidelines were supposed to be implemented on Sept. 10, 1990. Delays in publishing the interpretive guidelines caused enforcement to be postponed until April 4, 1991. The proficiency testing guidelines, which were to take effect Jan. 1, 1991, were not actually implemented until May 15, 1991.

Driven by public concern over erroneous laboratory results, Congress passed the Clinical Laboratory Improvement Amendments Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research.  of 1988. CLIA '88 was intended to standardize the quality of laboratory testing performed in all locations. Originally scheduled for implementation by January 1990, CLIA '88 remains mired mire  
n.
1. An area of wet, soggy, muddy ground; a bog.

2. Deep slimy soil or mud.

3. A disadvantageous or difficult condition or situation: the mire of poverty.

v.
 in questions of definition and interpretation. HCFA received more than 59,000 responses--a record--during the comment period.

HHS and HCFA are now reconsidering aspects of new testing technologies, redefining test categories, and reestablishing personnel requirements for each level of testing. Their efforts will delay the final regulations from being implemented until next year and possibly not until 1994.

History and immediate future of CLIA '88

Authors of five separate bills joined forces to sponsor the Clinical Laboratory Improvement Amendments of 1988.

* Oct. 31, 1988: Signed into law.

* May 21, 1990: Proposed standards rule published.

* Aug. 3, 1990: Proposed certifications and fee schedule rule published.

* Aug. 20, 1990: Proposed accreditation rule published.

* April 2, 1991: Proposed sanctions rule published.

To come:

* One more rule section, on responsibilities of state agencies, is yet to be published.

* HCFA must review comments for all five sections and rewrite rule For the use of "rewrite rules" in web servers, see .

A rewrite rule (phrase-structure rule or production) in generative grammar is a rule of the form A → X where A is a syntactic category label, such as noun phrase or sentence, and X is a sequence of
. The Office of Management and Budget The Office of Management and Budget (OMB), formerly the Bureau of the Budget, is an agency of the federal government that evaluates, formulates, and coordinates management procedures and program objectives within and among departments and agencies of the Executive Branch.  has required HCFA to write a Regulatory Impact Analysis In many countries, a Regulatory Impact Analysis or Regulatory Impact Assessment (RIA) is a document created before voting a new regulation. Its role is to perform a detailed evaluation of the potential impacts of this new regulation and establish whether it would have the .

* Once approved, the final rule will be published. Its effective date will be three to six months after publication.

* CLIA '88 will not take effect until at least 1992. If the final rule is determined to be substantially different from what was originally proposed, the revised rule may have to be re-proposed in the Federal Register, allowing another opportunity for public comment.

Diane Krienitz is ancillary testing coordinator and Dr. James Little is a pathologist at Lovelace Medical Center, Albuquerque, N.M.
COPYRIGHT 1991 Nelson Publishing
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1991 Gale, Cengage Learning. All rights reserved.

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Title Annotation:MLO Special Issue: Point-of-Care Testing
Author:Krienitz, Diane
Publication:Medical Laboratory Observer
Date:Sep 1, 1991
Words:2830
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