How accelerated regulation will affect point-of-care testing.
The underlying theme is improvement of patient care through more effective testing. Bedside blood glucose monitoring has earned the endorsement of the American Diabetes Association, 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 available through point-of-care testing. 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 (JCAHO) and the College of American Pathologists (CAP). In addition, HCFA audits 5% of the Joint Commission's inspections each year. Laboratories accredited 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 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 of CLIA. 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 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 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. 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 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 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 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; and continuing education 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 of reagents; and intervals at which the instruments should undergo preventive maintenance, 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 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 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. 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 the burden of manual recording.
* Safety. A chemical hygiene plan and universal precautions must be followed according to Occupational Safety and Health Administration (OSHA) 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) 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.
Bedside diagnostic testing. 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 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 scoring guidelines. Joint Commission Perspect. 10(1): A15-A17, January/February, 1990.
"Guidelines for Ancillary Blood Glucose 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 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, 1989.
Standards for decentralized testing in hospitals. Joint Commission Perspect. 9(2): 7-8 March April 1989.
Assignment of responsibilities for point-of-care testing at Lovelace Medical Center
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
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
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 (HHS) through its agency, the Health Care Financing Administration (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 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 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.
* 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. The Office of Management and Budget has required HCFA to write a Regulatory Impact Analysis.
* 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.
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|Title Annotation:||MLO Special Issue: Point-of-Care Testing|
|Publication:||Medical Laboratory Observer|
|Date:||Sep 1, 1991|
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