Compliance with the Clinical Laboratory Improvement Amendments of 1988 for Hemoglobin Screening -- California, 1995

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) * established standards for improving the quality of clinical laboratory testing in the United States (1). One intent of CLIA was the regulation of smaller, provider-based laboratories, such as those operated by health-care providers in the Child Health and Disability Prevention (CHDP) program. ** In 1995, in conjunction with an assessment of county-specific variations in prevalence rates of anemia, the California Department of Health Services conducted a mail survey of CHDP providers to assess compliance with CLIA regulations for hemoglobin screening. This report summarizes the results of that survey, which indicate that, in California, many CHDP providers do not comply with CLIA-mandated quality-assurance practices for hemoglobin screening in their clinical laboratories.

Questionnaires were mailed to each of the 418 CHDP providers that submitted hemoglobin data for greater than or equal to 100 children aged 6-59 months to the Pediatric Nutrition Surveillance System (PedNSS) during 1993. The questionnaires assessed the type of health-care practice, the method used for hemoglobin screening, and quality-assurance practices. Methods of hemoglobin screening were classified as waived or nonwaived based on CLIA standards. A waived test is one that is a "simple laboratory procedure which...has an insignificant risk of erroneous result." Clinical laboratories conducting only waived tests are exempt from routine federal inspections but must follow the manufacturers' recommendations for quality assurance (e.g., for specimen collection and handling, quality-control procedures, and frequency of calibration) and must obtain a certificate of waiver from the Health Care Financing Administration. A nonwaived test is moderately or highly complex and, therefore, requires a higher level of knowledge, training, and judgment to be performed properly. Clinical laboratories performing nonwaived tests are required to comply with a series of quality standards (including participation in a proficiency testing program) and to obtain a CLIA certificate of registration or accreditation.

Of the 418 CHDP providers surveyed, 344 (78%) returned a completed questionnaire; of these, 16 providers were excluded from analysis because nine used a contracted commercial laboratory to perform their hemoglobin measurements, and seven used hematocrit rather than hemoglobin assessment. Of the 328 providers, 239 (73%) reported performing hemoglobin determinations with a hemoglobinometer method classified as waived under CLIA (i.e., HemoCueTM) ***, and 89 (27%) reported nonwaived methods (Table_1). Of the providers using a nonwaived method, 59 used a color comparator (e.g., BMS HemoglobinometerTM or American Optical Hb-MeterTM); 23, an automated hematology analyzer (e.g., a Coulter counter); and seven, other instruments.

Of the 239 providers that used a waived hemoglobinometer, 147 (61.5%) reported performing quality-control checks on the instrument at least once daily as recommended by the manufacturer (Table_1). Although not required under CLIA, 75 (31.4%) of these providers reported participation in a proficiency testing program for hemoglobin. Of the 89 providers that used nonwaived methods, 37 (41.6%) reported performing quality-control checks on the instrument at least once daily, and 37 (41.6%) reported participating in a required proficiency testing program (Table_1). Rates of quality-control checks and proficiency testing were lowest for providers that used color comparators (15.3% and 20.3%, respectively).

Rates of compliance with CLIA regulations varied by type of health-care practice and hemoglobin screening method. For providers using waived methods, the overall rate of compliance with quality-control regulations was 61.5% (range: 50.0% for hospital-based practices to 79.1% for "other.") (Table_2). For providers using nonwaived methods, the overall rate of compliance with CLIA regulations for quality control was 41.6% (range: 35.2% for private practices to 83.3% for hospital-based practices). The overall rate of compliance with proficiency testing was 41.6% (range: 33.8% for private practices to 100.0% for hospital-based practices).

Reported by: MA Gregory, MD, C Bouchard, MS, Children's Medical Svcs Br, A Brydon, MA, Laboratory Field Svcs, K Acree, MD, Chronic Disease Epidemiologist, California State Dept of Health Svcs. Div of Laboratory Systems, Public Health Practice Program Office; Div of Nutrition and Physical Activity, National Center for Chronic Disease Prevention and Health Promotion, CDC.

Editorial Note

Editorial Note: The Clinical Laboratory Improvement Act was enacted in 1967 and mandated efforts to assure the quality of clinical laboratory testing; in 1988, this federal legislation was amended to include additional criteria for regulation and accreditation and to expand its regulatory authority to include all 154,721 clinical laboratories in the United States. Quality assurance ensures accuracy and precision of test measures within a laboratory and comparability across facilities. Elements essential for quality assurance include adherence to manufacturers' directions; maintenance of appropriate temperatures; performance of daily quality-control checks; and, when applicable, participation in a proficiency testing program (2). Quality control includes the measurement of materials of a known value to ensure test accuracy; proficiency testing requires participating laboratories to test simulated patient specimens of unknown values and report results to the officiating program. For a hemoglobin screening method to be determined accurate through proficiency testing, 80% of the tested specimens must be within 7% of the target value. ****

The findings in this report indicate that, in California, many CHDP providers do not comply with CLIA-mandated quality-assurance practices for hemoglobin screening in their clinical laboratories. Neither the effect of inadequate quality assurance on the reliability of PedNSS screening hemoglobin data nor their usefulness in public health decision making have been determined. However, unreliable screening results can reduce the sensitivity of hemoglobin tests, resulting in the possible failure to diagnose and treat anemia in children with low hemoglobin values.

Although incomplete compliance with CLIA regulations for hemoglobin screening may be related to lack of provider knowledge about CLIA regulations, determinants for noncompliance must be further assessed (CHDP providers, personal communications, March 12-April 6, 1995). In California, possible methods to improve provider compliance with CLIA regulations for hemoglobin screening include 1) distributing through professional organizations information highlighting CLIA regulations and the value of appropriate quality assurance in hemoglobin testing, 2) requiring providers to demonstrate adherence to quality laboratory methods for hemoglobin testing as a criterion for participation as a provider in a state or federally funded program, and 3) requiring ongoing in-service education for providers and their laboratory technicians about CLIA regulations for continuation as a provider in a state or federally funded program.

References

1. CDC. Regulations for implementing the Clinical Laboratory Improvement Amendments of 1988: a summary. MMWR 1992;41(no. RR-2).

2. CDC. Clinical laboratory performance on proficiency testing samples -- United States, 1994. MMWR 1996;45:193-6.

* Public Law 100-578 (42 USC section 201 note). 

** CHDP is a state-based Early, Periodic Screening, Diagnosis, and Treatment program for low-income families that provides preventive health-screening services for persons aged 0-21 years. 

*** Use of trade names and commercial sources is for identification only and does not imply endorsement by the Public Health Service or the U.S. Department of Health and Human Services. 

**** The average of all test values using similar methodology (i.e., peer group mean) for a given test or analyte.

TABLE 1. Number and percentage of Child Health and Disability Prevention
(CHDP) * providers performing daily quality-control checks and participating in
a proficiency testing program, by hemoglobin screening method + - California, 1995
====================================================================================
                                    Perform daily      Participate in a
                                   quality-control    proficiency testing
                                        checks              program
Hemoglobin screening     Sample    ---------------    -------------------
  method                  size       No.     (%)         No.        (%)
------------------------------------------------------------------------------------
Waived
 (Hemoglobinometer)        239       147    (61.5)       75       (31.4) &

Nonwaived                   89        37    (41.6)       37       (41.6)
 Color comparator           59         9    (15.3) @     12       (20.3)
 Automated hematology
  manalyzer                 23        22    (95.7)       22       (95.7)
 Other                       7         6    (85.7)        3       (42.9)
------------------------------------------------------------------------------------
* CHDP is a state-based Early, Periodic Screening, Diagnosis, and Treatment program
  for low-income families that provides preventive health-screening services for
  persons aged 0-21 years.
+ Based on the Clinical Laboratory Improvement Amendments of 1988 (CLIA), hemoglobin
  screening methods were classified as waived or nonwaived. A waived test is one
  that is a "simple laboratory procedure which...has an insignificant risk of
  erroneous result." A nonwaived test is moderately or highly complex and,
  therefore, requires a higher level of knowledge, training, and judgment
  to be performed properly.
& For health-care providers using waived methods for hemoglobin screening,
  proficiency testing is not required under CLIA.
@ Data were not available for one provider.
====================================================================================

TABLE 2. Percentage of Child Health and Disability Prevention (CHDP) * providers that
perform daily quality-control checks and participate in a proficiency testing program,
by type of health-care practice and hemoglobin screening method + - California, 1995
=========================================================================================
                                    Hemoglobin screening method
                  -----------------------------------------------------------------------
                             Waived                          Nonwaived
                  ------------------------------  ---------------------------------------
                                    Participates                     Participates
                          Performs      in a              Performs      in a
                          quality-  proficiency           quality-   proficiency
Type              Sample  control     testing     Sample  control      testing
  of practice      size    checks     program &    size    checks      program
-----------------------------------------------------------------------------------------
Private             133     51.9%      30.1%        71     35.2% @      33.8%
Hospital-based        6     50.0%      33.3%         6     83.3%       100.0%
HMO- or
 PPO-based **        18     77.8%      16.7%         0       -            -
County-based         39     69.2%      35.9%         7     42.9%        42.9%
Other                43     79.1%      37.2%         5     80.0%        80.0%

Total               239     61.5%      31.4%        89     41.6%        41.6%
-----------------------------------------------------------------------------------------
*  CHDP is a state-based Early, Periodic Screening, Diagnosis, and Treatment program for
   low-income families that provides preventive health-screening services for persons
   aged 0-21 years.
+  Based on the Clinical Laboratory Improvement Amendments of 1988 (CLIA), hemoglobin
   screening methods were classified as waived or nonwaived. A waived test is one that
   is a "simple laboratory procedure which...has an insignificant risk of erroneous
   result." A nonwaived test is moderately or highly complex and, therefore, requires a
   higher level of knowledge, training, and judgment to be performed properly.
&  For health-care providers using waived methods for hemoglobin screening, proficiency
   testing is not required under CLIA.
@  Data were not available for one provider.
** Health maintenance organization or preferred provider organization.
=========================================================================================

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