Are transfusion services in California utilizing non-Clinical Laboratory Scientists (CLS) within their laboratories, and if so, in what capacities?

A medical technologist in California asks if any transfusion services in California are utilizing non-Clinical Laboratory Scientists (CLS) within their laboratories, and if so, in what capacities? She comments that California state law seems to preclude using non-CLS technicians in the blood bank, yet she is aware of facilities who utilize such personnel to do re-types of units, issue blood, performing QC, etc.

Relevant sections of California law include:

Business and Professions Code (BPC) 1212, unlicensed laboratory personnel ('aides') cannot perform tests.

1. As used in this chapter, "unlicensed laboratory personnel" means a laboratory aide, histocompatibility technician, cardiopulmonary technician, or other person performing the activities authorized by Section 1269.
2. Any person who is authorized under California law or regulation to perform a clinical laboratory test or examination, or to engage in clinical laboratory practice, shall not come within the definition of "unlicensed laboratory personnel" when performing the clinical laboratory test or examination or engaging in the clinical laboratory practice authorized.

BPC 1206(a)(8), unlicensed persons require direct and constant supervision during the entire time that they are assisting in analytic phase. "Direct and constant supervision" means personal observation and critical evaluation of the activity of unlicensed laboratory personnel by a physician and surgeon, or by a person licensed under this chapter other than a trainee, during the entire time that the unlicensed laboratory personnel are engaged in the duties specified in Section 1269.

BPC 1269. (a) Unlicensed laboratory personnel may perform any of the activities identified in subdivision (b), in a licensed clinical laboratory, under the direct and constant supervision of a physician and surgeon, or a person licensed under this chapter other than a trainee, upon meeting all of the following criteria:

1. Have earned a high school diploma, or its equivalent, as determined by HCFA under CLIA.
2. Have documentation of training appropriate to ensure that the individual has all of the following skills and abilities:
   1. The skills required for proper specimen collection, including patient preparation, labeling, handling, preservation or fixation, processing or preparation, and transportation and storage of specimens.
   2. The skills required for assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory.
   3. The skills required for performing preventive maintenance, and troubleshooting.
   4. A working knowledge of reagent stability and storage.
   5. The skills required for assisting in the performance of quality control procedures, and an understanding of the quality control policies of the laboratory.
   6. An awareness of the factors that influence test results.

(b) The activities that may be performed are:

1. Biological specimen collection, including patient preparation, labeling, handling, preservation or fixation, processing or preparation, and transportation and storage of specimens.
2. Assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory.
3. Assisting in preventive maintenance, and troubleshooting.
4. Preparation and storage of reagents and culture media.
5. Assisting in the performance of quality control procedures.

(c) Notwithstanding subdivision (a), unlicensed laboratory personnel, other than a trainee, may, under the supervision and control of a physician and surgeon or person licensed under this chapter, perform specimen labeling, handling, preservation or fixation, processing or preparation, transportation, and storing if he or she meets the requirements of subparagraph (A) of paragraph (2) of, and paragraph (1) of, subdivision (a).

(d) Unlicensed laboratory personnel shall not do any of the following:

1. Record test results, but he or she may transcribe results that have been previously recorded, either manually by a physician and surgeon or personnel licensed under this chapter, or automatically by a testing instrument.
2. Perform any test or part thereof that involves the quantitative measurement of the specimen or test reagent, or any mathematical calculation relative to determining the results or the validity of a test procedure.
3. Perform any phase of clinical laboratory tests or examinations in the specialty of immunohematology beyond initial collection and centrifugation.

(e) When any of the following manual methods are employed, the activities of unlicensed laboratory personnel shall be limited as follows:

1. In the case of qualitative and semi-quantitative "spot, tablet, or stick" tests, the personnel may add the test reagent to the specimen or vice versa, but the results must be read by a physician and surgeon or person licensed under this chapter.
2. In the case of microbiological tests the unlicensed laboratory personnel may make primary inoculations of test material onto appropriate culture media, stain slide preparations for microscopic examination, and subculture from liquid media.

(f) When any of the following mechanical or electronic instruments are employed, unlicensed laboratory personnel shall not perform any of the following activities:

1. Standardizing or calibrating the instrument or assessing its performance by monitoring results of appropriate standards and control.
2. Reading or recording test results, except that the personnel may transcribe results that have been previously recorded automatically by a testing instrument.
3. Quantitatively measuring any sample or reagents unless done automatically by the instrument in the course of its normal operation or by the use of previously calibrated and approved automatic syringes or other dispensers.

BPC 1269, unlicensed persons performing pre-analytic and post-analytic procedures require supervision and control of licensed persons. Furthermore, there are limitations on what activities an unlicensed person can do in a laboratory.

The following comments have been received.

ADDENDA Feb. 2, 2007

1. A Transfusion Services Supervisor at a hospital near the capital of California reports that they use a non-licensed lab assistant to perform label/clerical checks on samples, receiving blood products into inventory, ordering supplies and blood products from their supplier, and thawing fresh frozen plasma and cryoprecipitate. The lab assistant is not involved in any testing of any kind, but is a valued member of their team, in part because she frees up the licensed staff from having to answer the ever-ringing phone, and she provides excellent customer service to their clients. The Supervisor concludes saying that "Lab assistants definitely have a place in the transfusion service".

ADDENDA Feb. 3, 2007

2. The Editors believe that the proposed California legislation, Assembly Bill 185, introduced by Assembly Member Dymally on January 24, 2007 [HTML | PDF] may be germane to the present discussion.

ADDENDA Feb. 7, 2007

3. A California colleague asked if an unlicensed person can run a blood bank automated analyzer, provided the assay performed is classified as a moderate complexity test and the machine is set up to do all the interpretation. This question was referred to another California colleague who is extremely knowledgeable about California law.

According to Section 1269(d) of the California Business and Professions Code, the aforementioned activity would be prohibited if done by unlicensed personnel.

1269(d) Unlicensed laboratory personnel shall not do any of the following:

1. Record test results, but he or she may transcribe results that have been previously recorded, either manually by a physician and surgeon or personnel licensed under this chapter, or automatically by a testing instrument.
2. Perform any test or part thereof that involves the quantitative measurement of the specimen or test reagent, or any mathematical calculation relative to determining the results or the validity of a test procedure.
3. Perform any phase of clinical laboratory tests or examinations in the specialty of immunohematology beyond initial collection and centrifugation.

4. A colleague asks if unlicensed personnel can take daily temperatures? The inquiring colleague acknowledges that their institution uses an outside company who sends a certified technician to do quarterly alarm checks and calibration of temperature displays and recorders. The colleague also asks if lab assistants who are not certified by 'refrigerator school' perform refrigerator, freezer, platelet incubator alarm checks and temperature calibration of digital temperature displays and chart recorders?
   
   
5. In response to the question immediately above, an individual with extensive experience with California regulations and their enforcement reports that in his opinion, with documented training and competence, a lab assistant would be able to the following:
   • Take daily temperatures if digital readout or printed
   • Perform refrigerator, freezer, platelet incubator alarm checks

A lab assistant would not be able to:

• Perform temperature calibration of digital temperature displays and chart recorders

ADDENDA June 12, 2007

6. A California colleague reports that her transfusion service laboratory will soon begin to utilize a non-licensed 'assistant' to enter blood products into the information system. This 'assistant' will be fully trained and be competent before performing any tasks without assistance. Although the California colleague thinks it is acceptable and compliant to use a non-licensed person as described, she recently talked to a CLS from another California facility who informed her that she might be wrong. Consequently, she would like to have a clarification from regulatory agencies, one way or the other.

Here is what the unlicensed assistant will be expected to do:

1. answer the phone
2. indicate to the nursing staff if a patient has products available
3. activate a printed order for a blood product as needed
4. print reports
5. help audit armbands for accuracy and Transfusion Records for completeness
6. forward incomplete Transfusion Records to the QA coordinator
7. will utilize a correspondent printed report to release expired crossmatched units from the crossmatched status to available units
8. place frozen products to thaw
9. enter blood products into the information system

The unlicensed person will NOT do any testing, and will not select or issue any blood products for transfusion.

ADDENDA July 6, 2007

7. A Supervisor of a Transfusion Service in the greater Sacramento area reports that like some other transfusion services in their general vicinity (near Sacramento), her academic medical center uses lab assistants to perform invaluable functions that assist their over burdened technologists. She wonders if any Transfusion Services currently utilize lab assistants to irradiate blood components, to wash red cells, or to dispense crossmatched blood components? Also, does anyone think these tasks inappropriate for unlicensed staff to perform?

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