Subject: Clinical Laboratory Personnel Standards: Draft Proposed Regulations:

Transcription

1 Ronald Chapman, MD, MPH Director, California Department of Public Health and State Health Officer California Department of Public Health Post Office Box , MS-0507 Sacramento, CA Subject: Clinical Laboratory Personnel Standards: Draft Proposed Regulations: Dear Director Chapman: The following organizations are writing to provide comment on the California Department of Public Health s Clinical Laboratory Personnel Standards draft proposed rule: The California Society of Pathologists, California Association of Cytotechnologists, California Society for Histotechnology, American Society for Clinical Pathology, American Society of Cytopathology, American Society for Cytotechnology and National Society for Histotechnology. Together, we represent thousand of licensed and certified laboratory professionals working in California. Overall, we believe that this document is substantially better than the emergency proposed rule released by the Department in The Department is to be congratulated for, and we appreciate, its efforts to reduce unnecessary and inappropriate barriers to licensure for individuals trained outside of California and to address many of the problems present in the previous version of the rule. For example, allowing laboratory personnel to use practical experience as a means to satisfy the clinical /experience requirement is critically important. While this draft proposed rule represents a significant improvement over the 2010 rule, there are several issues that we believe need to be addressed: Requiring accredited training programs to provide one year or 52 weeks of training activities;

2 Page 2 Recognizing practical experience in lieu of completing an accredited or Department-approved clinical training program; Clarifying the workscope of cytotechnologists to include molecular cytologic examinations; Imposing a ratio requirement on the use of unlicensed laboratory personnel, such as histotechnologists and histotechnicians, Treating certified histotechnologists and histotechnicians as unlicensed laboratory personnel, thus preventing them from exercising their full scope of practice; and Requiring NAACLS accredited training programs to match the training requirements specified for each licensure category. We urge the Department to address these issues in full as it works toward releasing the draft document as a proposed rule later this year. Section and Multiple Sections: 52 week (one year) clinical training requirement. On behalf of the California Society of Pathologists, California Association of Cytotechnologists, California Society for Histotechnology, American Society for Clinical Pathology, American Society of Cytopathology, American Society for Cytotechnology and National Society for Histotechnology, we are very concerned about the requirement that training programs provide 52 weeks or one year of training. This requirement applies to numerous licensed categories, including clinical laboratory scientists ( ), cytotechnologists (1030.5), and other licensed laboratory professionals. In developing our comments on this particular issue, we consulted with the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS) to ascertain the typical duration of a clinical laboratory training program. NAACLS was unaware of any clinical training programs that could meet this requirement, as academic-based training programs often work on an academic year, not a calendar year. The idea of a 52 week training program as assurance of competency is also an unnecessary redundancy. California licensed laboratory professionals are required to pass an examination to assess their knowledge and skills in laboratory medicine and laboratory directors must regularly verify the competency of their testing professionals. Laboratory professionals must also undergo regular assessment through CLIA proficiency testing requirements. Laboratory accreditation, such as that provided by the College of American Pathologists and the Joint Commission, also examines the competencies and training of laboratory testing personnel. We believe that these checks render unnecessary the requirement that NAACLS training programs provide 12 months of training. We are also concerned about the negative impact this requirement could have on training programs, including those in California. Since 1975, the number of accredited clinical laboratory training programs has dropped more than 60 percent. Many of the academic institutions that have ceased to offer academic and clinical training have done so due to the high cost of maintaining these programs. Mandating a longer training calendar puts these training programs at higher risk for closure, which, in turn, could threaten access to prompt, quality testing.

3 Page 3 Lastly, from a technical perspective, it may not be possible or practical for a training program to provide a schedule of activities for 52 weeks. This language would not appear to allow of breaks in the training calendar for winter holiday or a spring break. Compliance would require a constantly changing program calendar, which could unnecessarily burden the provision of clinical training. We strongly urge the Department to drop the requirement that NAACLS training programs last a specific period of time. Section and Multiple Sections--Practical Experience in Lieu of Training We strongly support the draft proposed regulations provision that allow for practical experience in lieu of training [See Section (a)(2)(C) and other sections]. The practical experience pathway to meeting the training and experience requirement is the only viable option for individuals who did not complete an accredited or Department-approved training program and yet have documented their ability to handle the professional demands of working in a CLIA certified laboratory. Further, for most categorical or specialist scientist licensure categories (blood banking, chemistry, hematology, microbiology), practice experience/on-the-job training is generally the only viable training option. Given that these individuals will have to pass a state-approved competency examination and that the Business and Professions Code allows for the recognition of appropriate work experience/practice training in lieu of completing an accredited or Department-approved training program, we strongly support the proposed provisions allowing licensure applicants to utilize out-of-state experience as an alternative to satisfying completion of a NAACLS or Department-approved training program. While we support the one year practical experience requirement, we may be willing to support one additional year of training (for a total of 2 years) for licensure as a medical laboratory technician or clinical laboratory scientist as an alternative to eliminating the practical experience provisions. Such an increase, however, such not be applied to categorical technologists, such as clinical chemist scientists. Section Licensure and Workscope of Cytotechnologists. We have a number of concerns about the proposed provisions regarding cytotechnologist licensure and scope of practice. Specifically we are concerned about the absence of provisions outlining the ability of cytotechnologists to perform molecular testing, the requirement that cytotechnologist earn a baccalaureate degree in a natural science, and the workload requirements. Molecular Testing: We believe that that the performance of molecular testing, such as HPV and FISH, by cytotechnologists is entirely consistent with their statutory scope of practice, as outlined in Business and Professions Code Section 1270a, and therefore the regulations must be updated to specifically recognize their ability to perform these molecular procedures. The following outlines why these procedures need to be codified in the regulations. The BPC 1270(a) states that cytotechnologists may perform examinations of cytologic slides. The term, cytologic slides is defined in BPC 1220 as cellular material (emphasis added) submitted for preliminary cytologic examination. In other words, the term cytologic slides means cellular

4 Page 4 material. Reading of the cytotechnologist scope of practice as cytotechnologists may perform preliminary examinations of cellular material is further supported by BPC 1271(c), which recognizes that cytotechnologists have other duties [than examining slides], including but not limited to (emphasis added), the preparation and staining of cellular material. It is also supported by section 1200 BPC, which states: (e)very provision of this chapter shall be liberally construed Taken as a whole, the pertinent provisions of the BPC casts a dynamic scope of practice for cytotechnologists that authorizes them to perform molecular testing. As both HPV and FISH testing involve the examination of cellular material (DNA) to render a result, the regulations must be changed to reflect the cytotechnologist s authority to perform these procedures. It should be noted that cytotechnologists possess the comprehensive, broad-based educational background and technical skills necessary to perform molecular testing. These skills are assessed via a competency examination, as a portion of the ASCP cytotechnologist examination includes test items on molecular testing. Molecular testing is viewed nationally as part of the cytotechnologists recognized scope of practice, and was recently recognized in the state of Florida when the Florida Board of Clinical Laboratory Professionals specifically authorized cytotechnologists to do molecular testing. Consequently, we urge the Department to change the draft proposed regulations to clarify in the cytotechnologist s workscope that these laboratory professionals may perform molecular testing. Workload Requirements: On the issue of workload, we note that the draft regulations outline that cytotechnologists may examine no more than 80 gynecologic specimens a day. The draft provisions rightly state that this workload requirement shall be reduced when other duties are assigned. Per BPC 1271(b), we believe that the 80 slide maximum applies not just to gynecologic slides but to nongynecologic slides as well. For purposes of ensuring that cytotechnologists do not exceed California s workload limits, we believe that Section (b)(3)(A) of the draft proposed rule should state that the 80 slide maximum workload also applies to the examination of non-gynecologic slides. Education Requirements; The draft proposed educational requirements for cytotechnologists increases the current requirements to mandate that these laboratory professionals possess a baccalaureate degree in a biological, chemical or physical science. These standards are not in sync with the educational requirements outlined in the Clinical Laboratory Improvement Amendments of 1988 (CLIA). These standards are also more demanding than those required of CAAHEP, which accredits cytotechnologist training programs, and by the ASCP Board of Certification, which certifies these professionals. We urge the Department to revise the educational requirements. Doing so will increase the potential pool of qualified candidates from which laboratories in California may hire. We would prefer that the department maintain the current requirements specified in 17 California Code of Regulations 1060(e)(1) Has a baccalaureate degree from a college or university accredited by the Western Association of Schools and Colleges or its equivalent with 20 semester hours (30 quarter hours) of biological science, 8 semester hours (12 quarter hours) of chemistry and 3 semester hours (4 quarter hours) of mathematics

5 Page 5 Section 1031 Supervision and Workscope of Unlicensed Personnel In general, we support the draft provisions for unlicensed laboratory personnel; however, there are two issues we have with the draft regulations pertaining to this section: the draft workscope of unlicensed personnel, the newly proposed ratio of unlicensed personnel to authorized personnel and the impact of these provisions on histotechnologists and histotechnicians. Workscope: For the most part, the proposed workscope for unlicensed personnel appears consistent with that outlined in BPC Section However, our review of these draft proposed rules provisions for these laboratory practitioners seems more limiting than the provisions outlined in BPC For example, BPC 1269(b)(1) indicates that unlicensed personnel may perform: Biological specimen collection, including patient preparation, labeling, handling, preservation or fixation, processing or preparation, and transportation and storage of specimens. It does not appear that all of these activities are permitted under the draft proposed rule. We believe this oversight should be corrected in the proposed rule. Ratio: A significant concern relates to the newly proposed ratio of one licensed supervisor to four unlicensed laboratory personnel. The proposed ratio of supervisors to unlicensed personnel could have a substantial impact on the operations of many California clinical laboratories. We note that it is not uncommon for laboratories to have 50+ unlicensed laboratory practitioner engaged in their authorized workscope, and with only one or two supervisors. We do not believe that this has been a problem and see this proposal as an unjustified and inappropriate burden, especially given that unlicensed laboratory personnel may not exercise independent discretion, report test results, or perform any quantitative or immunohematology tests or procedures. Moreover, we are unable to find any direct conveyance of authority from the legislature in BPC 1269 or elsewhere that appears to provide direct authority to mandate a ratio of supervisors to unlicensed personnel. The only allowance for such a ratio concerns trainees, who are authorized to perform testing. Also see comments on application of ratio requirement to Histotechnologists and Histotechnicians below. Histotechnologists and Histotechnicians: Ratio and Workscope: Since histotechnologists and histotechnicians are considered unlicensed personnel, per BPC 1212(a), it appears that these laboratory professionals are subject to the 4:1 ratio requirement. This is especially problematic, as technically it means that a histology laboratory would need to be staffed either by more pathologists or by delegating the supervisory responsibilities to a licensed individual other than a trainee or phlebotomist. This requirement would prevent an ASCP certified histotechnologist (baccalaureate degree) probably the most appropriate alternative to a pathologist from supervising the histology laboratory. As a result, it appears plausible that a histology laboratory could ultimately be supervised by an individual with little if any training in histotechnology. From a patient care perspective this does not make any sense. We are also concerned about the scope of practice outlined for unlicensed laboratory personnel, as it would bar ASCP certified histotechnologists/histotechnicians from performing high complexity molecular testing, such as Florescent in Situ Hybridization, Immunohistochemistry, and special stains as well as performing methods that provide results influencing companion diagnostics, such as HER2/neu

6 Page 6 (Herceptin). These are all well recognized as part of their recognized scope of practice nationally. For a histotechnologist to earn ASCP certification, he or she would need to (1) possess an appropriate baccalaureate degree, (2) complete either an accredited histotechnology training program or one year of acceptable work experience in histopathology, and (3) pass the ASCP histotechnologist examination. For a histotechnician to earn ASCP certification, he or she would need to (1) possess an appropriate associate degree, (2) complete either an accredited histotechnology training program or one year of acceptable work experience in histopathology, and (3) pass the ASCP histotechnician examination. Taken as a whole, these limitations on histotechnologists and histotechnicians would cripple almost every histology lab in the state of California as well as effecting quality testing directly related to patient diagnosis and treatment. We urge the Department to craft within its regulations provisions allowing histotechnologists and histotechnicians the most robust workscope possible, including the ability of appropriately qualified histotechnologists to supervise histology operations when designated this responsibility by the laboratory director/pathologist and to perform high complexity testing. Moreover, since clinical laboratory scientists/specialists and medical laboratory technicians are not subject to the ratio requirement, neither should qualified histotechnologists and histotechnicians. Section Approved NAACLS Accredited Training Program. We urge the Department to delete the provisions in the definition of an Approved NAACLS Accredited Training Program that states that the training program has met the training requirements for clinical laboratory personnel licensure pursuant to Sections , , and We believe these provisions may suffer from both technical and policy flaws. First, we note that the training requirements for sections , , and are already applicable to the licensure of clinical laboratory specialists (1030.1), medical laboratory technicians (1030.2), and clinical laboratory scientists (1030.3), and, therefore, appear redundant. On a technical note, we presume that the reference to section is erroneous as these provisions deal with Clinical Genetic Molecular Biologist Scientists, not clinical laboratory scientists ( ). Moreover, current Section does not appear to reference NAACLS training programs for Clinical Genetic Molecular Biologist Scientists. Moreover, it is unclear how these provisions would affect the applicants who have graduated from a NAACLS training program as they allow for certain training routes that seem inconsistent with accreditation. The only part of the training requirements that seems pertinent to NAACLS programs are the provisions for completing a NAACLS training program [See proposed Section (a)(2)(A)]. It is unclear to us what the rest of this particular subsection has to do with NAACLS training programs and we are concerned about possible unintended consequences. As these provisions are redundant, please delete the references to Sections , , and We appreciate this opportunity to provide comment on the department s proposed revision of the clinical laboratory personnel standards. If we can be of further assistance, please do not hesitate to contact Robert J. Achermann, CSP s Executive Director, at (916) or Matthew Schulze, ASCP s Senior Manager for Federal and State Affairs, at (202)

7 Page 7 Sincerely, California Society of Pathologists California Association of Cytotechnologists California Society for Histotechnology American Society for Clinical Pathology American Society of Cytopathology American Society for Cytotechnology National Society for Histotechnology cc: Mary Wogec, CDPH, LFS Beatrice O Keefe, CDPH, LFS Tim Hamill, MD, UCSF Clinical Laboratories Lee H. Hilborne, MD, FASCP, MPH, DLM(ASCP) CM