​​​​​​​​​​​Recommendations of the CLTAC Public Health Regulations Subcommittee 
Regarding Public Health Laboratory Regulations Presented to the CLTAC Committee ​

November 8, 2021 (edits made per CLTAC review 12/03/2021) 

​UPDATED January 23, 2024: edited to clarify Contributing Members​

Contributing Members include: 

CAPHLD: Zenda Berrada, Nicole Green, Katya Ledin, Megan Crumpler, Godfred Masinde, Rachel Rees, Donna Ferguson 

CLTAC: Christine Darmanian​​

Introduction and Background: 

• CCR Title 17, Chapter 2, Subchapter 1, Group 3. County and Municipal Laboratories. Sections 1075 – 1084
• CCR Title 17, Chapter 3, Subchapter 1. Article 1. Section 1255
• CCR Title 17, Chapter 3, Subchapter 1. Article 2. Section 1276
• CCR Title 17, Chapter 3, Subchapter 1. Article 3. Section 1302, 1302.1
• CCR Title 17, Division 1, Chapter 4, Subchapter 1, Article 3, Section 2612

The purpose is to update and modernize regulations and ensure consistency with other related clinical laboratory professions. We also hoped to identify additional regulatory needs based on changing laboratory practices. Guidance and recommendations are presented that impact public health laboratories.

The following definitions, updates, and recommendations have been agreed upon by the Subcommittee. The Subcommittee is asking the full CLTAC to approve the recommendations included:

1. Arrange and standardize regulations for public health microbiologists and public health laboratories similar to CCR Title 17, Chapter 2, Subchapter 1. Group 2. This section would standardize format to include content not limited to definitions, licensure of personnel, training, continuing education, and other applicable content. We understand that the clinical laboratory personnel regulations are also being updated and would like to request that the format be comparable.​
2. Define Public Health Microbiologist. “Public Health Microbiologist” means a person who has completed education, training and/or experience, and examination requirements pursuant to Section 1079, and who is authorized to perform clinical and public health laboratory tests and examinations specified in Section 1079 in an Approved Public Health Laboratory.
3. Define Public Health Laboratory Director. “Public Health Laboratory Director” means a person who has completed education, training and/or experience, and certification requirements specified in Sections 1080 and 1302 and is authorized to direct a High Complexity testing laboratory under CLIA CFR 42.493.1443.
4. Define Public Health Laboratory Technical Supervisor. “Public Health Laboratory Technical Supervisor” means a person who has completed education, training and/or experience, and certification requirements and is authorized to perform Technical Supervision in subspecialties for which qualifications are met under CLIA CFR 42.493.1449.
5. Define Public Health Laboratory General Supervisor. “Public Health Laboratory General Supervisor” means a person who has completed education, training and/or experience, and certification requirements and is authorized to perform General Supervision in subspecialties for which qualifications are met under CLIA CFR 42.493.1461.
6. Define Public Health Laboratory Technical Consultant. “Public Health Laboratory Technical Consultant” means a person who has completed education, training and/or experience, and certification requirements and is authorized to perform Technical Consultation over moderate complexity testing only in the specialties for which the qualifications are met under CLIA CFR 42.493.1411.
7. Define Public Health Clinical Consultant. “Public Health Clinical Consultant” means a person who has completed education, training and/or experience, and certification requirements and is authorized to perform Clinical Consultation in the specialties for which qualifications are met under CLIA CFR 42.493.1461.
8. Define “Accreditation” as it applies to acceptable institutions by which education and degrees are acquired by public health laboratory personnel (refer 17 CCR 1029).
   
9. Define criteria for Department qualifications to be a Public Health Microbiologist training laboratory (refer to 17 CCR 1080).
10. Define “direct and responsible” supervision and any other details related to PHM trainee work in a laboratory (refer to 17 CCR 1080). Define as stated in BPC 1206 (a)(10).
11. Define “Experience required for “all aspects of public health microbiology”(refer 17 CCR 1080). Suggested definition of Public Health Microbiology: Public Health Microbiology is an interdisciplinary field that includes clinical, environmental, animal and food microbiology with a focus on human health and infectious diseases.
12. Define scope of work for Dairy Technician and Certification requirements
13. Consider forming a CLTAC – PHL Subcommittee to explore new certification pathways (training, education, and certification requirements) for “Public Health Generalist” or other limited specialties relevant to public health laboratory testing.
14. Define “Approved Public Health Laboratory”.
15. Define the “laboratory of the State Department of Health” (Section 1075). Currently unclear whether the CDPH laboratories are regulated as Approved Public Health Laboratories under the same Health and Safety Codes and Title 17 regulations as County and Municipal laboratories, or if exempt and regulated only under CLIA.
16. Update designation of “State Department of Health” to “California Department of Public Health” throughout.
17. Revise the following regulations to include the updates or similar in CCR Title 17,Chapter 2, Subchapter 1, Group 3:​



​​​​​​​Section 1075. Local Health Departments.




Update: Each local health department shall have available the services of an approved public health laboratory. Local health jurisdictions having a population equal to or greater than 50,000 (reference Section 1276) shall be responsible for providing public health laboratory services through their own local government or by means of agreements or contracts with other jurisdictions. The California Department of Public Health may be designated the official laboratory to assist with provision of public health laboratory services for jurisdictions with populations less than 50,000.

​​


Justification: Specifies that local PHLs can serve as designated approved PHL for jurisdictions not covered by local lab service. Removes obligation for the State to serve as official laboratory where other local laboratories may be able to directly contract to provide public health laboratory services.​​​

​​


Section 1076, Certificates of Approval Required.

​​


​Update: A certificate of “Approved Public Health Laboratory” issued after inspection by the Department shall be required to be in the possession of and be on display in every approved public health laboratory and no such laboratory shall continue to operate following receipt ​of notice of cancellation of any existing certificate, or of refusal of the Department to issue a certificate. Laboratory registration is required to be updated annually. Approved Public Health Laboratories shall be exempt from renewal fees. An updated certificate shall be requested by the public health laboratory for any changes in laboratory name or address. CDPH shall provide updated certificates on request.

​​


Justification: Update regulation with the specific title of certificate (“Approved Public Health Laboratory”) and detail the requirements for CDPH to provide updated Certificate of Approval when needed for labs to comply.

​​


Adds requirement for public health laboratories to update facility information with the Department every year in order to ensure that accurate and up-to-date information is available to assess availability of testing services and capacity during public health emergencies in California.

​​


The Subcommittee recommends exemption from renewal fees due to the nature of the laboratory as a public service. Fees add to the fiscal demands placed on the operations of the public health laboratories.

​​


Section 1076.1, Public Health Laboratory

Update to incorporate the following changes:

1. Remove “Branch Public Health Laboratory”: Subcommittee agrees that this is no longer applicable.
2. Change “official” public health laboratory to “Approved” public health laboratory.
3. Define Approved Public Health Laboratory.
​​

Suggest the following: “The Approved Public Health Laboratory is a laboratory facility that provides major or total laboratory services to a public health department and meets the minimum requirements set forth under Section 1078”.

​​


Justification: This regulation describes a “principal” and “branch” public health laboratory structure. “Branch” laboratory has been determined to be obsolete. A public health jurisdiction which wishes to have more than one laboratory must still register for the separate facility under CLIA and CDPH; therefore, keeping Branch Laboratory in the regulations is confusing as there is no separate registration pathway or advantage to retaining the “Branch” laboratory designation as an option.​


​​

​Section 1077. Reports Required​​




Update: The following reports shall be transmitted to the Department by all laboratories approved under Section 1076. CDPH shall provide report forms in a format that collects the required information.

​


​[Remove 1077 (a), workload reporting requirement from current language, and renumber remaining items specified in the Section]




​​​a) The laboratory shall report within 30 days:​​​

[Define when 30-day ADVANCE notice needs to be given versus 30 days after changes].​​​




1. ​​Of any change in the directorship of the laboratory.
2. Of any proposed expansion, reduction or shift in the laboratory services.
3. ​Of any change in the location of the laboratory.

​

​​​(b) [Add] Immediately notify the Department if the laboratory is unable to continue operations due to unforeseen emergent circumstances to identify contingency strategies. Disruption of public health testing services due to lack of testing staff may warrant requests for temporary waivers of testing personnel PHM certification for individuals that meet CLIA qualifications for testing personnel.

​ ​​​(c) ​ [Add]​ The local health jurisdiction shall notify the Department at least one year prior to planning permanent closure of a local public health laboratory. The Department will consult in the evaluation process with the local health jurisdiction and provide alternatives to maintain operations or proceed with laboratory closure.

1. In the event of a local public health laboratory permanent closure, the local health jurisdiction shall provide a written plan to the Department on how the population will continue to have provision of equivalent public health laboratory testing services.


​​[Request: The Department would supply a form that includes th​e requested information for the written plan referenced in 1077 (c)1]



(d) ​​​Additional reports shall be made available as requested by the Department.


​​​​​Justification: The Subcommittee recommends removing 1077(a) as it is no longer requested by the Department or supplied by public health laboratories. This information may be requested during annual renewal of registration. The request for 1077 (a) 2 is to add specifics to #2, including specifics on when to notify LFS 30 days in advance of planned changes, and when it’s acceptable to notify 30 days after changes, for clarity.




​The Subcommittee recommends adding information regarding notification of planned closure of a public health laboratory by a local health jurisdiction (LHJ) and add a requirement for the LHJ to submit a plan detailing how lab services will be provided. This request will ensure that the Department is notified of the impending changes to the status of public health laboratory testing services and the jurisdiction’s plan to provide continuity of services for outbreaks or public health emergencies.




To ensure that staffing will not lead to temporary closure or significant disruption in public health laboratory test​ing, the Subcommittee is recommending requiring notification to CDPH of temporary closures due to emergent circumstances and the option to request a waiver of personnel certification for individuals who meet the CLIA qualifications for testing personnel, if the closure is due to personnel shortages.

​


Section 1078. Minimum Requirements Specified.​​




Updates:​

REMOVE: (a) (b) (d) (e) as written, replace with applicable CLIA and, if applicable, ELAP regulations. Applicable CLIA regulations are found under CFR Title 42: Public Health; Part 493 and for ELAP, primarily CCR Title 22. A cross-walk document is attached for CLIA and ELAP regulations but may not be inclusive of all existing and applicable regulations and codes.​




REMOVE: (i) and replace with "Meet requirements of Cal-OSHA for safety and health protection of all persons in the laboratory" (refer to H&SC for Clinical Labs)




​Justification: Most of these minimum requirements are stated in regulations specific to a lab’s certification. If these are not more specific ​than other regulatory requirements (federal or State), then it is not necessary to re-state in this regulation.




​Secti​on 1079. Professional Personnel to be certified




​​​​Update to recommendations including recent LFS recommendations:




a)​ No person may act as a Public Health Microbiologist or Clinical Laboratory Scientist approved to perform testing in any public health laboratory certified under Section 1076 who is not in possession of a Public Health Microbiologist’s Certificate or Clinical Laboratory Scientist license issued by the Department, except under Public Health Orders declared by the State or Local Health Officer as specified under Section XXXX (new Section proposed).




b) [REMOVE: Temporary certificates are no longer issued by the Department; therefore, this subsection is no longer applicable].




​​c) Examinations, either written or oral, or both, for the certificate of Public Health Microbiologist shall be held as needed and where designated by the Department. Such examinations shall be under the supervision of the Department or delegated by the Department to an approved testing and certification provider.




d) The minimum requirements for admission to the examinations for a certificate as Public Health Microbiologists shall be as follows:




1. ​​ ​​​Holds an earned doctoral degree from a college or university accredited by the Western Association of Schools and Colleges or an essentially equivalent accrediting agency, as determined by the Department; with a chemical, physical, or biological science as a major, and has completed at least one year of post-doctoral laboratory experience in clinical or public health microbiology approved by the Department; or
   
2. ​​​​A baccalaureate or higher degree with a major in Microbiology, or equivalent major as determined by the Department, with courses acceptable to the Department, from a college or university accredited by the Western Association of Schools and Colleges or an essentially equivalent accrediting agency, as determined by the Department; and experience represented by at least six months as a Public Health Microbiologist-trainee in a public health laboratory approved by the Department for such training; or equivalent training, experience and/or certification approved by the Department. Experience or training must have been completed within the last 10 years.




​​​​​​SPECIFY: Experience equivalent to training and acceptable criteria for a laboratory “as determined by the Department”.




​​​ADD: CEU language to Professionals to be certified See 17 CCR Section 1032.5 for CLS. PHM requirement for continuing education is supported. Use similar language to CLS regulations. Require 24 contact hours in 2 years, renewal every 2 years. If 1038.1 updated, make it the same as requirements for CLS.

​Renewal and inactive status. If inactive after 4 years you would need to provide CE. If 5 years, you need to take exam again.

​​​​​​e) ​​​​​​​The minimum requirements for providing supervision or consultation in the public health laboratory:

1. ​​​​​​​​Every public health laboratory director, under whom moderate or high complexity tests or examinations are performed, shall either perform the duties of a clinical consultant or employ a clinical consultant who can provide consultation about the appropriateness of testing ordered and interpretation of test results, as specified in Section 101160, chapter 2 of the Health and Safety Code.
1. ​​​​​​​​ The clinical consultant shall possess a current, valid Public Health Microbiologist Certificate or Public Health Laboratory Director Certificate issued by the State to direct a public health laboratory pursuant to chapter 2, Health and Safety Code, or current, valid license to practice medicine, osteopathy or podiatry pursuant to chapter 5 of the Business and Professions Code, appropriate to the specialties and subspecialties for which he or she is consulting.
2. The clinical consultant shall:
1. Provide clinical consultation to the clients of the laboratory; and
2. ​Assist in ordering tests appropriate to meet clinical expectations; and
3. Ensure that test results include pertinent information required for interpretation; and
4. ​Communicate matters about quality of test results reported and interpretation in relation to specific patient conditions.
2. Every public health laboratory director, under whom high complexity tests or examinations are performed, shall either perform the duties of a technical supervisor or employ a technical supervisor who is responsible for the technical and scientific oversight of the laboratory.
1. A technical supervisor of a public health laboratory performing high complexity testing shall:
1. ​​​​​​​​​​Possess an active, valid, Public Health Microbiologist certificate or Public Health Laboratory Director certificate issued by the State to perform high complexity testing pursuant to chapter 2 of the Health and Safety Code or to practice medicine, osteopathy or podiatry, pursuant to chapter 5 of Business and Professions Code appropriate to the specialty or specialties for which they are consulting; and
   
2. ​Meet the experience requirements in Section 493.1449 of Title 42 of the Code of Federal Regulations, as published October 1, 1994.​
   
3. ​While not required to be on site at all times testing is performed, a technical supervisor shall be available to laboratory testing personnel at all times to provide either on-site, telephone or electronic consultation.
   
4. A technical supervisor shall be responsible for all the activities listed in Section 493.1451 of Title 42 of the Code of Federal Regulations, as published October 1, 1994.
   
3. ​​​​​​​ Every public health laboratory director, under whom high complexity tests or examinations are performed, shall either perform the duties of ageneral supervisor or employ a general supervisor who shall be responsible for day-to-day supervision of laboratory operation and personnel performing and reporting high complexity tests.
1. ​​​​​A general supervisor shall:
1. ​​ Possess an active, valid Public Health Microbiologist Certificate or Public Health Laboratory Director certificate issued by the State to perform high complexity testing pursuant to chapter 2 of Health and Safety Code or to practice medicine, osteopathy or podiatry pursuant to chapter 5 of Business and Professions Code appropriate to the specialty or specialties they are supervising; and
   
2. Have a minimum of two years' experience in high complexity testing in the specialty or specialties they are supervising.
   
3. The general supervisor shall be accessible to testing personnel at all times high complexity testing is performed by providing on-site supervision; except as specified under 42 CFR § 493.1463 paragraph (c).
   
4. The general supervisor shall be responsible for ensuring that tests and examinations are performed in compliance with chapter 3 of the Business and Professions Code and Title 42, Code of Federal Regulations, Part 493 standards as published October 1, 1994, regarding clinical laboratories.
   
4. ​​​​​​​ ​Every public health laboratory director, under whom only moderate complexity tests or examinations are performed, shall either perform the duties of a moderate complexity laboratory technical consultant or employ a moderate complexity laboratory technical consultant who is responsible for providing technical and scientific consultation for each of the specialties and subspecialties performed. If moderate complexity testing is performed in a laboratory that is registered for high complexity testing, supervision will be under a Technical Supervisor.​
   
1. ​​​​​​A moderate complexity laboratory technical consultant of a laboratory performing moderate complexity testing shall:
1. Possess an active, valid Public Health Microbiologist Certificate or Public Health Laboratory Director certificate issued by the State pursuant to chapter 2 of the Health and Safety Code to perform high complexity testing, or to practice medicine, osteopathy or podiatry pursuant to chapter 5 of Business and Professions Code appropriate to the specialty or specialties for which he or she is consulting; and
2. ​​​Have a minimum of two years' experience in moderate or high complexity testing in the specialty or specialties for which he or she is consulting.
3. ​​​​​​A moderate complexity laboratory technical consultant shall be responsible for the technical and scientific oversight of the laboratory as specified in Section 493.1413, Title 42, Code of Federal Regulations, as published October 1, 1994.​
   

Justification:

Require continuing education for maintenance of a Public Health Microbiologist certificate. This is a standard for other similar scientific professions in California (CLS, EH Specialists) – adding this requirement ensures that PHMs are up to date with current laboratory practice and regulations; adds professionalism and a mechanism for LFS to track active PHMs. Refer to comparable continuing education requirements for CLS CCR 1038.1; BPC 1275

​Specify training and/or experience that is deemed acceptable by the Department to clarify.

​Currently there are no criteria specified for Technical Supervisor, General Supervisor, Clinical Consultant, and Technical Consultant of a public health laboratory. This should be added to clarify State requirements; otherwise defaults to CLIA requirements.

For training laboratories, it will be important to define acceptability criteria to be an approved PHM training laboratory by the Department.




Section 1080. Professional Training.




REMOVE: 1080(c)- requirement to notify the Department within 5 days of appointment or separation of PHM trainee as this is no longer performed.


​Renumber and Update the rest of the Section as follows:

​​(e) A Public Health Microbiologist-trainee shall not be entrusted with any microbiological examination except under the “direct and responsible” supervision of qualified personnel, nor shall he/she issue or sign a laboratory report for any clinical test until he/she is certified as a Public Health Microbiologist, unless he/she has documentation of previous licensing and/or satisfactory training meeting the regulations for that field of testing.

1. Public Health Microbiologist Trainee requirements​
   The department shall certify as trainees those individuals desiring to train for public health microbiologist certification, providing those individuals meet the following academic requirements:

​​​a) ​​​Hold a baccalaureate degree or higher in microbiology or an equivalent major, provided the coursework includes at least 25 semester or equivalent quarter units in biological science related courses, including at least 5 semester or equivalent quarter units in microbiology or bacteriology. Degree must be obtained from a college or university accredited by the Western Association of Schools and Colleges or an essentially equivalent accrediting agency, as determined by the Department.




​​​​​​(Examples of biology related courses include, but are not limited to bacteriology, parasitology, immunology, virology, molecular biology, cellular biology, mycology, genetics, food microbiology, epidemiology, biochemistry, and biostatistics).




2. ​​​​Public Health Microbiologist Certification requirements.
   The minimum requirements for the public health microbiologist certification shall be as follows: ​
   

a) Hold a baccalaureate degree or higher in microbiology or an equivalent major, provided the coursework includes at least 25 semester or equivalent quarter units in biological science related courses, including at least 5 semester or equivalent quarter units in microbiology or bacteriology. Degree must be obtained from a college or university accredited by the Western Association of Schools and Colleges or an essentially equivalent accrediting agency, as determined by the Department.




​(Examples of biology related courses include, but are not limited to bacteriology, parasitology, immunology, virology, cellular biology, mycology, genetics, food microbiology, epidemiology, biochemistry, and biostatistics.), AND




​b) Training or Experience –​


1. ​​​A total of at least 6 months (34 weeks or equivalent) as a public health microbiologist-trainee in state or local public health laboratory approved by the department for public health microbiologist training. The training experience shall include but not limited to, bacteriology, mycobacteriology, mycology, virology (including rabies testing), parasitology, food, water, molecular biology, serology (including syphilis serology) and public health orientation; or ​
2. ​Full credit for training and/or experience can be granted to applicants that possess either a clinical laboratory scientist (generalist) or limited clinical microbiologist scientist license issued by the State of California with at least 6 months of training and experience equivalent to that required of a PHM trainee. Applicants approved by the Department meeting these qualifications may be waived from the PHM certification exam. Training and experience must be verified by a CLIA laboratory director(s) from where the training and experience was obtained; or,
3. ​Credit of up to 13 weeks for training and/or experience can be granted to applicants that meet one of the following conditions:
1. Possess training and/or work experience obtained outside of California. The training and/or work experience obtained in a CLIA approved clinical laboratory and/or public health laboratory outside of California may include but not limited to, bacteriology, mycobacteriology, mycology, virology (including rabies testing), parasitology, food, water, molecular biology, serology (including syphilis serology).
2. Possess training and/or work experience obtained from a laboratory owned and operated by the United States government performing tests classified as high complexity under CLIA. The training and/or work experience may include but not limited to bacteriology, mycobacteriology, mycology, virology (including rabies testing), parasitology, food, water, molecular biology, serology (including syphilis serology) and public health orientation.
3. Possess training and experience as a military laboratory specialist that include one year of basic and advanced training as a clinical laboratory technician or medical laboratory technician from any branch of the armed forces of the United States. The training and/or work experience may include all the subspecialties as listed in (c1) above. Possess training and/or work experience obtained from a laboratory certified by ISO (International Organization for Standardization) 15189 and ISO/IEC (International Organization for Standardization/International Electrotechnical Commission) 17025 standards or later standards by an international accrediting organization that meets ISO/IEC 17011 standards or later standards for certifying technical facilities including clinical laboratories in all the subspecialties as listed in (c1) above; AND


4. Certifying Examination is required for any PHM applicant unless approved as described under (2b)b). Applicants must apply for a certificate on forms ​provided by the Department, and:
   1. Achieve satisfactory performance on an examination on California public health laboratory law pursuant to section 1079 of the California Code of Regulations and Professions Code; and,
   2. ​Achieve satisfactory performance on a Department approved Public Health Microbiologist certifying examination,​

3. The minimum requirements for the for Public Health Laboratory Director certification shall be as follows:




a) ​​​The department shall issue a public health laboratory director certificate to qualified applicants who have applied for the certificate on forms provided by the department and meet the following requirements:




(1) ​Hold an earned doctoral degree in a microbiology or field related to microbiology from an accredited university from a college or university accredited by the Western Association of Schools and Colleges or an essentially equivalent accrediting agency, as determined by the Department, with 25 semester or equivalent quarter hours of graduate course credit in microbiology posted on an official transcript from the university registrar;  and



1. ​Have at least 1 year (52 weeks) of public health laboratory training and/or experience, in all aspects of public health microbiology, including: bacteriology, mycobacteriology, mycology, virology (including rabies testing), parasitology, molecular biology, immunology (including syphilis serology) in a public health laboratory that possesses a certificate issued under CLIA for performing high complexity testing in the specialty of microbiology ; or


2. Have at least 1 year (52 weeks) of training and/or experience performing clinical laboratory tests or examinations in the subspecialties of bacteriology, mycobacteriology, mycology, parasitology, virology, molecular biology, and serology for diagnosis of infectious diseases in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing in the specialty of microbiology; or


3. Have at least 1 year (52 weeks) of training and/or experience performing laboratory testing in a laboratory certified by ISO (International Organization for Standardization) 15189 and ISO/IEC (International Organization for Standardization/International Electrotechnical Commission) 17025 standards or later standards by an international accrediting organization that meets ISO/IEC17011 standards or later standards for certifying technical facilities including clinical laboratories in the subspecialties as listed in (b)(I).m and


4. Have at least 3 years (52 weeks per year) of laboratory experience, in all aspects of public health microbiology; at least two of the required years must have been completed while supervising the performance of public health laboratory tests or examinations in a public health laboratory that possesses a certificate issued under CLIA for performing high complexity testing in the specialty of microbiology; or


5. Have at least 3 years (52 weeks per year) of laboratory experience, two of the required years must have been completed while supervising the performance of clinical laboratory tests or examinations in the subspecialties as listed in (b)(I) a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing in the specialty of microbiology; or


6. Have at least 3 years (52 weeks per year) of laboratory experience, two of the required years must have been completed while supervising the performance of laboratory testing in a laboratory certified by ISO (International Organization for Standardization) 15189 and ISO/IEC (International Organization for Standardization/International Electrotechnical Commission) 17025 standards or later standards by an international accrediting organization that meets ISO/IEC17011 standards or later standards for certifying technical facilities including clinical laboratories in the subspecialties as listed in (b)(I); and


7. Have written evidence of satisfactory performance on one of the below certifying examinations approved by the United States Health and Human Services Agency (HHS): ABB (High Complexity Laboratory Director - General Knowledge and Microbiology or Public Health Microbiology), ABMM (Medical Microbiology);



or




(2) Be California certified public health microbiologist and “On or before February 28, 1992, be qualified under State law to direct a laboratory in the State in which the laboratory is located” – 42 CFR § 493.1443; or

(3) Be a physician and surgeon licensed by the State to practice medicine pursuant to Chapter 5 of the Business and Professions Code, and have:​

1. Have at least 1 year (52 weeks) of public health laboratory training and/or experience, in all aspects of public health microbiology, including: bacteriology, mycobacteriology, mycology, virology (including rabies testing), parasitology, molecular biology, immunology (including syphilis serology) in a public health laboratory that possesses a certificate issued under CLIA for performing high complexity testing in the specialty of microbiology; or


2. Have at least 1 year (52 weeks) of training and/or experience performing clinical laboratory tests or examinations the in the subspecialties as listed in (b)(I). in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing in the specialty of microbiology; or


3. Have at least 1 year (52 weeks) of training and/or experience performing laboratory testing in a laboratory certified by ISO (International Organization for Standardization) 15189 and ISO/IEC (International Organization for Standardization/International Electrotechnical Commission) 17025 standards or later standards by an international accrediting organization that meets ISO/IEC17011 standards or later standards for certifying technical facilities including clinical laboratories in the subspecialties as listed in (b)(I); and


4. Have at least 3 years (52 weeks per year) of laboratory experience, in all aspects of public health microbiology; at least two of the required years must have been completed while supervising the performance of public health laboratory tests or examinations in a public health laboratory that possesses a certificate issued under CLIA for performing high complexity testing high in the specialty of microbiology; or


5. Have at least 3 years (52 weeks per year) of laboratory experience, of which two of the required years must have been supervising the performance of clinical laboratory tests or examinations in the subspecialties as listed in (b)(I) in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing the specialty of microbiology; or


6. Have at least 3 years (52 weeks per year) of laboratory experience, of which two of the required years must have been supervising the performance of laboratory testing in a laboratory certified by ISO (International Organization for Standardization) 15189 and ISO/IEC (International Organization for Standardization/International Electrotechnical Commission) 17025 standards or later standards by an international accrediting organization that meets ISO/IEC 17011 standards or later standards for certifying technical facilities including clinical laboratories in the subspecialties as listed in (b)(I); and


7. Except for a pathologist who meets the laboratory director qualifications in Section 493.1443(b)(1) of Title 42, Code of Federal Regulations, as published October 1, 1994, have written evidence of satisfactory performance on one of the below certifying examinations approved by the United States Health and Human Services Agency (HHS): ABB (High Complexity Laboratory Director - General Knowledge; and Microbiology or Public Health Microbiology) ABMM (Medical Microbiology).



​Justification: The current regulations describing professional training and qualification criteria are outdated and non-specific. The Subcommittee agrees that the Department should make clear the type of education, coursework, and training/experience that is required for public health laboratory personnel. In addition, due to the restrictions on who can perform testing and/or direction of a public health laboratory which may threaten operations under routine and emergency situations, the Subcommittee agrees that updates to the regulations are necessary to remove unnecessary barriers to meeting PHM certification and or directorship under State requirements.​




​This includes consideration of public health operations under emergency situations and outbreaks declared by the local health jurisdiction. The Subcommittee recommendations expand a PHLs ability to use other licensed personnel or unlicensed who meet CLIA requirements (with approval and under emergency circumstances) and have had training and competency assessed per laboratory policy and the federal regulatory requirements for which specific clinical and/or environmental testing is covered. The recommendations also include updating applicable experience and training requirements for Public Health Laboratory Directors (PHLD), expanding the type of acceptable laboratory experience removing the PHM certification requirement but adding a PHLD certification which serves as an assessment of education training and experience by the Department. The Subcommittee agrees that to qualify as a PHLD, an applicant must be board certified and have met acceptable minimum criteria in order to obtain that certification; these criteria would supersede PHM certification.​​​​​




Section 1081, Certain Cultures and Specimens to be Sent to the State Laboratory




Update title from State Laboratory to “Approved Public Health Laboratories”




Update​:

(a) ​​​​​​​Whenever a laboratory receives a specimen or testing request for the laboratory diagnosis of the diseases listed in CCR Title 17 2505 List (e)(1), such laboratory shall communicate immediately by telephone with the designated Approved Public Health Laboratory and, if the agent is a Select Agent listed under the 7 CFR Part 331, 9 CFR Part 121, and 42 CFR Part 73, the designated reference laboratory for its Centers for Disease Control and Prevention (CDC) Laboratory Response Network-Biological (LRN-B) catchment area.

​

(b) Specimens and cultures shall be submitted as required by the communicable disease regulations, Sections 2500 to 2699, to a Public Health Laboratory approved for such work by the Department in accordance with Section 1076.




​​Justification: Details of which specimens and cultures need to be submitted to PHLs are already included in Title 17 Section 2505.​




​​Update language to specify notification of local PHL and LRN-B reference laboratory of any request for testing/rule out of a biothreat agent as specified by CDC Division of Select Agents and Toxins, and USDA in federal regulation.




​​​​Section 1082, Certain Specimens to be Sent to Approved Laboratories




​Update:
(a) ​Specimens obtained for laboratory diagnosis of animal rabies or specified in CCR Title 17 2505 to be submitted to a public health laboratory, shall be sent by the animal care or control program to a public health laboratory approved for such work by the Department in accordance with Section 1076




​Justification: Same as 1081.




Section 1083, Inspections to be made.


Remove: ….. “When deemed advisable, the Department may send check specimens to local laboratories to evaluate the accuracy and precision of specific test performance.”




​Justification: This is no longer practiced by the Department; PHLDs are required to participate in external or internal proficiency testing in accordance with 42CFR§493 Subpart H in order to maintain regulatory compliance.




Section 1084, Health Departments May Contract with Private Labs




​​Remove Regulation.




​​​​Justification: Applicability is unclear. Regulation is not needed for LHJ to contract with any lab for services. Any new lab (clinical or public health) needs to meet all State and Federal laboratory licensing and registration requirements to operate.​​



18. Revise the following regulations to include the following updates or similar in CCR Title 17, Chapter 3, Subchapter 1. Article 1. 



​​​​Section 1255, Public Health Laboratory:

Update:

The approved public health laboratory shall be under the direction of a public health laboratory director. Public health laboratories shall be supervised by personnel meeting the applicable regulatory requirements described under Section 1079 for the type of testing conducted.




The public health laboratory shall be registered and hold a Certificate of Approval with the Department as detailed under Section 1076. The public health laboratory shall meet the Minimum Requirements listed under Section 1078.

Justification: Remove delineation of Branch and Principle Public Health Laboratory as justified for Section 1076.1 This regulation clarifies the requirements for director and supervising personnel of a public health laboratories and references the Minimum Requirements Section 1078.​​



19. ​​​Revise the following regulations to include the following updates or similar in CCR Title 17, Chapter 3, Subchapter 1. Article 2.



Section 1276, Basic Services:

The health department shall offer at least the following basic services to the health jurisdiction which it serves…:

(f) Laboratory services provided by an approved public health laboratory. Such laboratories shall provide or assure:

(1) Services necessary for the various programs of the health department.

(2) Consultation and reference services to further the development of improved procedures and practices in laboratories employing such procedures related to the prevention and control of human disease.​


REMOVE: population limit of 50,000 or more (if not restricted by HSC).




ADD: (3) Services to detect pathogens or toxins as listed by Title 17 Section 2505 and route specimens to the Department as specified by the regulation.

(4) Capability for biological threats and emerging infectious disease testing orreferral to an approved local public health laboratory that can provide these services​.

ADD: (g) Health Departments serving a population of less than 50,000 shall assure public health laboratory testing services are available through means of agreements or contracts with other local jurisdictions or the CDPH laboratories.


Justification: Every jurisdiction should have access to public health laboratory services regardless of population, including biothreat and emerging pathogen detection services. The recommended updates address gaps in specifying required public health laboratory services for certain diseases, pathogens, and other biothreat. It also adds language related to responsibilities of local health jurisdictions with populations less than 50,000.​



20. ​ Propose new regulation Section XXXX:



​In the event of a declaration of a local, regional, state or national emergency, or disruption of public health testing services due lack of testing staff, the State or Local Health Officer has the authority to suspend the State certification requirements defined in California Code of Regulations, Title 17, Section 1079 as to all persons who meet the requirements under the Clinical Laboratory Improvement Amendments of Section 353 of the Public Health Service Act for high complexity testing in order to meet the testing needs related to the emergency declaration and who are performing analysis of samples in any approved public health laboratory for the duration of the Health Order.




Justification: This regulation is being proposed in order to ensure that public health services can be maintained during a local state or national emergency. The regulation would give Local or the State Health Officer the ability to issue a Health Order that would temporarily waive the State certification requirements for testing in a public health laboratory if such a personnel shortage would lead to disruption in services and/or diminished capacity to respond to public health threats.​



21. Revise the following regulations to include the following updates or similar in CCR Title 17, Chapter 3, Subchapter 1. Article 3:



Update to include the following:




Section 1302, Director of the Public Health Laboratory

The director of an Approved Public Health Laboratory shall meet CLIA requirements described in CLIA '88, subpart M for High Complexity Director Qualifications and have a current Public Health Laboratory Director certificate issued by the Department. The PHLD shall have had four or more years of experience in a public health or clinical laboratory within the last 10 years and have PHLD certification by the Department.

The director of the public health laboratory can direct Moderate Complexity and point of care testing under specialties other than microbiology performed in Approved Public Health Laboratories in their local jurisdictions.




Justification: Experience in either a public health laboratory or a clinical laboratory is comparable as listed under revised qualifications. Some local health jurisdictions may own public health clinics by which only moderate complexity testing is performed. In these cases, it is important that the public health laboratory director (PHLD) can direct moderate complexity testing in other subspecialties in public health laboratories owned / operated by the local health jurisdiction.

Remove “The quality, variety and currency of this experience shall be satisfactory to the Department”, as this will be assessed during PHLD certification process.​




Section 1302.1, Director of a Branch Public Health Laboratory.




Remove regulation: Branch PHL no longer a necessary / applicable category.




Justification: The Subcommittee is recommending the removal of Branch Public Health Laboratory from these regulations as described for Section 1076.1.​



22. Revise the following regulations to include the following updates or similar in CCR Title 17, Division 1, Chapter 4, Subchapter 1, Article 3, Section 2612 Salmonella Infections (Other Than Typhoid Fever).​



Remove: requirement to submit all non-Typhi Salmonella isolates to the CDPH ​Microbial Disease Laboratory; add qualifiers as suggested below:





Update: 

A culture of the organisms on which the diagnosis is established shall be submitted first to an approved local public health laboratory. If the local public health laboratory lacks the capability to perform necessary definitive identification and epidemiologic characterization (approved by the Department), the isolate should be submitted to either a local public health laboratory with that capacity, or the California Department of Public Health (CDPH) Microbial Diseases Laboratory. Salmonella cultures and/or related test data will be made available to the CDPH upon request. 

Justification: Recommend removing requirement to send all Salmonella isolates to the CDPH Microbial Diseases Laboratory (MDL). Many local public health laboratories have or will be acquiring the capacity to fully characterize Salmonella isolates in-house using the same technology as MDL. 

Submission to the CDPH MDL in these cases means duplicative work and wasting of human and fiscal resources. Isolates and/ or reports should continue to be made available by request. 

Require approval or agreement with State Lab Director to determine if the level of epidemiologic testing is adequate and to make sure that these data are uploaded / accessible to surveillance networks.​​​