Cal. Code Regs. tit. 17 § 1036.3

Current through Register 2024 Notice Reg. No. 24, June 14, 2024

Section 1036.3 - Waived Laboratory Supervisor

(a) A laboratory director of a clinical laboratory performing waived tests may delegate or reapportion his or her responsibilities, as allowed by Section 1209 of the Business and Professions Code, by utilizing a waived laboratory supervisor. Except for a waived laboratory supervisor of a laboratory performing blood glucose testing by a person certified as an Emergency Medical Technician II or Paramedic pursuant to Division 2.5 (commencing with section 1797) of the Health and Safety Code and pursuant to subsection (c) and (d), a waived laboratory supervisor shall:

(1) Be listed in Section 1206.5 of the Business and Professions Code; and

(2) Possess at least a baccalaureate degree from an accredited college or university; and

(3) Have at least one year of training or experience in clinical laboratory testing in those tests or examinations that he or she will be supervising; and

(4) Document competency in those tests he or she will be supervising to the laboratory director at least semiannually during the first year and annually, or whenever new instrumentation is added, thereafter.

(b) Except for a waived laboratory supervisor of a laboratory performing blood glucose testing by a person certified as an Emergency Medical Technician II or Paramedic pursuant to Division 2.5 (commencing with section 1797) of the Health and Safety Code, a waived laboratory supervisor shall be responsible for:

(1) Selecting, in consultation with the laboratory director, the test methodology appropriate for clinical use of test results; and

(2) Establishing a quality control program appropriate for the tests performed, which follows the test manufacturer's parameters for acceptable levels of analytical performance and ensures that these levels are maintained throughout the entire testing process from initial receipt of the specimen through sample analysis and test result reporting; and

(3) Resolving technical problems and ensuring remedial actions are taken and documented whenever test systems deviate from the manufacturer's established performance specifications; and

(4) Ensuring patient test results are not reported until all corrective actions have been taken and the test system is performing properly; and

(5) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for waived testing; and

(6) Evaluating and documenting that the staff maintain their competency to perform test procedures and report tests promptly, accurately and proficiently by:

(A) Directly observing routine test performance, including patient preparations (if applicable), specimen handling, processing and testing; and

(B) Monitoring the recording and reporting of test results; and

(C) Reviewing quality control records and preventive maintenance records; and

(D) Directly observing performance of instrument maintenance and function checks; and

(E) Assessing problem solving skills; and

(F) Evaluating and documenting the performance of individuals responsible for waived testing at least semiannually during the first year the individual tests patient specimens. Thereafter evaluations shall be performed at least annually unless test methodology or instrumentation changes (in which case and prior to reporting patient test results, the individual's performance shall be re-evaluated to include the use of the new test methodology or test instrumentation).

(c) A waived laboratory supervisor of a laboratory performing blood glucose testing by a person certified as an Emergency Medical Technician II or Paramedic pursuant to Division 2.5 (commencing with section 1797) of the Health and Safety Code shall:

(1) Hold a current, active license as an Emergency Medical Technician-Paramedic pursuant to Health and Safety Code Section 1797.194, as a registered nurse pursuant to Chapter 6 (commencing with Section 2700) or as a person under Chapter 3 (commencing with Section 1200) authorized to engage in clinical laboratory practice or to direct a clinical laboratory; and

(2) Have at least one year training or experience in blood glucose testing in the method or procedure that he or she will be supervising.

(d) The waived laboratory supervisor of a laboratory performing blood glucose testing as specified in subsection (c) shall be responsible for:

(1) Documenting that each individual performing blood glucose is competent to perform the test before he or she starts testing and whenever new methodologies or technologies are added; and

(2) Ensuring that manufacturer's instructions for test performance, equipment maintenance and quality control are followed; and

(3) Resolving technical problems and ensuring remedial actions are taken and documented whenever test systems deviate from the manufacturer's established performance specifications.

(e) A waived laboratory technical supervisor shall be accessible to the laboratory testing personnel to provide onsite, telephone or electronic consultation. The laboratory director of a laboratory performing blood glucose testing by a person certified as an Emergency Medical Technician II or Paramedic pursuant to Division 2.5 (commencing with section 1797) of the Health and Safety Code may designate a licensed physician and surgeon or an authorized registered nurse at the hospital serving as the base hospital to provide such consultation.

Cal. Code Regs. Tit. 17, § 1036.3

1. New section filed 2-24-2000 as an emergency; operative 2-24-2000 (Register 2000, No. 8). A Certificate of Compliance must be transmitted to OAL by 6-23-2000 or emergency language will be repealed by operation of law on the following day.
2. New section refiled 6-21-2000 as an emergency; operative 6-24-2000 (Register 2000, No. 25). A Certificate of Compliance must be transmitted to OAL by 10-23-2000 or emergency language will be repealed by operation of law on the following day.
3. New section refiled 10-19-2000 as an emergency; operative 10-24-2000 (Register 2000, No. 42). A Certificate of Compliance must be transmitted to OAL by 2-21-2001 or emergency language will be repealed by operation of law on the following day.
4. Certificate of Compliance as to 10-19-2000 order, including amendment of section heading and section, transmitted to OAL 2-21-2001 and filed 4-3-2001 (Register 2001, No. 14).

Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1207, 1208, 1209, 1209.1 and 1210, Business and Professions Code.