New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-1 - Clinical Laboratories › Section 58-1.12 - Cytopathology standards and quality assurance

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Definitions.
(1) Examination means the initial review or
					 screening of cytopathology samples by a cytotechnologist to determine if the
					 sample is negative, abnormal or questionable and shall include the marking of
					 potentially abnormal cells and completion of laboratory records.
(2) Reexamination means the review of slides
					 which have been examined or screened as normal. The selection of these slides
					 must be made based on a protocol, available in the laboratory, which includes
					 patient history, qualifications of the examining cytotechnologist and source of
					 referral.
(3) Facilitating means
					 the preparation and review of nongynecological slides by a cytotechnologist for
					 diagnosis by a pathologist and shall include the marking of abnormal cells and
					 selection of representative slides.
(4) Quality control and quality assurance
					 means those procedures and protocols, including reexamination, in place in the
					 laboratory to assure consistency, reliability, documentation and accuracy of
					 results reported and shall include corrective actions taken in the event of
					 laboratory error.
(5)
					 Cytotechnologist means a clinical laboratory professional specializing in the
					 analysis of cytopathology samples, including Pap smears, for cervical cancer
					 and other related diseases, who meets the qualifications specified by the
					 department in section
					 58-1.5 
					 of this Subpart. For purposes of the work standard in subdivision (b) of this
					 section, this shall mean any person who is engaged in the examination of Pap
					 smears.
(6) Cytotechnologist work
					 standard means a limitation on the number of Pap smears (also known as
					 gynecologic slides) and nongynecologic slides which a cytotechnologist may
					 examine or facilitate during a particular time period, or other limitation on
					 the quantity, speed or manner of examination of slides by a
					 cytotechnologist.
(7) Employ means
					 to employ or contract with a cytotechnologist to examine cytological materials,
					 including gynecologic and nongynecologic slides.
(8) Part-time means working less than a seven
					 and one-half or an eight-hour day for a particular employer.
(9) Clinical laboratory means a clinical
					 laboratory licensed by the Department of Health of the City of New York or by
					 the New York State Department of Health.
(10) Work day means a 24-hour period during
					 which a cytotechnologist examines cytological materials for a clinical
					 laboratory.
(11) Work month means a
					 calendar month during which a cytotechnologist examines cytological materials,
					 including gynecologic slides, for a clinical laboratory.
(12) Nongynecological slide means a slide
					 containing material obtained from other than the cervical-vaginal area. For
					 each nongynecologic case for which up to three slides are submitted, each of
					 the slides shall count as one toward the work standard. For each nongynecologic
					 case where more than three slides are submitted, only the first three shall be
					 counted toward the work standard.
(13) Total hours worked means the time spent
					 during each work day at all employers examining slides and performing ancillary
					 duties as defined in paragraph (b)(3) of this section. For part-time
					 cytotechnologists, the denominator shall be based on a seven and one-half or an
					 eight hour day adjusted as described in paragraphs (b)(3)-(4) of this section
					 such as assisting in fine needle aspirations, staining and preparation of
					 slides, accessioning test requests, and reporting test results, but shall not
					 include quality control or quality assurance activities including reexamination
					 of slides determined to be negative by those qualified as cytology laboratory
					 supervisors or training. For part-time employees, the denominator shall be
					 based on an eight-hour day adjusted as above.