S T A T E O F N E W Y O R K
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10781
I N A S S E M B L Y
May 18, 2018
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Introduced by M. of A. GOTTFRIED -- read once and referred to the
Committee on Health
AN ACT to amend the public health law, in relation to clinical laborato-
ry supervision
THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:
Section 1. The public health law is amended by adding a new section
576-d to read as follows:
§ 576-D. CLINICAL LABORATORY SUPERVISION. 1. (A) EACH CLINICAL LABORA-
TORY SHALL HAVE ONE OR MORE SUPERVISORS WHO SHALL, UNDER THE GENERAL
DIRECTION OF THE DIRECTOR, SUPERVISE THE TECHNICAL PERSONNEL AND REPORT-
ING OF FINDINGS, PERFORM TESTS REQUIRING SPECIAL SCIENTIFIC SKILLS, AND,
IN THE ABSENCE OF THE DIRECTOR, BE RESPONSIBLE FOR THE PROPER PERFORM-
ANCE OF ALL LABORATORY PROCEDURES.
(B) A DIRECTOR WHO QUALIFIES AS PROVIDED IN REGULATIONS PROMULGATED
PURSUANT TO SECTION FIVE HUNDRED SEVENTY-THREE OF THIS TITLE SHALL ALSO
BE DEEMED QUALIFIED AS A SUPERVISOR.
(C) DEPENDING UPON THE SIZE AND FUNCTIONS OF THE CLINICAL LABORATORY,
THE DEPARTMENT MAY AUTHORIZE THE DIRECTOR TO ALSO SERVE AS THE SUPERVI-
SOR OF SUCH LABORATORY.
(D) THE SUPERVISOR SHALL BE ON THE CLINICAL LABORATORY PREMISES OR
AVAILABLE BY PHONE OR SYNCHRONOUS TWO-WAY ELECTRONIC AUDIO VISUAL COMMU-
NICATIONS WITHIN THIRTY MINUTES DURING ALL HOURS IN WHICH TESTS ARE
PERFORMED; PROVIDED, THAT IF THE SUPERVISOR IS NOT ON THE LABORATORY
PREMISES AND THE PERSON PERFORMING THE TEST QUALIFIES AS A MEDICAL TECH-
NOLOGIST AS PROVIDED IN REGULATIONS PROMULGATED PURSUANT TO SECTIONS
FIVE HUNDRED SEVENTY-FOUR AND FIVE HUNDRED SEVENTY-SIX OF THIS TITLE,
AND THIRTY-ONE HUNDRED TWENTY-ONE OF THIS CHAPTER, THE RESULTS OF HIS OR
HER WORK ARE REVIEWED BY THE SUPERVISOR OR DIRECTOR DURING HIS OR HER
NEXT DUTY PERIOD, AND A RECORD IS MAINTAINED TO REFLECT THE ACTUAL
REVIEW.
(E) AN INDIVIDUAL WHO QUALIFIES AS A SUPERVISOR AS PROVIDED IN REGU-
LATIONS PROMULGATED PURSUANT TO SECTIONS FIVE HUNDRED SEVENTY-FOUR AND
FIVE HUNDRED SEVENTY-SIX OF THIS TITLE, AND THIRTY-ONE HUNDRED TWENTY-
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD13946-02-8
A. 10781 2
ONE OF THIS CHAPTER SHALL SUPERVISE TECHNICAL PERSONNEL IN THE SPECIALTY
OF CYTOLOGY ONLY.
2. (A) FOR THE PURPOSES OF THIS SUBDIVISION, "CLINICAL LABORATORY
IMPROVEMENT AMENDMENTS" MEANS THE FEDERAL CLINICAL LABORATORY IMPROVE-
MENT AMENDMENT OF 1988, PUBLIC LAW 100-578, AS AMENDED AND ANY REGU-
LATIONS OR GUIDANCE ISSUED THEREUNDER.
(B) EVERY CLINICAL SUPERVISOR SHALL MEET ONE OF THE FOLLOWING REQUIRE-
MENTS:
(I) THE SUPERVISOR IS A PHYSICIAN LICENSED TO PRACTICE MEDICINE OR
OSTEOPATHY IN THE STATE, OR WHO HAS EARNED A DOCTORAL DEGREE IN A CHEMI-
CAL, PHYSICAL OR BIOLOGICAL SCIENCE FROM AN ACCREDITED INSTITUTION.
"ACCREDITED", AS USED IN THIS PARAGRAPH, REFERS TO ACCREDITATION BY A
NATIONALLY RECOGNIZED ACCREDITING AGENCY OR ASSOCIATION, AS DETERMINED
BY THE UNITED STATES COMMISSIONER OF EDUCATION. SUCH SUPERVISOR SHALL,
SUBSEQUENT TO GRADUATION, HAVE HAD AT LEAST THE REQUIRED NUMBER OF
YEARS' EXPERIENCE IN ONE OF THE LABORATORY SPECIALTIES IN A CLINICAL
LABORATORY OR BLOOD BANK HAVING A DIRECTOR AT THE DOCTORAL LEVEL, AS
PROVIDED FOR AND CONSISTENT WITH THE CLINICAL LABORATORY IMPROVEMENT
AMENDMENTS. THE CLINICAL LABORATORY OR BLOOD BANK SHALL BE PART OF A
HOSPITAL, HEALTH DEPARTMENT, UNIVERSITY, MEDICAL RESEARCH INSTITUTION,
OR OTHER INSTITUTION WHICH PROVIDES EQUIVALENT TRAINING;
(II) THE SUPERVISOR HOLDS A DEGREE OF MASTER OF ARTS OR MASTER OF
SCIENCE IN A CHEMICAL, PHYSICAL OR BIOLOGICAL SCIENCE FROM AN ACCREDITED
INSTITUTION AND, SUBSEQUENT TO GRADUATION, HAS HAD AT LEAST THE REQUIRED
NUMBER OF YEARS SPENT WORKING IN THE DESIGNATED LABORATORY SPECIALTY IN
A CLINICAL LABORATORY HAVING A DIRECTOR AT THE DOCTORAL LEVEL, AS
PROVIDED FOR AND CONSISTENT WITH THE CLINICAL LABORATORY IMPROVEMENT
AMENDMENTS. THE CLINICAL LABORATORY OR BLOOD BANK SHALL BE PART OF A
HOSPITAL, HEALTH DEPARTMENT, UNIVERSITY, MEDICAL RESEARCH INSTITUTION OR
OTHER INSTITUTION WHICH PROVIDES EQUIVALENT TRAINING;
(III) THE SUPERVISOR IS QUALIFIED AS A MEDICAL TECHNOLOGIST AS
PROVIDED IN REGULATIONS PROMULGATED PURSUANT TO SECTIONS FIVE HUNDRED
SEVENTY-FOUR AND FIVE HUNDRED SEVENTY-SIX OF THIS TITLE, AND THIRTY-ONE
HUNDRED TWENTY-ONE OF THIS CHAPTER AND HAS HAD AT LEAST THE REQUIRED
NUMBER OF YEARS OF PERTINENT CLINICAL LABORATORY EXPERIENCE, INCLUDING
TRAINING, SUBSEQUENT TO QUALIFYING, SPENT WORKING IN A CLINICAL LABORA-
TORY HAVING A DIRECTOR AT THE DOCTORAL LEVEL, AS PROVIDED FOR AND
CONSISTENT WITH THE CLINICAL LABORATORY IMPROVEMENT AMENDMENTS. THE
CLINICAL LABORATORY OR BLOOD BANK SHALL BE PART OF A HOSPITAL, UNIVERSI-
TY, HEALTH DEPARTMENT, MEDICAL RESEARCH INSTITUTION OR OTHER INSTITUTION
WHICH PROVIDES EQUIVALENT TRAINING; OR
(IV) THE SUPERVISOR IS QUALIFIED AS A CYTOTECHNOLOGIST AS PROVIDED IN
REGULATIONS PROMULGATED PURSUANT TO SECTIONS FIVE HUNDRED SEVENTY-FOUR
AND FIVE HUNDRED SEVENTY-SIX OF THIS TITLE, AND THIRTY-ONE HUNDRED TWEN-
TY-ONE OF THIS CHAPTER AND SUBSEQUENT TO QUALIFYING, HAS HAD AT LEAST
THE REQUIRED NUMBER OF YEARS OF PERTINENT CLINICAL LABORATORY EXPERI-
ENCE, INCLUDING TRAINING, IN CYTOTECHNOLOGY IN A LABORATORY HAVING A
DOCTORAL LEVEL DIRECTOR QUALIFIED IN CYTOPATHOLOGY, AS PROVIDED FOR AND
CONSISTENT WITH THE CLINICAL LABORATORY IMPROVEMENT AMENDMENTS. THE
CLINICAL LABORATORY SHALL BE PART OF A HOSPITAL, HEALTH DEPARTMENT,
UNIVERSITY, MEDICAL RESEARCH INSTITUTION, OR OTHER INSTITUTION WHICH
PROVIDES EQUIVALENT TRAINING.
(C) WITH RESPECT TO INDIVIDUALS FIRST QUALIFYING PRIOR TO APRIL FIRST,
NINETEEN HUNDRED SEVENTY-TWO, AN EXCEPTION TO THE REQUIREMENTS OF
SUBPARAGRAPH (I), (II) OR (III) OF PARAGRAPH (B) OF THIS SUBDIVISION MAY
BE MADE IF:
A. 10781 3
(I) THE SUPERVISOR WAS PERFORMING THE DUTIES OF A CLINICAL LABORATORY
SUPERVISOR AT ANY TIME BETWEEN JULY FIRST, NINETEEN HUNDRED SIXTY-ONE
AND SEPTEMBER FIRST, NINETEEN HUNDRED SEVENTY-ONE;
(II) THE SUPERVISOR HAS HAD AT LEAST FIFTEEN YEARS OF PERTINENT CLIN-
ICAL LABORATORY EXPERIENCE PRIOR TO SEPTEMBER FIRST, NINETEEN HUNDRED
SEVENTY-ONE; PROVIDED, THAT, A MINIMUM OF THIRTY SEMESTER HOURS OF CRED-
IT TOWARD A BACHELOR'S DEGREE IN A CHEMICAL, PHYSICAL OR BIOLOGICAL
SCIENCE, OR THIRTY SEMESTER HOURS IN AN APPROVED SCHOOL OF MEDICAL TECH-
NOLOGY SHALL REDUCE THE REQUIRED YEARS OF EXPERIENCE BY TWO YEARS, WITH
ANY ADDITIONAL HOURS FURTHER REDUCING THE REQUIRED YEARS OF EXPERIENCE
AT THE RATE OF FIFTEEN HOURS FOR ONE YEAR; AND
(III) HE OR SHE HAS PERFORMED THE DUTIES OF A SUPERVISOR FOR AT LEAST
TWO YEARS DURING THE QUALIFYING FIFTEEN YEARS IN:
(A) A CLINICAL LABORATORY HAVING A DIRECTOR AT THE DOCTORAL LEVEL OF A
HOSPITAL, UNIVERSITY, HEALTH DEPARTMENT OR MEDICAL RESEARCH INSTITUTION;
OR
(B) IN A LABORATORY APPROVED UNDER THE MEDICARE SUPPLEMENTARY MEDICAL
INSURANCE PROGRAM, PROVIDED ALSO, THAT WHERE QUALIFYING YEARS IN A CLIN-
ICAL LABORATORY DESCRIBED IN CLAUSE (A) OF THIS SUBPARAGRAPH ARE
OBTAINED AFTER JANUARY THIRTIETH, NINETEEN HUNDRED SIXTY-NINE, SUCH
LABORATORY MEETS APPLICABLE CONDITIONS UNDER THE MEDICARE HEALTH INSUR-
ANCE PROGRAM, OR UNDER THE REGULATIONS ISSUED PURSUANT TO THE FEDERAL
CLINICAL LABORATORIES IMPROVEMENT ACT OF 1967.
§ 2. This act shall take effect immediately.