(1) Upon a finding
by the
Board that a licensee has violated any provision of the Tennessee
Medical Laboratory Act (T.C.A. §§
68-29-101,
et seq.) or the rules promulgated pursuant thereto, the
Board may impose any of
the following actions separately or in any combination which is deemed
appropriate to the offense:
(a) Letter of
Concern/Letter of Warning - This is a written action issued to the licensee for
minor or near infractions. It is informal and advisory in nature and does not
constitute a formal disciplinary action.
(b) Reprimand - This is a written action
issued to a licensee for one time and less severe violations. It is a formal
disciplinary action.
(c) Probation
- This is a formal disciplinary action which places a licensee on close
scrutiny for a fixed period of time. This action may be combined with
conditions which must be met before probation will be lifted and/or which
restrict the licensee's activities during the probationary period.
(d) Licensure Suspension - This is a formal
disciplinary action which suspends a licensee' s right to practice laboratory
medicine for a fixed period of time. It contemplates the reentry of the
licensee into practice under the license previously issued.
(e) Licensure Revocation - This is the most
severe form of disciplinary action which removes a licensee from the practice
of laboratory medicine and terminates the license previously issued. If
revoked, it relegates the violator to the status he or she possessed prior to
application for licensure. The violator must apply for a new licensure if s/he
seeks to practice again in laboratory medicine. However, the Board may in its
discretion allow the reinstatement of a revoked license upon conditions and
after a period of time it deems appropriate. No petition for reinstatement and
no new application for licensure from a person whose license was revoked shall
be considered prior to the expiration of at least one (1) year unless otherwise
stated in the Board's revocation order.
(f) Conditions - Any action deemed
appropriate by the Board to be required of a disciplined licensee during any
period of probation or suspension or as a prerequisite to the lifting of
probation or suspension or the reinstatement of a revoked license.
(g) Once ordered, probation, suspension,
revocation, assessment of a civil penalty, or any other condition of any type
of disciplinary action may not be lifted unless and until the licensee
petitions, pursuant to paragraph (2) of this rule, and appears before the Board
after the period of initial probation, suspension, revocation, or other
conditioning has run and all conditions placed on the probation, suspension,
revocation, have been met, and after any civil penalties assessed have been
paid.
(2) Order of
Compliance - This procedure is a necessary adjunct to previously issued
disciplinary orders and is
available only when a petitioner has completely
complied with the provisions of a previously issued disciplinary order,
including an unlicensed practice civil penalty order, and wishes or is required
to obtain an order reflecting that compliance.
(a) The
Board will entertain petitions for an
Order of Compliance as a supplement to a previously issued order upon strict
compliance with the procedures set forth in subparagraph (b) in only the
following three (3) circumstances:
1. When the
petitioner can prove compliance with all the terms of the previously issued
order and is seeking to have an order issued reflecting that compliance;
or
2. When the petitioner can prove
compliance with all the terms of the previously issued order and is seeking to
have an order issued lifting a previously ordered suspension or probation;
or
3. When the petitioner can prove
compliance with all the terms of the previously issued order and is seeking to
have an order issued reinstating a license previously revoked.
(b) Procedures
1. The petitioner shall submit a Petition for
Order of Compliance, as contained in subparagraph (c), to the
Board's
Administrative Office that shall contain all of the following:
(i) A copy of the previously issued order;
and
(ii) A statement of which
provision of subparagraph (a) the petitioner is relying upon as a basis for the
requested order; and
(iii) A copy
of all documents that prove compliance with all the terms or conditions of the
previously issued order. If proof of compliance requires testimony of an
individual(s), including that of the petitioner, the petitioner must submit
signed statements from every individual the petitioner intends to rely upon
attesting, under oath, to the compliance. The Board's consultant and
administrative staff, in their discretion, may require such signed statements
to be notarized. No documentation or testimony other than that submitted will
be considered in making an initial determination on, or a final order in
response to, the petition.
2. The
Board authorizes its consultant and
administrative staff to make an initial determination on the petition and take
one of the following actions:
(i) Certify
compliance and have the matter scheduled for presentation to the Board as an
uncontested matter; or
(ii) Deny
the petition, after consultation with legal staff, if compliance with all of
the provisions of the previous order is not proven and notify the petitioner of
what provisions remain to be fulfilled and/or what proof of compliance was
either not sufficient or not submitted.
3. If the petition is presented to the Board
the petitioner may not submit any additional documentation or testimony other
than that contained in the petition as originally submitted.
4. If the Board finds that the petitioner has
complied with all the terms of the previous order an Order of Compliance shall
be issued.
5. If the petition is
denied either initially by staff or after presentation to the
Board and the
petitioner believes compliance with the order has been sufficiently proven the
petitioner may, as authorized by law, file a petition for a declaratory order
pursuant to the provisions of T.C.A. §
4-5-223 and
Rule
1200-10-01-.11.
(c) Form Petition
Petition for Order of Compliance
Tennessee Medical Laboratory Board
Petitioner's Name:
_____________________________________
Petitioner's Mailing Address:
______________________________
_________________________________
_________________________________
Petitioner's E-Mail Address:
___________________________________
Telephone Number:
_________________________________________
Attorney for Petitioner:
____________________________________
Attorney's Mailing Address:
_________________________________
_________________________________
_________________________________
Attorney's E-Mail Address:
________________________________
Telephone Number: ___________________________________
The petitioner respectfully represents, as substantiated by
the attached documentation, that all provisions of the attached disciplinary
order have been complied with and I am respectfully requesting: (circle
one)
1. An order issued reflecting
that compliance; or
2. An order
issued reflecting that compliance and lifting a previously ordered suspension
or probation; or
3. An order issued
reflecting that compliance and reinstating a
license previously revoked.
Note - You must enclose all documents necessary to prove your
request including a copy of the original order. If any of the proof you are
relying upon to show compliance is the testimony of any individual, including
yourself, you must enclose signed statements from every individual you intend
to rely upon attesting, under oath, to the compliance. The Board's consultant
and administrative staff, in their discretion, may require such signed
statements to be notarized. No documentation or testimony other than that
submitted will be considered in making an initial determination on, or a final
order in response to, this petition.
Respectfully submitted this the day of, 20.
Petitioner's Signature
(3) Order Modifications - This
procedure is not intended to allow anyone under a previously issued
disciplinary order, including an unlicensed practice civil penalty order, to
modify any findings of fact, conclusions of
law, or the reasons for the
decision contained in the order. It is also not intended to allow a petition
for a lesser disciplinary action, or civil penalty other than the one(s)
previously ordered. All such provisions of
Board orders were subject to
reconsideration and appeal under the provisions of the Uniform Administrative
Procedures Act (T.C.A. §§
4-5-301,
et seq.). This procedure is not
available as a substitute for reconsideration
and/or appeal and is only
available after all reconsideration and appeal rights
have been either exhausted or not timely pursued. It is also not
available for
those who have accepted and been issued a reprimand.
(a) The Board will entertain petitions for
modification of the disciplinary portion of previously issued orders upon
strict compliance with the procedures set forth in subparagraph (b) only when
the petitioner can prove that compliance with any one or more of the conditions
or terms of the discipline previously ordered is impossible. For purposes of
this rule the term "impossible" does not mean that compliance is inconvenient
or impractical for personal, financial, scheduling or other reasons.
(b) Procedures
1. The petitioner shall submit a written and
signed Petition for Order Modification on the form contained in subparagraph
(c) to the
Board's Administrative Office that shall contain all of the
following:
(i) A copy of the previously issued
order; and
(ii) A statement of why
the petitioner believes it is impossible to comply with the order as issued;
and
(iii) A copy of all documents
that proves that compliance is impossible. If proof of impossibility of
compliance requires testimony of an individual(s), including that of the
petitioner, the petitioner must submit signed and notarized statements from
every individual the petitioner intends to rely upon attesting, under oath, to
the reasons why compliance is impossible. No documentation or testimony other
than that submitted will be considered in making an initial determination on,
or a final order in response to, the petition.
2. The
Board authorizes its consultant and
administrative staff to make an initial determination on the petition and take
one of the following actions:
(i) Certify
impossibility of compliance and forward the petition to the Office of General
Counsel for presentation to the Board as an uncontested matter; or
(ii) Deny the petition, after consultation
with legal staff, if impossibility of compliance with the provisions of the
previous order is not proven and notify the petitioner of what proof of
impossibility of compliance was either not sufficient or not
submitted.
3. If the
petition is presented to the Board the petitioner may not submit any additional
documentation or testimony other than that contained in the petition as
originally submitted.
4. If the
petition is granted a new order shall be issued reflecting the modifications
authorized by the Board that it deemed appropriate and necessary in relation to
the violations found in the previous order.
5. If the petition is denied either initially
by staff or after presentation to the Board and the petitioner believes
impossibility of compliance with the order has been sufficiently proven the
petitioner may, as authorized by law, file a petition for a declaratory order
pursuant to the provisions of T.C.A. §
4-5-223 and
Rule 1 20010-01-.11.
(c)
Form Petition
Petition for Order Modification
Tennessee Medical Laboratory Board
Petitioner's Name: ___________________________
Petitioner's Mailing Address: ___________________
_________________________________
_________________________________
Petitioner's E-Mail Address:
_____________________________
Telephone Number: ___________________________________
Attorney for Petitioner:
_________________________________
Attorney's Mailing Address:
_____________________________
_________________________________
_________________________________
Attorney's E-Mail Address: ______________________
Telephone Number: ____________________________
The petitioner respectfully represents that for the following
reasons, as substantiated by the attached documentation, the identified
provisions of the attached disciplinary order are impossible for me to comply
with:
_________________________________
_________________________________
_________________________________
_________________________________
Note - You must enclose all documents necessary to prove your
request including a copy of the original order. If any of the proof you are
relying upon to show impossibility is the testimony of any individual,
including yourself, you must enclose signed and notarized statements from every
individual you intend to rely upon attesting, under oath, to the reasons why
compliance is impossible. No documentation or testimony other than that
submitted will be considered in making an initial determination on, or a final
order in response to, this petition.
Respectfully submitted this the ____ day of ___________,
20.
_________________________________
Petitioner's Signature
(4) Civil Penalties.
(a) Purpose - The purpose of this rule is to
set out a schedule designating the minimum and maximum civil penalties which
may be assessed.
(b) Schedule of
Civil Penalties
1. The Type A Civil Penalty
may be imposed whenever the Board finds a person who is required to be licensed
by the Board guilty of a willful and knowing violation of the Medical
Laboratory Act, or regulations promulgated pursuant thereto, to such an extent
that there is or is likely to be, an imminent, substantial threat to the
health, safety and welfare of an individual patient or the public. For purposes
of this section, willfully and knowingly practicing in the medical laboratory
without a license from the Board when licensure is required, is one of the
violations of the Medical Laboratory Act for which a Type A Civil Penalty is
assessable.
2. A Type B Civil
Penalty may be imposed whenever the Board finds the person required to be
licensed by the Board guilty of a violation of the Medical Laboratory Act or
regulations promulgated pursuant thereto in such a manner as to impact directly
on the care of patients or the public.
3. A Type C Civil Penalty may be imposed
whenever the Board finds the person required to be licensed by the Board guilty
of a violation of the Medical Laboratory Act or regulations promulgated
pursuant thereto, which are neither directly detrimental to patients or the
public, nor directly impact their care, but have only an indirect relationship
to patient care or the public.
(c) Amount of Civil Penalties
1. Type A Civil Penalties shall be assessed
in the amount of not less than $500 nor more than $1,000.
2. Type B Civil Penalties may be assessed in
the amount of not less than $100 and not more than $500.
3. Type C Civil Penalties may be assessed in
the amount of not less than $50 and not more than $100.
(d) Procedures for Assessing Civil Penalties
1. The Division of Health Related Boards may
initiate a civil penalty assessment by filing a Memorandum of Assessment of
Civil Penalty. The Division shall state in the memorandum the facts and law
upon which it relies in alleging a violation, the proposed amount of the civil
penalty and the basis for such penalty. The Division may incorporate the
Memorandum of Assessment of Civil Penalty with a Notice of Charges which may be
issued attendant thereto.
2. Civil
Penalties may also be initiated and assessed by the Board during consideration
of any Notice of Charges. In addition, the Board may, upon good cause shown,
assess a type and amount of civil penalty which was not recommended by the
Division.
3. In assessing the civil
penalties pursuant to these rules the
Board may consider the following factors:
(i) Whether the amount imposed will be a
substantial economic deterrent to the violator;
(ii) The circumstances leading to the
violation;
(iii) The severity of
the violation and the risk of harm to the public;
(iv) The economic benefits gained by the
violator as a result of noncompliance; and
(v) The interest of the public.
4. All proceedings for the
assessment of civil penalties shall be governed by the contested case
provisions of Title 4, Chapter 5, Tennessee Code
Annotated.
(5) Assessment of costs in disciplinary
proceedings shall be as set forth in T.C.A. §§
63-1-144
and
68-29-136.
(6) Subpoenas
(a) Purpose - Although this rule applies to
persons and entities other than
medical laboratory personnel, it is the
Board's
intent as to medical laboratory personnel that they be free to practice their
profession without fear that such practice or its documentation will be unduly
subjected to scrutiny outside the profession. Consequently, balancing that
intent against the interest of the public and patients to be protected against
substandard care and activities requires that persons seeking to subpoena such
information and/or materials must comply with the substance and procedures of
these rules.
It is the intent of the Board that the subpoena power
outlined herein shall be strictly proscribed. Such power shall not be used by
the Division or Board investigators to seek other incriminating evidence
against medical laboratory personnel when the Division or Board does not have a
complaint or basis to pursue such an investigation. Thus, unless the Division
or its investigators have previously considered, discovered, or otherwise
received a complaint from either the public or a governmental entity, then no
subpoena as contemplated herein shall issue.
(b) Definitions - As used in this chapter of
rules the following words shall have the meanings ascribed to them:
1. Probable Cause
(i) For Investigative Subpoenas - shall mean
that probable cause, as defined by case law at the time of request for subpoena
issuance is made, exists that a violation of the Medical Laboratory Practice
Act or rules promulgated pursuant thereto has occurred or is occurring and that
it is more probable than not that the person(s), or items to be subpoenaed
possess or contain evidence which is more probable than not relevant to the
conduct constituting the violation.
(ii) The utilization of the probable cause
evidentiary burden in proceedings pursuant to this rule shall not in any way,
nor should it be construed in any way to establish a more restrictive burden of
proof than the existing preponderance of the evidence in any civil disciplinary
action which may involve the person(s) or items that are the subject of the
subpoena.
2. Presiding
Officer - For investigative subpoenas shall mean any elected officer of the
Board, or any duly appointed or elected chairperson of any panel of the
Board.
(c) Procedures
1. Investigative Subpoenas
(i) Investigative Subpoenas are available
only for issuance to the authorized representatives of the Tennessee Department
of Health, its investigators and its legal staff.
(ii) An
applicant for such a subpoena must
either orally or in writing notify the
Board's Unit Director of the intention
to seek issuance of a subpoena. That notification must include the following:
(I) The time frame in which issuance is
required so the matter can be timely scheduled; and
(II) A particular description of the material
or documents sought, which must relate directly to an ongoing investigation or
contested case, and shall, in the instance of documentary materials, be limited
to the records of the patient or patients whose complaint, complaints, or
records are being considered by the Division or
Board.
I. In no event shall such subpoena be broadly
drafted to provide investigative access to medical laboratory records of other
patients who are not referenced in a complaint received from an individual or
governmental entity, or who have not otherwise sought relief, review, or Board
consideration of any medical laboratory personnel's conduct, act, or omission;
and
II. If the subpoena relates to
the prescribing practices of a licensee, then it shall be directed solely to
the records of the patient(s) who received the pharmaceutical agents and whom
the Board of Pharmacy or issuing pharmacy(ies) has so identified as recipients;
and
(III) Whether the
proceedings for the issuance is to be conducted by physical appearance or
electronic means; and
(IV) The name
and address of the person for whom the subpoena is being sought, or who has
possession of the items being subpoenaed.
(iii) The
Board's Unit Director shall cause
the following to be done:
(I) In as timely a
manner as possible arrange for either an elected officer of the Board or any
duly appointed or elected chairperson of any panel of the Board to preside and
determine if issuing the subpoena should be recommended to the full Board;
and
(II) Establish a date, time and
place for the proceedings to be conducted and notify the Presiding Officer, the
applicant and the court reporter; and
(III) Maintain a complete
record of the
proceedings including an audio tape in such a manner as to:
I. Preserve a verbatim record of the
proceeding; and
II. Prevent the
person presiding over the proceedings and/or signing the subpoena from being
allowed to participate in any manner in any resulting disciplinary action of
any kind, formal or informal, which involves either the person or the documents
or records for which the subpoena was issued.
(iv) The Proceedings
(I) The
applicant shall do the following:
I. Provide for the attendance of all persons
whose testimony is to be relied upon to establish probable cause; and
II. Produce and make part of the record
copies of all documents to be utilized to establish probable cause;
and
III. Obtain, complete and
provide to the Presiding Officer a subpoena which specifies the following:
A. The name and address of the person for
whom the subpoena is being sought or who has possession of the items being
subpoenaed; and
B. The location of
the materials, documents or reports for which production pursuant to the
subpoena is sought if that location is known; and
C. A brief, general description of any
materials, documents or items to be produced pursuant to the subpoena;
and
D. The date, time and place for
compliance with the subpoena.
IV. Provide the Presiding Officer testimony
and/or documentary evidence which, in good faith, the applicant believes is
sufficient to establish that probable cause exists for issuance of the subpoena
as well as sufficient proof that all other reasonably available alternative
means of securing the materials, documents or items have been
unsuccessful.
(II) The
Presiding Officer shall do the following:
I.
Be selected only after assuring the Board's Unit Director that he or she has no
prior knowledge of or any direct or indirect interest in or relationship with
the person(s) being subpoenaed and/or the licensee who is the subject of the
investigation; and
II. Commence the
proceedings and swear all necessary witnesses; and
III. Hear and maintain the confidentiality,
if any, of the evidence presented at the proceedings and present to the full
Board only that evidence necessary for an informed decision; and
IV. Control the manner and extent of inquiry
during the proceedings and be allowed to question any witness who testifies;
and
V. Determine, based solely on
the evidence presented in the proceedings, whether probable cause exists and if
so, make such recommendation to the full Board; and
VI. Not participate in any way in any other
proceeding whether formal or informal, which involves the matters, items or
person(s) which are the subject of the subpoena. This does not preclude the
Presiding Officer from presiding at further proceedings for issuance of
subpoenas in the matter.
(III) The
Board shall do the following:
I. By a vote of two-thirds (2/3) of the Board
members issue the subpoena for the person(s) or items specifically found to be
relevant to the inquiry, or quash or modify an existing subpoena by a majority
vote; and
II. Sign the subpoena as
ordered to be issued, quashed or modified.
2. Post-Notice of Charges
Subpoenas - If the subpoena is sought for a contested case being heard with an
Administrative Law Judge from the Secretary of State's office presiding, this
definition shall not apply and all such post-notice of charges subpoenas should
be obtained from the office of the Administrative Procedures Division of the
Office of the Secretary of State pursuant to the Uniform Administrative
Procedures Act and rules promulgated pursuant thereto.
(d) Subpoena Forms
1. All subpoenas shall be issued on forms
approved by the Board.
2. The
subpoena forms may be obtained by contacting the Board's Administrative
Office.
(e) Subpoena
Service - Any method of service of subpoenas authorized by the Tennessee Rules
of Civil Procedure or the rules of procedure for contested cases of the
Tennessee Department of State, Administrative Procedures Division may be
utilized to serve subpoenas pursuant to this rule.
Notes
Tenn. Comp. R. &
Regs. 1200-06-01-.15
Original rule filed May 3, 1995; effective July
17, 1995. Amendment filed September 9, 1996; effective November 23, 1996.
Amendment filed December 1, 2000; effective February 14, 2001. Amendment filed
March 22, 2001; effective June 5, 2001. Amendment filed July 8, 2004; effective
September 21, 2004. Amendments filed January 13, 2022; effective
4/13/2022.
Authority: T.C.A. §§
4-5-202,
4-5-204,
4-5-217,
4-5-223,
4-5-311,
63-1-122,
63-1-134,
63-1-144,
68-29104, 68-29-105, 68-29-109, 68-29-127, 68-29-128, 68-29-129, 68-29-130,
68-29-131, 68-29-132, and 6829-136.