CHAPTER 34 - LICENSING OF CLINICAL LABORATORIES AND BLOODBANKS
33-34-101. Definitions.
(a) As used in this act:
(i) "Blood bank" means a facility for the collection,processing or storage of human blood or blood derivatives, but shall notinclude such a facility located in a memorial, district or private hospital;
(ii) "Clinical laboratory" means any facility for themicrobiological, serological, chemical, hematological, biophysical, cytologicalor pathological examination of materials derived from the human body for thepurpose of obtaining information for the diagnosis, prevention or treatment ofdisease or the assessment of medical condition;
(iii) "Laboratory director" means the person who isresponsible for administration of the technical and scientific operation of aclinical laboratory or blood bank, including supervision of procedures andreporting of findings of tests;
(iv) "Laboratory reference system" means a system ofperiodic testing of methods, procedures and materials of clinical laboratoriesand blood banks, including without limitation the distribution of manuals ofapproved methods, inspection of facilities, cooperative research and periodicsubmission of test specimens for examination;
(v) "State agency" means the Wyoming department ofhealth;
(vi) "This act" means W.S. 33-34-101 through33-34-109.
33-34-102. Required license and certification.
(a) On and after July 1, 1978, no person shall own or operate aclinical laboratory or blood bank for the purpose of soliciting or accepting aspecimen for laboratory examination, or collecting, processing or storing humanblood or blood derivatives unless a valid laboratory license therefor has beenissued. A license shall be issued authorizing the performance of one (1) ormore laboratory procedures, or one (1) or more categories of such procedures. Aseparate license is required for each facility at which laboratory tests areperformed or at which a blood bank is operated.
(b) No person shall function as a laboratory director unless hehas been certified by the state agency.
33-34-103. Issuance of certificates of qualification.
(a) The state agency shall prescribe minimum qualifications forlaboratory directors in microbiology, serology, chemistry, hematology,biophysics, cytology or pathology.
(b) The state agency shall issue a certificate of qualificationto any person who meets the minimum qualifications and demonstrates that hepossesses the character, training and ability relating directly to the capacityto administer properly the technical and scientific operation of a clinicallaboratory or blood bank, including supervision of procedures and reporting oftest findings.
(c) Application for a certificate of qualification shall bemade on forms provided by the state agency. It shall specify the procedures orcategories of procedures for which the certificate is sought and such otherpertinent and qualifying information as the state agency needs to carry out therequirements of this act.
(d) The certificate is valid for a period of one (1) year fromthe date of its issuance and may be renewed each year thereafter.
(e) Notwithstanding the provisions of this section, the stateagency may issue a temporary certificate of qualification pending the issuanceof a regular certificate. A temporary certificate is valid for ninety (90) daysfrom the date of its issuance.
33-34-104. Issuance of laboratory license.
(a) Application for a laboratory license shall be made by theowner of the laboratory or his legally authorized representative upon formsprovided by the state agency. The application shall contain the name of theowner, the name of the laboratory director, the laboratory procedures orcategories of procedures for which the laboratory license is sought, thelocation and physical description of the facility at which tests are to beperformed or at which a blood bank is to be operated, and such other pertinentand qualifying information as the state agency needs to carry out therequirements of this act.
(b) A license shall not be issued unless a valid certificate ofqualification in the procedures for which the license is sought has been issuedto the laboratory director, and unless the state agency finds that thelaboratory is competently staffed, properly equipped and the laboratory will beoperated in the manner required by this act.
(c) If the owner of the laboratory is not the laboratorydirector, or if two (2) or more owners are codirectors of the laboratory, thelicense shall be issued jointly to the owner and the laboratory director or tothe codirector owners, and they are jointly and severally responsible to thestate agency for the maintenance and conduct of the laboratory and for anyviolations of this act or the rules and regulations promulgated hereunder.
(d) A license is valid for the calendar year for which it isissued. The initial application for a license shall be accompanied by a fee ofone hundred dollars ($100.00) for each category but not to exceed five hundreddollars ($500.00) maximum for each laboratory. All fees collected by the stateagency shall be deposited in the state general fund.
(e) The license shall specify the names of the owner and thedirector of the laboratory, the laboratory procedures or categories ofprocedures authorized and the location at which the procedures may beperformed. The license and the certificate of qualification shall be displayedat all times in a prominent place in the laboratory.
(f) A license is automatically void if there is a change in thelaboratory director. A license is automatically void thirty (30) days followinga change in the ownership or location of the laboratory. An application for anew license may be made prior to any change in the laboratory director,ownership or location, or prior to the expiration of the thirty (30) dayperiod, in order to permit the uninterrupted operation of the laboratory.
33-34-105. Duties and powers of state agency.
(a) The state agency may inquire into the operation oflaboratories and may conduct periodic inspections of facilities, methods,procedures, materials, staff and equipment.
(b) The state agency may require laboratories to submit, in aform prescribed by the state agency, periodic reports of tests performed andsuch other pertinent and qualifying information as the state agency may need tocarry out the provisions of this act. The state agency may also requirelaboratories to submit lists of medical technologists who are employed toperform laboratory procedures and to notify the state agency of any changes insuch personnel.
(c) The state agency shall operate and approve laboratoryreference systems and prescribe standards for the examination of specimens. Aspart of the laboratory reference systems, the state agency may requirelaboratories to analyze test samples submitted by the state agency or anapproved system and report the results to the state agency. The rules andregulations of the state agency shall prescribe the manner in which analyses ofsamples are performed and reports thereon submitted. Such analyses and reportsmay be considered by the state agency in proceedings under W.S. 33-34-108.
(d) The state agency shall adopt rules and regulations toimplement the provisions of this act. Where feasible such rules and regulationsshall equal or exceed minimum standards for laboratory certification containedin federal rules and regulations promulgated pursuant to the Clinical LaboratoriesImprovement Act of 1967 (Public Law 90-174) or subsequent federal clinicallaboratory acts. However, where feasible and consistent with the above, anyclinical laboratory which is located in the office of a physician who onlyperforms tests in the treatment of his own patients and accepts no referralspecimens, may be excluded from the licensing requirements of this act. Therules and regulations prescribed and adopted may not be implemented untilsubmitted to the Wyoming legislature for review and approval under proceduresas the legislature may prescribe.
(e) The state agency may employ inspectors, investigators,assistants and other employees necessary to carry out the provisions of thisact, fix their compensation within limits provided by law and prescribe theirduties. Qualifications for laboratory inspectors shall be the same as thequalifications established for supervisors pursuant to subsection (f) of thissection.
(f) The state agency may establish qualifications forsupervisor and technical personnel employed in laboratories with the advice andassistance of the advisory committee authorized under W.S. 33-34-106.
33-34-106. Advisory committee.
(a) The state agency shall appoint an advisory committee toadvise the state agency concerning implementation and administration of thisact. The advisory committee shall consist of seven (7) members, including one(1) pathologist actively engaged in the direction of a laboratory, a medicaldoctor actively engaged in the practice of medicine, an active hospitaladministrator, an active laboratory technologist, a professional medicallaboratorian from the state public health laboratory, a representative of thirdparty insurance carriers, and a representative consumer of medical care. Appointmentswill be made from a list of not less than two (2) names submitted byappropriate professional and consumer organizations in this state.
(b) Members of the advisory committee shall be reimbursed forexpenses incurred in attending committee meetings in the same manner and amountas state employees.
33-34-107. Acceptance, collection, identification and examination ofspecimens.
(a) A clinical laboratory shall examine human specimens only atthe request of a licensed physician, dentist or other person authorized by lawto use the findings of laboratory examinations.
(b) The results of a test shall only be reported to or asdirected by the person who requested it. The reports shall include the name ofthe director and the name and address of the clinical laboratory in which thetest was actually performed.
(c) All specimens accepted by a clinical laboratory shall betested on the premises unless forwarded to another properly licensed clinicallaboratory. Any tests made outside Wyoming must be made by a laboratory havinga valid federal interstate license.
(d) Only a licensed physician or an authorized person maycollect specimens.
33-34-108. Enforcement.
(a) A laboratory license or certificate of qualification may berevoked, suspended, limited or annulled, or the holder thereof may be censured,reprimanded or otherwise disciplined by the state agency on proof that thelicense or certificate holder or any person in his employ:
(i) Is guilty of misrepresentation in obtaining the license orcertificate or in the operation of the laboratory;
(ii) Knowingly accepts or permits to be accepted a specimen orassignment for laboratory examination from, or renders a report to, a personnot authorized by law to submit such assignment or specimen, or receive thereport;
(iii) Engages or attempts to engage in, or represents himself asentitled to perform any laboratory procedure or category of procedures notauthorized in the permit or certificate;
(iv) Renders a report on laboratory work actually performed inanother laboratory without acknowledging that fact;
(v) Demonstrates incompetence or shows consistent errors inperformance of laboratory examinations or procedures;
(vi) Fails to file any report required by the provisions of thisact or the rules and regulations promulgated hereunder; or
(vii) Violates or aids in the violation of any provision of thisact, the rules and regulations promulgated hereunder, or the state sanitarycode.
(b) Proceedings under this section may be initiated by aqualified inspector by filing written charges with the state agency.
(c) No license or certificate shall be revoked, suspended,limited or annulled without a hearing before the state agency.
(d) Any action of the state agency taken pursuant to or underthis act is reviewable as provided by state law.
(e) Notwithstanding subsections (d) and (e) of this section,upon receipt from the department of family services of a certified copy of anorder from a court to withhold, suspend or otherwise restrict a license issuedby the board, the board shall notify the party named in the court order of thewithholding, suspension or restriction of the license in accordance with theterms of the court order. No appeal under the Wyoming Administrative ProcedureAct shall be allowed for a license withheld, suspended or restricted under thissubsection.
33-34-109. Penalties.
(a) Any person who violates the provisions of this act isguilty of a misdemeanor, and upon conviction may be punished by imprisonmentfor not more than six (6) months, or by a fine of not more than seven hundredfifty dollars ($750.00), or both.
(b) Any person convicted of a second or subsequent violation ofthis act may be punished by both a fine and imprisonment.
CHAPTER 34 - LICENSING OF CLINICAL LABORATORIES AND BLOODBANKS
33-34-101. Definitions.
(a) As used in this act:
(i) "Blood bank" means a facility for the collection,processing or storage of human blood or blood derivatives, but shall notinclude such a facility located in a memorial, district or private hospital;
(ii) "Clinical laboratory" means any facility for themicrobiological, serological, chemical, hematological, biophysical, cytologicalor pathological examination of materials derived from the human body for thepurpose of obtaining information for the diagnosis, prevention or treatment ofdisease or the assessment of medical condition;
(iii) "Laboratory director" means the person who isresponsible for administration of the technical and scientific operation of aclinical laboratory or blood bank, including supervision of procedures andreporting of findings of tests;
(iv) "Laboratory reference system" means a system ofperiodic testing of methods, procedures and materials of clinical laboratoriesand blood banks, including without limitation the distribution of manuals ofapproved methods, inspection of facilities, cooperative research and periodicsubmission of test specimens for examination;
(v) "State agency" means the Wyoming department ofhealth;
(vi) "This act" means W.S. 33-34-101 through33-34-109.
33-34-102. Required license and certification.
(a) On and after July 1, 1978, no person shall own or operate aclinical laboratory or blood bank for the purpose of soliciting or accepting aspecimen for laboratory examination, or collecting, processing or storing humanblood or blood derivatives unless a valid laboratory license therefor has beenissued. A license shall be issued authorizing the performance of one (1) ormore laboratory procedures, or one (1) or more categories of such procedures. Aseparate license is required for each facility at which laboratory tests areperformed or at which a blood bank is operated.
(b) No person shall function as a laboratory director unless hehas been certified by the state agency.
33-34-103. Issuance of certificates of qualification.
(a) The state agency shall prescribe minimum qualifications forlaboratory directors in microbiology, serology, chemistry, hematology,biophysics, cytology or pathology.
(b) The state agency shall issue a certificate of qualificationto any person who meets the minimum qualifications and demonstrates that hepossesses the character, training and ability relating directly to the capacityto administer properly the technical and scientific operation of a clinicallaboratory or blood bank, including supervision of procedures and reporting oftest findings.
(c) Application for a certificate of qualification shall bemade on forms provided by the state agency. It shall specify the procedures orcategories of procedures for which the certificate is sought and such otherpertinent and qualifying information as the state agency needs to carry out therequirements of this act.
(d) The certificate is valid for a period of one (1) year fromthe date of its issuance and may be renewed each year thereafter.
(e) Notwithstanding the provisions of this section, the stateagency may issue a temporary certificate of qualification pending the issuanceof a regular certificate. A temporary certificate is valid for ninety (90) daysfrom the date of its issuance.
33-34-104. Issuance of laboratory license.
(a) Application for a laboratory license shall be made by theowner of the laboratory or his legally authorized representative upon formsprovided by the state agency. The application shall contain the name of theowner, the name of the laboratory director, the laboratory procedures orcategories of procedures for which the laboratory license is sought, thelocation and physical description of the facility at which tests are to beperformed or at which a blood bank is to be operated, and such other pertinentand qualifying information as the state agency needs to carry out therequirements of this act.
(b) A license shall not be issued unless a valid certificate ofqualification in the procedures for which the license is sought has been issuedto the laboratory director, and unless the state agency finds that thelaboratory is competently staffed, properly equipped and the laboratory will beoperated in the manner required by this act.
(c) If the owner of the laboratory is not the laboratorydirector, or if two (2) or more owners are codirectors of the laboratory, thelicense shall be issued jointly to the owner and the laboratory director or tothe codirector owners, and they are jointly and severally responsible to thestate agency for the maintenance and conduct of the laboratory and for anyviolations of this act or the rules and regulations promulgated hereunder.
(d) A license is valid for the calendar year for which it isissued. The initial application for a license shall be accompanied by a fee ofone hundred dollars ($100.00) for each category but not to exceed five hundreddollars ($500.00) maximum for each laboratory. All fees collected by the stateagency shall be deposited in the state general fund.
(e) The license shall specify the names of the owner and thedirector of the laboratory, the laboratory procedures or categories ofprocedures authorized and the location at which the procedures may beperformed. The license and the certificate of qualification shall be displayedat all times in a prominent place in the laboratory.
(f) A license is automatically void if there is a change in thelaboratory director. A license is automatically void thirty (30) days followinga change in the ownership or location of the laboratory. An application for anew license may be made prior to any change in the laboratory director,ownership or location, or prior to the expiration of the thirty (30) dayperiod, in order to permit the uninterrupted operation of the laboratory.
33-34-105. Duties and powers of state agency.
(a) The state agency may inquire into the operation oflaboratories and may conduct periodic inspections of facilities, methods,procedures, materials, staff and equipment.
(b) The state agency may require laboratories to submit, in aform prescribed by the state agency, periodic reports of tests performed andsuch other pertinent and qualifying information as the state agency may need tocarry out the provisions of this act. The state agency may also requirelaboratories to submit lists of medical technologists who are employed toperform laboratory procedures and to notify the state agency of any changes insuch personnel.
(c) The state agency shall operate and approve laboratoryreference systems and prescribe standards for the examination of specimens. Aspart of the laboratory reference systems, the state agency may requirelaboratories to analyze test samples submitted by the state agency or anapproved system and report the results to the state agency. The rules andregulations of the state agency shall prescribe the manner in which analyses ofsamples are performed and reports thereon submitted. Such analyses and reportsmay be considered by the state agency in proceedings under W.S. 33-34-108.
(d) The state agency shall adopt rules and regulations toimplement the provisions of this act. Where feasible such rules and regulationsshall equal or exceed minimum standards for laboratory certification containedin federal rules and regulations promulgated pursuant to the Clinical LaboratoriesImprovement Act of 1967 (Public Law 90-174) or subsequent federal clinicallaboratory acts. However, where feasible and consistent with the above, anyclinical laboratory which is located in the office of a physician who onlyperforms tests in the treatment of his own patients and accepts no referralspecimens, may be excluded from the licensing requirements of this act. Therules and regulations prescribed and adopted may not be implemented untilsubmitted to the Wyoming legislature for review and approval under proceduresas the legislature may prescribe.
(e) The state agency may employ inspectors, investigators,assistants and other employees necessary to carry out the provisions of thisact, fix their compensation within limits provided by law and prescribe theirduties. Qualifications for laboratory inspectors shall be the same as thequalifications established for supervisors pursuant to subsection (f) of thissection.
(f) The state agency may establish qualifications forsupervisor and technical personnel employed in laboratories with the advice andassistance of the advisory committee authorized under W.S. 33-34-106.
33-34-106. Advisory committee.
(a) The state agency shall appoint an advisory committee toadvise the state agency concerning implementation and administration of thisact. The advisory committee shall consist of seven (7) members, including one(1) pathologist actively engaged in the direction of a laboratory, a medicaldoctor actively engaged in the practice of medicine, an active hospitaladministrator, an active laboratory technologist, a professional medicallaboratorian from the state public health laboratory, a representative of thirdparty insurance carriers, and a representative consumer of medical care. Appointmentswill be made from a list of not less than two (2) names submitted byappropriate professional and consumer organizations in this state.
(b) Members of the advisory committee shall be reimbursed forexpenses incurred in attending committee meetings in the same manner and amountas state employees.
33-34-107. Acceptance, collection, identification and examination ofspecimens.
(a) A clinical laboratory shall examine human specimens only atthe request of a licensed physician, dentist or other person authorized by lawto use the findings of laboratory examinations.
(b) The results of a test shall only be reported to or asdirected by the person who requested it. The reports shall include the name ofthe director and the name and address of the clinical laboratory in which thetest was actually performed.
(c) All specimens accepted by a clinical laboratory shall betested on the premises unless forwarded to another properly licensed clinicallaboratory. Any tests made outside Wyoming must be made by a laboratory havinga valid federal interstate license.
(d) Only a licensed physician or an authorized person maycollect specimens.
33-34-108. Enforcement.
(a) A laboratory license or certificate of qualification may berevoked, suspended, limited or annulled, or the holder thereof may be censured,reprimanded or otherwise disciplined by the state agency on proof that thelicense or certificate holder or any person in his employ:
(i) Is guilty of misrepresentation in obtaining the license orcertificate or in the operation of the laboratory;
(ii) Knowingly accepts or permits to be accepted a specimen orassignment for laboratory examination from, or renders a report to, a personnot authorized by law to submit such assignment or specimen, or receive thereport;
(iii) Engages or attempts to engage in, or represents himself asentitled to perform any laboratory procedure or category of procedures notauthorized in the permit or certificate;
(iv) Renders a report on laboratory work actually performed inanother laboratory without acknowledging that fact;
(v) Demonstrates incompetence or shows consistent errors inperformance of laboratory examinations or procedures;
(vi) Fails to file any report required by the provisions of thisact or the rules and regulations promulgated hereunder; or
(vii) Violates or aids in the violation of any provision of thisact, the rules and regulations promulgated hereunder, or the state sanitarycode.
(b) Proceedings under this section may be initiated by aqualified inspector by filing written charges with the state agency.
(c) No license or certificate shall be revoked, suspended,limited or annulled without a hearing before the state agency.
(d) Any action of the state agency taken pursuant to or underthis act is reviewable as provided by state law.
(e) Notwithstanding subsections (d) and (e) of this section,upon receipt from the department of family services of a certified copy of anorder from a court to withhold, suspend or otherwise restrict a license issuedby the board, the board shall notify the party named in the court order of thewithholding, suspension or restriction of the license in accordance with theterms of the court order. No appeal under the Wyoming Administrative ProcedureAct shall be allowed for a license withheld, suspended or restricted under thissubsection.
33-34-109. Penalties.
(a) Any person who violates the provisions of this act isguilty of a misdemeanor, and upon conviction may be punished by imprisonmentfor not more than six (6) months, or by a fine of not more than seven hundredfifty dollars ($750.00), or both.
(b) Any person convicted of a second or subsequent violation ofthis act may be punished by both a fine and imprisonment.
CHAPTER 34 - LICENSING OF CLINICAL LABORATORIES AND BLOODBANKS
33-34-101. Definitions.
(a) As used in this act:
(i) "Blood bank" means a facility for the collection,processing or storage of human blood or blood derivatives, but shall notinclude such a facility located in a memorial, district or private hospital;
(ii) "Clinical laboratory" means any facility for themicrobiological, serological, chemical, hematological, biophysical, cytologicalor pathological examination of materials derived from the human body for thepurpose of obtaining information for the diagnosis, prevention or treatment ofdisease or the assessment of medical condition;
(iii) "Laboratory director" means the person who isresponsible for administration of the technical and scientific operation of aclinical laboratory or blood bank, including supervision of procedures andreporting of findings of tests;
(iv) "Laboratory reference system" means a system ofperiodic testing of methods, procedures and materials of clinical laboratoriesand blood banks, including without limitation the distribution of manuals ofapproved methods, inspection of facilities, cooperative research and periodicsubmission of test specimens for examination;
(v) "State agency" means the Wyoming department ofhealth;
(vi) "This act" means W.S. 33-34-101 through33-34-109.
33-34-102. Required license and certification.
(a) On and after July 1, 1978, no person shall own or operate aclinical laboratory or blood bank for the purpose of soliciting or accepting aspecimen for laboratory examination, or collecting, processing or storing humanblood or blood derivatives unless a valid laboratory license therefor has beenissued. A license shall be issued authorizing the performance of one (1) ormore laboratory procedures, or one (1) or more categories of such procedures. Aseparate license is required for each facility at which laboratory tests areperformed or at which a blood bank is operated.
(b) No person shall function as a laboratory director unless hehas been certified by the state agency.
33-34-103. Issuance of certificates of qualification.
(a) The state agency shall prescribe minimum qualifications forlaboratory directors in microbiology, serology, chemistry, hematology,biophysics, cytology or pathology.
(b) The state agency shall issue a certificate of qualificationto any person who meets the minimum qualifications and demonstrates that hepossesses the character, training and ability relating directly to the capacityto administer properly the technical and scientific operation of a clinicallaboratory or blood bank, including supervision of procedures and reporting oftest findings.
(c) Application for a certificate of qualification shall bemade on forms provided by the state agency. It shall specify the procedures orcategories of procedures for which the certificate is sought and such otherpertinent and qualifying information as the state agency needs to carry out therequirements of this act.
(d) The certificate is valid for a period of one (1) year fromthe date of its issuance and may be renewed each year thereafter.
(e) Notwithstanding the provisions of this section, the stateagency may issue a temporary certificate of qualification pending the issuanceof a regular certificate. A temporary certificate is valid for ninety (90) daysfrom the date of its issuance.
33-34-104. Issuance of laboratory license.
(a) Application for a laboratory license shall be made by theowner of the laboratory or his legally authorized representative upon formsprovided by the state agency. The application shall contain the name of theowner, the name of the laboratory director, the laboratory procedures orcategories of procedures for which the laboratory license is sought, thelocation and physical description of the facility at which tests are to beperformed or at which a blood bank is to be operated, and such other pertinentand qualifying information as the state agency needs to carry out therequirements of this act.
(b) A license shall not be issued unless a valid certificate ofqualification in the procedures for which the license is sought has been issuedto the laboratory director, and unless the state agency finds that thelaboratory is competently staffed, properly equipped and the laboratory will beoperated in the manner required by this act.
(c) If the owner of the laboratory is not the laboratorydirector, or if two (2) or more owners are codirectors of the laboratory, thelicense shall be issued jointly to the owner and the laboratory director or tothe codirector owners, and they are jointly and severally responsible to thestate agency for the maintenance and conduct of the laboratory and for anyviolations of this act or the rules and regulations promulgated hereunder.
(d) A license is valid for the calendar year for which it isissued. The initial application for a license shall be accompanied by a fee ofone hundred dollars ($100.00) for each category but not to exceed five hundreddollars ($500.00) maximum for each laboratory. All fees collected by the stateagency shall be deposited in the state general fund.
(e) The license shall specify the names of the owner and thedirector of the laboratory, the laboratory procedures or categories ofprocedures authorized and the location at which the procedures may beperformed. The license and the certificate of qualification shall be displayedat all times in a prominent place in the laboratory.
(f) A license is automatically void if there is a change in thelaboratory director. A license is automatically void thirty (30) days followinga change in the ownership or location of the laboratory. An application for anew license may be made prior to any change in the laboratory director,ownership or location, or prior to the expiration of the thirty (30) dayperiod, in order to permit the uninterrupted operation of the laboratory.
33-34-105. Duties and powers of state agency.
(a) The state agency may inquire into the operation oflaboratories and may conduct periodic inspections of facilities, methods,procedures, materials, staff and equipment.
(b) The state agency may require laboratories to submit, in aform prescribed by the state agency, periodic reports of tests performed andsuch other pertinent and qualifying information as the state agency may need tocarry out the provisions of this act. The state agency may also requirelaboratories to submit lists of medical technologists who are employed toperform laboratory procedures and to notify the state agency of any changes insuch personnel.
(c) The state agency shall operate and approve laboratoryreference systems and prescribe standards for the examination of specimens. Aspart of the laboratory reference systems, the state agency may requirelaboratories to analyze test samples submitted by the state agency or anapproved system and report the results to the state agency. The rules andregulations of the state agency shall prescribe the manner in which analyses ofsamples are performed and reports thereon submitted. Such analyses and reportsmay be considered by the state agency in proceedings under W.S. 33-34-108.
(d) The state agency shall adopt rules and regulations toimplement the provisions of this act. Where feasible such rules and regulationsshall equal or exceed minimum standards for laboratory certification containedin federal rules and regulations promulgated pursuant to the Clinical LaboratoriesImprovement Act of 1967 (Public Law 90-174) or subsequent federal clinicallaboratory acts. However, where feasible and consistent with the above, anyclinical laboratory which is located in the office of a physician who onlyperforms tests in the treatment of his own patients and accepts no referralspecimens, may be excluded from the licensing requirements of this act. Therules and regulations prescribed and adopted may not be implemented untilsubmitted to the Wyoming legislature for review and approval under proceduresas the legislature may prescribe.
(e) The state agency may employ inspectors, investigators,assistants and other employees necessary to carry out the provisions of thisact, fix their compensation within limits provided by law and prescribe theirduties. Qualifications for laboratory inspectors shall be the same as thequalifications established for supervisors pursuant to subsection (f) of thissection.
(f) The state agency may establish qualifications forsupervisor and technical personnel employed in laboratories with the advice andassistance of the advisory committee authorized under W.S. 33-34-106.
33-34-106. Advisory committee.
(a) The state agency shall appoint an advisory committee toadvise the state agency concerning implementation and administration of thisact. The advisory committee shall consist of seven (7) members, including one(1) pathologist actively engaged in the direction of a laboratory, a medicaldoctor actively engaged in the practice of medicine, an active hospitaladministrator, an active laboratory technologist, a professional medicallaboratorian from the state public health laboratory, a representative of thirdparty insurance carriers, and a representative consumer of medical care. Appointmentswill be made from a list of not less than two (2) names submitted byappropriate professional and consumer organizations in this state.
(b) Members of the advisory committee shall be reimbursed forexpenses incurred in attending committee meetings in the same manner and amountas state employees.
33-34-107. Acceptance, collection, identification and examination ofspecimens.
(a) A clinical laboratory shall examine human specimens only atthe request of a licensed physician, dentist or other person authorized by lawto use the findings of laboratory examinations.
(b) The results of a test shall only be reported to or asdirected by the person who requested it. The reports shall include the name ofthe director and the name and address of the clinical laboratory in which thetest was actually performed.
(c) All specimens accepted by a clinical laboratory shall betested on the premises unless forwarded to another properly licensed clinicallaboratory. Any tests made outside Wyoming must be made by a laboratory havinga valid federal interstate license.
(d) Only a licensed physician or an authorized person maycollect specimens.
33-34-108. Enforcement.
(a) A laboratory license or certificate of qualification may berevoked, suspended, limited or annulled, or the holder thereof may be censured,reprimanded or otherwise disciplined by the state agency on proof that thelicense or certificate holder or any person in his employ:
(i) Is guilty of misrepresentation in obtaining the license orcertificate or in the operation of the laboratory;
(ii) Knowingly accepts or permits to be accepted a specimen orassignment for laboratory examination from, or renders a report to, a personnot authorized by law to submit such assignment or specimen, or receive thereport;
(iii) Engages or attempts to engage in, or represents himself asentitled to perform any laboratory procedure or category of procedures notauthorized in the permit or certificate;
(iv) Renders a report on laboratory work actually performed inanother laboratory without acknowledging that fact;
(v) Demonstrates incompetence or shows consistent errors inperformance of laboratory examinations or procedures;
(vi) Fails to file any report required by the provisions of thisact or the rules and regulations promulgated hereunder; or
(vii) Violates or aids in the violation of any provision of thisact, the rules and regulations promulgated hereunder, or the state sanitarycode.
(b) Proceedings under this section may be initiated by aqualified inspector by filing written charges with the state agency.
(c) No license or certificate shall be revoked, suspended,limited or annulled without a hearing before the state agency.
(d) Any action of the state agency taken pursuant to or underthis act is reviewable as provided by state law.
(e) Notwithstanding subsections (d) and (e) of this section,upon receipt from the department of family services of a certified copy of anorder from a court to withhold, suspend or otherwise restrict a license issuedby the board, the board shall notify the party named in the court order of thewithholding, suspension or restriction of the license in accordance with theterms of the court order. No appeal under the Wyoming Administrative ProcedureAct shall be allowed for a license withheld, suspended or restricted under thissubsection.
33-34-109. Penalties.
(a) Any person who violates the provisions of this act isguilty of a misdemeanor, and upon conviction may be punished by imprisonmentfor not more than six (6) months, or by a fine of not more than seven hundredfifty dollars ($750.00), or both.
(b) Any person convicted of a second or subsequent violation ofthis act may be punished by both a fine and imprisonment.
