TITLE 25.HEALTH SERVICES

Part 1. DEPARTMENT OF STATE HEALTH SERVICES

The Executive Commissioner of the Health and Human Services Commission (commission), on behalf of the Department of State Health Services (department), adopts amendments to §73.21 concerning newborn screening, and §73.54 concerning fees for clinical testing and newborn screening. The amendments to §73.21 and §73.54 are adopted with changes to the proposed text as published in the July 21, 2006, issue of the Texas Register (31 TexReg 5749).

BACKGROUND AND PURPOSE

The amendments are authorized by Health and Safety Code, §§12.031, 12.032, and 12.0122, which allow the department to charge fees to a person who receives public health services from the department, and which are necessary for the department to recover costs for performing laboratory services. The amendments are also authorized by Health and Safety Code, Chapter 33, which was amended in 2005 to expand the scope of newborn screening in Texas.

SECTION-BY-SECTION SUMMARY

The proposed amendments to §73.21 included new definitions for "screen", "specimen collection form", "specimen collection kits", and "replacement specimen collection kits". The definition for "test kit" was deleted, the references to "test kit(s)" were replaced with "specimen collection kit(s)", and the references to "screening panel(s)" were replaced with "screen(s)". Section 73.54 included a new fee for a two-screen specimen collection kit that was equal to the fee for two single screen specimen collection kits.

The proposed amendments presented for public comment included a definition for "specimen collection kits" that gave the department an option to offer a "single screen" or a "two-screen specimen collection kit." Based upon public comment, the option for a "two-screen specimen collection kit" has been eliminated. The option for a "two-screen specimen collection kit" has been removed from the definition of "specimen collection kit" in §73.21. Pursuant to that change in the definition, editorial changes have been made to remove all references to a "two-screen collection kit" from §73.21 and from the fee schedule for Newborn Screening in §73.54.

COMMENTS

The department, on behalf of the commission, has reviewed and prepared a response to the comments received, which the commission has reviewed and accepts. The commenters were physicians, nurses, medical technologists, laboratory directors, a medical office administrator and the Coalition of Nurses in Advanced Practice. The commenters were not against the rules in their entirety; however, the commenters expressed concerns about the success of the proposed process for linking the first and second screen for each newborn using the "two-screen specimen collection kit" and asked specific questions about the process.

Comments: Commenters were concerned that mothers would damage, lose or forget the specimen collection form for the second screen and as a result, may not bring the baby in for the two-week visit; that expecting the mother to remember this is unrealistic; and that the cost of newborn screening would increase because of the large number of replacement forms that would purportedly be needed. The commenters preferred to have the forms for the second screen available in the physician's office rather than depending on the mother to bring it with her (if a two-screen model is employed). Commenters were concerned that mothers with a limited knowledge of English will not understand about bringing in the second form. Commenters wanted to know: who would pay for the "two-screen specimen collection kits"; how the hospitals and clinics would share the billing for the collection kits and for the collection of the second screen; how the second screen would be linked to the first if the mother damages, loses or forgets the original second screen collection form; if replacements forms would be available to the physician; if the physician may continue to send patients back to the hospital for the second screen; and who is responsible for ensuring that the second screen is performed-the hospital, the physician, or the parents?

Response: The commission agrees that there are concerns regarding the two-screen model, and has changed the definition of "specimen collection kits" by removing the option for a "two-screen specimen collection kit", and all other references to the "two-screen specimen collection kits" in both rules. Also, the proposed new fee has been removed from §73.54. The department's decision not to use a "two-screen specimen collection kit", or the proposed process for linking the first and second screens for every newborn, addresses the concerns expressed by the commenters summarized above. Changes have been made to these rules as a result of these comments.

Comment: One commenter requested a minor change to the definition of a "two-screen specimen collection kit". The definition refers to "first doctors visit". The commenter stated that language is inconsistent with the language throughout the proposed rule and suggested the phrase be changed to "the newborn's first health care visit".

Response: The commission disagrees because the department has decided not to use a "two-screen specimen collection kit", or the proposed process for linking the first and second screens for every newborn, for the reasons stated herein. It is, therefore, unnecessary to revise the two-screen option language in the rule. No changes were made to these rules as a result of this comment.

LEGAL CERTIFICATION

The Department of State Health Services General Counsel, Cathy Campbell, certifies that the rules, as adopted, have been reviewed by legal counsel and found to be a valid exercise of the agencies' legal authority.

STATUTORY AUTHORITY

The amended sections are adopted under Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of the Health and Safety Code, Chapter 1001; Health and Safety Code, Chapter 33, which requires the department to implement the newborn screening program, in accordance with rules adopted by the Executive Commissioner; §12.001, which provides the Executive Commissioner the authority to adopt rules for the performance of every duty imposed by law on the Executive Commissioner, department and commissioner; §12.031 and §12.032, which allows the Executive Commissioner to charge fees to a person who receives public health services from the department; §12.034, which requires the Executive Commissioner to establish collection procedures; §12.035, which requires the department to deposit all money collected for fees and charges under §12.032 and §12.033 in the state treasury to the credit of the Department of State Health Services public health service fee fund; and §12.0122 which allows the department to enter into a contract for laboratory services.

§73.21.Newborn Screening.

(a) Purpose. This section establishes procedures for the purchase and submission of newborn screening specimen collection kits provided by the Department of State Health Services (department).

(b) Definitions. The following words and terms, when used in this section, shall have the following meanings unless the context clearly indicates otherwise.

(1) Charity care newborn--A patient who is not insured and is not covered or eligible to be covered for newborn screening services by Medicaid or any other government program.

(2) Medicaid-eligible newborn--A patient whose mother is a Medicaid recipient or who is otherwise eligible for Medicaid coverage for the newborn-related services.

(3) Newborn Screening (NBS)--Newborn screening is a requirement of the Health and Safety Code, Chapter 33. Each screen consists of one or more tests to identify a newborn who may be at risk of having phenylketonuria, other heritable diseases, or hypothyroidism. Additional screens may be necessary under certain circumstances.

(4) Provider--The hospital, birthing center, physician, midwife, or clinic that collects and submits the NBS specimen.

(5) Screen--One or more tests that identify an increased risk for a disorder, which must be confirmed by diagnostic tests. A screen may produce false positive or false negative results and should not be relied upon as "diagnostic."

(6) Specimen collection form--The specimen collection form consists of a patient demographic information sheet (original and carbonless copy) with an attached filter paper collection device.

(7) Specimen collection kit--A single department-approved bar-coded, quality controlled filter paper collection device, demographic information sheet and envelope which may be used to submit a newborn's blood specimen for the first or second screen, repeat or follow-up testing. This term includes replacement specimen collection forms.

(8) Replacement specimen collection forms--consist of a specimen collection kit for instances when a previously purchased specimen collection form is lost, damaged or otherwise unavailable.

(1) The department will provide newborn screening specimen collection kits upon written request from a provider of newborn screening. A separate specimen collection form is required for each screen.

(A) The department will provide specimen collection kits for Medicaid-eligible or charity care newborns at no cost to the provider.

(B) The department will provide specimen collection kits for all other newborns at a fee described in §73.54(1)(H) of this title.

(2) When a provider requests specimen collection kits, the provider must identify the number estimated to be needed for Medicaid-eligible newborns, charity care newborns and other newborns. The provider's estimate shall be based on the provider's newborn screening services provided in the most recent fiscal or calendar year if the provider has previously provided these services. A provider shall provide further information upon request of the department to verify the appropriateness of the number of specimen collection kits provided at no cost. A provider may use the no cost specimen collection kit only for a Medicaid-eligible or charity care newborn.

(3) The department will bill the requesting provider for specimen collection kits when the specimen collection kits are sent to the provider. Payment is due within 120 days from the provider's receipt of the specimen collection kits.

(4) The department shall accept only its approved specimen collection kits for submission of specimens.

(5) The provider shall ensure that the identifying and demographic information provided with the specimen collection kit is complete and accurate when submitted to the department.

§73.54.Fee Schedule for Clinical Testing and Newborn Screening.

Fees for clinical testing and newborn screening shall not exceed the following amounts.

(1) Human specimens.

(A) Bacteriology.

(i) Aerobic isolation, comprehensive--$119.

(ii) Aerobic isolation, definitive I.D.--$35.

(iii) Anaerobic isolation, comprehensive--$94.

(iv) Anaerobic isolation, definitive I.D.--$35.

(v) Bioterrorism:

(I) culture--$119; and

(II) smear--$19.

(vi) Bordetella pertussis :

(I) culture--$138; and

(II) molecular testing--$125.

(vii) C. botulinum isolation--$94.

(viii) Diphtheria culture--$113.

(ix) Drug susceptibility testing:

(I) VRE (vancomycin resistant enterococcus)--$63;

(II) VRSA (vancomycin resistant Staphylococcus aureus --$63;

(III) MRSA (methicillin resistant Staphylococcus aureus )--$63;

(IV) Neisseria gonorrhoeae --$63; and

(V) One drug susceptibility testing--$63.

(x) Enteric pathogens--$88.

(xi) Magnetic bead enrichment for E. coli, Enterohemorrhagic E. coli (EHEC)--$50.

(xii) Fecal fat screen--$9.

(xiii) Fecal occult blood--$7.

(xiv) Fecal WBC smear--$10.

(xv) Genetic probe:

(I) gonorrhea/chlamydia (GC/CT)--$31;

(II) amplified probe for gonorrhea--$31;

(III) amplified probe for chlamydia--$31;

(IV) amplified probe for gonorrhea/chlamydia--$63; and

(V) amplified probe for human papillomavirus (HPV)--$52.

(xvi) Gram stain smear with fecal WBC--$12.

(xvii) Identification and typing:

(I) Immuno method, Salmonella and Shigella --$13;

(II) Haemophilus influenzae --$119;

(III) Neisseria meningitides --$119;

(IV) noncomplex typing ( Vibrio , Brucella , etc.)--$63;

(V) other complex typing--$130;

(VI) Salmonella --$119;

(VII) Shigella --$73;

(VIII) Streptococcus , Group A (GAS)--$88;

(IX) Streptococcus, typing Groups B, C, D, G--$88; and

(X) Legionella--$88.

(xviii) KOH exam except for skin, hair and nails--$10.

(xix) KOH for skin, hair and nails--$10.

(xx) Molecular studies:

(I) pulsed-field gel electrophoresis (PFGE)--$125; and

(II) polymerase chain reaction (PCR)--$56.

(xxi) Mycolic acid studies--$31.

(xxii) Neisseria gonorrhoeae culture--$56.

(xxiii) Pure culture identification:

(I) aerobes--$56;

(II) anaerobes--$100;

(III) Campylobacter --$69; and

(IV) Neisseria gonorrhoeae --$69.

(xxiv) Routine cultures:

(I) any source except urine--$22;

(II) blood--$22;

(III) stool, Campylobacter and E. Coli 0157--$34;

(IV) stool, Salmonella and Shigella --$34; and

(V) urine--$20.

(xxv) Streptococcus screen--$25.

(xxvi) Toxin studies:

(I) Botulinum toxin--$163;

(II) Clostridium difficile toxin--$21;

(III) Shiga toxin--$94;

(IV) Toxic Shock Syndrome Toxin-1 (TSST)--$160; and

(V) Vibrio cholera toxin--$88.

(xxvii) Vibrio culture--$88.

(xxviii) Wet mount, vaginal--$10.

(B) Clinical chemistry.

(i) 5'nucleotidase--$61.

(ii) Acetone--$8.

(iii) Albumin, serum, urine or other source--$9.

(iv) Aldose--$52.

(v) Alkaline phosphatase isoenzymes--$37.

(vi) Alkaline phosphatase--$9.

(vii) ALT (Alanine aminotransferase)--$9.

(viii) AST (Aspartate aminotransferase)--$9.

(ix) Amylase, serum--$11.

(x) Ammonia--$35.

(xi) B-12--$12.

(xii) B-12 and folic acid--$59.

(xiii) Bilirubin direct--$9.

(xiv) Bilirubin, Total--$9.

(xv) Blood typing:

(I) ABO typing--$9;

(II) antibody screen (blood type)--$25;

(III) antigen typing (blood type)--$13;

(IV) antigen titering--$13;

(V) direct COOMBS--$54; and

(VI) Rh typing--$13.

(xvi) Blood Urea Nitrogen (BUN)--$7.

(xvii) Calcium--$9.

(xviii) Calcium-125--$42.

(xix) Calcium, ionized--$80.

(xx) Carbon dioxide (CO2)--$9.

(xxi) CEA (carcinombryonic antigen)--$34.

(xxii) Chloride, serum--$9.

(xxiii) Chloride, urine--$10.

(xxiv) Cholesterol:

(I) cholesterol and high density lipoprotein (HDL)--$9; and

(II) cholesterol only--$8.

(xxv) Cholinesterase, RBC--$14.

(xxvi) Creatine Kinase (CK) assay--$11.

(xxvii) Creatine Kinase (CK) isoenzymes--$29.

(xxviii) Creatine Kinase (CK) MB fraction--$13.

(xxix) Creatinine assay--$9.

(xxx) Creatinine clearance test--$16.

(xxxi) Creatinine, urine--$9.

(xxxii) Cortisol--$29.

(xxxiii) Electrolyte Panel--$14.

(xxxiv) Estradiol, serum--$49.

(xxxv) Estradiol, free--$49.

(xxxvi) Estrogens, total--$100.

(xxxvii) Ferritin--$24.

(xxxviii) Folate--$12.

(xxxix) Folic acid, serum--$26.

(xl) Fructosamine--$26.

(xli) FSH (follicle stimulating hormone)--$32.

(xlii) G-6-PD--$24.

(xliii) Gastrin--$24.

(xliv) GGT (gamma-glutamyl transferase--$12.

(xlv) Glucose:

(I) glucose, postprandial, 0 and 2 hours--$14;

(II) glucose, random, fasting--$7;

(III) glucose tolerance test, 1 hour--$14;

(IV) glucose tolerance test, 2 hour--$21; and

(V) glucose tolerance test, 3 hour--$28.

(xlvi) Heavy metal screen, urine--$46.

(xlvii) Hantoglobin--$25.

(xlviii) Hemoglobin, total--$6.

(xlix) Hemoglobin A1C--$23.

(l) Hemoglobinopathy--$15.

(li) Hematology:

(I) CBC with differential--$14;

(II) CBC complete, automated with differential--$13;

(III) CBC complete, automated without differential--$11;

(IV) Differential, manual--$7;

(V) Erythropoietin--$46;

(VI) Platelet count--$9;

(VII) Prothrombin time--$9;

(VIII) PTT (partial pthromoplastin time)--$11;

(IX) Reticulocyte count--$10; and

(X) Sedimentation rate--$6.

(lii) Iron binding capacity--$16.

(liii) Iron panel--$87.

(liv) Iron, total--$11.

(lv) Lactic acid--$74.

(lvi) LDH (lactic acid dehydrogenase) isoenzymes--$41.

(lvii) LDH total--$10.

(lviii) lead, blood--$31.

(lix) Lead screen--$11.

(lx) Lipid profile, includes cholesterol; triglycerides; HDL; and low-density lipoprotein (LDL)--$28.

(lxi) LH (leutenizing hormone)--$32.

(lxii) Lipase--$14.

(lxiii) Liver (hepatic) function panel--$14.

(lxiv) Magnesium--$12.

(lxv) Osmolatity, blood--$63.

(lxvi) Osmolaity, urine--$87.

(lxvii) Parathyriod antibody, c-terminal, mid-mole--$92.

(lxviii) Phenylalanine--$38.

(lxix) Phosphorus--$9.

(lxx) Phosphorus, urine--$9.

(lxxi) Potassium, urine--$9.

(lxxii) Pregnancy test, serum--$13.

(lxxiii) Pregnancy test, urine (HCG-qualitative)--$13.

(lxxiv) Prolactin--$34.

(lxxv) Protein, total--$7.

(lxxvi) Protein, total, 24 hour--$10.

(lxxvii) PSA (Prostatic specific antigen)--$26.

(lxxviii) Rheumatoid factor--$10.

(lxxix) Serum, protein electrophoresis--$24.

(lxxx) Sodium--$9.

(lxxxi) T3 (Tri-iodothyronine) uptake--$11.50.

(lxxxii) T3, reverse--$45.

(lxxxiii) T3, total--$45.

(lxxxiv) Testosterone, total--$51.

(lxxxv) Thyriod peroxidate AB--$37.

(lxxxvi) Thyroxin, T4, total--$12.

(lxxxvii) Transferrin--$42.

(lxxxviii) Triglycerides--$10.

(lxxxix) Uric acid--$8.

(xc) Urinalysis with microscopic--$9.

(xci) Urinalysis without microscopic--$7.

(xcii) Urinalysis, auto, without microscopic--$9.

(xciii) Valprroic acid--$31.

(xciv) VMA, (vanillylmandelic acid)--$39.

(i) Fine needle aspiration, evaluation--$100;

(ii) Liquid based pap smear--$33;

(iii) Non-Gyn, smear, routine--$56;

(iv) Pap smear--$12;

(v) Pap smear with hormone evaluation--$112;

(vi) Pap smear, pathologist--$12; and

(vii) Pneumocystis, over 5 slides--$112.

(D) DNA (Deoxyribonucleic acid) analysis:

(i) Beta-Globin 6 mutation panel (HbS, HbC, Hb E, HbD, Beta-Thalassemias-29 and -88)--$150;

(ii) Beta-Globin 5 mutation panel (HbS, HbC, Hb E, Beta-Thalassemias-29 and -88)--$138;

(iii) Hemoglobin S and C mutation Test--$88;

(iv) Hemoglobin E mutation test--$88;

(v) Beta-Thalassemia-29 and--88 mutation test--$100;

(vi) Beta-Thalassemia-29 mutation test--$63;

(vii) Beta-Thalassemia-88 mutation test--$63;

(viii) Hemoglobin D mutation test--$63;

(ix) Beta-Globin sequencing (from 105 of cap site to IVS-1-60)--$188;

(x) Beta-Globin sequencing (from 105 of cap site to IVS-1-60) added to another test--$100;

(xi) Galactosemia--$506;

(xii) Galactosemia, DNA carrier analysis of family member--$206;

(xiii) Phenylketonuria--$600; and

(xiv) Phenylketonuria, DNA carrier analysis of family member--$206.

(E) Drugs:

(i) Amikacin level--$155;

(ii) Blood alcohol--$19;

(iii) DHEAs--$82;

(iv) Dioxin drug level--$23;

(v) Dilantin (phenytoin) drug level--$23;

(vi) Drugs of abuse screens, urine:

(I) 1 drug--$19;

(II) 3 drugs--$58; and

(III) 7 drugs--$135.

(vii) Gentamicin level--$29;

(viii) Insulin level--$20;

(ix) Isoniazid (INH), urine test, qualitative--$62;

(x) Lithium level--$13;

(xi) Phenobarbital level--$20;

(xii) Procainamide, NAPA drug level--$66;

(xiii) Quinidine level--$25;

(xiv) Salicylate level--$18;

(xv) Tegretol (Carbemazepine) level--$17;

(xvi) Theophylline (aminophylline) level--$25;

(xvii) Tobramycin level--$29; and

(xviii) Vancomycin level--$31.

(F) Genetics:

(i) alpha fetoprotein (AFP)--$31;

(ii) β-human chorionic gonadotropin (β-HCG)--$16;

(iii) unconjugated estriol-3 (UE3)--$22; and

(iv) triple screen, includes β-HCG, UE3, and AFP--$63.

(G) Mycobacteriology/mycology.

(i) Acid fast bacillus (AFB):

(I) amplification only--$69;

(II) concentration, any source--$12;

(III) culture, any source--$26;

(IV) culture probe only--$44;

(V) drug susceptibility studies:

(-a-) direct susceptibility, each drug--$10;

(-b-) disk method--$23;

(-c-) indirect susceptibility, each drug--$10;

(-d-) level 1 drugs:

(-1-) Ciprofloxacin--$100;

(-2-) Ethionamide--$100;

(-3-) Isoniazid--$100;

(-4-) Ofloxacin--$100;

(-5-) PAS (p-aminosalicylic acid)--$100;

(-6-) Pyrazinamide--$100; and

(-7-) Rifampin--$100.

(-e-) level 2 drugs:

(-1-) Azithromycin--$100;

(-2-) Clofazamine--$100;

(-3-) Cycloserine--$100;

(-4-) Ethambutol--$100;

(-5-) Kanamycin--$100; and

(-6-) Streptomycin--$100.

(-f-) level 3 drug, Capreomycin--$100;

(-g-) MIC (minimum inhibitory concentration)--$35;

(-h-) primary panel--$75; and

(-i-) secondary panel--$163.

(VI) identification, referred isolates--$31;

(VII) smear and culture--$56; and

(VIII) smear only--$19.

(ii) Direct High Performance Liquid Chromatography (HPLC)--$31.

(iii) Fungus:

(I) reference:

(-a-) culture--$75;

(-b-) identification--$69;

(-c-) identification, gen probe--$51; and

(-d-) probe only--$44.

(II) clinical:

(-a-) culture, fungi, blood (isolation and presumptive I.D.)--$21;

(-b-) culture, fungi, definitive I.D., mold--$25;

(-c-) culture, fungi, definitive I.D., yeast--$25;

(-d-) culture, fungi, other source except blood, isolation and presumptive I.D.--$20;

(-e-) culture, fungi, skin, hair, nails, isolation and presumptive I.D.--$19;

(-f-) India ink smear--$15; and

(-g-) PAS, fungal smear--$17.

(iv) M. kansasii susceptibility, Rifampin--$13.

(H) Newborn screening--$40. (Fees are based on the newborn screening specimen collection kit described in §73.21 of this title (relating to Newborn Screening), which includes the cost of screening).

(I) Parasitology.

(i) Blood/tissue parasites--$156.

(ii) Cryptosporidium preparation acid fast smear--$12.

(iii) Cryptosporidium screen, stool --$13.

(iv) Intestinal parasites--$119.

(v) Parasite culture--$169.

(vi) Pinworm swab--$31.

(vii) Worm identification--$44.

(J) Serology.

(i) Amoebic antibody--$31.

(ii) Anti-DNA, double stranded--$34.

(iii) ANA (antinuclear antibody)--$28.

(iv) Arbovirus:

(I) immunoglobulin G (IgG)--$63;

(II) immunoglobulin M (IgM)-$88; and

(III) panel--$150.

(v) Aspergillus --$31.

(vi) ASO (antistreptolysin O)--$21.

(vii) ASO (antistreptolysin O) titer--$21.

(viii) Brucella --$16.

(ix) C4 Complement, quantitative--$29.

(x) Cat scratch fever ( Bartonella )--$50.

(xi) CH 50 Complement, total qualitative--$29.

(xii) C-reactive protein, quantative--$11.

(xiii) Culture typing, immunofluorescent method--$12.

(xiv) Cytomegalovirus (CMV):

(I) IgG--$38;

(II) IgM--$44; and

(III) panel--$44.

(xv) Epstein-Barr panel--$156.

(xvi) Epstein-Barr virus antibody--$63.

(xvii) Erlichia --$50.

(xviii) FTA (fluorescent triponemal antibody) only--$38.

(xix) Fungus:

(I) identification--$69; and

(II) panel--$88.

(xx) Hantavirus, IgG/IgM--$94.

(xxi) Heliobacter pylori --$48.

(I) core total antibody--$38;

(II) core IgM antibody--$56;

(III) surface antibody (Ab)--$19; and

(IV) surface antigen (Ag)--$20.

(xxiv) Hepatitis B e Ab--$25.

(xxv) Hepatitis B e Ag--$19.

(xxvi) Hepatitis C (HCV)--$15.

(xxvii) Hepatitis C (RIBA)--$175.

(xxviii) Acute (comprehensive) hepatitis panel--$63.

(xxix) Herpes test, rapid method--$31.

(xxx) HSV (Herpes Simplex Virus) I, IgG AB--$128.

(xxxi) HSV I and II, IgG AB--$128.

(xxxii) HSV IgM AB with reflex titer--$128.

(xxxiii) HSV II IgG AB--$128.

(xxxiv) Human immunodeficiency virus (HIV):

(I) confirmation--$44;

(II) oral HIV, Orasure--$62;

(III) screen--$13; and

(IV) viral load--$175.

(xxxv) HIV/HCV panel--$28.

(xxxvi) Immunoglobulins, quantitative, IgG, IgA, IgM--$54.

(xxxvii) Legionella --$69.

(xxxviii) Lyme ( Borrelia ) IgG/IgM panel--$60.

(xxxix) Malaria antibody--$31.

(xl) Miscellaneous serological tests--$38.

(xli) Mononucleosis screen--$18.

(xlii) Mumps:

(I) IgG--$38; and

(II) IgM--$38.

(xliii) Mycoplasma antibody panel--$26.

(xliv) Parvovirus B-19, IgG/IgM--$75.

(xlv) Plague ( Yersinia )--$19.

(xlvi) Q-fever--$63.

(xlvii) Rheumatoid factor--$11.

(xlviii) Rickettsia Panel--$69.

(xlix) Rickettsia / Ehrlichia Panel--$119.

(l) RPR (rapid plasma reagent test)--$6.00.

(li) RPR/syphilis confirmation--$16.

(II) IgM--$44. (liv) Toxoplasmosis:

(liv) Toxoplasmosis:

(I) IgG--$50; and

(II) IgM--$50.

(lv) Tularemia ( Francisella )--$56.

(lvi) Varicella zoster --$56.

(lvii) VDRL (venereal disease research laboratory) test--$28.

(K) Surgical pathology:

(i) Level I, Global--$24;

(ii) Level II, Global--$60;

(iii) Level III, Global--$74;

(iv) Level IV, Global--$112;

(v) Level V, Global--$156; and

(vi) Level VI, Global--$227.

(L) Virology.

(i) Chlamydia culture--$100.

(ii) Dengue isolation--$100.

(iii) Electron microscope studies only--$356.

(iv) Herpes simplex isolation--$106.

(v) Influenza:

(I) surveillance--$156; and

(II) subtyping--$131.

(vi) Virus:

(I) viral detection by PCR--$125;

(II) virus identification on submitted isolate (reference specimen)--$313; and

(III) virus isolation, comprehensive--$263.

(2) Non-human specimens.

(A) Bacteriology.

(i) Environmental:

(I) Swabs--$31;

(II) Legionella --$88;

(III) bioterrorism--$250;

(IV) bioterrorism smear--$19;

(V) thermometer calibration--$38; and

(VI) weight calibration--$38.

(ii) Food.

(I) Bioterrorism--$250.

(II) Botulism ( C. botulinum )--$150.

(III) Pathogen panel:

(-a-) basic--$144; and

(-b-) complex--$350;

(IV) Single organism--$56.

(V) Standard plate count--$31.

(VI) Toxin--$56.

(iii) Milk and dairy products.

(I) Dairy, cultured--$44.

(II) Ice cream--$88.

(III) Milk:

(-a-) pasteurized milk panel--$119;

(-b-) raw milk panel--$150; and

(-c-) single test--$88.

(iv) Seafood:

(I) brevitoxin--$250;

(II) fecal coliform--$50;

(III) standard plate count--$44; and

(IV) Vibrios --$75.

(v) Water.

(I) Bay waters--$38.

(II) Coliform:

(-a-) fecal--$38; and

(-b-) coliform, total--$50.

(III) Potable water--$31.

(IV) Reagent water suitability--$113.

(B) Entomology.

(i) Insect examination, Chaga's disease--$31.

(ii) Insect identification--$25.

(iii) Mosquito identification:

(I) adult, per carton--$63; and

(II) larvae, per vial--$56.

(D) Serology.

(i) Arbovirus, equine, includes western equine encephalitis (WEE); eastern equine encephalitis (EEE); and west nile virus (WNV)--$63.

(ii) Hantavirus, animal--$94.

(iii) Plague ( Yersinia ), animal--$19.

(E) Virology.

(i) Arbovirus isolation:

(I) avian--$44; and

(II) mosquito--$75; and

(iii) Rabies testing--$81.

(iv) Rabies virus typing:

(I) molecular--$156; and

(II) monoclonal--$44.

(3) Handling fees.

(A) Clinical specimens and environmental samples--$38; and

(B) Pathogenic agents--$75.

(4) Service charges.

(A) A service charge of $15 will be added for work performed after hours (Monday-Friday 5:30 p.m. to 6:00 a.m. and Saturday and Sundays 12:00 p.m. to 7:00 a.m.).

(B) An additional charge of $15 will be added for after hours STAT analysis.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on December 21, 2006.

TRD-200606871

Cathy Campbell

General Counsel

Department of State Health Services

Effective date: January 10, 2007

Proposal publication date: July 21, 2006

For further information, please call: (512) 458-7111 x6972