G en. 225] 225

An “institution” is a hospi t al o r a “ lodgingfac ility .” HG §18- 1 202(a)

. H E AL T H

) C OM MUNICABL E D I SEASE S

— L ABORATOR IES

— A NONYM OUS H IV T EST S I TES R E MAI N P ERMI SSI BLE

J ul y26, 1993

The H onor abl e Paul a C

. H

ol l i nger Ma ry la n d

S e n a te

Y ou hav e request ed our op i nion w hether C hap t er 66 (H ou se B i l l 460) of t he L aw s of M ar y l and 1992 r equi r es anonym ous t es t i ng s i t es t o obt ai n and re por t t o t he count y heal t h offi cer a uni que pat i ent i dent i fy i ng num b er fort hos e w ho s eek t o be t es t ed fort he human im m u n o d e f

icie n c yv iru s (“ H IV ” ). T h e q u e stio n , in o th e r w o rd s, is w h e th er al l t estcenter s, even t ho se t hat w ou l d p referno tt o o btain t he i dent i fy i ng num ber , m us tdo so as a pre r equi s i t e t o t es t i ng for HI V.
For t h e rea s ons s etfor t h bel ow , w e conc l ude t hatC hapt er66 d o e s no t ba ra t e s tc e n t e rf r o m o b t a i n i n g a b l o o d s p e c i me n f r o m a pat i entw ho dec l i nes t o pr ovi de t he i nfor m at i on neede d fort he u n iqu e p ati en t iden ti fier, no r do es th e statute p rec lud e a labo ratory fr om t e s t i n g a s p e c i me n t h a ta r r i v e s a tt h e l a b o r a t o r ywi t h o u tt he u n iq u e p a tie n t id e n tif

ie r.

I Backg r ound
Un d e r§ 1 8

- 2 0 1 ( a ) o f

t h e He a l t h

- Ge n e r a l Ar t i c l e ( “ HG” A r t i cl e) , a phy s i ci an i s r equi r ed t o r epor t , by “name, age, r ace , s ex, and r es i dence addr es s of t he pat i ent , ” any“i nfec t i ous orcont agi ous di s eas e t hatendange r s publ i c hea l t h .

. . . ” H G §18-202 re qui r es t he s ame ki nd of r epor t i ng by“i ns t i tut i ons
. ” Fi nal l y , H G §18- 205( a) 1
r equi r es a medi cal l abor at or ydi r ect ort o r epor tan i ndi vi d ual by n a m e to th e h e a lth o f

f ice r o f th e c o u n tyw h e re th e lab o ra to ryis l ocat ed w i t hi n 48 hour s aft er an exami nat i on i f a s peci m en fr om t hat226 [7 8 O p
. A tt ’y

A l ow CD 4+c ount s ug g e sts tha t th e indivi du a l te ste d is 2 immunosuppressed, i.e., the p erson’s immune sy stem is compromised and not fully functional. Immunosuppression may indicate HIV infec tion, but it i s n ot c on c lus ive , b e c a use other dis e a se s a

nd c on dition s ma

y c a us e immunosuppression. Centers for D isease Control, Guidel ines for the Performanceof CD 4+ T-Cell Determinations in Persons with Human Immunode

ficiency Virus Infection, 41 Mo rb idi ty and Mo rt a lity W eekly Rep. No. RR-8 (May

8, 1992). i ndi vi dual s how s evi dence of ce r t ai n s peci fi ed cont agi ous di s eas es (fo r ex am p le, g o n o rrhe a, viral he p ati ti s typ e A , an d tu b e rcu losis). A l t hough H I V i nfec t i on, t he pr ecur s ort o A I D S, i s al s o an i nfec t i ous d ise a se , c u rre n t la w e sta b lish e s a q u ite d if f e re n t ru le w ith re g a rd to t he r epor t i ng of H I V t es tr es ul t s : “The di r ect oro f a medi cal l ab o rat or yi n w hi ch s erum s ampl es ar e t es t ed forhum an i m m unodefi ci encyvi rus m aynotdi s cl os e, di r ect l yori ndi r ect l y , t he i dent i t yof anyi ndi vi dual t es t ed forhum an i m m unodefi ci encyvi rus in an yrep o rt

. . . . ” H G § 1 8 -20 7 (d).
C hapt er66, eff

ect i ve O ct ober1, 1993, adds H I V i nfec t i on and “C D 4+ count , i f l es s t han 200/ M M 3, ” t o t he l i s t of condi t i ons t hat m u st b e re p o rte d u n d e r H G § 1 8 -2 0 5

. A s e x p lain e d in m o re d e tail 2 i n Par tI I bel ow , C hapt er 66 does not per m i t t he re por t t o cont ai n t he name of i ndi vi dual s w i th a l ow C D 4+ count orH I V i nfec t i on. R at her , C hapt er66 s peci fi es t hatt he r epor ti s t o cont ai n a “uni que pati ent i den t i fi cat i on nu m ber, ” t he use of w hich i s i ntend e d to f a c ili tate e p id e m io lo g ica l an a ly sis o f H IV in f

e c tio n a n d y e t to p r e s e r v e c o n f

i d e n t i a l i t y. A s w e under s t and pr es entH I V t es t i ng pr act i ces , a per s on m ay h a v e a t e s tp e r f

o r me d e i t h e rc o n f

i d e n t i a l l yo ra n o n y mo u s l y
. As defi n e d i n th e r e g u l a t i o n s gover ni ng H I V t es t i ng, confi dent i al t es t i ng m eans t hat“a pe r s on us es t he per s on’ s name as i d en ti fica t i on and that the p erso n ’s m ed ical reco rds c o n tai n the p erso n ’s na m e b u t are pr ot ect ed agai ns tdi s cl os ur e as pr ovi ded i n t he A nnot at ed C ode of M ar y l and. ” C O M A R 10. 52. 08. 02B ( 2)

. A nony m ous t es t i ng, on t he ot her hand, m eans “t hat a per s on does not us e t he per s on’ s name as i dent i fi cat i on and ca n onl y be i dent i fi ed t hr ough us e of an as s i gned pat i enti dent ify ing n u m b er.” C O M A R 1 0

. 5 2

. 0 8

. 0 2 B (1). Thi s pat i ent i dent i fy i ng num beri s a ra ndom l y as s i gned num ber t hat i s di ffe r ent fr om t he “uni que pa ti ent i dent i fy i ng num ber ” es t abl i s hed under C hapt er66. T he r andom num ber us ed i n anonym ous t es t i ng cannot b e trace d to the p ati en t; the u n iqu e p ati en t i d en ti fy ing n u m b er,G en. 225] 227

Subtit le 3 of HGT itle 4 contains e x tensive re quirements g overning 3 the conf identiality

of medical rec ords. A medical l ab o ra tory direc tor, moreove r, is prohibited from c ompili n g o r di stributing a list of name d patie nts wh o h avete ste d p os iti vefo r H IV o r who havea low CD 4+c ount. HG § 1 8

- 2 0 5 (h ) ( 2 ) ( a s amen d e d b y Ch a p ter 1 5 6 ( H o u s e B il l 3 7 5) of the L aws of Ma

ryland 1993). a lth o u g h n o t it se lf

re v e a lin g th e p a tien t’s i d e n tity , w ill c o n tain e le m e n ts th a t m ig h t b e tr a c e a b le to th e p a tie n t.
T h e p u rp o se b e h in d a n o n y m o u s tes tin g is to e n c o u ra g e p e o p le t o be t es t ed w i t houtfea rof l os i ng i ns ur ance orem p loy m en t or e x p e rie n c in g re p e rc u ss io n s fr o m f a m ily m e m b e rs o r oth e rs s h o u ld th e f act of the t estor i t s r esul tbeco m e pu bli cl ykn ow n d e sp ite c o n f id e n tiality r e q u ir e m e n ts. V irtu a llya ll o f th e tes t sites in 3 M ar y l and per for m bot h confi dent i al and anonym ous t es ti n g. For s om e t es ts i t es , t he pr ovi s i on of ano n y m ous t es t i ng i s a condi t i on esse n ti al t o the c o n ti n u ed fu n d ing o f th e sit e. F o r e x am p le, w e a re a w a r e of on e s uc h c l i ni c i n La nd ov e r , w hi ch i s fu nde d b yt he U

. S. C e n ter s f o r D ise a se C o n tro l.
A gainstt his back groun d, t he quest i on has ar i sen w hethera t est s i t e may cont i nue t o offe ranonym ous t es t i ng aft erC hapt er66 t akes e f f e c t o n O c to b e r 1 , 1 9 9 3

.

II
T he E vol ut i on of

H ouse B i l l 460 I nt o C hapte r 66
H G §18- 205 s et s for t h cer t ai n r equi r ement s fo r th e re por t i ng of cont a g i o u s d i s e a s e s
. I tr e q u i r e s t h e d i r e c t o ro f a me d i c al l abor at or yt o fi l e a r epor t of cer t ai n cont agi ous condi t i ons w i t h t he l ocal heal t h offi cer
. Speci fi cal l y , t he r epor t m us t i ncl ude the “na m e, ag e, sex, and r es i dence addr es s of the pat i entfr om w hom t he s peci m en w as t aken. ” H G §18- 205( b) ( i i ) 2. T hi s r equi r ement p a ra lle ls th o s e a p p lic a b le to p h y s ic ia n s a n d in s titu tio n s
. See HG § § 1 8 -20 1 (b)(3 ) an d 1 8 -20 2 (c)(1).
A s or i gi nal l y i nt r oduced, H ous e B i l l 460 added H I V i nfec t i on and l ow C D 4+ cou nt t o the l i st of r epo rt able con dit i on s. T h us, i ni t i al l y , H ous e B i l l 460 r ecogni zed no di s t i nct i on bet w een the228 [7 8 O p
. A tt ’y

Virtually identical leg islation was introduced in the 1993 Session. 4 SeeHouse B ill 416 and Senate B ill 336. Neither bill passed. r epor t i ng of H I V i nfec t i on and t he r epor t i ng of ot hercont agi ous d is e a s e s – a ll r e p o rt s w o u ld id e n tif yth e p a tie n t b yn a m e
. T he onl yexce pt i on t o H ous e B i l l 460’ s r equi r em entof r epor t i ng by name cal l ed fort he D epar t m entof H eal t h and M ent al H y g ien e (“ D H M H ” ) to “ d e sig n a te a t lea st 5 tes t sites e v e n ly di s perse d t hr oughoutM ar y l and t hatper for m H I V t es t s as a n o n y m o u s te st s ites .” T h e b ill w e n t o n to p ro v id e th a t “ th e id e n tity o f th e s u b

je c t o f a n H IV te s t p e rf

o rm e d a t a n a n o n y m o u s te s t s ite

... m a y n o t b e d iscl o sed

. ” A s ex p lai n ed in the flo o r rep o rt accom pan y i ng t he b i l l , t he p urpose o f t his provis i on w as as fol l ow s:

I n or dert o eff

ect i vely cont r ol t he s pr ead of H IV i nfec t i on , pu bli c health p rogram s m ust t ar gett he popul at i ons and ar eas w her e t he i nfec t i on occur s w i t h educa t i on and t r eatm ent p ro gram s. T he best w ay t o do this i s to pr ovi de anonym ous t es t i ng s i t es w her e hi gh r i s k per s ons m aybe t es ted and pr ovi de demogra phi c i nfor m at i on w i t houtr evea l i ng t heiri den t i t i es. Studi es h av e d em o n str ated that m an yhi gh r i s k popul at i ons do not gett es t ed bec aus e t hey a r e a f ra id th e ir id e n tityw ill b e c o m e p u b lic a n d d isc rim in a tio n w ill re su lt. T h is b ill w ill al l ow t hes e per s ons t o be t es t ed w i t hout r evea l i ng t hei r names, w hi l e provi di ng cr i t i cal i nfor m at i on conce r ni ng t he s pr ead o f t he d is e a s e
. T h e b i l l a l s o r e p e a l e d t h e c o n f i d e n t i a l i t yr e q u i r e me n to f HG §18- 207. T hus , as or i gi nal l yi ntr o d u ced, t he onl ypr ovi s i on for

4 anonym ous H I V t es t i ng i n H ous e B i l l 460 w as the des i gnat i on of t he f iv e a n o n y m o u s te s t c e n te rs
. D ur i ng cons i der at i on byt he H ous e and Senat e, H ous e B i l l 460 u n d e r w e n ts e v e r a l s i g n i f i c a n ta m e n d m e n t s
. F i r s t , a n d m o s tn o t a b l y, an exc ept i on t o t he nam e re por t i ng r equi r ement underH G §18- 205G en. 225] 229

As e n a c te d , Ch a

p ter 6 6 r e qu ire s D H M Hto d e v e lo p a unique 5 p at i e nti d e nt i f

yi n gnumb e r

s y s t e mt o b e i mp l e m e nt e d O c t o b e r 1 , 1 9 9 3

. In developingthe sy stem, DHMH is to “consider the use of ide ntifiers commonly

availableto health ca

re providers” a

nd is to “consult with the Medica l and Chirurg ical F aculty of Mar yland, the Mar

yland Hospital As so c iatio n, theGo ve rn or ’s Counc il o n HIV Pre ve nti on and Tre atme nt, AIDS ad v o c ac y gro u p s , a nd any other org anizations itdeems a ppropriate .”
The c ollection of this information may help to control the spre ad 6 of HIV i nf e c tio n a nd also ma

y inc re a setheamou

nt o f f e de ral A IDSre late d f un din gthat th e Statere c e ive s. Th is un c e rt a int

y is illus tr ate d by the fa c t that le g isl atio n, House 7 Bill 9 0 7 , wa s introduced during the1993 Session to make expli cit that anony mous test centers werenot require d to use the unique patient identifying numbe r. On the other hand, House B ill 480, also introduce d in the 1993 Session, would have require d anony mous te st sites to use the unique patient identifying numbe r. Ne ither bill passed. w as cr eat ed. Speci fi cal l y , H G §18- 205 w as amended t o pr ovi de t hat “r epor t s of hum an i m m unodefi ci encyvi rus i nfec t i on and C D 4+ countu n d er 200/ M M 3 [s hal l s t at e] t he uni que pat i ent i dent i f yi ng nu m ber, a g e , s e x , a n d z i p c o d e o f r e s i d e n c e o f

t h e p a t i e n t

. . . . ” HG § 1 8 -20 5 (b)(1 )(i i) B (em p h asis ad d ed ). C o n fo rm ing c h an g es w ere 5
m ad e to t h e rep o rt ing o b li g ati o n s o f ph y sici an s an d insti tuti o n s: I n the c ase o f “ asy m p tom ati c [ H IV ] i n fe ctio n , ” the ytoo are to rep o rt notby n am e butr at herbyuni que pat i enti dent i fi er
. H G §§18- 201( b) ( 3) ( i i ) and 18- 202( c) ( 1) ( i i )

. A tt he s ame t i m e, t he pr ovi s i on fort he es t abl i s hm en t of fi ve anonym ous t es tcent er s w as del et ed, a n d th e c o n f

id e n tia lity re q u ir e m e n t o f H G § 1 8 -2 0 7 w a s re s to re d

. T hes e amendm ent s t o H ous e B i l l 460 s ugges t s t r ongl y t hatt he G ener al A s s embl ys oughtt o fi nd a compr o m ise thatbal ance d t he p riv a c yi nter est s of pe rs on s bei ng t est ed ag ai nstt he p ub l i c health p o licyin te r e st in th e c o llec tio n o f a c c u ra te d e m o g ra p h ic d a ta conce r ni ng H I V cas es
. W h ati s notatal l cl earfr om t he 6 amendm ent s , how ever , i s how t he G ener al A s s em b ly int ended the new report i ng requi rem ents t o ap plyt o an on y m ou s t est s si t es. W e 7 tu rn n o w to a n a n a lysis o f th a t is s u e
.230 [7 8 O p
. A tt ’y
III
N a tu re o f R ep o rtin g R eq u irem en ts
I n det er m i ni ng w h et hert he G ener al A s s embl yi nt ended the uni qu e p a t i e n t i d e n t i f

i e r t o b e u s e d wi t h s p e c i me n s o b t a i n e d at an a n o n y m o u s te st s it e , w e lo o k f irst to th e lan g u a g e o f

th e sta tu te itse lf. O b v io u sly , “w h a t th e leg isla tu re h a s w ritten in a n e f f o rt to achi eve a goal i s a natur al i ngr edi ent o f ana l y s i s t o det er m i ne t hat goal

. ” Kaczorow ski v. C i t y of Ba l t i m ore , 309 M d. 5 0 5 , 5 1 3 , 525 A .2 d 6 2 8 (1 9 8 7 )

. L ik e w ise , the G e n e ra l A ss e m b ly ’s f a ilu re to i ncl ud e lang u age i n a s t atut e i s atl eas ti ni t i al l ys ugges t i ve of a l egi s l at i ve dec i s i on nott o pur s ue an obj ect i ve. C hapt er66 s i m pl ydoes notaddr es s rep o r t i ng byanonym ous t es ts i t es
. I tdoes nots ay tha tt es ts i t es m us ts ol i ci torobt ai n any par t i cul ari nfor m at i on. I tdoes not s ayt hatt es ts i t es ar e pr ohi bi t ed fr om s ubm i t t i ng bl ood foran H I V t es tw i t h o utt he uni que pat i ent i den t i fi er. N or does an y t hing i n the l egis l at i ve record refl ect t hese obj ect i ves i n a manners ugges t i ng an i nadver t ent om i s s i on fr om t he s ta tu to ry te x t. C

f

. Kacz or ow s ki , 309 M d. at518-20 (ev ide nce of “p aten t draf

ti n g erro r”).
T o be s ur e, i tcan be ar gued t hatt he del et i on of t he r equi r ement t hatD H M H des i gnat e fi ve anonym ous t es ts i t es , co n tai ned i n t he fi r s tr e a d e rv e r s i o n o f

Hou s e Bi l l 4 6 0 , i s e v i d e n c e o f t h e Gen e r al A s s embl y ’ s i nt entt o r eq u ir e all t es ts i t es t o us e t he uni que pat i ent i dent i fi er
. T he l aw as ul t i m at el y enac t ed, how ever , s i m pl y m akes no r efe r ence t o t es ts i t es t hemsel ves. O n t he bas i s of a ba r e i nfer ence a lo n e , w e a re u n w ill in g to im p o se a re q u ire m e n t o n tes t sites th a t is now her e t o be found i n t he s t atut or yt extand now her e di s cus s ed as a n o b j e c t i v e i n t h e l e g i s l a t i v e h i s t o r y. C hapt er66 d id

l egi s l at e r equi r ement s appl i cabl e t o phy s i ci ans and lab o ratorydi r ect or s
. W e tur n t o t hos e r equi r ement s t o s ee w het her t hey r equi r e a per s on s eeki ng an H I V t es t t o di s clos e t he el ement s of a uni que pat i enti dent i fi eras a pr er equi s i t e t o get t i ng t he te s t.
T he t ypi cal pat i entatan ano n y m o u s t es ts i t e has notbeen r efe r r ed t o t he s i t e bya phy s i ci an. N ever t hel ess, so m e phy s i ci an necessari l yhas ult i m at e res po nsi bil i t yfor t he p ract i ces att he tes tG en. 225] 231

s i t e. U nl es s the p erson dr aw i ng t he bl ood i s t he des i gnee of a phy s i ci an, he ors he w oul d be engagi ng i n t he unaut hor i zed pr act i ce o f m e d ic in e b yd ra w in g b lo o d f o r d ia g n o s tic p u r p o s e s
. See §14- 1 0 1 (j ) of the H e a lth O cc u p ati o n s A rt icl e. M o reo v er, a l ab o ratory per for m s an H I V t es tpur s uantt o a pr operm edi cal or dert o d o s o. See H G § 1 7 -2 0 2 .1 (c ); C O M A R 1 0 .5 2 .0 8 .0 4 A

. So, as w e s ee i t , t he phy s i ci an w ho s uper vi s es t he t es t s i t e i s t he phy s i ci an of the pat i ent s w ho s eek t o be t es t ed t her e, atl eas tfort hat l i m i t ed purpos e. T he fi r s t i s s ue, t hen, i s t he obl i gat i on t hatC hapt er 66 i m pos es on t hatphy s i ci an. W hen a pa t i entw al ks i nt o a t es ts i t e t o have bl ood dr aw n, t he p h y sic ian in c h a rg e o f

th e site w ill o rd in a rilyh a v e n o “ re a so n to s us pectt hata pat i ent under t he phy s i ci an’ s car e has a n i nfec t i ous or co n tagio u s d isease that en d an g ers pu b li c he alt h

. . . . ” H G § 1 8 -20 1 (a). If a p at i ent has “ a sy m

p to m a tic [H I V ] i nfec t i on, ” as di s t i nctfr om A ID S , the o n lyw a yto k n o w w h e th e r th e p a tien t h a s th e d ise a se is t o t es tt he pat i ent ’ s bl ood fort he pr es ence of a n ti b odi es
. B efor e a pos i t i ve t es tr es ul ti s know n, t he phy s i ci an has not hi ng t o r epor t , and t he l aw i m pos es no obl i gat i on on t he phy s i ci an t o obtai n uni que id e n tify in g in f

o rm a tio n in a n ticip a tio n o f a p o ss ib le f

u tu re re p o rt. N o r do es th e law p roh ibitthe p h y sici an fro m d raw ing b loo d (t h rou gh a des i gnee) and or der i ng t he t es tw i t houtobt ai ni ng t he i nfor m at i on.

W hen a bl ood s peci m en fr om an anonym ous t es ts i t e arr i ves at a l abor atory w ithoutt he uni que pat i enti dent i fi er , does C hapt er66 pr ohi bi tt he l abor at or yfr om t es t i ng t he s peci m en? T he s t atut e does no texp res sl yi m po se t hat pr oh i bit i on , and w e do no t beli eve thatso si gni fi cantan i nt er fer ence i n t he phy s i ci an- pat i entr el at i ons hi p
) pr event i ng t he phy s i ci an’ s or derfort he t es t fr om bei ng carr i ed out

)i s pr oper l yi nferr ed, atl eas ti n t he abs ence of expl i ci tl egi s l at i ve hi s t or yi dent i fy i ng t hi s i nt ended r es ul t

. A l abor at or ydi r ect or , i n our v iew , m a ytes t al l speci m en s re c e iv e d in a c c o rd a n c e w ith a p p ro p ria te p roc ed u res. If th e t est is p o sit ive fo r H IV , the d ir ec tor m u st r ep o rt w h a tev e r i n f

o rm a tio n item ize d in H G § 1 8 -2 0 5 (b )(ii) is a v a ilab le to t he di r ect or
. T he di r ect orcannotr epor tw hat has not been pr ovi ded.232 [7 8 O p
. A tt ’y

We have no occa sion in this opinion to c onsider the ef fec t of any 8 regulations that DHMH might a dopt to impl ement Chapter 66. I n s hor t , C hapt er 66 does not pr eventt he oper at i on of s i t es for anonym ous H I V t es t i ng. 8

IV
C oncl usi on
In su m m a ry , itis o u r o p in io n th a t:
1

. A ce n ter m ay take a b loo d sp ec im en fo r pu rpo ses o f H IV t es t i ng even i f a pat i ent decl i nes t o pr ovi de t he i nfor m at i on neede d to c re a te a u n iq u e p a tie n t id e n tif y in g n u m b e r. 2

. A labo ratoryd ir ec tor m aytesta b loo d sp ec im en fo r H IV even i f t he s peci m en i s notacc om pani ed bya uni que pat i ent id e n tif y in g n u m b e r.

J. Jo sep h C u rran , Jr. A t t or ney G ener al
Ja c k S c h w a rtz C hi ef C ouns el O pi ni ons & Advi ce
M ar yO ’ M al l eyL unden A s s is ta n t At t or ney G ener al
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