Ley Clia Federal - Phsa_353

5/14/2018 Ley Clia Federal - Phsa_353

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S ec . 3 53 P U O U C H E A L T H S E R V IC E A C T 2 2 2Subpart2-Clinical LaboratoriesCERTI1l'ICATIONOF LABORATORIESSEC. 353. (263a] (a) DEFINITION.-Aa used in this section, theterm "laboratory" or "clinical laboratory" means a facility for the bi-ological, microbiological, serological, chemical, Immune-hematological, hematological, biophysical, cytological, pathological,or other examination of materials derived from the human. body forthe purpose of providing information for the diagnosis, prevention,or treatment of anydisease or impairment of, or the assessment ofthe health of, human beings.(b) CERTIFICATE REQUIREMENT.-No person may solicit Or ac-cept materials derived from the human body for laboratory exam-ination or other procedure unless there is in effect for the labora-tory a certificate issued by the Secretary under this section applica-

bleto the .category-of exanriIiations or procedures which includes'such examination or procedure.(c) ISSUANCE ANDRENEWAL OF CERTIFICATES~--(1) IN GENERAL.- The Secretary ~ay issue or renew a cer-tificate fora laboratory only if the laboratory meets the re-quirements of subsection (d).(2) TERM.-.A certificate issued under this section shall bevalid fora period of2 years .or such shorter period as the Sec-retary may establish.(d) REQUIREMENTS FOR CERTIFICATES.-(1) IN GENERAL.-A laboratory may be issued a certificateor have its certificate renewed if~(A) the laboratory submits (or if the laboratory is ac-credited under subsection (e), the accreditation body whichaccredited the laboratory submits), an application-c-(i) insuch form and manner as the Secretary shallprescribe,(ii) that describes the characteristics of the labora-tory examinations and other procedures performed bythe laboratory ineluding-

(I) the number and types of laboratory exami-nations and other procedures performed,(II) the methodologies for laboratory examina-tions .and other procedures employed, and(III) the qualifications (educational back-ground, training, and experience) of the personneldirecting and supervising the laboratory and per-forming the laboratory examinations and otherproeedures,and(iii) that contains such other information as theSecretary may require to determine compliance withthis section, and .the laboratory agrees to provide to the Secretary (or if thelaboratory is accredited, to the accreditation body whichaccredited it) a description of any change in the mforma- .tion submitted under clause (ii) not later than 6 monthsafter the change was put into effect,(B) the laboratory provides the Secretary-


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223 P U B L IC H E A L T H S E R Y IC E A C T S ec . 3 53(i) with satisfactory assurances that the laboratorywill be operated in - accordance withstandards issuedby the Secretary under subsection (f), or

w. : (ti) with proof of accreditation under 'subsection(e),(C) the laboratory agrees to permit inspections by theSecretary under subsection (g),(D) the laboratory ,agrees to make records availableand submit reports to the Secretary as the Secretary mayreasonably req1lire,and "(E) the laboratory agrees to treat proficiency testingsamplesfn thesame manner as it treats materials derivedmomthe human body referredto it for laboratory examina-tions .01' other"pr()cedm-esIn.-the '!ordinarycourse of busi-ness.(2) REQUIREMENTS FOR CERTIFICATES OF WAIVER.-.(A) lNGENERAL.-A laboratory which onlyperformslaboratory examinations and procedures described in para-graph (3) shall be issued a certificate ofwaiver or have itscertificate ofwaiver renewedn-(i) the laboratory submitsanappli~ation-(I) in such form and manner as the Secretary.shall prescribe, .(II) that describes the characteristics of thelaboratory examinations and other procedures per-formed by the laboratory, including the numberand types .o f laboratory exam.in!ltionsand otherprocedures performed,' the methodologies for lab-oratory examinations -and other procedures em-ployed, and the qualifications (educational back-ground, training; and experience) of the personneldirecting and supervising the laboratory and per-forming the laboratory examinations and otherprocedures,and(III) that contains such other information asthe Secretary may reasonablyreqwl'e to deter-mine compliancewith this section, and(ii) the laboratory agrees to make records avail-able and submit reports to the Secretary as the Sec-l'etarymay require.

(B) CHANGJi!s.-Ifa laboratory makes changes in theexaminations and other procedures performed by it onlywith respect to examinations and procedures which are de-scribed in paragraph (3), the laboratory shall report suchchanges to the Secretary not later than 6 months after thechange has been put into effect. If a laboratory proposes tomake changes in the exaroinationsand procedures per-formed by it such that the laboratory will perform an ex-amination or procedure not describedin paragraph (3), thelaboratory shall report such change to the Secretary beforethe change takes effect.(C) EFFEC'I'.~Subsections(0 and (g) shall not apply toa laboratory to which has been issued a certificate ofwaiv-er.


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S ec . 3 53 P U B l iC H E M .T H S E R V IC E A C T 2 2 4(3) EXAMINATIONS ANDPRQCEDURES.-The exarnin.ations

an.d .proce. dures ide.. Wi.. ed . in . I . .ragraph.(2) ar.e.laoo.ratory ex-aJDinations and procedures t have been approved by theFood .and Drug Administration for home use or that, as deter-mined by the Secretary, are simple laboratory examinationsand procedures' that have an insignificant risk of anerrcneouaresult, including those that-(A) employ methodologies tbatare so simple and accu-rate as to render the likelihood of erroneous results by theuse r negligible, or(B) the Secretary has determined pose no unreason-able risk 'of harm to the patient if performed incorrectly.(4)DEFINlTION.-As used in this section, the term "certifi-cate"includes a certificate of waiver issued under paragraph(2).(e) ACCREDITATroN.-

(1) IN GENERAL.-Alaboratory may be accredited for pur-poses of obtainingacertifi.cate ifhe laboratory-- . .(A) m,*tsthe standards ofa.n approved accreditationbody, and(B) authorizes the accreditation body to submit to theSecretary (or such State agency as the Secretary may des-ignate) suehrecords or other information as the Secretarymay require.(2) APPROVAL OF ACCR,EDITATION .BODIES.-(A) iN GENERAL.-TheSecretary may approve .a pri-vatenonprofitorganizationto be an accreditation body forthe accreditation of laboratories if-(i) using inspectors qualified to evaluate the meth-odologies used by the laboratories in performing lab-oratoryeJi,amjnations and other procedures, the ac-creditation body agrees to inspect a laboratory for pur-poses of accreditation with such frequency as deter-mined by Secretary,l .(il) the .standards applied by the body in deter-mining whether or not to accre.dita laboratory areequal to or more stringent than the standards issuedby the Secretary under subsection (t),(iii) there is adequate provision for assuring thatthe standards of the accreditation body continue to bemet by the laboratory,(iv)in the case of any laboratory accredited by thebody .which has had its accreditation denied,sus-pended, withdrawn, or revoked or which has had anyother action taken against it by the aCCrediting body,the accrediting body agrees to submit .to the Secretarythe name of such laboratory within 30 days of the ac-tion taken, .(v) the accreditation body agrees to notify the Sec-retary at least 30 days before it changes its standards,and

ISo in law. Pr'obably should be "the Secretary";


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22 5 P U B U C H E A L T H S E R V IC E A C T S ec . 3 53(vi) ifthe accreditation body has its approval with-drawn by the Secretary ,the body a gr e e s to notify each

l a bo ,, ' , ',ra,to,y,' a t" ere,, ',ted, b , ~ , h~e, b o d , , ' , Y , " ' the withdrawalwithin 10 days of th e wi '" awal.(B)CIUTERIA ,AND 'POOCEDURES.-,The Secretary shallpromulgate criteria and proeed\1l"esfor approving .an ac -creditation body and for withdrawing ~uch approval if theSecretary determin~s .that the accreditation body does notmeet the requirements of subparagraph (A).(C) EFFECTOFWITHDRAWAL OFAPPRQVAL.-'fthe, Sec -retary withdraws the, approval of an accreditation bodyunder subparagraph (B), the certifieate of any laboratory'accredited by the body shall continue ineffect for 60 daysafter th e laboratory receives notification of the withdrawalof the approval, except that the Secretary may extend . s u chperiod for a laboratory if it 1determines that the Iabora ..tory submitted an application for accreditation ora certifi-cate in a timely manner after receipt of the notification ofthe withdrawal of approval. Ifan accreditation body with-draws or revokes the accreditation of a laboratory, thecer-tificate. of the laboratory shall continue in effect---(i) for 45 days after the laboratory receives noticeof the withdrawal or revocation of the accreditation. or(ii) until the effective date of any action taken bythe Secretary under subsection (0.(D) EvALUATIONS.-TbeSecretary shall evaluate an-nually the performance of each approved accreditationbodyby-(i) inspecting under subsection (g) a sufficientnumber of the laboratories accredited by such body toallow a reasonable estimate of the performance of suchbody, and

(ii) such other means as the Secretary determinesappropriate.(3) REPORT.-,Tbe. Secretary shall annually prepare andsubmit, to the Committee on Energy and COmmerce of theHouse of Representatives and the Committee on Labor andHuman Resources of the Senate, a report tbat describes the re-sults of the evaluation conducted under paragraph (2)(D).(f)1STANDARDS.-(1) IN GENERAL.~The Secretary shall issue standards toassure consistent performance' by laboratories issued a certifi-catsunder this section of valid and reliable laboratory exami-nations and other procedures. Such, standards shall requireeach laboratory issued a certificate under this section-c-(A) to maintain a quality assurance and quality con-trol program adequate and appropriate for the validity andreliability of the laboratory examinations and other proce-dures of the laboratory and to meet requirements relating

l1?ection3 of Public Law lO()....o578 provides that. with respect to subsection (g)( 1) and sub-sections (h) through (m), any reference made in any of such subsections to the standards estab-lished under subsection (0 "shall be considered a reference to the standards established undersubsection (d) [of sectionSbd], as ineffect onDecember 31. 1 98 8 ." ,


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S e c . 353 P U B L I C H E A L T H S E R V I C E A C T 2 2 6to the proper collection, transportation, and storage ofspecimens and the reporting of results,(B) to maintain records, equipment,and facilities nee..essary for the proper and effective operation .ofthe labora ..tory,(C) in performiIlg and carrying out its laboratory ex-aminations .and other procedures, to use only personnelmeeting such qu.a1ificationsas the Secretary may establish~!~~~:::r:tti:: = r : b ! ~ = : : e W ~ : h 8 : ! : I l =fications shall take into consideration competency, train-Ing, experience, job performance, and education and whichq~cations sliall, as .approp'riate, be different on~hebaais of the type ofexammations and 'proeedures bemgperformed by the laboratory and the risks and con-sequences of erroneollSresults associated with suchexami-nations and procedures,(D) to qualify under a proficiency testing programmeeting thestand~ds established by the Secretary underparagraph (3), and . . .(E) to meet such other requirements as the Secretarydetermines necessary to assure consistent performance bysuch laboratories of accurate and reliable laboratory ex-aminationsandprooedures.(2) CONSIDERATIONS.- In developing the standards to beissued. under paragraph (1), the Secretary shall, within theflexibility provided under subparagraphs (A) through (E) ofparagraph (1), take into consideration-(A) the examinations and procedures performed andthe methodologies employed,(B) the degree of mdependent judgment involved,(C) the amount of interpretation involved,(D) the difficulty of the calculations involved,(E) the calibration and quality control requirements ofthe instruments used,(.F.) th.e typ... e of t.r~. g.reqUl..re. to operate the instru-ments used in the methodology, and(G) such other factors as the Secretary considers rel-evant.(3) PROFICIENCY TESTING .PROGRAM.-(A) JNQENE&AL.- The Secretary shall establish stand-ards for the proficiency testing programs for laboratoriesissued a certificate under this section which are conductedby the Secretary, conducted by 811.organization approvedunder subparagraph (0), or conducted by an approved ac-crediting body. The standards shall require that a labora-tory issued a certificate under this section be tested foreach examination and 'procedure conducted within .acat-eg?ry of examinations or procedures for which it has re-eeived ia certificate, except for examinations and proce-dures for which the Secretary has determined that a pro-ficymcy test cannot reasonably be developed. The testingshall. be conducted on a quarterly basis, .exceptwhere theSecretary determines for technical and scientific reasons


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2 2 7 P U B L I C H E A L lH S E R V I C E A C T S ec . 3 53that a .partieu1ar examination or procedure .may be testedless frequently (but not less often than twice per year).(B)CRlTERIA.":""Thetandards established .under sub-paragraph (A) shall-include uniform: criteria .for acceptableperformance under a proficiency testing program, based onthe available .technologyand the clini.cal relevance of thelaboratory examination 'or other procedure subject to suchprogram. The criteria shall. be established for all examina-tions and procedures and shall be uniform .for each exam-ination and procedure. The standards shall also include asystem for grading .proficiency testing performance to de-termine whether a laboratory has performed acceptably forapa.rticular quarter and acceptably for .aparticuiar exam ..ination or procedure or category of examination or proee-dure over a period .ofsuccessive quarters.(C) AJlPROVEDPROFICIENCYESTINGPROGRAMS.-orthe purpose of administerln.gproficien'cy testing programswhiehmeet thestandards,established under subparagraph(A), the .Secre tary shallapprove .a proficiency testing pro-..gram offered by a private nonprofit.organization ora .Stateiftbeprogrammeets thestandards established 'under sub-paragraph (A) and the organizationor'state provides tech-nicalassistance to laboratories seeking to qualify underthe. program. The Secretary shall evaluate.each programapproved under this subparagraph annually to determine.ifthe program continue.s to meet the standards establishedunder subparagraph (A) arid sha11withdraw the approvalof any program that no longer meets such standards.(D) ON-SITE'TESTING.-TIle Secretary shall perform,or shall direct a program approved under subp!U'agraph(C) ..toperform, onsiteproficiency testing to assure .compli-ance with the. requirements of subsection (d)(5)2 The Sec-retary shall perform, on an onsite or other basis,pro-ficiency testing to evaluate the performance of a pro-ficiency testing program .approved under. subparagraph (e)and to assure 'quality performance by a laboratory.(El 1'RAINJNG,TECHNICALSSISTANCE,NJ)ENHANCEDPROFICIENCYESTING.--TheSecretary may, in . lieu of or inaddition to actions a.uthorized under subsection' (b), (n , or(j), require. any laboratory which fails to perform accept-ably on an individualexamination and procedure or a -cat-egory of examination andpreeedures-e-(i) to undertake training and to obtain the nee-essary technical assistance to meet the requirementsof the proficency 3 testing program,

(ii) to enroll ina program of enhanced proficiencytesting; or(iii) to undertake any combination of the training,technicalassistance, or testing described in clauses (i)and (ii).1So in law . Probably should not be hyphenated, Compare with text of subparagraph (D),2S0 in law, Probably should be "(d)(l)(E)",3So in law, Probably should be "proficiency" .. . . .


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S ec . 3 53 P U B U C H E A L T H S E R V IC E A C T 2 2 8(F)TEsTlNG I tESULTS . .-- Th eS e c re t ary s h al l. e s ta bl is h a

system to make thereaults .of th e proficiency .~ pro-grams subject to the standards established by the Bee-r e.. . tary . U D . d e . r. sUb.par.gr . a .ph (A.).. av. i la b . . Ie. on areaso. .D . able.basis, uponrequeat of any person. The Secretary shall in-cludewithresults made available under this subparagraphsuc.h .e:qJlana:..ory. informa:.....on as..ma... be appropriate to as-sist inthe interpretation of such results.(4) NATIONAL ST.ANJ)ARDSJ.i'OR QUALITY ASSURANCE IN cr-

TOLOGYSERVICES.-(A) ESTABUSHMENT.-Tb.eSecretary shall establishnational s tand ard s forquaJityassuran.ce in .cytology serv-ices designed toasSttre consistent performance by labora-tories of valid andreliablecytologieal services.(B) . 8 T AN D AR D S. - . The standards established undersubparagraph (A) shall Inelude-(i) he maximum number of cytology .slides thatMy individual may screen in a 24-hour period,(ii)requirements that a clinical laboratory main-tain areeord of (I) the number .of eyt;ologyslidesscreened during each 24-hour period byeachindi-vidual wbo eJtomines cytology slides for th e laboratory,and (H) the number ( ) f hours devoted during each 24-h()ur period t() screening .cytologyslides by suchindi-vidual,(iii) criteria for requiring rescreening of cytologicalpreparations, such as (I) random rescreening of cytol-ogy specimens determined to be in the benign cat-egory, (H) focused rescreening of such preparations inhigh risk groups, and (HI) for each abnormalcytological result, rescreening of all prior cytologicalspecimens for the patient, ifavailable,(iv) peri()dicconfinnationand evaluation of theproficiency of individuals involved in screening or in-terpreting cytological preparati()ns, including an-nounced and unannounced on-site 1proficiency .testingof such i.ndividuals, with such testing to take place, totbeextentpracticable, under normalworkingcondi-tions, ,(v) procedures for detecting inadequately preparedslides, for assuring that no cytological diagnosis is.ren-dered on such slides, and for notifying referring physi-cians ofsueh slides,

(vi) requirements tbatallcytQlogical screening bedone on the premises of a laboratory that is certifiedunder this section,(vii) requirements f()r the retention of cyt()logy-slides by laboratories for such periods of time as theSecretary considers appropriate, and

(viii) standards requiring periodic inspection ofcy-tology services by persons capable of evaluating thequality of cytology-services.lSee footnote 1 for paragraph (3)(0).


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2 2 9 P U B U C H E A L T H S E R V I C E A C T S ec. 3 53(g) INsPECTIONS.-

(1) IN GENERAL.-he Secretary may, on an announced orunannounced basis, enter and inspect, during regular hours ofoperation," laoor.atorles which have been I s s ued .a .certificateunder this" sectien, In conducting such inspections the Sec-retary shall have access to ,fill facilities, equipment, materials,records, :and infOl"D18.tionbatthe .Secretary determines .haveabearing .onwhether the laboratory is being operated in accord-ance with thissection, As part of such an inspection the Sec-.retary may copy any. such material or require to it be 1sub-mitted to the Secretary. An inspection under this paragraphmay be made only upon presenting identification to the owner,operator, or agent.in charge 'of the laboratory being .inspeeted,(2) COMPLIANCEWITH REQUIREMENTS ANDSTANDARDS.-The Secretary shall conduct inspections of Iaboratories underparagraph (1) to determine their compliance with the require-ments of subsection (d) and the standards issued under sub ...section .(f). In$peetions of laboratories not accredited under sub-section (e) shal lbe conducted -ona biennial basis or with such-other frequency as -the Secretary. determines to be necessary toassure compliance with such requirements and standards. In-spections of laboratories accredited under subsection (e) shallbe conducted on such basis as the Secretary determines is nec-essary to assure compliance with such requirements and stand-ards.(h) INTERMEDIATEANCTIONS.- .(1) IN GENERAL.-IC the Secretary determines that a lab-oratory which has been issued a certificate under this sectionno longer substantially meets the requirements for theissuance of a certificate, the. Secretary may impose 'inter-mediate sanctions in lieu of the actions authorized by sub-section (i).(2) TYPES OJ! SANCTIONS.-he intermediate sanctionswhich may be imposed under paragraph (1) shall consist of-(A) directed plans of correction,(B) civil money penalties in an amount not to exceed$10,000 for each violation listed in subsection (i)(1) or foreach day of substantialnoncompIiancewith the require-ments of this section,(C) payment for the costs of onsite.monitoring, or(Dfanycombination of the actions described in sub-paragraphs (A), (B), and (C).

(3) PlloCEDURIllS.-The Secretary shall develop and imple-ment procedures with respect to when and how each of the in-termediate .sanctions is to be imposed under paragraph (1).Such procedures shall provide for notice to the laboratory anda reasonable opportunity to respond. to the proposed sanctionand appropriate procedures for appealing determinations relat-ing to the imposition of intermediate sanctions 2(i) SUSPENSION,REVOCATION,ND LIMITATION.-1So in law. Probably should be "require it to be".280 in law. The sentence Iacks a period.


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S ec . 3 53 P U B L I C H E A lT H S E R V I C E A C T 2 3 0(1) IN GENERAL.-Except as provided in paragraph (2), thecertificate of a laboratory issued under this section may be sus-pended, revoked, or limited ifthe Secretary finds,after reason-able notice ..and opportunity for hearing to the owneror oper-ator of the laboratory, that such owner or operator or any em-ployee of the laboratory-(A) has been guilty of misrepresentation in obtainingthe certificate,. . .. . .. (B.) has..p.ed.ormed.0.r rep..es.e.nted th.e. l.abo..a..toryas.. en-titled to perform a laboratory examination .01" other proce-dure which is not within a category of laboratoryexamina-tions or other procedures authorized in the certificate,(C) has failed to comply with the requirements of sub-section (d) or the standards prescribed by the Secretaryunder subsection (f),(D).has failed to comply with reasonable requests ofthe Secretary for-(i)any informationo.rinaterials, or(ii) work on materials,that the Secretary concludes is necessary to determine thelaboratory's continued efuribility for its certificate or con-tinued compliance with the Secre!!U"}"sstandards undersubsection (f),(E) 'has refused a reasonable request of the Secretary,or any Federal officer or employee duly designated by theSecr.e.arY.. for/ermIS.. s.0.n to .i.nspect th. laborato. ry and itsoperations an pertinent records during the hours the lab-oratory is in operation,

(F) has violated or aided and abetted. in the violationof any provisions of this section or of any regulation pro-mulgated thereunder, or(n). has not complied with an intermediate sanctionimposed under subsection (h).

(2)' ACTIONBEFOREA HEARING.~Ifthe Secretary deter-mines that--(A) the failure ofa laboratory to comply with thestandards of t.he Secretary under. subsection (f) presents animminent and serious risk to human health, or(B) a laboratory has engaged in an action described insubparagraph (D) or (E) of paragraph (1),the Secretary may suspend or limit the certificate of the lab-oratory before holding 'a hearing under paragraph (1) regardingsuch failure or refusal. The opportunity fora hearing shall beprovided no later than 60 days from the effective date of thesuspension or limitation. A suspension or limitation under thisparagraph shall stay. in effect until the decision of the Sec-retary made after the hearing under paragraph (1),(3) INELIGmILITYO OWN OROPERATELABORATORIESFTERREVOCATION.-Noperson who has owned or operated a labora-tory which has had its certificate revoked may, within 2 years...of the revocation of the certificate, own or operate a laboratoryfor which a certifieate has been issued under this section. Thecertificate of a laboratory which has been excluded from par-tieipation, under the medicare program under title XVIII of the


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231 P U B L I C H E A L T H S E R V I.C E A C T Sec . 353Social Security A ct because of actions relating to the qu.a1ity ofthe laboratory shall be suspended for the period the laboratoryis so excluded.(4) IMPROPER REFERRALS.-Any laboratory that the Sec-retary determines intentionally refers its proficiency testingsamples to another laboratory .for analysis shall have its .cer-.tijicate revoked for.at least one year and .shall be


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S ec. 3 53 P U B L I C H E A L T H S E R V I C E A C T 2 3 2(4) FINALITYOFJUDGMENT.-The judgment of the court a f-firming or setting aside, in whole or in part, any such actionof. the.. S.ecre.tary sh.all..b.e. fi.nat, s.u.hjed.. to..reVl.e. . by the. Su.-preme Court of the United States upon certi.orarior certifi-cation as provided in section 1254 of title 28, United StatesCode.

( 1 ) S .ANCTIO.N.S.-Anyp.r.son who. intenti.on.J. i l l . Y violates any re-quirement of this section or any re2\llati.on pr.omulgated thereundershall be imprisoned forn.ot more t6.an one year or finedundee title18, United States Code or both, except that if the conviction is fora second or subsequent violationof such a requirement such personshall be imprisoned for not more than 3 years or fined in accord-ance witb title 18, United StatesC.ode or both.(m)FEEs.-.(1) CERTIFICATEFEES.-The Secretary shall require pay-ment of fees for the issuance and renewal .ofcertificates, excepttha. t.. t.he ..S.c t . . e t a r y . shall .onl.y .eq.w . e a no.minal fee for theissuance and renewal of certificates ofwaiver. . .(2) ADDITIONALFEES.-.The Secretary shall require thepayment of fees for inspections of .laboratories which are notaccredited and f.orthe cost of peri'onningproficieney testing onlaboratories which do not participate inproficieney testing pro-grams approved under sulisection (0(3)(C).(3) CRITERIA.-(A) FEESUNDERPAR.AGRAPFi(l).-Feesimposed underparagraph (1) shall be sufficient to cover the general costsof administering this section, including evaluating andmOni.toring....roficieney. testing programs.. approved. un.d.ersubsection (0 and accrediting b.odiesand implementingand m.onitoring compliance with the requirements of thissection.(B) FEES UNDERPAR.AGRAPFi~).-Fees imposed underparagraph (2) shall be sufficient to' coeer the cost of theSecretary in carrying out the inspectionsandproficieneytesting described in paragraph (2).(C) FEli1$ IMPOSEDUNDERPAR.AGRAPHS1) ANlJ (2).-Fees imposed under paragraphs (1) and (2) shall vary bygroup or classification of laboratory, based on such consid-erations .as the Secretary determines are relevant, whichmay include the doUarvolume and scope of the testingbeing performed by the laboratories ..(n) INFoRM.ATIoN.-OnApril 1, 1990 and annually thereafter,the Secretary shall compile and make available to physicians and

the general public information, baf)edon the previous calendaryear, which the Secretary determines is useful in evaluating theperformance of a laboratory, including-(1) a list of laboratories which have been convicted underFederal or State laws, relating to fraud and ebuse, false bil-lings, or kickbacks,(2) a list of Iaboratories=-(A) which have had their certificates revoked, sus:"pended, or limited under subsection (i), or(B) which have been the subject of a sanction undersubsection (I),


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2 3 3 P D B u e H E A l I I I S E R V I C E A C T S e c . 3 5 4together with a statement of the reasons for the revocation,suspension, limitation, or sanction,(3) a list of laboratories subject to intermediate sanctionsunder subsection (h) together with a statement of the reasons.for the sanctions,(4) a list oflaboratories whose accreditationhas beenwith-drawn or revoked together with a statement of the reasons forthe withdrawal or revocation,(5) a list of laboratories against which the Secretary hastaken action under subsection (j) together with a statement ofthe reasons for such .action,and(6) a list of laboratories which have been excluded fromparticipation under title XVIII or XIX of the Social SecurityAct.The information to b e compiled under paragraphs (1) through .(6)shall be information for .the calendar year precectingthe date the

information is to be made available to the pubJicandshall be ac-companiedby such .explanatoryinformation as may be appropriateto assist in the interpretation of the information compiled undersuch paragraphs.(0) D2lJi:GATION.- In carryfug out this section, the Secretarymay, pursuant to agreement, use the services or facilities of anyFederal or State or local public agency or nonprofit private organi-zation, .and may pay therefor in advance or by way of reimburse-ment, and in such installments,as the Secretary may determine.(p) STATELAWS.- -(1) Except as provided in paragraph (2), nothing in thissection shall be construed as affecting the power of any Stateto enact andenforce laws relating to the matters covered bythis section to the extent that such laws are not inconsistentwith this section or with the regulations issued under this sec-tion.(2) If a State enacts laws relating to matters covered bythis section which provide for requirements equal to or morestringent than the requirements of this section or than the reg-ulations issued under. this section, the Secretary may exemptclinical laboratories in that State from compliance with thissection.(q) CONSULTATIONS.-. In carrying out this section, the Sec-retary shall consult with appropriate private organizations andpublic agencies.


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SOURCE .....


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a reference to the standards established under sabseetton (d) ofsuch section 353, as in effect on December 31, 1988.During theperiod beginning January 1, 1989, and ending December 31, 1989,subsections (a) through (d) and subsection (i) through (I) ofsuchsection 353 as in effect on December 31,1988, shall continue toapply to clinical laboratories. The remaining subsections of suchsection 353,as so amended, shall take effect January 1, 1990,except that subsections (t)(l)(C) and (g)(2)shall take effect July1, 1991,with respect to laboratories which were not subject to therequirements of such section 353 as in effect on December 31,1988."EFFECTIVE DATE--Section 5(b) of Pub. L. 90-174 provided that: "The amendmentmade by subsection (a) (enacting this section) shall becomeeffective on the first day of the thirteenth month after the month(December 1967)in which it is enacted, except that the Secretaryof Health, Education, and Welfare may postpone such effective datefor such additional period as he finds necessary, but not beyondthe firs.tday of the 19th month after such month (December 1967) inwhich the amendment is enacted."STUDIES--Section 4 olPub. L. 100-578 directed Secretary to conductstudies and submit report to Congress, not later than May 1, 1990,relating to the reliability and quality control procedures ofclinical laboratory testing programs and the effect of errors inthe testing proceduresandresultsoa the diagnosis and treatmentof patients.SECTION REFERRED TO IN OTHER SECTIONS--This section is referred to in sectiens 263a-2, 300aa-2, 1395x,1395aa of this title; title 35 section 287.

PUHLlC HEALTH LAW, SEC 354

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Ley Clia Federal - Phsa_353