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3702 Fe dera l Regis ter / Vol. 68. No. 16 / Friday, January 24, 2003 / Rules and Regulations


-


Amendmeuts of 1988-the example of


FDA premarket clectrance or a p pro va l.


, 7 In§ 493.45(c)(3), remove the - ­


E

1111 ••

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the C li nical Labora to ry lmpr ove me1\l

pediatric office , bascd cholesterol

screening." Pedia tric :; 96. 2 (1995). pp,

. 230- 234.

Ward-Cook, K.. and Suzanne Tannar. "2000 wage and vacancy survey of medic.ii laboratories." Laboratory Medicine 32, 3,

(2001), pp,124- 138.

Go,ernment. Office of Personnel


this inc:ludes test systems exempt from

*

Reportable range means the spa n of

les t result values over which the laboratory can establis h or ver i fy the accuracy of the instru men t or test system measurement response.

* "


§ 493.45 [Ame nded ]

I.

reference to' 's ubpart P".

§ 493.47 [Amended)

8 . Amend §493.47 as follows:

a. In paragraph (c)(2). remove the reference to "subpar t P" ,

b. In paragraph (c)(3), remove the


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Management. Central Personnel Data file. "Retirement Projections, Fiscnl Years

2 001- 200 5 .' ' h ttp ;//t vivw.o pm .gov/ feddata/ rclirelr s-projl'!ctions.pd f. (April 16 , 20 02) .

Lis t of Subj ec ts in 42 FR·Par t 493 Grant programs- health. Health

facilities. Incorporation by Reference,

Labora tories, Medicaid, Medicare,

Reporting and recordkeeping requ iremen ts.

For the reasons set forth in the preamble. the Centers for Medicare & Medicaid S ervices is amend ing-42 CFR Chapter IV part 493 as set forth below:

PA T 49 3- LABO RATO RY REQUIREMENTS

l. The authority citation for part 493 con tinues to read as follows:

Au thori ty: Sec. 353 of the Public H11alth Service Act, secs . 1'102. 1861(e), the s;:ntcnce following sec tions 18!i1(s)(11) through 1861(s)(l6) of the Social Security Act (42

263a, 1302, 1395x(c). and tho sentence

followi11g l 39 5x(sl( 1 1 ) through 1395x(s)(16)).

Subpart A-G eneral Provisions

2. In § 493-2, the introductory tex t is republished. and the following definitions are added in alphabetical order to read as follows:

§ 493.2 De finition s


Test system means th e ins tr uc tions and all of the instrumentation. equipment, reagents. and supplies needed to perform an assay or examinatio n a n d genera te test results.

§ 493.3 [Am end ed]

3. Amend §493.3, as follows :

a. In paragra ph(b)(3), remove the words '' National Ins tit u tes on Drug Abuse (NIDA)" and add. in their place, the words "Substance Abuse and

Men tal Health Serv ices Adm i nis tration (SAMHSA )" :

b. ln paragraph (b)(3). remove the

word "NIDA" and add, in its place, the word "SAMtlSA",

§ 493.20 (Amen ded]

3a. Amend § 493.20, as follows:

a. In paragraph (b). remove the reference to " subpart P".

b. ln paragraph (b). remove the cross reference to "§493.1777" and add. in its place"§§493.1773 and 493.1777".

c. Jn paragraph (c). remove the cross

reference to "§§ 493.15(e) and 493.1775 " and add, in its place.

"§§ 493.lS(e), 493.1773 . and 493.1 775, "

§ 4 93 .2 5 [A me nded)

4. Amend § 493.25 as follows:

a. In paragraph (b), remove the

re


cross reference to"§ 493.1776" and add. in its place. "§§493.1773 and 493.1775''.

§ 493.49 [Amended] •

9. In §493.49(a)(3). remove the • reference to ''s ubpa rt P".

Subpart F-General Administr ation

§'493. 643 [Amend ed)

10. In § 493.643(c )(3)(ix). add the word "Clinical" before the word

" Cytogenetics ".

Subpart H- Partlcip ation in Proficiency Testing for Laboratories Performing Nonwaived Testing

11. Revi se the heading of Subpart H to read as set forth above.

§ 49, 3 80 1 [ Am e nd e d]

'12. In§ 493.801{a)(2)(ii), remov tho cross reference lo ·'§ 493.1709" and add. in its place. "§493.1236(c)(1)".

§ 493.803 (Amende d)

13. In § 493.803(a), remove the words ' 'tests of moderate complexity (including the subcategory) and/or high compl ex ity" and add, in their place , the words "nonwaived testing".

§ 49,3 807 (Amended)

14. Revise the heading of §493.807 to


As used in this part, unless the

r.ontext ind ica tes otherwise-

=-:,:..

•£.

t

and syst

Calibration mean.s a process of testing

ference to "subpart P".

b.In paragraph (c). remove

reference to "subpart

P".

c. ln paragraph (c). remove


th e


read as follows:

§ 493.807 Con ditio n: Re insta teme nt o f

la bo ra to ries pe rio rming no nwaive d te s ting.


....

..

'I

..

-

. .

adjusting an instrument or lest em to establish a correlation

'I ...

- .....

between the measuremen t response and the concentra tion or amou nt of the substance that is being measured by the test procedure.

....-.:

...

Calibration verification means lhe assaying of mate rials o f known

"§ 493.1777" and add, in its place, "§§ 49, 3 1773 and 493.1777'.'.

cl. l n paragraph (d), remove the

reference to " s ubpar t P".

e. In paragra ph (d ). remove the cross reference to''§§493.15(0) and

493. 1775 '' and add, in its place.

"§§ 493.lS(e), 493.1773, and 493.1775".


Subpart I- Proficiency Testing

Programs for Nonwaived Testing •

15. Revise the heading of subpart I to read as set forth above.

§§ 493.911, 493.913, 493.915, 493.917,

493.919, 493.923, 493,927, 493.931, 49,3 933,

493.937, a nd 493.941 [Amend ed)

..·-..

....

instrument or test system's calibration


Microscopy Procedures, and


493.919(c)(1), 493.923(b)( 1). •


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concentration in the same manner as

patient samples to substantiate the

throughou t the reportable range for patient test results.

FDA-cleared or approved test sys t em means a test system cleared or approved by the FDA th rough the premarket .

no tification (510{k)J or premarke t appro\·al (PMA) process for in-v i tro diagnostic use. Un less o therwise stated,


Subpart C- Registration Ce_rtificate,

Certificate for Provider-Periormed

Certificate of Compliance •

§ 493.43 [Amen de dJ

ty. or

add. ed tes

• •

6, In § 493.43(a}, remove the words " tes ts of modera te complexity (including the subca tegory) or high

.....

r.omplexi any com bination or these

tests." anrl in their place. the words

·•nonwai \· ting" ,

....·.

16. ln §§ 493.911(c)(1), 493.91 3(r.)(l ).

493.9 15(c)(1] . 493.917(c)(1).

4.93.927(c)(1), 493.931(c)(l).

493.933(c)(1), 493 .937(c)( 1), and

493.941{c)(1), remove "90 percent" and add, in its place. "80 percent" wherever it appears.

§ 493.945 [Amende d]

17. ln § 49, 3 945 (a l(1), remo\·e

"§ 493.1 25i '' and add. in its place.


-- • Federal Regis te r / Vol. GS, No. 1G / Frid ay, January 24, 2003 / Rules and Regulations 3703


'§§ 493.1 J 05(a)(7)(i)(A) am t .•

193 .12 7 4(f)(2)".

18. Subpart J, co nsis ting of

i§493.1JO0 thr ough '193 . 11 0 5. a n d

...

•• •

.ubpart K. consisting of§§ 493.1200 hrough 493.1299. are revised to read a$ allows:

• •

,ubpart J- Facility Administration for

on wai ved Testing

iec .

,93.1 1 00 Condition: F,1c:ililv • ad mi11is 1n11ion. ·


9:l.12:',4 Standard. tv!aintcn,mcc ;,nd function chcd .

49:! 1255 S1andard : Calibration ,ind calib ration ,·er,f1cation procedu res.

493.125G Standnr<l: Control proced ures.

49 3.126 1 Standa r<I: Dacteriolngy. 493.1262 Standard: Mycobactcriology . '193.1263 Standard · Mycology.

493.1 2(;.! Sta ndard: Parasitology.

493. J 265 Sta11dard: Viro logy. •

G7 S ta ndard: Ruuti ue chcmistn· .

<l93.1269 S tandard · l-!c111a tology. ·

'!93.1271 Standard: l111mu nuhematology.

493.1 273 Sta11d ard: Histopath olog y.


ensure protection from physical. chemic:al, biochemical. and electrical hazards, and biohazardous materials.

(e) Records anti, as applicable. slides. blocks, and tiss ues must be maint ained and stored under conditions that ensure proper preservation .

§ 493.1103 Standard: Requirements for trans fusion services.

A facility that provides transfusion services must meet all of the

req ui remen ts of thi s section and

Text Box: •


...


••

,93.1101 Standard: Fac:ilities.

,93.1103 S1andard '.Requirements for transfusion ser\'ices.


493.1274 Standard; Cytology.

493.1 27G S tandard: Clinical cytogcneti <.s .

• •

I

••

I

493.1278 Standard: Histocompatiliility.

document all transfusion-related

aclivilics.

(a) Arrangement/or services. Tho


,93.1105 Standard: Re tention requi rcmc11ts

,ubpart K-Q uality Systems for No nwaived

·es ting

93.1200 l11troduc1ion

493.128 1 Standard: Comparison of test

results.

'!93.1282 Standard: Corrective actions.

493 .128 3 S tandard ; Test records.

493.1189 Standard Analytic systems


facility must have a transfusion service agreement reviewed and approved by the res po nsible party(ies) that go\·orn the procurement. transfer. and

prod ucts. • • •

avai labi lity of blood and blood

• ••

•I •


- 93.120 1 Condi tion: Bac terio logy.

-93. 1 20 2 Conditio n: Mycobactcriology.

-

93.1 20 3 Condition: Mycology.

,93.120 4 Condition : Parasi tolog}' ·

-

93.1 205 Condition. Virology ,

-93.1207 Condit ion: Syphi lis serology.

·93 1208 Cond ition : General im mu nologv.

- 93.1210 Condition Routine r htmiis tr y.

:93.121 1 Condition : Urinalvsis.

,9 3. 12 1 2 Condi tion : Endoc;inology.

,93. 121 :J Co ndition: Toxico logy.

•9 3. 121 5 Condition : Hematology.

93.1 217 Condition · lmmunohcmatology.

- 9,3 1219 Condition · Histopa1hulogy.


assessmen t.

Postana lyti c Sys te ms

493 .129 0 Condi tion: Postanalytic systems

493.1291 Standard: Test.report .

493. 1 299 Standard: Postanalytic systems asse,ssmenl.

Subpart J-Facility Admini str ation for

Nonwaived Testing

§ 493.1100 Condition : Facility administration.

Each laboratory that performs


(b) Prov is io n of t esting . Tho facility • •

must provide prompt ABO grnuping, • •

])(Rho) typing. unexpected antibody detec tion. com patib ility losting, and

laboratory investigation of transfusion •

I

reactions on a cont inuous basis thr ough

a CUA-certified laboratory or a laboratory meeting equivalent requirements as determined by CMS.

(c)

.,

Dlood and blood products storage

a11d distribution. (1) If a facility stores r


,93. I220 Cond ition· Oral patliolog- ·

103. 1221 Cond itio n: C)•tology.

, 9J . l 125 Condition: Clinica l ,:yl0!;c ni:tic:s.

,93.1226 Condition. Rad iobioassay .

193.1227 Condition: Histoc;ompatil,ilitr,

, enera l Lalioratory Systems

••

19:1.1 2:J0 Co ndition : Ge neral labo rntory systems.

193.1231 Slandard : Confiden liali tv of

pa tient information, ·

19 3.123 2 Standard: Spc<.:imen idenlificatiun and in tei:rity.

193. 1 233 Standard : Complaint investi gat ions .

19:1.123q S tandard : Com mu nicatio ns,

193.1235 Standa rd. Porsonnel compc tem:y assessment policies.

193.1236 Standard: Evalua tio n of proficiency t;,sting perforrnanc:t{.

-

,

I

••

I

19:1.1239 Standard: Genera l laboratory systems assessment.

nonwa iv ed testing must mee t the ap plicable requirements und er

§§ 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the Stale Operatipns Manual (CMS Pub. 7).

§ 493.11 01 Standard: Facilities.

(a) The laboratory must be

constru c ted, a rranged, and main ta in ed to ensure the following:

(1) Tho space, \·entilation, and utilities necessary for conducting all phases of the testin g proc ess .

(2) Contamination of p a tie 11t

specimens. equipment. instruments , reagents, materials, and supplies is minim ized.

(3) Molecular am plificati on


or maintains blood or blood products for trans fusio n outside of a monitored refrigera tor. the facility must ensure the storage conditions. including

tempera ture, are app ropriate to prevent deterio ration of the blood or blood product.

(2) The facility must establish and follow policie s lo ensure positive identification of a blood or blood produc t recipi en t.

(d) lnvestigotion of transfusion

rea c tion s. The facilitv mus t have procedures for preve ling transfusion reactio n s and when necessary, promptly id e n tify. inves tiga te, and report blood and blood product transfusion reactions to tho laboratory and. as appropriate, tv

• -.

. :..-

••

f ederal and S tate autho riti es. •

·


-

....


I I

. • r

' reana lytic Systems

r

193.1240 Condi tion : Prea nalytic sys tP.111s.

.

...

193.12 4 1 S ta ndard: Test request.

procedure$ that are not contained in closed systems have a uni-directional workOow. This rnusl include separate


§ 493.1105 Standard: Retention requirements.

(a)

'I.

••

The labo rato ry mu s t retain its


3704 Federa l Register /Vol. 68, No. 16 / Priday, January 21, 2003 / Rul es and Regulations

(3) l\na/11ic s,·stems records Retain qualit y co trol and pa tie n t lest records (including instrument printouts, if applicable) and all analytic systems activities specified in §§493.1252

thro ugh 493.1289 for at least 2 years. I n addition, retain the follo'>ving:

(il Records of lest system performance speci fic;itio ns U1a t the la borat ory establishes or verifies under§ 493.1253 for the period of time the laborato ry

uses the tes t s ys te m but no l ess than 2 years.

(ii) lmmunohemalology records. blood and blood prod uc t ecords. and

transfusion reco rds as s pec ifi ed in 21 CFR 606.160(b)(3)(ii), (b)(3)(v). and (d).

(4) Proficiency testing records. Retain all proficiency testing records for at


(bl Each of the laboratory's quality systems m ust include an assessment co mpo ne n t that ensures co ntin uo us improvement of the laboratory's performance and services thr o ugh

ongoi ng monitoring th a t iden tifies , evaluates and resolves problems.

(c) The various components of the labora tory's q ualit y systems are used to meet th e requ ire me nts in th.is part and must be appropriate for the specialties and subspecialties of testing th e laboratory performs. services it offers, and clients it serves.

§ 493.1201 Condition: Bac teriolo g, y

If the laboratory provides services in the subspecialty of Bacteriology. the

labora tory must meet th e req uireme nts


§§ 493.1230 through 493 1256. and

§§93.1281 through 493.1299.

§ 493.1210 Conditio n: Routine chemis try.

If the la bora to ry provides services in the s ubspec ialty of Routine chemistry. the laboratory must meet the requirements specified in §§493.1230 throug h 4 93.1 256, § 493.1267, and

§§ 493.1 281 through 493.1299.

§ 493.1211 Condition : Urina lysis.

Ir th e la bo ratory prov id es se rvices in the subs pccia lt y of Urinalysis, the laboratory must meet the requirements specified in §§ 493.1230 th rough

493.1256, and §§493.1281 through

493.1299.

§493.1212 Condition: Endocrino lo gy.


least 2 vears.


quality systems


s pec i fied in §§493.1230 through


If the laboratory provides services in


(5) lnboratory

· assessment r ecords. Retain all laboratory quality systems assessment records for al least 2 yea.rs.

(6) Test roports. Retain or be able to

re tr ieve a copv of the original report (including final. preliminary. and corrected reports) al l<rns t 2 years after the dattJ of reporting. In addi tio n. re ta in the follo\,·ing:

(i) lmmunohem atology reports as

speci fied in 21 Cf R 60G. l 60(b)(3)(ii). (bl{3)(h·) . and (cl).

[ii) Pathology test reports for at leas t

10 years aft e r thn date of rnpnrting.

(7) Slide. /;Jock. all(/ tissue reten ti on-

(i) Slides.

(A) Ro1ain cy lulogy slid P. proparations for al least 5 \'ears from the date of examination (see§493.1274 (f) for proficiency testing exception).

(BJ Retain hislopathology slides for at

leas t 10 years from the date or examina tio n .

(ii) Blocks. Retain pat hology specimen

blocks for at least 2 years from the date of examination. -

(iii) Tissue. Presen·e remnants of

tissue for pathology examination until a diagnosis is made on the specimen.

(b) If the laboratory ceases operation.

the laboratory must make provis io ns lo ensure that all records and. as

l'lppl icah le. slid es . blm ; ks. and tiss ue <1rc maintained and available for the lime frames s pr.ci fiecl in this section.

Subpar t K- Ouality Systems for No nwaived Tes ting

§ 493.1200 Introd ucti on.

(a) Each laboratory that performs nonwaived testing must esta blis h and maintain writt e n poli ci es and

procedtmis th:it imp le ment and monitor quality syste ms for all phases or the

to ta l test ing prnc0ss (that is. preanalytic, analytic. and po 1:1n,.Jytic) as well as general lahor.!1l1ry s _v!' tmns .


493.1256. § 493.1261. and §§493.1281

through 493.129().

§ 493_1202 Condition: Myco bact e riology.

If the labo ratory pro vid es services in the subspecialty of Mycobacteriology. the laboratorv must meet the requirement; specified in §§ 493.1 230 through 493.1256. §493.1262. and

§§493.1281 through 493.1299 .

§ 493.1203 Cond itio n: My co log, y

H the laboratory provides services in the su bspcc;ia lty o f Mycology. the

la bo ra to ry must meet the req uirorne nts specified in §§493.1230 through 493.1256. §493.1263. .ind §§493.1281

th rough 1193. 1 299.

§ 4_931204 Condition: Parasitology.

If th e lahora tory pro vides services in th e su bs pecia lty of Par asi to l ogy. th e laboratory must meet the requirements specified in §§'193.1230 through 493.1256, § 493.1 264, and §§ 493.1281

through 493.1 29!:I.

§ 493.120 5 Condition: Virology,

ir the l;1l.,oratory provides services in the subspecialty of Virology, the

labo ra to ry must meet the req u ire me n ts specified in §§193.1230 through 493.1256. § 493.1 205. and§§ 493.1 281

through 493 ,1299.

§ 493.1207 Condition: Syphilis serology,

If th e laboratory provides services in th e su bspecia lt y o f Syphilis serolog, y th e laboratory must meet the requirnments specified in §§ 49::1. l 230 through 4 l3.l 256 . and §§ 493.128 J

through 49:1.1299

§ 493.1208 Condition: Ge ne ra l immunolog y.

If the laboratory provide scrvic:l's in th e s11h s pod a l ty of Genera l immunology. the lohoratory m u t nwc1 th<• requiremenls speci finri in


the s ubspec ialt y of Endoc ri nology. the la bora tory m ust meet th e roquiremonts specified in §§ 493.1230 thr ough 493.1256, and §§493.1281 through

49 3.1 29 9-

§ 493.1213 Conditio n: Toxico logy.

If the labo ra tory pro vides se rvices in

th e s ubs pecially of Toxicolo gy. the

lab orato ry mui;t meet the requirements specified in §§ 493.1 230 through

493. 1256 . and§§ 493.1 281 through

49:1.1299 .

§ 493.1215 Condition : Hem atolo gy.

If the la bo ra tory provides serdces in the s pecialty of Homatology, the labora tory must mee t th e requ irements specified in §§493.1230 through 493.1256, § 493.1269. and §§ 493.1281

through 493.1 299.

§493.1217 Condition: lmmun o hematolo gy.

If the la bo ra to ry provides sen·ices in the s pecia lty 0f lm mu nohematology, the laboratory must meet the requirements specifier! in§§493.1 230 thro ugh

493.1256, § 493.1 271 , and §§493.1281

' th ro ugh 493.1299.

§ 493.1219 Condition: Hist opa tholog y.

If the lab ora tory provides services in the s ubspecialty of Histopathology. the la bo rato ry must meet the requirements specified in §§493.1230 throug h 493.1256. §493.1273, and §§493.1281

through 493.1299.

§493.1220 Condition: Oral pathology,

If the la bor ato ry provides :-ervices in thB subs peci all y of Oral pathology, the laboratory must meet the requirements specified in §§ 493.1230 through

•193.1 256 , and §§ 49::1. 1 281 through

493.1 29, 9

§ 493.1221 Condition: Cytology.

If th e labor;itory provides sen-ice in tht• subspccialty of Cytolngy. thr




Text Box: •

!=·

-••

r::,


requirement; specified in §§ 493.1230 through 493.1256, § 493.1276, and

-

• •

§§493.1281 through 493.1299.

§ 493.1226 Condition: Radiobioassay.

If the laboratory provides services in 1he s pecia lty of Radiobioassay, the laboratory must meet the req uiremen ts specified in §§ 493.1230 th rough 493.1256, and §§ 493 "1281 through

493.1299.

§ 493.1227 Cond ition: Histocom patibility.

If the lab oratory provides services in the specialty of Histocompatibility. the laboratory must meet th e requir ements specified in §§493.1230 throu gh 493.1256. §493 1278. and §§493.1281

through 493.1299.

Genera l Lab oratory Sys te ms


place to identify and document problems that occur as a result of a breakdovvn in communication between the laboratory and an authorized individual who orders or receives lest results.

§ 493.1235 Standard: Personnel com petency assessment policies.

As sp ec ifie d in the personnel requirements in subpart M, the laboratory must establi sh and follow written policies and proced ures to assess em ployee and , if app licable, consultant competency.

§ 493.1236 Standard: Evaluation of prof iciency tes ting perfor mance.

(a) The lab orato ry must review and evaluate the results obtained on

pro ficiency testi ng performed as

specified in subpart H of this part.


recurrence of problems. and discussion of general laboratory systems assessment reviews wilh appropriate

staff. I

L

(c) The laboratory must document all general laboratory systems assessment • activi ties.

•s

Pcea na lytic Systems •

•••

I

,-

§ 493.1240 Condition: Preanalytic ys tems.

.•

Each laboratory that performs nonwaivod testing must meet the ap plicable prcana lytic system(s) require ments in §§ 493,1 241 and

1 2, unless HHS approves a procedure. specified in Appendix C of the State Operalions Manual (CMS Pub. 7). th al provides equival ent quality testing. The laboratory must monitor and eva luate the o\·erall quality of th e

preanalytic systems and correct


§ 493.1230 Condition: General laboratory systems.

Each la bo rato ry that pP.rforms non\\'aived testing must meet the


(bl The laboratory must \·erify the accuracy of the following:

(1) Any analyte or subspecialty

without analytcs listed in subpart I of this parl that is not evalua ted or sc;ored


identified problems as specified in

§ 493. 1249 for each specialty and subspccialty of testing perform r.d.

§ 493.1 241 Standard: Test request.


,+•

••


applicable general laborato ry systems

requiremen ts in§§ 493.1231 through 493.1236 . unless HHS approves a procedure. specified in Appendix C of the Stale Operations Manual (CI\IS Pub. 7), that provides equivalent quality

testing. The laboratory must monitor and evalua le the overall quality of t he

general laboratory systems and correct identified problems as specifie d in

§-193.1239 for each specialty and subspecialty of testing performed.

§ 493.1231 Standard: Con fidentiality of patient info rmation.

-• •

.. •

The laboratory must ens ure confidentiality of pati e n t information throughout all phases of the total testing process that are under the laboratory's control.

§ 493.1232 Standard: Specimen identification and integri ty,

Th e la boratory mu st es tablis h and follow written policies and procedures lhat ensure positive iden tifica tion and optimum in tegr ity of a pa ti e n t':; specimen from lhe time of collection or receipt of the s pecin\ l'll through r.omplt1tion of tcstin?, and rnporlin!,-: of rc, ul t::.

by a CMS-approved proficiency testing program.

(2) An · analyte. specialty or

subspecia lty assig ned a proficicnc:r testing score tha t does not reflec t

la boratory test performance (that is, when the profic ie ncy tes ting program does nol oblain the agreement requ ired for·scor ing as s pecified in subpart I of this part. or th e labora tory receives a zero score for nonparticipation. or late return of results).

(c) At least twice annually, th e

la borator y must verify the accura cy of the follo\\'ing :

(1) Any tes t or procedure it performs that is not included in subparl l of th is

earl.

(2) Any test or procedure listed in subpart J of thi s part for which compatible proficiency tes ting sa m ples are not offernd by a CMS-approved profic:1ency testing program.

(d) All profici ency testing evaluation and verification actidties must be documented .

§ 493.1239 Standard: General la boratory systems assessment.

s m to

..

la) The laboratory mus t estahli!,h and fn,ll w; written 11o l ic:iP and pwcodures fnr an <>11f!t' ing 11rncha11i llln nitor.


(·a ) The laboratory must have a written or elect ronic request for palient t1:s ti11g from an authorized person.

(b)

The laboralo ry may accept oral reque sts for laboratory tests if it solicits a written or electrooic authorization within 30 days of the oral request and maintains the au th or ization or documentation of its efforts to ob1ain the authoriza tion.

(cl The la boratory must ensure the test requisi tion solicits the following

in format ion:

(1)

I

-•

-•

The name and address or other suitable identifiers of the authorized person request ing the test and, if appropriate. the indiddual responsible for using the test results. or the 11ame and address of the laboratory submitting the s pecime n, incl ud ing, as applicab le. a contact person to enable lh o rnporling of imminenth· life 1hreateni11g

labo ratory resul ts or pani c ur akrl values.

(2) The patient's name or unique

patient identifier.

(3)

••

The sex and age or dale <if birth of the patient.

(4) The lest(s) lo lie performed

(5) Tht sourc:c oflhc spP-ci nw, n whr.n c1pprnpri,1tc.


• • •

3706 federal Reg is ter / Vol. 68, No. 16 / Ftiday, January 24. 2003 / Rules and Regulations

(6) The da le and, if a pp ropriate , time of specimen collection.

(7)

• ••

For Pap smears. the patien t's las t menstrual period. and indication of whether the patient had a previous abnormal report. treatment. or biops y.

(8) Any additional information

rl:)le vant and necessary for a specific lest

to ensure accurate and timely tes ting and reporting of res ults, including interpretation, if applicable.

(d) The patient's chart or medical record may be used as the test

requisition or authorization but must be available to the laboratory at the time of tes tin g and available to CMS or a CMS agent upon reques t.

(e) lf the laboratory transcribes or enters test requisition or auth orization information in to a record system or a laboratory information system, the laboratory must ensure th e in formation is transcribed or entered accurately.

§ 493.1242 Standard: Specimen submission, handling, and referral.

(a) The laboratory must establish and follow written policies and procedures for each of th e follow in g, if a pplicab le:

(1) Patient preparation.

(2) Specimen collection.

(3)

.

Specimen labeling. including patien t name or unique patien t identifier and. when a ppropr iate, specimen source.

(4) Specimen storage and

preservation.

(5) Conditions for specimen • transportation.

(6) Specime n processing.

(7) S pecimen acceptability and rejection.

(8) Specimen referral.

(b1The labora tory must document th e date and time it receives a specimen.

(cl The la boratory must refer a

s pecimen for tes ting only to a CLIA­ certified laboratory or a laboratory meeting equivalent requirements as determined Ly CMS.

(d) If the labo ratory accep ts a referral

specimen, written instructio ns must be ava ilab le t o the laboratory's clients a nd must include, as appropriate, the information s pecified in paragraphs (a)(l) through(a)(7) of t his sect ion.

§ 493.1249 Standard: Preanalytic systems assessment.

(al The laboratory must establish and follow writlen policies and procedu res for an ongoing mechaoism to mo_nitor, assess, and when indicated, correct problems ident ified in the p,reanaly tic

s ystems specif ied at §§493.1241 through 493. 1242.

(b) The preana lytic systems


Lo resolve problems. revision of policies and procedures necessary to preven t recllrre nce of problems, and discussion of p reana lytic s ys tems assessment reviews with appropriate staff.

(c) The labora to ry must document all preanalytic systems assessmen t

ac li, ·iti es .

Analytic Systems

§ 493.1250 Condition: Analytic systems.

Each laboratory that performs non waived tes tin g must meet the applicable analy tic sys tems

requfrements in §§493.1251 through 493.1283, unless HHS approves a procedure, specified in Appen dix C of the Stale Operations Manual (CMS Pub. 7). that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic ·s ystems and correct identifi ed problems as spec ified in§ 493.1289 for each s pec ia lt y and subs pecialty of testing performed.

§493.1251 Standard: Procedure manual.

{a) A writt en procedure manual for all tes ts. assavs , and exam inati ons performed by the laboratory must be available to, and followed by, labora tory personnel. Textbooks may supplement but not replace tho laboratory's writt en proced ures for tes ting or examining specimens.

(b) The procedure manual must

in clude the follow ing when applicable

to the test procedure:

(1) Requirements for patient preparation; s peci men collection, labeli ng, s torage , preseTvation,

tran s portat ion, processing. and referral; and criteria for s pec imen acce pta.b ility

a nd rejection as described in §493.1242.

(2) Microscopic examina tion,

inclu d ing the detection of inad equa tel y prepared slides.

(3) Ste p-by-s te p performance of th e

procedure, including test calc ulati ons and int erpreta tion of res ults.

(4) Preparation of s lid es, s olution s .

cali brat o rs. controls. reagents, stains. and other materials used in testing.

(5) Calibration and calibr at ion

verification procedures.

(6) The reportable range for tes t results for the tes t s ystem as established or ve ri fied in § 493.1253.

(7) Control procedures.

(8) Corrective action to take when calibration or con trol results fail to meet the laboratory's criteria for accep tabili ty.

(9) Limitations in th e test methodology, including inter feri ng subs tan ces.

(1 O) Reference in terva ls (no rmal

val ues).


(1 2) Pertinen t literature

(13)

The labo ratory' s system for entering results in tb e patient record and repor ting patient results including, when app ropriate, the protocol for reporting imminen t life threatening

res ults. or panic, or alert \'alues.

(14) Desc rip tion i;,f tho course of action lo take if a test system becomes inoperable.

(cl Manufacturer's test system

instructions or opera tor manuals may be used , when appl icable, to meet the

requirements of paragraphs (b)(1) throngh (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(l2) of this section not provided by the man ufacturer must be provided bv the laboratory.

{d) Proc·edures and changes in .

procedures must be approved. signed. and dated by the cur rent laboratory

director before nse.

(e) The laboratory must maintain a copy of each procedure with the dates of initial use and discon tin uance as described in §493.1105(a)(2).

§ 493.1252 Standard: Test systems, equipment, instruments, reagents , materials. and supplies.

(a) Tes t sys tems mus t be selec ted by th e laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratorv's stated performance

s pecificat ions for each lest system as determined under§493.1253.

(bl The laboratory must define criteria for th ose cond itions that are essential for proper storage of reagents and

s pec im ens, accurate and reliab le tes t system operation. and test result reporting. The criteria must be

nclu

and

cons is tent \\'ith the manufacturer's instructio ns. if provid ed. These cond ilions must be monitored and

-

documented and. if ap plicab le, i de the following:

(1)

Wa te r quality.

(2)

Te m peratur e.

(3) Humidity.

(4) Protection of eq uipm en t

ins truments from Ouctualions aod

in te rrup tions in elect rica l current that adversely affect patient test results and test reports.

(c) Reagents. solutions, culture media,

con trol materials. calibration materials, and other sup plies, as appropria te , must be labeled to indicate the fo ll owing:

(1) Identity and when sign ifican t.

titer, strength or concentra tion.

(2) Storage requiremen ts.

(3) Preparation and expiration dates.

(4)

Other pertinent informc'ltion

rnquircd for prope r use.



Federal Register/ Vo l. GB . No. 1G / friday. January 24, 2003 / Rules and Regulations 3707

and other ::.upp lics must not be used

....

\d,en they have cxceecled their expiration date. ha\"<? deteriorated. or are of subs tandard qual ity,

(cl Components of reagent kits of different lot numbers must not br. interchanged unless othenvi se specified by the manufacturer.

§ 493.t 253 Standard: Establishm ent and verification of performance specifications.

(a} A pplicability . Laboratorills are not required to verify or establish performance specifications for any test system used by the laboratory before Apri l 24, 2003.

(b}(J} \'crification of performance specifications. Each laboratory that introduc es an unmodified, FDA-cleared or approved test system must do the following before reporting patient test res ults:

(i) Demonstrate that it can obtain

performance specifications comparable to those established by the manufar.turer for the following performance characteristics:

(A) Accuracy.

(B} Precision.

(CJ Repor table range of test results for the test system.

(ii) Verify that the manufacturer's reference intervals (norinal v.:lluf:s) are appropriate for the laboratory' s patient


spe cifications verified or established under pc1ragrnph (b)(l) or (b)(2) of thi s sec tion .

(c} Docw 11ent ation. The laboratory must documen t all activities specified in this section.

§ 493.1254 Standard: Maintenance and function checks.

(a} Unmodified monufacturter·s

eq(li p111e 11 t, ins trum en ts , or test syste ms . The laborato_ry must perform and docurnt:nt the follow ing:

(1) Maintenance as defined by the manu facture r and with at least the freq uency specified by the manufacturer.

(2) Function checks as defined b}' the

manu fac turer and with at least th·e frequency specified by the

manu facturer . Function checks must be within tlie manufacturer's established limits before patient testing is conducted.

(b) Equipment, instrum en ts, or test

systems del'P.loped in-hous e, commercially avoilable and rnodifi<'d , b_, t he J ab ora ton-· , or maintenanc e and function chec,k protocols nre not prodded by t he 111011(1/acturer. The laboratory must do the following:

( I )(i) Establish a maintenance protocol that ensures equipme nt. instrument. and test svstem


with <1l lca::.t the freq uen cy rccommundcri bv the m;inufocturcr:

(2) Usin g th e c riter ia v11rifi1:d or

\!stablished bv the labornton- as

specified in §493.1253(b)(3j- (i} Using calibration materials

appropriate for lhr: test system and, if possiblc, traceable lo a rnfercnc:e method or reference matP.rial of l-.11om1 \·alue: and

(ii) Including the number. type. and cuncentralton of calibration materials, as well as ac:ce ptable limits for and the frequency of calibration: and

(3) \Vhene\·er calibrntion verification

fails to meet the laboratory's acceptable limits for calibration verification.

(h) Perform and document calibration

,·eri fication procedures-

(J) F'ollo\\'ing the manufacturer's calibration verification instructions:

(2) Using the criteria ver ified or established bv the laboratorv under

§ 493.1253(b)(3) - . .

(i) Including tho number. typo, and concentration of the materials. as well as acceptable limit:; for r.alibration

,·erification : and

(ii) Including al least a minimal (or zero) value. .i mid-µoint vah11·, and a maximum \'alur. 110.ir the uppnr li111it of the range 10 ,·crify the lalmralory's reportable rang£> of test ro ults for thC! le t svste111: and


population.

(2) ) Estab/ishmP.nt of pe1formance specifications. Each laboratory that modifies au FDA-cleared or appro\·cd test system, or introduces a lest system not subject to FDA clearance or approval (includin.g methods developed i n-house and standardized methods such as text book procedures, Gram stain, or potassium hydroxide prepaJ:alions). or uses a les t system in which performance specifications are not pro\·icled by tho manufacturer must , before reporting patient test results, establish for each tesl svstem the performance specificatrons for the fo1lowing performance character istir.s. as applicable:

(i) Accuracy .

(ii) Precision.

(iii} Analytical sensitivity.

(iv) Analytical s pecificity to in clud e interfering subs timces.

(v) Reportable range of lest results for th e lest system.

(vi) Reference inten·als (norma l

\·alues).

(vii) ) Any other performance charactP.ristic required for lest performance.

(3) Determination of calibration 01trl control procedures . The laboratory must determine the ll'Sl system ·s calibratitin procedures and c:rmtrol proccd11res uascd upon the perfurm..im:c


performance that is ,;ecessary for

accurate and reliable test results and test result reporting.

(ii} Perform and document the

maintena nce acti vities specified in paragraph (b)(1)(i} of this section.

(2l(i} Define a function check protocol that ensures equipmen t. instrument, c1nd test system performance that is nt:cessary for accurate and reliable test results and test resull reporting.

(ii) Perform and document the function checks, includin g background or baseline chec ks. s pecified in paragraph (b)(2J(i} of this section. Function checks mus t be within the laboratory's establis hed limits before patient testing is cond ucted .

§ 493.1255 Standard: Calib ration and calibration verification procedures.

Calibration and calibration verification procedures are required to substantiate the continued ar.curar.y of the test sys tem throughout the laboratory's repo rtable range of tes results for the test system. Unless

otherwise specified in this sub part. for r.ach applicable test system the laboratory must do th e following:

(a) Perform and document calibrntion procedures-

(1) Following the ma.J1ufacturor·s test sys tem in s trur.tions, using caliu ration materials proddC!d or spec:ifiC!rl. and


(:-l·) At least once p,\·t•ry Cl months and

whenever any of the following occur:

(i) :\ complete change of reagents fo r a proced ure is introducecl. m1less the laboratory c;in demonstrate th,it

cha nging.reagent lol numbers does nol affect the range used to report patient tes t results. nnd contro l \'alues are not

adversely affected l,y rnagent lo t numbrr changes.

(ii) There is major preventive maintenance or replacement of r.ritical parts that may influence test

performa nce.

(iii) Control mat erials reflect an unusual trend or shift. or are oulsiclo of the lal>or atory's accep table limits, and other 111e a11s of assessing and correctini; unacceptahltl control ,·alues fail to identi fv and correcl the problem.

(h·) The laboratorr·s established

sc hedlthi for verifyi;1g the reportable rc111gp. for patient te:;I rcsnlls rnquires more frequent calib1ation verific:,ition.

§ 493.t 256 Standard: Control procedures.

{a) For each lest syswm. tltr. laboratory is responsihl!l for ha\"in c:ontrol proccrlUios tlrnt 111011itor tl,w iccur ac.·: and prP-c:ision of the 1;omplete analyllcal pror.ess. .

(b) The labornlorv must establis h tht.l

numlwr. tqH . and fn:qucnc:1·of testing c:nn trnl m Hmia ls usi11g. if app lir.abk tlw prrformance s1wdfic,1ti1,11s ,·crificcl


._a_ •.• I •



or cstabl ishcd u,· the labornton- as

specified in§ 493.1253(b)(3) ·

(cl The con trol proccrlures mus l-


s peci mens , at least one control material contain in g th e s u bs tan ces bei ng

id e ntified or measured.


(ii) Check each batch of media for its ab ili ty to support growth a nd . as

a ppr o pr ia,te s e lec t o r in h ibit specific •


1-. ..


(1) Detect immediate e rro rs th a t occur rlue lo lest system failure. adverse

environ me nta l co nd it io ns. and o pe ra tor performance.

(2) Monitor over time the accuracy


(G) Pe r form control ma ter ia l0 tes ting as s pec i fi ed in this paragraph before resuming patient tes t in g when a complete changeof reagents is

in trod uced: major preve ntive


organisms o r p rod uce a biochemical response: and

(iii)

Doc um ent the physical

charac te ris tics of the media when

co mpr o mised and re por t any •

• •

I and precision of lest performance that may be in f1uen ced by c ha nges in test system performance and environ men tal co nd iti o n!', and var iance in operator performance.

(d) Unless CMS approves a proce d ure,

• •

• •

s pecified in A p pe nd ix C of the S ta te Operations Manual (CMS Pub. 7), that provid es eq u ivale nt qua li ty tes tin g, tht:: laboratory rnust-

(1)

Perform control procedures as defined in this sectio n unless otherwise specified in the additional speciall y a nd s ubs peci a lty req u ireme n ts at

§§493.1261 through 493.1278

• (2) For each lest system, perform control proced ures using the nu m ber

••

and frequency s pecified by the

ma nufac tu rer or es ta blish ed by the

labora tory whe n they meet o·r exceed th e requ irnme n ts in pa ragrap h (d)l3) of th is sec tion .

(3) At leas t once each day patirnt

specimens are assayed or examin e d perform the foll ow ing for-

(i)

Each q ua nt i ta ti\·e procedun . include two control materials ol different concentrations:

(ii)

---

) Each qt1alitath·e prowclurn,

include a nega ti\·e and pos it in: co n tro l material:

(iii)

Te t procedures producing graded or titered results, incl u de a ncgatini control mate ria l and a co nlrn l material with graded or titered rnac ti\·ity,

res pect i vely:

(iv) Each tes t svs tc m tha t has an

ex tr aclio n phase: include two contro l mater ials . i ncl ud ing one th a t is ca pab le of de tec ti ng erwr intheextrac tion process; and

(v) Eac h m olec ula r a mp lifica tio n proce d ur e, indude two co n trol materials and, if reaction inh ibit io n is a significan t source of false negative

results, a con tro l material capabk of detec ti ng the inhibition.

(4) For thin la ye r c hro matogra phy­

(i) Spot each pla te ur ca rcJ. as applicable. with a cali b r.ito r co n ta ini n g all known substances or drug groups, as appropriate. which are identified by

thi n layer chromalography and reported

by the laboratory; and

(ii)

I

Include at least one control material on each plate or card. as'

a pp li cab le, wh ic h must be process!!d

• thr o ug h eac h ste p of patie n t tes ting. including extrac ti o n processes .

incluclo. conc urr e nt with paticnl

(5) For each electro phore tic pr0cech1re

maintenance is performe d; or any

c rit ica l part that may influence test performance is replaced.

(7) Over time. rota te co n tro l m·a te rial tes tin g among all opera to rs who pe rform

the tes t.

(8) Test control materia ls in th e same

mannei: as patien t specimens.

(9) When using calibration material as a control material, use calibration

mate ria l fro m a different lot number than that used lo establis h a cut-o ff value or to calib rat e th e tes t sys te m.

(10) Es tab lis h or ve rify the criteria for

accepta bilit y of all control materials.

{i) Whe n co ntrol mate ria ls p ro vid in g q ua n tita tive res u lts are used. statis tica l parameters (for example. mean and

stan da rd de \'iat io n) for each batch and lot number of con tro l materials must bCI defined and avai la ble.

(ii) The labora tory may use thB s ta ted

\·alue of a com merci a lly assaynd co ntro l material provided the stated val ue is for the me thodo logy a nd instrumentation em ployed by lhe labo rator y nnd is verified by the laborato ry.

(iii) S ta tis tical parameters for

unassaved contro l materia ls must be establ is h ed orn r time UV th e laboratory tbrough concurrent tes ting of con tro l• materials having previo usly determined sta tis tical parameters.

(el Fo r reagent, media. and s up ply

c h1,i'cks . the labo ra to ry m us l do th e following:

(1) Check each batch (p repa red in ­ house). lot number (commercially prepared) and shipment of reage nt s. disks. sta ins, antisera, and identification systems (systems using two or more

substra tes o r two o r more reage nts. o r a combination) when prepared or opened for positive and negati ve reac tivit y, as

\\'ell as graded reactivity. if a p pli c:a b l e .

(2) Each dav of use (un lr.ss othP-rwise s pcr.ified in th is s ubpa rt). les l lai ning materials for intended reacti\'ity to

c,ns ur e p red ic table s tainin g ·

r.harac tc ris t ics. Con trol mate rials for both positive and Jl(Jgative reac tivit y must be included, as ap propriate.

(:J) Che c k fluo resce nt a nd

im m un o h is toch em ic<1I s t a ins for

posi tive a nd nega tive reac ti\·it y eac h lime of use.

(4) Before. or conr.urre n t with th e

inil ia l use-

(i)

tu:;lin

-

g:

Ch ec k each batch of media for sterility if s te rili ty is req u ired for

de ter ioration in th e media to the manufacturer.

(5) Follow the manufacturer's

specifications for using reagen ts. m ed ia, and supplies and be.respons ib le for

res u lts.

(0 Resu lts o f control materials must ·

meet the labora tory's an d , as a pplicable . th e manufacturer's test system criter ia for acceptability before reporting patient test resu lts .

(g) T h e lab o ra to ry must document all contro l proced u res pe rfo rm e d.

(h) If control mater ials a re n o t

available, the laboratory must have an altern a tive mec ha nis m to d etect

im med ia te erro rs and mo nitor tesl system performance over tim e. The performance of alternative con lro l procedures must be documented.

§ 493.1261 Standard : Bacte riolog y.

(a) The laborato ry m us t chec k the follo\\'ing for positive and negative reactivi ty using con tro l organisms:

(1) Each dav of use for beta -lactamase mP.thods o thc·r than CefinaseTM,

(2) Each week of use for Gra m s tain s.

(3) When each batch (prepaxed in ­ house). lo t number (commercia lly

pre pa red ), and shipment of antiscra is pre pa re d or-opened. and onc:e every 6 mo nt hs th erea fter.

(bl For antimicrobial susceptibilit y

tests. th e la borato ry must check each batch of media and ca c:h lot n umber a nd s hipment of an tim ic ro bial age nt(s ) before. or concurre n t \\'ilh, initial use, us in g a pp ro ved co ntro l o rgan isms.

(1) Each day tes ts are pe rformed . th e

labo ratory mus t use th e appro pr ia te con trol o rga nis m(s) lo chec k th e procedure.

(2) The laborator y's zo ne sizes or

minimum inh ibit o r y concentration for control o rganis ms mus t be within established lim its befo re repor ting

pa ti ent resu lts.

(c) The labora tory must document all

contro l pr oced u res performed. as s p0 c ified in this sectio n.

§ 493.1262 Sta nda rd: Myco bacteriology.

(a) Each day of use , the labo ratory mus t check all reage nt s o r tes t procedures used for mycobacteria

identificaliun with at least one acid-fast

organis m th at produces u positive

reac tio n an d a!1'aci cl-fast organism th at prod uces n negati\·c rea r.lion.

(b)

ra tory m

us

abo .....

..

,,Z•

....

s uscep ti b ili ty t;.:;ts. the l t

r

.

f o r a n timv c:o bac lerial

Text Box: •


,

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• • • •


I • •