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DE PARTMEN T OF CONSU MER AND INDUS TRY SER VIC ES DIRECTO R'S OFF ICE
OCC UPATIO NAL HEALT H STANDARDS --BLOO DB ORNE INFE CTIO US DISEASES
Filed with th e Secretar y of Stat e on J un e 28, 2001 .
These ru les tak e effect on October 18, 2001
(By auth ority conferr ed on th e director of th e dep artm ent of con sum er an d industr y services by sections 14 an d 24 of 1974 PA 154 , MCL 408 .1014 an d 408 .1024 , an d Execut ive Reorgan izat ion Order Nos. 1996 -1 an d 1996 -2, MCL 330 .3101 an d 445 .2001 )
R 325 .70001 , R 325 .70002 , R 325 .70004 , an d R 325 .70015 of th e Michigan Administrat ive Code ar e am ended as follows:
R 325 .70001 Scope .
Rule 1. These ru les apply to all employers that ha ve employee s with occu pat iona l exposur e to blood an d oth er potent ially infectious mat erial.
R 325 .70002 De finitio ns.
Rule 2. As used in th ese ru les:
(a) "Act" mean s 1974 PA 154 , MCL 408 .1001 et seq.
(b) "Biologically ha zar dous con ditions" mean s equipment, conta iners, room s, mat erials, expe rimenta l an ima ls, an ima ls infected with HBV or HIV viru s, or combi nat ions th ereof that conta in, or ar e contam inat ed with, blood or oth er potent ially infectious mat erial.
(c) "Blood" mean s human blood, human blood com ponent s, an d products ma de from human blood.
(d) "Bloodborn e path ogens" mean s path ogenic microorgan isms that ar e prese nt in human blood an d can cau se disease in human s. These path ogens include hep at itis B viru s (HBV) an d human immun odeficiency viru s (HIV).
(e) "Clinical laborat ory" mean s a work place where diagnostic or oth er screening proced ur es ar e perform ed on blood or oth er potent ially infectious mat erial.
(f) "Contam inat ed" mean s th e prese nce or th e reasona bly ant icipat ed prese nce of blood or oth er potent ially infectious mat erial on an item or surface.
(g) "Contam inat ed laun dry" mean s laun dry which ha s bee n soiled with blood or oth er potent ially infectious mat erials or which ma y conta in shar ps.
(h) "Contam inat ed shar ps" mean s an y contam inat ed object that can penetrat e th e skin, including an y of th e following:
(i) Needles .
(ii) Scalpels.
(iii) Broken glass.
(iv) Broken capillar y tu bes .
(v) Exposed ends of denta l wires.
(i) "Decontam inat ion" mean s th e use of physical or chemical mean s to remove, ina ctivat e, or des tr oy bloodb orn e path ogens on a sur face or it em to th e point where th ey ar e no longer capable of tran smitt ing infectious part icles an d th e sur face or item is rendered safe for han dling, use, or disposal.
(j) "Dep artm ent " mean s th e dep artm ent of con sum er an d industr y services. (k) "Director" mean s th e director of th e dep artm ent or his or her designee.
(l) "Disinfect" mean s to ina ctivat e virtua lly all recogn ized path ogenic micr oor gan isms, but not necess ar ily all microbial form s, on inan imat e objects.
(m) "En gineering contr ols" mean s contr ols, for exam ple, shar ps disposal conta iners, self- sheath ing needles , or safer medical devices, such as shar ps with engineered shar ps injur y protections an d needleless systems, that isolat e or remove th e bloodborn e path ogen ha zar d from th e work place.
(n) "Exposur e" mean s reasona bly ant icipat ed sk in, eye, mu cou s membran e, or par ent era l conta ct with blood or oth er potent ially infectious mat erials that ma y result from th e per forman ce of an employee' s dut ies. “Exposur e” does not include incidenta l exposur es which ma y tak e place on th e job, which ar e neith er reasona bly nor rout inely expe cted, an d which th e work er is not required to incur in th e norma l cour se of employment .
(o) "Exposur e incident " mean s a specific eye, mouth , oth er mu cou s membran e, noninta ct skin, or par ent era l conta ct with blood or oth er potent ially infectious mat erial that results from th e per forman ce of an employee' s dut ies.
(p) "Han dwashing facilities" mean s facilities that provide an adequat e supply of runn ing, pota ble wat er, soap, an d single-use towels or a hot-air drying ma chine.
(q) "Licensed health car e pr ofessi ona l" mean s a person whose legally perm itt ed scope of pra ct ice a llows him or her to indepe ndent ly per form th e activities required by R 325 .70013 con cern ing hepat it is B va ccinat ion an d post-exposur e evaluat ion an d follow-u p.
(r) "Needleless systems" mean s a device that does not use needles for an y of th e followin g:
(i) The colle ct ion of bodily fluids or with dra wal of body fluids after initial venous or art erial a ccess is esta blished.
(ii) The administrat ion of medicat ion or fluids.
(iii) Any oth er procedur e involving th e potent ia l for occupat iona l exposur e to bloodborn e path ogens due to percutan eous injur ies from contam inat ed shar ps.
(s) "Oth er potent ially infectious mat erial" mean s an y of th e followin g:
(i) Any of th e followin g human body fluids:
(A) Semen.
(B) Vagina l secretions.
(C) Amn iotic fluid.
(D) Cerebrospina l fluid. (E) Peritoneal fluid.
(F) Pleura l fluid.
(G) Pericar dial fluid.
(H) Synovial fluid.
(I) Saliva in denta l pr oced ur es.
(J ) Any body fluid that is visibly contam inat ed with blood.
(K) All body fluids in situat ions where it is difficu lt or impossible to differ ent iat e between body fluids.
(ii) Any un fixed t issue or organ , oth er than inta ct sk in, from a living or dead human .
(iii) Cell or t issue cultur es that conta in HIV, organ cultur es, an d cultur e medium or oth er solut ions that conta in HIV or HBV; an d blood, organ s, or oth er t issues from expe r imenta l an ima ls infected with HIV or HBV.
(t) ) "Par ent era l" mean s exposur e occurr ing as a result of piercing mu cou s membran e or th e sk in barr ier, such as exposur e thr ough subcutan eous, intramu scular , intra venous, or art erial rout es resulting from needles t icks, human bites, cut s, an d abra sions.
(u) "Persona l protective equipment " or "PPE " mean s spe cialized cloth ing or equipment that is worn by an employee to protect him or her from a ha zar d. Genera l work cloth es, such as un iform s, pant s, shirt s, or blouses, that ar e not int ended to fun ct ion as protection against a ha zar d ar e not con sidered to be persona l protective equipment .
(v) "Pr oduction facility" mean s a facility that is engaged in th e industr ial-scale, lar ge- volum e production of HIV or HBV or in th e high-concentrat ion production of HIV or HBV.
(w) "Regulat ed waste" mean s an y of th e following:
(i) Liquid or semiliquid blood or oth er potent ially infectious mat erial.
(ii) Contam inat ed items that would release blood or oth er potent ially infectious mat erial in a liquid or semiliquid stat e if com pressed .
(iii) Items which ar e cak ed with dried blood or oth er potent ially infectious mat erial an d which ar e capable of releasing th ese mat erials dur ing han dling.
(iv) Contam inat ed shar ps.
(v) Path ological an d microbiological waste that conta ins blood or oth er potent ially infectious mat erial.
(x) "Rese ar ch laborat ory" mean s a laborat ory that produces or uses rese ar ch laborat ory- scale am ount s of HIV or HBV. A rese ar ch laborat ory ma y produce high con centrat ions of HIV or HBV, but not in th e volum e foun d in a production facility.
(y) "Shar ps with engineered shar ps injur y protections" mean s a nonn eedle shar p or a needle device which is used for with dra wing body fluids, a ccessi ng a vein or art ery, or administering medicat ions or oth er fluids, an d which ha s a built-in safety featur e or mechan ism that effect ively reduces th e r isk of an exposur e incident .
(z) "Sour ce individua l" mean s an y living or dead individua l whose blood or oth er potent ially infectious mat erial ma y be a sour ce of occu pat iona l exposur e to an employee. Exam ples of a sour ce individua l include all of th e following:
(i) A pat ient of a hospita l or clinic.
(ii) A client of an institut ion for th e developmenta lly disabled .
(iii) A victim of trauma .
(iv) A client of a dru g or alcohol tr eatm ent facility.
(v) A reside nt of a hospice or nur sing home.
(vi) Human rema ins.
(vii) An individua l who donat es or sells his or her blood or blood com ponent s.
(aa ) "Stan dar d operat ing procedur es (SO Ps)" mean s an y of th e followin g that address th e per forman ce of work activities so as to reduce th e r isk of exposur e to blood an d oth er potent ially infectious mat erial:
(i) Writt en policies.
(ii) Writt en pr oced ur es.
(iii) Writt en directives.
(iv) Writt en stan dar ds of pra ctice.
(v) Writt en prot ocols.
(vi) Writt en systems of pra ctice.
(vii) Element s of an infection contr ol program .
(bb) "Sterilize " mean s th e use of a physical or chemical pr oced ur e to des tr oy all microbial life, including highly resis tant bacterial endospores.
(cc) "Un iversal precaut ions" mean s a meth od of infection contr ol that tr eat s all human blood an d oth er potent ially infectious mat erial as capable of tran smitt ing HIV, HBV, an d oth er bloodb orn e path ogens.
(dd) "Work pra ctices" mean s contr ols that reduce th e likelih ood of exposur e to bloodborn e path ogens by altering th e mann er in which a ta sk is per form ed.
R 325 .70004 Expos u re cont rol plan .
Rule 4. (a) If an employee is determ ined to be in cat egory A, th en an employer sha ll esta blish a writt en exposur e contr ol plan to minimize or eliminat e employee exposur e.
(b) An exposur e contr ol plan sha ll conta in all of th e followin g in format ion:
(i) The exposur e determ inat ion required by R 325 .70003 (1).
(ii) The schedule an d meth od of implementat ion for each of th e applicable ru les of th ese ru les.
(iii) The cont ent s or a summar y of th e tra ining program required by R 325 .70016 .
(iv) The pr oced ur es for th e evaluat ion of circum stan ces surr oun ding exposur e incident s as required by R 325 .70013 (5).
(v) Task -spe cific stan dar d operat ing pr oced ur es (SO Ps) that address all of th e followin g ar eas:
(A) Em ployee recogn it ion of reasona bly ant icipat ed exposur e to blood an d oth er potent ially infectious mat erial.
(B) Appropriat e selection, use, ma int enan ce, an d disposal of persona l protective equipment .
(C) Cont ingency plan s for for esee able circum stan ces that prevent followin g th e recomm ended SOPs.
(c) Genera l employer policies or ta sk-specific SOPs sha ll address th e mana gement of ina dvert ent exposur es such as needles t icks or mu cus membran e exposur es.
(d) The exposur e contr ol plan sha ll be reviewed at least annua lly an d updat ed as necess ar y. A review sha ll con sider chan ges in employees' ta sks an d pr oced ur es an d th e lat est in format ion from th e cent ers for disease contr ol or th e dep artm ent . See appe ndix A for addresses of th ese agencies. The review an d updat e of th e exposur e contr ol plan s sha ll com ply with both of th e followin g provisions:
(i) Reflect chan ges in techn ology that eliminat e or reduce exposur e to bloodborn e path ogens.
(ii) Docum ent annua lly con siderat ion an d implementat ion of appropriat e comm ercially available an d effect ive safer medical devices des igned to eliminat e or minimize occu pat iona l exposur e.
(e) An employer sha ll ensur e that only a person who ha s kn owledge of applicable contr ol pra ct ices is auth orized to write an d to review an exposur e contr ol plan .
(f) An employer sha ll ensur e that th e exposur e contr ol plan is ma de available to th e director or a represe ntat ive of th e director for exam inat ion an d copyin g upon request.
(g) An employer sha ll ensur e that a copy of th e exposur e contr ol plan is a ccessible to cat egory A employees in accordan ce with R 325 .3451 et seq.
(h) An employer, who is required to esta blish an exposur e contr ol plan sha ll solicit input from non-mana gerial employees resp onsible for direct pat ient car e who ar e potent ially exposed to injur ies from contam inat ed shar ps in th e ident ificat ion, evaluat ion, an d selection of effect ive engineering an d work pra ct ice contr ols an d sha ll docum ent th e solicitat ion in th e exposur e contr ol plan .
R 325 .70015 Reco rdkeeping .
Rule 15. (1) An employer sha ll esta blish an d ma inta in medical recor ds for each cat egory A employee in accordan ce with R 325 .3451 et seq.
(2) An employer sha ll ensur e that medical recor ds conta in, at a minimum , all of th e followin g in format ion:
(a) The nam e an d socia l secur ity num ber of th e employee.
(b) A copy of th e employee' s hepat it is B va ccinat ion statu s, including th e dat es administered an d medical recor ds relat ing to th e employee' s ability to receive a va ccinat ion as required by R 325 .70013 .
(c) A copy of th e medical history an d all results of physical exam inat ions, medical testing, an d follow-u p pr oced ur es as th ey relat e to eith er of th e followin g:
(i) The employee' s ability to wear protective cloth ing an d equipment an d receive vaccinat ion.
(ii) Postexposur e evaluat ion after an occu pat iona l exposur e incident .
(d) The employer's copy of th e physician 's writt en opinion.
(e) ) A copy of th e in format ion provided to th e physician as required by R 325 .70013 (6).
(3) An employer sha ll assur e that employee medical recor ds that ar e required by th is ru le ar e kept con fident ial an d ar e not disclosed or report ed with out th e employee' s express writt en con sent to an y person with in or out side th e work place, except as required by th is ru le or as ma y be required or perm itt ed by law.
(4) An employer sha ll ma inta in employee medical recor ds for not less than th e durat ion of employment plus 30 year s in a ccor dan ce with R 325 .3451 et seq.
(5) An employer sha ll develop an d ma inta in tra ining records for each cat egory A employee. Tra ining records sha ll be ma inta ined for 3 year s beyond th e dat e that th e tra ining occurr ed.
(6) Tra ining recor ds sha ll include all of th e followin g in format ion: (a) The dat es of th e tra ining sess ions.
(b) The cont ent s or a summar y of th e tra ining sess ions.
(c) The nam es an d qua lificat ions of persons who con duct th e tra ining.
(d) The nam es an d job t it les of all persons who att end th e tra ining sess ions.
(7) An employer sha ll assur e that all recor ds that ar e required to be ma inta ined by th ese ru les sha ll be ma de available, upon request, to represe ntat ives of th e dep artm ent or th e director for exam inat ion an d copying.
(8) ) An employer sha ll ensur e that employee tra ining recor ds ar e provided , upon request, for exam inat ion an d copyin g to employees, employee represe ntat ives, an d th e director in accordan ce with R 325 .3451 et seq.
(9) An employer sha ll ensur e that employee medical recor ds ar e provided , upon request, for exam inat ion an d copyin g to th e subject employee, to an yone who ha s th e writt en con sent of th e subject employee, an d to th e director in a ccor dan ce with R 325 .3451 et seq.
(10) An employer sha ll com ply with th e requirement s that involve th e tran sfer of recor ds set forth in R 325 .3451 et seq.
(11) If an employer ceases to do business an d th ere is no su ccess or employer to receive an d reta in th e recor ds for th e prescribed period, th en th e employer sha ll notify th e director, not less than 3 month s befor e disposing of th e recor ds, an d sha ll tran smit th e recor ds to th e director if required by th e director to do so with in th e 3-month period.
(12) ll of th e followin g provisions apply to a shar ps injur y log:
(a) An employer sha ll esta blish an d ma inta in a shar ps injur y log for th e recor ding of percutan eous injur ies from contam inat ed shar ps. The in format ion in th e shar ps injur y log sha ll be recor ded an d ma inta ined in a mann er that protects th e con fident ia lity of th e injur ed employee. At a minimum , a shar ps injur y log sha ll conta in all of th e followin g informat ion:
(i) The type an d bran d of device involved in th e incident .
(ii) The work un it or work ar ea where th e exposur e incident occurr ed.
(iii) An explanat ion of how th e incident occurr ed.
(b) The requirement to esta blish an d ma inta in a shar ps injur y log applies to an y employer who is required to ma inta in a log of occu pat iona l injur ies an d illnesses un der R 408 .22101 et seq., being Part 11. Recor ding an d Rep ort ing of Occu pat iona l Injur ies an d Illnesses .
(c) A shar ps injur y log sha ll be ma inta ined for th e period required by R 408 .22101 et seq., Part 11. Recording an d Rep ort ing of Occu pat iona l Injur ies an d Illnesses .
