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DE PARTMEN T OF CONSU MER AND INDUS TRY SER VIC ES BURE AU OF HEALT H SYSTEMS
FREES TAND ING SUR GICAL OUTPATI EN T FACILITI ES
Filed with th e Secretar y of Stat e on May 30, 2001 .
These ru les tak e effect 7 days after th e fili ng with th e Secretar y of Stat e
(By auth ority conferr ed on th e dep artm ent of con sum er an d industr y services by sections 2226 (d), 2233 , 20115 , 20145 , 20161 , 20171 , an d 21015 of 1978 PA 368 , an d section 9 of 1965
PA 380 , being MCL 333 .2226 (d), 333 .2233 , 333 .20115 , 333 .20145 , 333 .20161 , 333 .20171 ,
333 .20155 , an d 16.109)
R 325 .3801 , R 325 .3802 , R 325 .3811 , R 325 .3812 , R 325 .3815 , R 325 .3816 , R 325 .3826 , R
325 .3828 , R 325 .3832 , R 325 .3835 , R 325 .3857 , R 325 .3866 , R 325 .3867 , an d R 325 .3868 of
th e Michigan Administrat ive Code ar e am ended, R 325 .3803 an d R 325 .3868 a ar e added to th e Code, an d R 325 .3817 , R 325 .3818 , R 325 .3819 , an d R 325 .3851 of th e Code ar e rescinded as follows:
R 325 .3801 De finitio ns; A.
Rule 1. As used in th ese ru les:
(a) "Act" mean s 1978 PA 368 , being §§333 .1001 et seq.
(b) "Anes th esi a" mean s a stat e of loss of feeli ng or sensat ion an d is norma lly used to denote th e loss of sensat ion to pain pur posely induced by th e use of a specific gas or dru g to perm it th e performan ce of sur gery or oth er painful proced ur e.
(c) "Anes th esiologist" mean s a physician who specialize s in th e field of an es th esiology an d who ma y or ma y not be a diplomat e of his or her specialty boar d.
(d) "Anes th etic" mean s a dru g, gas, or oth er agent used to abolish th e sensat ion of pain. There ar e 3 classificat ions as follows:
(i) "Genera l an es th etic" mean s an an es th etic agent that produces a temporar y loss of con sciousness by th e administrat ion of a gas; ora l, intramu scular, an d intra venous dru gs; or a combi nat ion of th ese methods.
(ii) "Local an es th etic" mean s a dru g whose action is limited to an ar ea of th e body aroun d th e site of its applicat ion.
(iii) "Spina l," "epid ura l," or "cau dal" an es th etic mean s th e injection of an app ropriat e local type of an es th etic into th e spina l cana l, epid ura l ar ea, to produce a local loss of sensitivity to th e body ar eas at an d below th e sensory nerve distr ibut ion at th e level of injection.
(e) "An esth etist" mean s a person who is qua lified to administer an esth etic. In comm on usage, th e term applies to nur ses an d lay persons who ha ve ha d spe cial tra ining an d expe rience un der medical au spices in th e administrat ion of an esth etics.
R 325 .3802 De finitio ns ; C to S.
Rule 2. As used in th ese ru les:
(a) “Code” mean s 1978 PA 368 , MCL 333 .1101 et seq.
(b) "Dep artm ent " mean s th e dep artm ent of con sum er an d industr y services.
(c) "Director" mean s th e director of th e dep artm ent .
(d) "Fr ees tan ding sur gical out pat ient facility" or "fa cility" mean s a facility as defined in section 20104 (5) of th e code an d includes , but is not limited to, a facility that includes a privat e pra ct ice office in which 50% or more of th e pat ient s annua lly served at th e facility un dergo an abort ion.
(e) "Hospita l" mean s a facility defined in section 20106 (5) of th e code.
(f) "Nurs e" mean s an individua l who is curr ent ly licensed or registered as a nur se by th e stat e.
(g) "Ph ysician " mean s a person licensed to pra ct ice medicine or osteopath y in th is stat e.
(h )“Pr egnan cy term inat ion facility” mean s a facility, including, but not limited to, a privat e pra ct ice office in which 50% or more of th e pat ient s annua lly served at th e facility un dergo an abort ion. The calculat ion for percenta ge of pat ient s served un dergoing an abort ion sha ll be based on th e num ber of individua l pat ient s served an d not on th e num ber of pat ient visits or incident s of service.
(i) "Sur gery" mean s th e tr eatm ent of human beings by a physician , by th e use of 1 or more of th e followin g pr oced ur es:
(i) Cutt ing int o an y part of th e body by sur gical scalpel, electr o-caut ery, or oth er mean s for diagnosis or th e removal or repair of diseased or dama ged t issue, organ s, tum ors, or for eign bodies.
(ii) Red uction of fra ctur es or dislocat ions of a bone, joint , or bony stru ctur e.
(iii) Rep air of ma lformat ions or body defects resulting from injur y, birth defects, or oth er cau ses that require cutt ing an d man ipulat ion or sutur e.
(iv) Instrum entat ion of th e ut erine cavity including th e procedur e comm only kn own as dilatat ion an d cur etta ge for diagnostic or th era peut ic pur poses .
(v) Any instrum entat ion of or injection of an y substan ce int o th e ut erine cavity of a woman for th e pur pose of term inat ing a pregnan cy.
(vi) Human sterilizat ion pr oced ur es.
(vii) En doscopic pr oced ur es.
R 325 .3803 Te rms de fined in code
Rule 3. Term s defined in th e code ha ve th e sam e mean ings when used in th ese ru les.
R 325 .3811 Lic enses ; re quiremen ts ; app li cations .
Rule 11. (1) A frees tan ding sur gical out pat ient facility sha ll not be esta blished, ma inta ined, or operat ed with out fir st obta ining a license. The term "fr ees tan ding sur gical out pat ient facility" or oth er similar term sha ll not be used on un licensed places.
(2) An applicat ion for a license for a facility sha ll be ma de on form s auth orized an d provided by th e dep artm ent . The applicat ion sha ll include th e ident ity of th e owner of th e facility.
(3) An applicat ion for a license for a facility sha ll be ma de an d signed by th e individua l des ir ing to esta blish, con duct, or ma inta in a licensed facility, or by th e auth orized represe ntat ive of an individua l, co-partn ership, cor porat ion, or ass ociat ion des ir ing to esta blish, con duct, or ma inta in a facility. The applicat ion sha ll include a stat ement of th e int ended pur pose of th e facility by specifying th e types of sur gery to be per form ed in it . When appropriat e, th e nam e of th e facility ma y include a brief stat ement of th e services provided , for exam ple, han d sur gery, genera l sur gery, industr ia l sur gery. The brief des ignat ion ma y appe ar un der th e nam e of th e facility on an externa l sign of th e building visible to th e public if a sign is used .
(4) The owner or govern ing body ma y des ignat e a qua lified administrat or of a facility, who ma y be th e auth orized represe ntat ive, an d delegat e to th e administrat or th e resp onsibili ty for th e day-t o-da y operat ion in com plian ce with licensing requirement s an d such additiona l policies or regulat ions as th e owner or govern ing body ma y adopt.
(5) An auth orized represe ntat ive sha ll be auth orized to mak e applicat ion an d am endment s to th e applicat ion to provide th e dep artm ent with all in format ion necess ar y to th e dep artm ent ’s determ inat ion ma de in conn ection with issuan ce of th e license an d to ent er int o agreement s with th e dep artm ent in conn ection with th e issuan ce of th e license. A cert ificat e of appointm ent or oth er writt en evide nce of th e auth ority vested in th e auth orized represe ntat ive sha ll be atta ched to th e applicat ion.
(6) In matt ers relat ing to licensing, th e dep artm ent ma y cont inu e to deal with th e auth orized represe ntat ive unt il notified, in writing, that a new auth orized represe ntat ive ha s been appoint ed with equa l power, an d th e form er auth orized represe ntat ive is no longer auth orized to act.
(7) The dep artm ent ma y use an y appropriat e mean s of notice an d ma y direct notices of an y administrat ive action pur suant to licensing of a facility to th e applicant or th e auth orized represe ntat ive eith er persona lly or by ma il at th e address of th e facility.
R 325 .3812 Lic enses , pe rmits ; iss uance .
Rule 12. (1) If th e dep artm ent determ ines that a facility com plies with th e act an d th ese ru les, th en th e dep artm ent sha ll issue a license.
(2) The director ma y issue a provisiona l license or temporar y unr enewable perm it in a ccor d with th e act an d th ese ru les.
(3) The dep artm ent , upon issuing a provisiona l license or denying a license, sha ll give th e applicant or th e auth orized represe ntat ive writt en notice of th e action an d th e reasons th erefor .
R 325 .3815 Const ruc tio n and ma jor alt e rations of physica l faci liti es .
Rule 15. (1) The owner or govern ing body of a proposed frees tan ding sur gical out pat ient facility sha ll submit plan s of th e proposed facility to th e dep artm ent for review an d approval before beginn ing an y constru ct ion project; including modern izat ion, addition to, or con version of, an existing stru ctur e. The pur pose of th e review is to require that th e proposed facility is designat ed an d con stru cted in a ccor d with applicable ru les.
(2) A facility sha ll not be con stru cted nor ma jor alterat ions un dertak en with out fir st obta ining a con stru ct ion perm it from th e dep artm ent .
(3) A ma jor alterat ion is deemed to be an y extensive stru ctura l alterat ion of an existing building ar ea involving significant chan ges in th e int erior configurat ions or int ended use by th e moving of part it ions of a num ber of rooms an d involving an expe nditur e in excess of
$50 ,000 .00. Removal of th e part it ions between 2 adjacent r oom s to provide additiona l r oom space is not deemed to be a ma jor alterat ion, un less it cost s more than $50 ,000 .00 an d mu lt iple chan ges ar e to be ma de for a chan ged use of an ent ire wing or ar ea an d extensive plum bing an d electr ical wiring chan ges ar e required.
(4) The dep artm ent ma y modify or waive 1 or more of th e requirement s of th ese ru les regar ding con stru ct ion or equipment stan dar ds, or both , for a pregnan cy term inat ion facility if both of th e followin g provisions apply:
(a) The frees tan ding sur gical out pat ient facility was in existence an d operat ing on December 21, 1999 .
(b) The dep artm ent mak es a determ inat ion that th e existing con stru ct ion or equipment , or both , with in th e facility is adequat e to prese rve th e health an d safety of th e pat ient s an d employees of th e facility or that th e con stru ct ion or equipment stan dar ds, or both , can be modified to adequat ely prese rve th e health an d safety of th e pat ient s an d employees of th e facility with out meeting th e specific requirement s of th ese ru les.
R 325 .3816 Comp li ance w it h othe r law s , codes , and ordinances .
Rule 16. A facility sha ll com ply with applicable stat e laws an d sha ll furn ish such evide nce as th e dep artm ent ma y require to show com plian ce with th e applicable loca l laws, codes , an d ordinan ces.
R 325 .3817 Resc inded . R 325 .3818 Resc inded . R 325 .3819 Resc inded .
R 325 .3826 Su rgica l procedu res ; med icatio ns .
Rule 26. (1) A sur gical pr oced ur e per form ed in a facility sha ll be done by a licensed physician . A licensed podiatr ist or licensed dent ist ma y also per form sur gical pr oced ur es in a facility un der th e direction of a physician an d in a ccor d with writt en facility policies an d pr oced ur es adopted by th e govern ing body or owner.
(2) A qua lified physician sha ll be prese nt on th e premises of a facility, including a pregnan cy term inat ion facility, thr ough th e postoperat ive period of a pat ient 's sta y in th e facility.
(3) Medi cat ions, diagnostic pr oced ur es, an d tr eatm ent s customar ily given or per form ed by nur ses or oth er qua lified personn el sha ll be given only upon writt en order of th e resp onsible physician , except as follows :
(a) In emergencies, verbal orders of th e physician for medicat ions or tr eatm ent s ma y be carr ied out with subseq uent notat ion of such car e being ent ered in th e pat ient 's recor d an d signed by th e physician .
(b) Stan ding orders for specific tests an d pre- an d postoperat ive car e ma y be esta blished an d honored when provided in writing an d approved by th e medical sta ff or physician owner or operat or of th e facility.
R 325 .3828 Informed consents .
Rule 28. (1) Except as provided by subru le (2) of th is ru le, th e owner or govern ing body sha ll adopt an d en for ce a policy which will require that in form ed con sent s will be obta ined from a pat ient or, in case of an un eman cipat ed minor, th e resp onsible relat ive or guar dian befor e th e per forman ce of sur gical pr oced ur es, an d sha ll require that signed writt en con sent form s be placed in each pat ient 's chart .
(2) The owner or govern ing body of a pregnan cy term inat ion facility sha ll adopt an d enforce a policy which will require that in form ed con sent s be obta ined in com plian ce with section 17015 of th e code, MCL 333 .17015 . In th e case of an un eman cipat ed minor, in form ed con sent s will also be obta ined in com plian ce with 1990 PA 211 , MCL 722 .901 , et seq.
R 325 .3832 Transpo rt ation se rvices .
Rule 32. A facility, including a pregnan cy term inat ion facility, sha ll ha ve adequat e tran sportat ion services imm ediat ely available, or ha ve prot ocols esta blished for a ccessi ng 911 emergency tran sportat ion services, for emergency pat ient s requiring tran sfer to a hospita l. A facility, including a pregnan cy term inat ion facility, sha ll be locat ed not more than 30 minut es norma l tra vel t ime from th e hospita l with which writt en emergency admission arran gement s ar e ma de. When indicat ed, a physician or nur se from th e facility sha ll a ccom pan y th e pat ient to provide emergency car e en rout e.
R 325 .3835 Ph ysician qua lifi cations ; reco rds .
Rule 35. (1) A physician , podiatr ist , or dent ist per form ing sur gery in a facility sha ll possess adequat e qua lificat ions acquired by spe cial tra ining an d expe rience to evaluat e th e medical, podiatr ic or denta l con ditions, potent ial r isks , recogn ize an d adequat ely tr eat emergency com plicat ions en count ered in an y pr oced ur e un dertak en, an d per form th e pr oced ur e in a ccor dan ce with th e usua l stan dar ds of medical, podiatr ic, or denta l pra ctice.
(2) The facility sha ll ma inta in a record of th e educat iona l tra ining an d expe rience backgroun d of each person grant ed privilege s to per form sur gery in a facility.
(3) Except as provided by subru le (4) of th is ru le, a qua lified an esth esiologist or an esth etist sha ll be on th e sta ff an d, when medically indicat ed, part icipat e in th e selection of th e most appropriat e an esth etic agent to be used an d be prese nt to supervise or actua lly administer th e an esth etic when pr oced ur es ar e un dertak en which require such part icipat ion.
(4) A pregnan cy term inat ion facility sha ll secur e th e services of an an esth esiologist or an esth etist for an abort ion pr oced ur e when a pat ient requires un con scious sed at ion thr ough th e use of a genera l an esth etic.
R 325 .3851 Resc inded .
R 325 .3857 Interi or const ruc tio n.
Rule 57. (1) A building sha ll be of safe con stru ct ion an d sha ll be free from ha zar ds to pat ient s, personn el, or visitors.
(2) Ea ch ar ea of a facility sha ll be provided with light ing adequat e for th e use to be ma de of th e locat ion an d in complian ce with genera lly recognized light ing stan dar ds.
(3) Ea ch ar ea of a facility sha ll be provided with a type an d am ount of vent ilat ion comm ensurat e with it s use, to minimize th e occurr ence of tran smissible disease, contr ol odors, an d contr ibut e to th e com fort of pat ient s an d personn el.
(4) Corr idors, ha llways, passageways, an d door ways sha ll be kept free from obstru ction at all t imes.
(5) Floor s, walls, an d ceilings sha ll be cover ed an d finished in a mann er that perm it s ma int enan ce of a san itar y environm ent .
(6) Em ergency electr ical service sha ll be perman ent ly insta lled in th e facility, including a pregnan cy term inat ion facility, to provide light ing in corr idors, exits, pr oced ur e r oom s, recover y r oom s, con gregat e r oom s, nur se stat ions, an d oth er critical ar eas. In new con stru ct ion or renovat ions, an emergency generat or that ha s an aut omat ic tran sfer switch or an alternat ive sour ce of imm ediat e electr ical power a ccep ta ble to th e dep artm ent sha ll be provided for light ing an d operat ion of equipment necess ar y to pat ient car e.
(7) Pat ient exam inat ion, pr oced ur e, an d recover y r oom s sha ll ha ve a minimum door width of 3 feet.
R 325 .3866 Clin ical faci liti es .
Rule 66. (1) A facility sha ll ha ve enough exam inat ion r oom s to meet th e volum e of work to be a ccom plished, an d each r oom sha ll provide a minimum of 70 squar e feet of usable floor space. In new con stru ct ion or renovat ions, 80 squar e feet of usable floor space sha ll be provided.
(2) An exam ining room sha ll ha ve a han dwash lavat ory with in th e r oom , which sha ll be equipped with a goose neck inlet an d wrist, kn ee, or foot contr ols.
(3) A chan ge ar ea sha ll be provided for pat ient s an d provision sha ll be ma de for th e safe stora ge of th eir persona l effect s.
(4) A facility sha ll ha ve enough operat ing or pr oced ur e r oom s to meet th e volum e of work to be a ccom plished, an d each r oom sha ll provide a minimum of 120 squar e feet of usable floor space. In new con stru ct ion, 150 squar e feet of usable floor space sha ll be provided .
(5) Explosive an esth etic agent s sha ll not be used in th e r oom s.
(6) A supply of oxygen an d appropriat e ma sks or oth er mean s of administrat ion sha ll be available in each room.
(7) A r oom sha ll be designed to perm it th e tran sfer of a pat ient from th e ta ble to a str etcher an d to perm it su fficient clearan ce on eith er side an d at th e foot of th e ta ble with necess ar y equipment an d supplies in place.
(8) A nur se call signa l sha ll be provided from th e procedur e an d exam ining room to a centra l contr ol stat ion.
(9) A scru b sink that ha s a goose neck out let sha ll be available in or adjacent to th e pr oced ur e r oom s.
(10) Single-use soap, scru b bru shes, an d towels sha ll be ut ilize d in pat ient car e ar eas.
(11) The r oom sha ll conta in a suita ble operat ing ta ble an d oth er equipment necess ar y for th e types of pr oced ur es to be per form ed.
(12) Space for an d sterilizat ion equipment sha ll be provided to pr ocess all medical supplies that require sterilizat ion between uses . Equipment sha ll be capable of a ccomm odat ing th e
work load of th e facility, an d contr ols a ccep ta ble to th e director sha ll be used to check effect iveness an d assur e sterilizat ion.
(13) As provided by R 325 .3868 a, th e dep artm ent ma y waive a spe cific requirement of th is ru le as applied to a pregnan cy term inat ion facility.
R 325 .3867 Med icatio n and sto rage areas .
Rule 67. (1) A facility sha ll ha ve enough medicat ion work an d stora ge ar eas to meet th e volum e of work to be a ccom plished.
(2) A shelf or desk sha ll be provided for th e nur se's use in prepar ing an d administering medicat ions an d recor ding in format ion in pat ient s' recor ds an d sha ll be with in an d readily a ccessible to all pat ient car e ar eas for which that nur sing stat ion ha s resp onsibili ty.
(3) A medicat ion stora ge an d preparat ion ar ea equipped with a sink that ha s a goose neck inlet an d hot an d cold wat er an d lock ed stora ge for medicat ions sha ll be provided . This includes adequat e space for th e stora ge of medicat ions, fluids, an d electr olyte solut ions in a safe an d san itar y mann er.
(4) Space sha ll be available for th e stora ge of clean linens, equipment , supplies, wheelcha irs an d str etchers.
(5) A soiled ut ility r oom sha ll be available for temporar ily holding waste mat erials an d clean ing of items to be reused .
(6) A jan itor's closet that ha s a service sink sha ll be available.
(7) As provided by R 325 .3868 a, th e dep artm ent ma y waive a spe cific requirement of th is ru le as applied to a pregnan cy term inat ion facility.
R 325 .3868 P atient obse rvation and recove ry areas .
Rule 68. (1) Pat ient obse rvat ion an d recover y ar eas sha ll be provided in su fficient num bers to a ccomm odat e th e pat ient load with a plann ed minimum of a 3-hour recover y period an d longer when necess ar y for individua l pat ient s. The ar eas sha ll be com forta bly furn ished an d adequat ely equipped for th e pat ient 's safe postoperat ive obse rvat ion an d recovery.
(2) A facility sha ll provide at least 1 recover y r oom equipped for use by an d obse rvat ion of pat ient s requiring recum bent car e post-sur gically. A minimum of 1 hospita l-type bed or wheeled recover y r oom str etcher sha ll be provided for each 10 post-sur gical pat ient s to be car ed for at an y one t ime.
(3) Single bed /str etcher recover y r oom s sha ll provide a minimum of 100 squar e feet of usable floor space.
(4) Multiple bed/str etcher recover y r oom s sha ll provide a minimum of 80 squar e feet of floor space per bed or str etcher.
(5) A recover y r oom sha ll be des igned to provide a minimum of 3 feet between beds or str etchers an d 4 feet of clearan ce at th e foot of th e bed or str etcher.
(6) Com forta bly furn ished con gregat e r oom s equipped with eith er reclining or loun ge-type cha irs or cot s ma y be provided for th e post-sur gical obse rvat ion of pat ient s not needi ng bed or str etcher a ccomm odat ions. Ea ch con gregat e-type r oom sha ll provide a minimum of 50 squar e feet of usable floor space for each pat ient to be a ccomm odat ed. A con gregat e r oom sha ll not conta in a ccomm odat ions for more than 12 pat ient s.
(7) A toilet an d lavat ory sha ll be provided for each 6 recover y pat ient s at a minimum . One or more bath ing facilities ar e recomm ended .
(8) Corr idors used for pat ient entr y, egress , an d sur gical car e ar eas in a facility sha ll ha ve a minimum width of 6 feet.
(9) As provided by R 325 .3868 a, th e dep artm ent ma y waive a spe cific requirement of th is ru le as applied to a pregnan cy term inat ion facility.
R 325 .3868 a Waive r of ce rt ain requiremen ts .
Rule 68a. (1) Pur suant to R 325 .3815 (4), th e dep artm ent ma y waive a specific requirement of R 325 .3866 , R 325 .3867 , or R 325 .3868 as applied to a pregnan cy term inat ion facility if it reasona bly determ ines th e facility con stru ct ion, size, an d equipment of a r oom , ar ea, or equipment ut ilize d for pur poses of medicat ion preparat ion or stora ge, san itar y stora ge, or facility ma int enan ce ar e adequat e to protect th e health an d safety of th e pat ient s an d employees of th e facility, or that th e con stru ct ion, equipment or ma int enan ce stan dar ds can be modified to adequat ely prese rve th e health an d safety of th e pat ient s an d employees of th e facility with out meeting th e specific requirement s of th ese ru les.
(2) A pregnan cy term inat ion facility sha ll submit a request for var ian ce in writing at th e t ime of applicat ion for a license.
(3) The decision of th e dep artm ent , including an y qua lificat ion un der which th e var ian ce is grant ed, sha ll be sent to th e pregnan cy term inat ion facility an d placed in th e facility recor d.
(4) The var ian ce ma y rema in in effect for as long as th e pregnan cy term inat ion facility cont inu es to com ply with th e con ditions of th e var ian ce or ma y be t ime-limited.
