DEPARTMENT OF CONSUMER AND INDUSTRY SERVICES

                             BUREAU OF HEALTH SYSTEMS

                   FREESTANDING SURGICAL OUTPATIENT FACILITIES

(By authority  conferred  on  the  department  of   consumer   and   industry 
services by sections 2226(d), 2233, 20115, 20145, 20161, 20171, and 21015  of 
1978 PA 368, and section 9 of 1965 PA 380, being MCL  333.2226(d),  333.2233, 
333.20115, 333.20145, 333.20161, 333.20171, 333.20155, and 16.109)



R 325.3801    Definitions; A.
  Rule 1. As used in these rules:
  (a) "Act" means 1978 PA 368, being §§333.1001 et seq.
  (b)  "Anesthesia" means a state of loss of feeling  or  sensation  and   is 
normally used to denote the loss of sensation to pain  purposely  induced  by 
the use of a specific gas or drug to permit the  performance  of  surgery  or 
other painful procedure.
  (c)  "Anesthesiologist" means a physician who specializes in the field   of 
anesthesiology and who may or may not be a diplomate of his or her  specialty 
board.
  (d)  "Anesthetic" means a drug, gas, or other agent used to  abolish    the 
sensation of pain. There are 3 classifications as follows:
  (i)  "General anesthetic"  means  an  anesthetic  agent  that  produces   a 
temporary loss of  consciousness  by  the  administration  of  a  gas;  oral, 
intramuscular, and intravenous drugs; or a combination of these methods.
  (ii)  "Local anesthetic" means a drug whose action is limited to  an   area 
of the body around the site of its application.
  (iii)  "Spinal," "epidural," or "caudal" anesthetic means the injection  of 
an appropriate local type of anesthetic into the spinal canal, epidural area, 
to produce a local loss of sensitivity to the body areas  at  and  below  the 
sensory nerve distribution at the level of injection.
  (e)   "Anesthetist"  means  a  person  who  is  qualified  to    administer 
anesthetic.  In common usage, the term applies to nurses and lay persons  who 
have had special training and  experience  under  medical   auspices  in  the 
administration of anesthetics.

  History:  1979 AC; 2001 AACS.


R 325.3802    Definitions; C to S.
  Rule 2.  As used in these rules:
  (a)  "Code" means 1978 PA 368, MCL 333.1101 et seq.
  (b)  "Department" means the department of consumer and industry services.
  (c)  "Director" means the director of the department.
  (d)  "Freestanding surgical outpatient facility"  or  "facility"  means   a 
facility as defined in section 20104(5) of the code and includes, but is  not 
limited to, a facility that includes a private practice office in  which  50% 
or more of the patients annually served at the facility undergo an abortion.
  (e)  "Hospital" means a facility defined in section 20106(5) of the code.
  (f)  "Nurse" means an individual who is currently licensed  or   registered 
as a nurse by the state.
  (g)   "Physician"  means  a  person  licensed  to  practice  medicine    or 
osteopathy in this state.
  (h) "Pregnancy termination facility" means a facility, including, but   not 
limited to, a private practice office in which 50% or more  of  the  patients 
annually served at the facility undergo an  abortion.   The  calculation  for 
percentage of patients served undergoing an abortion shall be  based  on  the 
number of individual patients served and not on the number of patient  visits 
or incidents of service.
  (i) "Surgery" means the treatment of human beings by a physician,  by   the 
use of 1 or more of the following procedures:
  (i)   Cutting  into  any  part  of   the   body   by   surgical    scalpel, 
electro-cautery, or other means for diagnosis or the  removal  or  repair  of 
diseased or damaged tissue, organs, tumors, or foreign bodies.
  (ii)  Reduction of fractures or dislocations of a bone,  joint,  or    bony 
structure.
  (iii)  Repair of malformations or  body  defects  resulting  from   injury, 
birth defects, or other causes that require  cutting  and   manipulation   or 
suture.
  (iv)  Instrumentation  of  the  uterine  cavity  including  the   procedure 
commonly known as dilatation and  curettage  for  diagnostic  or  therapeutic 
purposes.
  (v)  Any instrumentation of or injection of any substance into the  uterine 
cavity of a woman for the purpose of terminating a pregnancy.
  (vi)  Human sterilization procedures.
  (vii)  Endoscopic procedures.

  History:  1979 AC; 2001 AACS.


R 325.3803    Terms defined in code
  Rule 3.  Terms defined in the code have the same  meanings  when  used   in 
these rules.

  History:  2001 AACS.


R 325.3811    Licenses; requirements; applications.
  Rule 11. (1)  A freestanding surgical outpatient  facility  shall  not   be 
established, maintained, or operated without first obtaining a license.   The 
term "freestanding surgical outpatient facility" or other similar term  shall 
not be used on unlicensed places.
  (2)  An application for a license for a facility shall be  made  on   forms 
authorized and provided by the department.  The application shall include the 
identity of the owner of the facility.
  (3)  An application for a license for a facility shall be made and   signed 
by the individual  desiring to establish, conduct,  or  maintain  a  licensed 
facility,  or  by   the   authorized   representative   of   an   individual, 
co-partnership, corporation, or association desiring to  establish,  conduct, 
or maintain a facility.   The application shall include a  statement  of  the 
intended purpose of the facility by specifying the types  of  surgery  to  be 
performed in it.   When appropriate, the name of the facility may  include  a 
brief statement of the services provided, for example, hand surgery,  general 
surgery, industrial surgery.   The brief designation  may  appear  under  the 
name of the facility on an external sign  of  the  building  visible  to  the 
public if a sign is used.
  (4)  The owner or governing body may designate a  qualified   administrator 
of a facility, who may be the authorized representative, and delegate to  the 
administrator the responsibility for the day-to-day operation  in  compliance 
with licensing requirements and such additional policies  or  regulations  as 
the owner or governing body may adopt.
  (5)  An authorized representative shall be authorized to make   application 
and amendments  to  the  application  to  provide  the  department  with  all 
information necessary to the department's  determination made  in  connection 
with issuance of the license and to enter into agreements with the department 
in connection with the issuance of the license.  A certificate of appointment 
or  other  written  evidence  of  the  authority  vested  in  the  authorized 
representative shall be attached to the application.
  (6)  In matters relating to licensing, the department may continue to  deal 
with the authorized representative until notified, in  writing,  that  a  new 
authorized representative has been appointed with equal power, and the former 
authorized representative is no longer authorized to act.
  (7)  The department may use any appropriate means of notice and may  direct 
notices of any administrative action pursuant to licensing of a  facility  to 
the applicant or the authorized representative either personally or  by  mail 
at the address of the facility.

  History:  1979 AC; 2001 AACS.


R 325.3812    Licenses, permits; issuance.
  Rule 12. (1)  If the department determines that a facility  complies   with 
the act and these rules, then the department shall issue a license.
  (2)  The director may issue a provisional license or temporary  unrenewable 
permit in accord with the act and these rules.
  (3)  The department, upon issuing  a  provisional  license  or  denying   a 
license, shall give the applicant or the  authorized  representative  written 
notice of the action and the reasons therefor.

  History: 1979 AC; 2001 AACS.


R 325.3813    Licenses; permits; transferability; notice of change; display.
  Rule 13.  (1)  A license, provisional  license,  or  temporary  unrenewable 
permit is not transferable between owners or from 1 location to another.
  (2) The applicant or authorized representative shall given  written  notice 
to the department within 5 business days of  any  change  in  information  as 
submitted in the application pursuant to which a license, provisional license 
or temporary unrenewable permit was issued.
  (3) The current license,  provisional  license,  or  temporary  unrenewable 
permit shall be posted in a conspicuous public area of the facility.

  History:  1979 AC.


R 325.3815    Construction and major alterations of physical facilities.
  Rule 15. (1)  The owner or  governing  body  of  a  proposed   freestanding 
surgical outpatient facility shall submit plans of the proposed  facility  to 
the department for review and  approval  before  beginning  any  construction 
project; including modernization, addition to, or conversion of, an  existing 
structure.  The purpose of  the  review  is  to  require  that  the  proposed 
facility is designated and constructed in accord with applicable rules.
  (2)  A facility shall not be constructed nor major alterations   undertaken 
without first obtaining a construction permit from the department.
  (3)   A  major  alteration  is  deemed  to  be  any  extensive   structural 
alteration of an existing building area involving significant changes in  the 
interior configurations or intended use by the  moving  of  partitions  of  a 
number of rooms and involving an  expenditure  in  excess  of  $50,000.00.
Removal of the partitions between 2 adjacent rooms to provide additional room 
space is not deemed to be a major  alteration,  unless  it  costs  more  than 
$50,000.00 and multiple changes are to be made for a changed use of an entire 
wing or area  and  extensive  plumbing  and  electrical  wiring  changes  are 
required.
  (4) The department may modify or waive 1 or more of  the  requirements   of 
these rules regarding construction or equipment standards,  or  both,  for  a 
pregnancy termination facility if both of the following provisions apply:
  (a) The freestanding surgical outpatient facility  was  in  existence   and 
operating on December 21, 1999.
  (b) The department makes a determination that the existing construction  or 
equipment, or both, within the facility is adequate to  preserve  the  health 
and safety of the  patients  and  employees  of  the  facility  or  that  the 
construction or equipment standards, or both, can be modified  to  adequately 
preserve the health and safety of the patients and employees of the  facility 
without meeting the specific requirements of these rules.

  History:  1979 AC; 2001 AACS.


R 325.3816    Compliance with other laws, codes, and ordinances.
  Rule 16.  A facility shall comply with applicable  state  laws  and   shall 
furnish such evidence as the department may require to show  compliance  with 
the applicable local laws, codes, and ordinances.

  History:  1979 AC; 2001 AACS.


R 325.3817    Rescinded.

  History:  1979 AC; 2001 AACS.


R 325.3818    Rescinded.

  History:  1979 AC; 2001 AACS.


R 325.3819    Rescinded.

  History:  1979 AC; 2001 AACS.


R 325.3820    Prohibitions
  Rule 20.  (1) The use of the words "state approved"  or  similar  words  is 
prohibited.  The word "licensed" may be used by a licensed facility.
  (2)  The use of the word "hospital" or  words  having  similar  meaning  is 
prohibited in reference to a facility, except to identify  a  facility  owned 
and operated by a licensed hospital by including, if desired, the name of the 
parent hospital in the name or by  a  modifying  phrase  or  a  clause  as  a 
subtitle of the facility's name.

  History:  1979 AC.


R 325.3822    Disaster and emergency procedures.
  Rule 22.  (1)  A facility shall have a written  plan  of  procedure  to  be 
followed in case of fire, explosion, or other emergency.
  (2)  A disaster plan shall specify persons  to  be  notified,  location  of 
alarm signals and fire extinguishers, evacuation routes, emergency procedures 
for patient care, and assignment of specific tasks.
  (3) Personnel shall be assigned and trained to perform specific task.

  History:  1979 AC.


R  325.3825   Patient care.
  Rule 25. (1)  A  facility  shall  be  planned,   staffed,   equipped,   and 
operated with the  individual  patient's  welfare  and  safety   to   be   of 
paramount concern.
  (2) The feelings, sensibilities, and comfort of  the   patient   shall   be 
fully respected and given meticulous attention by all personnel.
  (3) A person cared for in a facility shall be seen by, and  be  under   the 
care of, a currently licensed physician.

  History:  1979 AC.


R 325.3826    Surgical procedures; medications.
  Rule 26. (1)  A surgical procedure performed in a facility shall be    done 
by a licensed physician. A licensed podiatrist or licensed dentist  may  also 
perform surgical procedures in a facility under the direction of a  physician 
and in accord with written facility policies and procedures  adopted  by  the 
governing body or owner.
  (2)  A qualified physician shall be present on the premises of a  facility, 
including a pregnancy termination facility, through the postoperative  period 
of a patient's stay in the facility.
  (3)  Medications, diagnostic procedures, and treatments customarily   given 
or performed by nurses or other qualified personnel shall be given only  upon 
written order of the responsible physician, except as follows:
  (a)  In emergencies, verbal orders of the  physician  for  medications   or 
treatments may be carried out with subsequent notation  of  such  care  being 
entered in the patient's record and signed by the physician.
  (b)  Standing orders for specific tests and pre-  and  postoperative   care 
may be established and honored when provided in writing and approved  by  the 
medical staff or physician owner or operator of the facility.

  History:  1979 AC; 2001 AACS.


R 325.3827    Admission and registration.
  Rule 27. (1) A person referred, or applying,  for  care   in   a   facility 
shall be received and treated in a kindly and sympathetic manner.
  (2) An  applicant  for  care  shall  be  registered   promptly   with   the 
procurement  of  the  identification,  vital   and   financial    information 
essential to the initiation of requisite medical and  business  records   and 
any required departmental reports.

  History:  1979 AC.


R 325.3828    Informed consents.
  Rule 28. (1) Except as provided by subrule (2) of this rule, the owner   or 
governing body shall adopt and enforce  a  policy  which  will  require  that 
informed consents will  be  obtained  from  a  patient  or,  in  case  of  an 
unemancipated   minor,  the  responsible  relative  or  guardian  before  the 
performance of surgical procedures, and shall  require  that  signed  written 
consent forms be placed in each patient's chart.
  (2) The owner or governing body of a pregnancy termination facility   shall 
adopt and enforce a policy which  will  require  that  informed  consents  be 
obtained in compliance with section 17015 of the code, MCL 333.17015.  In the 
case of an unemancipated minor, informed consents will also  be  obtained  in 
compliance with 1990 PA 211, MCL 722.901, et seq.

  History:  1979 AC; 2001 AACS.


R  325.3831   Records.
  Rule 31. (1) Medical records shall be initiated and kept  on  all  patients 
receiving any type of surgical care.
  (2) A facility shall maintain administrative records  to   include   as   a 
minimum:
  (a) Records of surgical procedures performed each day.   These   shall   be 
maintained in chronological sequence in  a  permanent   bound   register   or 
logbook.
  (b) Monthly  statistical  summary  of  numbers   of   surgical   procedures 
performed, appropriately classified according to standard nomenclature.
  (c) Narcotics register.
  (d) Transfers to a hospital for post-surgical care and case outcome.

  History:  1979 AC.


R 325.3832    Transportation services.
  Rule  32.  A  facility, including a pregnancy termination facility,   shall 
have  adequate  transportation  services  immediately  available,   or   have 
protocols established for accessing 911  emergency  transportation  services, 
for emergency  patients  requiring  transfer  to  a  hospital.   A  facility, 
including a pregnancy termination facility, shall be located not more than 30 
minutes normal travel time from the hospital  with  which  written  emergency 
admission arrangements are made.  When indicated, a physician or  nurse  from 
the facility shall accompany the patient to provide emergency care en route.

  History:  1979 AC; 2001 AACS.


R 325.3833    Counseling and referrals for subsequent care.
  Rule  33.  (1)  When  procedures  having  present    or    future    social 
implications for a patient are performed, such as  human  sterilizations   or 
pregnancy terminations, or when indicated in other  situations,  a   facility 
shall make available and offer appropriate  counseling,  interpretation,  and 
referral for subsequent indicated care. To  accomplish   this,   a   facility 
shall:
  (a) Provide through physicians, qualified  nurses,   social   workers,   or 
specially trained and qualified counselors for  appropriate  assistance   and 
counseling as needed.
  (b) Maintain liaison with and  make  indicated   referrals   to   community 
counseling, family planning, or other social and health  service  agencies to 
help assure appropriate and adequate subsequent care of the patient.
  (c) Provide such counseling or assistance without coercion.
  (2) Counselors, other than a responsible physician,  should  consult   with 
the physician concerning results of counseling and the  initiation   of   any 
referrals that seem necessary.
  (3) An appropriate method for providing  information   to   and   receiving 
information  from  legitimate  referral  sources   shall   be    established, 
including adequate mechanisms for the scheduling and  fulfilling  of  advance 
appointments requested by a referral source.

  History:  1979 AC.


R 325.3834    Medical supervision and administrative management.
  Rule 34. (1) The medical care provided in a facility shall  be  under   the 
direction of a qualified licensed physician.
  (2)  There  shall  be  a  designated  responsible   person    in    overall 
administrative charge of a facility who may be the owner,  a   co-owner,   or 
person employed by the owner to fulfill this  responsibility.  If  qualified, 
the person may also be the medical director who shall  be   responsible   for 
the medical direction of the facility as well as  for   the   nonprofessional 
administrative   activities,   or   a    suitably    qualified     nonmedical 
administrator may be employed to assume  nonprofessional  administrative  and 
business management responsibility.

  History:  1979 AC.


R 325.3835    Physician qualifications; records.
  Rule 35. (1)  A physician, podiatrist, or dentist performing surgery in   a 
facility shall possess adequate qualifications acquired by  special  training 
and experience to evaluate  the  medical,  podiatric  or  dental  conditions, 
potential risks,  recognize  and  adequately  treat  emergency  complications 
encountered  in  any  procedure  undertaken,  and  perform  the procedure  in 
accordance with the usual  standards  of   medical,   podiatric,   or  dental 
practice.
  (2)  The facility shall maintain a record of the educational training   and 
experience background of each person granted privileges to perform surgery in 
a facility.
  (3)  Except  as  provided  by  subrule  (4)  of  this  rule,  a   qualified 
anesthesiologist or anesthetist shall be on the  staff  and,  when  medically 
indicated, participate in the selection of the  most  appropriate  anesthetic 
agent to be used and be present  to  supervise  or  actually  administer  the 
anesthetic when procedures are undertaken which require such participation.
  (4)  A pregnancy termination facility shall  secure  the  services  of   an 
anesthesiologist or anesthetist for an  abortion  procedure  when  a  patient 
requires unconscious sedation through the use of a general anesthetic.

  History:  1979 AC; 2001 AACS.


R 325.3836    Medical policies; rules.
  Rule 36. (1) In a hospital-owned  and  operated   facility,   the   medical 
staff rules, regulations, and policies adopted by the   hospital   for   such 
care shall prevail.
  (2) In a nonhospital-owned and  operated   facility,   comparable   written 
medical staff rules, regulations, and  policies  shall   be   developed   and 
adopted by the medical staff.

  History:  1979 AC.


R 325.3837    Medical consultations.
  Rule 37. Consultation and assistance in  any   needed   medical   specialty 
field shall be readily available and used as indicated prior  to  and,   when 
necessary,  following  a  surgical  procedure.  If  there   is   any    doubt 
concerning the patient's medical status, appropriate  consultation  shall  be 
required  and  written  reports   of   the    consultants'    findings    and 
recommendations shall be entered  in  the  patient's   clinical   record.   A 
facility shall maintain a current record of the  identites   of   consultants 
serving the facility.

  History:  1979 AC.


R 325.3838    Medical reviews.
  Rule 38. The conduct of the work of a facility shall   be   regularly   and 
frequently reviewed by the appropriate medical   staff   committee   (tissue, 
medical audit or utilization, medical  records)  in   a   hospital   operated 
facility to assure maintenance of high standards and quality  of   care.   In 
other facilities, comparable arrangements acceptable to  the   director   for 
impartial medical surveillance and review of the quality  of  care   provided 
shall be made.

  History:  1979 AC.


R 325.3839    Scrub procedures; policy.
  Rule 39. A facility shall have a written policy adopted  by   the   medical 
staff to provide for adequate handwashing and  surgical  scrub-up  procedures 
between patient examinations when actual contact with a  patient  occurs  and 
between surgical operative procedures in accord   with   generally   accepted 
standards for sanitation and surgical scrub-up cleanliness.

  History:  1979 AC.


R 325.3840    Nurse qualifications.
  Rule 40. (1) Nursing care in a facility shall be under the direction  of  a 
currently   registered   professional   nurse   who   possesses    additional 
qualifications acquired by training and experience essential  to  the  proper 
and safe conduct of the surgical procedure  undertaken   and   nursing   care 
attention to the postoperative observation and needs of the patients.
  (2) A registered professional nurse who possesses the  special  skills  and 
experience necessary to supply or supervise  all  nursing   care   needs   of 
patients in preparation for and during  the  surgical   procedure   and   the 
recovery period until discharge by the responsible physician,  shall  be   on 
duty.
  (3) A licensed practical nurse with  special   training   and   experience, 
working under appropriate  supervision  and  direction,  may   be   used   to 
complement the registered professional nursing  staff   to   perform   duties 
within the scope  of  his  competence  and  restrictions   of   the   nursing 
practice act.

  History:  1979 AC.


R 325.3841    Ancillary personnel.
  Rule 41. Ancillary personnel  participating  in  patient   care   who   are 
adequately trained and working under appropriate  direction  or   supervision 
may be employed to assist within the areas  of  their   competence   in   the 
conduct of the work of the facility.

  History:  1979 AC.


R 325.3842    Supplies, equipment, and processing.
  Rule  42.  (1)  Supplies  of  appropriate   drugs,   medications,   fluids, 
electrolyte solutions (including plasma volume  expanders),  sterile   linens 
(gowns, drapes, towels, and so forth), gloves, dressings,  bandages  and   so 
forth shall  be  maintained  in  sufficient  quantities   for   regular   and 
emergency use. The drug storage,  dispensing,   and   administration   system 
shall comply fully with applicable state laws and rules.
  (2) Such surgical instruments, accessory and operating  room  lights,   and 
resuscitation equipment as are appropriate for the types   of   surgery   and 
surgical risks which may be encountered in a facility   shall   be   provided 
and maintained in clean and sterile condition.
  (3) Adequate supplies of  linens  shall  be   maintained,   sufficient   to 
provide for all indicated changes after 1 use.
  (4) There shall be appropriate provision for the satisfactory laundering of 
linens and garments.

  History:  1979 AC.


R 325.3843    Beverages and nourishments.
  Rule 43. Hot and cold beverages and appropriate light nourishments shall be 
provided and offered to patients, especially for  those  patients   kept  for 
observation for periods longer than  the  3-hour  minimum  observation period 
specified in R 325.3868(1). These shall be stored and served in  an appealing 
and sanitary manner.

  History:  1979 AC.


R 325.3844    Housekeeping.
  Rule 44. (1) The building, supplies, equipment, and  furnishings  shall  be 
maintained in a clean, sanitary, safe, and usable condition.
  (2) A facility shall have a housekeeping manual   stating   frequency   and 
procedure for cleaning various areas in  the   facility.   These   procedures 
shall be followed to assure a sanitary environment.
  (3) The building, equipment, fixtures, and operation  shall   comply   with 
applicable local and state fire, safety, and sanitation codes.

  History:  1979 AC.


R 325.3845    Laboratory services.
  Rule 45. (1) Provision shall be made for the   performance   of   indicated 
services by a laboratory that is licensed or exempt   from   licensing,   and 
provides competent personnel  and  adequate  equipment   to   make   accurate 
determinations. Written documents of the arrangements  shall   be   available 
for inspection.
  (2) While laboratory services to be performed on   a   particular   patient 
are  matters  of  medical  judgment,  it  is  expected   that   those   tests 
appropriate to the individual case will be performed and results  recorded in 
the patient's clinical record.  A   facility   shall   adopt   and   maintain 
written policies specifying such  minimal  laboratory   procedures   as   are 
required for specific types of surgical procedures.
  (3) A facility shall provide for the services of a qualified pathologist to 
be available to it for  the  pathological  examination  and   reportings   of 
findings of all surgical specimens removed at the facility   which   in   the 
judgment of the surgeon  require  pathological   examination.   Tissues   not 
examined by a  pathologist  shall  be  described  and   identified   in   the 
clinical record by the operating surgeon.

  History:  1979 AC.


R 325.3846    X-ray services.
  Rule 46. (1) In a facility offering services   which   ordinarily   require 
diagnostic x-ray examinations, appropriate arrangements shall  be   made   to 
assure their availability.
  (2) Depending on the volume and urgency of  x-ray   needs,   the   facility 
shall do 1 of the following:
  (a) Arrange with a nearby radiology  service  operated   by   a   qualified 
radiologist for the provision of the examination.
  (b) Provide appropriate x-ray equipment with necessary  staff  within   the 
facility. In such installations, the service shall be  maintained  under  the 
direction of a  physician  qualified  for  the   responsibility   and   shall 
include  protection  of  patients  and  personnel   from   overexposure    to 
radiation or electric shock.
  (3) A report of a finding on an x-ray examination made shall be  entered in 
the patient's record.
  (4) Radiographic equipment shall be maintained in  accord   with   existing 
law and rules.

  History:  1979 AC.


R 325.3847    Medical records.
  Rule 47. (1)  Medical  records  shall  be  originated   on   all   patients 
undergoing surgery, signed by the responsible physician,  indexed,   and   so 
filed as to assure their ready access and future availability. They  shall be 
maintained in accordance with a written retention policy acceptable   to  the 
director. In a  hospital  operated  facility,  the  recordkeeping  shall   be 
incorporated into the  hospital  medical  records   system,   including   and 
subject to its established retention policies.
  (2) Medical records shall contain as a minimum:
  (a) Patient identification, including name, address,  marital  status,  and 
birthdate.
  (b) Medical history.
  (c) Physical examination.
  (d) Medical orders signed by the responsible physician.
  (e) Laboratory findings.
  (f) Special   examination    findings,    for     example,     x-ray     or 
electrocardiogram.
  (g) Preoperative and final diagnosis.
  (h) Nurses' notes which shall include a recording of  vital   signs,   pre- 
and postoperatively, color, appearance, and   other   relevant   observations 
with  such  frequency  postoperatively  as  to   document    the    patient's 
stabilized condition at time of discharge.
  (i) Record of the sedation and  anesthetic  used  by   product   name   and 
dosage, identity of anesthetist if other than the  surgeon,  procedure,   and 
any pertinent information concerning results or reactions.
  (j) Written consultation reports signed by the consultant.
  (k) Social or social service information relevant to the case.
  (l) Surgeon's operative note including naming   of   procedure   performed, 
physician performing surgery, anesthetic agent used,  names   of   assistants 
(whether another physician, a  nurse  or   specially   trained   technician), 
duration of procedure and any unusual problems  or  occurrences  encountered, 
and surgeon's description of gross appearance of tissues removed.
  (m) Physician's progress  notes  and  discharge   note.   The   physician's 
progress and discharge notes may be combined  in   the   patient's   clinical 
record.
  (n) Summary of instructions given for followup observation  and   care   as 
well as recording of all referrals  for  counseling,   family   planning   or 
other medical conditions requiring further attention.
  (o) Identification of the physician who actually discharges the patient.
  (3) Medical records shall be available for survey and review of  content at 
any time by authorized members of the department.
  (4) Medical records shall be maintained as  confidential   documents   with 
the following exceptions:
  (a) Information required under these rules.
  (b) Information required by law.
  (c) Information authorized for disclosure  by  written   release   by   the 
patient.
  (5) A facility in  which  pregnancy  terminations   are   performed   shall 
maintain records of the procedures, and shall  file   reports   and   furnish 
statistical and such other information as may be required by the director.
These shall be reported on forms provided by the director  in   accord   with 
definitions and notification procedures as he may specify.  They   shall   be 
signed in each instance by the physician  performing   the   procedure.   The 
report forms shall not require identification of   the   patient   undergoing 
the procedure.
  (6) Failure or refusal  of  a  facility  to  file   the   notification   of 
termination of pregnancy properly executed and personally   signed   by   the 
responsible  physician  is  sufficient  cause   for   immediately   beginning 
proceedings for revoking the license and closing the facility.
  (7) Information submitted by a referral source shall  become  an   integral 
part of the clinical record of the patient.

  History:  1979 AC.


R 325.3848    Medical records; storage.
  Rule 48. Adequate space shall be provided for  the   storage   of   medical 
records so located as to assure their  confidentiality   and   protect   them 
from access by unauthorized persons. Additional work space in or  adjacent to 
the medical records storage area  shall  be  provided   for   the   assembly, 
completion and review of medical records.

  History:  1979 AC.


R 325.3851    Rescinded.

  History:  1979 AC; 2001 AACS.


R 325.3855    Plans and specifications.
  Rule 55. (1) A floor plan of the  facility  with   description   of   rooms 
showing size, door locations and fixed equipment shall be on  file   in   the 
facility and at the department.
  (2) Complete plans and  specifications  for   new   buildings,   additions, 
major building changes and conversion of existing facilities for  use  as   a 
facility shall be submitted to the department for review and approval.
  (3) Plans and specifications meeting the requirements  of   the   law   and 
these rules  shall  be  approved  by  the  department  and   a   permit   for 
construction issued.
  (4) Construction of new buildings, additions,   major   building   changes, 
and conversion of existing structures for use  as  a   facility   shall   not 
begin until the  plans  and  specifications  have  been   approved   by   the 
department and a permit for construction issued.

  History:  1979 AC.


R 325.3856    Exterior.
  Rule 56. (1) The premises of a facility shall be maintained   in   a   safe 
and sanitary condition and in a manner consistent with  the   public   health 
and welfare.
  (2) At least 1 entrance to a facility shall provide safe  and  easy  access 
for the physically handicapped.
  (3) Exterior ramps and steps shall have a handrail on both sides.
  (4) Sufficient light for an exterior ramp or steps shall  be  provided  for 
the safety of persons using the facility.

  History:  1979 AC.


R 325.3857   Interior construction.
  Rule 57. (1)  A building shall be of safe construction and shall  be   free 
from hazards to patients, personnel, or visitors.
  (2)  Each area of a facility shall be provided with lighting adequate   for 
the use to  be  made  of  the  location  and  in  compliance  with  generally 
recognized lighting standards.
  (3)  Each area of a facility shall be provided with a type and  amount   of 
ventilation  commensurate  with  its  use,  to  minimize  the  occurrence  of 
transmissible disease, control  odors,  and  contribute  to  the  comfort  of 
patients and personnel.
  (4)  Corridors, hallways, passageways, and doorways  shall  be  kept   free 
from obstruction at all times.
  (5)  Floors, walls, and ceilings shall be covered and finished in a  manner 
that permits maintenance of a sanitary environment.
  (6)  Emergency electrical service shall be permanently  installed  in   the 
facility, including a pregnancy termination facility, to provide lighting  in 
corridors, exits, procedure rooms, recovery rooms,  congregate  rooms,  nurse 
stations, and other critical areas.  In new construction or  renovations,  an 
emergency generator that has an automatic transfer switch or  an  alternative 
source of immediate electrical power acceptable to the  department  shall  be 
provided for lighting and operation of equipment necessary to patient care.
  (7)  Patient examination, procedure,  and  recovery  rooms  shall  have   a 
minimum door width of 3 feet.

  History:  1979 AC; 2001 AACS.


R 325.3858    Elevators.
  Rule 58. An elevator shall be provided where patient care  is  provided  at 
different floor levels. The cab size of the elevator shall  be  sufficient to 
accommodate a stretcher and attendant.

  History:  1979 AC.


R 325.3859    Public and personnel areas.
  Rule 59. (1) Space shall be provided for   adequate   reception,   waiting, 
interviewing, administrative, and business office functions.
  (2)  Space  provided  for  admission,   interviewing    and    consultation 
functions shall be so located as to provide privacy.   This   shall   include 
adequate office space and furnishings for the  social  worker   if   one   is 
employed by a facility and for counselors and outside  agency  workers,  when 
indicated, to interview and advise patients in reasonable privacy.
  (3) One or more rooms equipped with toilet and lavatory facilities shall be 
provided near the waiting and reception areas.
  (4) Locker room space or other security resources shall  be  provided   for 
employee's personal effects.
  (5) In new construction or renovations, an approved  type  public  drinking 
fountain shall be provided.

  History:  1979 AC.


R 325.3860    Communications.
  Rule 60. Adequate telephone communication and a nurse call system  shall be 
provided for patient and staff  use   appropriate   for   the   size   of   a 
facility and scope of services rendered.

  History:  1979 AC.


R 325.3866    Clinical facilities.
  Rule 66. (1)  A facility shall have enough examination rooms to  meet   the 
volume of work to be accomplished, and each room shall provide a  minimum  of 
70 square feet of usable floor space.  In new construction or renovations, 80 
square feet of usable floor space shall be provided.
  (2)  An examining room shall have a handwash  lavatory  within  the   room, 
which shall be equipped with a gooseneck  inlet  and  wrist,  knee,  or  foot 
controls.
  (3)  A change area shall be provided for patients and provision  shall   be 
made for the safe storage of their personal effects.
  (4)   A facility shall have enough operating or procedure  rooms  to   meet 
the volume of work to be accomplished, and each room shall provide a  minimum 
of 120 square feet of usable floor space.  In new  construction,  150  square 
feet of usable floor space shall be provided.
  (5)  Explosive anesthetic agents shall not be used in the rooms.
  (6)   A  supply  of  oxygen  and  appropriate  masks  or  other  means   of 
administration shall be available in each room.
  (7)  A room shall be designed to permit the transfer of a patient from  the 
table to a stretcher and to permit sufficient clearance on either side and at 
the foot of the table with necessary equipment and supplies in place.
  (8)  A nurse  call  signal  shall  be  provided  from  the  procedure   and 
examining room to a central control station.
  (9)  A scrub sink that has a gooseneck outlet shall  be  available  in   or 
adjacent to the procedure rooms.
  (10)  Single-use soap, scrub brushes, and  towels  shall  be  utilized   in 
patient care areas.
  (11)  The  room  shall  contain  a  suitable  operating  table  and   other 
equipment necessary for the types of procedures to be performed.
  (12)  Space for and sterilization equipment shall be provided  to   process 
all medical supplies that  require  sterilization  between  uses.   Equipment 
shall be capable of  accommodating  the  work  load  of   the  facility,  and 
controls acceptable to the director shall be used to check effectiveness  and 
assure sterilization.
  (13)  As provided by R 325.3868a, the  department  may  waive  a   specific 
requirement of this rule as applied to a pregnancy termination facility.

  History:  1979 AC; 2001 AACS.


R 325.3867    Medication and storage areas.
  Rule 67. (1)  A facility shall have enough  medication  work  and   storage 
areas to meet the volume of work to be accomplished.
  (2)  A shelf or desk shall be provided for the nurse's  use  in   preparing 
and administering medications and recording information in patients'  records 
and shall be within and readily accessible to  all  patient  care  areas  for 
which that nursing station has responsibility.
  (3)  A medication storage and preparation area equipped with a  sink   that 
has a gooseneck  inlet  and  hot  and  cold  water  and  locked  storage  for 
medications shall be provided.  This includes adequate space for the  storage 
of medications, fluids, and electrolyte solutions  in  a  safe  and  sanitary 
manner.
  (4)  Space shall be available for the storage of clean linens,   equipment, 
supplies, wheelchairs and stretchers.
  (5)  A soiled utility room shall  be  available  for  temporarily   holding 
waste materials and cleaning of items to be reused.
  (6)  A janitor's closet that has a service sink shall be available.
  (7)  As provided by R 325.3868a,  the  department  may  waive  a   specific 
requirement of this rule as applied to a pregnancy termination facility.

  History:  1979 AC; 2001 AACS.


R 325.3868    Patient observation and recovery areas.
  Rule 68. (1)  Patient observation and recovery areas shall be provided   in 
sufficient numbers to accommodate the patient load with a planned  minimum of 
a 3-hour recovery period and longer when necessary for individual patients.
The areas shall be comfortably furnished  and  adequately  equipped  for  the 
patient's safe postoperative observation and recovery.
  (2)  A facility shall provide at least 1 recovery room equipped for use  by 
and observation of  patients requiring  recumbent  care  post-surgically.   A 
minimum of 1 hospital-type bed or wheeled recovery room  stretcher  shall  be 
provided for each 10 post-surgical patients to be cared for at any one time.
  (3)  Single bed/stretcher recovery rooms shall provide a  minimum  of   100 
square feet of usable floor space.
  (4)  Multiple bed/stretcher recovery rooms shall provide a minimum of    80 
square feet of floor space per bed or stretcher.
  (5)  A recovery room shall be designed to provide a   minimum  of  3   feet 
between beds or stretchers and 4 feet of clearance at the foot of the  bed or 
stretcher.
  (6)  Comfortably furnished congregate rooms equipped with either  reclining 
or  lounge-type  chairs  or  cots  may  be  provided  for  the  post-surgical 
observation of  patients not needing bed or stretcher  accommodations.   Each 
congregate-type room shall provide a minimum of  50  square  feet  of  usable 
floor space for each patient to   be    accommodated.    A  congregate   room 
shall not contain accommodations for more than 12 patients.
  (7)  A toilet and lavatory shall be provided for each 6 recovery   patients 
at a minimum.  One or more bathing facilities are recommended.
  (8)  Corridors used for patient entry, egress, and surgical care areas   in 
a facility shall have a minimum width of 6 feet.
  (9)  As provided by R 325.3868a,  the  department  may  waive  a   specific 
requirement of this rule as applied to a pregnancy termination facility.

  History:  1979 AC; 2001 AACS.


R 325.3868a    Waiver of certain requirements.
  Rule 68a. (1) Pursuant to  R  325.3815(4),  the  department  may  waive   a 
specific requirement of R 325.3866, R 325.3867, or R 325.3868 as applied to a 
pregnancy termination facility  if  it  reasonably  determines  the  facility 
construction, size, and equipment of a room, area, or equipment utilized  for 
purposes of medication preparation or storage, sanitary storage, or  facility 
maintenance  are adequate to protect the health and safety  of  the  patients 
and employees of the  facility,  or  that  the  construction,   equipment  or 
maintenance  standards can be modified to adequately preserve the health  and 
safety of the patients and employees of  the  facility  without  meeting  the 
specific requirements of these rules.
  (2)  A pregnancy termination facility shall submit a request for   variance 
in writing at the time of application for a license.
  (3)  The decision of the department,  including  any  qualification   under 
which the variance is granted,  shall be sent to  the  pregnancy  termination 
facility and placed in the facility record.
  (4)  The variance may remain in  effect  for  as  long  as  the   pregnancy 
termination facility continues to comply with the conditions of the  variance 
or may be time-limited.

  History: 2001 AACS.

R 325.3869    Capacities.
  Rule 69. The numerical capacity of a facility shall be  determined  by  the 
number of observation  and  recovery  units   provided.   The   post-surgical 
occupancy of a facility shall not exceed the determined capacity.

  History:  1979 AC.


R 325.3871    Heating and electrical systems.
  Rule 71. (1) A safe heating system shall be provided.
  (2) A room used for patient care shall be maintained at a temperature of at 
least 70 degrees Fahrenheit with  a  maximum  temperature   of   78   degrees 
Fahrenheit as measured 3 feet above floor level.
  (3) Duplex electrical outlets with a 3-wire system shall  be  provided   in 
sufficient numbers to meet the needs of the areas served.
  (4) Electrical equipment shall be maintained in good  repair  and  properly 
grounded.

  History:  1979 AC.


R 325.3872    Water supply system.
  Rule 72. (1) A facility located in an area  served  by   a   public   water 
system shall connect to and use that system.
  (2) When a public water  system  is  not  available,   the   location   and 
construction of a well and the operation of a private  water   system   shall 
comply with the department rules "Minimum Standards for  the   Location   and 
Construction of Certain Water Supplies," being R 325.1451 to  R  325.1461  of 
the Michigan Administrative Code.
  (3) There shall be no cross-connections between water  systems   that   are 
safe for human consumption and those that are, or may  become,   unsafe   for 
human consumption.
  (4) Minimum water pressure available  to  each   plumbing   fixture   shall 
exceed 20 pounds per square inch.
  (5) The plumbing system shall supply an adequate amount of  hot  water   at 
all times to meet the needs of each patient and  the   functioning   of   the 
various service areas.
  (6) Hot water temperatures at fixture  outlets  shall   be   regulated   to 
provide tempered water in range of 110 to 125 degrees Fahrenheit.

  History:  1979 AC.


R 325.3873    Liquid wastes.
  Rule 73. (1) Liquid wastes shall be discharged into   a   public   sanitary 
sewage system when such a system is available.
  (2) When a public sanitary sewage system is not available  and  a   private 
liquid waste disposal system is used, the  type,   size,   construction   and 
alteration of, or major repairs to, the system shall be   approved   by   the 
department.
  (3) The liquid waste disposal system shall be maintained  in   a   sanitary 
manner.

  History:  1979 AC.


R 325.3874    Solid wastes.
  Rule 74. (1) The collection, storage,  and  disposal   of   solid   wastes, 
including garbage, refuse, and dressings, shall be accomplished  in  a   safe 
and sanitary manner to minimize the danger  of   disease   transmission   and 
avoid creating a public nuisance or  a  breeding  place   for   insects   and 
rodents.
  (2) Suitable containers for garbage, refuse, dressings,  and  other   solid 
wastes shall be provided, emptied at frequent intervals, and maintained in  a 
clean and sanitary condition.
  (3) Dressings, bandages, and similar materials shall be disposed  of  in an 
incinerator provided with  auxiliary   fuel   or   in   some   other   manner 
approved by the director.
  (4) A facility shall  have  and  enforce  a  written   policy   to   govern 
storage, transportation  and  disposal  of   surgical   specimens.   Surgical 
specimens not sent to a pathology laboratory shall be  disposed   of   in   a 
medically acceptable manner.

  History:  1979 AC.


R 325.3877    Miscellaneous storage.
  Rule 77. (1) Hazardous and toxic materials shall be  stored   in   a   safe 
manner.
  (2) A  central  general  storage  room  shall  be   provided   with   space 
necessary to meet storage needs of the facility.

  History:  1979 AC.