reglab/statecodes huggingface dataset:
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7 - Primary Care Clinics › Article 7 - Physical Plant › Section 75063 - Water Supply and Plumbing

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
				  Where water for human consumption is obtained from an independent source, it
				  shall be subjected to bacteriological analysis by the local health department,
				  the Department or a licensed commercial laboratory at least every three months.
				  A copy of the most recent laboratory report shall be available for
				  inspection.
(b) Plumbing and
				  drainage facilities shall be maintained in compliance with Chapter 1, Division
				  T17, Title 24, California Administrative Code.
Note: Authority cited: Sections
						208(a)
						and
						1225,
						Health and Safety Code. Reference: Section
						1226,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7 - Primary Care Clinics › Article 7 - Physical Plant › Section 75064 - Autoclaving and Sterilizing

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
				  Each clinic shall make provision in the clinic, or by acceptable arrangements
				  with an outside service, for proper sterilization of instruments, utensils,
				  supplies and solutions used in the clinic.
(b) All sterilization of instruments and
				  equipment in the clinic shall be under the supervision of a person who is
				  qualified by experience and training.
(c) Instructions for operating autoclaves and
				  sterilizers shall be posted.
(d)
				  Written procedures for preparing supplies for autoclaving and for the operation
				  of autoclaves shall be developed, maintained and made available to personnel
				  responsible for sterilization of supplies and equipment. These procedures shall
				  include the method of packaging, dating, loading the autoclave, temperature and
				  pressure to be applied, and the period of exposure.
(e) Autoclaves shall be checked on each day
				  they are in use to verify that recording thermometers and indicating
				  thermometers reasonably coincide. Autoclave tape may be used as an alternative
				  to thermometers. Records of recording thermometers shall be retained for one
				  year. Recording thermometers shall not be required on portable
				  sterilizers.
(f) Autoclaving
				  results shall be checked at least monthly by a bacteriological test. Records of
				  results of such tests shall be retained at least one year.
(g) Sterilized items shall show expiration
				  dates.
Note: Authority cited: Sections
						208(a)
						and
						1225,
						Health and Safety Code. Reference: Section
						1226,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7 - Primary Care Clinics › Article 7 - Physical Plant › Section 75065 - Disinfecting

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Every clinic
				  shall make provision for the cleaning and disinfecting of contaminated
				  articles, surfaces and equipment which cannot be sterilized.
(b) Written procedures shall be developed and
				  maintained for the disinfection of articles and surfaces.
Note: Authority cited: Sections
						208(a)
						and
						1225,
						Health and Safety Code. Reference: Section
						1226,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7 - Primary Care Clinics › Article 7 - Physical Plant › Section 75066 - Cleaning Equipment and Fixtures

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Each clinic shall provide for the cleaning of articles,
					 equipment and surfaces such as furniture, walls, exhaust grills and light and
					 plumbing fixtures.
Note: Authority cited: Sections
						208(a)
						and
						1225,
						Health and Safety Code. Reference: Section
						1226,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7 - Primary Care Clinics › Article 7 - Physical Plant › Section 75067 - Storage and Disposal of Solid Wastes

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Solid wastes shall be stored and disposed
				  of in a manner that will not permit the transmission of a communicable disease,
				  create a nuisance, provide a breeding place or food source for insects or
				  rodents or permit public access.
(b) Solid waste containers shall be stored
				  and located in a manner that will protect the patients from odors.
(c) Syringes and needles, before being
				  discarded into waste containers, shall be rendered unusable.
Note: Authority cited: Sections
						208(a)
						and
						1225,
						Health and Safety Code. Reference: Section
						1226,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7 - Primary Care Clinics › Article 7 - Physical Plant › Section 75068 - Solid Waste Containers

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
				  All containers, except movable bins, used for storage of solid wastes shall
				  have tight-fitting covers in good repair, external handles and shall be
				  leakproof and rodent-proof.
(b)
				  Movable bins, stored outside of the clinic when used for storing or
				  transporting solid wastes from the premises, shall have tight-fitting covers
				  and shall be rodent-proof, unless stored in an enclosed area.
(c) All containers used for storing
				  infectious wastes shall display a prominent sign which identifies the contents
				  as "Infectious Wastes."
(d) All
				  containers receiving putrescible wastes shall be emptied daily and more often
				  if necessary.
(e) Solid waste
				  containers, including movable bins, shall be thoroughly washed and cleaned each
				  time they are emptied, unless soil contact surfaces have been completely
				  protected from contamination by disposable liners, bags or other devices
				  removed with the waste. Each movable bin shall be accessible and shall have a
				  drainage device to allow complete cleaning at the storage area.
1. Repealer
					 of subsection (f) filed 12-30-83 as an emergency; effective upon filing
					 (Register 84, No. 3). A Certificate of Compliance must be transmitted to OAL
					 within 120 days or emergency language will be repealed on
					 4-29-84.
2. Certificate of Compliance transmitted to OAL 4-30-84 and
					 withdrawn 5-30-84 (Register 84, No. 24).
3. Repealer of subsection
					 (f) filed 5-30-84 as an emergency; effective upon filing (Register 84, No. 24).
					 A Certificate of Compliance must be transmitted to OAL within 120 days or
					 emergency language will be repealed on 9-27-84.
4. Certificate of
					 Compliance transmitted to OAL 9-26-84 and filed 10-16-84 (Register 84, No.
					 42).
Note: Authority cited: Sections
						208(a),
						1225
						and
						1254,
						Health and Safety Code. Reference: Sections
						1226,
						1250
						and
						25157.3,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7 - Primary Care Clinics › Article 7 - Physical Plant › Section 75069 - Infectious Waste

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Infectious waste, as defined in Health and Safety Code
					 Section
					 25117.5,
					 shall be handled and disposed of in accordance with the Hazardous Waste Control
					 Law, Chapter 6.5, Division 20, Health and Safety Code (beginning with Section
					 25100) and the regulations adopted
					 thereunder (beginning with Section
					 66100 of this
					 Title).
1. Repealer
					 and new section filed 12-30-83 as an emergency; effective upon filing (Register
					 84, No. 3). A Certificate of Compliance must be transmitted to OAL within 120
					 days or emergency language will be repealed on 4-29-84.
2.
					 Certificate of Compliance transmitted to OAL 4-30-84 and withdrawn 5-30-84
					 (Register 84, No. 24).
3. Repealer and new section filed 5-30-84 as
					 an emergency; effective upon filing (Register 84, No. 24). A Certificate of
					 Compliance must be transmitted to OAL within 120 days or emergency language
					 will be repealed on 9-27-84.
4. Certificate of Compliance
					 transmitted to OAL 9-26-84 and filed 10-16-84 (Register 84, No.
					 42).
Note: Authority cited: Sections
						208,
						1254,
						25150
						and
						25157.3,
						Health and Safety Code. Reference: Sections
						1250,
						25117
						and
						25117.5,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7 - Primary Care Clinics › Article 7 - Physical Plant › Section 75070 - Gases for Medical Use

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
				  Gases covered by this Section include both flammable and nonflammable
				  gases.
(b) Provision shall be made
				  for safe handling and storage of medical gas cylinders.
(c) All medical gas cylinders, pressure
				  regulators, wall outlets from piping systems, and external removable connection
				  hoses used therewith shall, by physical design, be so constructed that
				  connections for different gases are not interchangeable.
Note: Authority cited: Sections
						208(a)
						and
						1225,
						Health and Safety Code. Reference: Section
						1226,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7 - Primary Care Clinics › Article 7 - Physical Plant › Section 75071 - Linen and Laundry

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A
				  supply of linen to meet the needs of the clinic shall be maintained.
(b) Soiled and clean linens shall be stored
				  in separate areas at all times.
Note: Authority cited: Sections
						208(a)
						and
						1225,
						Health and Safety Code. Reference: Section
						1226,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7 - Primary Care Clinics › Article 7 - Physical Plant › Section 75072 - Space Conversion

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Spaces approved for specific use at the time of licensure
					 shall not be converted to other uses without the written approval of the
					 Department. All areas, rooms, fixtures and equipment required by Chapter 1,
					 Division T17, Title 24, California Administrative Code, shall be maintained.
					 Any request for Department approval of a proposed space conversion shall either
					 be granted or denied, in writing, within 30 days of receipt by the
					 Department.
Note: Authority cited: Sections
						208(a)
						and
						1225,
						Health and Safety Code. Reference: Section
						1226,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7 - Primary Care Clinics › Article 8 - Appeals Procedure › Section 75073 - Appeals Procedure

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
				  District office responsibility:
(1) Request
				  for appeal of a licensing evaluator's decision may be made by the licensee or
				  administrator to the evaluator's supervisor. Such requests should be in writing
				  and give specific reason for the request. If the matter is not resolved to the
				  satisfaction of the licensee at this level, the licensing supervisor shall
				  prepare a written summary for review by the district administrator.
(2) Where the procedure outlined in (1) above
				  does not resolve the matter, the licensee or administrator may request an
				  office conference at the district office. This office conference shall be
				  attended by:
(A) District administrator or
				  designee.
(B) Licensing
				  supervisor.
(C) Facility
				  evaluator.
(D)
				  Licensee/administrator and consultant or attorney, if desired by the licensee
				  or administrator.
(E) Consultant
				  and/or other Department representative when appropriate in the opinion of the
				  District Administrator.
(3) The results of an office conference shall
				  be confirmed in writing by the district office to the
				  licensee.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7 - Primary Care Clinics › Article 9 - Birth Services › Section 75077 - Birth Services-Policies and Procedures

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Written policies and procedures shall be
				  implemented and shall include but not be limited to:
(1) Defining the criteria for
				  admission.
(2) Defining high risk
				  consistent with Section
				  75009.1 and identifying
				  specifically the maternal patients whom the clinic will not accept and those
				  requiring transfer to a hospital.
(3) Referral and transfer policies and
				  procedures for a patient who, during the course of pregnancy or labor, is
				  determined to have become a high-risk patient.
(4) Provision for the education of the
				  patient and significant others in pregnancy, childbirth and infant
				  care.
(5) Plans for the follow-up
				  of patients within 24 hours after discharge and during the subsequent 6 weeks,
				  with emergency consultation when required.
(6) Contractual arrangements for emergency
				  medical transportation.
(7)
				  Provisions for family planning information and education.
(8) Registration of births and reporting of
				  congenital anomalies and complications as required by Section
				  10000 et seq., Division 9, Chapter
				  1, Health and Safety Code.
(9)
				  Treatment of the eyes of a newborn for prevention of ophthalmia neonatorum as
				  required by Section
				  2560, Title 17, California
				  Administrative Code.
(10) Newborn
				  screening for heritable disorders as required in Sections
				  6500.1 through
				  6510, Title 17, California
				  Administrative Code, notwithstanding any reference in those sections to
				  hospitals or health facilities, rather than clinics.
(11) Screening for Rhesus(Rh) Hemolytic
				  Disease as required in Section
				  6510, Title 17, California
				  Administrative Code, notwithstanding any reference in those sections to
				  hospitals or health facilities, rather than clinics.
(A) Provisions for administration of Rh
				  immunoglobulin within 72 hours after birth for mothers who are
				  candidates.
(12) Written
				  policies for identifying support persons and others who may be present during
				  labor and delivery which shall provide for the safety, comfort and privacy of
				  the patient.
(13) Infection control
				  policies and procedures which include screening criteria for participants and
				  staff.
(14) Provision for food and
				  fluid intake for mothers and infant.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7 - Primary Care Clinics › Article 9 - Birth Services › Section 75079 - Birth Services-Equipment and Supplies

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Each birth service shall maintain the
				  equipment and supplies necessary to provide the services offered, including at
				  least the following:
(1) Double or single
				  size bed.
(2) Equipment for
				  maintaining infant body temperature and ventilation.
(3) Portable emergency light
				  source.
(4) Suction equipment for
				  both mother and infant.
(5)
				  Suturing equipment.
(6) Oxygen
				  source and basic resuscitation equipment for both mother and infant.
(7) Emergency medications for both mother and
				  infant.
(8) Intravenous fluids and
				  infusion equipment.
(9) Clock with
				  a sweep second hand.
(10) Other
				  equipment and supplies necessary to provide maternity and infant care and to
				  initiate emergency procedures when indicated.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7 - Primary Care Clinics › Article 9 - Birth Services › Section 75081 - Birth Services - Staff

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A
				  physician with current knowledge and specific training in obstetrics who is
				  certified or eligible for certification by the American Board of Obstetrics and
				  Gynecology, or a physician with current knowledge and specific training in
				  obstetrics shall be responsible for the medical services at the birth center.
				  This individual may also hold the position of professional director of the
				  clinic and shall have hospital privileges in obstetrics.
(b) In addition, there shall be a sufficient
				  number of physicians with current knowledge and specific training in obstetrics
				  and newborn care, and/or certified nurse midwives and/or physician assistants
				  competent in obstetrics and authorized by the physician supervisor to perform
				  obstetrics to care for the number of patients accepted by the clinic. In the
				  case of physician assistants, the responsible physician shall be certified by
				  the Medical Board of California to be a physician assistant
				  supervisor.
(c) There shall be
				  sufficient number of licensed registered nurses with current knowledge and
				  specific training in maternity and newborn care to care for the number of
				  patients accepted by the clinic.
(d) A physician, certified nurse midwife or
				  physician assistant meeting the above criteria and at least one other person
				  meeting the above criteria shall be present for all births.
(e) A system ensuring staff availability on a
				  24-hour basis shall be established and maintained.
(f) Appropriate medical consultation services
				  shall be available.
(g) Continuing
				  education and/or in-service training shall be required for all staff. The
				  training shall include but not be limited to:
(1) Physical assessment of mother and
				  infant.
(2) Infant and adult
				  resuscitation and stabilization. Annual skills reviews shall be
				  conducted.
(3) Family centered
				  birthing.
(4) The birth process,
				  including complications of labor and delivery.
(5) Emergency skills.
(6) Care of the newborn.
(7) Prenatal, intrapartum and postpartum
				  care.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7 - Primary Care Clinics › Article 9 - Birth Services › Section 75083 - Birth Services-Space

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Each birthing room shall have an area
				  which can accommodate the equipment and supplies required in Section
				  75079 and the staff required in
				  Section 75081. There may be no more than
				  one mother in this area at any given time.
(b) A toilet and handwashing sink shall be
				  maintained in conformance with Part 5, Title 24, California Administrative
				  Code.
(c) Adequate counter top or
				  table work space shall be maintained in the birthing room.
1. New
					 section filed 9-2-86; effective thirtieth day thereafter (Register 86, No.
					 36).
Note: Authority cited: Sections
						208(a)
						and
						1225,
						Health and Safety Code. Reference: Sections
						1203
						and
						1226,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7.1 - Specialty Clinics › Article 6 - Hemodialyzer Reuse › Section 75172 - Automated Reuse Machines

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Automated reuse machine means a machine which has been
					 recognized by the Department and the Food and Drug Administration as being safe
					 and effective for automated reprocessing of hemodialyzers.
1. New
					 Chapter 7.1 (Article 6, Sections
					 75172-75208, not consecutive)
					 filed 4-8-87; effective thirtieth day thereafter (Register 87, No.
					 16).
Note: Authority cited: Sections
						208(a),
						417.10,
						1225
						and
						1275,
						Health and Safety Code. Reference: Sections
						417.10-
						417.15,
						1226
						and
						1276,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7.1 - Specialty Clinics › Article 6 - Hemodialyzer Reuse › Section 75173 - Cleaning

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Cleaning, when used in reference to a dialysis facility and
					 dialysis filters, means the passage of solution through the blood and dialysate
					 compartments to purge the dialyzer of blood and blood protein
					 residuals.
1. New
					 section filed 4-8-87; effective thirtieth day thereafter (Register 87, No.
					 16).
Note: Authority cited: Sections
						208(a),
						417.10,
						1225
						and
						1275,
						Health and Safety Code. Reference: Sections
						417.10-
						417.15,
						1226
						and
						1276,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7.1 - Specialty Clinics › Article 6 - Hemodialyzer Reuse › Section 75174 - Clearance

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Clearance means the volume of solvent that is cleared of
					 solute per unit of time.
1. New
					 section filed 4-8-87; effective thirtieth day thereafter (Register 87, No.
					 16).
Note: Authority cited: Sections
						208(a),
						417.10,
						1225
						and
						1275,
						Health and Safety Code. Reference: Sections
						417.10-
						417.15,
						1226
						and
						1276,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7.1 - Specialty Clinics › Article 6 - Hemodialyzer Reuse › Section 75175 - Device History Record

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Device History Record means the compilation of records
					 containing the complete reprocessing history of a dialyzer.
1. New
					 section filed 4-8-87; effective thirtieth day thereafter (Register 87, No.
					 16).
Note: Authority cited: Sections
						208(a),
						417.10,
						1225
						and
						1275,
						Health and Safety Code. Reference: Sections
						417.10-
						417.15,
						1226
						and
						1276,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7.1 - Specialty Clinics › Article 6 - Hemodialyzer Reuse › Section 75176 - Dialysis Facility

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
A dialysis facility means a licensed free-standing
					 specialty clinic which provides less than 24-hour care for the treatment of
					 patients with End-stage Renal Disease, including provision of renal dialysis
					 services or a general acute care hospital having a special permit to provide
					 care and treatment services to patients with End-stage Renal
					 Disease.
1. New
					 section filed 4-8-87; effective thirtieth day thereafter (Register 87, No.
					 16).
Note: Authority cited: Sections
						208(a),
						417.10,
						1225
						and
						1275,
						Health and Safety Code. Reference: Sections
						417.10-
						417.15,
						1226
						and
						1276,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7.1 - Specialty Clinics › Article 6 - Hemodialyzer Reuse › Section 75177 - Dialysis Treatment

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Dialysis treatment means the act of performing hemodialysis
					 therapy on a patient with a hemodialysis filter at a dialysis
					 facility.
1. New
					 section filed 4-8-87; effective thirtieth day thereafter (Register 87, No.
					 16).
Note: Authority cited: Sections
						208(a),
						417.10,
						1225
						and
						1275,
						Health and Safety Code. Reference: Sections
						417.10-
						417.15,
						1226
						and
						1276,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7.1 - Specialty Clinics › Article 6 - Hemodialyzer Reuse › Section 75178 - Dialyzer

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Dialyzer,
				  artificial kidney, hemodialyzer, or hemodialysis filter means an apparatus,
				  excluding in-line blood filters and tubing, by which hemodialysis may be
				  performed.
(b) Types of dialyzers
				  include:
(1) Coil, which incorporates a
				  membrane in the form of a flattened tube which is wound around a central,
				  rigid, cylindrical core, with a supporting mesh separating the coil;
(2) Parallel plate, which incorporates
				  membrane sheets interspersed between supporting plates in a sandwiched
				  configuration; and
(3) Hollow
				  fiber, which incorporates a membrane in the form of a very small hollow fiber
				  core.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7.1 - Specialty Clinics › Article 6 - Hemodialyzer Reuse › Section 75178.5 - Disinfectant Chemical

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Disinfectant solution is a chemical solution intended for
					 use in the disinfection of dialyzers which, when placed into a dialyzer, will
					 kill microorganisms. These chemicals have been recognized by the FDA, and the
					 Department as being safe and effective in reprocessing of
					 hemodialyzers.
1. New
					 section filed 4-8-87; effective thirtieth day thereafter (Register 87, No.
					 16).
Note: Authority cited: Sections
						208(a),
						417.10,
						1225
						and
						1275,
						Health and Safety Code. Reference: Sections
						417.10-
						417.15,
						1226
						and
						1276,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7.1 - Specialty Clinics › Article 6 - Hemodialyzer Reuse › Section 75179 - Disinfectant Rinsing

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Disinfectant rinsing means the passage of solution through
					 the blood and dialysate compartments to purge the dialyzer of disinfectant
					 solution.
1. New
					 section filed 4-8-87; effective thirtieth day thereafter (Register 87, No.
					 16).
Note: Authority cited: Sections
						208(a),
						417.10,
						1225
						and
						1275,
						Health and Safety Code. Reference: Sections
						417.10-
						417.15,
						1226
						and
						1276,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7.1 - Specialty Clinics › Article 6 - Hemodialyzer Reuse › Section 75180 - Documentation

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Documentation means any record, form, notice, or other
					 written material used by the dialysis facility to comply with the requirements
					 of this Article.
1. New
					 section filed 4-8-87; effective thirtieth day thereafter (Register 87, No.
					 16).
Note: Authority cited: Sections
						208(a),
						417.10,
						1225
						and
						1275,
						Health and Safety Code. Reference: Sections
						417.10-
						417.15,
						1226
						and
						1276,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7.1 - Specialty Clinics › Article 6 - Hemodialyzer Reuse › Section 75181 - Fiber Bundle Volume

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Fiber bundle volume or FBV, means the aggregate volume of
					 the hollow fibers contained within the blood compartment of a hollow fiber
					 dialyzer. This volume added to the header volume equals the total cell volume
					 of the hollow fiber dialyzer which is the volume of the blood compartment of
					 said dialyzer.
1. New
					 section filed 4-8-87; effective thirtieth day thereafter (Register 87, No.
					 16).
Note: Authority cited: Sections
						208(a),
						417.10,
						1225
						and
						1275,
						Health and Safety Code. Reference: Sections
						417.10-
						417.15,
						1226
						and
						1276,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7.1 - Specialty Clinics › Article 6 - Hemodialyzer Reuse › Section 75182 - Formaldehyde

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Formaldehyde means Formaldehyde Solution, USP, (nominal 37%
					 aqueous solution).
1. New
					 section filed 4-8-87; effective thirtieth day thereafter (Register 87, No.
					 16).
Note: Authority cited: Sections
						208(a),
						417.10,
						1225
						and
						1275,
						Health and Safety Code. Reference: Sections
						417.10-
						417.15,
						1226
						and
						1276,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7.1 - Specialty Clinics › Article 6 - Hemodialyzer Reuse › Section 75183 - Formaldehyde Disinfectant

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Formaldehyde disinfectant means an aqueous dilution of
					 formaldehyde solution ESP.
1. New
					 section filed 4-8-87; effective thirtieth day thereafter (Register 87, No.
					 16).
Note: Authority cited: Sections
						208(a),
						417.10,
						1225
						and
						1275,
						Health and Safety Code. Reference: Sections
						417.10-
						417.15,
						1226
						and
						1276,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7.1 - Specialty Clinics › Article 6 - Hemodialyzer Reuse › Section 75184 - Label

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Label means the display of written, printed, or graphic
					 matter upon a dialyzer.
1. New
					 section filed 4-8-87; effective thirtieth day thereafter (Register 87, No.
					 16).
Note: Authority cited: Sections
						208(a),
						417.10,
						1225
						and
						1275,
						Health and Safety Code. Reference: Sections
						417.10-
						417.15,
						1226
						and
						1276,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7.1 - Specialty Clinics › Article 6 - Hemodialyzer Reuse › Section 75185 - Membrane

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Membrane means the semipermeable interface between the
					 blood and dialysate compartments of a hemodialysis filter.
1. New
					 section filed 4-8-87; effective thirtieth day thereafter (Register 87, No.
					 16).
Note: Authority cited: Sections
						208(a),
						417.10,
						1225
						and
						1275,
						Health and Safety Code. Reference: Sections
						417.10-
						417.15,
						1226
						and
						1276,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7.1 - Specialty Clinics › Article 6 - Hemodialyzer Reuse › Section 75186 - Performance

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Performance means the solute and fluid removal capabilities
					 of the dialyzer.
1. New
					 section filed 4-8-87; effective thirtieth day thereafter (Register 87, No.
					 16).
Note: Authority cited: Sections
						208(a),
						417.10,
						1225
						and
						1275,
						Health and Safety Code. Reference: Sections
						417.10-
						417.15,
						1226
						and
						1276,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7.1 - Specialty Clinics › Article 6 - Hemodialyzer Reuse › Section 75187 - PPM

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
PPM is the abbreviation for parts per
					 million.
1. New
					 section filed 4-8-87; effective thirtieth day thereafter (Register 87, No.
					 16).
Note: Authority cited: Sections
						208(a),
						417.10,
						1225
						and
						1275,
						Health and Safety Code. Reference: Sections
						417.10-
						417.15,
						1226
						and
						1276,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7.1 - Specialty Clinics › Article 6 - Hemodialyzer Reuse › Section 75188 - Pyrogen

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Pyrogen means a fever producing agent of bacterial
					 origin.
1. New
					 section filed 4-8-87; effective thirtieth day thereafter (Register 87, No.
					 16).
Note: Authority cited: Sections
						208(a),
						417.10,
						1225
						and
						1275,
						Health and Safety Code. Reference: Sections
						417.10-
						417.15,
						1226
						and
						1276,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7.1 - Specialty Clinics › Article 6 - Hemodialyzer Reuse › Section 75189 - Record

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
For the purpose of this Article, record means the
					 compilation of reprocessing procedures of a dialyzer inclusive of
					 specifications and test procedures and test results; descriptions of
					 reprocessing tasks and training curricula; equipment maintenance procedures,
					 schedules, tests and test results; quality assurance audit procedures and
					 results; and complaints and complaint resolutions.
1. New
					 section filed 4-8-87; effective thirtieth day thereafter (Register 87, No.
					 16).
Note: Authority cited: Sections
						208(a),
						417.10,
						1225
						and
						1275,
						Health and Safety Code. Reference: Sections
						417.10-
						417.15,
						1226
						and
						1276,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7.1 - Specialty Clinics › Article 6 - Hemodialyzer Reuse › Section 75189.5 - Reprocessing

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Reprocessing means the act or actions of restoring a
					 previously used hemodialyzer so that it is suitable for another dialysis
					 treatment.
1. New
					 section filed 4-8-87; effective thirtieth day thereafter (Register 87, No.
					 16).
Note: Authority cited: Sections
						208(a),
						417.10,
						1225
						and
						1275,
						Health and Safety Code. Reference: Sections
						417.10-
						417.15,
						1226
						and
						1276,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7.1 - Specialty Clinics › Article 6 - Hemodialyzer Reuse › Section 75190 - Reprocessing Technician

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Reprocessing technician means a person who is experienced
					 and/or trained in dialyzer reprocessing procedures and who has been assigned
					 the task of dialyzer reprocessing.
1. New
					 section filed 4-8-87; effective thirtieth day thereafter (Register 87, No.
					 16).
Note: Authority cited: Sections
						208(a),
						417.10,
						1225
						and
						1275,
						Health and Safety Code. Reference: Sections
						417.10-
						417.15,
						1226
						and
						1276,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7.1 - Specialty Clinics › Article 6 - Hemodialyzer Reuse › Section 75191 - Reuse or Multiple Use

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Reuse or multiple use means the practice by which dialyzers
					 are reprocessed and used for more than one dialysis treatment without the
					 replacement of the membrane or other surfaces in contact with the
					 blood.
1. New
					 section filed 4-8-87; effective thirtieth day thereafter (Register 87, No.
					 16).
Note: Authority cited: Sections
						208(a),
						417.10,
						1225
						and
						1275,
						Health and Safety Code. Reference: Sections
						417.10-
						417.15,
						1226
						and
						1276,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7.1 - Specialty Clinics › Article 6 - Hemodialyzer Reuse › Section 75192 - Reuse Number

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Reuse Number means the number of times the dialyzer has
					 been used in patient dialysis treatments.
1. New
					 section filed 4-8-87; effective thirtieth day thereafter (Register 87, No.
					 16).
Note: Authority cited: Sections
						208(a),
						417.10,
						1225
						and
						1275,
						Health and Safety Code. Reference: Sections
						417.10-
						417.15,
						1226
						and
						1276,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7.1 - Specialty Clinics › Article 6 - Hemodialyzer Reuse › Section 75193 - Ultrafiltration

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Ultrafiltration means the transfer of fluid from the blood
					 to the dialysate through the dialysis membrane due to a pressure gradient
					 (transmembrane pressure) existing between the blood and dialysate
					 compartments.
1. New
					 section filed 4-8-87; effective thirtieth day thereafter (Register 87, No.
					 16).
2. Editorial correction of Reference cite (Register 95, No.
					 25).
Note: Authority cited: Sections
						208(a),
						417.10,
						1225
						and
						1275,
						Health and Safety Code. Reference: Sections
						417.10-
						417.15,
						1226
						and
						1276,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7.1 - Specialty Clinics › Article 6 - Hemodialyzer Reuse › Section 75194 - Validation or Process Validation

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Validation or process validation, means the establishment
					 of a rigid set of process controls, with quality assurance audit challenges, to
					 assure an acceptable product quality based upon a defined set of
					 standards.
1. New
					 section filed 4-8-87; effective thirtieth day thereafter (Register 87, No.
					 16).
Note: Authority cited: Sections
						208(a),
						417.10,
						1225
						and
						1275,
						Health and Safety Code. Reference: Sections
						417.10-
						417.15,
						1226
						and
						1276,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7.1 - Specialty Clinics › Article 6 - Hemodialyzer Reuse › Section 75195 - Scope and Application

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
				  This Article applies to all dialysis facilities which are engaged in the
				  practice of hemodialyzer reprocessing and reuse.
(b) Deviation from any of the sections
				  contained in this Article without an alternative reuse protocol approved by the
				  Department constitutes a violation as referenced in Health and Safety Code,
				  Division 21, Section
				  417.14.
(c) A dialysis facility may submit an
				  alternative protocol for Department approval for any of the sections contained
				  in this Article. Within 30 days of receipt of a request for approval of an
				  alternative protocol, the Department shall inform the applicant, in writing,
				  that the request is complete and accepted for consideration or that the request
				  is deficient and what specific information is required. The Department shall
				  approve or disapprove the request within 90 days of receipt.
(d) These regulations shall not apply to
				  dialysate delivery systems nor new dialyzers.
1. New
					 section filed 4-8-87; effective thirtieth day thereafter (Register 87, No.
					 16).
Note: Authority cited: Sections
						208(a),
						417.10,
						1225
						and
						1275,
						Health and Safety Code. Reference: Sections
						417.10-
						417.15,
						1226
						and
						1276,
						Health and Safety Code.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7.1 - Specialty Clinics › Article 6 - Hemodialyzer Reuse › Section 75196 - Contraindications

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Reuse and
				  reprocessing of hemodialyzers is prohibited in the following:
(1) Patients known to be HBsAg-positive or
				  suspected to have non-A/non-B hepatitis, except where the dialysis patient
				  treatment area and the dialyzer reprocessing area or room is isolated from
				  patients free of hepatitis.
(2)
				  Patients sensitive to disinfectant solution residuals.
(3) Bacteremic patients.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7.1 - Specialty Clinics › Article 6 - Hemodialyzer Reuse › Section 75197 - Informed Consent

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) The
				  patient or his or her legal guardian or conservator may execute written consent
				  for the reuse of hemodialysis filters. Non-execution shall indicate the patient
				  chooses not to participate in a reuse program.
(b) The written consent form shall include,
				  but not be limited to, the following statements:
(1) The patient's name, the dialysis facility
				  name, and the name of the staff person who explained the facility's reuse
				  program and process.
(2) A
				  statement that the reuse process has been fully explained to the patient and
				  that the facility's written policies and reuse procedures are available upon
				  request.
(3) A statement that a
				  reused dialyzer will only be used by the same patient again.
(4) A statement that single-use dialyzers are
				  recommended by the dialyzer manufacturer for one-time use only.
(5) A list of the advantages and
				  disadvantages associated with reuse which shall include, but not be limited to:
(A) Entry of a residual amount of (name of
				  the disinfectant chemical), the long-term effect of which is unknown.
(B) The increased possibility of infection
				  and/or fever producing reactions if procedures are not correctly followed at
				  this dialysis facility.
(C) A lower
				  incidence of back and chest pain, cramps, fever, sweating, blood pressure
				  problems, nausea, and/or vomiting often associated with the initial use of a
				  dialyzer in hypersensitive patients.
(6) A list of patient rights regarding the
				  reuse of dialyzers which shall be adhered to by the facility and include:
(A) The right to ask questions at any time
				  about dialysis reuse and reprocessing procedures, and to receive answers which
				  fully, fairly, and understandably respond to such questions.
(B) The right to withdraw authorization for
				  dialysis reuse by oral request, followed by a written notice, to the
				  supervising practitioner for any reason.
(C) The right to file a written complaint
				  with the dialysis facility and the Department of Health Services' Licensing and
				  Certification Division, and expect a resolution of that complaint by the
				  dialysis facility.
(D) The right to
				  expect safe and effective reprocessing of the dialyzer.
(E) The right to know the number of times the
				  dialyzer has been reprocessed prior to each dialysis treatment.
(F) The right not to participate in the
				  dialysis facility's reuse program without abridgement of any service of the
				  facility.
California Code of Regulations › Title 22 - Social Security › Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies › Chapter 7.1 - Specialty Clinics › Article 6 - Hemodialyzer Reuse › Section 75198 - Record Keeping

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) All
				  records, forms, and notices required by this Article shall be maintained in a
				  secure location(s) at the dialysis facility.
(1) Access to documentation shall be
				  restricted to authorized dialysis facility personnel except where otherwise
				  noted in this Article or as required by law.
(2) Documentation shall be made available to
				  departmental representatives for inspection and copying.