| (1) Facility laboratory services. A facility that provides
laboratory services shall comply with the Clinical Laboratory Improvement
Amendments of 1988 (CLIA 1988), in accordance with the requirements
specified in 42 Code of Federal Regulations (CFR), §§493.1
- 493.1780. CLIA 1988 applies to all facilities with laboratories
that examine human specimens for the diagnosis, prevention, or treatment
of any disease or impairment of, or the assessment of the health of,
human beings.
(2) Contracted laboratory services. The facility shall
ensure that all laboratory services provided to its patients through
a contractual agreement are performed in a facility certified in the
appropriate specialties and subspecialties of service in accordance
with the requirements specified in 42 CFR Part 493 to comply with
CLIA 1988.
(3) Adequacy of laboratory services. The facility shall
ensure the following.
(A) Emergency laboratory services shall be available
24 hours a day.
(B) A written description of services provided shall
be available to the medical staff.
(C) The laboratory shall make provision for proper
receipt and reporting of tissue specimens.
(4) Chemical hygiene. A facility that provides laboratory
services directly shall adopt, implement, and enforce written policies
and procedures to manage, minimize, or eliminate the risks to laboratory
personnel of exposure to potentially hazardous chemicals in the laboratory
which may occur during the normal course of job performance.
(f) Linen and laundry services. The facility shall
provide sufficient clean linen to ensure the comfort of the patient.
The facility, whether it operates its own laundry or uses commercial
service, shall ensure the following.
(1) Employees of a facility involved in transporting,
processing, or otherwise handling clean or soiled linen shall be given
initial and follow-up inservice training to ensure a safe product
for patients and to safeguard employees in their work.
(2) Clean linen shall be handled, transported, and
stored by methods that will ensure its cleanliness.
(3) All contaminated linen shall be placed and transported
in bags or containers labeled or color-coded.
(4) Employees who have contact with contaminated linen
shall wear gloves and other appropriate personal protective equipment.
(5) Contaminated linen shall be handled as little as
possible and with minimum agitation. Contaminated linen shall not
be sorted or rinsed in patient care areas.
(6) All contaminated linen shall be bagged or put into
carts at the location where it was used.
(A) Bags containing contaminated linen shall be closed
prior to transport to the laundry.
(B) Whenever contaminated linen is wet and presents
a reasonable likelihood of soak-through of or leakage from the bag
or container, the linen shall be deposited and transported in bags
that prevent leakage of fluids to the exterior.
(C) All linen placed in chutes shall be bagged.
(D) If chutes are not used to convey linen to a central
receiving or sorting room, then adequate space shall be allocated
on the various nursing units for holding the bagged contaminated linen.
(7) Linen shall be processed as follows:
(A) If hot water is used, linen shall be washed with
detergent in water with a temperature of at least 71 degrees Centigrade
(160 degrees Fahrenheit) for 25 minutes. Hot water requirements specified
in Table 5 of §134.131(e) of this title (relating to Tables)
shall be met.
(B) If low temperature (less than or equal to 70 degrees
Centigrade) (158 degrees Fahrenheit) laundry cycles are used, chemicals
suitable for low-temperature washing at proper use concentration shall
be used.
(C) Commercial dry cleaning of fabrics soiled with
blood also renders these items free of the risk of pathogen transmission.
(8) Flammable liquids shall not be used in the laundry.
(g) Medical record services. The facility shall have
a medical record service that has administrative responsibility for
medical records. A medical record shall be maintained for every individual
who presents to the hospital for evaluation or treatment.
(1) The organization of the medical record service
shall be appropriate to the scope and complexity of the services performed.
The facility shall employ adequate personnel to ensure prompt completion,
filing, and retrieval of records.
(2) The facility shall have a system of coding and
indexing medical records. The system shall allow for timely retrieval
by diagnosis and procedure, in order to support medical care evaluation
studies.
(3) The facility shall adopt, implement, and enforce
a policy to ensure that the facility complies with Health and Safety
Code, §576.005 (relating to Confidentiality of Records) and Chapter
611, (relating to Mental Health Records).
(4) The medical record shall contain information to
justify admission and continued hospitalization, support the diagnosis,
and describe the patient's progress and response to medications and
services. Medical records shall be accurately written, promptly completed,
properly filed and retained, and accessible.
(5) The facility shall use a system of author identification
and record maintenance that ensures the integrity of the authentication
and protects the security of all entries to the records.
(A) The author of each entry shall be identified and
shall authenticate his or her entry.
(B) Authentication shall include signatures, written
initials, or computer entry.
(C) Use of signature stamps by physicians may be allowed
in facilities when the signature stamp is authorized by the individual
whose signature the stamp represents. The administrative offices of
the facility shall have on file a signed statement to the effect that
he or she is the only one who has the stamp and uses it. Delegation
of use to another individual shall not be acceptable.
(D) A list of computer codes and written signatures
shall be readily available and shall be maintained under adequate
safeguards.
(E) Signatures by facsimile shall be acceptable. If
received on a thermal machine, the facsimile document shall be copied
onto regular paper.
(6) Medical records (reports and printouts) shall be
retained by the facility in their original or legally reproduced form
for a period of at least ten years. Films, scans, and other image
records shall be retained for a period of at least five years. For
retention purposes, medical records that shall be preserved for ten
years include:
(A) identification data;
(B) the medical history of the patient;
(C) evidence of a physical examination and psychiatric
evaluation;
(D) admitting diagnosis;
(E) diagnostic and therapeutic orders;
(F) properly executed informed consent forms for procedures
and treatments specified by the medical staff, or by federal or state
laws if applicable, to require written patient consent;
(G) treatment plans;
(H) clinical observations, including the results of
therapy and treatment, all orders, nursing notes, medication records,
vital signs, and other information necessary to monitor the patient's
condition;
(I) reports of procedures, tests, and their results,
including laboratory, pathology, and radiology reports;
(J) results of all consultative evaluations of the
patient and appropriate findings by clinical and other staff involved
in the care of the patient;
(K) discharge summary with outcome of hospitalization,
disposition of care, and provisions for follow-up care; and
(L) final diagnosis with completion of medical records
within 30 calendar days following discharge.
(7) If a patient was less than 18 years of age at the
time he was last treated, the facility may authorize the disposal
of those medical records relating to the patient on or after the
date of his 20th birthday or on or after the 10th anniversary of the
date on which he was last treated, whichever date is later.
(8) The facility shall not destroy medical records
that relate to any matter that is involved in litigation if the facility
knows the litigation has not been finally resolved.
(9) If a licensed facility should close, the facility
shall notify the department at the time of closure the disposition
of the medical records, including the location of where the medical
records will be stored and the identity and telephone number of the
custodian of the records.
(h) Medical staff.
(1) The medical staff shall be composed of physicians
and may also be composed of podiatrists, dentists and other practitioners
appointed by the governing body.
Cont'd... |
