CMS SOM App. E, Tag I-153

Pathology Services

Speech pathology services are given or supervised by a qualified speech pathologist

and the number of qualified speech pathologists is adequate for the volume and

diversity of speech pathology services offered. At least one qualified speech

pathologist is present at all times when speech pathology services are furnished.

Interpretive Guidelines §485.715(c)

A - General

A qualified speech-language pathologist meets the requirements found in § 484.4.

Adequate service cannot be determined based upon the mere proportion of the staff to

patient ratio. Qualified staff must possess the knowledge and skills required for the

treatment of the various patients’ diagnoses.

Surveyors should verify through record review, observation, and interview:

• That patient evaluations or reevaluations are being performed by or under the

supervision of a SLP a speech-language pathologist;

• That a qualified speech-language pathologist is providing speech-language

pathology services; and

• That the clinical record notes and/or observations show that the plan of care is

being followed.

B – Major Sources of Information

• Personnel records for licensure, certification, or registration;

• Policies and procedures regarding patient care;

• Observations and interviews; and

• Clinical record review (plans of care and progress notes).

I-67

(Rev. 83, Issued: 03-15-13, Effective: 03-15-13, Implementation: 03-15-13)

§485.717 Condition of Participation: Rehabilitation Program

This condition and standards apply only to a rehabilitation agency’s own patients,

not to patients of hospitals, skilled nursing facilities (SNFs), or Medicaid nursing

facilities (NFs) to which the agency furnishes services. The hospital, SNF, or NF is

responsible for ensuring that qualified staff furnishes services for which they

arrange or contract for their patients. The rehabilitation agency provides physical

therapy and speech-language pathology services to all of its patients who need them.

Interpretive Guidelines §485.717

A - General

The concept of rehabilitative therapy includes recovery or improvement in function and,

when possible restoration to a previous level of health and well-being. A rehabilitation

agency must provide either physical therapy and/or speech pathology services.

The rehabilitation agency may either hire its staff directly or under a contract. Also, a

facility such as a SNF may contract with a rehabilitation agency to provide to provide the

therapy services for the SNF inpatients or outpatients.

The rehabilitation agency must have a coordinated approach to providing therapy to the

patients it accepts for service if the patient receives more than one service.

The term rehabilitation agency will be used throughout this section as § 485.717 applies

only to a rehabilitation agency and not a clinic or public health agency.

B - Major Sources of Information:

• Contract for services under arrangement;

• Personnel records–job descriptions, employee qualifications and health

examinations as specified;

• Clinical records; and

• Patient care policies.

I-68

(Rev. 83, Issued: 03-15-13, Effective: 03-15-13, Implementation: 03-15-13)

§485.717(a) Standard: Qualifications of Staff

The agency’s therapy services are furnished by qualified individuals as direct

services and/or services provided under contract.

Interpretive Guidelines § 485.717(a)

A – General

All individuals who furnish therapy services in a rehabilitation agency must meet the

qualifications of § 484.4; and have the required license, registration or certification as

required by national certification organizations, State practice acts, and Federal, State and

local laws.

The licenses must be for the States in which the services are being provided.

B – Major Sources of Information

• Personnel records containing current licenses and/or certificates of registration or

certification;

• State licensure laws for health care providers; and

• State practice acts.

I-69

(Rev. 83, Issued: 03-15-13, Effective: 03-15-13, Implementation: 03-15-13)

§485.717(b) Standard: Arrangements for services.

If services are provided under contract, the contract must specify the term of the

contract, the manner of termination or renewal and provide that the agency retains

responsibility for the control and supervision of the services.

Interpretive Guidelines §485.717(b)

A – General

For guidelines, refer to I-80, §485.719(a).

I-79

(Rev .83, Issued: 03-15-13, Effective: 03-15-13, Implementation: 03-15-13)

§485.719 Condition of Participation: Arrangements for Physical

Therapy and Speech Pathology Services to be Performed by other than

Salaried Organization Personnel

Interpretive Guidelines

§485.719

Organizations may hire their own personnel to provide outpatient physical therapy or

speech pathology services or they may arrange to provide these services under a contract.

I-80

(Rev. 83, Issued: 03-15-13, Effective: 03-15-13, Implementation: 03-15-13)

§485.719(a) Conditions. If an organization provides outpatient physical therapy

or speech pathology services under an arrangement with others, the services are to

be furnished in accordance with the terms of a written contract, which provides that

the organization retains professional and administrative responsibility for, and

control and supervision of, the services.

Interpretive Guidelines §485.719(a)

A – General

An organization that does not provide services using its own employees (i.e., salaried

personnel) may obtain those services by means of written agreements or contracts with

individuals or organizations. The employees hired under contract may provide services

wherever the organization provides therapy services.

The contracts must specify the time frame of the contract (beginning and end dates), the

organization’s administrative responsibility and its control and supervision over the

services, and must detail the manner of termination or renewal of the contract.

Review contracts to assure that the organization’s responsibility is specified and

described in detail. The contract should contain both the names of a representative of the

organization requesting therapy services and the name of the contracted employee or the

representative of the organization that is supplying the contracted employees. The

signatures of both parties indicate both the knowledge of the terms of the contract and the

responsibilities of both parties.

B - Major Source of Information

• Contract for services under arrangement.

I-81

(Rev. 83, Issued: 03-15-13, Effective: 03-15-13, Implementation: 03-15-13)

§485.719(b) Standard: Contract Provisions

The contract-

(1) Specifies the term of the contract and the manner of termination or

renewal;

(2) Requires that personnel who furnish the services meet the

requirements that are set forth in this subpart for salaried personnel;

and

(3) Provides that the contracting outside resource may not bill the patient

or Medicare for the services. This limitation is based on section 1861

(w)(1) of the Act, which provides that-

(i) Only the provider may bill the beneficiary for covered services

furnished under arrangements; and

(ii) Receipt of Medicare payment by the provider, on behalf of an

entitled individual, discharges the liability of the individual or

any other person to pay for those services.

Interpretive Guidelines §485.719(b)

A - General

Organizations can provide outpatient therapy services under arrangement with others.

These services are to be furnished in accordance with a written contract. The terms of the

contract provide that the organization maintains professional and administrative

responsibility for, and control and supervision of, the services. The terms also include

termination/renewal procedures, as well as qualifications to be met by those furnishing

services under arrangements. Only the organization, not the contracted outside resource,

may bill for services performed by the contracted resource.

Review the contracts to assure that the organization has specified the qualifications the

outside service provider must meet. The contract should state that the outside service

provider may not bill for services rendered.

B – Major Sources of Information

• Contracts; and

• Policies and procedures regarding contract specifications.

I-90

(Rev. 83, Issued: 03-15-13, Effective: 03-15-13, Implementation: 03-15-13)

§485.721 Condition of Participation: Clinical Records

The organization maintains clinical records on all patients in accordance with

accepted professional standards, and practices. The clinical records are completely

and accurately documented, readily accessible, and systematically organized to

facilitate retrieving and compiling information.

Interpretive Guidelines §485.721

A - General

The clinical record serves as a basis for documentation of medical care rendered to the

patient. Clinical records should contain at least the following documentation:

evaluations/reevaluations, plan of care, progress notes, monthly summaries, records of

communication with the patient’s physician and other therapists, family or caregivers who

may supply additional information such as the patient’s prior level of functional abilities,

and discharge summaries. Refer to § 485.721(b) for further details on the contents of the

clinical records.

In addition to serving as a basis for documentation of care rendered to patients, clinical

records provide evidence of the organization’s implementation of policies and procedures

as they relate to patient care.

All entries in the clinical record must be signed, dated, legible, and applicable to current

treatment. Note: outpatient clinical entries are only required to have the date

documented, not the time associated when the clinical notes are entered. However,

inpatient clinical entries must have all entries documented with time and date.

Documentation written by those employees providing services under contract or

arrangement must meet the documentation standards of the organization.

Sample a minimum of 25 clinical records, representing both the organization’s current

roster of patients, as well as records from discharged patients, from the past six months.

The sample must include records from both the primary site and any extension locations.

Include in the sample those patients whose treatment are/were provided by a contracted

employee, to ascertain whether evaluations, plans of care, progress notes, and other

pertinent clinical material are present and that the clinical records for all patients are

maintained on the premises of any location at which services are rendered.

The sample should be representative of all the services that are provided at the facility

(e.g., OT, PT, SLP and any other services that are provided by the organization.

Electronic records, if part of the sample review, must be available to surveyors during the

survey.

Organizations must maintain policies regarding the protection and confidentiality , of

clinical records. Some examples might include: the location of locked cabinets,

passwords required to access electronic clinical records, securing the records from

unauthorized use, etc.

B - Major Sources of Information

• Active and closed clinical records; and

• Policies regarding retention, protection, unauthorized use of, and the

confidentiality of patient information contained in clinical records.

I-91

(Rev. 83, Issued: 03-15-13, Effective: 03-15-13, Implementation: 03-15-13)

§485.721(a) Standard: Protection of Clinical Record Information

The organization recognizes the confidentiality of clinical record information and

provides safeguards against loss, destruction, or unauthorized use. Written

procedures govern the use and removal of records and the conditions for release of

information. The patient’s written consent is required for release of information

not authorized by law.

Interpretive Guidelines §485.721(a)

A – General

Clinical records are to be stored according to all Federal, State, and local privacy laws

where they are protected from unauthorized use. All locations, including extension

locations that store clinical records, are to be secure in order to protect the records from

loss, destruction, unauthorized use, and patient confidentiality. For example, records left

in patients’ rooms, in common areas, waiting rooms, and on staff desks after work hours

are not protected from visitors who may read the charts.

B – Major Sources of Information

• Policies and procedures should reflect protections of clinical records from

unauthorized use and ensure that all Federal, State, and local laws are followed;

and

• Observations of common areas where clinical records may not be protected.

I-93

(Rev. 83, Issued: 03-15-13, Effective: 03-15-13, Implementation: 03-15-13)

§485.721(b) Standard: Content

The clinical record contains sufficient information to identify the patient clearly, to

justify the diagnosis(es) and treatment, and to document the results accurately. All

clinical records contain the following general categories of data:

(1) Documented evidence of the assessment of the needs of the patient, of an

appropriate plan of care, and of the care and services furnished.

(2) Identification data and consent forms.

(3) Medical history.

(4) Report of physical examinations, if any.

(5) Observations and progress notes.

(6) Reports of treatments and clinical findings.

(7) Discharge summary including final diagnosis(es) and prognosis.

Interpretive Guidelines §485.721(b)

A – General

Assessment and Plan of Care: Each patient’s clinical records must contain an

assessment of the patient (initial evaluation and reevaluations where appropriate). The

assessment should address areas, including the immediate therapy needs, which may

affect the outcome of therapy such as family, home, employment, etc.

The clinical record must have a plan of care (including the types, amount, duration, and

frequency of services provided), identification data (name and address of patient), and

should have documented observations, treatment notes, progress reports of treatments and

clinical findings, and discharge summary. Other documentation should include

coordination efforts between professionals providing services, as well as communication

between the professionals, physicians, and families/caregivers.

Identification Data and Consent: Does the documentation in the clinical record contain

adequate patient identification information—have entries in the clinical record been

misfiled due to lack of identification information? Have consent forms been signed

(patients are often asked to sign consent forms either to obtain information about the

patient or for pictures to be taken of the patient), and are they in the clinical record? It

may be an authorized family member or guardian who signs the consent forms, as

permitted under State law.

Medical History & Reports: Medical history and report of the physician’s physical

examination may or may not appear in clinical records. Where medical history does

appear in clinical records, it may not have been transmitted by the physician, but rather

may have been obtained from the patient when their past and present history was related

verbally. It is acceptable for the patient to provide his/her present and past history for

documentation by the therapist. The therapist may also gather information from the

family, caregivers, and /or physician.

Observations and Progress notes: The progress note is a summary of treatment, and

should include observations and an assessment of the patient’s improvement or lack

thereof. It should also include the extent of progress toward goals, any changes to the

goals, and the patient’s potential for improvement. Physical therapist assistants or

occupational therapy assistants may write subjective elements of the progress notes, but

the objective elements of the progress notes (results of evaluation, revision of type of

therapy, and therapeutic goals) must be written by the qualified therapist. Do we have to

limit this entry to the therapist? Can the assistant make more substantive entries if they

are reviewed by the therapist?

Reports of treatments and Clinical Findings: Treatment notes are often written after

each treatment session. The purpose of treatment notes are to create a record of all

treatments and skilled interventions that are provided, and to record the time spent in

treatment.

Discharge note/discharge summary: The discharge note or discharge summary is

required when a patient is discharged from the rehabilitation agency. The discharge note

should contain the final diagnoses, information regarding the patient status at the time

treatment was initiated, current status of the patient, outcomes of treatment, whether goals

were met, and the final prognosis (whether the patient will benefit from any further

therapeutic intervention). The discharge summary may indicate if the patient is being

referred to another facility for further therapeutic intervention; the name and location of

the facility and if the patient will be living independently or will require assistance.

Where emergency care is provided, the clinical record should include the following: type

of care rendered, date, personnel involved, and the incident that precipitated the need for

such care.

B – Major Sources of Information

• Policies and procedures for required documentation in clinical records; and

• Clinical Records.

I-95

(Rev .83, Issued: 03-15-13, Effective: 03-15-13, Implementation: 03-15-13)

§485.721(c) Standard: Completion of Records and Centralization of

Reports

Current clinical records and those of discharged patients are completed promptly.

All clinical information pertaining to a patient is centralized in the patient’s clinical

record. Each physician signs the entries that he or she makes in the clinical record.

Interpretive Guidelines §485.721(c)

A - General

Regardless of whether the organization provides services through its own employees or

through an arrangement with others, all information and materials that are pertinent to the

patient’s treatment are to be part of the clinical record; which is to be securely maintained

on the premises of any location at which services are rendered. All information appearing

in the clinical record is to be dated appropriately, signed, and incorporated weekly into

the clinical record.

If omission of any pertinent information is noted in the clinical records, complete

additional clinical record reviews to determine the prevalence of such omissions. If there

is evidence of many instances of non-compliance, the surveyor should expand the sample

and pull an additional 5 records.

A discharge summary should include: the date and reason for discharge, a brief summary

of the status of the patient from the date of the last report to the last day of treatment, and,

where applicable, provision for referral of the patient to another source for continuing

care.

B – Major Sources of Information

• Policies and procedures for required documentation in the clinical record; and

• Clinical records.

I-96

(Rev. 83, Issued: 03-15-13, Effective: 03-15-13, Implementation: 03-15-13)

§485.721(d) Standard: Retention and Preservation

Clinical records are retained for at least:

(1) The period determined by the respective State statute, or the statute of

limitations in the State; or

(2) In the absence of a State statute—

(i) Five years after the date of discharge; or

(ii) In the case of a minor, 3 years after the patient becomes of age under

State law or 5 years after the date of discharge, whichever is longer.

Interpretive Guidelines §485.721(d)

A - General

Review the organization’s policy pertaining to retention and preservation of clinical

records, and verify that such policy is consistent with applicable State law or regulation

where such exists. Verify that there is a provision in organization policies for the

retention and transfer of clinical records if the organization ceases to function.

B – Major Sources of Information

• State statutes regarding clinical record retention; and

• Policies and procedures detailing length of time to retain records, and methods for

preserving clinical records.

I-97

(Rev. 83, Issued: 03-15-13, Effective: 03-15-13, Implementation: 03-15-13)

§485.721(e) Standard: Indexes

Clinical records are indexed at least according to name of patient to facilitate

acquisition of statistical medical information and retrieval of records for research or

administrative action.

Interpretive Guidelines §485.721(e)

A – General

Clinical records are indexed according to the last name of each patient. The organization

will determine its system for indexing its electronic health records. These systems may

be utilized for indexing either active and/or discharged patient clinical records as

determined by organizational need.

B – Major Source of Information

• Policy or procedure for indexing clinical records.

I-99

(Rev. 83, Issued: 03-15-13, Effective: 03-15-13, Implementation: 03-15-13)

§485.721(f) Standard: Location and Facilities

The organization maintains adequate facilities and equipment, conveniently located,

to provide efficient processing of clinical records (reviewing, indexing, filing, and

prompt retrieval).

Interpretive Guidelines §485.721(f)

A – General

The clinical records are to be easily retrievable, and available to all professional staff

members of the organization as well as other authorized individuals. Clinical records

may be maintained at a site other than the primary location (e.g., the extension location) if

the patient receives outpatient therapy services at that other site. However, all records

must be available to the surveyor during the course of the survey regardless of where

the records are kept.

NOTE: Records may be delivered to the surveyor electronically, or in person, as

long as the delivery is within a reasonable amount of time during the course

of the onsite survey. Delivery is essential to enable the surveyor to review

the records within the time of the onsite survey.

B – Major Source of Information

• Policy and procedure manual (clinical records section).