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Before comprehensive assessments (that include collection of OASIS data items) are conducted, the HHA must tell patients about OASIS and explain their rights with respect to the collection and reporting of OASIS information. These rights include: 1) the right to be informed that OASIS information will be collected and for what purpose; 2) the right to have the information kept confidential and secure; 3) the right to be informed that OASIS information will not be disclosed except for legitimate purposes allowed by the Privacy Act; 4) the right to refuse to answer a specific question; and 5) the right to see, review, and request changes on their assessment. A standard notice to patients that explains these rights in plain language was published in the Federal Register on June 18, 1999, (64 FR 32984) and is available in English and Spanish on the OASIS website (www.hcfa.gov/medicaid/oasis/oasishmp.htm). HHAs must present and explain this required notice to beneficiaries before their initial OASIS assessment.

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How do HHA employees, and staff used by the HHA under an arrangement or contract, implement HHA procedures for informing patients of their rights?

How does the HHA assure that the patient understands the OASIS Privacy Act Statement? Is the patient given a copy of the OASIS Privacy Act Statement?

Does the patient receive a written copy of the HHA’s response when a change request is not granted?

(2) The HHA must maintain documentation showing that it has complied with the requirements of this section.

(1) The patient has the right to exercise his or her rights as a patient of the HHA.

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During home visits, discuss the services that the patient is receiving specific to the medical plan of care. Determine if the patient response shows that the HHA has offered specific instructions in areas mentioned in the standard. For example, if the patient is recovering from a fractured hip and has been receiving physical therapy services for several weeks, ask the patient to show or explain to you what exercises he or she has been doing, how often they are to be done, and what results are anticipated. Also, ask how often the physical therapist comes, when the therapist is expected next, and how plans for therapy have changed as the condition has changed. If the patient responds that he/she has written instructions telling him or her what to do, request to see them.

Ask the patient how he or she participated in developing the plan of care to be furnished by the HHA and when he/she was told about changes in the plan of care. The HHA may discuss changes with the patient by telephone prior to the HHA visit or at the time of the visit, but the patient should feel that he or she has time to consider the implications of the change(s) and concur or object to them prior to implementation.

Advance directives generally refer to written statements, completed in advance of a serious illness, about how an individual wants medical decisions made. The two most common forms of advance directives are a living will and a durable medical power of attorney for health care.

This information must be furnished in advance of the individual coming under the care of the HHA and may be provided during admission, the patient’s initial evaluation, or the patient’s first professional visit.

(1) The patient has the right to be informed, in advance, about the care to be furnished, and of any changes in the care to be furnished.

(i) The HHA must advise the patient in advance of the disciplines that will furnish care, and the frequency of visits proposed to be furnished.

(ii) The HHA must advise the patient in advance of any change in the plan of care before the change is made.

(2) The patient has the right to participate in the planning of the care.

(i) The HHA must advise the patient in advance of the right to participate in planning the care or treatment and in planning changes in the care or treatment.

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(1) What documentation in the clinical records indicates that the HHA advised the patient, in advance, of his or her right to participate in planning the care or treatment to be provided? What documentation indicates that the HHA informed the patient about the types of services to be provided, the disciplines involved, the frequency of the services, and the anticipated outcomes?

(2) How does the HHA inform the patient about changes in the plan of care and solicit the patient’s participation in that care prior to the change being implemented?

(3) How does the agency advise patients of the need for the physician to agree with the plan of treatment and with any changes to that plan?

(2) If the HHA leaves a portion of the clinical record in the home (such as in some high technology situations when frequent clinical entries are important), how does the HHA instruct the patient or caretaker about protecting the confidentiality of the record?

The patient has the right to confidentiality of the clinical records maintained by the HHA.

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Look for a written statement in the home that might serve as a resource or reminder to the patient about the information the HHA has presented. Also, note whether there are subsequent written statements about payments for items or services of which the HHA has become aware.

1. What process is followed by the HHA to inform the patient of home care charges and probable payment sources, patient’s payment liability (if any), and of changes in payment sources and patient liabilities?

2. What documentation in the clinical record indicates that the HHA informed the patient of Federally-funded or aided covered and noncovered services?

(1) The patient has the right to be advised, before care is initiated, of the extent to which payment for the HHA services may be expected from Medicare or other sources, and the extent to which payment may be required from the patient.

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Before the care is initiated, the HHA must inform the patient, orally and in writing, of--

(i) The extent to which payment may be expected from Medicare, Medicaid, or any other Federally funded or aided program known to the HHA;

(ii) The charges for services that will not be covered by Medicare; and

(2) The patient has the right to be advised orally and in writing of any changes in the information provided in accordance with paragraph (e)(1) of this section when they occur. The HHA must advise the patient of these changes orally and in

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writing as soon as possible, but no later than 30 calendar days from the date that the HHA becomes aware of a change.

The patient has the right to be advised of the availability of the toll-free HHA hotline in the State. When the agency accepts the patient for treatment or care, the HHA must advise the patient in writing of the telephone number of the home health hotline established by the State, the hours of its operation, and that the purpose of the hotline is to receive complaints or questions about local HHAs. The patient also has the right to use this hotline to lodge complaints concerning the implementation of the advanced directives requirements.

During home visits, ask the patient for the number of the HHA State hotline, when he/she would use it, and what he/she would expect as a result of its use. If the patient has difficulty answering questions about the hotline, ask the patient for a copy of the written information that the HHA has provided.

Federal facilities are not required to participate in the HHA State hotline.

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The HHA and agent acting on behalf of the HHA in accordance with a written contract must ensure the confidentiality of all patient identifiable information contained in the clinical record including OASIS data, and may not release patient identifiable information to the public.

Protection of confidentiality of OASIS information is two-fold; the HHA has a responsibility to keep OASIS information confidential and HCFA has a responsibility to keep it confidential, once it has been transmitted to the OASIS State system.

Under this condition of participation, the HHA is required to maintain the confidentiality of OASIS data while it is being used for patient care and may not release it without the consent of the patient for any reason other than for what it is intended, which is to appropriately deliver patient care. HHAs must have policies and procedures for limiting access to OASIS information to only those persons the HHA designates.

If the HHA contracts with a vendor for transmission of its OASIS data, a written agreement that addresses the confidentiality of that data must be in place. Violations of data confidentiality by an entity contracted by the HHA are still the responsibility of the HHA and would constitute condition-level non-compliance; therefore the HHA is ultimately responsible for compliance with the confidentiality requirements and is the responsible party if the requirements are not met by the contractor.

For privacy and security reasons, communication of OASIS information (from branch to branch, branch to parent, parent to vendor, etc.) must be done in accordance with HCFA policies on the communication of patient-identifiable information. HHAs must have processes in place to assure that access to and transfer and delivery of OASIS information is limited to only authorized personnel.

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The other step in assuring confidentiality of the OASIS data is at the Federal level and involves the Federal Privacy Act of 1974. Coverage under the Federal Privacy Act begins when the data reaches the State agency. The Privacy Act requires that policies and procedures related to the collection of information be made available to the public describing the reasons for collecting OASIS data, what will be done with it, and who will have access to it in an identifiable format. The Privacy Act puts into place certain processes that protect patient identifiable data from unauthorized use and disclosure. Provisions of the Privacy Act as they relate to the collection of OASIS data are described in detail on the OASIS Statement of Patient Privacy Rights (See 484.10(a)).

Onsite Activity - Verify that the HHA has established a mechanism to ensure confidentiality of OASIS data. Interview the administrator and staff regarding:

Determine how OASIS data, whether in hard copy or electronic format is kept confidential before and after transmission to the State agency.

Interview the HHA administrator or system administrator for:

If possible, observe security of the OASIS data-entry location. Observe if the computer screen is logged off or password protected when not attended.

If applicable, review vendor contracts for provisions protecting confidentiality of OASIS data and determine what systems are in place to assure confidentiality throughout the transmission process. Vendors must be aware of the requirements and security policies of the HHA.

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How does the HHA assure that only specified personnel have access to OASIS assessment information?

How is the security of passwords maintained?

What policies and procedures address password assignment and use?

Who in the HHA has the password information needed to electronically report OASIS data to the State agency? At least two staff persons should have the password.

If the HHA has branches, how is OASIS data protected and kept secure during transfer from the branch to the parent agency?

If the HHA contracts out OASIS encoding and reporting, what systems are in place to assure that the contracted vendor maintains confidentiality of OASIS data?

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Personnel practices and patient care are supported by appropriate, written personnel policies.

Personnel records include qualifications and licensure that are kept current.

The numbers and qualifications of personnel available to provide services must be sufficient to implement the plans of care and the medical, nursing, and rehabilitative needs of the patients admitted by the HHA.

1- What does the HHA include in the personnel records about the qualifications and licensure of its employees?

2- If the HHA does not keep duplicate personnel records of staff hired under arrangement, how does it ensure that records are kept current?

If an HHA, which has been established as hospital-based for Medicare payment purposes, has arranged with the hospital to provide the second qualifying service or other HHA services (see 42 CFR 484.14(a)) through hospital employees, the HHA would not be required to have an hourly or per visit contract with these hospital employees. The HHA should identify in its records the names of these employees and the amount of time they spend at the HHA. However, if these hospital employees provide services to the HHA outside of their own usual working hours or shifts (i.e., "moonlight" as HHA employees, as opposed to working overtime for the hospital), a contract as specified in standard (f) applies.

1- How does the HHA orient contractual personnel to HHA objectives, policies, procedures, and programs?

2- How does the HHA evaluate whether contractual personnel inform the patient of his/her rights prior to the beginning of care or when there are changes in care?

If personnel under hourly or per visit contracts are used by the HHA, there is a written contract between those personnel and the agency that specifies the following:

(1) Patients are accepted for care only by the primary HHA.

(2) The services to be furnished.

(3) The necessity to conform to all applicable agency policies, including personnel qualifications.

(4) The responsibility for participating in developing plans of care.

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(5) The manner in which services will be controlled, coordinated, and evaluated by the primary HHA.

(6) The procedures for submitting clinical and progress notes, scheduling of visits, periodic patient evaluation.

4- Who reviews the recertification requests to determine if continuing patient care is indicated as a probable medical necessity?

1- What is the HHA's policy related to facilitating exchange of information among staff?

2- How does coordination of care among staff and/or contract personnel providing services to individual patients occur?

The clinical record or minutes of case conferences establish that effective interchange, reporting, and coordination of patient care does occur.

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timing. Other costs related to capital expenditures include title fees, permit and license fees, broker commissions, architect, legal, accounting, and appraisal fees; interest, finance, or carrying charges on bonds, notes and other costs incurred for borrowing funds.

(ii) If the anticipated source of financing is, in any part, the anticipated payment from title V (Maternal and Child Health and Crippled Children's Services) or title XVIII (Medicare) or title XIX (Medicaid) of the Social Security Act, the plan specifies the following:

(A) Whether the proposed capital expenditure is required to conform, or is likely to be required to conform, to current standards, criteria, or plans developed in accordance with the Public Health Service Act or the Mental Retardation Facilities and Community Mental Health Centers Construction Act of 1963.

(B) Whether a capital expenditure proposal has been submitted to the designated planning agency for approval in accordance with section 1122 of the Act (42 U.S.C. 1320a-1) and implementing regulations.

(C) Whether the designated planning agency has approved or disapproved the proposed capital expenditure if it was presented to that agency.

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o Dipstick/tablet reagent urinalysis;

o Blood glucose by glucose monitoring devices cleared by the Food and Drug Administration (FDA) specifically for home use;

o Some prothrombin time tests; and

o Some glycosolated hemoglobin tests.

(1) If the HHA engages in laboratory testing outside of the context of assisting an individual in self-administering a test with an appliance that has been cleared for that purpose by the FDA, such testing must be in compliance with all applicable requirements of part 493 of this chapter.

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If the HHA performs any other testing procedures, (i.e., moderate or high complexity testing), it would require a registration certificate, a certificate of accreditation, or a certificate of compliance. While some prothrombin testing is in the waived category, as mentioned above, other prothrombin testing is considered moderate complexity testing depending on the skill level required to operate the instrument.

If the facility does not possess the appropriate CLIA certificate, inform the facility that it is in violation of CLIA law and that it must apply immediately to the State agency for the appropriate certificate. The facility is out of compliance with 42 CFR 484.14(j). Also, refer this facility's non-compliance to the department within the State agency responsible for CLIA surveys.

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(2) If the HHA chooses to refer specimens for laboratory testing to another laboratory, the referral laboratory must be certified in the appropriate specialties and subspecialties of services in accordance with the applicable requirements of part 493 of this chapter.

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If an HHA has a branch(es), the annual review includes services delivered through the branch(es).

The parent agency's group of professional personnel or a subcommittee of the group may also serve as the subunit's group of professional personnel or the subunit may establish its own group.

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1. How does an HHA evaluate whether the plan of care, and the coordination of services, help the patient attain and maintain his or her highest practicable functional capacity based on medical, nursing, and rehabilitative needs?

2. How does the HHA monitor the delivery of services, including those provided under arrangement or contract, to ensure compliance with the specificity and frequency of services ordered in the plan of care?

3. If a range of visits is ordered, how does the HHA ensure that the frequency of visits meets the clinical needs of the patient?

Changes in the patient’s condition that require a change in the plan of care should be documented in the patient’s clinical record.

When a Medicare beneficiary elects to transfer to a different HHA or is discharged and returns to the same HHA, it warrants a new clock for purposes of payment, OASIS assessment, and physician certification of the new plan of care. When a new 60-day episode begins, the original 60-day episode payment is proportionally adjusted to reflect the length of time the beneficiary remained under the HHA‘s care before the intervening event. The proportional payment is the Partial Episode Payment (PEP) adjustment.

A Significant Change In Condition (SCIC) adjustment occurs when a Medicare beneficiary experiences a significant change in condition during a 60-day episode that was not envisioned in the original plan of care. In order to receive a new case-mix assignment for purposes of SCIC payment during the 60-day episode, the HHA must complete an OASIS assessment and obtain the necessary physician change orders reflecting the significant change in treatment approach in the patient’s plan of care. Refer to current policy for the use of the OASIS assessment for SCIC adjustments.

Agency professional staff promptly alert the physician to any changes that suggest a need to alter the plan of care.

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Review HHA policies and procedures in regard to obtaining physician orders, changes in orders, and verbal orders. All physician orders must be included in the patient’s clinical record. Plans of care must be signed and dated by the physician.

How does the HHA secure the physician’s signature on verbal, change, or renewal orders?

How does the HHA ensure that verbal orders are accepted, co-signed by the nurse or therapist, and countersigned by the physician appropriately?

Drugs and treatments are administered by agency staff only as ordered by the physician.

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Tag 167 expired on 6/1/99. A new tag concerning drug review is found at G337 and is applicable to all patients serviced by the HHA.

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HHAs must, at least monthly, electronically report OASIS data on all applicable patients in a format that meets HCFA electronic data and edit specifications. For purposes of this requirement, the term "reporting" means electronic reporting.

OASIS data on non-Medicare/non-Medicaid patients receiving skilled services are reported when the requirement to mask non-Medicare/non-Medicaid OASIS data is effective so that their personally identifiable information remains unidentifiable except to the reporting HHA. At that time, HHAs using software developed by private vendors must use software that is appropriately masking non-Medicare/non-Medicaid records for all assessments in a similar manner to the functionality provided by the Home Assessment Validation Entry (HAVEN) software and be able to cross-reference a masked code to the name of the patient, as HAVEN does.

HHAs or contracted entities acting on behalf of the HHA can report OASIS data to the State agency using the HAVEN software HCFA provides free of charge or by using HAVEN-like software that conforms to the same specifications used to develop HAVEN. Reported OASIS data will be analyzed and findings made available to HHAs by way of reports that will help HHAs identify their performance level in the provision of care to the patient population they serve as compared with other HHAs on either a national, State or local level.

As part of the ongoing survey process, State agencies may establish policies in keeping with unannounced surveys that include the ongoing request, at specified intervals, for the submission of a current census (number) of patients being serviced by the HHA. Census information should include only a count of non-Medicare/non-Medicaid patients. Since OASIS data on non-Medicare/non-Medicaid patients will be received by the OASIS State system in an unidentifiable format, names of non-Medicare/non-Medicaid patients on the census are not appropriate.

The HHA must encode and be capable of transmitting OASIS data for each agency patient within 7 days of completing an OASIS data set.

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Pre-Survey Activity - Check with the State OASIS Education or Automation Coordinator and/or review OASIS data management reports to determine if encoding is completed within 7 days after completing the OASIS data set.

Onsite Activity -Check to see if the HHA is transmitting its own data or has an arrangement with an outside entity acting on behalf of the HHA to electronically submit OASIS data to the State agency. If so, make sure a written contract exists that describes the arrangement the HHA has with the outside entity to enter and transmit OASIS data on behalf of the HHA.

Determine the process for encoding and locking OASIS data being readied for transmission to the State.

Initial Survey - New HHAs seeking initial certification must apply for appropriate State and Federal HHA identification and passwords and be able to demonstrate compliance with collecting, completing, encoding and reporting OASIS data for all applicable patients in an electronic format that meets HCFA specifications prior to the initial survey. Check with the OASIS Automation Coordinator for information on assignment of test identification numbers and passwords.

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The encoded OASIS data must accurately reflect the patient’s status at the time of assessment.

Check to see how the HHA monitors the accuracy of their data to ensure the data collected, encoded, and reported accurately reflects the patient’s status at the time of the assessment. Some tips for establishing a program to monitor the quality and accuracy of OASIS data are found in Chapter 12 of the OASIS Implementation Manual – Data Quality Audits.

Onsite Activity - When reviewing the clinical records, determine that a visit was made to conduct the assessment, as applicable. Also, determine that other clinical information in the patient record does not contradict OASIS data collected during the assessment, encoded or reported.

New patient admission: If possible, include a home visit for a newly admitted patient who is scheduled to have a comprehensive assessment done. Determine that the OASIS data collected accurately reflects the patient’s status at the time of the assessment.

Patient currently on service: If a home visit is made on a patient for whom an assessment has already been conducted and is not now scheduled to have one conducted, review the most current assessment and compare it with your observation of patient status, keeping in mind the patient’s progress/decline and the normal progression of the clinical condition.

Determine that other clinical information in the patient record does not contradict OASIS data.

How does the HHA conduct clinical and data entry audits to verify that collected OASIS data is consistent with reported OASIS data?

How does the HHA assure consistency?

How does the HHA review the final validation reports for accuracy purposes?

Has the HHA identified any discrepancies in data collected and reported? If so, how were discrepancies addressed?

How does the HHA handle the correction of errors?

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The HHA must-

By the last day of the current month, HHAs must electronically transmit all OASIS data collected, encoded, and locked in the previous month for each patient (as applicable), to the State agency or HCFA OASIS contractor. At a minimum, HHAs must transmit OASIS data at least monthly; HHAs may transmit OASIS data more frequently, if desired, and are free to develop schedules for transmitting data to best suit their needs.

Rejected data that requires correcting and re-transmitting must be received by the OASIS State system within the same required time frame. Submission of data with identified fatal errors does not justify extending the required time frame. While overdue assessments will be accepted, HHAs (or their contracted vendors) may not wait until the end of the month to transmit their OASIS data in case errors are identified that require re-transmittal or system problems develop that prevent transmission.

Entities submitting OASIS data to the State agency or HCFA OASIS contractor on behalf of the HHA, i.e., corporate offices or vendors under contract, must share the feedback reports with the HHA in order for them to monitor their encoding and transmission process.

Pre-Survey Activity - Check with the State OASIS Education or Automation Coordinator and/or review OASIS data management reports to determine if OASIS data are being transmitted as required.

Onsite Activity - Ask the HHA to demonstrate how it creates, saves and transmits OASIS data to the State agency. Randomly select patient assessments and ask the HHA for the final validation report to demonstrate that they were received by the State.

Is the HHA successfully transmitting OASIS data at least once a month?

What is the HHA’s back-up plan if it is unable to submit OASIS data to the State agency?

If questions arise, review HHA policies and procedures regarding OASIS data transmission.

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(2) For all assessments completed in the previous month, transmit OASIS data in a format that meets the requirements of paragraph (d) of this section:

Determine that all required OASIS assessments are being transmitted.

Certain missing information or inconsistencies will cause a record to be completely rejected requiring correction by the HHA and retransmission. These are called fatal errors. An example of a fatal error is when a record is submitted without the HHA’s State-assigned identification number, without the patient’s last name, or the record is a duplicate of one previously received. A complete listing of current record rejection criteria is available on the OASIS website (www.hcfa.gov/medicaid/oasis/oasishmp.htm).

HHAs may correct mistakes to records that have been transmitted to the State agency or HCFA OASIS contractor. Until the system to completely automate correction of errors is available to HHAs, non-key fields may be updated and re-transmitted to the OASIS State system. Corrections to key fields must be communicated to the State agency and manually made there. A description of key fields vs. non-key fields is available on the OASIS website (www.hcfa.gov/medicaid/oasis/oasishmp.htm).

How is the HHA responding to identified fatal errors?

How does the HHA verify that assessment data is consistent with the required format?

What are the established times of OASIS data transmission to the State? (They must be at least monthly.)

Are all required OASIS assessments that are locked in the previous month, transmitted during the next month?

Who is assigned to transmit OASIS data?

If questions arise during interview and record review, review the HHA policies on OASIS data transmission.

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The purpose of making a test transmission to the State agency or HCFA OASIS contractor is to establish connectivity. Once the test has been successfully completed, HHAs must not routinely use the test function to prepare their submission of production (required) OASIS data.

Initial Survey - New HHAs seeking initial certification must apply for State and Federal HHA identification numbers and passwords in order to demonstrate compliance with the OASIS submission requirements prior to Medicare approval.

HHAs must demonstrate connectivity to the OASIS State system by--

NOTE: The OASIS system is not authorized to maintain unmasked OASIS information on non-Medicare/non-Medicaid patients receiving skilled services. If the HHA has indicated at M0150 that the patient is a non-Medicare/non-Medicaid patient, the data should be masked when the requirement to mask non-Medicare/non-Medicaid data is effective. Unmasked data on non-Medicare/non-Medicaid patients receiving skilled services are rejected by the State system.

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G326</