Agency Name: Agency ID Code

Regulatory ReviewPilotProtocol 11/30/2010

Agency Name: Agency ID Code:

Agency Address:

Date of Review:

Reviewer Name: Team #:

AGENCY STAFF INTERVIEWED: / REGARDING / AGENCY STAFF INTERVIEWED: / REGARDING

Please Note:

The guidelines in this document cannot be inclusive of every scenario a surveyor may encounter and are not meant to substitute for the judgment and knowledge base of experienced DQM staff. If items not specifically identified in the protocol are found to be inadequate the surveyor is responsible to take appropriate action to identify, notify and ensure corrective action.
Procedures identified in this document do not restrict OPWDD's ability to assess any item determined to influence the regulatory compliance of an agency.

Central – RIGHTS

GENERAL GUIDELINES:

The following standards to be reviewed are a review of agency procedures in place and to be implemented. The purpose is to verify that the agency has planned actions to facilitate compliance with these requirements.

Please Note: There are also review activities that need to take place during site reviews that will serve as additional verification that the procedures are implemented and effective. Throughout the survey year, the findings of both Central and Site review activities will provide the best overall assessment of the agency's competence to comply with these requirements.

Central – RIGHTS
TAG # / CITE / REQUIREMENT/
STANDARD / MET / NOT MET / COMMENTS / GUIDELINES
633.4(b)(1) / 1.The agency has procedures to ensure that individuals, family members, guardians and correspondents are informed of individual rights. / Verify that the agency has written procedures for the informing parties of their rights and responsibilities. They should minimally address:

Informing of rights upon admission or initial receipt of service
Informing of rights when they are revised/amended
How the information will be communicated
Timeframes
Staff (by title) responsible

 How the agency verifies that parties
have been informed
633.4(b)(2)(ii)
633.12(b)(1) / 2.The agency has procedures to ensure that Individuals, family members, guardians and correspondents are informed of what to do if they have an objection, problem, or complaint. / Verify that the agency has written procedures for informing parties of the actions to take if they have an objection, problem, or complaint. The procedures should minimally include:

How the information will be communicated
Timeframes
Staff (by title) responsible
How the agency verifies that parties have been informed

NOTE: Agency procedures may be similar or interrelated with those for #4. Ensure that both rights grievances and objections to services are addressed if there is only one written procedure.
633.4(a)(3)
633.4(b)(6)
633.2(b) / 3.The agency hasprocedures to ensure that individuals' rights are only limited with clinical justification and for a limited time period, and that these determinations are documented in the person's clinical record. / Verify through interview and documentation review that the agency has procedures that minimally include the following:

Defines rights limitations
Defines clinical justification
Describes the determination of time period for limitations
Identifies staff responsible to ensure rights are limited only with clinical justification and time period established
Identifies staff responsible for necessary documentation

Note: Verification activities will be included in the site review protocol section.
633.12(a)(1) / 4.The agency has written policies and procedures which establish mechanisms to resolve objection to services, in accordance with Part 633.12. / Verify through interview and documentation review that the agency has written procedures that minimally include the following:

Identifies situations for which objections may be initiated (plans of service, plans for placement or discharge, or proposals to reduce, suspend or discontinue waiver services)
Parties that may initiate and participate in the objection process (See 633.12(a)(4-7)
Describes the objections process (See 633.12(a)(8-12)
Identifies agency staff responsible to ensure due process is afforded to objecting parties
Documentation responsibilities and maintenance

NOTE: Agency procedures may be similar or interrelated with those for #2. Ensure that both rights grievances and objections to services are addressed if there is only one written procedure.
633.12(a)(8) / 5.Objections of Service reported to the agency were addressed appropriately per Part 633.12 and agency procedures. / Interview appropriate agency staff regarding their objections processes. Inquire whether they have had any situations requiring initiation of the objection process. Review documentation maintained by the agency regarding the situation. Evaluate that appropriate actions were taken as required by the regulation.
Note: Supportingactivities may occur as part of site visits through inquiry on admissions, discharges, service changes, etc. Also, interview with individuals receiving services and family members should include inquiry regarding satisfaction, agency response to objections/concerns, etc. Site review sections will include related guidelines.
Central -- HEALTH CARE

GENERAL GUIDELINES:

Central -- HEALTH CARE
TAG # / CITE / REQUIREMENT/
STANDARD / MET / NOT MET / COMMENTS / GUIDELINES
633.17(a)(14)(iii)(c)
633.17(b)(5)(ii) / The agency has procedures to ensure that all non-licensed AMAP staff who pass medications have current certification. / Verify through interview and documentation review that the agency implements actions to track medication administration certification dates, remind responsible staff of recertification needed, and ensure that recertification procedures are conducted.
633.17(a)(15)(i)
633.17(a)(15)(ii) / The agency has procedures to ensure that there is RN availability to direct support staff 24 hours a day 7 days a week. / Verify through interview and documentation review that the agency has established procedures to provide RN consultation and triaging 24/7 to staff rendering professional nursing services (e.g. medication administration, tube feeding). These procedures need to minimally include:

24/7 availability of the services of an RN on site or by telephone. The services may be provided by agency RNs, Consulting RNs, or external RN service agencies
Informing staff of the procedure

633.17(a)(7)
633.17(a)(15)(ii) / The agency has a Medication Error Reporting System which includes procedures to address/remediate causes for the errors. / Verify through documentation review and interview, that the agency has a standardized means to report and address medication errors. The procedure should minimally include:

A standardized formatto document medication error information. The reporting form should include:
Name of staff committing the error;
Name of service recipient involved;
Prescribed Medication name(s) and dosages involved in the error (what the individuals should receive as ordered
Time(s) of error
Description of type(s) of error, e.g. med omission, wrong med(s) administered, wrong dosage, wrong time, wrong route
Affect error had on the individual
Assessment of causes or factors contributing to the medication error and documentation of the findings
Determination of necessary corrective and/or preventative action to be taken to address the contributing factors and prevent reoccurrences and implementation.
Verification that corrective/preventative actions were implemented

Commissioner’s Directive:
Paul Kietzman Memo of
July 19, 2000 / The agency has procedures to ensure that medications to modify or control inappropriate behaviors are administered in OPWDD certified facilities, only with appropriate written informed consent. / Verify through documentation review and interview that the agency has written procedures to obtain initial and annual consents for the administration of medications prescribed to address behaviors. The procedures should identify:

Medications and circumstances for medication administration that require consents
Time Frames for consent requests and receipt initially and annually
Procedures to request consents, monitor receipt and communicate receipt to parties/sites administering medication
The information that needs to be provided to the consenting party regarding the medication and its use to ensure "informed" consent
Parties from whom consent may be received
Staff by title responsible to request/obtain consents
Staff by title responsible to verify that consents have been obtained prior to med administration

Reference 681.13(a)(2) for written informed consent requirements.
NOTE: On-site verification activities will also occur.
Central – INFECTION CONTROL

GENERAL GUIDELINES:Tuberculosis Requirements

New OPWDD regulations related to the control of tuberculosis were effective June 1, 2010. Review for these requirements applies to staff hired after June1, 2010.

Regulations specify what agencies must do to be in compliance. The new TB regulations applies to all developmental centers and facilities certified by OPWDD including family care. A certified site is a site that holds an operating certificate issued by OPWDD such as an IRA, Day Hab, Community Based ICF, etc. Staff in a non certified program that share building space with a certified program will be required to receive initial testing if they are likely to; share the same air space and come into routine contact with the recipients of service of the certified program.

Per regulation, all Recipients of Service in certified sites, Employees including relief staff, Respite Providers, Family Care Providers, and Volunteers, Students and Contractors who are regularly present at certified sites must have initial testing* if they cannot provide written evidence of acceptable testing. See below for details on acceptable testing*. There are also exceptions and exclusions to testing, and the related requirements are included in this protocol.

Annual testing is no longer required (except in developmental centers). Repeat testing will be required if there is a suspected or known exposure to active pulmonary TB. All exposure testing must be done in cooperation with State and Local Health Depts. Any authorized health care provider may require or request testing.

Acceptable testing per the new regulations is one of the following:

At least two documented consecutive negative PPDs within 12 months (365 days or less) of each other.
Documented two-step PPD which was completed within one year (365 days or less) of employment or service prevision date. (See definition of two-step PPD in 633.14(b)(13).

Note: Person may work prior to second TST is the first is negative. Note: for individuals that have no prior PPD documented the procedure for the two-step includes the initial PPD stick and then 1-3 weeks later the second PPD test.

Blood Assay Test: Whole blood interferon-gamma release assays (IGRAs) approved by the FDA such as QuantiFERON-TB Gold, 2005; QuantiFERON-TB Gold In-Tube, 2007; and TSpot.TB, 2008, performed and interpreted in compliance with manufacturer, FDA and CDC guidance.
New testing using Blood Assay test prior to employment or Two-Step PPD with first part occurring and reading negative prior to employment.

Exception: If there is a previous documented positive TST result, no Tuberculosis testing is required. Evaluation for signs/symptoms of excluded persons in the through use of a screening tool is required. Review of compliance for exclusion from testing and assessment/documentation requirements for individuals with positive TST results are found further in this protocol. Guidelines for contraindication for testing are included in the document also.

For the purposes of Central Regulatory Review the survey sample will include agency Employees, Contract Employees, and Students who are regularly present at a certified site.

Central – INFECTION CONTROL

Do a sample review of tuberculosis testing records as follows:

# OF NEW STAFF HIRED
New Staff = Applicable employees hired since last review or past year, whichever is shorter. / SAMPLE SIZE
39 or Less / All New Hires
with Maximum of 10
40+ / 25% with a maximum of 15

Employee Sample:

STAFF NAME / STAFF NAME
Central – INFECTION CONTROL
TAG # / CITE / REQUIREMENT/
STANDARD / # SAMPLED / # Not Met / COMMENTS / GUIDELINES
633.14(c)(1)(i) / 1.All employees, volunteers, and contractors, family care providers and approved substitute/respite providers have TB testing completed prior to their first day of employment or service provision.
If using the two-step PPD
individuals may begin work if
the first test is negative. / Review for staff TB testing will occur annually and centrally at the agency's office.
Procedure:

Review documentation verifying that PPD testing occurred prior to first day of employment or contact with service recipients. Note; If using the two-step PPD, the second PPD must be administered in 1-3 weeks.
Evidence of testing may be an agency tracking system/document that identifies the staff person, date of employment/service provision, and type of testing/evaluation and testing date(s). It is not necessary to review the specific test results.

If systemic problems in TB test tracking are noted, consult with the regional director to determine whether to review Policies and Procedures.

Exception: If there is a previous documented positive test result, no TST is required. Review of compliance for exclusion from testing and screening/documentation requirements for individuals with positive TST results are found further in this protocol.
633.14(d)(1) / 2.Exclusions From Testing Review only if sample included persons not tested due to stated exclusions
In order for a service
provider to permit an
employee's exclusion from
either pre-employment or
pre-delivery of services TB
testing or follow-up TST, the
service provider shall have
documentation of one of the
following reasons for
contraindication:
(i) prior documented significant reaction to TB testing; or
(ii) adequate treatment for active pulmonary tuberculosis; or
(iii) completion of adequate preventive therapy. / Review only if sample included persons not tested due to stated exclusions
Employees may not refuse testing.
This exclusion to testing (and related requirements) relates to an employee's previous TB history.
An agency may waive TB testing of an employee without consultation with the person’s health care provider, as long as the agency has documented proof of one of the three conditions described in the requirement at left. Verify that the documentation is present for the sample selected if applicable.
For employees who have had a past positive reaction to TB testing they are not permitted to begin employment until they have been evaluated by a healthcare provider and found to be free of active TB or they meet the following criteria:

Adequate treatment has been instituted

The cough has resolved

Sputum specimens are negative
on 3 AFB smears.
Regarding (iii) "preventative therapy" does no t include BCG immunization. Acceptable preventative therapy would include INH treatment exclusive of symptoms.
633.14(d)(2) / 3.Contraindication To Testing – EmployeesReview only if sample included persons not tested due to stated contraindications.
A statement by a physician,
nurse practitioner or
physician's assistant of
contraindication to TB
testing shall be acceptable
as long as the statement
includes: (i) a
recommendation as to when
and if testing would be
appropriate at a designated
point in the future; and
(ii) how the party will be
evaluated for active
pulmonary tuberculosis in
the interim. / Review only if sample included persons not tested due to stated contraindications.
This exclusion to testing applies to situations in which testing is contraindicated due to factors other than previous TB history.
For this exclusion the person’s health care provider provides the written documentation that the person has a contraindication to testing, such asan extreme fear of needles (trypanophobia).
The regulation allows an MD, PA or NP to write a letter/note stating the contraindication, the plan for assessment of the person for s/s of active pulmonary TB and a statement as to when testing may be able to be conducted in the future.
For sample employees excluded from testing due to contraindication, verify that documentation is present from an MD, PA or NP that:

Describes the contraindication, and
Includes recommendations for when testing would need to occur, and
How they will be evaluated until that time that TB testing can be conducted.

633.14(d)(3) / 4.Review Only If #2 or #3 Above Apply
For Employees excluded
from TB testing, a registered
nurse shall conduct a general
evaluation of the person
taking into account any
symptomology and history
since the person's previous
TB test or evaluation.
Appropriate referral for
formaldiagnostic evaluation
mayoccur based on the
evaluation. / Applies to people excluded from TB testing.
Individuals for whom TB testing was not necessary or contraindicated (#2 and #3 above) should be evaluated using a questionnaire that screens for the presence of any signs or symptoms of active pulmonary TB. (e.g. malaises, fever, weakness, weight loss, cough and night sweats.)
The screen must be done by an RN, NP, PA, or MD. This screening is to be conducted with the same frequency as TB testing would be done if the individuals were to be tested.
NOTE: Persons with a history of a positive PPD can be screened with a whole blood interferon-gamma release assays (IGRAs) if the agency so desires and the test is available in the person’s geographic area.
NOTE: If warranted by results of an RN evaluation, the nurse may refer the person to a physician, nurse practitioner or physician’s assistant for a formal diagnostic evaluation to exclude active pulmonary tuberculosis.
NOTE: OPWDD does not requirenor encourage, theuse of chest x-rays for routine screening of persons for TB.
Review only if problems are noted during sample review of Tuberculosis testing.
633.14(c)(1)(iii) / 5.The agency has procedures to ensure that TB testing is conducted and documented as required. / 1 / If it is determined that the agency cannot consistently evidence appropriate TB testing and/or evaluation, in consultation with the regional director it may be determined that a review of an agency's written procedures may needs to occur.
Written procedures must be consistent with regulatory requirements and need to include:

Who requires TB testing
Timeframes for testing
Acceptable testing methods
Exclusions/Contraindications
Required documentation
Interpretation of testing
Qualified parties to conduct and interpret evaluation and testing
Agency procedures to track testing and maintain records
Response to positive testing or exposure
Monitoring that the procedures identified are being implemented
Tuberculosis Control Plan

Central – STAFFING