INITIAL COMMENTS
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This report is a result of an onsite follow-up inspection regarding the plans of correction for the January 23-24, 2012 licensure renewal inspection. The follow-up inspection was conducted on May 23, 2012 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the onsite follow-up inspection, Asociacion De Puertorriquenos En Marcha Proyecto Nueva Vida was found not to be in compliance with the applicable chapters of 28 PA Code which pertain to the facility. The following deficiencies were identified during this inspection.
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Plan of Correction
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704.11(a)(1) LICENSURE Training Needs assessments
704.11. Staff development program.
(a) Components. The project director shall develop a comprehensive staff development program for agency personnel including policies and procedures for the program indicating who is responsible and the time frames for completion of the following components:
(1) An assessment of staff training needs.
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Observations
Based on the review of employee records, the facility failed to document assessments of staff training needs in four of five employee records reviewed.
The findings include:
Five employee records were reviewed on January 23, 2012. Training need assessments were required in all employee records reviewed, #1, 2, 4, 5 and 6. Per the facility's policy training need assessments are due by the end of the facility's fiscal year that runs July 1 through June 30 of each year. This was discussed with facility staff on January 24, 2012.
This was still out of compliance at the time of the follow-up conducted on May 23, 2012.
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Plan of Correction
All employee records as they relate to yearly training assessments, with regards to the Proyecto Nueva Vida program will be brought up to date by July 20, 2012. The Facility and HR Directors will conduct monthly reviews of the training assessments to determine if updates are required throughout the fiscal year. Going forward, the Facility and HR Directors will compile the appropriate information regarding the yearly training assessments to ensure that all assessments are completed by June 30th of each fiscal year and remain in compliance. |
704.11(a)(3) LICENSURE Training Feedback
704.11. Staff development program.
(a) Components. The project director shall develop a comprehensive staff development program for agency personnel including policies and procedures for the program indicating who is responsible and the time frames for completion of the following components:
(3) A mechanism to collect feedback on completed training.
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Observations
Based on a review of employee records, the facility failed to ensure that feedback forms are filled out following trainings in two of five employee records reviewed.
The findings include:
Five employee records were reviewed on January 23, 2012. Feedback forms were required in all employee records reviewed, #1, 2, 3, 4 and 5. Per the facility's policy, feedback forms are to be filled out after every training. During the review of employee records, #4 and 5's feedback forms were not documented and could not be review. This was discussed with facility staff on January 24, 2012.
This was still out of compliance at the time of the follow-up conducted on May 23, 2012.
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Plan of Correction
The Facility Director, Quality Assurance and Human Resources are developing a system to ensure that the feedback forms are available to each staff person upon the completion of all on-site and off-site trainings. The forms have been uploaded electronically for easy staff access. The feedback forms will also be distributed concurrent with sign-in sheets at the beginning of each training session.
The process will be completely implemented by July 20, 2012. It will ultimately be monitored by HR at the time of submitting all training certificates for the purpose of inclusion in personnel files. This process will also be monitored during monthly Quality Assurance and Facility Director meetings.
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704.11(c)(2) LICENSURE CPR CERTIFICATION
704.11. Staff development program.
(c) General training requirements.
(2) CPR certification and first aid training shall be provided to a sufficient number of staff persons, so that at least one person trained in these skills is onsite during the project's hours of operation.
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Observations
Based on a review of employee records, the facility failed to provide a sufficient number of staff persons trained in Cardio Pulmonary Resuscitation (CPR) during the project's hours of operation.
The findings include:
The employee records were reviewed on May 23, 2012. It was determined that the facility did not have sufficient CPR coverage during the project's hours of operation, Monday - Friday 8:30 am to 5 pm. A discussion with the facility on May 23, 2012 confirmed the findings.
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Plan of Correction
The Substance Abuse Counselor was issued his CPR/First Aid certificate on January 26, 2012. Any outstanding CPR/First Aid trainings for the remaining staff will be addressed in the development of the APM yearly training series that is being developed by the Facility and HR Directors along with assistance from the Quality Assurance Coordinator. All staff remaining completed CPR training on June 15, 2012. |
705.22 (4) LICENSURE Building exterior and grounds.
705.22. Building exterior and grounds.
The nonresidential facility shall:
(4) Store all trash, garbage and rubbish in noncombustible, covered containers that prevent the penetration of insects and rodents, and remove it at least once every week.
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Observations
Based on a licensing inspection observation, the facility failed to have noncombustible covered containers that prevent the penetration of insect and rodents.
The findings include:
At the time of the licensing specialist's arrival to the facility on May 23, 2012, it was observed that the dumpster was not covered. Also, the dumpster was observed to be full and additional trash bags were located alongside the dumpster.
A discussion was conducted with facility staff on May 23, 2012, informing them of the licensing specialist's observations on May 23, 2012; they confirmed the findings.
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Plan of Correction
A larger dumpster has been secured as of June 15, 2012, thus addressing any overflow of trash between scheduled trash pick up days. Continuous monitoring of this deficiency will be conducted by the Facility Director and the Facilities Manager on a weekly basis to ensure that trash is properly secured. It is also to be noted that the dumpster is currently located over 100 meters away from any of APM's usable space / buildings or programs. |
709.22(e) LICENSURE Governing Body
709.22. Governing body.
(e) If a facility is publicly funded, the governing body shall make available to the public an annual report which includes, but is not limited to:
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Observations
Based on the review of the policy and procedure manual, the facility failed to make available to the public an annual report.
The Findings Include:
The policy and procedure manual was reviewed on May 23, 2012. The 20010/2011 annual report was to be made available to the public by the end of the facility's fiscal year June 30, 2011. During the inspection, the 2010/2011 annual report was presented for review. The 2010/2011 annual report was completed, but at the time of the inspection it had not been made available to the public.
An interview was conducted with facility staff on May 23, 2012 confirmed the findings.
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Plan of Correction
The Project Director, Vice President of Finance, The Facility Director and The Communications Manager are working together to complete the annual report and make it available to the public for the 2010-2011 fiscal year. The completion date of the pending Annual Report was May 23, 2012. A timeline for the coordination of the audit and the annual report will be developed by the Project Director, Vice President of Finance and Facility Director to ensure the timely completion of this project. The timeline will be monitored by the Project Director along with the Facility Director. The timelines will focus on preparation of the financial audit with all members of the fiscal team as soon as the information becomes available. The Communications Manager will meet with Senior Management staff quarterly to gather the information needed for the Annual Report. The Project Director will monitor the development of the Annual Report during administration meetings with the Communications Director. |
709.26(d)(4) LICENSURE Personnel Management
709.26. Personnel management.
(d) The personnel records shall include, but not be limited to:
(4) Salary information.
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Observations
Based on a review of personnel records, the facility failed to document salary information in one of five personnel records, as required by regulation.
The findings include:
Five personnel record were reviewed on May 23, 2012. Per regulation, personnel records should include salary information. Personnel record #4 did not include documentation of salary history.
Employee #4 was hired on November 1, 2010. There was no documentation of salary history in personnel record #4.
A discussion with facility staff on May 23, 2012 confirmed the findings.
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Plan of Correction
All salary information will be documented in all personnel files by July 20, 2012. The Facility Director, Project Director and Human Resources developed a plan of correction to address the need to have salary information documented in each personnel record. The HR Director will monitor, monthly, any changes in salary for all staff and ensure that all changes are appropriately documented in each personnel file. This process will continue as a regular agency practice. |
709.26(d)(5)(i) LICENSURE Personnel Management
709.26. Personnel management.
(d) The personnel records shall include, but not be limited to:
(5) Work performance evaluation including the following:
(i) Individual staff performance shall be evaluated at least annually.
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Observations
Based on a review of personnel records, the facility failed to document annual performance evaluations as required by agency policy and regulation in four of four personnel records.
The findings include:
Four personnel records were reviewed on May 23, 2012. All personnel records were required to include documentation of annual performance evaluations or a three month performance evaluation for newly employed staff. Per agency policy, performance evaluations are conducted at three months and annually after thereafter. There were no annual performance evaluations documented in personnel records #1, 2 and 4 . There was no three month performance evaluation documented in personnel record #3.
Employee #1 was hired on July 1, 1997 and the current annual performance evaluation was to be documented by July 1, 2011. Employee record #1 did not have documentation of the annual performance evaluation as of May 23, 2012.
Employee #2 was hired on November 29, 2010 and the current annual performance evaluation was to be documented by November 29, 2011. Employee record #2 did not have documentation of their annual performance evaluation as of May 23, 2012.
Employee #3 was hired on October 11, 2011 and the three month performance evaluation was to be documented by January 11, 2012. Employee record #3 did not have documentation of their annual performance evaluation as of May 23, 2012.
Employee #4 was hired on November 1, 2010 and the current annual performance evaluation was to be documented by November 1, 2011. Employee record #4 did not have documentation of their annual performance evaluation as of May 23, 2012.
An interview was conducted with facility staff on May 23, 2012 and confirmed the findings.
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Plan of Correction
All annual performance evaluations will be completed, submitted and brought up to date for each staff member by August 24, 2012. This includes the 3 month performance evaluation and the yearly performance evaluations. The HR Director will monitor performance as it relates to the completion of the annual performance evaluation on an ongoing basis. Quality Assurance will also monitor on-going completion of the annual performance evaluation on a quarterly basis. |
709.28 (c)(1) LICENSURE Confidentiality
709.28. Confidentiality.
(c) The project shall obtain an informed and voluntary consent from the client for the disclosure of information contained in the client record. The consent shall be in writing and shall include, but not be limited to:
(1) Name of the person, agency or organization to whom disclosure is made.
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Observations
Based on the review of client records, the facility failed to obtain an informed and voluntary consent from the client that included the name of the person, agency or organization to whom disclosure is made in six of eleven client records reviewed.
The findings include:
Eleven client records were reviewed on May 23, 2012. Eleven client records were required to have informed and voluntary consent forms which included the name of the person, agency or organization to whom disclosure is made. The name of the person, agency or organization to whom disclosure is made was not documented in the informed and voluntary consent forms in client records, #1, 2, 8, 9, 10 and 11.
An interview with facility staff on May 23, 2012 confirmed the findings.
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Plan of Correction
On January 27, 2012 the Quality Assurance Coordinator reviewed the structure of the informed and voluntary consent forms to ensure that the format is accurate in its collection of information. Upon completion of the form review, modifications were made to the form. The Facility Director completed a 2nd in-service training that provided instruction on the thorough completion of the informed and voluntary consent forms. . This in-service training was completed on June 14, 2012. Weekly monitoring will be conducted by the Facility Director in one-on-one supervision sessions. The Quality Assurance Coordinator will conduct monthly chart audits to assess the quality of documentation in this area. |
709.28(c)(2) LICENSURE Confidentiality
709.28. Confidentiality.
(c) The project shall obtain an informed and voluntary consent from the client for the disclosure of information contained in the client record. The consent shall be in writing and include, but not be limited to:
(2) Specific information disclosed.
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Observations
Based on the review of client records, the facility failed to obtain an informed and voluntary consent from the client that included specific information disclosed in six of eleven client records reviewed.
The findings include:
Eleven client records were reviewed on May 23, 2012. Eleven client records were required to have informed and voluntary consent forms which included specific information disclosed. The specific information disclosed was not documented in the informed and voluntary consent forms in client records, #1, 2, 8, 9, 10 and 11.
An interview with facility staff on May 23, 2012 confirmed the findings.
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Plan of Correction
On January 27, 2012 the Quality Assurance Coordinator reviewed the structure of the informed and voluntary consent forms to ensure that the format is accurate in its collection of information. Upon completion of the form review, modifications were made to the form. The Facility Director completed a 2nd in-service training that provided instruction on the thorough completion of the informed and voluntary consent forms. . This in-service training was completed on June 14, 2012. Weekly monitoring will be conducted by the Facility Director in one-on-one supervision sessions. The Quality Assurance Coordinator will conduct monthly chart audits to assess the quality of documentation in this area. |
709.28(c)(3) LICENSURE Confidentiality
709.28. Confidentiality.
(c) The project shall obtain an informed and voluntary consent from the client for the disclosure of information contained in the client record. The consent shall be in writing and include, but not be limited to:
(3) Purpose of disclosure.
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Observations
Based on the review of client records, the facility failed to obtain an informed and voluntary consent from the client that included the purpose of disclosure in six of eleven client records reviewed.
The findings include:
Eleven client records were reviewed on Mayn 23, 2012. Eleven client records were required to have informed and voluntary consent forms which included the purpose of disclosure. The purpose of disclosure was not documented in the informed and voluntary consent forms in client records, #1, 2, 8, 9, 10 and 11.
An interview with facility staff on May 23, 2012 confirmed the findings.
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Plan of Correction
On January 27, 2012 the Quality Assurance Coordinator reviewed the structure of the informed and voluntary consent forms to ensure that the format is accurate in its collection of information. Upon completion of the form review, modifications were made to the form. The Facility Director completed a 2nd in-service training that provided instruction on the thorough completion of the informed and voluntary consent forms. . This in-service training was completed on June 14, 2012. Weekly monitoring will be conducted by the Facility Director in one-on-one supervision sessions. The Quality Assurance Coordinator will conduct monthly chart audits to assess the quality of documentation in this area. |
709.28(c)(6) LICENSURE Confidentiality
709.28. Confidentiality.
(c) The project shall obtain an informed and voluntary consent from the client for the disclosure of information contained in the client record. The consent shall be in writing and include, but not be limited to:
(6) Expiration date of the consent.
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Observations
Based on the review of client records, the facility failed to obtain an informed and voluntary consent from the client that included the name of the expiration date of the consent in six of eleven client records reviewed.
The findings include:
Eleven client records were reviewed on May 23, 2012. Eleven client records were required to have informed and voluntary consent forms which included the expiration date of the consent. The expiration date of the consent was not documented in the informed and voluntary consent forms in client records, #1, 2, 8, 9, 10 and 11. An interview with facility staff on May 23, 2012 confirmed the findings.
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Plan of Correction
On January 27, 2012 the Quality Assurance Coordinator reviewed the structure of the informed and voluntary consent forms to ensure that the format is accurate in its collection of information. Upon completion of the form review, modifications were made to the form. The Facility Director completed a 2nd in-service training that provided instruction on the thorough completion of the informed and voluntary consent forms. . This in-service training was completed on June 14, 2012. Weekly monitoring will be conducted by the Facility Director in one-on-one supervision sessions. The Quality Assurance Coordinator will conduct monthly chart audits to assess the quality of documentation in this area. |
709.28(d) LICENSURE Confidentiality
709.28. Confidentiality.
(d) A copy of a client consent shall be offered to the client and a copy maintained in the client records.
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Observations
Based on the review of client records, the facility failed to obtain an informed and voluntary consent from the client that showed the client was offered a copy of the consent in six of eleven client records reviewed.
The findings include:
Eleven client records were reviewed on May 23, 2012. Eleven client records were required to have informed and voluntary consent forms which showed the client was offered a copy of the consent. The informed and voluntary consent forms did not show that the client was offered a copy in client records, #1, 2, 8, 9, 10 and 11. An interview with facility staff on May 23, 2012 confirmed the findings.
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Plan of Correction
On January 27, 2012 the Quality Assurance Coordinator reviewed the structure of the informed and voluntary consent forms to ensure that the format is accurate in its collection of information. Upon completion of the form review, modifications were made to the form. The Facility Director completed a 2nd in-service training that provided instruction on the thorough completion of the informed and voluntary consent forms. . This in-service training was completed on June 14, 2012. Weekly monitoring will be conducted by the Facility Director in one-on-one supervision sessions. The Quality Assurance Coordinator will conduct monthly chart audits to assess the quality of documentation in this area. |
709.91(b)(6) LICENSURE Intake and admission
709.91. Intake and admission.
(b) Intake procedures shall include documentation of:
(6) Psychosocial evaluation.
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Observations
Based on a review of client records, the facility failed to document a psychosocial evaluation in six of eleven client records.
The findings include:
Eleven client records were reviewed on May 23, 2012. There was no documentation of psychosocial evaluations in five records reviewed, #1, 2, 8, 9 and 10. Also, in client record #11 did not evaluate the client when it came to the clients assets/strengths, support systems, coping mechanisms, negative factors and the counselor conclusions/impressions of the client. An interview with facility staff on May 23, 2012 confirmed the findings.
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Plan of Correction
On January 27, 2012 the Quality Assurance Coordinator and Facility Director reviewed the current Biopsychosocial format. Modifications were made to the Biospsychosocial to include a psychosocial evaluation (case formulation). The revised Biopsychosocial, which includes a psychosocial evaluation (case formulation), was implemented February 3, 2012. The Facility Director completed a 2nd in-service instruction with the Substance Abuse Counselor on June 14, 2012 on the inclusion and completion of the revised form. All Psychosocial Evaluations will have a case formulation as of the date indicated. Quality Assurance will conduct monthly chart audits to assess the quality of documentation. The Facility Director will assess performance in this area in weekly one-on-one supervision sessions. |
709.92(a) LICENSURE Treatment and rehabilitation services
709.92. Treatment and rehabilitation services.
(a) An individual treatment and rehabilitation plan shall be developed with a client. This plan shall include, but not be limited to, written documentation of:
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Observations
Based on a review of client records, the facility failed to document treatment plans within the facility's identified time in five of eleven client records.
The finding includes:
Eleven client records were reviewed on May 23, 2012. Treatment plans were reviewed in nine client records, #1, 2, 3, 4, 5, 6, 8, 9, 10 and 11. Per the facility's policy, treatment plans will be completed within 30 days of the clients admission date into the drug and alcohol program after the completion of the client ' s biopsychosocial histories and evaluation. A discussion with facility staff on May 23, 2012 confirmed the findings.
Client #1 was admitted to the program on February 23, 2012 and their treatment plan was completed on February 27, 2012. Client record #1's treatment plan was completed on February 27, 2012, prior to the completion of the client's psychosocial evaluation which was not documented in record reviewed.
Client #2 was admitted to the program on February 6, 2012 and their treatment plan was to be completed on or before February 22, 2012. Client record #2's treatment plan was completed on February 22, 2012, prior to the completion of the client's psychosocial evaluation which was not documented in record reviewed.
Client #8 was admitted to the program on March 22, 2012 and their treatment plan was completed on March 22, 2012. Client record #8's treatment plan was completed on March 22, 2012, prior to the completion of the client's psychosocial evaluation which was not documented in record reviewed.
Client #9 was admitted to the program on March 14, 2012 and their treatment plan was completed on March 14, 2012. Client record #9's treatment plan was completed on March 14, 2012, prior to the completion of the client's psychosocial evaluation which was not documented in record reviewed.
Client #10 was admitted to the program on March 2, 2012 and their treatment plan was completed on March 2, 2012. Client record #10's treatment plan was completed on March 2, 2012, prior to the completion of the client's psychosocial evaluation which was not documented in record reviewed.
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Plan of Correction
The Facility Director completed in-service instruction with the Substance Abuse Counselor regarding the completion of treatment plans on February 3, 2012. Direct on-going instruction is being given to educate the counselor that comprehensive treatment plans must be completed 30 days after the client's admission to the program (and completion of the psychosocial evaluation.) The Facility Director will conduct continued evaluation on the timely completion of treatment plans in weekly one-on-one supervision sessions. The Quality Assurance Coordinator will conduct monthly chart audits to assess the quality of this documentation. |
709.93(a)(8) LICENSURE Client records
709.93. Client records.
(a) There shall be a complete client record on an individual which includes information relative to the client's involvement with the project. This shall include, but not be limited to, the following:
(8) Case consultation notes.
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Observations
Based on a review of client records, the facility failed to document case consultations in five of eleven client records.
Findings:
Eleven client records were reviewed on May 23, 2012. Case consultations were required in five client records, #2, 3, 4, 5 and 7. Per the facility's policy and procedure case consultations are to be documented quarterly, every 90 days. An interview with facility staff on May 23, 2012 confirmed the findings.
Client #2 was admitted on February 6, 2012 and their case consultation was to be documented by May 6, 2012. As of May 23, 2012, there was no documentation of client #2's case consultation.
Client #3 was admitted on January 11, 2012 and their case consultation was to be documented by April 11, 2012. As of May 23, 2012, there was no documentation of client #3's case consultation.
Client #4 was admitted on January 26, 2012 and their case consultation was to be documented by April 26, 2012, 2012. As of May 23, 2012, there was no documentation of client #4's case consultation.
Client #5 was admitted on January 26, 2012 and their case consultation was to be documented by April 26, 2012, 2012. As of May 23, 2012, there was no documentation of client #5's case consultation.
Client #7 was admitted on January 6, 2012 and their case consultation was to be documented by April 6, 2012, 2012. As of May 23, 2012, there was no documentation of client #7's case consultation.
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Plan of Correction
The Facility Director conducted in-service training with the Substance Abuse Counselor on the completion of case consultations. Direct instruction and education was provided to ensure that case consultations are completed every 90 days. A 2nd in-service training was completed on June 14, 2012. A new form will be created by July 20, 2012 specifically addressing this requirement. Continued monitoring in this area will be conducted in weekly one-on-one supervision sessions with the Facility Director. The Quality Assurance Coordinator will conduct monthly chart audits to ensure the quality of this documentation is congruent with agency and regulatory expectations. |
709.93(a)(11) LICENSURE Client records
709.93. Client records.
(a) There shall be a complete client record on an individual which includes information relative to the client's involvement with the project. This shall include, but not be limited to, the following:
(11) Follow-up information.
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Observations
Based on a review of client records, the facility failed to document follow-up information in one of one discharge records.
The findings include:
Eleven client records were reviewed on May 23, 2012. Record #6 was required to have follow-up documented. Per the facility's policy, follow-ups will be done within 30 days following discharge date and 7 days if being referred. An interview with facility staff on May 23, 2012 confirmed the finding.
Client #6 was admitted on October 14, 2012 and discharged on February 17, 2012. The follow-up was due by March 19, 2012. As of the date of review there was no documentation of a follow-up in client record #6.
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Plan of Correction
The Facility Director conducted in-service training in the area of follow up procedures. A 2nd in-service training was completed on June 14, 2012. A new form will be created by July 20, 2012 specifically addressing this requirement. Direct instruction and education was provided regarding the follow up procedures, as per regulations and the facility's policy: all client follow ups will be completed within 30 days after discharge and within 7 days if the program participant is being referred. Continued monitoring in this area will be conducted by the Facility Director in weekly one-on-one supervision sessions. The Quality Assurance Coordinator will conduct monthly chart audits to ensure the quality of this documentation is congruent with agency and regulatory expectations. |
709.94(g) LICENSURE Project management services
709.94. Project management services.
(g) Outpatient projects which receive reimbursement under the medical assistance program shall have a current, signed provider agreement with the Department of Public Welfare and comply with 55 Pa. Code Part III (relating to Medical Assistance Manual).
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Observations
Based on a review of client records and a discussion with the Facility Director, the facility failed to provide a medical physician to comply with 55 Pa. Code Part III (relating to Medical Assistance Manual).
The findings include:
Eleven client records were reviewed on May 23, 2012. Nine of the eleven client records were required to have a physician review and sign the clients treatment plans. Per the Department of Welfare standards, all treatment plans are to be signed by the physician within 15 days of the completion of the initial treatment plan. The initial treatment plans, comprehensive treatment plans and/or treatment plan updates did not have documentation of the physician signature for records, #1, 2, 3, 5, 7, 9 and 10. A discussion with facility staff on May 23, 2012 confirmed that the initial treatment plans, comprehensive treatment plans and treatment plan updates were not signed by the physician in records reviewed.
Client record #1's initial treatment plan was completed on February 27, 2012 ; the physician did not sign the treatment plan as of May 23, 2012.
Client record #2's initial treatment plan was completed on February 22, 2012; the physician did not sign the treatment plan as of May 23, 2012.
Client record #3's initial treatment plan was completed on January 11, 2012; the physician did not sign the treatment plan as of May 23, 2012.
Client record #5's initial treatment plan was completed on January 9, 2012 and treatment plan update April 2, 2012; the physician did not sign the treatment plans as of May 23, 2012.
Client record #7's initial treatment plan was completed on January 6, 2012 and treatment plan update February 6, 2012; the physician did not sign the treatment plan as of May 23, 2012.
Client record #9's initial treatment plan was completed on March 14, 2012; the physician did not sign the treatment plan as of May 23, 2012.
Client record #10's initial treatment plan was completed on March 2, 2012; the physician did not sign the treatment plan as of May 23, 2012.
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Plan of Correction
As of February 1, 2012 the Facility Director has ensured that all treatment plans, both initial and comprehensive, are signed by the physician. The Facility Director will review all treatment plans [initial treatment plans within the first 7 days, and comprehensive treatment plans within 15 days] to ensure that they are signed by the physician. The Facility Director met a 2nd time with the physician and counselor on June 13, 2012 to review the current treatment plans for the appropriate signatures. The Quality Assurance Coordinator will conduct chart audits on a monthly basis to ensure the quality of this documentation is congruent with agency and regulatory expectations. |