INITIAL COMMENTS
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Based on the concerns arising from COVID-19, The Department of Drug and Alcohol Programs, Bureau of Quality Assurance for Prevention and Treatment, has implemented temporary procedures for conducting an annual renewal inspection.
The inspection will be divided into two parts.
1, an abbreviated off-site inspection, will be conducted off site, and will require the submission of administrative information via email to a Licensing Specialist.
2, an abbreviated on-site inspection, will be conducted on-site, at a later date and will include a review of client/patient records, and a physical plant inspection.
This report is a result of Part 1, an abbreviated off-site inspection, conducted on July 24, 2020 by staff from the Department of Drug and Alcohol Programs, Bureau of Quality Assurance for Prevention and Treatment. Not all regulations were reviewed, the remainder of the regulations, not reviewed during Part 1, will be reviewed at a later date.
Based on the findings of Part 1, an abbreviated off-site inspection, KARE Services, LLC dba Kolmac Outpatient Recovery 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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704.5(c) LICENSURE Qualifications for Proj/Fac Dir
704.5. Qualifications for the positions of project director and facility director.
(c) The project director and the facility director shall meet the qualifications in at least one of the following paragraphs:
(1) A Master's Degree or above from an accredited college with a major in medicine, chemical dependency, psychology, social work, counseling, nursing (with a specialty in nursing/health administration, nursing/counseling education or a clinical specialty in the human services), public administration, business management or other related field and 2 years of experience in a human service agency, preferably in a drug and alcohol setting, which includes supervision of others, direct service and program planning.
(2) A Bachelor's Degree from an accredited college with a major in chemical dependency, psychology, social work, counseling, nursing (with a specialty in nursing/health administration, nursing/counseling education or a clinical specialty in the human services), public administration, business management or other related field and 3 years of experience in a human service agency, preferably in a drug and alcohol setting, which includes supervision of others, direct service and program planning.
(3) An Associate Degree from an accredited college with a major in chemical dependency, psychology, social work, counseling, nursing (with a specialty in nursing/health administration, nursing/counseling education or a clinical specialty in the human services), public administration, business management or other related field and 4 years of experience in a human service agency, preferably in a drug and alcohol setting, which includes supervision of others, direct service and program planning.
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Observations
Based on a review of personnel records, the facility failed to ensure that employee #5, who was hired as the facility director on July 15, 2020, met the minimum qualifications to be the facility director. The personnel record documented that the facility director has an Associate's Degree; however, the employee only had 3 years of documented experience in a human service agency with no prior experience in supervision of others and program planning.
This finding was reviewed with facility staff during the licensing inspection.
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Plan of Correction
The Chief Compliance Officer has updated our policies and procedures manual to reflect that our Clinical Director is equivalent to the Project Director and the Facility Director. Going forward, the Clinical Director will handle the responsibilities of both the Project Director and the Facility Director. The VP of HR will verify the credentials and background of every Clinical Director hired to ensure they meet the minimum qualifications for a clinical director/project director/facility director. The Chief Compliance Officer has added this item to our Risk Management Plan to allow us to monitor compliance and ensure the new policy is enforced. |
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 an administrative review, the facility failed to include, in their staff development program policy and procedures, the specific time frames of completion and who is responsible for the completion of the assessment of staff training needs.
This finding was reviewed with facility staff during the licensing inspection.
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Plan of Correction
The Chief Compliance Officer has incorporated a comprehensive staff development plan into chapter 18, section 6 of our Policies and Procedures manual. The policies and procedures we incorporated had been previously reviewed and approved by DDAP while the company was operating under the name Biocare Recovery. The policy assigns responsibility for the annual assessment of training needs to the project director.
The Chief Compliance Officer has added this as an item on our Risk Management Plan to monitor compliance and ensure the issue is resolved. |
704.11(a)(2) LICENSURE Overall Training plan
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:
(2) An overall plan for addressing these needs.
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Observations
Based on an administrative review, the facility failed to include, in their staff development program policy and procedures, the specific time frames of completion and who is responsible for the completion of an overall plan for addressing staff training needs.
This finding was reviewed with facility staff during the licensing inspection.
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Plan of Correction
The Chief Compliance Officer has incorporated a comprehensive staff development plan into chapter 18, section 6 of our policies and procedures manual. The policies and procedures we incorporated had been previously reviewed and approved by DDAP while the company was operating under the name Biocare Recovery. The policy assigns responsibility for the annual review of the overall training plan to the project director. |
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 an administrative review, the facility failed to include, in their staff development program policy and procedures, the specific time frames of completion and who is responsible for developing a mechanism to collect feedback on completed training.
This finding was reviewed with facility staff during the licensing inspection.
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Plan of Correction
The Chief Compliance Officer has incorporated a comprehensive staff development plan into chapter 18, section 6 of our policies and procedures manual. The policies and procedures we incorporated had been previously reviewed and approved by DDAP while the company was operating under the name Biocare Recovery. The policy describes the training plan feedback process which includes questionnaires and staff debriefings.
The Chief Compliance Officer will add this as an item on our Risk Management Plan to monitor compliance. |
704.11(a)(4) LICENSURE Evaluation of Overall Plan
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:
(4) An annual evaluation of the overall training plan.
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Observations
Based on an administrative review, the facility failed to include, in their staff development program policy and procedures, the specific time frames of completion and who is responsible for the completion of an annual evaluation of the overall training plan.
This finding was reviewed with facility staff during the licensing inspection.
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Plan of Correction
The Chief Compliance Officer has incorporated a comprehensive staff development plan into chapter 18, section 6 of our Policies and Procedures manual. The policies and procedures we incorporated had been previously reviewed and approved by DDAP while the company was operating under the name Biocare Recovery. The policy assigns responsibility for the annual evaluation of the overall training plan to the project director.
The Chief Compliance Officer has added this as an item on our Risk Management Plan to monitor compliance going forward. |
704.11(b)(1) LICENSURE Individual training plan.
704.11. Staff development program.
(b) Individual training plan.
(1) A written individual training plan for each employee, appropriate to that employee's skill level, shall be developed annually with input from both the employee and the supervisor.
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Observations
Based on a review of personnel records, the facility failed to provide documentation of that the individual training plan developed with input from both the employee and the supervisor in one of four applicable personnel records reviewed.
Employee #1 was hired as the project director on July 19, 2019. The individual training plan was signed by the employee on August 8, 2019 but there was no verification that the plan was developed with input from the supervisor.
This finding was reviewed with facility staff during the licensing process.
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Plan of Correction
The VP of HR will ensure that all individual training plans are created with the input of an appropriate supervisor. Proof of that input will be
indicated by the supervisor's signature on the plan. In the case of the Project Director, the Chief Clinical Officer or Regional Clinical Director will serve as the supervisor and will be responsible for providing input and signing off on the form.
The VP of HR will work with the Chief Clinical Officer to ensure the individual training plan form in question is signed by 9/11/2020.
The Chief Compliance Officer will add this as an item on our Risk Management Plan to monitor compliance. |
705.28 (d) (4) LICENSURE Fire safety.
705.28. Fire safety.
(d) Fire drills. The nonresidential facility shall:
(4) Maintain a written fire drill record including the date, time, the amount of time it took for evacuation, the exit route used, the number of persons in the facility at the time of the drill, problems encountered and whether the fire alarm or smoke detector was operative.
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Observations
Based on an administrative review of the October 2019 through June 2020 fire drill logs, the facility failed to include the time of the drill, the amount of time it took for evacuation, the exit route used, the number of persons in the facility at the time of the drill, problems encountered and whether the fire alarm or smoke detector was operative on every documented fire drill log.
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Plan of Correction
The Chief Compliance Officer has created a new more detailed emergency drill log. The drill log indicates the time of the drill, any problems encountered, the evacuation route used, evacuation time, number of people in the facility and whether the fire alarm or smoke detector was operative. The new drill log also allows for a more in-depth analysis of the drills and better tracking of any performance improvement plans.
The Clinical Director, Office Manager and Front Desk staff member form the local safety team that is responsible for carrying out the drills. The Office Manager is responsible for completing the drill logs and ensuring any corrective actions are completed and monitored. Our Senior Office Manager is responsible for establishing a calendar of unannounced drills and ensuring the local safety teams complete each drill for a number of different types of emergencies, including fire and evacuation. We will add this as an item on our Risk Management Plan to ensure it is monitored and corrected. |
709.30 (1) LICENSURE Client rights
§ 709.30. Client rights.
The project shall develop written policies and procedures on client rights and document written acknowledgement by clients that they have been notified of those rights.
(1) A client receiving care or treatment under section 7 of the act (71 P. S. § 1690.107) shall retain civil rights and liberties except as provided by statute. No client may be deprived of a civil right solely by reason of treatment.
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Observations
Based on an administrative review, the facility failed to include, in their client rights policies and procedures, that a client receiving care or treatment under section 7 of the act (71 P. S. 1690.107) shall retain civil rights and liberties except as provided by statute and that no client may be deprived of a civil right solely by reason of treatment.
This finding was reviewed with facility staff during the licensing process.
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Plan of Correction
The Chief Compliance Officer has updated chapter 6, section 2 of our policies and procedures manual to indicate that a client receiving care or treatment under section 7 of the act (71 P. S. 1690.107) shall retain civil rights and liberties
except as provided by statute and that no client may be deprived of a civil right solely by reason of treatment. The Chief Compliance Officer has also updated the Patient Rights statement that each patient signs upon admission. The Chief Compliance Officer has also added this as an item to our Risk Management Plan to ensure compliance. |
709.30 (2) LICENSURE Client rights
§ 709.30. Client rights.
The project shall develop written policies and procedures on client rights and document written acknowledgement by clients that they have been notified of those rights.
(2) The project may not discriminate in the provision of services on the basis of age, race, creed, sex, ethnicity, color, national origin, marital status, sexual orientation, handicap or religion.
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Observations
Based on an administrative review, the facility failed to include, in their client rights policies and procedures, that the project may not discriminate in the provision of services on the basis of age, race, creed, sex, ethnicity, color, national origin, marital status, sexual orientation, handicap or religion.
This finding was reviewed with facility staff during the licensing process.
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Plan of Correction
The Chief Compliance Officer has updated chapter 6, section 2 of our policies and procedures manual to indicate that we may not discriminate in the provision of services on the basis of age, race, creed, sex, ethnicity, color, national origin, marital status, sexual orientation, handicap or religion.
The Chief Compliance Officer has also updated the Patient Rights statement that each patient signs upon admission.
The Chief Compliance Officer will add this as an item to our Risk Management Plan to ensure compliance.
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709.30 (4) LICENSURE Client rights
§ 709.30. Client rights.
The project shall develop written policies and procedures on client rights and document written acknowledgement by clients that they have been notified of those rights.
(4) Clients have the right to appeal a decision limiting access to their records to the director.
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Observations
Based on an administrative review, the facility failed to include, in their client rights policies and procedures, that clients have the right to appeal a decision limiting access to their records to the director.
This finding was reviewed with facility staff during the licensing process.
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Plan of Correction
The Chief Clinical Officer has updated chapter 6, section 2 of our policies and procedures manual to indicate that clients have the right to appeal a decision limiting access to their records to the director.
The Chief Clinical Officer has also updated the Patient Rights statement that each patient signs upon admission.
The Chief Compliance Officer has added this as an item on our Risk Management Plan to monitor compliance. |
709.30 (5) LICENSURE Client rights
§ 709.30. Client rights.
The project shall develop written policies and procedures on client rights and document written acknowledgement by clients that they have been notified of those rights.
(5) Clients have the right to request the correction of inaccurate, irrelevant, outdated or incomplete information in their records.
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Observations
Based on an administrative review, the facility failed to include, in their client rights policies and procedures, that clients have the right to request the correction of inaccurate, irrelevant, outdated or incomplete information in their records.
This finding was reviewed with facility staff during the licensing process.
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Plan of Correction
The Chief Compliance Officer has updated chapter 6, section 2 of our policies and procedures manual to indicate that clients have the right to request the correction of inaccurate, irrelevant, outdated or incomplete information in their records.
The Chief Compliance Officer has also updated the Patient Rights statement that each patient signs upon admission.
The Chief Compliance Officer has added this as an item on our Risk Management Plan to monitor compliance. |
709.30 (6) LICENSURE Client rights
§ 709.30. Client rights.
The project shall develop written policies and procedures on client rights and document written acknowledgement by clients that they have been notified of those rights.
(6) Clients have the right to submit rebuttal data or memoranda to their own records.
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Observations
Based on an administrative review, the facility failed to include, in their client rights policies and procedures, that clients have the right to submit rebuttal data or memoranda to their own records.
This finding was reviewed with facility staff during the licensing process.
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Plan of Correction
The Chief Compliance Officer has updated chapter 6, section 2 of our policies and
procedures manual to indicate that clients have the right to submit rebuttal data or memoranda to their own records.
The Chief Compliance Officer has also updated the Patient Rights statement that each patient signs upon admission.
The Chief Compliance Officer has added this as an item on our Risk Management Plan to monitor compliance. |
709.34 (a) (5) LICENSURE Reporting of unusual incidents
§ 709.34. Reporting of unusual incidents.
(a) The project shall develop and implement policies and procedures to respond to the following unusual incidents:
(5) Theft, burglary, break-in or similar incident at the facility.
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Observations
Based on an administrative review, the facility failed to develop and implement unusual incident reporting policies and procedures on how the facility would respond to theft, burglary, break-in or similar incident at the facility.
This finding was reviewed with facility staff during the licensing process.
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Plan of Correction
The Chief Compliance Officer has implemented a more robust incident reporting system that specifically allows a user to enter "theft, burglary or break-in" as an incident category. The Chief Compliance Officer has also updated chapter 16, section 7, subsection A of our policies and procedures manual to reflect that change.
The Chief Compliance Officer has added this as an item on our Risk Management Plan to monitor compliance. |
709.34 (a) (6) LICENSURE Reporting of unusual incidents
§ 709.34. Reporting of unusual incidents.
(a) The project shall develop and implement policies and procedures to respond to the following unusual incidents:
(6) Event at the facility requiring the presence of police, fire or ambulance personnel.
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Observations
Based on an administrative review, the facility failed to develop and implement unusual incident reporting policies and procedures on how the facility would respond to an event at the facility requiring the presence of police, fire or ambulance personnel.
This finding was reviewed with facility staff during the licensing process.
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Plan of Correction
The Chief Compliance Officer has implemented a more robust incident reporting system that specifically allows a user to enter "event that requires the presence of police, fire or ambulance personnel" as an incident category. The Chief Compliance Officer has also updated chapter 16, section 7, subsections A and C of our policies and procedures manual to reflect that change and that events requiring emergency personnel shall also be reported to DDAP within 3 days.
The Chief Compliance Officer has added this as an item on our Risk Management Plan to monitor compliance. |
709.34 (a) (7) LICENSURE Reporting of unusual incidents
§ 709.34. Reporting of unusual incidents.
(a) The project shall develop and implement policies and procedures to respond to the following unusual incidents:
(7) Fire or structural damage to the facility.
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Observations
Based on an administrative review, the facility failed to develop and implement unusual incident reporting policies and procedures on how the facility would respond to a fire or structural damage to the facility.
This finding was reviewed with facility staff during the licensing process.
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Plan of Correction
The Chief Compliance Officer implemented a more robust incident reporting system
that specifically allows a user to enter "fire or structural damage" as an incident category. The Chief Compliance Officer has also updated chapter 16, section 7, subsections A and C of our policies and procedures manual to reflect that change and to reflect that events involving fire or structural damage shall be reported to DDAP within 3 days.
The Chief Compliance Officer has added this as an item on our Risk Management Plan to monitor compliance. |
709.34 (b) (4) LICENSURE Reporting of unusual incidents
§ 709.34. Reporting of unusual incidents.
(b) Policies and procedures must include the following:
(4) Ongoing monitoring of the corrective action plan.
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Observations
Based on an administrative review, the facility failed to include, in their unusual incident policy, written procedures to follow regarding the ongoing monitoring of the corrective action plan.
This finding was reviewed with facility staff during the licensing inspection.
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Plan of Correction
The Chief Compliance Officer has implemented a more robust incident reporting system that ensures supervisors and the Executive Team are aware of, and respond to, all critical incidents. We have updated chapter 16, section 7, subsections B and D to assign ongoing monitoring of corrective actions plans to the Executive Team. Corrective actions will be made part of the annual Risk Management Plan to ensure follow up as necessary throughout the year.
The Chief Compliance Officer is also responsible for analyzing critical incidents in an effort to identify causes, trends and areas for improvement.
The Chief Compliance Officer has added this as an item on our Risk Management Plan to monitor compliance. |
709.34 (b) (5) LICENSURE Reporting of unusual incidents
§ 709.34. Reporting of unusual incidents.
(b) Policies and procedures must include the following:
(5) Reporting mechanism to ensure that reporting of an unusual incident to an entity is in compliance with State and Federal confidentiality laws.
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Observations
Based on an administrative review, the facility failed to include, in their unusual incident policy, written procedures to follow regarding a reporting mechanism to ensure that reporting of an unusual incident to an entity is in compliance with State and Federal confidentiality laws.
This finding was reviewed with facility staff during the licensing inspection.
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Plan of Correction
The Chief Compliance Officer has updated chapter 16, section 7, subsection C of our policies and procedures manual to more clearly define steps taken to ensure critical incident reporting is in compliance with State and Federal laws.
The Chief Compliance Officer has added this as an item on our Risk Management Plan to monitor compliance. |
709.94(f)(1) LICENSURE Project management services
709.94. Project management services.
(f) The project shall develop a written plan providing for outreach services which shall include, but not be limited to:
(1) Identifying persons in need of project services.
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Observations
Based on an administrative review, the facility failed to develop a written plan providing for outreach services which shall include identifying persons in need of project services.
This finding was reviewed with facility staff during the licensing inspection.
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Plan of Correction
The Chief Compliance Officer has updated chapter 15,section 1 of our policies and
procedures manual to more clearly define outreach activities and their intended target audiences.
The Chief Compliance Officer has added this as an item on our Risk Management Plan to monitor compliance. |
709.94(f)(2) LICENSURE Project management services
709.94. Project management services.
(f) The project shall develop a written plan providing for outreach services which shall include, but not be limited to:
(2) Alerting persons and their families to the availability of project services.
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Observations
Based on an administrative review, the facility failed to develop a written plan providing for outreach services which shall include alerting persons and their families to the availability of project services.
This finding was reviewed with facility staff during the licensing inspection.
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Plan of Correction
The Chief Compliance Officer has updated chapter 15, section 1 of our policies and procedures manual to more clearly define outreach activities and their intended target audiences.
Chapter 8, section 15 of our policies and procedures manual describes services available for family members and outreach efforts that are made to family members. Services include:
1. Family therapy
2. Free Family and Friends
support group
3. Free Family Resource
Specialist
Outreach efforts include:
1. Dedicated section of our
website tailored to family
members
2. Letters inviting family
members to Family Group
The Chief Compliance Officer has added this as an item on our Risk Management Plan to monitor compliance. |
709.94(f)(3) LICENSURE Project management services
709.94. Project management services.
(f) The project shall develop a written plan providing for outreach services which shall include, but not be limited to:
(3) Encouraging persons to utilize the service delivery system.
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Observations
Based on an administrative review, the facility failed to develop a written plan providing for outreach services which shall include encouraging persons to utilize the service delivery system
This finding was reviewed with facility staff during the licensing inspection.
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Plan of Correction
The Chief Compliance Officer has updated chapter 15, section 1 of our policies and procedures manual to more clearly define outreach activities and their intended target audiences.
In addition, the Chief Compliance Officer has an Accessibility Plan that is updated quarterly and focuses on removing any potential barriers to treatment a patient might encounter, including the following types of barriers: Architectural, Environmental, Attitudinal, Financial, Employment, Communication, Transportation, Community Integration, and Technology.
The Chief Compliance Officer has added this as an item on our Risk Management Plan to monitor compliance. |
709.14(b)(4) LICENSURE Subchapter B.Licensing Procedures.Restriction
709.14. Restriction on license.
(b) The licensee, using Department forms, shall notify the Department within 90 days of the occurrence of any of the following conditions:
(4) Change in activity/discontinuance of an activity.
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Observations
Based on an administrative review, the facility failed to notify the Department within 90 days of a change in an activity/discontinuance of an activity. The facility was prescribing buprenorphine without prior approval from the Department.
This finding was reviewed with facility staff during the licensing process.
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Plan of Correction
This error was the result of a change in our staffing model, which changed doctors and other prescribers from independent contractors to employees. Historically, prescribers paid as independent contractors with buprenorphine waivers would keep separate records for their buprenorphine patients. That practice ended when the medical providers were made employees of Kolmac. All of our prescribers are approved to prescribe buprenorphine by SAMHSA. Kolmac has applied for its buprenorphine waiver from DDAP and has ceased prescribing buprenorphine for new patients, pending the appropriate approval from DDAP. We have also added this as an item for monitoring on our Risk Management plan to ensure a resolution is reached. |
709.14(b)(5) LICENSURE Subchapter B.Licensing Procedures.Restriction
709.14. Restriction on license.
(b) The licensee, using Department forms, shall notify the Department within 90 days of the occurrence of any of the following conditions:
(5) Change in authorized maximum capacity.
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Observations
Based on an administrative review, the facility failed to notify the Department within 90 days of a change in the authorized maximum capacity. The facility provided documentation showing that they are serving 180 clients; however, the facility's authorized maximum capacity is 150.
This finding was reviewed with facility staff during the licensing process.
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Plan of Correction
The Clinical Director has cleaned up our census and removed patients who were no longer actively involved in treatment. Our current census is 151 patients. The Chief Compliance Officer will make a request to DDAP by 9/11/2020 to add some additional capacity and he will ensure we have the staff required to accommodate that capacity.
The Chief Compliance Officer will meet weekly with the Clinical Director to monitor the census. The primary goal of those meetings will be to bring the census to 150 and maintain it there, while awaiting a decision from DDAP on the approval of additional capacity. The census will be controlled by discharging patients who are no longer actively involved or compliant in treatment and by limiting admissions if necessary.
The Chief Compliance Officer has added this as an item on our Risk Management Plan to ensure follow up and ongoing compliance. |