INITIAL COMMENTS
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This report is a result of an on-site licensure renewal inspection conducted on April 09, 2026 by staff from the Department of Drug and Alcohol Programs, Bureau of Program Licensure. Based on the findings of the on-site inspection, Gaudenzia Inc. Harrisburg Concept 90 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(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 a written individual training plan for each employee, appropriate to that employee's skill level per the facility's policy and procedure manual in one out of eighteen employee records reviewed. The facility's policy and procedure manual states that the individual training plan is due by the end of January.
Employee #16 was hired on June 30, 2016 as a RSP and was still in the position as of the date of the inspection. The individual training plan was not completed until February 01, 2026.
This is a repeat citation from April 28, 2025 annual licensing inspection.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The Individual Training Plan (ITP) will be developed annually with input from both the employee and the supervisor, as specified in Gaudenzia Policy.
The Individual Training Plan will be finalized, signed by both employee and supervisor within the month of January of each calendar year. The Program Director will verify the Individual Training Plan is completed for each Employee by the end of January.
The Program Director will utilize the Relias Training Platform to document each employee's training plan.
The Regional Clinical Director will review all Training Plans by January 15th of each year to ensure compliance. Any Training Plans not completed will be brought to the Program Directors attention. Once completed, the Program Director will inform the Regional Clinical Director.
Program Director
Division Director
Regional Clinical Director
Regional Executive Director
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704.11(c)(1) LICENSURE Mandatory Communicable Disease Training
704.11. Staff development program.
(c) General training requirements.
(1) Staff persons and volunteers shall receive a minimum of 6 hours of HIV/AIDS and at least 4 hours of tuberculosis, sexually transmitted diseases and other health related topics training using a Department approved curriculum. Counselors and counselor assistants shall complete the training within the first year of employment. All other staff shall complete the training within the first 2 years of employment.
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Observations
Based on a review of eighteen personnel records and the Facility ' s Staffing Requirement Facility Summary Report (SRFSR) form, the facility failed to ensure that one employee received the minimum of 4 hours of TB/STD training and 6 hours of HIV/AIDS training within the regulatory timeframe.
Employee #10 was hired as the RSP Supervisor on August 23, 2023 and was due to have the communicable disease training no later than August 23, 2025. However, there was no documentation for the completion of the HIV/AIDS training as of the date of the inspection.
This finding was reviewed with facility staff during the licensing process.
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Plan of Correction
All training will be completed within the required timeframe.
Outstanding training will be completed as soon as they can be scheduled. This is anticipated to be no later than 6/30/26.
All staff members have an Individual Training Plan generated on their start date and then updated annually in January. This is reviewed with the staff member and signed to indicate that they understand the training requirements.
The Supervisor will work with the staff member to schedule the trainings prior to the due dates and will monitor to ensure full and timely completion.
The Clinical Supervisor and Program Director will review the Individual Training Plans weekly for new hires, and at least quarterly for all staff. Staff who have upcoming training due dates within the next quarter will be reminded of this and the Supervisor will work with them to schedule training sessions prior to the due dates and will monitor to ensure full and timely completion.
If any issues are noted with staff failing to complete scheduled trainings, this will be specifically addressed with them in a documented supervision session with a clear plan to have all trainings completed.
If any issues are noted with unavailability of required training session opportunities, this will be addressed with the Division Director and the Regional Executive Director to assist in advocating with the training provider.
The Gaudenzia Compliance Department will conduct a review of all citations within 90 days to ensure full implementation, identify any barriers to implementation, and coordinate support, where needed.
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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 a review fire drill logs from May 2025 through March 2026, the facility failed to ensure that the fire drill logs included the time used for the fire drills conducted June 2025, September 2025, October 2025, November 2025, December 2025, January 2026, and February 2026 fire drills.
This is a repeat citation from April 28, 2025 annual licensing inspection.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
This requirement will be reviewed with all appropriate staff members in a documented in-service training within the next two weeks, and no later than 5/22/26. This training will include a detailed review of the standard and all relevant Gaudenzia policies.
The Program Director will review each fire drill held and documented to ensure all of the necessary components, including the time and duration of the fire drill are included in the fire drill log.
The Division Director will review the fire drill log on a quarterly basis to ensure all documentation is found.
The Gaudenzia Compliance Department will conduct a review of the citation within 90 days to ensure full implementation, identify any barriers to implementation, and coordinate support, where needed.
Program Director 5/5/2026
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709.28 (c) 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.
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Observations
Based on a review of seven client records, the facility failed to obtain informed and voluntary consent from the client for the disclosure of information in four out of the seven records reviewed.
Client #1 was admitted on June 03, 2025, and discharged September 15, 2025. There was documentation that was disclosed to a halfway house on August 20, 2025; however, the record did not contain documentation of an informed and voluntary consent from the client for the disclosure of information.
Client #3 was admitted on February 11, 2026 and still was active at the time of the inspection. There was documentation that was disclosed to an outside mental health facility on March 17, 2026; however, the record did not contain documentation of an informed and voluntary consent from the client for disclosure of information until April 08, 2026.
Client #6 was admitted on December 19, 2025 and discharged January 06, 2026. There was documentation that was disclosed to the funding source; however, the record did not contain documentation of an informed and voluntary consent from the client for disclosure of information.
Client #7 was admitted on January 08, 2026 and discharged on January 14, 2026. There was documentation that was disclosed to the funding source; however, the record did not contain documentation of an informed and voluntary consent from the client for disclosure of information.
This is a repeat citation from May 24, 2023, May 23, 2024, and April 28, 2025 annual licensing inspection.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
All documentation will be completed correctly and in a timely manner.
This requirement will be reviewed with all appropriate staff members in a documented in-service training within the next two weeks, and no later than 5/22/26 This training will include a detailed review of the standard; all relevant Gaudenzia policies; the Gaudenzia workflow document which specifies the required timeframes; the specific areas of the clinical chart in which to document this information, and; how to request assistance when needed.
The Clinical Supervisor will complete at least weekly reviews, the Program Director will complete at least monthly reviews, and the Quality Assurance Manager will complete at least quarterly reviews of a representative sample of clinical charts utilizing our standard review tools which assess for the presence, timeliness and quality of each chart document.
Any issues noted will be reviewed by the Clinical Supervisor or Program Director with the clinician responsible in a documented supervision session and corrected within 48 hours.
Progress in this area will be monitored by the Division Director and Regional Clinical Director in regular supervision sessions, and any barriers to implementation addressed at that time.
The Gaudenzia Compliance Department will conduct a review of any repeat citations within 90 days to ensure full implementation, identify any barriers to implementation, and coordinate support, where needed.
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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 record.
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Observations
Based on a review of the client records, the facility failed to document that a copy of a client consent shall be offered to the client and a copy maintained in the client record in five out of seven client records reviewed.
Client #1 was admitted on June 03, 2025, and discharged on September 15, 2025. A consent form signed and dated June 03, 2025, for the funder, hospital, lab, and a pharmacy did not have documentation that the client was offered a copy of the consent form.
Client #2 was admitted on October 07, 2025 and discharged on October 24, 2025. A consent form signed and dated October 07, 2025, for the funder, lab, pharmacy, and probation did not have documentation that the client was offered a copy of the consent form.
Client #3 was admitted on February 11, 2026 and was still active at the time of the inspection. A consent form signed and dated February 11, 2026, for the funder, lab, pharmacy, hospital, and a family member, did not have documentation that the client was offered a copy of the consent form.
Client #5 was admitted on March 04, 2026 was still active at the time of the inspection. A consent form signed and dated March 04, 2026, for the funder, lab, pharmacy, hospital, and parole, did not have documentation that the client was offered a copy of the consent form.
Client #6 was admitted on December 19, 2025 and discharged on January 06, 2026. A consent form signed and dated December 19, 2025, to the funder, lab, pharmacy, hospital, and probation, did not have documentation that the client was offered a copy of the consent form.
These findings were reviewed by facility staff during the licensing process.
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Plan of Correction
All documentation will be completed correctly and in a timely manner.
This requirement will be reviewed with all appropriate staff members in a documented in-service training within the next two weeks, and no later than 5/22/26 This training will include a detailed review of the standard; all relevant Gaudenzia policies; the Gaudenzia workflow document which specifies the required timeframes; the specific areas of the clinical chart in which to document this information, and; how to request assistance when needed.
The Clinical Supervisor will complete at least weekly reviews, the Program Director will complete at least monthly reviews, and the Quality Assurance Manager will complete at least quarterly reviews of a representative sample of clinical charts utilizing our standard review tools which assess for the presence, timeliness and quality of each chart document.
Any issues noted will be reviewed by the Clinical Supervisor or Program Director with the clinician responsible in a documented supervision session and corrected within 48 hours.
Progress in this area will be monitored by the Division Director and Regional Clinical Director in regular supervision sessions, and any barriers to implementation addressed at that time.
The Gaudenzia Compliance Department will conduct a review of any repeat citations within 90 days to ensure full implementation, identify any barriers to implementation, and coordinate support, where needed.
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709.32 (c) (3) (i) - (v) LICENSURE Medication control
§ 709.32. Medication control.
(3) Inspection of storage areas that ensures compliance with State and Federal laws and program policy. The policy must include, but not be limited to:
(i) What is to be verified through the inspection, who inspects, how often, but not less than quarterly, and in what manner it is to be recorded.
(ii) Disinfectants and drugs for external use are stored separately from oral and injectable drugs.
(iii) Drugs requiring special conditions for storage to insure stability are properly stored.
(iv) Outdated drugs are removed.
(v) Copies of drug-related regulations are available in appropriate areas.
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Observations
Based on a review of the facility's policy and procedure manual and the physical plant inspection on April 09, 2026, the drug storage areas and medications shall be inspected by an assigned nurse or designated trained staff member at least quarterly. The facility's policy and procedure manual states the nurse or a designated trained staff member will make quarterly inspection of all drug storage units to include emergency equipment and medical supplies. These areas are maintained in compliance with Federal, State and local regulations. The facility did not have documentation of quarterly inspections of the drug area or medications.
This is a repeat citation from the May 23, 2024 and April 28, 2025 licensing inspections.
These findings were reviewed with the facility staff during the licensing process
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Plan of Correction
This requirement will be reviewed with all medical staff members in a documented in-service training within the next two weeks, and no later than 5/22/26. The training will include a detailed review of the standard; all relevant Gaudenzia policies and; how to request assistance when needed.
The Nurse Manager or nurse designee will be responsible for ensuring quarterly inspections of the drug area and medications are completed and documented as per Gaudenzia's policy and procedures.
Progress in this area will be monitored by the Division Director, and any barriers to implementation addressed at that time.
The Gaudenzia Compliance Department will conduct a review of all citations within 90 days to ensure full implementation, identify any barriers to implementation, and coordinate support, where needed.
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709.53(a)(10) LICENSURE Discharge Summary
709.53. 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:
(10) Discharge summary.
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Observations
Based on a review of client records, and the facility's policy and procedure manual, the facility failed to ensure a complete client record included information relative to the client's involvement with the project, to include discharge summary information, in two out of three records reviewed. Per the facility's policy and procedure maual, discharge summaries are due 7 days after discharge.
Client #2 was admitted on October 07, 2025 and was discharged on October 24, 2025. The client record did not contain documentation of discharge summary information.
Client #6 was admitted on December 19, 2025 and was discharged on January 06, 2026. The client record did not contain documemtation of discharge summary information.
This is a repeat citation from April 28, 2025 annual licensing renewal inspections.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
All discharge documentation will be completed correctly and in a timely manner.
This requirement will be reviewed with all appropriate staff members in a documented in-service training within the next two weeks, and no later than 5/22/26. This training will include a detailed review of the standard; all relevant Gaudenzia policies; the Gaudenzia workflow document which specifies the required timeframes; the specific areas of the clinical chart in which to document this information, and; how to request assistance when needed.
Any missing or incorrect documentation for any active client will be updated within 1 week and reviewed by the Clinical Supervisor to ensure that it is accurate and comprehensive. This will be completed no later than 5/22/26.
The Clinical Supervisor will complete at least weekly reviews, the Program Director will complete at least monthly reviews, and the Quality Assurance Manager will complete at least quarterly reviews of a representative sample of clinical charts utilizing our standard review tools which assess for the presence, timeliness and quality of each chart document.
Any issues noted will be reviewed by the Clinical Supervisor or Program Director with the clinician responsible in a documented supervision session and corrected within 48 hours.
Progress in this area will be monitored by the Division Director and Regional Clinical Director in regular supervision sessions, and any barriers to implementation addressed at that time.
The Gaudenzia Compliance Department will conduct a review of all citations within 90 days to ensure full implementation, identify any barriers to implementation, and coordinate support, where needed.
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709.53(a)(11) LICENSURE Follow-up information
709.53. 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 ensure a complete client record included information relative to the client's involvement with the project, to include follow-up information, in three out of three records reviewed.
Client #1 was admitted on June 03, 2025 and was discharged on September 15, 2025. The client record did not contain documentation of follow-up information.
Client #2 was admitted on October 07, 2025 and was discharged on October 24, 2025. The client record did not contain documentation of follow-up information.
Client #6 was admitted on December 19, 2025 and was discharged on January 06, 2026. The client was due to have a follow by February 06, 2026; however, one was not completed until February 17, 2026.
This is a repeat citation from the April 28, 2025 annual licensing renewal inspections.
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Plan of Correction
All follow-up documentation will be completed correctly and in a timely manner.
This requirement will be reviewed with all appropriate staff members in a documented in-service training within the next two weeks, and no later than 5/22/26. This training will include a detailed review of the standard; all relevant Gaudenzia policies; the Gaudenzia workflow document which specifies the required timeframes; the specific areas of the clinical chart in which to document this information, and; how to request assistance when needed.
Any missing or incorrect documentation for any active client will be updated within 1 week and reviewed by the Clinical Supervisor to ensure that it is accurate and comprehensive. This will be completed no later than 5/22/26.
The Clinical Supervisor will complete at least weekly reviews, the Program Director will complete at least monthly reviews, and the Quality Assurance Manager will complete at least quarterly reviews of a representative sample of clinical charts utilizing our standard review tools which assess for the presence, timeliness and quality of each chart document.
Any issues noted will be reviewed by the Clinical Supervisor or Program Director with the clinician responsible in a documented supervision session and corrected within 48 hours.
Progress in this area will be monitored by the Division Director and Regional Clinical Director in regular supervision sessions, and any barriers to implementation addressed at that time.
The Gaudenzia Compliance Department will conduct a review of all citations within 90 days to ensure full implementation, identify any barriers to implementation, and coordinate support, where needed.
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709.17(a)(3) LICENSURE Subchapter B.Licensing Procedures.Refusal/rev
709.17. Refusal or revocation of license.
(a) The Department may revoke or refuse to issue a license for any of the following reasons:
(3) Failure to comply with a plan of correction approved by the Department, unless the Department approves an extension or modification of the plan of correction.
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Observations
Based on a review of client records, the facility failed to comply with plans of correction that were approved by the Department.
A plan of correction for completing and documenting quarterly inspections of all drug storage units was submitted and approved by the Department for the May 23, 2024, and April 28, 2025 annual licensing inspections. Completing and documenting documenting quarterly inspections of all drug storage units was again found to be a deficiency in the April 09, 2026 licensing inspection.
This finding was reviewed with facility staff during the licensing process.
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Plan of Correction
This requirement will be reviewed with all medical staff members in a documented in-service training within the next two weeks, and no later than 5/22/26. The training will include a detailed review of the standard; all relevant Gaudenzia policies and; how to request assistance when needed.
The Nurse Manager or nurse designee will be responsible for ensuring quarterly inspections of the drug area and medications are completed and documented as per Gaudenzia's policy and procedures.
Progress in this area will be monitored by the Division Director, and any barriers to implementation addressed at that time.
The Gaudenzia Compliance Department will conduct a review of all citations within 90 days to ensure full implementation, identify any barriers to implementation, and coordinate support, where needed.
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