INITIAL COMMENTS
|
This report is a result of an on-site licensure renewal inspection conducted on June 2, 2021 through June 3, 2021 by staff from the Department of Drug and Alcohol Programs, Bureau of Program Licensure. Based on the findings of the on-site inspection, Malvern Institute 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:
|
Plan of Correction
|
705.7 (b) (5) LICENSURE Food service.
705.7. Food service.
(b) A residential facility may operate a central food preparation area to provide food services to multiple facilities or locations. A residential facility that operates an onsite food preparation area or a central food preparation area shall:
(5) Keep cold food at or below 40F, hot food at or above 140F, and frozen food at or below 0F.
|
Observations
Based on a physical plant inspection on June 3, 2021, the facility failed to keep frozen food at or below 0 as the freezer located outside the kitchen registered temperatures above 0 findings were reviewed with facility staff during the licensing process.
|
Plan of Correction
Identification of Failure: On June 3, 2021, the facility completed its daily temperature check at which time the freezer registered 0F degrees. Later in the day and at the time of the inspection the temperature had risen above 0.
Action: At the time of the survey the thermostat was lowered to ensure the freezer remained at 0 degrees. Service was completed on the freezer 6/15/2021 and the door to the freezer was readjusted correcting the issue. Designated kitchen staff will increase their temperature monitoring to twice daily and record it in the temperature log.
Monitoring: Designated kitchen staff will keep a log of temperature recordings twice daily and report any discrepancies immediately to the Regional Food Services Director. |
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.
|
Observations
Based on a review of client records, the facility failed to obtain a written informed and voluntary consent from the client for the disclosure of information contained in the client record in one of fourteen records reviewed.
Client # 8 was admitted to the residential level of care on September 7, 2019 and discharged on September 30, 2019. There was documentation of a disclosure to a government agency on September 13, 2019; however, there was no consent to release information form signed by the client documented in the record prior to the disclosure.
These findings were reviewed with facility staff during the licensing process.
|
Plan of Correction
Identification of Failure: Client # 8 's counselor failed to meet facility/regulatory expectations to obtain a written informed and voluntary consent from the client for the disclosure of information contained in the client record prior to disclosing information to a government agency.
Action: All Counselors will be re-educated on the expectations for obtaining a written informed and voluntary consent from the clients for the disclosure of information in the client record.
Monitoring: Monitoring will be completed monthly by the clinical supervisors/designated staff and monitored by the Director of PI during monthly chart audits to establish compliance with ROI. 25 charts will be audited each month with a goal of 100% compliance for 3 months. |
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 must be in writing and include, but not be limited to:
(2) Specific information disclosed.
|
Observations
Based on a review of client records, the facility failed to keep consent to release information forms within the limits established by 4 Pa. Code 255.5 (b) for releases of information in one of fourteen client records reviewed.
Client # 10 was admitted to the residential level of care on October 21, 2020 and was discharged on November 17, 2020. A release of information form to a government agency was signed and dated by the client on November 2, 2020, allowed for the release of discharge summary, history and physical, aftercare treatment plan, lab reports, diagnosis, referral source, and consultations, all of which exceeded the limits established by 4 Pa. Code 255.5.
These findings were reviewed with facility staff during the licensing process.
|
Plan of Correction
Identification of Failure: The facility had a process to limit the amount of information released per 4 Pa. Code 255.5 (b) but the client's counselor utilized the incorrect form to receive consent.
Action: The Release of Information (ROI) forms were changed on May 26, 2021 in the new electronic medical record (EMR) to limit the amount of information released to government agencies per 4 Pa Code 255.5 (b). Counselors will be re-educated on these limits.
Monitoring: Monitoring will be completed monthly by the clinical supervisors/designated staff and monitored by the Director of PI during monthly chart audits to establish compliance with ROI. 25 charts will be audited each month with a goal of 100% compliance for 3 months. |
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.
|
Observations
Based on an administrative review of the facility's policy and procedrue manual, the facility failed to develop and implement written policies and procedures pertaining to the inspection of medication storage areas, including what is to be verified through the inspection, who performs the inspections, how often they occur, and in what manner the inspections are to be documented.
These findings were reviewed with facility staff during the licensing process.
|
Plan of Correction
Identification of Failure: While the facility maintained a process to conduct inspections of medication storage areas, the policy did not specifically detail the process and person responsible.
Action: Policy MM111 Medication Storage and Temperature was revised on 6/4/21 to include what is to be verified through the inspection, who performs the inspections, how often they occur, and in what manner the inspections are to be documented.
Monitoring: Medication room inspections are reviewed quarterly during the P&T Committee meetings. |
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.
|
Observations
Based on a review of the project's policy and procedure manual, the project failed to develop and implement policies and procedures on how the project would respond to an event at the facility that requires the presence of police, fire, or ambulance personnel.
These findings were reviewed with facility staff during the licensing process.
|
Plan of Correction
Identification of Failure: While the facility has a process for responding to the presence of emergency personnel, the project failed to detail its process regarding emergency personnel in its policy.
Action: Policy Policy SUB 715.28 Unusual Incidents was revised on 6/3/21 to include how the project would respond to an event at the facility that requires the presence of police, fire, or ambulance personnel.
Monitoring: Incident reports are monitored monthly in the facility PI committee. |
709.34 (a) (8) 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:
(8) Outbreak of a contagious disease requiring Centers for Disease Control (CDC) notification.
|
Observations
Based on a review of the project's policy and procedure manual, the project failed to develop and implement policies and procedures on how the project would respond to an outbreak of a contagious disease requiring notification to the Centers for Disease Control (CDC).
These findings were reviewed with facility staff during the licensing process.
|
Plan of Correction
Identification of Failure: The facility had a policy on reporting unusual incidents and a plan for infection control but it failed to specifically indicate how it would report an outbreak of a contagious disease requiring notification to the CDC and to the Department of Drug and Alcohol Programs in the policy.
Action: Policy: Policy SUB 715.28 Unusual Incidents was revised on 6/3/21 to include how the project would respond to an outbreak of a contagious disease requiring notification to the Centers for Disease Control (CDC).
Monitoring: Incident reports are monitored monthly in the facility PI committee. |
709.34 (c) (1) LICENSURE Reporting of unusual incidents
§ 709.34. Reporting of unusual incidents.
(c) To the extent permitted by State and Federal confidentiality laws, the project shall file a written unusual incident report with the Department within 3 business days following an unusual incident involving:
(1) Physical or sexual assault by staff or a client.
|
Observations
Based on a review of the facility's unusual incident report logs, the facility failed to report several incidents of physical assault by clients to the Department within 3 business days.
There were documented incident report logs of physical assaults by clients on August 2, 2020, August 26, 2020, August 30, 2020, September 5, 2020 and September 13, 2020; however, none of the incidents were not reported to the Department within 3 business days.
These findings were reviewed with facility staff during the licensing process.
|
Plan of Correction
Identification of Failure: Although the facility routinely submits reports to DDAP for unusual incidents it failed to report several physical assault reports to DDAP within 3 business days.
Action: The Director of PI or designee will submit all incidents of physical assaults to the DDAP Incident Tracking Reporting System within 3 business days of an incident.
Monitoring: The Director of PI will review all facility incident reports daily during business days to determine if external reporting is required and will submit incident reports to DDAP as appropriate. Incident reporting is reviewed monthly in the facility PI committee. |
715.9(a)(4) LICENSURE Intake
(a) Prior to administration of an agent, a narcotic treatment program shall screen each individual to determine eligibility for admission. The narcotic treatment program shall:
(4) Have a narcotic treatment physician make a face-to-face determination of whether an individual is currently physiologically dependent upon a narcotic drug and has been physiologically dependent for at least 1 year prior to admission for maintenance treatment. The narcotic treatment physician shall document in the patient 's record the basis for the determination of current dependency and evidence of a 1 year history of addiction.
|
Observations
Based on a review of patient records, the facility failed to ensure that the face-to-face determination between the narcotic treatment phsycian and the client occurred prior to the administration of an agent in one of nine applicable patient records reviewed. Additionally, the narcotic treatment physician failed to document that the patient had been physiologically dependent upon a narcotic drug for at least 1 year prior to the administration of a maintenance agent in two of nine applicable patient records reviewed.
Patient # 11 was admitted to the residential level of care on November 28, 2019 and was discharged on December 14, 2019. The patient's first dose of medication was prescribed on December 10, 2020; however, the initial face-to-face determination meeting between the physician and the patient was held on December 11, 2020. Additionally, the physician failed to document that the patient was physiologically dependent upon a narcotic drug for at least 1 year prior to the administration of a maintenance agent during the December 11, 2020 initial face to face meeting with the patient.
Patient # 13 was admitted to the residential level of care on May 16, 2021 and was still active at the time of inspection. The physician failed to document that the patient was physiologically dependent upon a narcotic drug for at least 1 year prior to the administration of a maintenance agent during the May 24, 2021 initial face to face determination meeting with the patient.
These findings were reviewed with facility staff during the licensing process.
|
Plan of Correction
Identification of Failure: The facility utilizes the services of CRNP's per federal regulations to support the physicians in the assessment and treatment of patients in our facility and the CRNP had a face-to-face with the clients and documented the physiological dependency time of addiction. Based on a review of patient records, the facility failed to ensure that the face-to-face determination between the narcotic treatment physician and the client occurred prior to the administration of an agent in one of nine applicable patient records reviewed. Additionally, the narcotic treatment physician failed to document that the patient had been physiologically dependent upon a narcotic drug for at least 1 year prior to the administration of a maintenance agent in two of nine applicable patient records reviewed.
Action: As per Licensing Alert 01-21, dated June 16, 2021, Malvern Treatment Centers will no longer be considered a Narcotic Treatment Program starting July 1, 2021 and will, per the Drug Addiction Treatment Act of 2000 (DATA 2000), be considered an "other chemotherapy" program. The facility will continue to have a member of the medical staff assess patients for the appropriateness of medication-assisted treatment. All policies and procedures have been revised to reflect the changes in the regulatory requirements.
Monitoring: As per Licensing Alert 01-21, dated June 16, 2021, Malvern Treatment Centers will no longer be considered a Narcotic Treatment Program starting July 1, 2021 and will, per the Drug Addiction Treatment Act of 2000 (DATA 2000), be considered an "other chemotherapy" program. The facility will continue to have a member of the medical staff assess patients for the appropriateness of medication-assisted treatment. All policies and procedures have been revised to reflect the changes in the regulatory requirements.
|