Fla. Admin. Code Ann. R. 65D-30.004 - Common Licensing Standards

Current through Reg. 48, No. 66; April 5, 2022

(1) Operating Procedures. Providers shall demonstrate organizational capability required by paragraph 65D-30.0036(1)(e), F.A.C., through a written, indexed system of policies and procedures that are descriptive of services, and the population served. Administrative and clinical services must align with current best practices as defined in subsection 65D-30.002(7), F.A.C. All staff shall have a working knowledge of the operating procedures. These operating procedures shall be submitted with new applications and available for review by the Department at any time.
(2) Quality Improvement. Providers shall have a quality improvement program which complies with the requirements established in section 397.4103, F.S., and which ensures the use of a continuous quality improvement process.
(3) Provider Governance and Management.
(a) Governing Body. Any provider that applies for a license, shall be a legally constituted entity. Providers that are government-based and providers that are for-profit and not-for-profit, as defined in section 397.311, F.S., shall have a governing body that shall set policy for the provider. The governing body shall maintain a record of all meetings where business is conducted relative to provider operations. These records shall be available for review by the department.
(b) Insurance Coverage. In regard to liability insurance coverage, providers shall assess the potential risks associated with the delivery of services to determine the amount of coverage necessary and shall purchase policies accordingly.
(c) Chief Executive Officer. A chief executive officer shall be appointed. If the entity is operated by a governing board, the governing body shall appoint a chief executive officer. The qualifications and experience required for the position of chief executive officer shall be defined in the provider's operating procedures. Documentation shall be available from the governing body providing evidence that a background screening has been completed in accordance with chapters 397 and 435, F.S., and there is no evidence of a disqualifying offense. Providers shall notify the regional office in writing within 24 hours when a new chief executive officer is appointed. (Inmate Substance Abuse Programs operated by or under contract with the Department of Corrections, or the Department of Management Services are exempt from the requirements in this paragraph. Juvenile Justice Commitment Programs and detention facilities operated by the Department of Juvenile Justice, are exempt from the requirements of this paragraph.)
(4) Personnel Policies. Personnel policies shall clearly address recruitment and selection of prospective employees, promotion and termination of staff, code of ethical conduct, sexual harassment, confidentiality of individual records, attendance and leave, employee grievance, non-discrimination, abuse reporting procedures, and the orientation of staff to the agency's universal infection control procedures. The code of ethical conduct shall prohibit employees and volunteers from engaging in sexual activity with individuals receiving services for a minimum of two (2) years after the last professional contact with the individual. Providers shall also have a drug-free workplace policy for employees and prospective employees.
(a) Personnel Records. Records on all personnel shall be maintained. Each personnel record shall contain:
1. The individual's current job description with minimum qualifications for the position and documentation that the staff meets the minimum qualifications outlined in the job description;
2. The employment application or resume;
3. The employee's annual performance appraisal;
4. A document signed and dated by the employee indicating that the employee received new staff orientation and understand the personnel policies and the programs operating policies and procedures;
5. A verified or certified copy of degrees, licenses, or certificates of each employee;
6. Documentation of employee screening as required in paragraph (b); and
7. Documentation of required staff training (Inmate Substance Abuse Programs operated by the Department of Corrections are exempt from the provisions of this subparagraph).
(b) Screening of Staff. All owners, chief financial officers, chief executive officers, and clinical supervisors of service providers are subject to level 2 background screening and local background screening as provided under chapters 435 and 397, F.S. All service provider personnel, and volunteers who have direct contact with children receiving services or with adults with intellectual disabilities receiving services are subject to level 2 background screening as provided under chapter 435, and section 397.4073, F.S. In addition, individuals shall be re-screened within five (5) years from the date of their last screening and shall include a local background screening. Re-screening shall include a level 2 screening in accordance with chapter 435, F.S. Service provider personnel who request an exemption from disqualification must submit the request within 30 days after being notified of the disqualification. If five (5) years or more have elapsed since the most recent disqualifying offense, service provider personnel may work with adults who have substance use disorders under the supervision of a qualified professional until the Department makes a final determination regarding the request for an exemption from disqualification. (Personnel operating directly with local correctional agency or authority, Inmate Substance Abuse Programs operated by or under contract with the Department of Corrections or the Department of Management Services are exempt from the requirements in this paragraph, unless they have direct contact with unmarried inmates under the age of 18 or with inmates who are intellectually disabled.)
(c) Employment History Checks and Checks of References. The chief executive officer or designee, such as human resources staff, shall assess employment history checks and checks of references for each employee who has direct contact with children receiving services or adults who are intellectually disabled receiving services.
(5) Standards of Conduct. Providers shall establish written rules of conduct for individuals. Each individual receiving services shall be given rules of conduct during orientation to be reviewed, signed and dated.
(6) Medical Director. This requirement applies to addictions receiving facilities, detoxification, intensive inpatient treatment, residential treatment, and methadone and medication-assisted treatment for opioid addiction. Providers shall designate a medical director who shall oversee all medical services. The medical director's responsibilities shall be clearly described.
(a) The Medical Director shall have overall responsibility for the following:
1. Medical services provided by the program;
2. Oversight of the development and revision of medical policies, including:
a. The means for the detection and referral of health problems through medical surveillance and regular examination;
b. Implementation of medical orders regarding treatment of medical conditions;
c. Reporting of communicable diseases and infections in accordance with federal and state laws;
d. Procedures and ongoing training for routine medical care, specialized services, specialized medications, and medical and psychiatric emergency care;
3. Collaborative supervision with the clinical supervisor of non-medical staff in the provision of substance use disorder services; and
4. Supervision of medical staff in the performance of medical services.
(b) The Medical Director must meet at least twice a year with the risk management and quality assurance program of the facility to review incident reports, grievances, and complaints to identify and implement processes to reduce clinical risks and safety hazards. This process shall be documented in the risk management and quality assurance committee meeting minutes. When the Medical Director is the attending physician of an individual receiving services, they shall participate in the development of the treatment plan.
(c) The Department shall utilize the following methodology for determining the maximum number of individuals a medical director may serve pursuant to subparagraph 397.410(1)(c)5., F.S.:

Component

Average Length of Stay (LOS) in Days

Total Service Time over LOS

Work Days

Work Days per LOS

Hours worked per LOS (Work Days x Work Days per LOS)

Calculation (Time in LOS/Total Service Time)

Total Case Load

Inpatient Detoxification

4 days

1.0 hour*

8 hours

4 days

32 hours

32 /1 hour

32 individuals

Outpatient Detoxification

5 days

1.2 hours*

8 hours

5 days

40 hours

40/1.2 hours

33 individuals

Residential Level I

19 days

1 hour**

8 hours

15 days

120 hours

120/1 hour

120 individuals

Residential Level II

41 days

1.75 hours**

8 hours

30 days

240 hours

240/1.75

137 individuals

Residential Level III

54 days

2.25 hours**

8 hours

40 days

320 hours

320/2.25

142 individuals

Residential Level IV

42 days

1.75 hours**

8 hours

30 days

240 hours

240/1.75

137 individuals

Medication and Methadone Maintenance

1,030 days

3.25 hours***

8 hours

709 days

5,672 hours

5,672/3.25

1,745 individuals

*Service Times: New Patient Visit (30 minutes), Daily Follow-up (10 minutes)

**Service Times: New Patient Visit (30 minutes), Weekly Follow-up (15 minutes)

***Service Times: New Patient Visit (30 minutes), Quarterly Follow-up (15 minutes)

(d) A medical director may not serve in that capacity for more than a maximum of the indicated number of individuals for the treatment types listed below:
1. Addiction receiving facilities, inpatient detoxification, and intensive impatient providers - a cumulative total of 32 individuals at any given time.
2. Outpatient detoxification - a cumulative total of 33 individuals at any given time.
3. Residential treatment (level 1) - a cumulative total of 120 individuals at any given time.
4. Residential treatment (level 2) - a cumulative total of 137 individuals at any given time.
5. Residential treatment (level 3) - a cumulative total of 142 individuals at any given time.
6. Residential treatment (level 4) - a cumulative total of 137 individuals at any given time.
7. Medication and methadone maintenance treatment - a cumulative total of 1,745 individuals at any given time.
(e) Providers licensed for multiple service components shall ensure compliance with this medical director standard by applying the percentage of time dedicated to each service component to the Department's methodology for maximum individuals served. This information shall be submitted with the application for licensure and updated at the time of any licensure renewal. The provider shall be responsible for providing documentation to support the case load maximum upon request.
(f) A provider may not operate without a medical director on staff at any time. When a medical director is not available, the medical director shall ensure that a qualified physician who is available is designated. Upon the departure of a medical director, an interim medical director shall be appointed. The provider shall notify the regional office in writing within 24 hours when there is a change in the medical director, provide proof that the new or interim medical director holds a current license in the state of Florida, and is free of administrative action(s) against their license.
(g) In cases where a provider operates treatment components that are not identified in this subsection, the provider shall have access to a physician through a written agreement who will be available to consult on any medical services required by individuals involved in those components. Physicians serving as a medical consultant shall adhere to all requirements and restrictions as described for medical directors in this chapter.
(h) A medical director or medical consultant in violation of any of the requirements set forth in chapter 65D-30, F.A.C., or chapter 397, F.S., is permanently barred from being employed by or contracting with a service provider.
(7) Medical Services.
(a) Written Medical Provisions. For components identified in subsection 65D-30.004(6), F.A.C., each physician working with a provider shall establish written protocols for the provision of medical services pursuant to chapters 458 and 459, F.S., and for managing medication according to medical and pharmacy standards, pursuant to chapter 465, F.S. Such protocols will be implemented only after written approval by the chief executive officer and medical director.
(b) The medical protocols shall also include:
1. The manner in which certain medical functions may be delegated to Advanced Registered Nurse Practitioners and Physician's Assistants in those instances where these practitioners are utilized as part of the clinical staff;
2. Issuing orders; and
3. Signing and countersigning results of physical health assessments;
4. Procedures shall be documented for the administration of medication by a qualified medical professional as authorized by their scope of practice.
(c) Supervision of self-administration of medication may be provided, including at the community housing location, under the following conditions:
1. A secure, locked storage for medications must be maintained;
2. Individuals must receive prescription medication in accordance to the prescriptions of qualified physicians, as required by law;
3. Supervision of self-administration of medication must be provided by trained personnel in accordance with paragraph 65D-30.0046(1)(f), F.A.C. of this chapter.
4. A record of all instances of supervision of self-administration of medication shall be maintained in a medication observation record, to include the date, time, and dosage in accordance to the prescription. The personnel who witnessed the self-administration of the medication shall sign and date the medication observation record.
(d) All medical protocols shall be reviewed and approved by the medical director and chief executive officer on an annual basis and shall be available for review by the Department.
(e) Emergency Medical Services. All licensed providers shall describe the manner in which medical emergencies shall be addressed. (Inmate Substance Abuse Programs operated by or under contract with the Department of Corrections or the Department of Management Services are exempt from the requirements of subsection 65D-30.004(7), F.A.C. Juvenile Justice Commitment Programs and detention facilities operated by or under contract with the Department of Juvenile Justice are exempt from the requirements of this subsection.)
(8) State Approval Regarding Prescription Medication. In instances where the provider utilizes prescription medication, medications shall be purchased, handled, dispensed, administered, and stored in compliance with the State of Florida Board of Pharmacy requirements for facilities which hold Modified Class II Institutional Permits and in accordance with chapter 465, F.S. This shall be implemented in consultation with a state-licensed consultant pharmacist and approved by the medical director. The provider shall ensure that policies implementing this subsection are reviewed and signed and dated annually by a state-licensed consultant pharmacist. (Inmate Substance Abuse Programs operated by or under contract with the Department of Corrections, the Department of Juvenile Justice, or the Department of Management Services are exempt from the requirements of this subsection.) All providers purchasing, dispensing, handling, administering, storing, or observing self-administration of medications shall adhere to best practices, state and federal regulations.
(9) Universal Infection Control. This requirement applies to addictions receiving facilities, detoxification, intensive inpatient treatment, residential treatment, day or night treatment with community housing, day or night treatment, intensive outpatient treatment, outpatient treatment, and medication assisted treatment for opioid addiction.
(a) Plan for Exposure Control.
1. A written plan for exposure control regarding infectious diseases shall be developed and shall apply to all staff, volunteers, and individuals receiving services. The plan shall be initially approved and reviewed annually by the medical director or consulting physician. The plan shall be in compliance with chapters 381 and 384, F.S., and in accordance with the Department of Health's requirements as stated in chapters 64D-2 and 64D-3, F.A.C. The plan shall be signed and dated by the medical director or consulting physician as required by this paragraph.
2. The plan shall be consistent with the protocols and facility standards published in the Federal Centers for Disease Control and Prevention Guidelines and Recommendations for Infectious Diseases.
(b) Required Services. The following Universal Infection Control Services shall be provided:
1. Risk assessment and screening individuals for both high-risk behavior and symptoms of communicable disease as well as actions to be taken on behalf of individuals identified as high-risk and individuals known to have an infectious disease;
2. HIV and TB testing and HIV pre-test and post-test counseling to high-risk individuals, provided directly or through referral to other healthcare providers which can offer the services; and
3. Reporting of communicable diseases to the Department of Health in accordance with sections 381.0031 and 384.25, F.S.

(Inmate Substance Abuse Programs operated by or under contract with the Department of Corrections or Department of Management Services are exempt from the requirements of this subsection but shall provide such services as required by chapter 945, F.S., titled Department of Corrections. Juvenile Justice Commitment Programs and detention facilities operated by or under contract with the Department of Juvenile Justice are exempt from the requirements of this subsection but shall provide such services as required in the policies, standards, and contractual conditions established by the Department of Juvenile Justice.)

(10) Universal Infection Control Education Requirements for Employees and Individuals. Providers shall meet the educational requirements for HIV and AIDS pursuant to section 381.0035, F.S., and all infection prevention and control educational activities shall be documented. (Inmate Substance Abuse Programs operated by or under contract with the Department of Corrections, the Department of Juvenile Justice, or the Department of Management Services are exempt from the requirements of this subsection but shall provide such services as required in the policies, standards, and contractual conditions established by the Department of Juvenile Justice.)
(11) Meals. At least three (3) meals per calendar day shall be provided to individuals in addictions receiving facilities, inpatient detoxification, intensive inpatient treatment, and residential treatment. In addition, at least one (1) snack shall be provided each day. For day or night treatment with community housing and day or night treatment, the provider shall make arrangements to serve a meal to individuals involved in services a minimum of five (5) hours at any one time. Individuals with special dietary needs shall be reasonably accommodated. Under no circumstances may food be withheld for disciplinary reasons. The provider shall document and ensure that nutrition and dietary plans are reviewed and approved by a dietitian/nutritionist licensed under section 468.509, F.S., at least annually. (Inmate Substance Abuse Programs operated by or under contract with the Department of Corrections, the Department of Juvenile Justice, or the Department of Management Services are exempt from the requirements of this subsection but shall provide such services as required in the policies, standards, and contractual conditions established by the respective department.)
(12) Verbal De-escalation. This applies to all components with the exception of universal direct and indirect prevention services. Providers shall have written policies and procedures of the specific verbal de-escalation technique(s) to be used. Direct care staff shall be trained in verbal de-escalation techniques as required in paragraph 65D-30.0046(1)(b), F.A.C. The provider shall provide proof to the Department that affected staff have completed training in those techniques.
(13) Compulsory School Attendance for Minors. Providers which admit juveniles between the ages of 6 and 16 shall comply with chapter 232, F.S., entitled Compulsory School Attendance; Child Welfare.
(14) Data. Providers shall report data to the department pursuant to paragraph 397.321(3)(c), F.S.
(15) Special In-Residence Requirements. Service providers housing individuals for treatment shall only furnish beds to individuals admitted for substance use treatment for the specific level of care for which the individuals meet criteria. Providers that house males and females together within the same facility shall provide separate sleeping arrangements for these individuals and must have at least one staff member present at all times. Providers which serve adults in the same facility as persons under 18 years of age shall ensure individual safety with one-on-one supervision, separate bedrooms, and programming according to age. Providers, aside from Juvenile Justice Commitment Programs and detention facilities operated by or under contract with the Department of Juvenile Justice, shall not collocate children or adolescents with adults. Admitted seventeen-year-olds who turn 18 while completing treatment shall be allowed to stay only if it is clinically indicated, there is one-on-one supervision, and they have separate bedrooms.
(16) Reporting of Abuse, Neglect, and Deaths. Providers shall adhere to the statutory requirements for reporting abuse, neglect, and deaths of children under chapter 39, F.S., and of adults under sections 415.1034 and 397.501(7)(c), F.S.
(17) Critical Incident Reporting Pursuant to paragraph 397.4103(2)(f), F.S.
(a) Every provider shall develop policies and procedures for submitting critical incidents into the Department's statewide designated electronic system specific to critical incident reporting.
(b) Every provider shall report the following critical incidents within 24 hours of the incident occurring.
1. Adult Death. An individual 18 years old or older whose life terminates:
a. While receiving services; or
b. When it is known that an adult died within thirty (30) days of discharge from a program.
c. The final classification of an adult's death is determined by the medical examiner. In the interim, the manner of death shall be reported as one of the following:
(I) Accident. A death due to the unintended actions of one's self or another.
(II) Homicide. A death due to the deliberate actions of another.
(III) Natural Expected. A death that occurs, because of, or from complications of, a diagnosed illness for which the prognosis is terminal.
(IV) Natural Unexpected. A sudden death that was not anticipated and is attributed to an underlying disease either known or unknown prior to the death.
(V) Suicide. The intentional and voluntary taking of one's own life.
(VI) Undetermined. The manner of death has not yet been determined.
(VII) Unknown. The manner of death was not identified or made known.
2. Adolescent Arrest. The arrest of an adolescent.
3. Adolescent Death. An individual who is less than 18 years of age whose life terminates:
a. While receiving services; or
b. When it is known that an adolescent died within 30 days of discharge from a program;
c. The final classification of an adolescent's death is determined by the medical examiner. In the interim, the manner of death will be reported as one of the following:
(I) Accident. A death due to the unintended actions of one's self or another.
(II) Homicide. A death due to the deliberate actions of another.
(III) Natural Expected. A death that occurs, because of, or from complications of, a diagnosed illness for which the prognosis is terminal.
(IV) Natural Unexpected. A sudden death that was not anticipated and is attributed to an underlying disease either known or unknown prior to the death.
(V) Suicide. The intentional and voluntary taking of one's own life.
(VI) Undetermined. The manner of death has not yet been determined.
(VII) Unknown. The manner of death was not identified or made known.
4. Adolescent-on-Adolescent Sexual Abuse. Any sexual behavior between adolescents less than 18 years of age which occurs without consent, without equality, or because of coercion.
5. Elopement. An unauthorized absence of any individual.
6. Employee Arrest. The arrest of an employee for a civil or criminal offense.
7. Employee Misconduct. Work-related conduct or activity of an employee that results in potential liability for the Department; death or harm to an individual receiving services; abuse, neglect or exploitation of a vulnerable adult; or which results in a violation of statute, rule, regulation, or policy. This includes falsification of records; failure to report suspected abuse, neglect, or abandonment of a child; contract mismanagement; or improper commitment or expenditure of state funds.
8. Missing Adolescent. When the whereabouts of an adolescent in the custody of the Department are unknown and attempts to locate the adolescent have been unsuccessful.
9. Security Incident - Unintentional. An unintentional action or event that results in compromised data confidentiality, a danger to the physical safety of personnel, property, or technology resources; misuse of state property or technology resources; or, denial of use of property or technology resources. This excludes instances of compromised information of individuals in treatment.
10. Sexual Abuse/Sexual Battery. Any unsolicited or non-consensual sexual activity by one individual receiving services to another individual receiving services; or, sexual activity by a service provider employee or other person to an individual receiving services, or an individual receiving services to an employee regardless of the consent of the individual receiving services. This may include sexual battery, as defined in chapter 794, F.S.
11. Significant Injury to Individuals in Treatment. Any severe bodily trauma received by an individual in a program that requires immediate medical or surgical evaluation or treatment in a hospital emergency department to address and prevent permanent damage or loss of life.
12. Significant Injury to Staff. Any serious bodily trauma received by a staff member as result of a work-related activity that requires immediate medical or surgical evaluation or treatment in a hospital emergency department to prevent permanent damage or loss of life.
13. Suicide Attempt. A potentially lethal act which reflects an attempt by an individual to cause his or her own death as determined by a licensed mental health professional or other licensed healthcare professional.
14. Other. Any major event not previously identified as a reportable critical incident but has, or is likely to have, a significant impact on individuals receiving services, on the Department, such as:
a. Human acts that jeopardize the health, safety, or welfare of individuals receiving services, such as kidnapping, riot, or hostage situation;
b. Bomb or biological/chemical threat of harm to personnel or property involving an explosive device or biological/chemical agent received in person, by telephone, in writing, via mail, electronically, or otherwise;
c. Theft, vandalism, damage, fire, sabotage, or destruction of state or private property of significant value or importance;
d. Death of an employee or visitor while on the grounds of the facility;
e. Significant injury of a visitor while on the grounds of the facility that requires immediate medical or surgical evaluation or treatment in a hospital emergency department to prevent permanent damage or loss of life; or
f. Events regarding individuals receiving services or providers that have led to or may lead to media reports.
(18) Confidentiality. Providers shall comply with Title 42, Code of Federal Regulations, Part 2, titled "Confidentiality of Alcohol and Drug Abuse Patient Records," and with sections 397.501(7) and 397.752, F.S., regarding confidential individual information.
(19) Certified Recovery Residence Referrals. Providers shall comply with the statutory requirements established in section 397.4873, F.S., regarding referrals to and admissions from certified recovery residences. All providers shall maintain an active referral log of each individual referred to a recovery residence. The log shall include the individual's name being referred or accepted, name and address of the certified recovery residence, signature of the employee making the referral, and date of the referral. The log shall be made available for review by the Department. (Service Providers under contract with the Managing Entities are exempt from this requirement.)
(20) Telehealth Services.

Prior to initiating services utilizing telehealth, providers shall submit detailed procedures outlining which services they intend to provide as described in paragraph 65D-30.003(1)(l), F.A.C. Providers delivering any services by telehealth are responsible for the quality of the equipment and technology employed and are responsible for its safe use. Providers utilizing telehealth equipment and technology must be able meet or exceed the prevailing standard of care. Service providers must meet the following additional requirements:

(a) Must be capable of two (2)-way, real-time electronic communication, and the security of the technology must be in accordance with applicable federal confidentiality regulations 45 CFR § 164.312;
(b) The interactive telecommunication equipment must include audio and high-resolution video equipment which allows the staff providing the service to clearly understand and view the individual receiving services;
(c) Clinical screenings, assessments, medication management, and counseling are the only services allowable through telehealth; and
(d) Telehealth services must be provided within the state of Florida except for those licensed for outpatient, intervention, and prevention.
(21) Group Counseling. The maximum number of individuals allowed in a group session is 15.
(22) Overdose Prevention.
(a) All providers must develop overdose prevention plans. All staff must have a working knowledge of the overdose prevention plan. Overdose prevention plans shall include:
1. Education about the risks of overdose, including having a lower tolerance for opioids if the individual is participating in an abstinence-based treatment program or is being discharged from a medication-assisted treatment program.
2. Information about Naloxone, the medication that reverses opioid overdose, including how to use Naloxone and where and how to access it.
(b) Providers who maintain an emergency overdose prevention kit must develop and implement a plan to train staff in the prescribed use and the availability of the kit for use during all program hours of operation.
(c) Overdose prevention information, as described in subparagraphs (22)(a)1. and 2. of this rule, must be shared with individuals upon admission.
(d) Providers must offer overdose prevention information, as described in subparagraphs (22)(a)1. and 2. of this rule, to individuals placed on a waitlist to receive treatment services.

Notes

Fla. Admin. Code Ann. R. 65D-30.004

Rulemaking Authority 397.321(5) FS. Law Implemented397.321, 397.4014, 397.4073, 397.4075, 397.410, 397.4103, 397.411FS.

New 5-25-00, Amended 4-3-03, 12-12-05, Amended by Florida Register Volume 45, Number 157, August 13, 2019 effective 8/29/2019.

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