DDS: Medication Administration Regulations

DDS MEDICAL ADVISORY #99-3
(Revised #89-1, 93-1, 97-1)
July 1999
 
INTERPRETIVE GUIDELINES FOR THE DMR
REGULATIONS CONCERNING THE ADMINISTRATION
OF MEDICATION BY CERTIFIED UNLICENSED PERSONNEL

PURPOSE

The intent of this advisory is to ensure consistency in the application of the regulations concerning the administration of medications by certified unlicensed personnel.

APPLICABILITY

This advisory applies to all day and residential programs and facilities as defined in the regulations.

Section 17a-210-1 - Definitions

For the purposes of these regulations, the following definitions shall apply:

(a) "Administration" means the direct application of a medication by inhalation, ingestion or any other means to the body of a person, other than by injection.

(b) "Certified unlicensed personnel" means any person who has successfully completed a training program approved by the department pursuant to Section 17a-210-3 of these regulations and who has been issued a certificate authorizing him to administer medication to clients.

(c) "Certificate" means written authorization issued by the commissioner to a person to administer medication.

(d) "Client" means any person attending a day program or residing in a residential facility operated, licensed, or funded by the department.

(e) "Community Training Home" (CTH) means a residential facility licensed as such by the department pursuant to Section 17a-227 of the Connecticut General Statutes (CGS).

(f) "Commissioner" means the commissioner of the Department of Mental Retardation or his designated representative.

(g) "Day Program" means the following programs operated or funded by the department: supported employment, sheltered employment, work activity, opportunities for older adults, community experience and adult day treatment.

(h) "Department" means the Department of Mental Retardation.

(i) "Dwelling" means any building designed for human habitation.

(j) "Employee" means any individual employed by a residential facility operated, licensed, or funded by the department or by a day program operated or funded by the department.

(k) "Error" means failure to administer medication to a client, failure to administer medication within one hour of the time designated by the prescribing practitioner, failure to administer the specific medication prescribed for a client, failure to administer the correct dosage of medication, failure to administer the medication by the correct route and failure to administer the medication according to generally accepted medical practices.

(l) "Investigational Drug" means any medication which is being scientifically tested and clinically evaluated to determine its efficacy, safety and side effects, and which has not yet received Federal Food and Drug Administration approval.

(m) "Licensed Personnel" means a physician licensed under Chapter 370 of the Connecticut General Statutes (CGS), a dentist licensed under Chapter 379 of the CGS, a registered nurse licensed under Chapter 378 of the CGS, a licensed practical nurse licensed under Chapter 378, practicing under the direction of a registered nurse, and a pharmacist licensed under Chapter 382 of the CGS.

(n) "Medication" means any medicinal preparation including controlled substances, Schedules II-V, as defined in Section 21a-240 and regulations adopted pursuant to Section 21a-243 of the CGS.

(o) "Residential Facility" means any community-based dwelling which is operated, funded, or licensed pursuant to Section 17a-227 of the CGS by the department as a residence for the lodging of clients. A dwelling which is not community-based or a community-based dwelling in which more than 15 persons reside, may be included only upon the written approval of the commissioner. Such approval shall be valid for a period not to exceed one hundred eighty (180) days, unless renewed by the commissioner, and contains such terms and conditions to protect the health and safety of clients. A dwelling in which eight or fewer residents reside which is not community-based may be approved by the commissioner for an indefinite period subject to such terms and conditions deemed necessary by the commissioner to protect the health and safety of clients.

(p) "Regional Director" means that person appointed by the commissioner to be directly responsible for the management of one of the five regions of the department [and Southbury Training School].

(q) "Regional health services coordinator" means that person designated by the regional director to be directly responsible for the management of client health services in each of the five regions of the department [current title is regional health services director and shall include the Southbury Training School].

(r) "Self administration of medication" means that a client is able to identify the appropriate medication by size, color, amount, or other label identification, know independently or with the prompting of an employee or adaptive device the frequency of time of day for which medication is ordered, and consume the medication appropriately.

(s) "Supervisor" means an employee assigned by a residential facility or day program to be directly responsible for the management of the specific residential or day program, including other persons employed by such program.

(t) "Supervising Nurse" means a registered nurse assigned by a residential facility or day program to be directly responsible for the management of medical services provided to the client in the specific residential or day program, including other nurses employed by such program.

Section 17a-210-2 - Administration of Medication

(a) Licensed personnel shall administer medication in any residential facility operated, licensed or funded by the department in which 16 or more persons reside.

Discussion
Regions may obtain a waiver of this section to allow certified, unlicensed personnel to administer medications in a residential facility which 16 or more persons reside as noted in Section 17a-210-1 (o) of these regulations.

(b) Licensed personnel or certified unlicensed personnel may administer medication in any residential facility operated, licensed, or funded by the department in which 15 or fewer persons reside, or in residential facilities approved in accordance with Subsection (o) of Section 17a-210-1 of these regulations, provided that investigational drugs shall be administered by licensed personnel.

Discussion:
Regions seeking approval for the use of certified unlicensed personnel in facilities which require commissioner approval, shall submit documentation in writing to the central office director of health and clinical services stating the name of the facility and the reason for the request. The director will confer with the Office of the Attorney General and make recommendations to the commissioner. The commissioner shall respond in writing with either a denial of request or approval with terms and conditions as appropriate.

(c) Licensed personnel or certified unlicensed personnel may administer medications to clients who reside in non-community based residential facilities as necessary for recreational activities occurring outside the residential facility.

(d) Licensed personnel or certified unlicensed personnel may administer medication at any day program operated or funded by the department.

(e) All prescription medications shall be administered in accordance with the written orders or directions of a physician or dentist. If a physician or dentist determines that the training of certified unlicensed personnel is inadequate to safely administer medications to a particular client, he may order that such administration be performed by licensed personnel.

Discussion
Medications may be administered as ordered by other legally authorized prescribers such as a physician's assistant, an advance practice registered nurse, etc. Discussion throughout the remaining document shall include these additional practitioners.

When a prescriber determines that training of unlicensed personnel is inadequate to administer medication safely to a client, the following criteria shall be met:

  1. the order shall be on a client-by-client basis;
  2. the order shall be written as a doctor's order;
  3. the order shall be accompanied with physician rationale for medication administration only licensed personnel; and
  4. the order and rationale shall be reviewed and renewed every 90 days by physician.

(f) No over-the-counter drug may be administered to a client unless a physician or dentist has previously approved of such administration.

Discussion:
Over-the-counter is defined as any medicinal preparation which may be purchased without a written prescription presented to a pharmacist. All over-the-counter medications being administered to the client must have a written physician's order documented in the client's record per Section 17a-210-6. Over-the-counter medications may be purchased in bulk supply as long as client-specific physician orders are in place in the client record. For clients who self administer medications, see Section 17a-210-4.

(g) Prescribed medications shall only by administered to or taken by the person for whom the prescription has been written.

Discussion
Prescription medication for one client cannot be borrowed for administration to another client.

(h) (1) Any residential or day program in which medications are administered by certified unlicensed personnel, except for community training homes, shall have a written policy which specifies the administrative procedures to be followed, the employees to be notified, the local poison information center telephone number, the person responsible for decision making and the physician, clinic, emergency room or comparable medical personnel to be contacted in the event of a medication emergency. Such policy shall include a list of employees and medical personnel to be contacted which is up to date, readily available to employees and clearly indicates who is to be contacted on a 24-hour-a-day, seven-day-a-week basis.

Discussion
The agency's written procedures will reflect actions relative to any medical emergency as a result of medication administration. Emergency numbers shall be readily available. All other information shall be readily available on site to all staff.

Agency procedures shall define the method of documenting a medication emergency and reporting to DMR when appropriate per DMR policy.

(h) (2) Community training home providers shall have readily available the following information: the local poison information center telephone number, the physician, clinic, emergency room or comparable medical personnel to be contacted in the event of a medical emergency and the name of the person responsible for decision making in the absence of the provider.

Discussion
Per CTH regulations Subsection (a)(h) of Section 18a-227, the CTH licensee shall provide a "responsible designee who is available at all times if such supervision is necessary as documented in the overall plan of services." Neither the CTH licensee nor the designee make emergency medical decisions. The person responsible, if other than the client, shall be identified in the client's overall plan of service and shall be readily available.

(i) Certified unlicensed personnel shall administer only oral, topical, gastrostomy tube or jejunostomy tube medications, or inhalant medications, suppositories or medications applied to mucous membranes. The prescribing physician may require that the initial administration of suppositories, inhalants, or medication instilled in the ears, nose, eyes, gastrostomy tube or jejunostomy tube be done under the direct supervision of licensed personnel.

Discussion
The physician's request for supervision by licensed personnel of the initial medication administration shall accompany the prescription and/or be documented as part of the physician's written order. The agency's policy will determine how the initial administration shall occur under the supervision of licensed personnel when required by the prescribing physician.

The facility or agency delegating nurse shall provide and document additional training to certified unlicensed staff prior to such staff administering medications via gastrostomy or jejunostomy tube (per agency policy and procedure).

(j) A prescription for medication shall be limited to a ninety-day (90) supply with one refill. The prescribing practitioner shall be notified of this requirement by the employee designated by the residential facility.

Discussion
Orders for prescription medication may be written for up to 180 days which includes refills except where stricter regulations apply, e.g. ICF/MR standards, or unless otherwise specified by the physician.

(k) The supervisor of any residential facility operated, licensed, or funded by the department shall notify the appropriate employee of a client's day program of any medications which the client will take on a regular basis during those hours the person attends the day program.

Discussion

Agencies shall have a procedure that identifies the mechanism for communicating new orders or changes in medication regimens which occur during the day program. The department strongly advises that any changes in medications, even when medications are not to be given during the day program or recreational outing, be communicated to the appropriate parties to ensure client health and safety.

(l) (1) When multiple doses of a given medication are required to be administered to a client at a location other than a residential facility, one of the following procedures shall be utilized: (A) a physician may order a separate prescription in the required number of doses and issue such prescription to the person authorized to administer the medication; (B) each medication container stored in the residential facility for a client may be transported to the other location and given to persons authorized to administer medication at the other location; or (C) a separate properly packaged and labeled medication container may be kept at each location.

Discussion
The intent of this regulation is not to utilize authorized persons in lieu of unlicensed certified personnel but to support involvement in the community with families and friends. Agencies shall have written policies or procedures which address how to handle multiple dosages of medication administered at another site including tracking and documenting medications transported, procedures to be followed if discrepancies occur in transport, and identifying the responsible person.

(1) (2) When a single dose of a given medication is required to be administered to a client at a location other than a residential facility, one of the following procedures shall be utilized: (A) any one of the procedures specified in subsection (l) (1) of this section; or (B) certified unlicensed personnel or licensed personnel may place the single dose in a suitable container and ensure that it is given to persons authorized to administer medication at the other location. The container shall be labeled with the client's name, the drug name and strength and scheduled time and date for administration.

Discussion
Agencies shall have written policies which address:

  • the method for tracking and documenting medications transported from one location to another, including identifying the responsible person and procedures to be followed if discrepancies occur in transport;
  • the method for handling situations where individuals other than certified unlicensed staff may administer medications on specific trips, home visits, or other similar activities with "authorized persons" such as volunteers, family members, friends, or other similar individuals; and
  • how the agency defines "authorized person" for the specific client for each excursion.

(m) The residential facility or day program shall adopt a written policy which specifies the procedure for reporting errors in the administration of medication. Such policy shall include a provision that any such error shall be reported immediately to the supervising nurse or prescribing physician. Such policy shall also specify the procedures to be followed in obtaining medical treatment required as a result of such error and the corrective procedures to be followed in the event certified unlicensed personnel make more than three (3) errors in the administration of medication during a one-month period. Such policy shall be approved by the Division of Quality Assurance of the department.

Discussion
Agencies shall develop policies and procedures which specify personnel actions to be taken in addressing errors in medication administration in the following classes:

Class A - Documentation errors

  • Failure to document according to procedures
  • Failure to secure/maintain keys according to established procedures
  • Failure to submit required documentation relative to medication errors
  • Failure to order/document all medications ordered from pharmacy
  • Failure to follow procedures to maintain an adequate supply of medications and required documentation

Class B: Violation of Rights
Violation of any one of the five rights, i.e. correct person, medication, dose, time, and/or route. Errors of time generally mean more than one hour before or after the scheduled or ordered time.

  • Use of prohibited techniques such as but not limited to unlicensed staff taking physician orders, improper storage or destruction of medications, etc.
  • Transcription errors resulting in the violation of one of the five rights.

Class C: Serious Errors

  • Errors resulting in death or serious injury to client, e.g. hospitalization, injury requiring treatment in a medical facility such as ER, clinic, or physician's office, and/or
  • Prohibited practices such as but not limited to:
  • Falsification of records and/or certification paperwork
  • Administration of medications in the absence of a valid medication certificate (e.g., certificate was suspended, revoked, expired, etc.)

Agency policies shall include:

  1. the mechanism for reporting to supervising nurse or physician and other designated individuals;
  2. procedures for obtaining treatment for involved client;
  3. corrective action to be taken if three (3) errors are made within 30 days from the initial error; and
  4. the method for tracking errors made and corrective actions taken, from the employee's date of certification to his or her annual certification evaluation and biannual recertification.

Agency policies will be reviewed at the time of inspection or by the DMR regional health service director and/or the DMR central office director of health and clinical services.

Department of Mental Retardation (DMR)-operated facilities shall adhere to procedures and sanctions outlined in the Criteria for Assessment of Medication Administration Errors (See Attachment A).

(n) Any error in the administration of medication shall be documented in the client's record and an incident report completed within 24 hours. If the medication error results in the need for medical treatment, such fact shall be noted in the incident report and a copy of such report shall be sent to the appropriate regional health services director and to the Division of Quality Assurance of the department for review or further action as required no later than 48 hours following the error. A copy of the incident report shall be maintained in the client's record.

Discussion
DMR's procedure and format for incident reporting shall be utilized for all medication errors. Class C errors require immediate notification to DMR regional health services director and the Division of Quality Assurance. Per licensing regulations, the DMR regional director shall be notified when the medical treatment included hospitalization.

Sec. 17a-210-3 - Training of Unlicensed Personnel

(a) No employee of either a residential facility or day program, except for community training home providers, may administer medications without successfully completing a department approved training program, which includes but is not limited to, instruction in the following areas:

(1) Theory

(A) Medical Terminology

(B) Drug classifications, including controlled substances, dosage, measurement and forms

(C) Intended purpose and effects of medication

(D) Assessment of drug reactions, including but not limited to, known side effects, interactions and the proper course of action if a side effect occurs

(E) Correct and safe techniques of medication administration including, but not limited to, the correct methods to prepare, administer and chart medication

(F) Prohibited and dangerous techniques of medication administration

(G) Documentation of medication administered to each client, including but not limited to, evaluation, reporting and recording responses of clients to the medication administered

(H) Responsibilities associated with control and storage of medication

(I) Available medication reference texts or other written materials

(J) Lines of authority and areas of responsibility relative to certified unlicensed personnel, licensed personnel and others

(K) State and federal statutes and regulations pertaining to medication.

Discussion
This component shall be taught by a registered nurse, pharmacist or physician who is licensed pursuant to Connecticut General Statutes and who has experience in training persons to administer medications. There are three (3) options to prepare for the written exam for the medication administration certification program. They are:

1. Option A:

Employees may attend the department approved 21 hour course given by the DMR or it's designee. There is no fee for this agencies participating in this option.

2. Option B:

A provider agency may have its registered nurse, pharmacist or physician become endorsed to teach the DMR 21 hour course. DMR supplies the curriculum, student workbooks, and instructor materials to train and certify priority personnel.

3. Option C:

Employees who have previous experience and knowledge may be able to waive the classroom theory instruction and enter the exam directly. This is referred to as "testing in".* An employee can test in, if the agency Executive Director or Regional Director and the supervising nurse in consultation with the residential supervisor, believes the person has sufficient knowledge of the theory to pass the exam. The following criteria should be considered:

  • content of previous training: did the previous training address all the areas described in the regulation?
  • time elapsed since the previous training: did the training occur a long time ago or recently?
  • nature of the experience: how many years/months has the person been administering medications? How long ago was the person's experience?
  • formal educational experience, work history, and comfort with testing.

A letter of recommendation must accompany the registration packet. Using the above criteria, the agency Executive Director or Regional Director must identify in what ways a staff person using option C meets the criteria. Any registration packet submitted without the letter of recommendation will be denied certification until all appropriate requirements have been met.

*It is strongly advised that the employee study, be tutored,, or receive a refresher course prior to taking the exam through Option C.

People participating in the 21 hour department-approved program through Option A (DMR or it's designee) or Option B (endorsed instructor) will complete the training program and take the exam. If the person fails, he or she may retest. Options to prepare for the retest are:

  • repeat the 21 hour program,
  • take a refresher class,
  • self study, and/or
  • tutorial assistance by agency nurse.

This decision will be made on a case-by-case basis with the employee and the appropriate agency personnel (i.e. RN, residential supervisor, etc.) or according to the agency policy.

If the person fails the second attempt, he or she may retest one more time. Options to prepare for this third test are the same as above. If the person fails on the third attempt, he or she begins the process again.

People participating in Option C (test in) will take the test without completing the DMR approved 21 hour program with the following test criteria:

  • If the person fails to test in with a score of 60 or below, he or she must take the 21 hour program through Option A or B.
  • If a person fails the test with a score of 61 or above, he or she may retest one more time. Options to prepare for the retest are: 1) refresher class, 2) self study, and/or 3) tutorial assistance by agency nurse.
  • If the person fails the second attempt, he or she must take the 21 hour program through Option A or B.

A person is limited to a total number of six (6) attempts (tests) for certification. Further requests for considerations for entry into a 21 hour course and/or testing shall be made in writing to the central office medication administrator coordinator, the executive director or DMR regional director, including the rationale for such request.

Registration for Option A:
People must register with the DMR regional medication administration coordinator at least five (5) days in advance of course or test dates. The agency shall ensure that the registration form is complete, including any additional required documentation such as executive director recommendation (drug-related conviction) and/or RN recommendations (lack of high school diploma or GED), and shall retain the original and send a copy to DMR or it's designee.

Testing for all Options:

People must:

  • take the DMR-approved initial exam administered by DMR or its designee;
  • register with the DMR regional medication administration coordinator at least five (5) days in advance of test dates and arrive at the test with a photo identification and a pen or pencil; and
  • arrive at least 15 minutes in advance of the testing time to sign in and receive instructions.

The regional medication administration coordinator will send test scores to each agency contact person.

See Attachment B for a complete outline of the application process including required forms.

 (2) Laboratory Practicum

Discussion
This component shall be taught by a registered nurse, pharmacist or physician who is licensed pursuant to Connecticut General Statutes with experience in training persons to administer medications. The laboratory practicum consists of:

  • demonstration of administration and documentation procedures;
  • return demonstration of administration and documentation procedures by the employee; and
  • successful completion of a competency checklist.

The DMR's (or the DMR designee's) instructor will do the lab practicum along with the theory.

An employee who "tests in" must also complete the laboratory practicum. There are two options for doing this:

(1) labs will be offered through the DMR or designee on an as-needed basis or

(2) an endorsed instructor will teach the lab.

Documentation of the employee's successful completion shall be attached to the application packet and sent to the DMR central office medication administration coordinator.

(3) Worksite practicum under the supervisor of a registered nurse

Discussion
This component shall be done by the provider agency's registered nurse (referred to as the supervising nurse in the regulations) who per regulation, shall supervise the unlicensed, certified employee on an ongoing basis as defined in Section 17a-210-7a of these regulations. The on-site practicum consists of:

  • an orientation to medications, procedures, and systems at the participant's actual worksite;
  • demonstration of administration and documentation procedures; and
  • successful completion of a competency checklist.

All persons enrolled in the certification training program must complete an on-site practicum.

Documentation of successful completion (i.e. Checklists A and B) shall be attached to the application packet and sent to the DMR medication administration coordinator

(b) Community Training Homes

Training shall be provided that is specific to the needs of the clients in residence. A community training home provider may be required by a physician or a regional director to complete a course of instruction in or demonstrate a proficiency in the administration of medication, including requiring such provider to attend the training program provided for herein.

(c) Qualifications of Students

Each residential facility and day program shall select the employees to be enrolled in the training program. Such employees shall be admitted to the training program if they are high school graduates or otherwise qualified to participate in such program and if such employees are approved by the department. A person convicted of a crime involving the manufacture, sale, dispensing, possession, or possession with intent to sell any controlled substance may be denied admission to the training program if after considering (1) the nature of the crime and its relationship to the position to which the certificate applies; (2) information pertaining to the degree of rehabilitation of the convicted person; and (3) the time elapsed since the conviction it is determined that such person is not suitable for admission.

Discussion
Each agency, with it's employee, decides through which option the employee will participate and register the employee with the DMR regional medication administration coordinator. Each agency determines which eligible employees will participate in the program. The department strongly recommends that agencies obtain police checks for drug-related convictions prior to completion of the certification process.

DMR requires the use of the attached registration form (See Attachment B).

If a registrant indicates on registration form that he or she has a drug-related conviction, a letter from the agency executive director (private) or the regional director (DMR) which documents the administrative decision to recommend the registrant for training despite the drug conviction, must accompany registration form (See Attachment B).

If a registrant indicates on the registration form that he or she has had a previous medication certificate revoked, a letter from executive director (private) or regional director (DMR) which documents the rationale for recommending retraining for the registrant, must accompany the registration form.

Agencies retain, and keep secure, all paperwork including registration forms until course, test, lab and on-site practicums are successfully completed and send the originals which comprise the application packet to the DMR central office medication administration coordinator.

(d) Qualifications of Instructors

The training program provided for in Sections 17a-210-1 to 17a-210-9, inclusive, shall be taught by a registered nurse, licensed pursuant to Chapter 378 of the CGS, a pharmacist, licensed pursuant to Chapter 382 of the CGS or a physician licensed pursuant to Chapter 370 of the CGS, with experience in training persons to administer medications.

Discussion
To become an endorsed instructor one must be a registered nurse, pharmacist, or physician with a current license as defined by Connecticut State Statutes, demonstrate experience in teaching people, and demonstrate experience of knowledge in the area of developmental disabilities. Applications may be obtained from the DMR central office medication administration coordinator in the planning and development group and upon completion be sent back to central office. The coordinator will notify the applicant of acceptance and the regional coordinator will provide materials and resources. (See Attachment C for detailed information on instructor qualification and application process.)

(e) (1) Certification

Each person who successfully completes the training program specified in subsections (a) and (b) of this section shall be issued a certificate authorizing him or her to administer medication to clients.

Discussion
See Attachment B for complete instruction packet including forms and checklists. Use of forms provided in Attachment B is required.

Option A (DMR or DMR Designee/agent): agency retains original registration form and sends copy to the DMR designee with the employee. The lab practicum sheet and test results will be sent to the DMR regional coordinator from the DMR designee. The regional coordinator will send the lab practicum sheets and test results to the appropriate agencies. The exam answer sheets will be sent to the DMR central office medication administration coordinator by the DMR designee.

Option B (21-hour endorsed instructor course): endorsed instructor contacts the regional coordinator to get participant handbooks and lab practicum supplies. Upon completion of the theory training and the laboratory practicum, the instructor notifies the DMR regional coordinator to register the employees for exam. The agency retains original paperwork.

 Option C (alternate department-approved program): agency schedules the lab practicum with an endorsed instructor or through the DMR or DMR's designee. The agency registers employees for exams as in Option B through the DMR regional coordinator.

The agency retains all paperwork including registration form until successful completion of course, test, and lab and on-site practicums. The agency retains copies and forwards the originals to the DMR central office medication administration coordinator.

The DMR central office coordinator reviews paperwork, including original examination data, types certificates, logs information in the computer, files paperwork, and sends the certificates to the private agency or DMR regional coordinator as appropriate. The certification date is the date of the successful completion of the on-site practicum.

Central office maintains a list of certified, unlicensed personnel. Agencies who wish to verify certification of new employees may contact:

DMR Central Office
Planning and Development
460 Capitol Avenue
Hartford, CT 06106
860/418-6135

Agencies' procedures shall include:

  • maintaining copies of paperwork,
  • making copies of certificates prior to sending to employees, and
  • maintaining all paperwork and certificate copies in appropriate, secure files.

(e) (2) No person may continue to administer medication beyond two years from the issuance of his [or her] certificate unless such person has met the requirements for recertification established by the department. A person shall be recertified to administer medications if he [or she] successfully completes a department-approved worksite practicum conducted under the supervision of a registered nurse and otherwise remains qualified in accordance with subsection (c) of this section.

Discussion
The medication administration certificate expires every two years. A person must become recertified if he or she intends to continue administering medications in any day program or residential facility as defined in the regulation. No one may continue administering medications beyond the expiration date indicated on the certificate.

For each employee, agencies shall track the employee's certification expiration date provided on the certification card. If the employee does not have a card, the agency coordinator should contact the DMR central office medication administration coordinator for identification of current certificate status and issuance of a verification letter. A person may not administer medications without a valid current card or DMR central office verification letter, in hand.

The department strongly advises that prior to recertification, agencies conduct a police check for drug-related convictions that may have occurred during the person's current certification. If a record of a drug-related conviction is discovered or a registrant indicates on the registration form that he or she has had such a conviction, a letter from the agency executive director (private) or DMR regional director which documents the administrative decision to recommend the registrant for recertification despite the drug conviction must accompany the registration form.

There are two components to the recertification process: a written examination and an on-site practicum which must be completed within 90 days prior to the employee's certification expiration date. There is no order in which the exam and on-site practicum must be completed.

1. Written examination:
The exam tests the employee's knowledge of the theory behind safe administration of medication. It is a multiple-choice exam consisting of 30 questions.

The exam will be administered and scored by each agency. The person administering and scoring the exam must be someone other than the nurse who does the on-site practicum. The department recommends the person administering the exam be a nurse trainer or a manager not participating in the medication administration certification program. Access to the exam shall be limited. The exam shall not be reviewed by participants prior to testing.

The exam will be graded PASS or FAIL. A score of zero to five wrong is a passing grade. A score of six or more wrong is a failing grade. If a person fails the exam, they should participate in further training and may retest until they meet the criteria for passing.

2. On-site practicum:
The practicum requires the employee's demonstration of administration and documentation procedures and provides a re-orientation to medications, procedures, and systems at the employee's worksite.

The on-site practicum consists of two components, a review of agency-specific components and an on-site observation. The on-site practicum must be completed by the supervising nurse and must be someone other than the person giving the written exam. Checklists A and B (See Attachment B) provide detailed information to be covered to complete the on-site practicum. Review the information listed on Checklist A as it pertains to the employee's worksite.

To pass the on-site practicum, employees must successfully complete three medication pour and passes with 100% accuracy. (See Criteria for On-site Practicum for a more detailed description. Please note: the checklist has been revised to include a review of all drugs administered at the site.)

 Once the employee completes the two required components for recertification, the agency shall submit the following to DMR Central Office, Planning and Development (address provided previously in this document).

  • the written examination,
  • the on-site practicum (Checklists A and B), and
  • the registration form.

The DMR central office medication administration coordinator will process the application and issue the certificate.

 Anyone who does not complete the requirements for recertification prior to his or her expiration date must complete the requirements for an initial certification which are: pass a written exam; pass a laboratory practicum; pass an on-site practicum; and submit a registration form and required paperwork to the DMR central office medication administration coordinator. Exceptions will be made for people whose certificates expire while on an approved leave of absence or during a period of non-employment in the field of mental retardation. People in these situations have up to one year to complete the requirements for recertification. However, upon return to work, they cannot pass medication and must complete their recertification within 90 days.

 Completing the Recertification Registration Form (See Attachment B)
Most sections of the registration form are self explanatory. The following is a description of sections that may not be self explanatory:

Part 1 - to be completed by employee. Demographic information: self explanatory.
1) If an employee's certification card has expired prior to completing the certification process, explain why. People whose certification card has expired while on a leave of absence or during a period of non-employment in the field of mental retardation have one year in which to complete the recertification process. All others whose certification has lapsed must go through the process for initial certification.

2) If an employee has a drug-related conviction since his or her initial certification or last recertification, refer to Directive 90-1 (See Attachment D) and attach a letter with the necessary information and recommended action to the registration form.

Part 2 - to be completed by agency supervising nurse or administrator.
Agencies attach the exam answer sheet, Checklists A and B, and a letter regarding any drug-related convictions that have occurred since certification or last recertification (See Directive 90-1, Attachment C, if applicable); sign and date the form to indicate the information is true and complete to the best of your knowledge.

NOTE: If the person is in the process of certification revocation, do not submit paperwork for recertification until an outcome has been determined

(e) (3) Any employee of a residential facility or day program who holds a certificate or equivalent documentation authorizing such employee to administer medication in another state may apply to the department for a certificate authorizing him or her to administer medication in this state. The department may issue such certificate, in lieu of the successful completion of the training program provided for in this program, if:

 (A) the department finds that the applicant successfully completed a training program substantially similar to or of greater scope than that required by the department;

(B) the applicant submits the certificate or equivalent documentation to the department for purposes of verification; and

(C) such certificate or equivalent documentation was issued no later than two years preceding the date of the application.

Discussion
The registration form and documentation/verification of equivalent training must be submitted to the DMR central office planning and development division. Employees shall not administer medications in Connecticut until a Connecticut DMR certificate is issued.

Sec. 17a-210-4 - Self Administration of Medications

Clients who are able to self administer medication, as defined in these regulations, may do so, provided a physician writes an order for self administration.

Discussion
The client must be able to identify medication by size, color, amount or other label identification. He or she must be able to identify time of day medication is administered, independently or with employee prompt or adaptive device, such as alarm clock or medication dispenser. Staff providing such (indirect) assistance do not have to be medication certified when the client is fully self medicating. However, if any direct assistance or supervision by staff is necessary, such staff shall be medication certified.

Supervision of self-administration program training to the client shall be provided by the supervising nurse or certified unlicensed staff. It is strongly recommended that the IDT acknowledges and evaluates the client's ability to self medicate at the time of the OPS.

Agency procedures shall indicate how they will address over-the-counter medications for those clients who self administer their own medications.

Sec. 17a-210-5 - Storage and Disposal of Medications

(a) All medications, except for controlled substances, shall be kept in a locked container, cabinet, or closet used exclusively for the purpose of storage of medications. All controlled substances shall be stored in accordance with Section 21a-252-10 of Regulations of State Agencies.

Discussion
All medications must be self contained and properly packaged in a locked area. Controlled substances shall be stored as outlined in Connecticut Regulations of State Agencies, Department of Consumer Protection, 21a-252-10 (See Attachment E).

(b) Medications requiring refrigeration shall be stored separately from food. If a separate refrigerator is not available, these medications may be placed in a locked container in the same refrigerator in which food is stored. The temperature of the refrigerator shall be maintained between 36-46 degrees Fahrenheit.

(c) Access to medications shall be limited to persons authorized to administer medications. Each residential facility and day program in which certified unlicensed personnel may administer medication must maintain a current list of those persons authorized to administer medications on its premises.

Discussion
"Authorized" is defined as certified and/or licensed in this section.

Agency procedures shall include the process for handling keys and security procedures to limit access to certified and/or licensed staff. The list of persons authorized to administer medications shall be updated annually and need not be posted, but must be available upon request. Copies of staff medication certificates shall be maintained in the facility.

(d) Medications for clients who are permitted to self administer medication in accordance with these regulations shall be stored in such a way as to make them inaccessible to other clients. Such medications shall be stored in a locked container or area unless the supervising nurse makes a determination that unlocked storage of the medication poses no threat to the health or safety of the client or other clients.

Discussion
Agencies shall have a written procedure that details the way individual client medications are stored and that includes the nurse determination that storage poses no threat to health and safety of other residents. The supervising nurse shall provide necessary documentation if unlocked storage is permissible.

(e) All medications shall be stored in their original prescription containers.

(f) Unused, outdated or unlabeled medications shall be destroyed by licensed or certified unlicensed personnel by incineration or by flushing into a sewerage or septic system in the presence of at least one witness. When unused, outdated or unlabeled controlled substances are destroyed, proper documentation shall be made on the receipt and distribution form or forms.

Discussion
Agencies shall provide a written procedure for drug disposal and identification of individuals designated with authority to destroy medications and ensure that appropriate documentation is available. It is strongly recommended that licensed staff witness drug destruction on all occasions.

Sec. 17a-210-6 - Documentation

(a) All documentation on the administration of medications shall be made in ink.

Discussion
Agencies shall provide a procedure which includes all elements of documentation requirements.

(b) A copy of all physician's orders shall be maintained in the client's file.

Discussion
Copies of dental and other practitioner orders shall also be retained in client file.

(c) A physician's or dentist's verbal orders, including telephone orders, for any medications can only be received by licensed personnel as defined in these regulations. The physician or dentist shall sign such verbal orders as soon as is practicable, but not later than two weeks from the date of receipt of the verbal order.

Discussion
Verbal and/or telephone orders are to be communicated to licensed persons (RN, LPN, or Pharmacist) only. Such orders shall be client specific, indicate purpose, amount and duration of order, and include pertinent information to allow appropriate implementation. Orders may be communicated per the following:

  1. Telephone orders: Telephone orders are defined as orders given by a physician or other authorized prescriber to a licensed person (RN, LPN, or pharmacist) over the telephone which must be documented on an order sheet by the licensed person who accepted the order. These orders shall be countersigned by the prescriber no later than two weeks (14 days) from date of receipt. For the purpose of these regulations, the term "verbal order" should be interpreted to mean a telephone order.
  2. Verbal orders; Verbal orders are defined as orders given to a licensed person (RN, LPN, or Pharmacist) while in the presence of the prescriber. The department advises that the prescriber be asked to write the order rather than accepting a verbal order. If a verbal order is taken, it shall be documented on an order sheet by the licensed person who accepted the order and shall be countersigned by the prescriber within the time frames given in number 1, above.
  3. Faxed orders: Faxed orders are defined as written orders by a physician or other legally authorized prescriber that are sent via facsimile machine to the person's home or pharmacist. Such orders, previously considered to be telephone orders, are now considered original orders and therefore, do not need to be countersigned by the prescriber.

(See Attachment F: DMR Health Bulletin #97-1 (Revised July 1999), Medication Ordering Guidelines for DMR Licensed/operated Facilities.)

(d) Any change in medications or dosage levels of medications shall be treated as a new medication for the purpose of documentation.

(e) Documentation of each administration of all medications shall be made by the residential facility or day program on a separate medication record for each client.

Discussion
Medication documentation records are retained as part of a client's permanent medical record. (Physician's orders, progress notes and laboratory and diagnostic test results are also considered to be a medical record which must be maintained as part of the client's permanent record.)

A copy of medication record from day program must be returned to residential client file.

(f) Medication records shall include the following information:

1) The client's name
2) The name of the medication
3) The name of the prescribing physician
4) The dosage
5) The frequency of administration
6) The route of administration
7) The initials and signatures of employees who have administered the medication
8) The renewal date of the prescription
9) Whether the medication was administered
10) When the medication was administered
11) The expiration date of the prescription
12) Client allergies to food and medication
13) Cooperation of the client in accepting medications

Discussion
For number 7) above, employee signatures means the employee's full, legal signature. Medication names shall not be abbreviated and shall be documented on the prescription. If the medication is abbreviated on the pharmacy label, the kardex must contain both the full name and abbreviated name. If the prescription has the medication trade name and the pharmacy label has the generic name, the kardex must list both names.

Client cooperation shall be documented only when the client is resistive or non compliant. This is considered to be a client unusual incident, not an employee medication error. Agency policy should address how to address client resistance or non-compliance that occurs frequently.

(g) The receipt by a residential facility or day program of each prescription for a controlled substance and the documentation of the administration of such controlled substance shall be made on a receipt and disposition form or forms.

Discussion
Agencies shall have procedures for receipt of controlled substances from pharmacies and staff documentation procedures including the location of receipts and disposition forms.

The supervising nurse shall document regular (at least quarterly) review of controlled substance receipt and disposition as required in Subsection 7 (3) of these regulations.

(h) The receipt and disposition form or forms shall include the following information:

l) The client's name
2) The prescription number
3) The prescription date
4) The name of the pharmacy
5) The name of the prescribing physician
6) The date of receipt of the controlled substance
7) The quantity of the controlled substance
8) The name of the medication
9) The dosage
10) The form of the medication
11) The signature of the employee who received the controlled substance
12) The frequency of administration
13) The route of administration
14) The renewal date of the prescription
15) The initials and signatures of employees who have administered the medication
16) The month, day, year, and time the medication was administered
17) The amount of medication remaining
18) The expiration date of the prescription
19) Client allergies to food and medication

Discussion
Agency policies and procedures shall indicate the method and frequency of control drug counts. It is strongly recommended that a count be conducted on each shift that medications will be administered. Control drug counts shall be done only by medication certified staff.

 Agency policies and procedures shall indicate the process for reporting and investigating incorrect control drug counts, including reporting missing drugs to the DMR Regional Health Service Director.

(i) Any errors in the administration of medications shall be documented on accordance with Section 17a-210-2(l) and (m) of these regulations.

(j) At the end of each month, the client's medication record shall become a permanent part of the client's record. The receipt and disposition form shall be kept in a location separate from the client's medical record.

Sec. 17a-210-7 - Supervision and Quality Assurance

(a) The supervising nurse or physician of the residential facility or day program shall:

(1) Supervise the initial worksite administration of medications by certified unlicensed personnel and document such supervision.

Discussion
The initial administration of medications shall be observed by the supervising nurse or physician at the employee's worksite and documented on Checklist B. The supervising nurse's observation that occurs during the on-site practicum, if successfully completed, constitutes "supervision of the initial worksite administration of medications."

The supervising nurse or physician shall supervise and document an initial worksite administration of medications by any employee who holds a current certificate and is newly employed by the agency. Documentation of this observation completed by the supervising nurse shall be maintained as per agency policy.

(2) Make periodic observations of the administration of medications by certified unlicensed personnel at least annually and document such observations.

Discussion
Subsequent to the initial worksite observation, the supervising nurse shall observe each certified unlicensed personnel administer medications at least once annually at the employees usual worksite. This annual observation shall be done one year prior to the certificate expiration date (plus or minus four weeks). Documentation of the supervising nurse's observation shall be maintained as per agency policy. The department advises use of Checklist B as the documentation tool. Such documentation shall be made available upon request.

(3) Monitor and document on an ongoing basis, but at least quarterly, documentation pertaining to the administration of medication. Review shall include, but not be limited to: (a) physician or dentist orders; (b) medication bottle labels and medications listed on the medication record and receipt and distribution form or forms to determine whether they match the orders of the physician or dentist and (c) the medication record and receipt and disposition form or forms to ensure that they contain the following information: medication error documentation; whether medication was administered as prescribed; compliance or noncompliance of the client; the existence of full signatures for all initials used by persons documenting the administration of medication.

Discussion
At least four times a year on a quarterly schedule, the supervising nurse shall review documentation to ensure the following:

  • orders are current and transcribed to medication record correctly;
  • pharmacy labels match physician's orders;
  • controlled substance receipts and disposition forms match prescriber's orders;
  • all components of Sec. 6 A-J are in compliance and
  • employee full signatures (employee's legal signature and title) are present.

If the record review shows that a client demonstrates a pattern of noncompliance with medication administration as determined by agency policy and procedure, a referral should be made to the IDT to review and address.

(4) Submit a written report to the appropriate regional health services coordinator if such physician or nurse has information which appears to show that:

(A) Any certified unlicensed personnel has failed to administer medication in accordance with the training received pursuant to Section l7a-210-3(1) (E) and (F) of these regulations, or

Discussion
The supervising nurse shall ensure the following:

  • incident reports are available on employees who are demonstrating noncompliance with regulations;
  • employee records reflect documentation of corrective action taken as a result of errors per agency policy; and
  • reports must be submitted to regional health services director in accordance with agency policy.

(B) Any certified unlicensed personnel has otherwise failed to comply with these regulations. Such report shall be submitted within five (5) working days from the date the supervising nurse or physician conclude that a report is required to be submitted to the health services coordinator pursuant to this subsection of the regulations, provided that such written report shall be submitted immediately and oral notice shall immediately be given if such physician or nurse believes that the life, health, or safety of a client is in jeopardy.

Discussion
The five-day timeframe refers to a report that includes the incidents and previous actions taken in response to the medication errors. The supervising RN/physician shall use the the Report of Non-Compliance with Medication Regulations report form (See Attachment G) and shall include the supervising nurse/physician's recommendation for agency action such as retraining or department sanctions: probation, suspension, or revocation.

 In reviewing requests for department sanctions, the regional health services directors will use criteria for assessment of medication administration errors (Attachment A, Criteria for Assessment of Medication Administration Errors) as basis for evaluation of the agency's recommended action. DMR-operated facilities shall comply with the recommended sanctions and corrective actions as outlined in the aforementioned criteria detailed in Attachment A.

If the life, health or safety of client is believed to be in jeopardy, immediate verbal notice of action taken with written report submitted within two working days to the regional health services director is required.

(5) Such physician or nurse may rely on information concerning the performance of certified unlicensed personnel acquired as a result of complying with the requirements set forth in subsections (1), (2), and (3) of this section in making a determination as to whether a report should be submitted pursuant to subsection (4) of this section. Such persons may also rely on the incident reports documenting errors in the administration of medications in making such a determination.

Discussion
Basis of report reflects noncompliance of requirements as outlined in Sections (7) (a) (1),  (7) (a) (2), and (7) (a) (3).

Agencies shall adhere to DMR incident report procedures and shall use incident report forms in providing supporting documentation.

(6) Such report shall include, but not be limited to, the following information:

(A) the name of the employee

(B) the specific section or sections of the regulations with which the employee failed to comply,

(C) the basis for the belief that such employee failed to administer medication in accordance with the training received pursuant to Section 17a-210-3 (E) and (F) of these regulations or has otherwise failed to comply with these regulations.

(D) the written document or documents upon which such nurse or physician relied in submitting the report.

(E) recommendations concerning whether any of the sanctions authorized by Section 17a-210-8 of these regulations should be imposed as a result of the failure of certified unlicensed personnel to comply with these regulations. If the supervising nurse or physician recommended the imposition of these sanctions, such persons shall specify the recommended sanction for each alleged violation.

Discussion
The supervising nurse/physician shall submit a written report using attached "State of Connecticut DMR Report of Non-Compliance with Medication Regulation's form to the appropriate regional health services director (Attachment G) as follows:

  • within five (5) days of the verbal notification of a Class C error;
  • within five (5) working days of a 3rd Class A or B error within 30 days from the initial error; and/or
  • when a med-certified staff fails to demonstrate ability during the supervising nurse's quarterly audit and annual observations, to apply knowledge and skills in accordance with training as noted in DMR Medication Advisory Regulation, Section 3 (1) (E) and (F), namely: Theory, Correct and Safety Techniques; and Prohibited and Dangerous Techniques.

The supervising nurse/physician shall indicate on the attached form, the regulation section(s) with which the certified unlicensed staff has failed to comply and shall attach the following additional documents:

  • written documentation of medication errors, including copies of DMR "Other Incident report forms or other agency medication reporting forms; and
  • a report of agency corrective actions, including dates of counseling, retraining, and any other corrective actions taken.

Copies of all documentation and recommendations shall be maintained by the agency in a confidential personnel file.

When DMR or a private agency becomes aware of a drug-related conviction of an employee who is currently certified by DMR to administer medications, the following shall occur:

  • The administrator shall immediately suspend the employee's medication administration responsibilities pending agency review.
  • Following this review and a review of the personnel directive 90-1, the agency executive director or DMR regional director shall submit a letter regarding the recommended action(s) (e.g., request that certification be revoked, retained for a probationary period, etc.) and all other related documentation shall be sent to the DMR regional health services director.
  • The DMR regional health service director shall review the materials, request more information if necessary, and forward to the DMR director of health and clinical services for review.
  • The DMR central office director of health and clinical services shall review the documentation and refer to the commission for action as necessary.

Section 17a-210-8 - Sanctions

(a) The regional health services director, after review of the reports submitted to them pursuant to Section 17a-210-7 of these regulations and any other investigation they deem appropriate, shall make written recommendations to the commissioner concerning whether the certificate of any certified unlicensed personnel should be suspended or revoked or whether other conditions should be imposed on the continued administration of medication by certified unlicensed personnel.

Discussion
Upon receipt of submitted reports, submitted on the DMR Certified Unlicensed Personnel Sanctions Request Form (See Attachment G), the regional health services directors shall:

  • review the documentation and recommendations;
  • state their conclusions;
  • make written recommendations to the central office director of health and clinical services for review on the sanctions request form; and
  • send copies to the appropriate DMR or private agency manager and for DMR employees to personnel.

The director of health and clinical services shall:

  • review documentation, requesting further information as necessary;
  • make written recommendation; and
  • forward these recommendations to the commissioner for final action.

(b) The commissioner, after review of the recommendations submitted pursuant to Section 8 (a) of these regulations and any other information he deems appropriate, may suspend or revoke a certificate or may impose probationary conditions such as further training or supervision of certified unlicensed personnel, if he finds that such employee has failed to comply with these regulations or has failed to administer medication in accordance with the training received pursuant to Section 3 (1) (E) and (F) of these regulations.

Discussion
Upon receipt of the director of health and clinical services recommendations, the commissioner of DMR shall determine the sanction to be imposed, such as: suspension, probation, revocation and shall notify the person via certified mail, with copies to the central office medication administration coordinator and to other appropriate DMR or agency staff and/or managers such as DMR personnel (for DMR employees).

Only the commissioner may revoke or suspend certification issued by the department. Actions by the commissioner concerning and individual's certification are separate and distinct from any progressive disciplinary action which may be taken by an employer.

(c) If any error in the administration of medication constitutes abuse or neglect of a client, as defined in Section 46a-11a of the CGS, Section 17b-407 of the CGS, or Section 14a-401 of the CGS, a report of such suspected abuse or neglect shall be made in accordance with these sections.

Discussion
If abuse or neglect of a client is suspected, the incident shall be reported and investigated pursuant to Sections 19a-458, 17-135 or 17-38a and/or PA 97-2 as amended by PA 133 of the C Connecticut General Statutes. With the exception of Class C errors which shall automatically be reported for investigation in the abuse/neglect system, medication errors will be addressed through the medication error sanction process and would NOT rise to the level that would warrant report and investigation in the abuse/neglect system.

Sec. 17a-210-8 - Hearing on Revocation or Suspension of Certificate

Any person aggrieved by the decision of the commissioner to revoke or suspend a certificate in any way may, within twenty (20) days after receipt of a notice of revocation or suspension of a certificate, submit a written request to the commissioner for reconsideration of his or her decision. Within twenty (20) working days after receipt of such request, the commissioner or his/her designee shall conduct an informal hearing, at which the health services coordinator and the employee may present written or oral evidence.

The commissioner or his/her designee shall render a decision within twenty (20) working days after the hearing. The decision of the commissioner or his or her designee shall be final. Revocation or suspension of a certificate shall be stayed pending the outcome of such hearing except where the health services coordinator has determined that the continued administration of medication by the aggrieved employee would threaten the life, health or safety of a client or clients. In the absence of a request for a reconsideration during this time period, the certificate shall either be revoked or suspended.

Discussion
The commissioner or his or her designee shall inform the person of the informal hearing via certified mail, with copies to the appropriate agency personnel, DMR regional health services director and the central office medication administration coordinator and director of health and clinical services. The commissioner or his or her designee shall consult the Office of the Attorney General as appropriate. The DMR regional health service director, the person's supervising nurse, and other appropriate agency personnel shall attend the informal hearing to provide additional written or oral evidence.

The commissioner or his or her designee shall inform the person of his or her final decision via certified mail within 20 working days of the informal hearing, with copies to the central office medication administration coordinator, the director of health and clinical services, the DMR regional health service director, and other appropriate DMR or agency staff and managers.

Copies of all sanction requests and decisions shall be maintained in a confidential file.


Attachments: (Not all are available online - see Regional Contact)

Attachment A: Criteria for Assessment of Medication Administration Errors
Attachment B: Complete outline of the application process including required forms
Attachment C: Detailed information on instructor qualification and application process
Attachment D:
Attachment E: CT Regulations of State Agencies, Dept of Consumer Protection, 21a-252-10
Attachment F: DMR Health Bulletin #97-1
Attachment G: Report of Non-Compliance with Medication Regulations, and DMR Certified Unlicensed Personnel Sanctions Request Form 



Content Last Modified on 11/7/2007 3:08:54 PM