Regulatory Compliance

This is Unit Twenty-Nine of Medical Assistant Prep. Unit Twenty-Eight kept the record honest. This unit gathers the other federal rules a practice lives under: workplace safety, laboratory certificates, controlled substances, and the reports the law and the practice require. Carry one idea through this lecture. Compliance is daily practice, and a discrepancy or incident is reported at once rather than handled quietly. A constructed count that did not match closes the unit. By the end you will be able to name the three federal programs and what each requires. To place controlled substances in their schedules. To store, count, record and report them as required. And to make the other reports the law and the practice expect.

Four entries on the programs: the three agencies, workplace safety, laboratory certificates and inspections.

Agencies and rules.

MAS 701 Three Agencies, Three Kinds of Rules

Three federal programs shape daily compliance in a medical office: workplace safety, laboratory testing and controlled substances. Workplace safety rules protect staff; laboratory rules govern testing on human specimens; drug enforcement rules govern controlled substances. State rules often add to federal ones, so the practice's policies reflect both.

Daily, not a binder.

MAS 702 Workplace Safety Compliance

Workplace safety compliance rests on the bloodborne pathogens and hazard communication standards from unit ten. The practice keeps a written exposure control plan, provides protective equipment and training, offers the hepatitis B vaccine, and keeps safety data sheets accessible. Compliance is daily practice, not a binder on a shelf.

Tests the practice may run.

MAS 703 CLIA Certificates

Any site that performs laboratory testing on human specimens needs the right federal laboratory certificate for the tests it runs. Certificates include a certificate of waiver for waived tests only, a certificate for provider-performed microscopy, and certificates of registration or compliance for more complex testing. Running a test the practice's certificate does not cover is a compliance violation.

Records every day.

MAS 704 Laboratory Inspections

Laboratories with certificates beyond a waiver are subject to inspection requirements. A certificate of compliance, for example, is issued after an inspection finds the laboratory meets all applicable requirements. Keep testing records, quality checks and instructions in order every day, not only before an inspection.

Five entries on controlled substances: what they are, and schedules one through five.

Five schedules.

MAS 705 Controlled Substances

Controlled substances are drugs regulated under federal law because of their potential for abuse and dependence. They are placed in five schedules, from schedule one, the highest abuse potential with no accepted medical use, to schedule five, the lowest. Every controlled substance in the office must be stored, counted and recorded under strict rules.

No accepted use.

MAS 706 Schedule One

Schedule one substances have a high potential for abuse and no currently accepted medical use in treatment in the United States. Examples listed in the federal schedules include heroin and LSD. These substances are not prescribed in a medical office, and none should ever be found in one.

Strictest prescribable.

MAS 707 Schedule Two

Schedule two substances have a high potential for abuse that may lead to severe dependence, but they have an accepted medical use. Examples include opioids such as morphine, oxycodone and fentanyl, and stimulants such as amphetamine and methylphenidate. Schedule two prescriptions carry the strictest rules of the prescribable schedules.

Moderate dependence.

MAS 708 Schedule Three

Schedule three substances have less abuse potential than schedules one and two, and an accepted medical use. Examples include certain codeine combination products, buprenorphine products used to treat opioid addiction, ketamine and anabolic steroids. Abuse may still lead to moderate physical or high psychological dependence.

Lower, still controlled.

MAS 709 Schedules Four and Five

Schedules four and five have progressively lower potential for abuse, and accepted medical uses. Schedule four includes tramadol and benzodiazepines such as alprazolam, diazepam and lorazepam; schedule five consists mainly of preparations with limited amounts of certain narcotics. Lower schedule does not mean no risk; all are controlled.

Six entries on handling: storage, inventory, records, refill limits, theft or loss, and your part.

Limited access.

MAS 710 Locked Storage

Practitioners must store controlled substances in a securely locked, substantially constructed cabinet. Access to the keys or codes is limited to authorized staff, following the practice's policy. Never leave the cabinet unlocked, even for a moment between patients, and never share keys or codes with anyone.

At least every two years.

MAS 711 Inventory Every Two Years

Practices registered to handle controlled substances must take a new inventory of all stock at least every two years. The inventory is in addition to the ongoing records of what is received, dispensed or administered. Many practices count far more often; follow the practice's schedule.

Two years, every unit.

MAS 712 Keeping Controlled-Substance Records

Required controlled-substance records must be kept for at least two years and be available for inspection. Records include inventories and records of receipt and use, kept so that every unit can be accounted for. A missing record is treated as seriously as a missing drug.

Six months, five refills.

MAS 713 Refill Limits

Federal rules limit refills on controlled-substance prescriptions. Prescriptions for schedule three and four substances cannot be filled or refilled more than six months after they were issued, or refilled more than five times. Refill decisions belong to the provider; route every controlled-substance refill request to them.

Reported to the agency.

MAS 714 Theft or Significant Loss

A theft or significant loss of controlled substances must be reported to the federal drug enforcement agency. The report is made on DEA Form one hundred six, as the rules require, after the practice is notified. If a count does not match, tell your supervisor at once; do not recount quietly and hope it resolves.

No shortcuts.

MAS 715 Your Part in Controlled-Substance Compliance

Medical assistants help with controlled-substance compliance only as the practice allows, with no room for shortcuts. Handle them only if your state and practice permit it and you are trained. Keep them locked at all times, never sharing keys or codes. Record every unit received, given or wasted at the time it happens, with any required witness. Route every prescription or refill request to the provider. Report any discrepancy, suspected theft or loss immediately. Most problems begin as small recording lapses, so exact, immediate records and reporting rather than covering protect everyone.

Seven entries close the unit: reportable diseases and incidents, workplace and patient-safety reports, record review, changing rules, and a constructed count.

Through the provider.

MAS 716 Reportable Diseases

Some communicable diseases must be reported to public health authorities. Requirements vary by state, but practices routinely report certain diseases through the provider and the practice's process. Know your practice's reporting process; the provider usually decides when a report is needed, and the practice submits it.

Abuse, wounds, bites.

MAS 717 Other Reportable Incidents

State laws require reporting of certain other situations seen in health care. Commonly required reports include suspected abuse of children, older adults and other vulnerable people, gunshot wounds and dog bites. Bring anything that may require a report to the provider promptly, and record what you observed.

Same day.

MAS 718 Reporting Workplace Incidents

Workplace incidents, such as needlesticks and chemical exposures, are reported through the practice's process. Reporting starts the follow-up care the worker is owed and lets the practice correct the cause. Report the same day, every time, however minor the incident seems, because delays can limit follow-up care.

How a practice learns.

MAS 719 Reporting Patient Safety Incidents

Errors and near misses involving patients are reported through the practice's incident process. The report triggers a review of what happened and why, so the system can be fixed. An incident report is not a confession or a punishment; it is how a practice learns.

Contractors read records.

MAS 720 Records Can Be Reviewed

Federal contractors review medical records to confirm that billed services were documented and necessary. Services are expected to be documented when they are provided; corrections and late entries must show their date and author, and reviewers refer suspected fraudulent entries for investigation. Document every day as if a reviewer will read it, because one may.

Current policy.

MAS 721 Rules Change

Regulations, schedules and code sets change over time. Federal agencies update their rules, drugs are added to or moved between schedules, and laboratory test categories are revised. Follow the practice's current policies and training, not what you learned years ago or saw at another job.

One unit short.

MAS 722 A Count That Did Not Match

A constructed count pays off the opening idea. At day's end, an assistant and a nurse, each with their own access, find one medication one unit short of the record. She does not suggest recounting until it matches or assume a slip. A careful recount gives the same result, and checking the day's records shows one administration where the wasted portion was not witnessed and documented as required. They report to the supervisor and provider at once and document exactly what they found. The supervisor investigates, including whether it is a theft or significant loss to report to the drug enforcement agency, and the practice retrains everyone on wasting. Recounting until it matched would have hidden the gap, which would have caused the same shortfall the next week.

Look at what you can now do. You can name the three federal programs and what laboratory certificates cover. You can place controlled substances in their five schedules, from no accepted use to the lowest abuse potential. You can explain locked storage, inventories, two-year records and refill limits, and report a mismatch at once. And you can make the reports the law and the practice require, and follow current rules. Unit Thirty, the capstone, follows one patient visit from start to finish.