Tips for Surviving a CMS Survey
Standards and Regulations taken from FORM CMS-2567(02-99)
*Bolded states regulation *{Italicized provides examples of area competency}**Documentation
A 492482.25 (1)PHARMACIST RESPONSIBILITIES
A full-time, part-time, or consulting pharmacist must be responsible for developing, supervising, and coordinating all the activities of the pharmacy services.
{record review and interviews will take place to ensure pharmacist supervises and evaluates performance and competency of pharmacy personnel who provide pharmacy services pharmacy services when the Consultant Pharmacist (PIC) is not on the premises}
**Necessary documents: include evidence of COMPETENCY EVALUATIONS and ORIENTATION for pharmacy/drug room personnel specifically for the pharmacy/drug room by the Consultant Pharmacist (PIC).
A 494482.25(a) (3) PHARMACY DRUG RECORDS
Current and accurate records must be kept of the receipt and distribution of all scheduled drugs.
{record review and interviews will take place with hospital staff to ensure that a system is in place to track all scheduled drugs from the point of entry into the hospital to the point of disposition either through the administration to patients or wastage. Records must be current and accurate, reconciled by pharmacy personnel and the system provides documentation in a readily retrievable manner. Surveyors may ask staff if periodic review of documentation of doses given and wastage documented are done by pharmaceutical services. Surveyors may also ask if drug discrepancies are analyzed and trended to determine possible diversion.}
**Necessary documents:Partial Dose Administration and Wastage Documentation and DRUG DIVERSION PREVENTION POLICY and current and accurate records of controlled inventory.
A 505482.25(b)(3) UNUSABLE DRUGS NOT USED
Outdated, mislabeled, or otherwise unusable drugs and biological must not be available for patient use.
{record review, observation, and interviews with hospital staff will take place to ensure facility as a system in place to identify outdated, mislabeled or unusable drugs in the hospital. Routine inspections of all medication storage areas must be done and documented by pharmacy/drug room personnel to identify outdated, mislabeled or unusable drugs. Examples of findings could include missing documentation of monthly inspections of all medication storage areas in hospital, outdated drugs in radiology department or crash carts, IV fluids or solutions in warmer or hood not properly labeled with date made and expiration date and a temperature log kept, or unlabeled syringes.}
**Necessary documents: MONTHLY INSPECTION OF MEDICATION STORAGE AREAS throughout hospital by drug room personnel and PIC, POLICY FOR MONITORING EXPIRED OR UNUSABLE MEDICATIONS.
A 508482.25(B)(6) PHARMACY: REPORTING ADVERSE EVENTS
Drug administration errors, adverse drug reactions, and incompatibilities must be immediately reported to the attending physician and, if appropriate, to the hospital’s quality assessment and performance improvement program.
{record review and interviews with hospital staff must ensure that medication errors identified by the hospital are measured, analyzed and tracked. Review of Medical Staff Meetings minutes should have evidence of review, analysis or tracking of medication errors identified in incident reports. Quality Assurance Performance Improvement (QAPI) program or medical staff meeting minutes should have evidence and documentation that medication errors are reviewed, analyzed or tracked.
**Necessary documents:POLICY FOR REPORTING AND TRACKING MEDICATION ERRORS AND ADVERSE DRUG EVENTS and MEDICATION INADVERTENT INCIDENT REPORTING FORM.
A 535482.26(b) SAFETY POLICY AND PROCEDURES
The radiologic services, particularly ionizing radiology procedures, must be free from hazards for patients and personnel.
{interview and observation will include IV bags used for procedures, that should include patient name, date, and single use procedure. High level disinfectants (HLD) will be inspected to ensure proper storage and use including within date inspection and temperature log and test strip results. Product information and MSDS sheets should be kept and readily accessible for staff. Policy and Procedure should be written including method for use as well as staff education and competency exams. Crash carts will be inspected for in-date medications as well as proper materials included and clean packaging. A crash cart contents sheet is recommended to be placed on top of cart as a reference tool for personnel during evaluations of the carts content and operations. Monthly monitoring recommended to ensure compliance and safety.
**Necessary documents:MONTHLY INSPECTION OF MEDICATION STORAGE AREAS throughout hospital by drug room personnel and PIC (including labs and crash carts) , POLICY FOR MONITORING EXPIRED OR UNUSABLE MEDICATIONS (including those medications contained within lab and crash carts).