2016 Plan of Correction Data 1

Transcription

1 2016 Plan of Correction Data 1 Retail Data Calendar Year Number of Inspections number of Plan of Correction s (POC s) issued Regulatory Citations 2 & number of POC s issued upon Retail Display Licensure and Registration of Pharmacy Staff Manager of Record Pharmacy Interns and Technicians Controlled Substance Records Equipment, Facility, and Drug Storage Refrigeration CQI 4 4 Immunization Regulatory Citations number of POC s issued upon Retail Display Licensure and Registration of Pharmacy Staff Manager of Record Pharmacy Interns and Technicians Controlled Substance Records Equipment, Facility, and Drug Storage Refrigeration CQI 0 0 Immunization Page 1 of 2

2 Regulatory Citations number of POC s issued upon Retail Display 5 7 Licensure and Registration of Pharmacy Staff 5 4 Manager of Record Pharmacy Interns and Technicians 9 11 Controlled Substance Records Equipment, Facility, and Drug Storage Refrigeration CQI 4 4 Immunization 25 5 POC Statistics for Calendar Year 2016 Plan of Correction Issued upon Retail Per Month January February March April May June July August September October November December Plan of Correction Issued upon Retail Information is an estimate based off information available as of January 27, as defined in Acts of 2014 Ch159 a retail drug organization that operates 10 or more retail drug stores within the commonwealth Page 2 of 2

3 Level 1 Plans of Correction Associated with for 2016 Reviewed Pursuant to Enforcement Policy for Inspections Conducted in January 2016-December Plans of Correction Received Approved POC that adequately address the deficiencies and brings the pharmacy into compliance with applicable laws and regulations; Approved POC, conditioned upon a satisfactory re-inspection and completion of follow up Reject the POC in entirety and require the licensee to resubmit a POC that adequately corrects all deficiencies; or Refer the matter to the Triage Group for further investigation Licensure and Registration of Pharmacy Staff Registration 247 CMR 8.04 (1)(1) and 247 CMR 8.07 (3)(b) Supervisory Ratios 247 CMR 8.06 (3) Primary Areas of Deficiency Regulatory Citation A pharmacy technician shall carry, or have readily available, at all times where the pharmacy technician is employed, evidence of current registration with the Board. (247 CMR 8.07(3)(b)) Pharmacy technicians currently registered with the Board and certified by a Board-approved certifying body, may perform the duties as authorized to be performed by a certified pharmacy technician in 247 CMR 8.04 (2) (Evidence of current National Certification required). (247 CMR 8.04 (1)(a)) Manager of Record Supervisory ratio observed out of compliance in violation of (247 CMR 8.06 (3)) 1. 1:4 One pharmacist for a maximum of four support personnel; provided: a. at least one of the four support personnel is a certified pharmacy technician and one is a pharmacy intern; or b. at least two of the support personnel are certified pharmacy technicians. 2. 1:3 One pharmacist for a maximum of three support personnel; provided at least one of the three support personnel is a pharmacy intern or a certified pharmacy technician. (247 CMR 8.06 (3)) Pharmacy Interns & Technicians (247 CMR 8.03 (3, 2a), 247 CMR 8.01(11), and 247 CMR 8.04(2)(a)) Pharmacy Interns and Technicians An individual may act and be designated as a pharmacy technician trainee for not more than 1000 hours, unless an extension is granted by the Board. Pharmacy technician trainees under the age of 18 are not subject to the 1000-hour limitation. (247 CMR 8.03 (3)) A pharmacy intern shall wear a name tag which indicates the intern's name and the words "pharmacy intern". (247 CMR 8.01(11)) A pharmacy technician eligible to function as a certified pharmacy technician shall wear a name tag with the individual's name and the title "Certified Pharmacy Technician". (247 CMR 8.04(2)(a)) A pharmacy technician shall wear a name tag which indicates the individual's name and the title "Pharmacy Technician". (247 CMR 8.03(2)(a))

4 Perpetual Inventory (14) Biennial (1) (21 CFR (a) Sanitation 247 CMR 6.02(1) Equipment 247 CMR 6.01 (5) (a) (5) Balance 247 CMR 6.01 (5) (a) (4) and 247 CMR 9.01 (1) Sink 247 CMR 6.01 (5) (a) (7) Expired Meds (10) Signage Controlled Substance Records Observed discrepancies in the perpetual inventory log in violation of (1) and 21 CFR (d); Expired schedule II medications were not inventoried in violation of 247 CMR 9.01 (14); Biennial inventory not available at the time of inspection (247 CMR 6.07 (1) (b), 247 CMR 6.07 (1) (i), (1) and 21 CFR (a)). Biennial inventory not to date in violation of (1) and 21 CFR (a); Equipment, Facility, and Drug Storage The general premises of the pharmacy was visibly dirty in violation of 247 CMR 6.02(1). Unsatisfactory equipment necessary to conduct the practice of pharmacy noted in violation of (247 CMR 6.01 (5) (a) (5)). Balance test and seal out of date in violation of (247 CMR 6.01 (5) (a) (4) and (1)). Observation of damaged and unsanitary pharmacy sink counter and cabinet in violation of (3), USP Chapter <795> and 247 CMR 6.02)(1) Observation of expired medications on pharmacy shelves were found in violation of (10) Display Pharmacy hours were not posted at the consumer entrance of the pharmacy in violation of 247 CMR 6.02 (8)(a)) Pharmacy permit, MA controlled substances registration, and DEA registration not posted in violation of 247 CMR 6.02(3) (a) (b)(c)(d) No signage in store entrance displaying MOR (247 CMR 6.02 (7)) No sign identifying the presence of a pharmacy or pharmacy department. (247 CMR 6.02 (5)) 11" x 14" Signage informing consumer of their rights not posted pursuant to 247 CMR 9.07 and to M.G.L. c. 94C, 21A, (247 CMR 9.07 (3) (c)) No sign identifying designated consultation area (247 CMR 6.01 (5) (d) (1)) 4" x 5" signage informing consumer of lock boxes not posted 247 CMR 9.01 (1)) (Session Laws: Ch. 244 Section 6 (b) of the Acts of 2012) Refrigeration Refrigeration compliant refrigerators observed. (Dorm style refrigerators) (247 CMR 9.01 (1) and (5) and Board Policy No ). Pharmacy refrigerators and freezers are not kept clean, organized and defrosted ( (1) and (5) and Board Policy No ). Refrigerators and freezers do not provide adequate space for amount and type of medications stored by the pharmacy ( (1) and (5) and Board Policy No ). Refrigerator temperatures were not consistently recorded, nor within required temperature range, in violation of (1) and (5) and Board Policy No ; Expired medications were found in a refrigerator in violation of 247 CMR 9.01 (10);

5 USP <795> Compounding BUD (3) (USP Chapter <795>) CQI (247 CMR 15) Immunization (1) (105 CMR (6) CPR 247 CMR 6.01 (5)(a)(3) Vaccines (1)) (105 CMR (6) (c) (3) Pharmacy does not have adequate space specifically designated for compounding prescriptions ( (3) and USP <795>). Compounding equipment such as graduated cylinders used for compounding were visibly dirty in violation of (3) and USP Chapter <795>; Written standard operating procedures did not cover all significant procedures performed in the compounding area in violation of 247 CMR 6.07 (1)(d) and (e), (3), and USP Chapter <795>; Master formulation records for compounded medication were not available. (3), USP Chapter <795>; Compounded medication did not contain labeling indicating this is a compounded preparation in violation of (3) and USP Chapter <795>; Excessive amounts of outdated compounding chemicals were found in the compounding area, violation of (3) and USP Chapter <795>; Material Safety Data Sheets for employees working with drug substances or bulk chemicals were not readily accessible in violation of (3) and USP Chapter <795> Documentation to support extended Beyond Use Dates (BUD s) were not available in violation of (3), USP Chapter <795>; API used for compounding was not labeled with an open date for determining the BUD assignment ( (3)) (USP Chapter <795>). CQI Pharmacy is lacking a complete Continuous Quality Improvement Program including policy and procedure and corrective action in violation (247 CMR 15) Immunization Unable to provide immunization certificates during the inspection in violation of ( (1)) (105 CMR (6) (c)) Unable to provide CPR certification during the inspection in violation of (247 CMR 6.01 (5)(a)(3)) Expired vaccines were found in a refrigerator in violation of (247 CMR 9.01 (1)) (105 CMR (6) (c) (3)) Inconsistent temperature monitoring log for refrigerator in violation of (1)) (105 CMR (6) (c) (3)) Information is an estimate based off information available as of January 27, as defined in Acts of 2014 Ch159 a retail drug organization that operates 10 or more retail drug stores within the commonwealth