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Based on observation during tour, review of facility documentation, contractor reports, email correspondence, interviews, and policy review, it was determined that the hospital failed to meet the Conditions of Participation for Pharmaceutical Services by failing to:


1. Ensure that all primary engineering controls (PEC) were tested and/or that highly pathogenic microorganisms noted during environmental testing in the clean rooms were immediately remedied in accordance with USP 797 standards and/or policies.

2. Demonstrate a microbiological state of control of the clean rooms following work performed by the facility engineering department and/or ensure that staff recognized and addressed concerns noted in the clean rooms resulting in the inability to support USP 797 beyond use dates.

On 2/14/18, the facility provided the Department with an immediate action plan that included in part, institution of a 12 hour beyond-use date (BUD), the removal of loose screws noted on top of the BSC, caulking of the sink followed by terminal cleaning of the IV compounding rooms, environmental monitoring, and recertification of the clean rooms.

Please refer to A-501

1. Based on observation, review of facility documentation, contractor reports, email correspondence, interviews, and policy review, the hospital failed to provide the necessary supervision of Pharmacy services to ensure that all primary engineering controls (PEC) were tested in accordance with USP 797 standards and/or policies and/or that highly pathogenic microorganisms noted during environmental testing in the ante and/or chemo rooms were immediately remedied in accordance with USP-797 standards.

The findings include:

a. Review of certification and environmental reports during the period of 2/25/16 through 12/21/17 identified that primary engineering control 1 (LAFW) located in the chemo room, had no viable air and/or surface samples obtained for microbial growth and/or was certified every six months in accordance with USP 797 standards. Observation of the compounding rooms on 2/14/18 at 10 AM noted that the chemo room had one biological safety cabinet in use and an LAFW which had been out of service since 12/2015. Interview with Pharmacy Technician #8 on 2/14/18 at 10:40 AM stated the LAFW is included in the daily cleaning, however, not operational. Interview on 2/14/18 at 11:30 AM with the CEO/President identified that the plan was to remove the LAFW once the Cancer Center pharmacy was operational. Review of the certification policy directed that PEC's would be certified every six months. Review of the environmental monitoring surface sampling policy directed that a sampling plan will be identified that includes each PEC and should be performed at least quarterly. Review of the environmental monitoring air sampling policy directed to sample all PEC's at least every six months.

b. Review of the action plan form dated 4/14/17 identified that environmental testing of the ante and chemo rooms was completed on 3/22/17 with the final report received on 4/14/17 that noted actionable sterile white hyphae (mold) on the floor and on the cart in the ante room. The ante room floor, cart, and sink was cleaned on 4/14/17 and a terminal clean was conducted on 4/17/17. Re-testing was conducted on 4/19/17 with notification on 4/24/17 that preliminary results show no actionable levels. Review of the environmental report dated 4/19/17 identified an actionable level of gram negative rods were noted in the ante room in the air, a discrepancy noted from the action plan dated 4/24/17. A terminal clean was not conducted until 5/2/17.

c. Review of the environmental testing report dated 8/3/17 noted actionable sterile white hyphae on the cart in the ante room with appropriate interventions taken. Review of the re-test completed on 8/26/17 identified actionable sterile white hyphae in the air of the ante room. Review of facility documentation failed to indicate that remediation was taken until a terminal cleaning was done on 9/12/17.

d. Review of the environmental testing report dated 9/21/17 noted actionable levels of mold (Cladosporium) in the air of the ante room. The action plan dated 9/27/17 noted the actionable mold (final genus and species pending) with a plan to consult infection control, requested a work order to replace pipes that were corroded and caulk around the sink, remove faucet aerator, and replace ceiling tiles in the pharmacy. The plan further noted that a terminal clean would be done and re-testing of the ante room once work orders were complete. A terminal clean to address the mold growth was not conducted until 10/10/17.

Review of email correspondence dated 10/18/17 between the pharmacy Manager and Certification Company #1 identified that Staphylococcus, Corynebacterium, and Micrococcus (noted during testing on 9/21/17) were considered human contaminants, the remediation plans dated 10/18/17 failed to address personnel work practices and/or cleaning procedures in accordance with facility policy.

Review of the environmental reports and interview with the Interim Pharmacy Manager on 2/14/17 at 11:10 AM stated she is new in her role and couldn't speak to interventions during the aforementioned periods discussed.

Review of USP 797 standards directed in part, the counts of colony forming units (cfu's) are to be used as a measure of the environmental microbial bioburden. Regardless of the number of cfu's identified in the pharmacy, further corrective actions would be dictated by the identification of microorganisms recovered (at the genus level). Highly pathogenic microorganisms (e.g. Gram-negative rods, coagulase positive staphylococcus, molds and yeasts) can be potentially fatal to patients receiving CSP's (compounded sterile products), and must be immediately remedied, regardless of cfu count, with the assistance of a competent microbiologist, infection control professional, or industrial hygienist. Additionally, a cfu count that exceeds its respective action level should prompt a re-evaluation of the adequacy of personnel work practices, cleaning procedures, operational procedures and air filtration efficiency within the aseptic compounding location. An investigation into the source of the contamination shall be conducted, the source shall be eliminated and re-sampling performed.

Review of the Cleaning and Disinfecting policy directed that sterile preparation rooms, including the anterooms and buffer rooms will be cleaned and disinfected at regular intervals and when microbial contamination is known to have been introduced into the compounding area.


2. Based on a review of hospital documentation, contracted service reports, hospital committee meeting minutes, interviews and policies, the hospital failed to ensure microbiological state of control following work performed by the facility engineering department.

The findings include:


Review of certification reports from contracted service #1 identified that the anteroom and buffer rooms were certified on 8/18/16, 2/6/17, and 8/3/17. Review of work orders for corrective maintenance during the period of 1/5/17 through 11/20/17 identified the following:

a. Caulked light in the IV room.

b. Trap is leaking in the sink located in the ante-room. Installed new trap.

c. Replaced sink in the ante-room.

d. Both pre-filters changed.

e. New sink is leaking. Changed trap.

f. Chipping paint in the IV room, caulking falling off. Repainted/touchup walls around sink, recaulked ceiling grid and recaulked around light fixtures.

g. Faucet is leaking and spraying in the ante-room sink. Installed new eyewash station on faucet.

h. Touched up wall paint, recaulked around door, sealed cracked seam in corner and base of corner sink wall, touched up paint.

i. Cut out old caulk bottom of door frame and resealed. Taped off top of the sink and repainted top and behind sink in corner.

j. Changed two pre-filters.

k. The pipes on the sink are corroded and must be replaced. There should be caulking around the sink. Painted pipes with 2 coats of epoxy paint. Caulked back and rear of stainless sink.

l. Installed new antibacterial laminar flow aerator in the ante-room sink.

m. Installed plastic wall conduit to hide wires that runs to the booster, caulked seams. Recaulked around sink.

n. Remove screws on the wall and fill with caulk and paint.

o. Install mop brackets in the ante-room and the IV room. Drilled out the two holders from the mounting bracket, installed 2 stainless holders with stainless screws in the clean room and ante-room, caulked around brackets, and recaulked the ante-room door frame on the lower left side.

Interview with the CEO on 2/14/18 at 2PM identified that the prior Manager managed the certification process and that it was his understanding that the rooms did not require recertification with minor projects.

Review if USP 797 standards identified certification of each ISO classification area (ISO 8, ISO 7, ISO 5) is within established guidelines and shall be performed by a qualified individual no less than every 6 months and whenever the device or room is relocated or altered or major service to the facility is performed.






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3. Based on observation, review of facility documentation, review of contractor reports, interviews, and policy review, the hospital, who compounds sterile pharmaceuticals, failed to maintain a steady state of control in accordance with Federal and/or state laws, and United States Pharmacopeia, Chapter 797, Pharmaceutical Compounding - Sterile Preparations standards.

The findings include:


On 02/14/18 at 10:0 AM and at various times throughout the day during a tour of the pharmacy hazardous/non-hazardous chemotherapy mixing room and ante room with the Director of Engineering, Pharmacy Manager and Hospital CEO the following was identified:

a. The ceiling light fixtures in the Ante Room and Mixing Room were not installed in a fashion promoting the effective cleaning procedures, the light covers were installed upside down not allowing for them to be free from particulates and able to be cleaned.

b. The plastic hangers attached to the wall in the Ante Room were not secured to the wall properly and sealed with caulk to allow for effective cleaning of the area.

c. The flooring at the door area entering the Ante Room were of VCT style tiles and not continuous vinyl flooring as the remaining area not allowing for the effective cleaning of the area.

d. The low air return vents in the Ante Room and Mixing Room had filters which showed dirt/debris on them.

e. The doors to the Ante Room and Mixing Room had brush style floor guards installed on them not promoting a sanitary condition.

f. The doors to the Ante Room and Mixing room had mechanical locking devices in the door and strike plate penetrations in the frame which were not sealed not allowing the rooms to be free of voids and penetrations for effective cleaning and certifications.

g. The doors to the Ante Room and Mixing Room had porous brush gasketing installed on the frames not allowing for effective cleaning of the areas.

h. There were foam/sponge type materials located under four corners of the LAFW which is currently not in use not allowing for effective cleaning and sanitary conditions.

i. The Biological safety Cabinet had loose nuts and washers on the top of the cabinet which were removed from the exhaust canopy and never replaced back to their original position.

j. The sink in the Ante Room was not secured to the wall properly and had caulk that was not sealing the void against the wall.

k. There was a non-certified LAFW hood in the mixing room which has been out of service since 2015. Interview with the Interim Pharmacy Manager on 2/14/18 at 2:00 PM stated that although the LAFW was not in use, staff clean the machine in accordance with policy.

Review of certification reports from contracted service #1 identified that the anteroom and chemo rooms were certified on 8/18/16, 2/6/17, 8/3/17, and 1/10/18.

Review of the cleaning logs during the period of 1/2/17 through 1/31/18 identified that numerous pharmacy staff performed daily cleaning of the sink, hoods, surfaces (tables, carts, sills, and ledges), chemo hood tray, and floors.

Review of the terminal cleaning logs during the period of 8/1/16 through 2/10/18 identified that contracted service #1 mopped and sanitized ceilings and walls, clean and sanitized designated surfaces including benches, carts, and hoods, doors, glass, and the exterior of equipment located in the ante and chemo rooms.

Interview with Pharmacy Technician (PT) #10 on 2/14/18 at 11:45 AM stated that he intermittently observed the terminal cleaning on 2/8/18 by a contracted service representative. PT#10 further identified that although he was trained how to conduct daily and terminal cleaning when he was hired (7/31/16), there was no training for the observation of contracted company #1.

Interview with the Interim Pharmacy Manager on 2/14/18 at 2:00 PM stated that the facility did not have a policy that directed staff on the monitoring of terminal cleaning by the contracted company. The Interim manager was unable to identify why the aforementioned concerns were not addressed.

Review of the aforementioned concerns and interview with the Regional Infection Control Practitioner on 2/14/18 at 3:00 PM stated that facility staff should have seen the issues and addressed the problems noted.

According to USP 797, Engineering Control Performance Verification- PECs (LAFWs, BSCs, CAIs, and CACIs) and secondary engineering controls (buffer and ante-areas) are essential components of the overall contamination control strategy for aseptic compounding. As such, it is imperative that they perform as designed and that the resulting levels of contamination be within acceptable limits.

Review of the job description for the Manager of Pharmacy reflected responsibility for the management and coordination of resources on a daily basis including anticipation and identification of potential problems in either direct pharmaceutical care and/or assigned area of operations with facilitation of an effective resolution of problems.

On 2/14/18, the facility provided the Department with an immediate action plan that included in part, institution of a 12 hour beyond-use date (BUD), the removal of loose screws noted on top of the BSC, caulking of the sink followed by terminal cleaning of the IV compounding rooms.