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Based on observation, a review of hospital documentation, contracted service reports, hospital committee meeting minutes, e-mail communications, interviews and policies, it was determined that the hospital did not meet the Condition of Participation for Pharmaceutical Services by failing to:

1. Maintain compliance with federal and state laws including United States Pharmacopeia Chapter 797 (USP-797).

2. Ensure the day-to day operations of the pharmacy were effectively supervised.

3. Ensure pharmacy policies/procedures were implemented and/or approved in accordance with the hospital's development and management policy.

Please refer to A-492

Based on observation, a review of hospital documentation, contracted service reports, hospital committee meeting minutes, e-mail communications, interviews and policies, the hospital failed to ensure that the day to day operations of Pharmacy services were adequately supervised to maintain compliance with federal and state laws including United States Pharmacopeia Chapter 797 (USP-797) and/or

On 8/23/17, the IV room hood failed inspection and the facility stopped production of IV compounding in that room. Although an "ad hoc" policy was developed that directed staff to compound medications utilizing the biological safety cabinet in the chemo room, staff failed to follow this directive and commenced compounding in the IV room on 8/30/17. As of 9/6/17, 87 medications were compounded and administered to 47 patients (Patient #23-#67, 69, and #70). During an onsite visit on 9/11/17, it was identified that the facility halted compounding in the IV room on 9/7/17 resulting in Immediate Jeopardy corrected.

The findings include:


a. Review of the environmental monitoring (EM) report identified that five samples were obtained and sent to an independent lab on 9/20/16 for processing. The final report dated 9/29/16 identified 23 colony forming units (CFU) of bacteria in the anteroom, (action limit for ISO class 7 is >10 cfu's). Review of email correspondence dated 9/30/16 between the Sterile Products Coordinator and a consulting microbiologist, identified that the aforementioned results were noted with a recommendation to re-clean and re-test the anteroom with a field control to confirm compliance. Review of facility reports and interview with the Sterile Products Coordinator on 9/12/17 during the period of 3 PM-4 PM stated he was unable to locate evidence that cleaning and/or retesting was completed as this testing was prior to his hire date of 1/9/17. The hospital failed to provide documentation of remediation.

According to USP 797 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.


b. The 4/6/17 certification report's environmental sampling log indicated that the Sabouraud Dextrose Agar (SDA) plates for fungal organisms were "incubated at 25°-30° for 5-7 days". Review of the EM Data Sheet noted that the Sterile Products Coordinator incubated the samples during the period of April 5-12 at 31° Celsius (C) on 4/5/17, 4/6/17, 4/7/17, 4/8/17, 4/10/17, and 4/11/17 and at 30° C on 4/9/17 and 4/12/17. Review of the viable air sampling policy directed that the SDA plates are incubated at 26-30° C for 5-7 days.


Additionally, the environmental sampling log indicated that the sample was collected on "WED 05 APR 17" but failed to indicate the date on which the results for either the SDA or Tryptic Soy Agar (TSA) plates were determined. Review of the reports and interview with Sterile Products Coordinator on 9/12/17 during the period of 3 PM-4 PM stated he utilized the fungal incubator at hospital #2 and subsequently realized the temperature range set for the incubator was not in compliance with the policy.


c. Review of the 4/6/17 viable air sample results indicated 6 cfu's (alert level) of micrococcus luteus located on the IV room (ISO 7 room) counter. Review of the reports and interview with Sterile Products Coordinator on 9/12/17 during the period of 3 PM-4 PM stated that the cfu was below the 797 action level (10 cfu's) therefore he didn't implement the policy for retesting. The Sterile Products Coordinator further stated that he reports all abnormal EM results to the pharmacy Director. Review of the viable air sampling policy identified that if the results exceed the designated alert level but do not exceed the action level, re-test the areas affected at the end of that particular work day/shift. Report any out of limit results to the pharmacy Manager or designee immediately.


d. Review of the semiannual cleanroom certification testing conducted on August 23, 2017, identified 2 holes in the HEPA filter for the Air Flow Workbench (LAFW) in the IV room. The 2 holes in the filter were unrepairable and required replacement. Email correspondence dated August 25, 2017 identified that the Sterile Products Coordinator contacted CT Drug Control to inform them that the LAFW failed on August 23, 2017, was immediately taken out of service, and replaced with a new LAFW which was cleaned and certified on August 24, 2017. An "ad hoc" procedure was developed by the Sterile Products Coordinator that directed staff to use the Biological Safety Cabinet (BSC) located in the chemo room to prepare both hazardous and non-hazardous Compounded Sterile Preparations (CSP).

The plan further identified that the entire cleanroom complex would be cleaned utilizing the monthly cleaning protocols, after cleaning with the disinfectant, all surfaces will be allowed to dry, and the entire process will be repeated using sterile 70% IPA to remove the cleaner residue. Once the cleaning has been completed the clean room complex will be
tested for viable surface and airborne particles utilizing Tryptic Soy Agar (TSA) and Sabouraud Dextrose Agar (SDA) active air sample plates and surface sample plates with Lecithin & Polysorbate 80 will be used. Upon completion of all testing, test results and reports will be provided to CT Drug Control for review and approval to resume operation of the new LAFW.

Subsequent email correspondence dated August 29, 2017 from the Sterile Products Coordinator to Drug Control (copied on the email was the Pharmacy Director and Pharmacy Manager), identified that the preliminary environmental monitoring (EM) testing results completed on August 24, 2017 showed 2 Active Air (AA) samples collected from the anteroom. The 2 active air sample plates grew 15 and 28 cfu's of micrococcus luteus, exceeding the 10 cfu recommended action levels for microbial contamination for an ISO 7 room.

The plan identified that the LAFW will remain out of service until final microbial report has been received, reviewed, and approved by CT Drug Control. The beyond-use-date (BUD) for all CSP's will be set at 12 hours until further notice. The cleanroom complex will be re-cleaned and following re-cleaning then will be re-tested. A "Safety Stand-Down" will be in place for all pharmacy personnel. The Infection Control Department will be consulted as part of the pharmacy's review and "Safety Stand-Down."

Review of the environmental monitoring (EM) report dated 9/4/17 identified the following was a re-test of the clean room complex following a cfu count above action levels. The report noted specimens were incubated resulting in 4 cfu's located on the ante room sink. The plates were sent to an independent lab for genus level identification.

Although an "ad hoc" procedure was developed on 8/23/17 that directed staff to compound medications utilizing the biological safety cabinet in the chemo room, staff failed to follow this directive and commenced compounding in the IV room on 8/30/17. During the period of 8/30/17 until 9/7/17, 87 medications were compounded and administered to 48 patients.

Review of the cleaning documentation identified that the Pharmacy Manager and a Technician cleaned the cleanroom complex on 9/1/17, however, only one cleaning occurred when action levels were reached failing to implement the Sanitization of the Controlled Sterile Compounding Environment policy. The policy directed that three-time cleaning of controlled environments should occur before the introduction of new equipment (LAFW installed 8/24/17) and/or after action levels are exceeded occurring during environmental monitoring air or surface sampling procedures.

Interview with the Sterile Products Coordinator on 9/12/17 during the period of 3 PM-4 PM stated he developed the 'ad hoc" procedure on 8/23/17 and informed both the pharmacy Director and Manager of the tentative contingency plan to compound in the chemo room and not to use the IV room until cleared by CT Drug Control.

Interview with the Pharmacy Director on 9/11/17 at 9:30 AM stated that a miscommunication occurred and the IV Room was utilized to compound medications from 8/30/17 until it was shut down on 9/7/17. The Director further identified that the surface and air samples obtained on 9/4/17 were sent to an independent lab and were still pending.

Interview with the Pharmacy Manager on 9/12/17 at 4PM stated he misinterpreted the direction from the Director resulting in the use of the IV room by himself and a few Technicians. The Manager was unable to identify what a "safety stand-down" meant, in reference to the designated plan dated 8/29/17, and was not asked to notify the infection control department that the IV room was out of service. The Manager further identified that he was not informed of any previous cfu concerns.

Interview with the Infection Preventionist #2 on 9/12/17 at 11:25 PM stated she was notified via email on 9/9/17 (received 9/11/17) that patients' received compounded medications in the IV room that should have been closed.

Interview with the Infection Control physician on 9/12/17 at 1:25 PM stated he was made aware that 47 patients received IV medications compounded in the IV room during the period of time when EM cultures were pending. The physician indicated the 8/26/17 and 9/4/17 final EM results were still pending therefore could not speak to risk factors posed to the affected patients until knowing that information and it was his understanding that fungal cultures were not part of the obtained samples. The physician identified he was informed that a deep cleaning of the cleanroom was completed between 8/29/17 and 9/1/17 thus lowering the risk to the patients who received medications after 9/1/17.

Interview with the Hospital President on 9/12/17 at 1PM identified that he was made aware that the LAFW was switched out, but unaware that the IV room was closed and subsequently used in error until last week. The President stated he sits on almost all of the medical executive meetings and would expect cfu reporting up to the Board of Directors and at this point in time, that was not happening.

e. Review of the following policies indicated they were established and implemented during the period of 3/7/17-5/29/17 by the Sterile Products Coordinator absent approval by the Executive Leadership Team:

i: Sanitization of the Controlled Sterile Compounding Environments. Section 3.15.1 is incomplete.
ii: Hand Hygiene and Garbing
iii: Surface Sampling
iv: Viable Air Sampling
v: Certification and Preventative Maintenance of Controlled Environments and Related Equipment
vi: Hazardous Drug Compounding Techniques
vii: HD Spill, Deactivation and Waste Management

Interview with the Sterile Products Coordinator on 9/12/17 during the period of 3 PM-4 PM stated he wrote the policies and there was no formal structure for approval. The Coordinator stated there was no documentation that identified staff were educated to the aforementioned policies.

Review of the Policy Development and Management policy identified that the Executive Leadership Team maintain exclusive authority to approve hospital wide policies and policy related components and include the Chief Operating Officer, VP of Nursing, VP of Medical Affairs, and Director of Human Resources.

f. Interview with the Sterile Products Coordinator on 9/12/17 during the period of 3 PM-4 PM identified that he collects the surface and air samples and transports them over to hospital #2 where he incubates then reads the culture results. Interview with the Pharmacy Director on 9/13/17 at 2PM stated that although a cooler was used to transport the samples, the hospital did not have a standard operating procedure/policy for this practice.

g. Review of air and surface sampling logs during the period of 4/6/17-9/4/17 indicated that samples were collected and evaluated by the Sterile Products Coordinator (SPC). There was no documentation of the Sterile Products Coordinator being trained on Active Air Sampling, Surface Sampling, or CFU Evaluation. On 9/13/17, the Pharmacy Director provided the surveyor with critical point modules completed by the Sterile Products Coordinator dated 9/8/17 titled, Viable Facility Sampling Metrics-Volumetric Air Sampling, and on 9/13/17 completed a module titled, Viable Facility Sampling Metrics-Surface Sampling. The hospital failed to ensure that the SPC was evaluated for competence to perform his assigned duties.


h. Review of the Pharmacy and Therapeutics (P&T) committee minutes during the period of 9/7/16 through 6/7/17 lacked evidence that the facility incorporated into the QAPI program abnormal results of air and surface sampling in the compounding area. The 6/7/17 minutes reflected the July and August meetings will be cancelled, may reschedule if emergent issues arise or virtual email meeting conducted. The minutes reflected that the Pharmacy Manager and/or the Pharmacy director attended these meetings. Interview with the pharmacy Director on 9/13/17 at 1:15 PM stated there was turn-over with staff and moving forward would ensure abnormal EM results be reported to the appropriate QAPI committees.

i. Review of the pressure log for the non-hazardous IV room dated 8/7/17, 8/8, 8/10, 8/12, 8/13, 8/15, 8/16, 8/17, 8/28-8/31/17 indicated abnormal results. Interview with the Sterile Products Coordinator on 9/12/17 during the period of 3 PM-4 PM stated the data was inconsistently entered by staff members rendering an inability to determine if the results were within normal limits.


Review of the job description for the Sterile Products Coordinator indicated responsibility to schedule and oversee required biannual testing of cleanrooms, maintains records, reviews reports from outside vendors, and makes recommendations to leadership on required actions. The Coordinator provides continuous quality control in the sterile compounding area and makes recommendations to supervisors as appropriate. The SPC reports to the Regional Director of Pharmacy.

Review of the job description for the Manager of Pharmacy reflected responsibility for the overall day-to-day activities of the Pharmacy department relating to control, distribution, monitoring, and dispensing of prescription drug products. The Manager supervises staff Pharmacists and Technicians. The Manager ensures policies and procedures of the department are upheld. The Manager reports to the Regional Director of Pharmacy.

Review of the job description for the Regional Director of Pharmacy indicated responsibility for promoting, and supporting all aspects of a high reliability organization to ensure the highest level of quality and safety standards are adhered to. The Director manages the daily operations of the pharmacy and is responsible to ensure that divisional operations conform to local, state, and federal government regulations. And complies with established policies, procedures, and work processes of the organization and department. In addition the Director of Pharmacy serves on inter and intra-department committees representing and coordinating the services provided by the Division. The job description indicated the Director of Pharmacy reports to the Vice President of Clinical Operations.

Based on observation, review of facility documentation, contracted service reports, interviews and policy review it was determined that the hospital did not meet the Condition of Participation for Infection Control by failing to:

1. Ensure the Infection Control program was comprehensive to include high risk areas including surveillance of the hospital's pharmacy.


Please refer to A-749

Based on a review of hospital documentation, contracted service reports, hospital committee meeting minutes, interviews and policies, the hospital failed to demonstrate that the Infection Control program was comprehensive and included high risk areas such as the pharmacy to ensure a safe environment was maintained when compounding medications. The findings include:


a. Review of the environmental monitoring (EM) report dated 9/29/16 identified 23 colony forming units (CFU) of bacteria in the anteroom, (action limit for ISO class 7 is >10 cfu's). The 4/6/17 viable air sample results indicated 6 cfu's (alert level) of micrococcus luteus located on the IV room (ISO 7 room) counter. Review of the semiannual cleanroom certification testing conducted on August 23, 2017, identified 2 holes in the HEPA filter for the Air Flow Workbench (LAFW) in the IV room. The 2 holes in the filter were unrepairable and required replacement. Email correspondence dated August 25, 2017 identified that the Sterile Products Coordinator contacted CT Drug Control to inform them that the LAFW failed on August 23, 2017, was immediately taken out of service, and replaced with a new LAFW which was cleaned and certified on August 24, 2017. An "ad hoc" procedure was developed by the Sterile Products Coordinator that directed staff to use the Biological Safety Cabinet (BSC) located in the chemo room to prepare both hazardous and non-hazardous Compounded Sterile Preparations (CSP).

The plan further identified that the entire cleanroom complex would be cleaned then tested for viable surface and airborne particles and upon completion of all testing, results and reports will be provided to CT Drug Control for review and approval to resume operation of the new LAFW.

Subsequent email correspondence dated August 29, 2017 from the Sterile Products Coordinator to Drug Control (copied on the email was the Pharmacy Director and Pharmacy Manager), identified that the preliminary environmental monitoring (EM) testing results completed on August 24, 2017 showed 2 Active Air (AA) samples collected from the anteroom. The 2 active air sample plates grew 15 and 28 cfu's of micrococcus luteus, exceeding the 10 cfu recommended action levels for microbial contamination for an ISO 7 room.

The plan identified that the LAFW will remain out of service until final microbial report has been received, reviewed, and approved by CT Drug Control. The beyond-use-date (BUD) for all CSP's will be set at 12 hours until further notice. The cleanroom complex will be re-cleaned and following re-cleaning then will be re-tested. A "Safety Stand-Down" will be in place for all pharmacy personnel. The Infection Control Department will be consulted as part of the pharmacy's review and "Safety Stand-Down."

Facility documentation identified that during the period of 8/30/17 through 9/7/17, 87 medications were compounded in the IV room and administered to 47 patients (Patient #23-#67, 69, and #70). During an onsite visit on 9/11/17, it was identified that the facility halted compounding in the IV room on 9/7/17 resulting in Immediate Jeopardy corrected.

Interview with Infection Preventionist #2 on 9/13/17 at 12:45 PM stated she was notified via email on 9/9/17 (received 9/11/17) that patients' received compounded medications in the IV room that should have been closed. Infection Preventionist #2 further identified that environment of care rounding is conducted biannually in the pharmacy, however, does not include surveillance of the compounding areas.

According to the Infection Control Plan & Risk Assessment, a component of the plans purpose was to collect and analyze data relevant to epidemiology/infection prevention and review, approve and promote the application of all policies and procedures related to infection surveillance, prevention and control activities in all departments/services. The plan indicated that a risk assessment would be performed to identify key internal and external infection vulnerabilities that can inhibit efforts to prevent and control infections through the organization.

According to the USP 797, highly pathogenic microorganisms, to include mold, must be immediately remedied regardless of the colony forming unit count, with the assistance of a competent microbiologist, IC professional, or industrial hygienist.


b. Review of environment of care rounding tool dated 4/6/17 and 8/24/17 identified that Infection Preventionist #1 and a Quality representative toured the pharmacy. The environmental rounds/inspection did not include inspection of the ante room, IV chemotherapy room or IV room. The results of the audit were sent to the Pharmacy Manager for review. Interview with Infection Preventionist #2 on 9/13/17 at 12:45 PM stated she had no follow-up information to determine if the issues were remediated.

c. Review of the Infection Control Committee minutes dated 7/21/16 noted a positive result from air sampling in the clean room bio-safety cabinet where chemo is prepared. The meeting minutes dated 8/18/16 noted growth under the hood in chemo room. Chemo room air pressure was too negative and ante room was too positive with a plan to install a switch to better control the negative and positive pressure. Further review of the meeting minutes during the period of 9/16/16 through 8/17 failed to identify that staff reported back on subsequent and/or new pharmacy issues. Interview with Infection Preventionist #2 on 9/13/17 at 12:45 PM stated that a member from pharmacy should attend the monthly infection control meetings, however, there was a turnover in staff and a representative has not been attending.

Interview with the Director of Quality on 9/13/17 at 1:30 PM stated the Infection Control Committee reports go to the Medical Executive Committee for review then to the Board of Directors. The Director confirmed that issues related to abnormal cultures and any other pertinent pharmacy concerns were not discussed at these meeting but moving forward would be.

d. Review of the monthly QAPIC meeting minutes during the period of 12/16 through 6/15/17 failed to indicate that a pharmacy representative reported abnormal EM results. Interview with the Director of Quality on 9/13/17 at 1:30 PM stated the monthly QAPIC meeting minutes are reviewed by the Board of Directors and going forward, senior leadership would ensure pertinent pharmacy issues would be included to ensure the Board is made aware of any concerns.