Bringing transparency to federal inspections
Tag No.: A0043
This condition is not met as evidenced by:
Based on review of hospital documentation including time lines of contaminants in the pharmacy, hospital committee meeting minutes, hospital corrective action plans, e-mail communications, observations, hospital policies and procedures and staff interviews, the hospital failed to meet the condition of Governing Body as evidenced by the following 5 areas:
1. The Governing Body failed to ensure that services offered and provided meet the Medicare Conditions of Participation. The areas of identified noncompliance include Pharmaceutical Services and Physical Environment related to recurrent actionable levels of microbial growth in the hospital's Intravenous (IV) preparation areas (September 2012, September 2013, and September 2014) and/or the hospital's response to the contaminants in the IV preparation areas and/or the condition of the hospital pharmacy environment.
a. For the year 2012: The Board of Directors Quality and Credentialing meeting minutes dated 10/23/12 identified that the recent closure of outside Compounding Pharmacy's #1 and #2 had resulted in a significant increase in work load for the hospital pharmacy, and that staffing needs in the hospital pharmacy were under review. Review of the Board of Directors meeting minutes dated 11/20/12 failed to identify that the increased work load was reviewed and/or addressed. Review of Governing Body minutes for the time period of 01/19/12 through 12/12/12 failed to identify the impact of the closure of Compounding Pharmacy #1 and Compounding Pharmacy #2 on the hospital pharmacy including safety concerns, increased workload, consideration of staffing needs and/or the correlation of the increased work load and the presence of contaminants in the IV preparation rooms.
b. Additionally for the year 2012: Board of Directors Quality and Credentialing minutes failed to address the identification of fungal contamination in the pharmacy IV preparation rooms, including the need for ongoing remediation. Review of Board of Directors Meeting minutes for the time period of 12/12/12 through 09/19/13 failed to identify the temporary relocation of the pharmacy IV preparation rooms to Satellite Hospital #1 on 12/12/12, and/or resumption of compounding services in the hospital on 12/18/12.
c. For the year 2013: Review of Board of Directors Meeting minutes dated 09/19/13 presented by the Regional Vice President (VP) of Medical Affairs identified two pharmacy events. A preliminary review of air samples collected on 09/12/13 with reports to the pharmacy on 09/17/13 identified a contamination in sterile IV products that were compounded in the hospital's pharmacy IV preparation room. This prompted the shut down of IV preparations and a recall of IV sterile products compounded on 09/12/13. The positive culture was found in an epidural product compounded at the hospital and used on 10 patients. According to the Regional VP of Medical Affairs, receiving the contaminated epidural posed no substantive risk to the patients and that physicians and patients were notified of the issue. Review of Board of Directors Meeting minutes from 09/19/13 through 07/19/14 did not identify any further follow-up to issues identified in the pharmacy. In addition, during this same time frame, it was determined that the air filters in the IV preparation areas were overloaded due to a construction project located outside the pharmacy walls.
d. The Governing Body failed to provide oversight and/or guidance to pharmacy staff when recurrent actionable levels of microbial growth were identified in the pharmacy's IV preparation areas and/or failed to ensure that recurrent actionable levels of microbial growth in the pharmacy IV preparation areas were reported to the Governing Body for review and appropriate action.
Please refer to A49 and A84.
2. The Governing Body failed to ensure that Nursing Services were provided within the scope of practice of the Registered Nurse (RN) when RN's were observed actively participating in the surgical insertion of a feeding tube.
Please refer to A385 and A395.
3. The Governing Body failed to ensure that the Pharmacy Department was in compliance with federal and state laws including United States Pharmacopeia Chapter 797 (USP-797), failed to coordinate an ongoing investigation of causative factors related to recurrent actionable levels of microbial growth in viable air/surface samples in multiple compounding areas identified in September 2012, 2013, and 2014 and failed to ensure implementation of successful remediation, and failed to ensure that an epidural solution compounded in the pharmacy on September 13, 2013 was free of bacterial contamination.
Please refer to A490 and A501
4. The Governing Body failed to ensure that the Physical Environment in the Pharmacy Departments were in compliance with federal and state laws including United States Pharmacopeia Chapter 797 (USP-797), failed to maintain the environment within the IV preparation areas in a manner that ensured sterility of the environment, failed to coordinate an ongoing investigation of causative factors related to recurrent actionable levels of microbial growth of viable air/surface samples in multiple compounding areas and failed to ensure implementation of successful remediation within the environment.
Please refer to A700 and A701
5. The Governing Body failed to ensure that the Infection Control program assisted with and/or ensured that the environment in the pharmacy intravenous (IV) preparation areas was maintained in a manner appropriate for IV compounding according to industry standards (USP Chapter <797>).
Please refer to A749
Tag No.: A0049
Based on review of hospital time lines of recurrent actionable levels of microbial growth in the pharmacy, hospital committee meeting minutes, hospital corrective action plans, email communications, hospital policies and procedures and staff interviews, the hospital failed to ensure that the medical staff was accountable to the governing body for the quality of care provided to patients as evidenced by:
Hospital documentation of time lines of recurrent actionable levels of microbial growth in the pharmacy intravenous (IV) preparation rooms and documentation of email streams between the Director of Pharmacy and members of the medical staff were reviewed. The time lines of recurrent actionable levels of microbial growth in the (IV) preparation rooms identified recurrent actionable levels of microbial growth were identified in September 2012, two separate incidents of recurrent actionable levels of microbial growth in September 2013, and recurrent actionable levels of microbial growth from September 2014 to present (12/29/14).
1a. A stream of hospital emails dated 11/29/12 sent by the Director of Pharmacy to five members of the medical staff and pharmacy air and surface sample reports were reviewed. The email identified that air samples taken in the pharmacy IV preparation rooms on 09/17/12 indicated actionable levels of microbial growth. Remediation was implemented following consultation with hospital infection control staff, and IV preparation resumed on 10/24/12. Retesting results were received on 11/29/12 identified recurrent actionable levels of microbial growth (mold). The Director of Pharmacy recommended transferring the chemotherapy preparation operations to Satellite Hospital #1, which took place on 12/12/12. Although evidence of recurrent actionable levels of microbial growth were identified based on the 9/17/12 samples, the move to Satellite Hospital #1 did not take place until 12/12/12, (13 days with a known recurrent actionable levels of microbial growth of mold in the environment).
1b. Review of Staff Executive Committee meeting minutes identified that the Pharmacy and Therapeutics (P&T) Committee reported to the Staff Executive Committee biannually. Staff Executive Committee meeting minutes dated 10/05/12 identified that the P&T Committee report dated 07/12/12 was submitted and reviewed. However, the P&T report failed to include documentation related to the routine pharmacy environmental inspections, routine culture results and/or any issues related to the sterility of IV preparation areas. At the time of the Staff Executive Committee meeting on 10/5/12, the pharmacy staff and 5 members of the medical staff were aware of the recurrent actionable levels of microbial growth in the pharmacy's IV preparation areas; however there was no documentation that these issues were reported to all medical staff as well as to the Governing Body.
1c. Staff Executive Committee meeting minutes for 3/12/13 included review of a P&T report dated 11/08/12. The report identified that two outside compounding pharmacy companies that supplied IV medications to the hospital had closed. Due to these closures, the hospital's pharmacy and the Satellite Hospital's pharmacy were compounding IV's at higher than normal capacity and the chemotherapy preparation volume had increased, leading to significant workload increases. Additionally, safety was identified as an increased concern. At the time of the Staff Executive Committee meeting on 3/12/13, the pharmacy staff, including 5 members of the medical staff were aware of the recurrent actionable levels of microbial growth in the pharmacy's IV rooms dating from 9/17/12 and the subsequent move of the hospital's pharmacy to Satellite Hospital #1 on 12/12/12, however there was no documentation that these issues were reported to all medical staff as well as to the Governing Body.
2a. Review of routine air and surface samples collected on 09/14/13 in the hospital's IV preparation areas identified preliminary actionable levels of microbial growth . It was also determined that the HEPA air filters in the IV preparation areas were overloaded due to a hospital construction project occurring near the pharmacy department. Based on the reported actionable levels of microbial growth, all IV preparations were transferred to Satellite Hospital #1 on 9/14/13. An email stream from the Director of Pharmacy dated 9/18/13 was sent to 4 members of the medical staff. The email identified that new HEPA filters were not available and IV preparations would continue at Satellite Hospital #1 (other than emergently needed IV preparations). IV operations were transferred to Satellite Hospital #1 on 9/14/13 and transferred back to the hospital pharmacy on 9/30/13. Although 4 members of the medical staff were notified of the actionable levels of microbial growth and relocation of the IV preparations, there was no documentation that these issues were reported to all medical staff as well as to the Governing Body.
2b. An additional event dated 9/19/13 involved a positive culture found in epidural IV products compounded at the hospital that were used on 10 patients. All remaining epidural IV products were recalled from the units. Patients who received the contaminated epidural's and their physicians were notified of the contamination. Review of Board of Directors meeting minutes from 9/19/13 through 7/19/14 failed to identify any further follow-up to patients who received the contaminated product. According to the Regional VP of Medical Affairs, the contaminated IV epidural's posed no substantive risk to the patients who received them. Medical Staff was notified that patient safety was at risk due to Pharmacy issues. However, the hospital lacked consistent documentation of a plan of action and/or follow-up regarding the risk to patient safety.
Interview with the Regional VP of Medical Affairs, Chief Operating Officer, and the Director of Performance Improvement on 10/07/14 at 11:00 AM identified that any detailed information regarding pharmacy issues that was not communicated in the P&T report must have been communicated via email, but not necessarily documented elsewhere. And although all communication between physicians and staff regarding pharmacy issues was not consistently documented, members of the Medical Staff were consistently informed during daily check-In Monday through Friday.
A Staff Executive Committee meeting minutes dated 9/06/13 included a review of a P&T report dated 7/11/13 that failed to identify issues related to positive routine cultures, workload increases, and/or safety issues or follow-up to issues related to the closure of the two compounding pharmacies.
Review of the daily check-In form identified the objective to maintain situational awareness of issues affecting Safety & Quality of patient care and to give direction about priority and responsibility for problem resolution. Each department is represented at the meeting along with the Infectious Disease physician, the VP of Medical Affairs, and the Director of Pharmacy.
3a. Review of email streams dated 9/24/14 and 9/25/14 between the Regional Director of Pharmacy, infection control practitioners, Infectious Disease physician, and other members of administration identified that air samples from the pharmacy IV preparation areas identified a fungus and that any fungal growth required action to remediate the fungus. Construction occurring above the pharmacy could not be ruled out as the source of recurrent actionable levels of microbial growth. The Director of Pharmacy identified that pharmacy staff could hear debris falling on their ceiling and that it could account for the presence of mold. The Infectious Disease physician identified that ceiling tiles have spores on them and any vibration from above would release the spores. An email dated 10/2/14 from the Regional Director of Pharmacy to Administrative staff identified that despite extra disinfection of the IV preparation areas, retesting continued to identify fungal growth.
The hospital lacked documentation that continued recurrent actionable levels of microbial growth in the pharmacies were reported to Governing Body in September 2014 and/or that the Governing Body provided resources to the pharmacy department to ensure the recurrent actionable levels of microbial growth were remediated.
Tag No.: A0084
Based on review of facility documentation and interviews with facility personnel, the facility failed to ensure that contracted services and other hospital departments were reviewed during the governing body meetings. The findings include:
Review of Governing Body meeting minutes from 2012-2014 failed to identify that contracted services and additional hospital departments were reviewed during the board of director meetings. Interview with the Director of Quality on 10/1/14 identified that, although most hospital departments were reviewed during the meetings, some departments including pharmacy and contracted services were not reviewed.
Tag No.: A0385
This condition is not met as evidenced by:
Based on observation of a Percutaneous Gastrostomy (PEG) tube insertion for one sampled patient (Patient #49), the facility failed to ensure a qualified practitioner conducted the procedure in accordance with the Association of Perioperative Registered Nurses (AORN). The findings include:
Despite managerial and/or administrative staff having prior knowledge that nurses were not adequately trained or educated in the insertion of PEG tubes, the hospital failed to ensure nursing services addressed this practice.
Please refer to A395
Tag No.: A0395
Based on observation of a Percutaneous Gastrostomy (PEG) tube insertion for one sampled patient (Patient #49), the facility failed to ensure a qualified practitioner conducted the procedure in accordance with the Association of Perioperative Registered Nurses (AORN). The finding included:
Review of the clinical record identified Patient #49 was admitted to the hospital on 9/24/14 with diagnoses that included advanced dementia, a seizure disorder, a history of several cerebral vascular accidents, gastro esophageal reflux, and failure to thrive who presented with aspiration pneumonia and a myocardial infarct. Further review of the clinical record indicated after family discussions consent was obtained for the insertion of a PEG tube for enteral feedings as Patient #49 was unable to orally ingest fluids or food.
Observation of the PEG tube insertion on 9/30/14 at 2:10 PM indicated after MD #6 inserted the endoscope and identified the intended surgical site RN #6 marked the site with her finger, cleansed the surgical area and injected Lidocaine into the site. Further observation identified RN #6 utilized a scalpel to incise the area and then proceeded to advance the trocar into the abdomen with the guide wire until placement was achieved.
Interview with RN #6 on 10/2/14 at 9:30 AM identified she was trained by the gastroenterologist's to perform PEG tube insertions sixteen years ago. RN #6 indicated the hospital administration approved registered nurses to insert PEG tubes.
Interview with MD #7 on 10/3/14 at 11:10 AM identified he was responsible for the implementation and training of the registered nurses to perform PEG tube insertions. MD #7 indicated he felt the guidelines for the placement of a PEG tube was in accordance with the society of gastroenterology's position statement dated 2008 that directed in part, educated and experienced registered nurses in gastroenterology and endoscopy can be given the responsibility for performing an expanded role if it fell within the scope of their state nurse practice act.
Interview with Director #5 on 10/3/14 at 11:15 AM identified she had inquired about this practice as she was unsure if a registered nurse was qualified to perform this procedure but had not completed the investigation. Director #5 indicated according to the association of operating room nurses (AORN) the standard identified a trained registered nurse first assistant (RNFA) may be required to perform a PEG tube insertion with appropriate education, certification and clinical proficiency. Director #5 identified that none of the six nurses who assisted with PEG insertion met the criteria outlined in the AORN for a RNFA. Further interview with and Director #5 and MD #7 indicated they did not conduct a comprehensive inquiry to identify if registered nurses could practice this procedure in accordance with the state nurse practice act and/or the standard set by AORN.
Review of AORN standards for registered nurses first assistant (RNFA) directed in part, that educational preparation was necessary to assume function in the role of the first assistant during operative and other invasive procedures by advanced practice registered nurses (APRN) and registered nurses (RN). The program would require a minimum equivalent to six semester credit hours of formal, post basic RN education with additional admission requirements that included nursing certification in the operating room. The didactic component would include content that emphasized the expanded functions unique to the RNFA during preoperative, intraoperative and postoperative phases of care for patients undergoing operative and other invasive procedures. Successful completion of all requirements of the didactic component would be required for matriculation into the clinical component. The clinical component required a minimum equivalent of three semester credit hours and would include intraoperative first assisting and additional hours of preoperative and postoperative patient care management. The intraoperative first-assisting hours would be a minimum of one hundred twenty of the total hours. A board certified surgeon in the RNFA intern's primary area of practice would be required as the clinical on site preceptor with specified evaluation methods to determine successful course completion.
Subsequent to the surveyors observation and inquiry registered nurses would no longer be performing PEG tube insertions. A corrective action plan dated 10/2/14 identified a physician or surgical physician's assistant would provide first assist with the insertion of Percutaneous Gastrostomy tubes.
Tag No.: A0490
This condition is not met as evidenced by:
Based on observation, review of hospital time lines of recurrent actionable levels of microbial growth in the pharmacy, hospital committee meeting minutes, hospital corrective action plans, e-mail communications, hospital policies and procedures and staff interviews, the hospital failed to ensure that intravenous solutions and/or chemotherapeutic agents were compounded in preparation rooms that were free of recurrent actionable levels of microbial growth.
The hospital failed to ensure that the Pharmacy Department was in compliance with federal and state laws including United States Pharmacopeia Chapter 797 (USP-797), failed to coordinate an ongoing investigation of causative factors related to recurrent actionable levels of microbial growth in viable air samples in multiple compounding areas identified in September 2012, 2013, and 2014 and failed to ensure implementation of successful remediation. Additionally, the pharmacy failed to ensure that an epidural solution compounded in the pharmacy on September 13, 2013 was free of bacterial contamination.
Please refer to A501
Tag No.: A0501
Based on observations, review of hospital time lines of recurrent actionable levels of microbial growth in the pharmacy, hospital committee meeting minutes, hospital corrective action plans, e-mail communications, hospital policies and procedures and staff interviews, the pharmacy department failed to ensure that all compounding of intravenous (IV) preparations was conducted under the supervision of a pharmacist and performed consistent with State and Federal Laws and/or USP-797 to include the maintenance and sterility of the IV preparation rooms over a three year period. The findings include:
1a. For the time period of 09/17/14 to 12/22/14: On 9/17/14 Company #1 performed biannual certification of all IV preparation rooms and hoods at the hospital's main campus. HEPA filters; particle counts and PEC were all within normal limits and were operating correctly. Pharmacist #1 performed viable air samples on 9/18/14 with hospital owned equipment (SAS). On 9/20/14 the hospital's microbiology laboratory notified pharmacy staff that one of the viable air samples collected on 9/18/14 from the chemotherapy room contained fungal growth. A top-to-bottom cleaning of the chemotherapy room was performed that evening with a sporicidal cleaning product. Consultant #1 recommended that everything being used for compounding inside the biological safety cabinet (BSC) be wiped down with a specialized bleach solution. On 9/22/14 the chemotherapy hood was decontaminated using a bleach solution and neutralizing sodium thiosulfate solution and all items brought into the BSC were wiped with the bleach solution. Retesting was performed at two additional locations to capture any air that might be leaking through the pass-through. On 9/24/14, the hospital's microbiology laboratory identified that actionable levels of microbial growth was noted on three plates. On 9/25/14 recurrent actionable levels of microbial growth was identified on an additional plate including the pass-through sample. On 9/26/14 no additional growth was noted and all results from the initial testing on 9/18/14 were final. No fungal and/or bacterial growth was identified in any of the hoods. The hospital was awaiting determination of fungal species and a microbiological specialty firm had been contacted for assistance in determining the possible cause of the bio burden.
Between 9/26/14 and 10/1/14 air and/or surface sampling obtained on multiple days throughout the month of September 1014 continued to identify recurrent actionable levels of microbial growth. Such as a report dated 10/8/14 identified IV room air sampling results in the Positive Pressure Room from 9/18/14 reported that two Fungal Plates identified 1 CFU Beauveria and Cladosporium 1 CFU. In the chemotherapy room results from 9/22/14 identified Cladosporium growth on 3 plates (1 CFU, 3 CFU, 4 CFU).
On 10/01/14 the Pharmacy Department developed an initial action plan with continual and on-going reviews and revisions as needed. Due to the recurrent actionable levels of microbial growth and problems with the physical environment, on 10/2/14, all non-stat sterile IV preparations were moved from the hospital pharmacy to Satellite Hospital #1's pharmacy. The hospital's pharmacy continued to produce immediate use IV preparations to be administered within one hour of preparation.
The hospital's consulting microbiologist identified that recurrent actionable levels of microbial growth (September and October 2014) in the IV preparation rooms was related to construction which was occurring directly above the IV preparation rooms. Air was being pulled from other areas into the IV preparation areas, thus introducing microbes into the IV preparation areas. Interview with the Regional Director of Pharmacy on 10/1/14 at 10:45 AM identified that the impact on the pharmacy was not considered prior to initiating the construction in the area directly above the pharmacy.
Observations made by State Agency #2's staff members #1, #2 and #3 from 10/1/14 to 10/6/14 and interviews with the Regional Director of Pharmacy, Pharmacist #1, Manager of Engineering, and Facilities and Support Services regarding the hospital's pharmacy on 10/6/14 at 5:15 PM identified that a ceiling tile at the entrance to the IV preparation area was observed to have a dried stain that appeared to be water related. It was later disclosed that there were a series of water leaks in the area of the stained ceiling tile. The pharmacy staff were unable to provide documentation that the stained tile was tested for any contaminants. Drop down ceiling tiles for the ante and buffer areas were not calked around each perimeter to seal them to the support frame. The calking used to seal the ceiling tiles in the chemotherapy buffer area was described as polyurethane and later described as silicone. Two ceiling tiles in the ante room and one in the IV buffer room over the LAFW were observed to be displaced. When the mechanical doors leading into the ante area, IV buffer area, and chemotherapy buffer area are opened using the automated button, the pressure drops below the acceptable limit due to the length of time the doors remain open. It was observed that the ante area was being used to make oral syringes and oral tablets were being split in the ante area as seen by the paraphernalia used to perform these tasks. There was paper poster on the ante room wall preventing cleaning behind and due to the chemicals used for cleaning, the clear coating is gone in many areas. Due to space seen around the pass-thru from a non-ISO classified area into the chemotherapy buffer area (ISO classified), there is potential for unfiltered air being pulled into the negative pressure chemotherapy buffer area. The pass through door from the ante room to the IV preparation room had gaps around the entire perimeter allowing air to pass from the ante room into the IV preparation room. Following this observation, staff used a duct tape type adhesive to seal the gaps around the pass through despite the duct tape being a non-smooth product and unable to be properly cleansed. Debris and dirt was observed behind the PEC's in the IV room, HEPA filters were stained in both the LAFW's. There was a black substance on the grate of the return vent in the IV room that was cleaned by Housekeeping without identification of the substance. The integrity of the IV room chair was compromised with visible holes. The area under the BSC's direct compounding area has not been cleaned. an additional observation included a cracked light diffuser in the laminar flow hood.
Additional observations made by State Agency #2's staff members #1, #2 and #3 from 10/1/14 to 10/6/14 include a technician compounding in the IV room without following garbing requirements including wearing earrings, hair escaping from the hair cover, after washing his/her hands, the technician proceeded to fix his/her clothes under the gown then proceeded in the IV buffer area without re-washing his/her hands. Cleaning not being performed from back of the PEC to the front of the PEC, a chemotherapy mat being used in the Laminar air flow workbench (LAFW) and no reason could be provided as to why it was being used by the technician. The waterless alcohol based surgical scrub used had no persistent activity as required. And there are no upper or lower limits set for temperature or humidity that is being monitored by facilities, therefore there leaving no way to tell if the temperature or humidity were out of expected range.
There was a lack of documentation of PEC daily cleaning in the compounding areas in 2013 and 2014, and no documentation of daily cleaning on 44 days over 8 months in 2014 (in excess of 17%).
In regards to Media fills, there was lack of documentation of required elements that included temperature of incubation, media type, lot and expiration dates. In 2013, one technician and 8 pharmacists did not perform media fills. In regards to fingertips, in 2013, one technician failed initial fingertip testing and continued to compound before passing a re-test. In 2014, two technicians failed initial fingertip testing and continued to compound before passing a re-test. When asked about Technician #1's re-test of the failed initial fingertip test, staff identified that the technician was not here at the facility often, but it was later determined that the technician had been regularly compounding since the failed fingertip testing.
It was determined that no fungal specific plates were used to conduct EM testing in March 2014 even though this practice was recommended by the hospital's expert in 2013, after having actionable levels of CFU's in 8 air samples which included all ISO 5 PEC's.
Review of the hospitals 2013 timeline, it stated that the 9/24/13 sampling "passed" showing no growth, and operations were moved from Satellite Hospital #1 back to the main hospital. However, documentation identified there were actionable levels in both the LAFW's and mold in the IV room as reported by Company #1, however, the pharmacy did not have a final report.
Interviews with the Regional Director of Pharmacy, Manager of Engineering, Manager of Engineering, and Facilities and Support Services on 10/6/14 at 5:15 PM identified that the environmental rounds team documented by exception and the team did look at the pharmacy's environment. However, the environmental rounds/inspection do not include inspection of the ante room, IV chemotherapy room or IV room in either the hospital's pharmacy or the Satellite hospital's pharmacy. The Manager of Engineering identified that he/she did not know who inspected the IV preparation areas.
Between 11/1/14 to 12/22/14, the Hospital Pharmacy has remained closed with the exception of production of immediate use IV preparations due to the physical environment and continued contaminants throughout the IV preparation areas. The hospital's consulting microbiologist's report dated 12/22/14 was reviewed. The report identified continued sporadic growth of coagulase negative staphylococcus (CNS) in the IV buffer rooms and the anteroom because of ceiling tiles "still have not been sealed." Recommendations included to change the disinfection process for products entering the buffer rooms and on to the anteroom. The report identified the need to complete repair work (noted during the investigation of October 2014) including: calking ceiling tiles, gasket pass through doors, correct exposed fiberglass in the pass through, and decrease door open time in the anteroom as soon as possible.
1b. Review of hospital documentation and interviews with pharmacy staff identified that Satellite Hospital #1's pharmacy had recurrent actionable levels of microbial growth of in the IV preparation areas. An email dated 10/31/14 from the Regional Director of Pharmacy to Administrative staff identified that despite extra disinfection of the satellite hospital's pharmacy, retesting continued to identify recurrent actionable levels of microbial growth.
Observations of the Satellite hospital's pharmacy were made between 10/1/14 to 10/6/14 by State Agency #2's staff members #1, #2 and #3 on 10/2/14 and 10/9/14. Drop down ceilings were not caulked around each perimeter to seal them to the support frame in any of the compounded areas (chemo buffer, ante, IV buffer). A ceiling tile was displaced above the Laminar flow workbenches (LAFW) in the IV buffer allowing plenum unfiltered air into the room. A "sticky" residue was on the floors of the IV buffer area causing resistance and making it difficult to walk across with booties. An unlabeled plastic container with purple liquid was found under the sink. An open space between the cabinet and wall under the sink was filled with debris and dirt.
Following the inspection on 10/2/14, the hospital's facilities team made holes in the wall of the ante area to mount mop handles. The holes were made through the epoxy painted walls into the sheetrock-potentially releasing contaminants held within. The debris from the holes made still could be found on the coving and floors (on 10/9/14) despite being in an environment that required daily cleaning. Cuts were found on the ante room vinyl flooring compromising the integrity to the clean room environment. The door to the room leading from the main pharmacy to the ante area was kept open for extended periods of time, causing the room pressure to drop to 0.009. An exhaust vent in the ceiling of the chemo buffer area was next to the rooms HEPA filter. Staff could not explanation or provide validation for the vent and/or the vents role in the air movement inside the room.
Staff were observed using a Dexamethasone vial with no label showing the beyond use date (BUD). The integrity was compromised in the IV room due to a chair with holes in it. An insect was observed in the light fixture in the IV buffer area. The line of demarcation (separating the "dirty" and "clean" side) in the ante room was marked in such manor that it encompassed the only garbage receptacle, therefore staff on the clean side were required to enter the dirty side to dispose of garbage while fully garbed.
A wall integrity was compromised by a waste receptacle within the IV buffer area leaving exposed wallboard.
Pharmacy staff were observed using a single use scrub brush and soap kit for hand washing, and then saving the kit for re-use. Staff were observed cleaning the trash receptacle in the IV room and then attempting to use the same gloves to compound sterile products. The temperature high and lows were inappropriately set between 35 and 100 degrees respectively for them to alarm. The pressure for the chemo buffer area was incorrectly set up to alarm if the pressure goes below negative 0.01 (the minimum pressure in the chemo buffer area should be 0.02). There was no documentation of when the pre-filters were changed in the LAFW's and staff were unaware that these filters existed and needed to be monitored or changed.
Cleaning personnel were observed with facial makeup while mopping in the compounding rooms. Terminal/monthly cleaning of the compounding areas were not documented as being performed for 6 of 8 months in 2014. Daily cleaning of the compounding areas were not documented as being performed for 39 days in 8 months of 2014 (excess of 15% of the time). Pressure documentation was absent for 30 days in 8 months of 2014 (excess of 12% of the time).
Since moving IV compounding including chemotherapy agents from the main hospital to Satellite Hospital #1 on 10/2/14, EM (environmental monitoring) trending showed an increased number of recurrent actionable levels of microbial growth with no explanation for this trend. Since 10/27/14, the facility had been required to perform terminal clean daily vs monthly, however, the recurrent actionable levels of microbial growth continued.
The Hospital's laboratory did not provide the required data for the laboratory results (i.e. sample date, temperature of incubation, volume of air collected.) When growth was identified, in many cases the laboratory did not incubate for the entire required period (Surface samples--August 2013, February 2014, July 2014). There was no genus level identification of CFU growth (only went to gram positive/mold level). No sampling was performed at the direct compounding area (DCA) in the LAFW till end of October 2014.
The EM reporting of results from the Hospital laboratory to the pharmacy was recognized by State Agency #2 staff to be flawed due to transcription errors and/or misinterpretation of sampling locations. This was identified in the 9/29/14 data since the laboratory reported a surface sample growth of 5cfu in the LAFW which is actionable level but ultimately found that this growth was a surface sample from ante room which rendered it non-actionable. The direct adverse consequence was to be forced to compound both the IV and chemo products with the BSC and to set up extensive decontamination procedures.
The acceptance criteria is noted incorrectly in the certification reports regarding ACPH in the ante area (March 2013 and all of 2014). This was not identified by the facility and corrected in the reports. In addition, the ante room ACPH do not meet USP797 minimal requirements (2014).
The Hospital did not provide the certification report for September 2013. A comparison of certification reports and the air balancing reports showed a significant difference in the measured room volume of the IV buffer and ante areas. The hospital staff failed to note this discrepancy which is a vital component to calculate ACPH's for the rooms.
An environment of care/safety management plan identified that the Safety Officer was responsible for the management plan/risk assessment and hazard surveillance process known as Environmental Rounds. The hazard surveys are conducted to evaluate environmental and life safety conditions and to observe current practices, staff knowledge and skill.
Between 11/1/14 and 12/29/14, Satellite Hospital #1's Pharmacy has continued to produce compounded IV medications for both hospitals and also continued to identify recurrent actionable levels of microbial growth throughout the IV preparation areas. Review of a viable surface sampling report dated 12/15/14 with final results updated on 12/21/14 identified continued sporadic growth of (CNS) with a total of 4 species in the anteroom. Also, the report identified that other surface sampling was not performed due to a shortage of plates.
2. For the time period of 9/19/13 through 9/26/13: On 9/19/13 the hospital's laboratory reported that routine testing of an epidural solution (PCA) compounded in the hospital pharmacy resulted in positive cultures for propionibacterium. It was determined that the affected batch was prepared on the evening of 9/13/13. Pharmacy staff retrieved all unused affected epidural preparations throughout the hospital. A total of 10 patients had received the epidural product from the 9/13/13 batch. Drafts letters to the 10 patients and their physicians were prepared and reviewed. Physicians were notified on 9/25/13 and the 10 patients were notified on 9/26/13 that they had received an epidural preparation from the 9/13/13 batch. Interview with Infection Preventionist #1 on 10/06/14 at 12:25 PM identified that no further follow up on the 10 patients who received the epidural's was completed by the hospital, as it was considered to be the responsibility of their Primary Care Physicians (PCP's). The Infection Preventionist was unaware if there were any adverse consequences.
Concurrently, for the time period of 09/12/13 through 09/30/13: On 9/12/13 routine biannual viable particle air cultures were performed by Company #1 as part of certification of ISO Class 7 clean rooms and ISO Class 5 Hoods. The Company's technician identified that particle counts were high but passed recommended standards. However, filters were found to be leaking and tears were also noted. The recommendation to replace the filters was discussed with engineering staff. On 9/14/13, preliminary reports identified organisms of concern for six of the air impaction sample locations all of which were of actionable levels. The affected areas included the chemotherapy room, IV room, ante room and Primary Engineering Control (PEC) 3. Operations in PEC3 were immediately stopped and all IV compounding operations were transferred to Satellite Hospital #1. Immediate use (stat) products continued to be prepared in PEC2. Consultant #1 was brought in to assist with the investigation into the possible cause of the high bioburden on 9/18/13, and engineering was contacted regarding replacement of the HEPA filters. On 9/19/13, Company #1 repeated testing to rule out human contamination. The HEPA filters were replaced on 09/23/13 and the rooms were cleaned top-to-bottom three times with germicidal and sporicidal agents. Company #1 repeated environmental sampling using a double plate method. Retesting results were received on 9/30/13 that identified no growth. At that time, pharmacy compounding operations were moved back to the hospital.
Consultant #1 had recommended in 2013 that the hospital conduct their own routine air sampling tests using hospital equipment rather than using the services of Company #1. The pharmacy purchased an air sampling machine (SAS) to perform their own viable air sampling and all areas were retested. Based on review of the SAS-180 air sampler instructions, interviews, and review of an email stream between the Sterile Products Coordinator (Pharmacist #1) and Consultant #1 dated 09/30/14 and 10/07/14, documentation failed to identify that Pharmacist #1 received training on the newly purchased SAS Super 180 Microbial Air Sampler machine and failed to document a competency review to ensure that the testing was performed accurately and that the equipment was properly maintained.
An email from Consultant #1 to Pharmacist #1 dated 9/30/14 identified that the hospital borrowed an air sampler from another provider. Training was allegedly performed on 9/20/13 (one year prior). However, training for use of the equipment was not documented until 10/07/2014 via email from Consultant #1 to the Director of Pharmacy.
Interview with the Regional Director of Pharmacy on 10/1/14 at 10:45 AM identified that the hospital concluded that the September 2013 construction project occurring outside the IV compounding room and the condition of the HEPA filter contributed to the recurrent actionable levels of microbial growth in the IV compounding areas of the pharmacy. In addition, the impact on the pharmacy was not considered prior to initiating the construction.
3. For the time period of 9/17/2012 through 12/18/12: On 09/17/12 routine biannual viable particle air cultures were performed by Company #1 as part of certification of International Organization for Standardization (ISO) Class 7 Clean Rooms and ISO Class 5 Hoods. On 10/23/12, a final report by Company #1 identified action level growth in the chemotherapy preparation room. On 10/24/12 a top-to-bottom cleaning of buffer, ante room, and chemotherapy rooms was performed twice, using a sporicidal agent. On 11/12/12, a retest of viable air sampling in the chemotherapy room was conducted. On 11/29/12, the preliminary results from the retest showed microorganisms associated with skin flora. Another top-to-bottom cleaning of buffer, ante room, and chemotherapy room was performed with a product other than a sporicidal agent. Company #1 retested viable air sampling in the chemotherapy room on 12/06/12 with a preliminary report received on 12/12/12 that identified 1 Colony Forming Unit 1 (cfu) of mold. Based on the presence of mold, the compounding of chemotherapy preparations was moved to Satellite Hospital #1. On 12/12/12, the negative pressure in the chemotherapy room was identified to be out of range and was adjusted. Additionally, all ceiling tiles were sealed around the edges so no air from above could be pulled into the room. All compounding rooms were cleaned top-to-bottom with a sporicidal agent and viable air sampling testing was performed in the chemotherapy room on 12/14/12. On 12/17/12 preliminary results identified no growth in the chemotherapy room and the production of chemotherapy preparations was returned to the hospital's pharmacy.
Review of Pharmacy and Therapeutic (P&T) meeting minutes for 10/11/12 identified that the hospital had been purchasing 10 different IV medication products from Compounding Pharmacies that had recently closed. As a result, the hospital pharmacy began compounding all heparin and Patient Controlled Analgesia (PCAs).
Review of the hospital's documented time lines with the Director of Pharmacy and the Sterile Products Coordinator (Pharmacist #1) on 10/7/14 at 11:00 AM identified the following: Board of Directors Quality and Credentialing minutes dated 10/23/12 identified that the recent closure of the Compounding Pharmacies resulted in a significant increase in work load for the hospital pharmacy staff, as many IV products were now being prepared internally. The meeting minutes also identified that in order to ensure patient safety, staffing needs in the hospital pharmacy were under review. However, the resultant increase in work load in the pharmacy was not addressed.
Pharmacy & Therapeutics (P&T) minutes for 11/08/12 identified that as a result of the closure of the Compounding Pharmacies, the hospital pharmacy was compounding at a higher capacity than normal with an additional increase in chemotherapy volume leading to significant work overload. The Director of Pharmacy identified that he/she was investigating the possibility of adding 1 more technician. However, There was no evidence that an additional technician was added or that an assessment of work production was conducted to demonstrate that additional staff was not necessary.
Tag No.: A0700
This condition is not met as evidenced by:
Based on a review of hospital documentation of action plans and time lines, review of policies, review of environmental rounds documentation, interviews with staff and observations, the hospital failed to ensure that the condition of the environment in the Pharmacy Department intravenous (IV) preparation areas in the main Hospital and Satellite Hospital #1 were maintained in a manner appropriate for IV compounding according to industry standards (USP Chapter <797>). The findings include:
The hospital failed to ensure that the environment in the Pharmacy Departments were in compliance with federal and state laws including United States Pharmacopeia Chapter 797 (USP-797), failed to maintain the environment within the IV preparation areas in a manner that ensured sterility of the environment, failed to coordinate an ongoing investigation of causative factors related to recurrent actionable levels of microbial growth of viable air samples in multiple compounding areas and failed to ensure implementation of successful remediation within the environment.
Please refer to A701
Tag No.: A0701
Based on a review of hospital documentation of action plans and time lines, review of policies, interviews with staff and observations, the hospital failed to ensure that the environment in the pharmacy intravenous (IV) preparation areas was maintained in a manner appropriate for IV compounding according to industry standards (USP Chapter <797>). The findings include:
Review of the hospital's environmental rounds schedule and inspection worksheets identified that the hospital's pharmacy department was included in the Facilities Management environmental rounds on an annual basis. Inspections occurred on 4/4/2013 and 5/8/2014. Review of the 2013 and 2014 inspection reports failed to identify that the pharmacy's IV preparation areas including the ante room, chemotherapy room and the IV rooms were inspected.
Review of a Hazard Surveillance Inspection Items list identified that the environmental rounds report would identify 80 seperate items by exception. Items identified for review/observation included ceiling tiles intact and free of stains, no holes or dings in walls, environmental issues such as claen floors, protective coverings and staff compliance with hand hygiene and personal protective equipment.
Interviews with the Regional Director of Pharmacy, Manager of Engineering, Manager of Engineering, and Facilities and Suport Services on 10/6/14 at 5:15 PM identified that the environmental rounds team documents by exception and the team does look at the pharmacy's environment. However, the rounds/inspection do not include inspection of the ante room, IV chemotherapy room or IV room in either the N.B. or B. campus pharmacies. The Manager of Engineering identified that he/she did not know who inspected the IV preparation areas.
An environment of care/safety management plan identified that the Safety Officer was responsible for the management plan/risk assessment and hazard surveillance process known as Environmental Rounds. The hazard surveys are conducted to evaluate environmental and life safety conditions and to observe current practices, staff knowledge and skill.
Review of email streams dated 9/24/14 and 9/25/14 between the Regional Director of Pharmacy, infection control practitioners, Infectious Disease physician, and other members of administration identifed that air samples from the pharmacy IV preparation areas identified a fungus and that any fungal growth required action to remediate the fungus. Construction occurring above the pharmacy could not be ruled out as the source of the contamination. The Director of Pharmacy identified that pharmacy staff could hear debris falling on their ceiling and that it could account for the presence of mold. The Infectious Disease physician identified that ceiling tiles have spores on them and any vibration from above would release the spores. An email dated 10/2/14 from the Regional Director of Pharmacy to Administrative staff identified that despite extra disinfection of the IV preparation areas, retesting continues to identify recurrent actionable levels of microbial growth.
On 10/01/14 the Pharmacy Department developed an initial action plan with continual and on-going reviews and revisions as needed related to recurrent actionable levels of microbial growth and problems with the physical environment in the IV preparation areas. On 10/2/14, the production of all non-stat sterile IV preparations were moved from the hospital pharmacy to Satellite Hospital #1's pharmacy. The hospital's pharmacy continued to produce immediate use IV preparations to be administered within one hour of preparation.
The hospital's consulting microbiologist identified that recurrent actionable levels of microbial growth (September and October 2014) in the IV preparation rooms was related to construction which was occurring directly above the IV preparation rooms. Air was being pulled from other areas into the IV preparation areas, thus introducing actionable levels of microbial growth into the IV preparation areas. Interview with the Regional Director of Pharmacy on 10/1/14 at 10:45 AM identified that the impact on the pharmacy was not considered prior to initiating the construction in the area directly above the pharmacy.
Observations made by State Agency #2's staff members #1, #2 and #3 from 10/1/14 to 10/6/14 and interviews with the Regional Director of Pharmacy, Pharmacist #1, Manager of Engineering, and Facilities and Support Services regarding the hospital's pharmacy on 10/6/14 at 5:15 PM identified that a ceiling tile at the entrance to the IV preparation area was observed to have a dried stain that appeared to be water related. It was later disclosed that there were a series of water leaks in the area of the stained ceiling tile. The pharmacy staff were unable to provide documentation that the stained tile was tested for any contaminants. Drop down ceiling tiles for the ante and buffer areas were not calked around each perimeter to seal them to the support frame. The calking used to seal the ceiling tiles in the chemotherapy buffer area was described as polyurethane and later described as silicone. Two ceiling tiles in the ante room and one in the IV buffer room over the LAFW were observed to be displaced. When the mechanical doors leading into the ante area, IV buffer area, and chemotherapy buffer area are opened using the automated button, the pressure drops below the acceptable limit due to the length of time the doors remain open. It was observed that the ante area wass being used to make oral syringes and oral tablets were being split in the ante area as seen by the paraphernalia used to perform these tasks. There was paper poster on the ante room wall preventing cleaning behind and due to the chemicals used for cleaning, the clear coating is gone in many areas. Due to space seen around the pass-thru from a non-ISO classified area into the chemotherapy buffer area (ISO classified), there is potential for unfiltered air being pulled into the negative pressure chemotherapy buffer area. The pass through door from the ante room to the IV preparation room had gaps around the entire perimeter allowing air to pass from the ante room into the IV preparation room. Following this observation, staff used a duct tape type adhesive to seal the gaps around the pass through despite the duct tape being a non-smooth product and unable to be properly cleansed. Debris and dirt was observed behind the PEC's in the IV room, HEPA filters were stained in both the LAFW's. There was a black substance on the grate of the return vent in the IV room that was cleaned by Housekeeping without identification of the substance. The integrity of the IV room chair was compromised with visible holes.
The area under the BSC's direct compounding area has not been cleaned. an additional observation included a cracked light diffuser in the laminar flow hood.
Additional observations made by State Agency #2's staff members #1, #2 and #3 from 10/1/14 to 10/6/14 include a technician compounding in the IV room without following garbing requirements including wearing earrings, hair escaping from the hair cover, after washing his/her hands, the technician proceeded to fix his/her clothes under the gown then proceeded in the IV buffer area without re-washing his/her hands. Cleaning not being performed from back of the PEC to the front of the PEC, a chemotherapy mat being used in the Laminar air flow workbench (LAFW) and no reason could be provided as to why it was being used by the technician. The waterless alcohol based surgical scrub used had no persistent activity as required. And there are no upper or lower limits set for temperature or humidity that is being monitored by facilities, therefore there leaving no way to tell if the temperature or humidity were out of expected range.
There was a lack of documentation of PEC daily cleaning in the compounding areas in 2013 and 2014, and no documentation of daily cleaning on 44 days over 8 months in 2014 (in excess of 17%).
In regards to Media fills, there was lack of documentation of required elements that included temperature of incubation, media type, lot and expiration dates. In 2013, one technician and 8 pharmacists did not perform media fills. In regards to fingertips, in 2013, one technician failed initial fingertip testing and continued to compound before passing a re-test. In 2014, two technicians failed initial fingertip testing and continued to compound before passing a re-test. When asked about Technician #1's re-test of the failed initial fingertip test, staff identified that the technician was not at the facility often, but it was later determined that the technician had been regularly compounding since the failed fingertip testing.
It was determined that no fungal specific plates were used to conduct EM testing in March 2014 even though this practice was recommended by the hospital's expert in 2013, after having actionable levels of cfu's in 8 air samples which included all ISO 5 PEC's.
Review of the hospitals 2013 timeline, it stated that the 9/24/13 sampling "passed" showing no growth, and operations were moved from Satelite Hospital #1 back to the main hospital. However, documentation identified there were recurrent actionable levels of microbial growth in both the LAFW's and mold in the IV room as reported by Company #1, however, the pharmacy did not have a final report.
Interviews with the Regional Director of Pharmacy, Manager of Engineering, Manager of Engineering, and Facilities and Support Services on 10/6/14 at 5:15 PM identified that the environmental rounds team documented by exception and the team did look at the pharmacy's environment. However, the environmental rounds/inspection do not include inspection of the ante room, IV chemotherapy room or IV room in either the hospital's pharmacy or the Satellite hospital's pharmacy. The Manager of Engineering identified that he/she did not know who inspected the IV preparation areas.
1b. Review of hospital documentation and interviews with pharmacy staff identified that Satellite Hospital #1's pharmacy had recurrent actionable levels of microbial growth of in the IV preparation areas. An email dated 10/31/14 from the Regional Director of Pharmacy to Administrative staff identified that despite extra disinfection of the satellite hospital's pharmacy, retesting continued to identify recurrent actionable levels of microbial growth.
Observations of the Satellite hospital's pharmacy were made by State Agency #2's staff members #1, #2 and #3 on 10/2/14 and 10/9/14. Drop down ceilings were not caulked around each perimeter to seal them to the support frame in any of the compounded areas (chemo buffer, ante, IV buffer). A ceiling tile was displaced above the Laminar flow workbenches (LAFW) in the IV buffer allowing plenum unfiltered air into the room. A "sticky" residue was on the floors of the IV buffer area causing resistance and making it difficult to walk across with booties. An unlabeled plastic container with purple liquid was found under the sink. An open space between the cabinet and wall under the sink was filled with debris and dirt.
Following the visit on 10/2/14, the hospital's facilities team made holes in the wall of the ante area to mount mop handles. The holes were made through the apoxy painted walls into the sheetrock-potentially releasing contaminants held within. The debris from the holes made still could be found on the coving and floors (on 10/9/14) despite being in an environment that required daily cleaning. Cuts were found on the ante room vinyl flooring compromising the integrity to the clean room environment. The door to the room leading from the main pharmacy to the ante area was kept open for extended periods of time, causing the room pressure to drop to 0.009. An exhaust vent in the ceiling of the chemo buffer area was next to the rooms HEPA filter. Staff could not explanation or provide validation for the vent and/or the vents role in the air movement inside the room.
Staff were observed using a Dexamethasone vial with no label showing the beyond use date (BUD). The integrity was compromised in the IV room due to a chair with holes in it. An insect was observed in the light fixture in the IV buffer area. The line of demarcation (separating the "dirty" and "clean" side) in the ante room was marked in such manor that it encompassed the only garbage receptacle, therefore staff on the clean side were required to enter the dirty side to dispose of garbage while fully garbed.
A wall integrity was compromised by a waste receptacle within the IV buffer area leaving exposed wallboard.
Additional observations of the Satellite hospital's pharmacy were made by State Agency #2's staff members #1, #2 and #3 on 10/2/14 and 10/9/14. Pharmacy staff were observed using a single use scrub brush and soap kit for hand washing, and then saving the kit for re-use. Staff were observed cleaning the trash receptacle in the IV room and then attempting to use the same gloves to compound sterile products. The temperature high and lows were inappropriately set between 35 and 100 degrees respectively for them to alarm. The pressure for the chemo buffer area was incorrectly set up to alarm if the pressure goes below negative 0.01 (the minimum pressure in the chemo buffer area should be 0.02). There was no documentation of when the pre-filters were changed in the LAFW ' s and staff were unaware that these filters existed and needed to be monitored or changed.
Cleaning personnel were observed with facial makeup while moping in the compounding rooms. Terminal/monthly cleaning of the compounding areas were not documented as being performed for 6 of 8 months in 2014. Daily cleaning of the compounding areas were not documented as being performed for 39 days in 8 months of 2014 (excess of 15% of the time). Pressure documentation was absent for 30 days in 8 months of 2014 (excess of 12% of the time).
Since moving IV compounding including chemotherapy agents from the main hospital to Satelite Hospital #1 on 10/2/14, EM (environmental monitoring) trending showed an increased number of recurrent actionable levels of microbial growth with no explanation for this trend. Since 10/27/14, the facility had been required to perform terminal clean daily vs monthly, however, recurrent actionable levels of microbial growth had continued.
The Hospital's laboratory did not provide the required data for the laboratory results (i.e. sample date, temperature of incubation, volume of air collected.) When growth was identified, in many cases the laboratory did not incubate for the entire required period (Surface samples: August 2013, February 2014, July 2014). There was no genus level identification of CFU growth (only went to gram positive/mold level). No sampling was performed at the direct compounding area (DCA) in the LAWF till end of October 2014.
The EM reporting of results from the Hospital laboratory to the pharmacy was recognized State Agency #2 staff to be flawed due to transcription and interpretation of sampling locations. This was identified in the 9/29/14 data since the laboratory reported a surface sample growth of 5cfu in the LAFW which is actionable level but ultimately found that this growth was a surface sample from ante room which rendered it non-actionable. The direct adverse consequence was to be forced to compound both the IV and chemo products with the BSC and to set up extensive decontamination procedures.
The acceptance criteria is noted incorrectly in the certification reports regarding ACPH in the ante area (March 2013 and all of 2014). This was not identified by the facility and corrected in the reports. In addition, the ante room ACPH do not meet USP797 minimal requirements (2014).
The Hospital did not provide the certification report for September 2013. A comparison of certification reports and the air balancing reports showed a significant difference in the measured room volume of the IV buffer and ante areas. The hospital staff failed to note this discrepancy which is a vital component to calculate ACPH's for the rooms.
An environment of care/safety management plan identified that the Safety Officer was responsible for the management plan/risk assessment and hazard surveillance process known as Environmental Rounds. The hazard surveys are conducted to evaluate environmental and life safety conditions and to observe current practices, staff knowledge and skill.
Tag No.: A0749
Based on a review of hospital documentation of action plans and time lines, review of policies, interviews with staff and observations, the Infection Control program failed to assist with and/or ensure that the environment in the pharmacy intravenous (IV) preparation areas was maintained in a manner appropriate for IV compounding according to industry standards (USP Chapter <797>). The findings include:
The hospital's environmental rounds program included members from the infection control committee. Review of the hospital's environmental rounds schedule and inspection worksheets identified that the hospital's pharmacy department was included in the Facilities Management environmental rounds on an annual basis. Inspections occurred on 4/4/2013 and 5/8/2014. Review of the 2013 and 2014 inspection reports failed to identify that the pharmacy's IV preparation areas including the ante room, chemotherapy room and the IV rooms were inspected related to infection control and prevention.
Review of a Hazard Surveillance Inspection Items list identified that the environmental rounds report would identify 80 separate items by exception. Items identified for review/observation included ceiling tiles intact and free of stains, no holes or dings in walls, environmental issues such as clean floors, protective coverings and staff compliance with hand hygiene and personal protective equipment.
The infection prevention and control plan identified that the infection prevention and control staff participate in the scheduled and spontaneous Environment of Care rounds. The responsibility during the rounds include observations of infection control practices and cleanliness of the environment.
Interviews with the Regional Director of Pharmacy, Manager of Engineering, and Facilities and Support Services on 10/6/14 at 5:15 PM identified that the environmental rounds team documents by exception and the team does look at the pharmacy's environment. However, the rounds/inspection do not include inspection of the ante room, IV chemotherapy room or IV rooms were not included in their surveillance. Interview with the infection preventionist on 10/7/14 identified that their participation in the environmental rounds do not include observations of the IV preparation areas.
The infection prevention program annual report 2013 identified that construction and renovation surveillance included providing inservice education to contractors. However, the impact of construction on the pharmacy department was not included. Review of Infection control meeting minutes identified that pharmacy issues are reported by the Regional Director of Pharmacy.
The hospital's consulting microbiologist identified that recurrent actionable levels of microbial growth (September and October 2014) in the IV preparation rooms was related to construction which was occurring directly above the IV preparation rooms. Air was being pulled from other areas into the IV preparation areas, thus introducing microbial growth into the IV preparation areas. Interview with the Regional Director of Pharmacy on 10/1/14 at 10:45 AM identified that the impact on the pharmacy was not considered prior to initiating the construction in the area directly above the pharmacy.
Infection Control breaches:
Observations made by State Agency #2's staff members #1, #2 and #3 from 10/1/14 to 10/6/14 and interviews with the Regional Director of Pharmacy, Pharmacist #1, Manager of Engineering, and Facilities and Support Services regarding the hospital's pharmacy on 10/6/14 at 5:15 PM identified in part that a ceiling tile at the entrance to the IV preparation area was observed to have a dried stain that appeared to be water related. It was later disclosed that there were a series of water leaks in the area of the stained ceiling tile. The pharmacy staff were unable to provide documentation that the stained tile was tested for any contaminants. Two ceiling tiles in the ante room and one in the IV buffer room over the LAFW were observed to be displaced. There was paper poster on the ante room wall preventing cleaning behind and due to the chemicals used for cleaning, the clear coating is gone in many areas. Following this observation, staff used a duct tape type adhesive to seal the gaps around the pass through despite the duct tape being a non-smooth product and unable to be properly cleansed. Debris and dirt was observed behind the PEC's in the IV room, HEPA filters were stained in both the LAFW's. There was a black substance on the grate of the return vent in the IV room that was cleaned by Housekeeping without identification of the substance. The integrity of the IV room chair was compromised with visible holes. The area under the BSC's direct compounding area has not been cleaned.
Additional observations made by State Agency #2's staff members #1, #2 and #3 from 10/1/14 to 10/6/14 include a technician compounding in the IV room without following garbing requirements including wearing earrings, hair escaping from the hair cover, after washing his/her hands, the technician proceeded to fix his/her clothes under the gown then proceeded in the IV buffer area without re-washing his/her hands. Cleaning not being performed from back of the PEC to the front of the PEC, the waterless alcohol based surgical scrub used had no persistent activity as required.
There was a lack of documentation of PEC daily cleaning in the compounding areas in 2013 and 2014, and no documentation of daily cleaning on 44 days over 8 months in 2014 (in excess of 17%).
In regards to fingertips, in 2013, one technician failed initial fingertip testing and continued to compound before passing a re-test. In 2014, two technicians failed initial fingertip testing and continued to compound before passing a re-test. When asked about Technician #1's re-test of the failed initial fingertip test, staff identified that the technician was not here at the facility often, but it was later determined that the technician had been regularly compounding since the failed fingertip testing.
1b. Review of hospital documentation and interviews with pharmacy staff identified that Satellite Hospital #1's pharmacy had continued contaminant growth of in the IV preparation areas. An email dated 10/31/14 from the Regional Director of Pharmacy to Administrative staff identified that despite extra disinfection of the satellite hospital's pharmacy, retesting continued to identify contaminate growth.
Observations of the Satellite hospital's pharmacy were made by State Agency #2's staff members #1, #2 and #3 on 10/2/14 and 10/9/14. A ceiling tile was displaced above the Laminar flow workbenches (LAFW) in the IV buffer allowing plenum unfiltered air into the room. A "sticky" residue was on the floors of the IV buffer area causing resistance and making it difficult to walk across with booties. An unlabeled plastic container with purple liquid was found under the sink. An open space between the cabinet and wall under the sink was filled with debris and dirt.
Following the visit on 10/2/14, the hospital's facilities team made holes in the wall of the ante area to mount mop handles. The holes were made through the epoxy painted walls into the sheetrock-potentially releasing contaminants held within. The debris from the holes made still could be found on the coving and floors (on 10/9/14) despite being in an environment that required daily cleaning. Cuts were found on the ante room vinyl flooring compromising the integrity to the clean room environment. Staff were observed using a Dexamethasone vial with no label showing the beyond use date (BUD). The integrity was compromised in the IV room due to a chair with holes in it. An insect was observed in the light fixture in the IV buffer area. The line of demarcation (separating the "dirty" and "clean" side) in the ante room was marked in such manor that it encompassed the only garbage receptacle, therefore staff on the clean side were required to enter the dirty side to dispose of garbage while fully garbed. A wall integrity was compromised by a waste receptacle within the IV buffer area leaving exposed wallboard.
Additional observations of the Satellite hospital's pharmacy were made by State Agency #2's staff members #1, #2 and #3 on 10/2/14 and 10/9/14. Pharmacy staff were observed using a single use scrub brush and soap kit for hand washing, and then saving the kit for re-use. Staff were observed cleaning the trash receptacle in the IV room and then attempting to use the same gloves to compound sterile products. Cleaning personnel were observed with facial makeup while moping in the compounding rooms. Terminal/monthly cleaning of the compounding areas were not documented as being performed for 6 of 8 months in 2014. Daily cleaning of the compounding areas were not documented as being performed for 39 days in 8 months of 2014 (excess of 15% of the time).
Since moving IV compounding including chemotherapy agents from the main hospital to Satellite Hospital #1 on 10/2/14, EM (environmental monitoring) trending showed an increased number of recurrent actionable levels of microbial growth with no explanation for this trend. Since 10/27/14, the facility had been required to perform terminal clean daily vs monthly, however, recurrent actionable levels of microbial growth has continued.
The infection prevention and control plan identified that the infection prevention and control program incorporates multiple strategies to minimize, reduce or eliminate the risk of infection through surveillance, prevention, control, data analysis, and provision of education.
14528
Based on a tour of the hospital, review of manufacturer's recommendations, review of facility policies, observations and interviews the facility failed to ensure that a sanitary environment was maintained and/or that patient equipment was properly sanitized. The finding includes:
1. A tour of the Special Procedures department was conducted on 9/29/14 with the Director of Nursing (DON). Observation on 9/29/14 at 2:20 PM identified a build- up of dust on the horizontal surfaces of door hardware and door frames for three of three procedure rooms. Interview with the DON at this time identified that the rooms are cleaned by hospital cleaning staff at the end of each procedural day. The facility policies for cleaning of surgical/invasive areas directed to damp dust furniture fixtures and horizontal surfaces and/or ledges with germicidal solution for cleaning between cases and terminal cleaning.
2. A tour of the scope decontamination room was conducted with the DON and the Gastrointestinal Technician (GI Tech) on 9/29/14 at 2:30 PM. Observations identified that the scope cleaning sink's required water level fill was marked in black marker with a line on each side of the sink. The water level line on the left side of the sink was lower than the water level line on the right side of the sink. Interview with the GI Tech at this time identified that he/she puts four pumps, or ounces, of enzymatic cleaner once the water reaches the marked water level line. He/she further indicated that he/she did not know the exact amount of water required to reach the water level line. Observation of water measurements needed to fill the sink noted that 7 gallons of water was required to fill to the water level line on the left side of the sink and 8 gallons was required to fill to the water level line on the right side of the sink. Review of the manufacture's recommendations and interview with the with the GI Tech and
DON on 9/29/14 at 2:30 PM directed to add 1 ounce (pump) of concentrate (enzymatic cleaner) to one gallon of warm water and that the amount of enzymatic cleaner that had been used to clean the scopes for the past two weeks was insufficient.
3. A tour of the satellite hospital campus physical therapy department was conducted on 9/30/14 at 9:25 AM. Observation at this time identified that Patient #16 was exercising with a weighted ball. The observation further indicated that PT #2 retrieved the ball from Patient #16 and placed the ball into a bin filled with other patient equipment, without the benefit of sanitizing. Interview with the Director #6 on 9/30/14 at 9:27 AM noted that PT #2 should have cleaned the weighted ball with a cloth (germicidal wipe) prior to placing the ball back in the bin. The facility IC policy for equipment cleaning identified that non critical patient care equipment (equipment that touches intact skin) must be cleaned with the hospital approved disinfectant or germicidal wipes after use on every patient.
4. The infection control (IC) program was reviewed with Infection Preventionist (IP) #1 and #2 on 9/30/14. Interview with IP #2 on 9/30/14 indicated that staff receives IC education, in part, on a yearly basis. Review of personnel and/or credential files was conducted on 10/1/14. The review indicated that that personnel files contained evidence of yearly required infection control (IC) education. Review of credential files and interview with Credential Staff on 10/1/14 at 10:55 AM noted that staff was credentialed every two years and received IC education at the time of credentialing (every two years). The facility infection control policy for education and training identified that all health care workers must participate in the annual mandatory education program to include IC training, bloodborne pathogen and tuberculosis exposure plans, personal protective equipment and other protective measures.
5. During a tour of the main operating room on 9/29/14, it was observed that multiple cleaning supplies and equipment utilized for surgical procedures being stored in a soiled utility room. Further observation identified that the soiled utility room was propped open to a hallway in the main operating room.
6. During tour of the ambulatory surgical unit on 9/29/14, it was observed that multiple carts of clean supplies/equipment were being stored in a soiled utility room that was being partitioned off my two supply carts. Further observation identified that staff was able to enter either door and enter both a soiled area and clean area within the room.
7. During tour of the PACU area on 9/29/14, it was observed that clean supplies were being stored in a soiled utility room. Review of hospital policy identified that work practice controls are preventive infection control measure which include separation of clean and dirty areas and items. Interview with the Infection Preventionist on 10/2/14 identified that clean supplies and equipment should not be stored in any soiled utility rooms.
19907