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Based on interview and record review, the Facility ' s Quality Assessment Performance Improvement Program failed to ensure the hospital's outpatient services are integrated into the Facility ' s Quality Assessment Performance Improvement Program.

Findings:

Interview on 01/26/2016 at 8:00 a.m. with the Facility ' s Chief Nursing Officer revealed the facility has a hospital outpatient service which provides radiology and CAT scan.(computerized axial tomography scan).


Interview on 01/26/2016 at 2:50 p.m. with the Facility ' s Chief Nursing Officer revealed the services at the hospitals's outpatient department was not integrated into the Facility ' s Quality Assessment Performance Improvement Program.

Interview with the Facility's Director of Pharmacy on 01/27/2016 at 12:40 p.m., he said he did not provide service or oversight to the outpatient service.

Interview on 01/28/2016 at 7:40 a.m. with the Facility's Quality Improvement Director revealed the Facility's Director of Radiology collects the data on the numbers of procedures done at the hospital's outpatient department, but it is not analyzed and included in the Facility's Quality Assessment Performance Improvement minutes.

Review of data provided by the Facility ' s Chief Nursing Officer on 01/27/2016, revealed the following documentation which indicated that during the months of October 2015, 233 procedures were done, November 2015, 192 procedures were done and January 2015, 186 procedures were done.
Review of the Facility's Quality Assessment Performance Improvement Program data for December 9, 2015 and January 22, 2016 revealed no evidence that this data was included in the minutes and that the data was analyzed by the committee.

Review of data included in the Quality Assessment Performance Improvement minutes provided by the Facility's Pharmacy Department revealed no evidence of information included from the facility's outpatient department.

Review of the Facility ' s Quality Assessment Performance Improvement Program data and meeting minutes, dated December 9, 2015, January 22, 2016 revealed no evidence that the hospital's outpatient service is integrated into the Facility ' s Quality Assessment Performance Improvement Minutes.

Based on observation, interview, and record review, the facility failed to ensure the pharmacist provided supervision and oversight of medications at the hospital outpatient department (HOPD).

Findings include:

Observation on 01-27-16 at 8:35 a.m. at the HOPD in the CAT (computerized axial tomograhy) room revealed a large black box that contained several emergency medications.

Interview at this same time with Staff- S- Lead Tech , she stated this box was considered the facility's crash cart. Drugs observed in this "crash cart" box included: atropine, epinephrine; solu-cortef; lasix; clonidine; dextrose; and others. She said the hospital pharmacist did not visit this department; "I think the drugs came from one of the doctor's offices."

Interview on 01-27-16 at 9:00 a.m. with Staff T- Management CEO, he stated the hospital pharmacist was not involved at the HOPD; "there is no need."

Interview on 01-27-16 at 9:45 a.m. with facility Stafff Y- Director of Pharmacy, he stated he had not visited the HOPD. He was unaware the HOPD had multiple medications on site.

Review of facility policy titled" Pharmacy Scope of Service," dated 12-12-15, read:"...Standards:...2. Pharmacy services shall maintain the selection, procurement, and storage of drugs..3 Pharmacy services shall prepare and dispense drugs and pharmaceuticals...7. Pharmacy services shall supervise all drug storage and preparation areas within the pharmacy and throughout the facility..."

Based on observation, interview, and record review, the facility failed to ensure expired drugs were not available for patient use in the hospital outpatient department (HOPD).

Two (2) of 2 epinephrine pens observed in the HOPD were expired.

Findings include:

Observation on 01-27-16 at 8:35 a.m. at the HOPD in the CAT (computerized axial tomograhy) room revealed a large black box that contained several emergency medications.

Further observation inside this box revealed a plastic cylinder that contained an "epinephrine pen." Staff S- Lead Tech was unable to locate an expiration date on the epinephrine pen or the the cylinder.

Continued observation in this same room revealed a metal cart. Observed inside one of the drawers was an epinephrine pen with an expiration date of July 2015. Interview with Staff S-Lead Tech , at this same time , she stated " this should not be in here." She discarded the drug.

Review of facility policy titled" Expired Drugs." dated 12-12-15, read: Procedure:: 1. All expired drugs that are not controlled substances are immediately returned to the designated area in the pharmacy on a daily basis...5. each unit is responsible for checking expiring medications ad must return them to the pharmacy for proper disposal and replacement.."

Based on record review and interview the facility failed to include duration of stay and professional services as an area for review in their Utilization Review Plan. This failed practice have the potential to adversely affect the quality and necessity of care for the facility's patients. Citing all patients admitted to the facility.

Findings:

Review of the facility's Utilization Review Plan dated 1/18/2016 revealed the plan did not include duration of stay nor professional services provided at the facility including drugs and biologicals as areas to be reviewed, to determine necessity for care and services.

The plan documented that ''all admissions, readmissions and third party payers would be reviewed''.

During an interview on 1/27/2016 at 1:45 PM at the facility with Staff X, Chief Nursing Officer she stated the plan was recently developed and the facility held it's first Utilization Committee Meeting in January 2016. She stated the facility would review the current plan and make the required additions for review.

Based on observation, interview, and record review, the facility failed to ensure an effective system for controlling infections and communicable diseases. The facility failed to ensure:

* appropriate high-level disinfection of transvaginal ultrasound probes.

* biological indicators used to test the effective operation of of autoclaves were not expired.

* proper storage of laryngoscope blades per professional standards.

* cleaning and daily maintenance of autoclaves per manufacture recommendation.

* equipment in the operating room (OR) did not contain rust; was able to be disinfected / cleaned.

* proper storage of linen to prevent contamination.

* maintenance of a sanitary environment in the the Magnetic Resonance Imaging (MRI) room.

Findings include:

High-level disinfection: transvaginal ultrasound probes:

Observation on 01-27-16 at 9:15 a.m at the hospital based outpatient department (HOPD) revealed a portable transvaginal ultrasound machine (Toshiba Xario-XR).

Interview at the time of observation with Staff O-ultrasound tech, she stated she cleaned the transvaginal ultrasound probes in between patients and placed a new probe cover on before each use. She went on to say she cleaned the probes by spraying them with "Transeptic Cleansing Solution" spray and then immediately wiped them off with disposable wipes called "PPS Select Disinfecting /Deodorizing /Cleansing Wipes."

Review of the label of "Transeptic Cleansing Solution" spray read: "A multi-purpose spray cleaner containing isopropyl alcohol and chlorhexidine gluconate...May be used as a routine cleaner or as a cleaning step prior to sterilization..."

Review of the label of the "PPS Select Disinfecting /Deodorizing /Cleansing Wipes" read: "FOR USE ON ENVIRONMENTAL SURFACES...Directions for use: It is a violation of U.S. Federal law to use this product in a manner inconsistent with its labeling. This product is not to be used as a terminal sterilant /high level disinfectant on any surface or instrument that is (1) introduced directly into the human body..."

Interview on 01-27-16 at 9:45 a.m. with Staff T-Management CEO, he stated he had recently purchased a new transducer probe for the ultrasound. Review of the invoice provided by the CEO revealed it was a "PVT-661VT-endocavitary transducer."

Staff T- Management CEO provided the manufacturer's guidelines for the PVT-661VT-transvaginal transducer.

Review of the document:"Toshiba Guidelines/ Manual for Cleaning, Disinfection, and Sterilization of Transducers,"undated, read: "...p. 4...(7)..If chemicals or methods other than those specified in this guide are used, the transducer may not be properly cleaned, disinfected...p. 6... (2). Disinfect the transducer using the disinfectant or disinfectant devices shown in the table on the last page..." Review of the manufacturer's table of high-level disinfectants failed to reveal any product used by the facility (on the transvaginal probes) listed on the table.

Review of Centers for Disease Control (CDC) "Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008" read: "...A vaginal probe and all endocavitary probes without a probe cover are semicritical devices because they have direct contact with mucous membranes..While the use of a probe cover could be considered changing the category...because probe covers can fail...the probe should also be high-level disinfected... findings (show) that sterile transvaginal probe covers have a very high rate of perforations even before use ( 0%, 25%, 65% from 3 suppliers)..."

Record review of facility patient log of all radiological exams/ procedures performed between 08-01-15 and 01-27-16 revealed transvaginal ultrasounds were performed on 23 patients.



Expired autoclave biological indicators ( BI):

Observation on 01-26-16 at 9:45 a.m. during a tour of sterile processing department (SPD) revealed three (3) Getinge Steam sterilizers and two(2) Sterrad NX sterilizers.

Interview at time of observation with Staff -A sterile processing tech, she stated she "ran a biological indicator (BI) every day the Sterrad NX was used." She went on to say she kept daily logs for all the performance testing ran for all the sterilizers

Further observation revealed a box of 24 Sterrad NX CylcleSure biological indicators( BI) ; label read: "expired 12/2015." The lot number of the BIs was 10115245. Staff-A was unable to locate any BIs (Sterrad NX) that were not expired.

Review of facility binder with forms "Sterrad System-Daily Biological Indicator Control Sheet" revealed the Sterrad NX was last used on 01-06-16. The cycle load contents was listed as "Rhinoplasty." The BI used was documented :" Lot #19115245," the same lot number of the BIs that expired 12/2015.

Surveyor was informed on 01-27-16 this instrument set had not been used on a patient. The instruments were removed from sterile supply storage and would be re-sterilized.

Review of "Sterrad NX User Guide," it read: ""Preparing the Load:...Biological indicators (BI) : confirming that sterilizing conditions were achieved during a cycle is an important part of the sterilization process. Biological indicators are one way to ensure that your sterilizer is operating correctly... Place a STERRAD CycleSure BI in the chamber at the back of the bottom shelf. BI testing should be performed at least once per day..."


Storage of laryngoscope blades:

Observation on 01-26-16 between 9:30 a.m. and 10:30 a.m. in the surgical department revealed the following in OR # 2; 3; 4; 5; and 7:

Multiple (eight [8] +) unwrapped, loose laryngoscope blades located in a drawers of the Omincell machine in each of the ORs observed.

Interview on 01-26-16 at 1:45 p.m. with Staff C- Director of Surgical Services, she stated the laryngoscope blades were high-level disinfected; many were received in individual packages. She went on to say another surveyor told her it was acceptable to store them uncovered in the drawer.

Review of "Association of periOperative Registered Nurses (AORN) clinical practice guidelines: instrument cleaning(website) : "... Laryngoscopes blades are considered semicritical..and should be cleaned and high-level disinfected or sterilized. Cleaned and disinfected laryngoscope blades and handles should be packaged and stored in a manner that prevents contamination. Laryngoscope blades should be stored in individual packages..."


Routine maintenance of autoclaves

Observation on 01-26-16 at 9:45 a.m. during a tour of sterile processing department (SPD) revealed three(3) Getinge Steam sterilizers and two(2) Sterrad NX sterilizers.

Interview on 01-26-16 at 10:00 a.m. with Staff -A sterile processing tech, she stated the only cleaning she did was wiping off the outside of the sterilizers when needed. She was unaware of any daily /weekly tasks needed as part of routine care /maintenance of the autoclaves. Staff A went on to say that annual preventative maintenance (PM) was done by the autoclave technician.

Getinge Sterilizers (3):

Review of "Getinge Steam Sterilizer User Manual ( 400/500 HC series)," read:

Table p. 7-1:

"Daily: clean sediment screens..

Weekly: : clean chamber interior... accessories...door gaskets.."

Page 7-2 :" remove sediment screens from the chamber drain and clean thoroughly.."

Page 7-4: " ..the interior chamber should be cleaned with a nonchloric cleaner...and rinsed or flushed with clean water.."

Page 7-4: "...stainless steel accessories ( loading cars, transfer carriages, rack, shelves, and trays) must be cleaned and maintained properly..failure to maintain the stainless steel surfaces properly may result in ..deterioration of the surfaces..

Page 7-5: " ..the door gaskets should be cleaned weekly. Clean the door gaskets with a damp cloth.."

Sterrad NX Sterilizers (2):

Review of "Sterrad NX User Guide," it read: " Cleaning the Hydrogen Peroxide Monitor Detector Lens: The hydrogen peroxide monitor must be kept clean. Clean the lens once every three months or when an accumulation of debris is noted... Replacing the Air Filter: The air filter should be replaced when it is clogged with dust or debris..Periodically check the air filter for dust and debris.."


Rust on equipment in the ORs:

Observation on 01-26-16 between 9:30 a.m. and 10:30 a.m revealed the following:

Operating Room # 6:

* large amount of rust on all 4 wheel casters on the anesthesia chair.

* large amount of rust on all 4 wheel casters of a large metal instrument table.

Operating Room # 5:

* large amount of rust on a canister of nitrous gas located on the anesthesia cart.

Operating Room # 3:

* large amount of rust on all 4 wheel casters on the anesthesia chair.

Interview at the time of observation with facility Staff B-Infection Preventionist, she acknowledged rusty surfaces were not cleanable.


Linen Storage:

Observation on 01-27-16 at 9:15 a.m at the hospital based outpatient department (HOPD) revealed the following:

*Linen stored, uncovered on open "bookcase" type shelving in the CAT scan room and the X-ray room. The linen was exposed to potential contamination by staff, patients, and vendors.

Review of facility policy titled " Infection Control-Linen Supplies," dated 12/15/15, read: "...C. Clean Linen:...c, When stored in the patient care areas or elsewhere in the hospital, it must remain covered at all times..."


Sanitary Environment: MRI Room :

Observation on 01-27-16 at 8:40 a.m. at the hospital based outpatient department (HOPD) revealed a large room that contained the MRI machine.

The following infection control issues were identified:

1.) A large ( approximately 2 1/2 feet by 5 feet) open panel in the wall exposing multiple wires and electrical -type equipment. The area was very dirty and dusty at the lower portion of the opening in the wall and the floor.

Surveyor was informed later this day by Staff -T- Management CEO that the vendor failed to replace the "cosmetic cover" cover the area & it had been replaced.

2. ) A large uncovered area on the floor at the base of the MRI machine itself. The uncovered portions of the floor had large electrical wires , equipment, and tubing extending from it. The floor tile and the area inside the opening had a large accumulation of dust ( clumps).

Surveyor was informed later this day by Staff -T -Management CEO that the vendor failed to replace the "cosmetic cover" cover after the last servicing of the MRI. This cover had been replaced.

3.) A large area of the floor ( approximately 3 feet by 3 feet) in the back left corner contained multiple "clumps" of dust and dirt.

4. ) A large cardboard box of supplies located directly on the floor immediately adjacent to the MRI machine.

5.) A large foam wedge stored directly on the floor next to the MRI machine. Interview at this same time with Staff-Z-MRI Tech, he stated the wedge was used to positron patients and should not be stored on the floor.

Continued interview with Staff -Z -MRI Tech he stated the techs were responsible for cleaning and maintaining the radiology rooms. He was unsure when the MRI room had last been cleaned.

Based on record review and interview the facility failed comply with their responsibilities outlined in their agreement with lifeGift that require the Hospital to develop protocol for determining when death occurs, and protocol that defines ''imminent death'' to ensure timely notification to LifeGift. This failed practice had the potential for decreased viability of an organ when there is a potential donor.

Findings:

Review of the Donor Institution Agreement between the facility and LifeGift Organ Donation Center (LifeGift) dated 2/6/2014 revealed the agreement require the hospital to be responsible for establishing a protocol for determining when death occurs.

To establish procedure for notifying LifeGift whenever a patient reaches the criteria for imminent death or cardiac death .

Review of the facility's policy/procedure for Organ/Tissue Donation dated 12/15/2015 revealed the policy did not define '' imminent death and cardiac death''. The policy did not outline when death occurs for the purposes of organ donation.

During an interview on 1/28/2016 at 11:12 am with Staff X,Chief Nursing Officer she stated she recognized that the policy and procedure was missing important components and that would be addressed.

Based on record review and interview the facility failed to ensure facility staff have training in organ donation issues. This failed practice had the potential for limiting the organ donation and procurement process in the hospital. Citing all applicable hospital personnel.

Findings:

Review of the facility's Donor Institution Agreement between LifeGift Organ Donation Center and the facility dated 2/6/2014 revealed information that ''LifeGift agrees to assist the facility in training of Hospital personnel who are involved in the referral process''.

Review of the facility's Organ Tissue Donation Policy# NUR.87 dated 12/15/2015 revealed no information regarding staff training or the category of personnel that would be trained in organ donation issues.

During an interview on 1/27/2016 at 10:15 am at the facility with Staff X, Chief Nursing Officer she stated a training model would be developed for staff education on organ donation issues.

Based on observation, interview, and record review, the facility failed to fully integrate outpatient services with inpatient services.

The facility failed to fully integrate the hospital based outpatient department (HOPD) into the main hospital's Infection Control Program ; Pharmacy Services; and Quality Assessment / Performance Improvement (QAPI) Program.

Findings include:

Infection Control:

Observation on 01-27-16 at between 8:30 a.m. and 10:45 a.m. at the hospital based outpatient department (HOPD) revealed the following infection control issues:

* improper high-level disinfection of transvaginal ultrasound probes.

* unsanitary environment: MRI room

* improper storage of linen.

Interview on 01-27-16 at 9:30 a.m. with Staff B-hospital Infection Preventionsist she stated the HOPD staff had attended her hand hygiene program & other infection control training.

Staff B-hospital Infection Preventionsist went on to say she had never visited the HOPD and not conducted any infection control/environmental rounds. She was unaware of the method the ultrasound tech was using to clean the transvaginal ultrasound probes between patients.

Review of facility policy titled "Infection Control-2016 Infection Control Program/Plan," dated 12-12-15, read: "The primary objective of the Infection Control Program is to improve patient outcomes through surveillance, prevention, and control of infections..and to provide an environment that is safe from preventable microbial risk... Infection control at the hospital allows for a systematic, coordinated and continuous approach which includes:...4. Patient care services include Emergency Department, Medical , Surgical, Operating Room, Post-Anesthesia, Outpatient Surgery, Special procedures/ Pain Management.."

** Of note: the facility "Infection Control Program" did not include the HOPD.


Pharmacy Services :

Observation on 01-27-16 at 8:35 at the hospital based outpatient department (HOPD) revealed multiple medications (atropine, epinephrine; solu-cortef; lasix; clonidine; dextrose; and others) kept in a "crash cart" box; along with 2 of 2 epinephrine pens expired.

Interview on 01-27-16 at 9:45 a.m. with facility Staff Y- Director of Pharmacy, he stated he had not visited the HOPD. He was unaware the HOPD had multiple medications on site.

QAPI Program :

Interview on 01/28/2016 at 7:40 a.m. with the Facility's Quality Improvement Director revealed data was collected by facility's Director of Radiology but it is not analyzed and included in the facility's QAPI minutes.

Review of the facility's QAPI data and meeting minutes, dated December 9, 2015 and January 22, 2016 failed to reveal evidence that the hospital's outpatient service (HOPD) was integrated into the facility's QAPI Program.
(* See Tag A-0308 for more details)