HospitalInspections.org

Based on medical record review and staff interview, it was determined that the facility failed to ensure that its Medical Record Documentation: Medical Staff Requirements policy is implemented.

Findings include:

Reference: Facility policy titled 'Medical Record Documentation: Medical Staff Requirements' states, "... Discharge Summary ...it must be included in the medical record within 30 days of discharge, transfer or death."

1. During a review of Medical Record #4, there was no evidence that the discharge summary was included in the medical record within 30 days of discharge.

a. This finding was confirmed by Staff #2 and Staff #29.

A. Based on observation it was determined that the facility failed to discard all multi-dose vials within its date of expiration.

Findings include:

1. On 7/28/15 at 10:30 AM the Oncology Unit was toured in the presence of Staff #2. At 11:45 AM, a portable medication station was observed to contain an opened ten (10) milliliter (ml) vial of Levimir 100 units/ml. The vial was labeled with an expiration date of 6/10/15. The vial was available for use forty-eight (48) days past the expiration date documented on its label. This was confirmed by Staff #10.


33800


B. Based on observation, facility policy review and staff interview conducted on 7/28/15 and 7/29/15, it was determined that the facility failed to ensure that its Hand Hygiene policy is implemented.

Findings include:

Reference #1: Facility policy titled 'Handwashing and Hand Hygiene Protocol' states, "... III. Indications for Hand Hygiene ... After removing gloves ... VII. Skin Care and Other Aspects of Hand Hygiene ... D. Keep natural nail tips less than 1/4" long so as not to perforate gloves when worn tightly."

Reference #2: Guideline for Hand Hygiene in Health Care Settings: Recommendation of the Healthcare Infection Control Practices Advisory Committee [HICPAC] and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force, published in the CDC (Centers for Disease Control and Prevention) Morbidity and Mortality Weekly Report at MMWR 2002; 51 (No. RR-16) page 32 states, "Recommendations: 1. Indications for Handwashing and Hand antisepsis ... C. Decontaminate hands before having direct contact with patients. ... E. Decontaminate hands before inserting ... peripheral vascular catheters, or other invasive devices ... F. Decontaminate hands after contact with a patient's intact skin ... G. Decontaminate hands after contact with ... a patient's nonintact skin ... I. Decontaminate hands after contact with inanimate objects ... in the immediate vicinity of the patient. J. Decontaminate hands after removing gloves."

1. During the entrance interview with Staff #5 at 9:43 AM on 7/28/15, he/she stated that the facility's Infection Control program follows CDC, AAMI, AORN, SGNA and OSHA guidelines.

2. On 7/29/15 at 10:53 AM in Operating Room (O.R.) #2, Staff # 47 was observed to remove a pair of soiled gloves without sanitizing his/her hands.

a. This finding was confirmed with Staff #47.

3. On 7/29/15 in the Endoscopy Decontamination Room at 11:40AM, Staff #49 removed a pair of soiled gloves, proceeded to write the patient's information on the Automated Endoscope Reprocessor (AER) printout tape, then don a new pair of gloves without sanitizing his/her hands.

a. This finding was confirmed by Staff #49.

4. On 7/29/15, in the Sterile Processing Department (SPD) at 1:45 PM, in the presence of Staff #5, Staff #15 was observed to have long and sharp fingernail tips > one inch long.

a. Staff #15 stated that he/she does not have artificial nails.

b. Staff #15 stated he/she performs all tasks within the SPD Decontamination, Prep and Pack and Sterilization areas.

c. The facility failed to ensure that its Hand Hygiene policy was implemented.

d. This finding was confirmed by Staff #5.

5. On 7/28/15 on Unit 2 East, Staff # 24 was observed removing gloves without sanitizing his/her hands.

a. This finding was confirmed by Staff #21.

6. On 7/29/15 on the Labor and Delivery Unit, Staff #33 and #34 were observed removing gloves, after a procedure, without sanitizing their hands.

a. These findings were confirmed by Staff #35.

7. On 7/29/15 in the OR, Staff #45 was observed removing gloves without sanitizing his/her hands.

a. This finding was confirmed by Staff #13 and #19.

C. Based on observation, facility document review and staff interview conducted on 7/28/15 and 7/29/15, it was determined that the facility failed to ensure a sanitary environment for the provision of surgical services.

Findings include:

1. During a tour of the Mediplex ASC (Ambulatory Surgery Center) Operating Room #3 on 7/28/15, in the presence of Staff #5, #13, #18, and #19, yellowish and brownish stains were observed on the floor around the O.R. table.

a. This finding was confirmed by Staff #5, #13, #18, and #19.

2. The head attachment for the O.R. table was observed to be stored on the floor.

a. This finding was confirmed by Staff #5, #13, #18, and #19.

3. At 1:55 PM, in the Mediplex ASC O.R. Substerile Room between O.R. # 1 and O.R. #2, the "FlashGuard flash pan" (i.e., tray used for Immediate Use Steam Sterilization [IUSS]) was observed to be stored on the counter on top of a standing stool.

a. There were gel positioning devices that were stored on the counter next to the standing stool.

b. Staff #18 stated that the FlashGuard flash pan is not re-washed before using for IUSS.

c. This finding was confirmed with Staff #5, #13, and #19.

4. During a tour of the Linen Department at 2:30 PM, a linen cart that had arrived through the receiving dock was observed to contain clean linen.

a. The clean linen cart was observed to be partially covered with a plastic cover that was pulled halfway upwards.

b. The linen stored on the bottom shelves of the cart were exposed to the elements.

c. The facility failed to ensure that its clean linen are transported and stored in a manner that maintains their cleanliness.

d. This finding was confirmed by Staff #5 and #16.

5. During a tour of the O.R. on 7/29/15 at 10:58 AM, in the presence of Staff #5, #13 and #19, a metal storage cart that contained sterile Orthopedic Loaner trays was observed to be stored on the O.R. hallway.

a. The storage cart was inadequately covered by plastic sheeting that contained multiple holes and a large tear on the front.

b. This finding was confirmed with Staff #5, #13 and #19.

6. During a tour of the SPD Decontamination Room on 7/29/15 in the presence of Staff #5 and #15, the floors were observed to be cracked, gouged and in some areas, missing large patches of floor tiles.

a. The damaged floor areas cannot be cleaned adequately.

b. This finding was confirmed with Staff #5 and #15.

Reference #3: Facility policy titled Flash Sterilization in the O.R. states, "Procedure: ... B. Items shall be sterilized using Sterion containers."

1. On 7/28/15, during a tour of the Mediplex ASC, in the presence of Staff #5, #13, #18 and #19, a FlashGuard container was observed in the substerile area between O.R. #1 and O.R. #2.

a. According to Staff #18, this is the container they use in the Mediplex ASC for Flash Sterilization (also called Immediate Use Steam Sterilization or IUSS).

i) There were no Sperion containers in the Mediplex ASC.

b. The facility failed to provide Sperion containers for IUSS in the Mediplex ASC, in accordance with its Flash Sterilization policy.

2. This finding was confirmed with Staff #5, #13, #18 and #19.

D. Based on observation, facility document review and staff interview conducted on 7/28/15, it was determined that the facility failed to ensure that its reusable critical equipment are reprocessed in accordance with the nationally recognized Infection Control guidelines it has selected, i.e., AAMI and AORN, and its own Infection Control policy.

Reference #4: Facility policy titled 'Flash Sterilization in the O.R.' states, "Procedure: ... A. ... 1. All items needed immediately shall be thoroughly cleaned, decontaminated, and dried utilizing standard precautions before the item is sterilized. ..."

Reference #5: AAMI (Association for the Advancement of Medical Instrumentation) Sterilization in Health Care Facilities, 2014 edition states in ST 79 section 7.5.1, "For all reusable medical devices, the first and most important step in decontamination is thorough cleaning and rinsing. ... Effective cleaning is a multistep process that relies on several interdependent factors: the quality of the water, the quality, concentration and type of detergent or enzymatic cleaner; and acceptable washing method; proper rinsing and drying; ... Thorough rinsing and cleaning are vital to the effectiveness of subsequent microbiocidal processes used for decontamination, disinfection, and/or sterilization. ... Any organic material or residual cleaning agents remaining on an item can inactivate chemical disinfectants or sterilants as well as protect microorganisms from destruction. ... Adequate cleaning and rinsing should result in low bioburden, which is essential to the effectiveness of terminal sterilization and to the protection of patients from pyrogens."

1. During the entrance interview with Staff #5 at 9:43 AM on 7/28/15, he/she stated that the facility's Infection Control program follows CDC, AAMI, AORN, SGNA and OSHA guidelines.

2. On 7/28/15 at 1:50 PM, during a tour of the Mediplex ASC in the presence of Staff #5, #13 and #19, Staff #18 stated that the facility staff in the ASC use enzymatic pre-cleaning gel to clean and decontaminate the soiled instruments prior to conducting IUSS.

3. It was observed that there were no enzymatic cleaning solutions available in both substerile areas: between OR #1 and OR #2 and between OR #3 and OR #4.

a. The facility failed to provide proper cleaning agents for instrument reprocessing.

4. The facility failed to implement proper instrument cleaning methods for the reprocessing of soiled reusable critical instruments.

5. These findings were confirmed with Staff #5, #13 and #19.

Reference #6: AORN Perioperative Standards and Recommended Practices 2013 section RP: Care of Instruments Recommendation I.a. states, "The manufacturer's written instructions should be used to determine how to replicate the validated cleaning and processing methods."

1. At 1:55 PM, during an interview with Staff #18 in the Mediplex ASC, in the presence of Staff #5, #13 and #19, three (3) out of three (3) manufacturers' instructions for use (IFUs) were requested and not received:

a. FlashGuard container

b. Stryker battery

c. Trilliant Tray 3.0 cannulated screw

2. The facility failed to ensure that the device manufacturer's written instructions for decontamination and sterilization are readily available and followed in the Mediplex ASC.

3. These findings were confirmed with Staff #5, #13, #18 and #19.


33802


E. Based on observation, facility policy review and staff interview conducted on 7/29/15, it was determined that the facility failed to ensure that its Guideline for Insertion and Daily Care of Foley Catheter policy is implemented.

Findings include:

Reference #7: Facility policy titled 'uidelines for Insertion and Daily Care of Foley Catheters states, "... Proper Techniques for Urinary Catheter Maintenance ... B. ... 2. Keep the collecting bag below the level of the bladder at all times. Do not rest the bag on the floor. ..."

1. On 7/29/15 in the OR, Staff #41 was observed inserting a Foley catheter into Patient #10. Following the insertion, Staff #41 allowed the Foley bag to rest on the floor.

a. This finding was confirmed by Staff #13 and #19.

F. Based on observation and staff interview conducted on 7/29/15, it was determined that the facility failed to ensure a sanitary environment for patients in the OR.

Findings include:

1. On 7/29/15 in the OR, Patient #10 was observed being repositioned on the OR table by the OR staff. A towel was covering Patient #10's perineal area. While Patient #10 was being repositioned the towel fell on the floor. Staff #42 picked the towel up from the floor and placed it over Patient #10's perineal area.

a. This finding was confirmed by Staff #13 and #19.

Based on medical record review and staff interview, it was determined that the facility failed to ensure that a list of acute rehabilitation facilities was presented to all patients requiring acute rehabilitation upon discharge.

1. Review of Medical Record #4 revealed the following:

a. Patient #4 was discharged to an acute rehabilitation facility on 6/26/15.

b. There was no evidence that Patient #4 was provided with choices of acute rehabilitation facilities.

c. There was no evidence that Patient #4 was provided with a list of acute rehabilatation facilities.

2. These finding was confirmed by Staff #29 and Staff #31.