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Based on document review, interview, and observation, it was determined that the Governing Body failed to demonstrate it is effective in carrying out the responsibilities of the operation and management of the hospital. The Governing Body failed to provide necessary oversight and leadership as evidenced by the lack of compliance with the following Condition of Participation:

CFR 482.24 Infection Control

Based on medical record review, review of facility policies and procedures and staff interview, it was determined that the facility failed to ensure that all policies and procedures were implemented.

Findings include:

REFERENCE #1: Facility Policy Number 175, Subject: "Valuables and Belongings, under Method of Implementation, D. Discharges:" states, "At the time of discharge the patient/family will check the patient Valuables Clothing List with the RN/LPN against the patient's belongings/valuables and sign. If there is no family member present or the patient is unable to participate in the process the RN/designee (see #2) of the discharge unit will do the check."

1. Upon admission, documentation on the "Patient Valuable & Clothing List" in Medical Record #4 indicated that the patient had eyeglasses and dentures. The signature line stated "Pt. unable to sign."

2. Documentation in the nurse's notes dated 6/6/10 at 1800 indicated, "Patient discharged to home via wheelchair personal possessions with patient. A/O forgetful, lethargic, able to understand commands, swallows medications. Daughter and son in law at side."

3. Documentation on the "Patient Valuable & Clothing List" upon discharge was not completed as indicated in the above referenced policy. The discharge date, time, and signature line was left blank.

4. The above was confirmed by Staff #3.

REFERENCE #2: Facility Policy Number: Nsg 1005, Subject: "Balance & Motion Vestibular Assessment," states, "All patients will have a Vestibular Assessment completed on admission. Score above 5 will be referred to the Balance and Motion Center for possible need for assessment."

1. Documentation on the Vestibular Assessment Scale form in Medical Record #2 stated that the patient's score was 21.

2. According to the above referenced policy, a patient with a score of above 5 is to be referred to the Balance and Motion Center for a possible assessment. Documentation on the Vestibular Assessment Scale was not completed as indicated in the 'Balance & Motion Vestibular Assessment' policy.

3. The above was confirmed by Staff #3.

Based on a tour and staff interview, it was determined that the facility failed to ensure that all patients receive care in a safe setting.

1. A tour was conducted of the Sleep Center on 11/16/10 at approximately 8:00 AM in the presence of Staff #36. It was observed during the tour that the facility had the capacity to perform two sleep studies simultaneously.

2. Staff #36 stated that there is no more than one staff member scheduled at all times. Therefore, if an emergency situation occurs, there is only one staff member available.

Based on document review and staff interview conducted on 11/16/10, it was determined that the facility failed to ensure that the medications were administered in accordance with physician's orders.

Findings include:

1. A physician's order was written in Medical Record #12 on 11/15/10 for "Ancef 1 GM IV q 8h x 2 doses [1 gram intravenously every 8 hours times 2 doses]." The administration of Ancef 1gm is recorded on the Medication Administration Record on 11/15/10 at 10:00 PM. There was no evidence of administration of a second dose 8 hours later, at 6:00 AM on 11/16/10. This findings was confirmed by Staff #16 and Staff #27.

2. A physician's order was written in Medical Record #15 on 11/15/10 for "Ancef 1 GM IV q 8h x 2 doses [1 gram intravenously every 8 hours times 2 doses] Post op 1st dose due: Date 11/15 Time: 1645." The administration of Ancef 1gm is recorded on the Medication Administration Record on 11/15/10 at 20:30 instead of 16:45. There was no evidence of administration of a second dose 8 hours later. This findings was confirmed by Staff #16 and Staff #27.

Based on observation, staff interview, and review of documentation and sterilization records, it was determined that the Condition for Coverage - Infection Control was not met.

Findings include:

The infection control officer or officers failed to develop a system for controlling infections and communicable diseases of patients and personnel (Cross Reference to A0749).

A. Based on observation, staff interview, and document review, it was determined that the Infection Control Officer's activities for controlling infections and communicable diseases did not include mitigation of risks contributing to healthcare-associated infections.

Findings include:

Reference #1: CDC's Hospital Infections Program, "Guideline for Prevention of Surgical Site Infection" states in Sterilization of surgical instruments (Section II C. 2-d-2), "Perform flash sterilization only for patient care items that will be used immediately (e.g., to reprocess an inadvertently dropped instrument). Do not use flash sterilization for reasons of convenience, as an alternative to purchasing additional instrument sets, or to save time."

Reference #2: The facility's policy and procedure titled "Flash Sterilization of Non-Implantable Items in the Operating Room" states, "Bayshore Community Hospital discourages the use of flash sterilization. Flash sterilization is to be utilized only as a last resort option in an emergency when flash sterilization is unavoidable (see exceptions below.) Policy Exceptions (if applicable): There is a one-of-a-kind instruments that becomes contaminated during the procedure or is brought to the OR by the surgeon for use in a procedure .... Specialty instrumentation is brought in by vendor for use in an emergency case and there is insufficient time to process in Central Sterile Department."

1. A review of the facility's "Flash PI" record used by Staff #12 for surveillance revealed the following: "Date, item flashed, reason for flashing and surgeon."

a. The August 2010 "Flash PI" record indicated that six (6) flash cycles had occurred. Five (5) out of the six (6) cycles were for reasons other than an emergency.

b. The September 2010 "Flash PI" record indicated that thirteen (13) flash cycles occurred and all were for reasons other than an emergency.

c. The October 2010 "Flash PI" record indicated that ten (10) flash cycles had occurred. Eight (8) out of the ten (10) cycles were for reasons other that an emergency.

2. Staff #24 and Staff #25 stated during interviews on 11/16/2010 that surgeries are pre-scheduled so vendors have adequate time to provide proper instrumentation sterilization prior to surgery.

B. Based on review of the facility sterilization records and a review of approved infection control guidelines, it was determined that the facility failed to ensure that all instruments are processed according to manufacturers instructions.

Findings include:

Reference #1: CDC's Hospital Infections Program, "Guideline for Prevention of Surgical Site Infection" states in Sterilization of surgical instruments (Section II C. 2-d-1), "Sterilize all Surgical instruments according to published guidelines."

Reference #2: AAMI ST 79:2006, "Comprehensive Guide to Steam, Sterilization and Sterility Assurance in Health Care Facilities" states in 10.3.1, "Ideally, every reprocessed medical device, especially an implant, should be fully traceable to the patient on whom it is used or in whom it is implanted; such traceability can be accomplished by recording the sterilizer load identifier on the patient chart or the patient mane on the load record."

Reference # 3: AAMI ST 79:2006, "Comprehensive Guide to Steam, Sterilization and Sterility Assurance in Health Care Facilities" states in 7.2.2, "The written recommendations of the device manufacturer should always be followed ...The manufacturer's written instructions should be kept on file and periodically reviewed for any updates."

Reference # 4: AAMI ST 79:2006, "Comprehensive Guide to Steam, Sterilization and Sterility Assurance in Health Care Facilities" states in 10.3.2, "for each sterilization cycle, the following information should be recorded and maintained: b) the specific content of the lot or load, including quantity, department, and specific description of the items."

Reference #5: AAMI ST 58:2005, "Chemical sterilization and high-level disinfection in health care facilities" states in 7.3.2, "Health care personnel should follow the LCS/HLD manufacturer's written instructions."

Reference #6: The facility's policy and procedure titled "Ureteroscopes (flexible) - Manual Cleaning and Disinfection" states, "B. Disinfecting (for Storage) 1. Test Cidex Plus solution prior to each use."

Reference #7: The "Manufacturer Advanced Sterilization Products" states in the Cidex Plus instructions, "Usage: Test the solution prior to each use to assure that the glutaraldehyde concentration is above its MEC."

Reference #8: The facility's policy and procedure titled "Ureteroscopes (flexible) - Manual Cleaning and Disinfection" states, "C. Disinfecting (for use) Instruments are soaked for twenty (20) minutes. The timing is to be done on the clock in the room ONLY."

Reference #9: The facility's policy and procedure titled "Cleaning of Surgical Suite: states, "No dry mops or brooms are to be used in the Operating Room."

1. A review of the facility's "Flashing PI" records indicated that on 8/4/10 and 8/11/10 cytoscopes were flashed.

2. Autoclave tapes from the Operating Room (OR) Suite sterilizers were also reviewed and revealed that cystoscopes were flashed on 10/20/10 at 12:16PM and 1:12 PM for 10 minutes at 270 degrees Fahrenheit. In addition, on 10/8/10 at 9:59AM, a cystoscope was flashed for 10 minutes at 270 degrees Fahrenheit.

3. Staff #23 and Staff #24 stated during interviews on 11/16/10 and 11/17/10 that the scopes flashed are ACMI brand Cystourethroscopes and that the facility uses a gravity flash cycle as a standard for the above stated scopes. Staff #23 further stated that the facility does not use a prevac cycle.
The manufacturer's instructions for sterilization of the scopes recommends a Prevac wrapped/flash cycle of 270 degrees Fahrenheit at 4 minutes. There was no evidence that the published guidelines recommend a gravity cycle for sterilization.

4. A review of the implant medical devices biological log lacked any evidence of traceability of implants to the surgical patients' whom were precipitants of devices that were sterilized in-house prior to the surgical procedure as indicated in Reference #2.

5. A review of the facility's "Flash PI" logs for September 2010 revealed that on 9/27/10 "Dr. S. Cataract instru" and on 9/29/10 "Dr. E. Cataract instruments" were flashed.

a. Staff #23 and #24 were asked on 11/15/10 to provide the manufacturer's instructions for the Cataract instruments that were flashed in September 2010. The instructions were not provided as requested by the end of the on-site survey on, 11/17/10. There was no evidence that the instruments were sterilized as per the manufacturers instructions as indicated in Reference #3.

6. A review of the steam sterilization records (autoclave tapes and sterilizer logs) from Central Process and the OR do not adequately list the specific description of items sterilized. For example on 2/23/10, Sterilizer #2 ran a load which was labeled "Spine DePuy." Staff #23 stated on 11/17/10 that there are multi trays that are used in spinal surgery. Staff #23 could not identify which tray was sterilized during the load dated 2/23/10 and labeled "Spine DePuy" as indicated in Reference #4.

7. A review of the Cidex Plus log used to record efficiency of the disinfectant had only one daily reading per day along with the date in which the solution was changed. There were no written results available showing that the solution was tested prior to each use as indicated in Reference #6 and #7.

8. The room that is used to soak the scopes in the Cidex solution lacked any clock as indicated in Reference #8. Staff #23 was asked were the clock was and he/she responded that the staff use their personal watches to time the cleaning process. There was no evidence that the facility has implemented the above stated policy as indicated in Reference #8.

9. On 11/15/10 at approximately 10:40AM, housekeeping staff was observed sweeping OR #1 with a broom and dust pan around the OR table. There was no evidence that OR #1 was being cleaned in accordance with the facility policy as indicated in Reference #9.


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C. Based on staff interview, review of facility documents and medical record review, it was determined that the facility failed to be responsible for a plan of action for preventing, identifying, and managing infections.

Finding include:

Reference #1: The CDC (Centers for Disease Control) document titled "Special Articles-Guideline for Prevention of Surgical Site Infection, 1999" states, "Table 1. Criteria for Defining a Surgical Site Infection (SSI), Superficial Incisional SSI, Infection occurs within 30 days after the operation and infection involves only skin or subcutaneous tissue of the incision and at least one of the following: 1. Purulent drainage...Organisms isolated from an aseptically obtained culture...symptoms of infection...Diagnosis of superficial incisional SSI by the surgeon or attending physician..."

1. A review of 3 of 3 medical records (#16, #17 and #31) of post- operative surgical patients, revealed that the patients were not tracked or monitored for possible infections within 30 days after the surgical procedure was performed.

2. An interview with Staff #12 on 11/16/10 revealed that the facility did not have a mechanism in place, provided by the surgeon or attending physician, to monitor post-operative surgical site infections past 24 hours after the surgical procedure was performed as indicated in Reference #1.

3. A review of the "Flash Sterilization QI 2010" log indicated the following:
a. The month of January, 10 items were flashed.
b. The month of February, 15 items were flashed.
c. The month of March, 9 items were flashed.
d. The month of April, 16 items were flashed.
e. The month of May, 13 items were flashed.

4. The "Infection Control Committee Meeting Minutes" dated 2/3/10, indicated "Perioperative/Flash: Flash report for April we had eight flashed, May approximately 10 with final report pending. Issues continue to include those instruments which are one of kind... Consulting (Name of the Consulting Company) on their opinion as to whether we need a formal flashing policy for implants. Strict language was included in policy that physician's must document emergency situation..."

5. A review of the "Operating Room Committee" meeting minutes dated January 11, 2010, July 19, 2010 and April 12, 2010, did not indicate any discussion and/or identify the use of flashing surgical instruments as stated above in the "Flash Sterilization QI 2010" log.

6. There was no evidence that the facility had developed an effective plan of action to prevent the use of flash sterilization of operative instruments for emergency use only, to effectively minimize the potential risk for post operative infections.

7. There was no evidence that the Infection Control Committee is receiving accurate data as reported in the Flash Sterilization log for 2010.

Based on medical record review and staff interview, it was determined that the facility failed to ensure that all patients requiring post-hospital care are provided with such services post hospital-stay.

1. Documentation on the discharge summary of Medical Record #5 indicated, "She had a PICC (Peripherally Inserted Central Catheter) line inserted and a port-A-Cath was removed by Dr._______ on 5/6/2010."

2. The patient was discharged on 5/8/2010.

3. The discharge instructions did not include instructions for the care of the PICC line. The section for "Access Device (type)" on the discharge instructions was left blank.

4. There was no evidence of a referral for post hospital service related to the patient's PICC Line.

5. The above was confirmed by Staff #34.

Based on document review and staff interview conducted on 11/16/10, it was determined that the facility failed to ensure implementation of polices and procedures addressing "time-out" prior to the start of a surgical procedure.

Findings include:

Reference #1: Facility policy titled "Site Marking for Surgical/Procedural Site, Time-out, Universal Protocol," under C.1. states, "Time-Out: Immediately prior to the start of the procedure a "time-out" must be conducted in the location where the procedure is being done. The "time-out" must involve the entire operative team using active communication..."

Reference #2: Facility policy titled "Site Marking for Surgical/Procedural Site, Time-out, Universal Protocol," under C.2. states, "Documentation of the "time-out" process is to be done on the Universal Protocol/Time-Out Checklist..."

1. Upon review of the "Final Verification Universal Protocol Time-Out Checklist" in the following Medical Records, it was noted that the name of the participants in the "time-out" was not completed in the following instances:

a. Medical Record #29 on 11/5/10 at 11:00 AM.

b. Medical Record #31 on 6/7/10 at 16:06.

c. Medical Record #21 on 10/15/10 at 17:15 and 10/4/10 at 16:00.

d. Medical Record #28 on 10/7/10 at 14:05.

e. Medical Record #18 on 10/1/10 at 10:45.

f. Medical Record #19 on 10/4/10 at 8:35 AM.

g. Medical Record #20 on 10/5/10 at 11:45 AM.

h. Medical Record #12 on 11/15/10 at 12:35.

2. The "Final Verification Universal Protocol Time-Out Checklist," dated 10/20/10 at 09:35, in Medical Record #21, lacked evidence that anesthesia and the physician/surgeon participated in the "time-out." The names are not present and the box next to each title was not checked off.

3. These findings were confirmed by Staff #2.

Based on a review of facility documents and staff interview, it was determined that the facility failed to ensure that all surgeries are recorded in a operating room register, which is complete and up to date.

Findings include:

1. Upon request on 11/16/10, the facility was unable to produce a register of all surgeries performed.

2. Staff #24 stated upon interview on 11/16/10, that the facility does not have a current register of all surgeries performed by the surgery service.