HospitalInspections.org

Based on records review, observations and interviews with hospital staff, the governing body failed to ensure quality and safe patient care at an off-site outpatient surgery center.

Findings:

1. The hospital's governing body failed to ensure that the hospital's pharmaceutical services performed appropriate oversight of an off-site surgical center to ensure safe and appropriate use of medications. See A Tags A 0491 and 0494.

2. The hospital's governing body failed to ensure an active ongoing program to prevent, control, and investigate infections and communicable diseases to minimize infections and communicable diseases in patients and staff. See A Tags 0747, 0748, and 0749.

3. The hospital's governing body failed to ensure that surgical services provided are well organized and provided in accordance with acceptable standards of practice, and are in compliance with all the requirements of the Condition of Participation for Surgical Services. See A Tags 0940, 0941, 0944, 0951, 0956, 0957 and 0958.

4. Findings discovered during the survey on 01/28 and 29/2014 were findings that were also cited in previous surveys.

Based on record review and interviews with hospital staff, the hospital failed to ensure that the hospital's pharmaceutical services performed appropriate oversight of an off-site surgical center to ensure safe and appropriate use of medications. Review of records and policies provided did not have evidence that policies and procedures were developed and followed; that employees provide pharmaceutical services within their scope and license, and that current and accurate records of scheduled drugs are maintained and reconciled

Findings:

1. Pharmacy policies and procedures provided for review concerning medication compounding of admixtures outside of the pharmacy state that these admixtures will be used immediately with no intervening steps between admixture and administration. The policy also states all sterile admixtures containing additives will be mixed in the pharmacy during pharmacy hours.

a. Eight (8) Basic Salt Solution (BSS) 500 ml ( milliliter) bottles with Vancomycin and Epinephrine added by a nurse were observed on 01/29/14 in the operating suite premixed and ready for administration to patients. There was no laminar flow hood in the surgery center.

b. There was no policy addressing the compounding of Buffered Lidocaine used for intravenous (IV) starts. This medication is compounded by nurses by adding 8 ml (milliliters) of Sodium Bicarbonate to the 50 ml bottle of 1% Lidocaine. This medication had an expiration date of two weeks from the initial addition of the Sodium Bicarbonate. The bottle is entered each time by the nurse for each individual patient's IV start. Staff Q stated that they had determined that the Buffered Lidocaine was good for two weeks. There was no mention of the consequences of multiple punctures or how it affects the sterility of the admixture. On 01/28/14 there were 12 procedures with IVs. On 01/29/14 there were 18 procedures with IVs.

2. Review of medication records and interviews with staff did not have evidence of regular periodic on site review of drug storage areas in the surgery center by pharmacy staff. Staff Q stated that he only made onsite visits two times a year. The only documentation of drug storage inspections was by surgery center staff.

3. There was no evidence of the reconciliation by pharmaceutical services of scheduled drug documentation to assure wastage was being documented correctly.

Based on records review and interviews with hospital staff, the hospital failed to ensure that a system is in place to track all scheduled drugs from the point of entry into the hospital to the point of disposition either through the administration to patients or wastage. The system does not ensure records are current and accurate, reconciled by pharmacy personnel and the system provides documentation in a readily retrievable manner. Four
(1, 14, 17, 18) of five (1, 14, 16, 17, 18) outpatient surgical patients' records reviewed at the hospital's offsite surgery center did not have documentation of wastage of scheduled drugs when partial doses were documented as given to patients. There was no evidence of pharmaceutical services periodically reviewing documentation of doses given and wastage documented.

Findings:

1. Patient #1's record documented the nurse removed 3 two milliliter (ml), 1 mg (milligram) per ml, vials of Versed (a benzodiazapine) from the Pyxis, an automatic medication dispensing machine. Documentation in Patient #1's record documented the nurse administered a total of 4mg of Versed to the patient. There was no wastage documented in the patient's chart.

2. Patient #14's record documented the nurse had removed 1 two milliliter (ml), 1 mg (milligram) per ml, vial of Versed (a benzodiazapine) from the Pyxis, an automatic medication dispensing machine. Documentation in Patient #14's record documented the nurse administered a total of 3mg of Versed to the patient. There was no evidence of where the extra medication was obtained.

3. Patient #17's record documented the nurse had removed 1 five milliliter (ml), 1 mg (milligram) per ml, vial of Versed (a benzodiazapine) from the Pyxis, an automatic medication dispensing machine. Documentation in Patient #17's record documented the nurse administered a total of 3 mg of Versed to the patient. There was no wastage documented in the patient's chart. The physician's procedure note documented that only 3 mg of Versed was administered to the patient.

4. Patient #18's record documented the nurse had removed 4 mg (milligram) of Versed (a benzodiazapine) from the Pyxis, an automatic medication dispensing machine. Documentation in Patient #1's record documented the nurse administered a total of 3 mg of Versed to the patient. There was no wastage documented in the patient's chart.

Staff stated on 01/29/14, in the afternoon that the wastage is always documented in the Pyxis machine. The staff stated they did not know how to access the wastage documentation out of the Pyxis machine. There was no evidence that the records of scheduled drug administration are reconciled to assure they are accurate and complete.

Based on observation and staff interview, it was determined that the hospital failed to ensure all medications in the surgery department were secured at all times.

Findings:

During observations of the surgery department on 01/28/14 and 01/29/14, various types of medications were found outside of the Pyxis machines. Many of the medications were multi-dose vials that were used on multiple patients.

The staff stated the medications outside of the Pyxis were usually kept on tabletops or other non-secured areas in the operating rooms, even when the department was closed.

At the end of the day on 01/29/14, when surgery cases were finished and the rooms had been terminally cleaned, medications were observed left out unsecured in various locations in the operating rooms.

The staff stated the surgery suite could not be locked after hours.

Based on observation, interviews with staff and review of hospital documentation, the hospital failed to maintain an active ongoing program to prevent, control, and investigate infections and communicable diseases to minimize infections and communicable diseases in patients and staff that ensured safe infection control practices for the off-campus unit identified as Surgery West.

Findings:

1. The program and active surveillance did not ensure the high level disinfection and sterilization processes were carried out in a manner consistent with nationally accepted standards of practice and according to manufacturer's directions at the Surgery West unit.

2. The infection control practitioner did not ensure infection control policies and procedures were developed, implemented and followed for the Surgery West unit.

3. The infection control program did not monitor the use of multi-does vials for multiple patient use to ensure safe injection practices were followed and safe medications were provided for patient use.

Based on review of hospital policies and procedures, surveyors' observations and interviews with hospital staff, the hospital failed to ensure infection control policies and procedures were developed, approved, implemented and followed for surgical services at the Surgery West unit.

Findings:

1. The hospital did not have policies and procedures to identify that instrument packs opened during a surgical case were considered contaminated/dirty and procedures developed to ensure all instruments were washed, inspected and reprocessed. Refer to Tag A-0748 for further examples.

2. A policy and procedure for manufacturer recommended cleaning of eye instruments had not been developed. Staff could not provide the manufacturer's guidelines for recommended cleaning and processing of eye instruments.

3. Although surgical services had a policy that required all hair be covered in the surgical and central sterile area, infection control did not ensure this policy was followed. Staff M was observed on 01/28 and 29/2014 without entire coverage of his beard. Administrative staff stated that the hospital had masks for this purpose, but Staff M did not wear the correct mask.

Based on surveyors' observations, review of infection control (IC) data, surveillance activities, meeting minutes, and hospital documents and policies and procedures, and interviews with hospital staff, the hospital failed to ensure the infection control practitioner (ICP) developed and maintained an ongoing comprehensive hospital-wide system to identify, report, prevent and control infections and communicable diseases among patients and staff and ensuring a sanitary environment.

Findings:

1. The program and active surveillance did not ensure the high level disinfection and sterilization processes were carried out in a manner consistent with nationally accepted standards and according to manufacturer's directions at the Surgery West unit. Refer to Surgery observations for details observed by surveyors.

Surveillance activities for the Surgery West unit provided for surveyor review only included a bi-annual environmental walk-through. Although Staff E told the surveyors that monitoring of the surgery area were performed by the hospital's surgery supervisor, no evidence was provided.

Infection control meeting minutes did not contain evidence that problems discovered by surveyor observation in the surgery area had been identified and processed through the hospital's infection control program.


2. Infection control meeting minutes did not contain evidence that disinfectant application at the Surgery West location had been monitored to ensure they were applied appropriately and according to manufacturer guidelines to ensure a sanitary environment.

Surveyors observed on 01/28/2014:
a. One disinfectant towelette was used to clean an entire pre-operative Room 1 at 0940. The product, Cavi-Wipes, did not remain wet on the surfaced the manufacturer specified one minute. Staff G did not know the manufacturer's recommended surface area for each towelette and told the surveyor that the one minute time was the "wait time" before a patient could be brought to the room.

b. At 0850, surveyors observed Staff I disinfecting a wheelchair that had been used to transport a patient. Not all surfaces were cleaned.

c. Refer to Surgery observation for disinfectant applications observed in the Surgical and Central Sterile area.

Staff E told the surveyor on the afternoon of 01/28/2014 at 1550 that staff had been provided an inservice on the disinfectant, but she not monitored disinfectant application at Surgery West unit to ensure it was applied to all surface areas according to manufacturer guidelines.


3. Pre-operative rooms/bays do not have hand sanitizer available inside the room. Hand sanitizers are mounted on the wall outside between the rooms. The surveyors observed Staff G on the morning of 01/28/2014. Staff G did not follow the hospital's hand hygiene policy. Staff G did not perform hand hygiene between alternately touching the patient and environmental surfaces, including the patient record. Staff G did not perform hand hygiene before gloving or immediately after removing the gloves. Staff G was observed to only cleanse her hands when she entered or exited the patient's pre-operative room.

Monthly hand hygiene monitoring at the Surgery West unit was not performed by Staff E. The data provided, including meeting minutes, did not demonstrate that Staff E or the individual who performed the observations had provided corrective instructions to the individual who did not perform appropriate hand hygiene.


4. Meeting minutes did not demonstrate the infection control program addressed the use of multi-dose Buffered Lidocaine vials used in the pre-operative area of Surgery West used to anesthetize the skin before intravenous (IV) starts (including IV saline locks) to ensure safe medication was provided for patient use.

The Buffered Lidocaine is compounded by nurses by adding 8 ml (milliliters) of Sodium Bicarbonate to the 50 ml bottle of 1% Lidocaine. Once compounded, the vial contains approximately 58 ml. Nursing staff inject 1/10 ml underneath patients' skin as an anesthetic before starting the IV. The vial observed on 01/28/2014, had an expiration date of 02/05/2014, two weeks from the initial addition of the Sodium Bicarbonate on 01/22/2014. The bottle is entered each time by the nurse for each individual patient's IV start.

According to the surgery schedules and staff observation, this vial had been entered at least 30 times for the dates of the investigation, 01/28, and 29/2014. Each mixed vial of Buffered Lidocaine had the opportunity to be entered 580 times (580 punctures into the septum) during a two-week period.

On 01/29/2014 at 1000, Staff Q stated that they had determined that the Buffered Lidocaine was good for two weeks. There was no mention of the consequences of multiple punctures or how it affects the sterility of the admixture.




28713


The following observations were made in the operating rooms and surgery support areas at the Surgery West unit of the hospital.

General surgery staff practices

~ Multi-dose medication vials were observed open and in use for more than one patient in the operating rooms and in the operating room Pyxis machines. Open, multi-dose vials found in the operating rooms were not dedicated to one patient and were not discarded after use on one patient. Nursing staff and anesthesia staff used these multi-dose vials on multiple surgery patients on a regular basis.

~ Staff stated they poured large quantities of potentially infected fluids collected during surgical procedures into a hopper in the surgery department. The staff stated the only personal protective equipment (PPE) they used was a cover gown and gloves. The hospital did not have a policy and procedure that instructed staff on all the PPE required for this situation where aerosol-generating contaminants were present.

~ Non-hospital approved household handwashing soap was found at the surgical scrub sinks between the operating rooms. The manager stated this was used for staff regular handwashing while working in the surgery department. The surgery department did not have staff handwashing facilities in the semi-restricted/restricted areas.

~ The surgery department did not have a sub-sterile room between the operating rooms that allowed staff to limit the numbers of times they needed to leave the ORs and travel into the surgical corridor.

~ The surgery department did not maintain a log of reprocessed items used on patients that identified a patient with the type of reprocessed item used.

~ The hospital did not enforce its policy requiring surgical staff to cover facial hair. One surgical staff person working in the decontamination and sterile processing areas was observed on two days of the survey without an adequate beard cover.

~ The hospital did not enforce its policy that required eye shields to be worn during the direct care of patients during surgery.

~ The hospital did not enforce its policy that non "scrubbed-in" staff were required to wear long sleeved, buttoned jackets.

Surgery department

~ Wheelchairs used to transport patients to cars in the parking lot were also used to transport patients into the operating rooms. The hospital did not have a process to adequately terminally clean the wheelchairs before they entered into the semi-restricted and restricted sterile areas.

~ The surgery department did not have an identified biohazard waste collection room, did not have an identified soiled utility room and did not have a room with negative pressure to store soiled linens. Staff stated they either placed bags of waste in a large rolling bin in the sterile corridor or left the surgery department to take trash to an area outside.

~ The surgery department did not have identified areas to store clean and dirty surgical equipment. The staff stated an open space with a half-wall was used to store clean equipment. There was no way to determine if all equipment in this area was actually clean or if some of it was dirty.

~ The surgery department did not have a policy and procedure for the collection and storage of soiled mop heads and departmental cleaning cloths. There was no policy and procedure for laundering mop heads and cleaning cloths. There was no policy that described how often mop heads and mop bucket water was to be changed during the day.

~ There was no policy that described OR pre-cleaning requirements before the first surgical case.

~ The operating rooms, decontamination room and sterile processing room did not have self closing doors. These doors were not fully closed at all times, such as when a sterile field was open in an OR. The doors to the decontamination and sterile processing rooms were observed partially open at different times of the day.

~ Surgical masks were not available to staff immediately outside the operating rooms. The surgical masks were stored on a shelf in an "office" alcove away from the surgery corridor. Staff did not always change masks between surgical patients.

~ Clean linen received from the contracted linen service was brought into the surgery department on a cart that had been rolled outside the surgery department and then rolled back in to the semi-restricted corridor. The linens were brought into the department in their original shipping plastic wrap.

~ None of the rooms/spaces within the surgery department were labeled so that staff could easily identify clean and dirty areas. Staff said some of the rooms in the surgery department had been re-purposed and were used for reasons other than specified in the original design plans.

Operating rooms

~ During an observation of a surgical procedure, a sterile back table was placed within 6 inches or less of a standing trash receptacle that was the same height as the back table. The scrub tech did not ensure a wide clearance was maintained between the sterile field and a non-sterile item.

~ Suction tubing attached to wall vacuum outlets in both operating rooms had evidence of dirt and grime on the connectors that indicated they had not been wiping clean, disinfected or changed for a significant period of time. This tubing was also discolored, indicating it was old.

~ Rusted equipment was found in both operating rooms. Rusted and pitted surfaces could not be adequately disinfected.

~ The area around the head of the bed in the operating rooms was inadequately cleaned between patients. High touch surfaces on the anesthesia machine and the Pyxis machine were not disinfected between patients.

~ All trash was not removed from the OR before cleaning began. Trash at the head of the bed was allowed to collect between patients until the trash can was full. The insides of trash receptacles were not cleaned after the trash was removed.

~ Trash was not removed before terminal cleaning was started. during one observation, trash at the head of the bed was removed after terminal cleaning was finished.

~ Floors were not cleaned between all surgical cases.

Door handles or cabinet/drawer knobs were not disinfected between cases. The floor was not wet-mopped during terminal cleaning at the end of the day. Wheels and casters were not cleaned. Surgical lights, tracks and other wall mounted equipment was not cleaned. Ceilings were not cleaned.

Sterile processing

~ During an observation of the sterile processing room, a scrub tech that had been working on an eye surgery case entered the room and placed an opened eye instrument set on the counter top. The staff member working in sterile processing was asked about the instrument set.

He stated the scrub tech brought the set out of surgery when the case was over. He stated the instruments in it had not been used, although the set was opened and placed on the back table during the case. He was asked why it was not considered contaminated. He stated, "The tech said she didn't touch it."

He was asked to describe the usual practices for handling sets after cases were over. He stated any "non-used" instruments and the instrument cases were not washed and processed like other contaminated items taken out of surgery. He stated he added the used instruments back to the sets when those instruments were cleaned. He stated then the sets were sterilized.

~ The hospital failed to develop and implement special policies and procedures related to the decontamination and sterile processing of intraocular surgical instruments. The staff confirmed there were no special hospital requirements for processing these instruments. The instrument tech stated the hospital did not have the manufacturer's instructions for cleaning these instruments.

~ Items stored within the splash zone near the handwashing sink. There were no paper towels in the dispenser above the handwashing sink during the first observation of the morning.

~ Extraneous items (books, papers, excess equipment and surgical instruments, etc.) were stored on the counter tops. There was grime and dust that indicated the counter tops were not cleaned regularly. These observations were made early in the day when the department had just opened.

~ The room did not have evidence of regular terminal or deep cleaning.

~ The hospital had conflicting policies for labeling and dating sterile supplies. One policy documented hospital sterilized items had a five year shelf-life. The policy also documented packages and sets should be labeled with an expiration date. However, the staff only documented the date the item was processed. There was no expiration date on any packages and the staff was not aware of a five year shelf life policy.

Decontamination area

~ The eye instrument set mentioned above, (incorrectly placed in the sterile processing area) was later found on the cleanest side of the decontamination room in preparation to go through the pass-through window to the sterile processing room.

The staff member was asked if the set had been broken down and put through regular washing and rinsing before moving to sterile processing. He stated it was not normal practice to fully disassemble and wash surgical instruments that "were not used" on a surgical case, even if the set was open and placed on the sterile field. He stated he planned to "wipe it down later before it went to the clean side."

~ The decontamination room did not have a wall-mounted magnifier to allow staff to inspect instruments for residual soil prior to sterilization.

~ When asked, the staff did not identify a handwashing sink in this area. One sink had an empty paper towel dispenser over it. The tech stated he did not wash his hands in this room, but waited until he entered the sterile processing room to wash his hands.

~ This room did not have evidence of regular terminal or deep cleaning.

Based on observation, document review and staff interview, it was determined the hospital failed to ensure:

a. clear lines of authority were designated for all surgical services. See Tag A-0941;

b. a registered nurse was assigned to perform circulating duties for each surgical case. See Tag A-0944;

c. all surgical services were provided according to the same governing policies and failed to ensure those policies were enforced. See Tag A-0951;

d. post-operative care was provided according to aceeptable standards of practice. See Tag A-0957;

e. the surgery center west operating room log contained all the required information. See Tag A-0958;

f. staff adhered to aseptic technique and standard infection control practices for the surgery department. See Tag A-0749;

g. appropriate cleaning between surgical cases and terminal cleaning as required. See Tag A-0749; and

h. the hospital failed to ensure policies were followed for labeling and documenting an expiration date on sterile supplies. See Tag A-0749.

In addition, the hospital failed to obtain manufacturer's instructions for cleaning intraocular surgical instruments, failed to develop related policies and procedures, and failed to enforce appropriate intraocular surgical instrument processing according to accepted standards of practice.

Based on observation, document review and staff interview, it was determined the hospital failed to ensure clear lines of authority were designated for all surgical services.

Findings:

On 01/28/14, the hospital was asked to provide an organizational chart for surgical services. The chart provided by the administrative staff, dated January 2014, documented a portion of the hospital's surgical services (main hospital surgery department) was under the Vice President of Patient Services. The off-campus surgery center was documented under the Vice President of Administrative Services.

There was no documentation, and the staff acknowledged, that the surgery center did not report to the hospital's main surgical services. The staff stated they reported to the surgery center's clinical manager and the clinical manager reported to the surgery center's Director.

The hospital did not provide an organizational chart that documented the chain of command for surgical nursing and related staff.

The hospital did not have documentation the surgery center was integrated within the hospital's main surgical services department. There was no evidence the surgery center's clinical manager reported to the hospital's Director of Surgical Services.

The surgery center had not adopted all the policies and procedures followed by the main campus surgery department.

Based on clinical record review and staff interview, it was determined the hospital failed to ensure a registered nurse was assigned to perform circulating duties for each surgical case.

Findings:

On 01/28/14, during a review of clinical records for patients who had gastrointestinal endoscopy procedures, it was determined the only registered nurse identified on the surgical record was the nurse who provided conscious sedation.

The registered nurse who provided conscious sedation could not also perform circulating duties.

Operating room staff verified there was not an identified circulating nurse present in surgery with endoscopy patients.

Based on document review and staff interview, it was determined the hospital failed to ensure;

a. surgical policies and procedures were developed, approved, implemented and enforced;

b. surgical policies and procedures were current and based on nationally recognized standards; and

c. failed to ensure all areas where surgical services were provided followed the same governing policies.

Findings:

On 05/14/13, a validation survey of the hospital was conducted by OSDH. During that survey, the surgery center clinical manager stated she was revising policies and procedures for that location. The policies in place in May 2013 were policies used when the surgery center was a privately owned ambulatory surgery center (ASC). The main hospital had not required the surgery center to adopt and implement its surgery policies and procedures.

During the May 2013 survey, the surgery center's policies were not current, were not referenced with recognized sources, and were not consistent with current standards of practice. At that time, the hospital was cited for deficiencies related to surgery policies and procedures.

On 01/28/14, the hospital was asked to provide various surgery department policies and procedures. The policies provided by the clinical manager were essentially the same policies and procedures provided to the surveyors during the previous validation survey.

Again, the policies were not current and were in the process of revision by the clinical manager. None of the policies provided at the surgery center had documentation of approval by the chief of surgery, the medical staff and the governing body. It was evident the policies provided to the surveyors were not policies adopted and enforced by the main hospital.

Many policies provided to surveyors were former ASC policies. The policies documented hand-written changes made by the clinical manager. Some changes were not appropriate. For example, a policy titled, Personnel Attire Dress Code, documented, "... A cover gown is to be worn whenever leaving the surgical suite..."

An addendum written on the last page of the policy documented the cover gown requirement was "not applicable" to the surgery center.

Some surgical policies were missing or had not been developed. For example, the hospital was asked to provide a policy or policies instructing OR staff on the special cleaning requirements for intraocular surgical instruments. None were provided.

Some surgical policies provided were not enforced by the hospital. Examples included attire in the surgery department, handling of contaminated instruments, handwashing requirements, among others. See also Tag A-0749.

Based on clinical record review and staff interview, it was determined the hospital failed to ensure post-operative care was provided according to acceptable standards of practice.

Findings:

Clinical records were reviewed for post-operative care. The records for gastrointestinal (GI) endoscopy patients did not have documentation of assessment of the GI system at the time of admission to recovery and again immediately prior to discharge from recovery.

Patients who had an EGD were not assessed for the presence of a gag reflex if a topical throat numbing agent was used.

Recovery staff was asked if these assessments were required during the post-operative period. No comment was made.

Based on review of the hospital's operating room(OR) log and interview's with hospital staff, the hospital failed to ensure the Surgery West OR log contained all the required information.

Findings:

1. The outpatient surgery OR log for the unit identified as Surgery West was reviewed on the morning of 01/28/2014 with Staff C.

2. The OR log was a hand written register. The log did not identify:
a. The name of the person administering the anesthetic when IV conscious sedation was administered;
b. The name of the scrub staff;
c. If the person listed as Surgical nurse was the circulator;
d. If an other individuals, students, representatives, etc. were present, and if so, their names;
e. Inclusive time of the operation, or at least the time surgery began and ended;
f. Age of the patient.

3. The above findings were reviewed and confirmed with Staff C on 01/28/2014.