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Tag No.: C0231
Based on observation, Generator Log review and interview, it was determined the facility did not meet Life Safety Code requirements related to 5 of 36 unsecured medical gas cylinders and required thirty minute generator tests under load conditions for 12 of 12 months (June 2015 to May 2016). The failed practices had the potential to affect all patients, staff, and visitors. See K077 and K144.
Tag No.: C0276
Based on observation, review of policy and interview, it was determined Surgical Services failed to assure two of two syringes pre-drawn up with Lidocaine were not labeled per policy in that the did not have the strength or expiration date. By not labeling the syringes properly, the facility could not assure the safety and efficacy of the medication in the syringe when administered to a patient. The failed practice had the likelihood to affect all patients in Surgical Services. Findings follow:
A. During a tour of Surgical Services on 06/07/16 from 1355 to 1520, two syringes were observed on a counter in the Medication Room, with labels that stated "Lidocaine 06/06/16". There was no strength or expiration date on them.
B. Review of policy titled Labeling Standards stated "At a minimum, all medications are labeled with the following: Medication name ...strength (concentration) ...Expiration date when not used within 24 hours."
C. During an interview on 06/07/16 the Director of Surgical Services stated the syringes were drawn up on the date stated (06/06/16) and intended to be used for the next days ' procedures (06/08/16). The Director of Surgical services also verified the information on the label.
Tag No.: C0281
Based on review of Rehabilitation staff employee files and Rehabilitation contract staff credentialing files, review of policy and interview, it was determined the facility failed to ensure two (#2 and 3) of five (#1-5) physical therapists and one (#1) of two (#1 and 2) speech language pathologists maintained certification in Cardiopulmonary Resuscitation (CPR) per policy. By not ensuring all persons with direct patient care responsibilities maintained certification in CPR, the facility could not assure a prompt and efficient response in the event of an emergency. The failed practice had the likelihood to affect all patients who received services from Rehabilitation Services. Findings follow:
A. Review of Rehabilitation staff employee files on 06/08/16 revealed Physical Therapist #2 and 3 did not have CPR certification. Review of Speech Language Pathologist #1's (contracted) credentialing file revealed it did not have CPR certification.
B. Review of policy titled Rehabilitation Department Policy Emergency Response Plan stated "All staff will be CPR certified." Also "All personnel shall be currently certified in CPR ..."
C. During an interview on 06/08/16 at 1513, the Chief Nursing Officer verified the lack of CPR for the above mentioned Physical Therapists and the Speech Language Pathologist.
Tag No.: C0320
Based on observation and interview, it was determined the facility failed to assure a Tracheotomy set was available in the operating room suite. Failure to have a Tracheotomy set in the Operating Room Suite did not assure it would be available for surgery patients in the event of an emergency. The failed practice affected the 10 patients listed on the Operating Room Schedule for 06/07/16 and was likely to affect all patients who had surgery in the facility. The findings were:
A. Observation on 06/07/16 at 1515 with the Director of Surgery Services revealed the facility did not have available in the Operating Room Suite a Tracheotomy Set. In an interview with the Director of Surgery Services at the time of observation, she stated they had a Cricothyrotomy Catheter Set on the Emergency Cart.
B. The Director of Nursing Services and the Director of Surgery Services were interviewed and confirmed on 06/09/16 at 1110 that the facility did not have a Tracheotomy set available in the Operating Room Suite.
Based on observation, review of policies and interview, it was determined the facility failed to assure four (Pre-operative bed #2, #4, #6 and Operating Room #1) of eight observed sterile, single use Yankauer suction catheters and 2 of 2 intravenous tubing sets remained intact prior to use. The sterility of the items could not be assured in that the sterile packages were opened in advance of use. The failed practice was likely to affect all patients who had surgery in the facility. The findings were:
A. Observation on 06/07/16 at 1250 of Pre-operative Bed #1-#6 revealed a sterile, single use Yankauer suction catheter at Pre-operative Bed #2, #4 and #6 that was opened and attached to suction tubing. The Director of Surgery Services confirmed the findings of opened sterile Yankauer suction catheters at the time of observation.
B. Observation of Operating Room #1 and #2 on 06/07/16 at 1435 revealed a sterile, single use Yankauer suction catheter in Operating Room #1 that was opened and attached to suction tubing. The Director of Nursing confirmed the finding of the opened sterile Yankauer suction catheter at the time of observation.
C. Observation of the Surgical Services Medication Room on 06/07/16 at 1415 revealed two of two 1000 milliliter bags of Lactated Ringers intravenous (IV) solution hanging on an IV pole that had IV tubing sets attached to the bag. The IV tubing sets were open, and the date on the IV bag was 06/07/16 at 1030. The Director of Surgery Services was interviewed at the time of observation and stated the IV bags and tubing were removed from the original package and set up for surgical procedures scheduled for 06/08/16.
D. Review of the facility policy "Sterile Processing: Sterilization Expiration Dates" on 06/09/16 revealed "It is the responsibility of the persons opening any sterile item to check the date of expiration. If an item is outdated, the nurse will open the item and return it to the Sterile Processing Department for re-sterilization, unless it is a disposable item, at which time it would be discarded. Any package found with a hole in it, wet, partially unwrapped, or with no expiration date is considered unsterile ..."
E. The Director of Nursing and Director of Surgery Services were interviewed on 06/09/16 at 1120 and confirmed the findings in A, B and C.
Based on observation, interview, policy review and review of AORN (Association of periOperative Registered Nurses) standards, it was determined the facility failed to assure 15 of 15 laryngoscope blades were stored to prevent re-contamination after high level disinfection. Failure to store laryngoscope blades to prevent contamination did not assure patients would be protected from potential sources of infection. The failed practice was likely to affect all patients who required general anesthesia and intubation. The findings were:
A. Observation on 06/07/16 at 1255 of the Anesthesia Cart stored in the Surgical Services Medication Room revealed 15 Laryngoscope blades and 2 handles were on a blue towel on the top of the anesthesia cart. The Laryngoscope blades and handles were also covered with a blue towel. The Director of Surgery Services stated at the time of observation the anesthesia cart was taken into the Operating Rooms and the Laryngoscope blades and handles were stored as observed.
B. The Director of Nursing and Director of Surgery Services stated on 06/07/16 at 1250 the facility adhered to AORN standards. Review of the AORN, 2013 Edition of "Peri-Operative Standards and Recommended Practices" as provided by the Director of Nursing on 06/08/16 at 0945 revealed:
1) "Anesthesia equipment that comes in contact with mucous membranes should be sterilized or undergo high-level disinfection before use. Reusable items (e.g., laryngoscope blades) are considered semi-critical. The CDC (Centers for Disease Control and Prevention ) has determined that their potential for transmitting infectious agents is significant and has classified these items as semi-critical" (page 451).
2) "The CDC recommends that reusable semi-critical items be high-level disinfected, pasteurized, or sterilized to minimize the risk of transmission of infectious agents. Disinfected items should be dried thoroughly and stored in a manner that prevents re-contamination or damage" (page 452).
C. Review of the policy "Laryngoscope Processing" revealed "The Sterile Processing area will process blades in the high level disinfectant processor. The blades from anesthesia will be returned to anesthesia carts."
D. The Director of Nursing and Director of Surgery Services were interviewed on 06/09/16 at 1120 and confirmed the findings in A and B.
Based on review of AORN (Association of periOperative Registered Nurses) standards, observation, interview and policy review, it was determined the facility failed to assure each sterilization cycle (terminal and IUSS (immediate use steam sterilization) for two of two (#1 and #2) sterilizers were monitored by the sterilizer operator to verify physical load parameters (i.e., time and temperature). Failure to monitor sterilizer time and temperature did not assure sterilizer cycle parameter failures would be rapidly identified. The failed practice was likely to affect all patients who had a procedure at the facility. The findings were:
A. The Director of Nursing and Director of Surgery Services stated on 06/07/16 at 1250 the facility adhered to AORN standards. Review of the AORN, 2013 Edition of "Peri-Operative Standards and Recommended Practices" as provided by the Director of Nursing on 06/08/16 at 0945 revealed:
1) "Each sterilization cycle should be monitored to verify that parameters required for sterilization have been met.
2) The sterilizer operator should review physical monitors to verify cycle parameters for every load. Physical monitors record cycle parameters (e.g., time for each phase of the cycle, temperature during each phase of the cycle)" (page 518).
B. Observation on 06/07/16 at 1445-1500 revealed Sterilizer #1 (Central Sterile Clean Core) and Sterilizer #2 (Sterile Core of OR) were used for sterilization (terminal/IUSS) of instruments. The "3M Steam Sterilization Record Keeping" documentation and sterilizer printout for Sterilizer #1 and #2 were reviewed for 2016. There was no evidence of review by the individual sterilizer operator of any of the instrument loads to verify cycle parameters on the record keeping documents or on the sterilizer printouts reviewed for 2016.
C. The Director of Surgery Services was interviewed at the time of observation and stated the sterilizer printouts were placed in the record keeping envelope by OR (operating room) staff. The Director of Surgery Services confirmed 06/07/16 at 1500 there was no documentation of sterilizer operator review of the cycle parameters (i.e., the sterilizer printout) for every sterilizer load either on the sterilizer printout or on the record keeping envelope. OR Nurse #1 stated on 06/07/16 at 1500 "we don't really do anything with them (printouts) except put them in the envelope."
D. On 06/08/16 at 1340, Surgical Services Sterile Processing Autoclave Testing policy was reviewed and revealed the purpose was to "Provide a daily check and control measure for determining the efficiency of the sterilizing process. Autoclaves are tested with a minimum requirement of time exposure at 270 degrees Fahrenheit. Always verify operating parameter on print-out after test cycle is complete." The policy did not include a requirement for the sterilizer operator to review physical monitors (i.e., time and temperature) for every load to verify cycle parameters.
E. On 06/09/16 at 1130, the Director of Nursing and the Director of Surgery Services were interviewed and given an opportunity to provide evidence the individual sterilizer operator had verified cycle parameters for each sterilizer load. The Director of Nursing and Director of Surgery Services confirmed the findings in B, C and D above.
Based on interview, review of AORN (Association of periOperative Registered Nurses) standards and policy review, it was determined the facility failed to assure contaminated instruments from the operating room suite were covered and labeled bio-hazard before transporting to prevent exposure of patients or personnel to likely sources of infectious organisms. The failed practice was likely to affect all staff and patients in the operating room. The findings are:
A. In an interview on 06/07/16 at 1520 with OR Nurse #1, the Director of Surgery Services and the Director of Nursing, it was determined the transport of soiled surgical instruments from OR #1 and #2 was in open containers without a biohazard label. OR Nurse #1 stated soiled instruments were placed in sterile water after use and carried to the soiled instrument processing area in an open tray or basin. The Director of Nursing and OR Nurse #1 stated the instruments were not in an enclosed container or labeled as bio-hazard.
B. The Director of Nursing and Director of Surgery Services stated on 06/07/16 at 1250 the facility adhered to AORN standards. Review of the AORN, 2013 Edition of "Peri-Operative Standards and Recommended Practices" as provided by the Director of Nursing on 06/08/16 at 0945 revealed:
1) "Contaminated instruments must be contained during transport and should be transported in a timely manner to a location designed for decontamination.
2) Proper containment of instruments decreases the potential for injury to personnel or their exposure to infectious organisms and prevents damage to the instruments during transport.
3) During transport to a decontamination area, soiled instruments must be contained in a manner to prevent exposure of patients or personnel to bloodborne pathogens and other potential infectious organisms."
4) "The transport container must be labeled to indicate bio hazardous contents." (page 488)
C. Review of policy "Surgical Services/Sterile Processing Instrument and Supply Processing" revealed:
1) "Soiled items are to be returned to Central Sterile using aseptic techniques to avoid cross-contamination. All items in patient care areas are considered contaminated and a source of infection.
2) All soiled items are to be covered prior to returning to Central Sterile."
D. On 06/09/16 at 1130 the Director of Nursing and the Director of Surgery Services were interviewed and confirmed the findings in A.