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Based on review of policy, procedure, documents and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure a physician, in conjunction with the mid-level practitioners periodically reviewed 3 of 3 mid-level practitioner's patient medical records (Staff B, Staff D, and Staff E) in the Mercy Family Practice Clinic. The CAH staff reported Staff B evaluated approximately 9 patients a day, Staff D evaluated approximately 8 patients a day and Staff E evaluated approximately 8 patients a day.

Failure to ensure a physician periodically reviewed in conjunction with the mid-level practitioners, the care provided by the mid-level practitioners could potentially affect the facility's ability to assure the mid-level providers are consistently providing quality care to patients.

Findings include:

1. Review of CAH policies and procedure titled "External Peer Review" reviewed 4/2015 revealed in part, "...Mid-level Practitioners: A periodical chart review is completed with a physician and mid-level practitioner together to evaluate and review the patient's record. All active medical staff participate in chart review with mid-level practitioners..."

2. Review of patient medical records in the Mercy Family Practice Clinic revealed no documentation of mid-level practitioner participation with a physician in the review of the mid-level practitioner's (Staff B, Staff D, and Staff E) patient medical records.

3. During an interview on 10/20/15 at 3:00 PM, Staff A, Doctor of Osteopathy stated the physicians do not complete a face to face patient medical record review with the mid-level practitioners. Staff A reported the physicians will periodically review the mid-level practitioners patient medical records, however, the physicians did not document the reviews and/or complete the reviews in conjunction with the mid-level practitioners.

During an interview on 10/20/15 at 4:00 PM, Staff B, Nurse Practitioner stated the physicians do not complete a face to face review of the patient medical records with the mid-level practitioners.

During an interview on 10/20/15 at 4:15 PM, Staff C, Quality Coordinator agreed the physicians and mid-level practitioners did not complete formal face to face reviews of the mid-level practitioner's patient medical records. Staff C reported in October of 2014 she assigned each midlevel practitioner to a physician and implemented a document for the physician to document a face to face patient medical record review between the physician and midlevel practitioner. Staff C said the physicians and mid-level practitioners failed to implement the system.

Based on review of policies, procedures, documentation, and staff interview, the Critical Access Hospital (CAH) failed to ensure 3 of 3 mid-level practitioners, (Nurse Practitioners) reviewed and participated with a physician in the periodic review of the mid-level practitioner's patient medical records (Nurse Practitioners B, D and E) in the Mercy Family Practice Clinic. The CAH staff reported Staff B evaluated approximately 9 patients a day, Staff D evaluated approximately 8 patients a day and Staff E evaluated approximately 8 patients a day.

Failure to ensure 3 of 3 mid-level practitioners participated with a physician during a periodic review of the mid-level practitioner's patient medical records could potentially result in the facility's inability to assure the mid-level practitioners are consistently providing quality care to patients.

Findings include:

1. Review of CAH policy and procedure titled "External Peer Review" reviewed 4/2015 revealed in part... "Mid-level Practitioners: A periodical chart review is completed with a physician and mid-level practitioner together to evaluate and review the patient's record. All active medical staff participate in chart review with mid-level practitioners."

2. Review of documentation in the Mercy Family Practice Clinic lacked evidence the mid-level practitioners participated with a physician in the review of the mid-level practitioner's (Staff B, D and E) patient medical records.

3. During an interview on 10/20/15 at 3:00 PM, Staff A, Doctor of Osteopathy stated the physicians do not complete a face to face patient medical record review with the mid-level practitioners. Staff A reported the physicians will periodically review the mid-level practitioners patient medical records, however, the physicians did not document the reviews and/or complete the reviews in conjunction with the mid-level practitioners.

During an interview on 10/20/15 at 4:00 PM, Staff B, Nurse Practitioner stated the physicians do not complete a face to face review of the patient medical records with the mid-level practitioners.

During an interview on 10/20/15 at 4:15 PM, Staff C, Quality Coordinator agreed the physicians and mid-level practitioners did not complete formal face to face reviews of the mid-level practitioner's patient medical records. Staff C reported in October of 2014 she assigned each midlevel practitioner to a physician and implemented a document for the physician to document a face to face patient medical record review between the physician and midlevel practitioner. Staff C said the physicians and mid-level practitioners failed to implement the system.

I. Based on observation, review of policy, procedures, manufacturer's guidelines, AORN (Association of Operating Room Nurses) guidelines, sterilization logs, personal file, and staff interviews the CAH (Critical Access Hospital) failed to follow manufacturer's instructions when using 2 of 2 types of biological indicators. (A sterilization process-monitoring device commercially prepared with a known population of highly resistant spores that tests the effectiveness of the method of sterilization being used.) The surgery department identified 515 surgical procedures performed in 2014.

Failure to ensure staff used the followed the manufacturer's instructions when using the biological indicator during the sterilization pro could potentially result in the sterilization process failing to kill all infectious organisms on surgical equipment and instruments.****

Findings include:

1. Review of the procedure titled, "Sterilizer: Biological Testing and Load Control" dated 10/15 included in part "...D. Sterilizer Test Indicator is run in the first wrapped load of each day. 1. A biological indicator ampule with load number, sterilizer number, and processing date is placed on the bottom shelf of the cart directly over the drain. 4. Check biological indicator label for no media change. a. Getinge and 3M Attest biological's used. The procedure lacks information regarding how to wrap the biological indicator test, if wrapping is necessary, or the use of readymade pack..."

Review of the document titled, "AORN 2015 Edition Guidelines for Preoperative Practices" included in part, "...The biological monitor should be placed in the most challenging location with the sterilizer chamber and within the IUSS (Immediate Use Steam Sterilization) container as indicated by the sterilizer and container manufacturer's..."

Review of the manufacturer's instructions titled, "3M Attest Biological Monitoring System, Technical Product Profile" undated included in part "...For optimal quality assurance of the sterilization process, an Attest biological indicator be used in test packs to monitor each load of steam sterilized supplies. (See Addendum for further details). AORN (Association Operating Room Nurses) Recommended Practices/Sterilization, 1990 Biological Indicator Requirements Should be uses in a 12 " x 12 " x 20 " heterogeneous test pack for steam..."

Review of manufacturer's instructions titled, "3M Attest 1292 Rapid Readout Biological Indicator" dated 2013 included in part "...Directions for use 2. Place the Attest 1292 biological indicator in an appropriate process challenge device according to recommended practices. Place an Attest 1292 biological indicator in an AAMI (Association for the Advancement of Medical Instrumentation) 16 towel pack..."

Review of manufacturer's instructions titled, "3M Attest 41382/41382F Rapid 5 Steam-Plus Test Pack" dated 2013 included in part "...Product Description - The 3M Attest 41382 Rapid 5 Steam-Plus Test Pack is specifically designed to routinely challenge the steam sterilization process in health care facilities. This convenient disposable pack is designed to present a resistant challenge to the sterilization process as is the standard 16 towel pack recommended by AAMI. The test pack is a single use device..."

2. Observation on 10/20/15 at 8:00 AM with Staff G, Scrub tech, during the initial tour of the surgery unit revealed use of 2 biological indicators. The CAH used a Getting Assure Pack and a 3M Attest biological indicator. The autoclave located in the central sterile room was used to sterilize wrapped packages, and the autoclave located in the scrub sink room was used for immediate sterilization of instruments.

Staff G reported when the immediate use sterilizer was used the 3M indicator was placed toward the front of an immediate use pan, with no lid and the window of the pan was left open, and freely floating among the instruments being sterilized. Use of the immediate sterilization unit was not encouraged, due to the age of the machine and the need to have 2 autoclaves available for use in central sterilization at all times. Staff G reported the 3M indicator produced a readout in 3-5 minutes and was used on Mondays mornings and for the immediate use sterilizer (Gravity Flash Autoclave).

3. During an interview on 10/20/15 at 10:30 AM, with Staff G, Scrub Technician and Staff F, Director of Nursing revealed the immediate use steam sterilizer is used only when necessary; it is run empty each Monday. A 3M Attest biological indicator is run with empty load in a flash pan, close to the front of the pan with no lid and the window of the pan open. The flash pan is placed over the drain and a cycle is run. When a load of instruments is run the biological indicator is free floating in the flash pan with the instruments. At 2:00 PM, Staff G added she did not think anything was wrong with the way the CAH was using doing the test.



II. Based on observation, review of policy, procedures, manufacturer's guidelines, AORN (Association of Operating Room Nurses) and staff interviews the CAH (Critical Access Hospital) failed to follow manufacturer's instructions when using the Bowie-Dick test. (A test designed to detect air leaks, ineffective air removal, and presence of noncondensable gasses in dynamic air removal steam sterilizers.) The surgery department identified 515 surgical procedures performed in 2014.

Failure to ensure staff performed the Bowie Dick test in accordance with the manufacturer's instructions could potentially result in micro-organisms on surgical equipment and instruments during the sterilization process resulting in severe illness.

Findings include:

1. Observation on 10/20/15 at 8:00 AM with Staff G, Scrub Technician, during the initial tour of the surgery unit revealed staff used the Bowie Dick test during the sterilization procedure. Two autoclaves were identified by Staff G, the Prevac autoclave, in the central sterile room and the Gravity Flash Autoclave (Immediate Use Sterilizer) in the scrub sink room. Staff G reported the Bowie-Dick test wasn't used in the Gravity Flash autoclave and staff used the Bowie Dick test at the beginning of the day with no wrapped instruments in the Prevac Autoclave.

2. Review of manufacturer's guidelines titled 3M Comply 00135LF Plus Test Pack with Early Warning Sheet; dated 2/10 reads in part ...Instructions for use 1. Test Frequency-The Bowie-Dick test must be carried out each day in an empty sterilizer before the first processed load. The test is run in an otherwise empty chamber because this is a more rigorous test than if the chamber was full with a normal load..."

Review of the document tilted, "AORN 2015 Edition Guidelines for Perioperative Practices" included in part, "...Bowie-Dick-type indicators- For routine sterilizer testing (dynamic air-removal sterilizers only), should be run within a test pack each day in an empty sterilizer before the first processed load..."

3. On 10/20/15 at 10:45 AM Staff F, Registered Nurse (RN) Director of Nursing (DON) verified the hospital lacked a policy and procedure for the use of the Bowie Dick test.

4. During an interview on 10/20/15 at 2:00 PM, with Staff G, Scrub Technician, and Staff F, RN DON revealed Staff G was not running a Bowie-Dick in the Gravity Flash autoclave. Staff G reported the reason for not using the Bowie-Dick in the Gravity Flash autoclave was due to the age of the machine and Staff G did not want it to break the Gravity Flash autoclave.