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Based on employee file review, interview, and Medical Staff Bylaw review, the facility failed to ensure credentialing for two (CC and DD) of two Registered Nurse First Assistants (RNFA, provides aid in exposure, hemostasis [stop bleeding], closure, and other intraoperative [during surgery] technical functions that help the surgeon carry out a safe operation with optimal results for the patient) according to policies and procedures approved by the facility medical staff and governing board and failed to delineate privileges for one (Q) of one Advance Practice Registered Nurse (APRN) working in the Operating Room (OR) and failed to list surgical privileges for both the RNFA and the APRN on the surgical roster available to the OR staff. These deficient practices failed to ensure care was provided by qualified staff and failed to ensure a safe environment for all patients presenting to the facility for surgical care. The facility performs approximately 760 surgical cases per month. The facility census was 253.

Findings included:

1. Review of the facility's policies titled, "Medical Staff Rules & Regulations" dated 11/13, showed:
- An application for clinical privileges without a request for Medical Staff membership shall contain the same information as an application for Staff membership.
- An applicant for clinical privileges shall be subject to the same obligations as are imposed upon an applicant for Staff appointment, as provided in these Bylaws.
- Only those clinical privileges supported by evidence of competence and proof that the applicant meets the criteria for each privilege will be processed through the application process.
- Applications and requests for clinical privileges shall be evaluated on the basis of the applicant's education, training, current competence, the ability to perform the clinical privileges requested, professional references, and peer recommendations that include written information about the applicant's medical/clinical knowledge, technical and clinical skills, clinical judgment, interpersonal skills, communication skills, professionalism and health status as related to ability to perform the requested privileges, information from the applicant's current or past facility affiliations, professional liability experience and insurance coverage, and other relevant information, including an evaluation by the Chairperson of the Clinical Department in which the privileges have been sought.

2. Record review of the personnel file on 04/22/14 at approximately 2:00 PM for Staff CC, RNFA, showed no evidence of credential or privileging process according to the bylaws and no Quality Assurance (QA) evaluation of clinical practice. Staff CC provided RNFA services for 77 surgical cases for the past six months.

3. Record review of the personnel file on 04/22/14 at approximately 2:30 PM for Staff DD, RNFA, showed no evidence of credential or privileging process according to the bylaws and no QA evaluation of clinical practice. Staff DD provided RNFA services for 89 surgical cases for the past six months.

4. Record review of the personnel file on 04/22/14 at approximately 3:30 PM for Staff Q, APRN, showed no evidence of privileging process for surgical services according to the bylaws and no QA evaluation of clinical practice. Staff Q provided assistance for six surgical cases for the past six months.

5. During an interview on 04/24/14 at 11:30 AM, Staff FF, Director of Medical Staff Services, stated that she did not know why the facility quit credentialing and privileging the RNFAs. Staff FF stated that RNFA files were handled the same as all other hospital employees. Staff FF stated that the credential file available to OR staff on the intranet failed to list privileges for surgery for both the RNFA and the APRN.

Based on observation, interview, record review, and policy review, the facility failed to ensure that staff followed Surgical Services policies and standards. The facility failed to:
- Develop policies and procedures to prevent wound vacuum system (wound VAC, negative pressure applied for wound healing) sponges (dressings inserted into the wound) from being retained in the body for one patient (#1) of one patient reviewed;
- Ensure staff properly wore surgical attire generally and during preparation for one patient (#16) of two Caesarean section (C-section, delivery of an infant through a surgical opening in the abdominal wall) patients observed;
- Ensure staff maintained glove sterility and washed hands after removing gloves during preparation for one patient (#16) of two C-section patients observed;
- Ensure staff performed sponge and instrument counts correctly during preparation for two patients (#16 and #17) of two C-section patients observed;
- Ensure staff kept linen and waste containers in the Operating Room (OR) until the patient was transferred out of the room for one OR of one OR observed being cleaned;
- Ensure staff maintained the correct temperature range for one blanket warming cabinet of four blanket warming cabinets reviewed for temperature readings;
- Ensure OR Managers were familiar with Surgical Services policies; and
- Develop a policy for outpatient surgery post-operative care planning and coordination, and provisions for follow-up care.
These failures increased the risk for patient harm from infection, retained surgical items, and injury, and increased the potential for all surgical patients to receive substandard care.
The facility performs approximately 760 surgical cases per month. The facility census was 253.

Findings included:

1. Record review of the 2014 Association of Perioperative Registered Nurses (AORN, an organization that promotes safe care of the surgical patient by providing practice support to operative personnel) guideline titled, "Recommended Practice for Prevention of Retained Surgical Items," showed retained surgical items (RSI) are considered a preventable occurrence. Further review of the guideline showed that when the patient leaves the OR with wound packing in place, a standardized procedure should be defined and implemented to communicate the location of packing and the plan for eventual removal of items.

2. Record review of the Discharge Summary in Patient #1's medical record showed these procedures performed in the OR:
- On 02/16/14, excision of eschar (removal of dead tissue) with drainage of seroma (pocket of fluid) and wound VAC application to right thigh wound;
- On 02/19/14, primary closure and drain placement of right thigh wound;
- On 03/07/14, removal of sutures and wet-to-dry dressing to right thigh wound;
- On 03/11/14, debridement (removal of dead tissue) of right thigh wound; and
- On 03/14/14, excision of retained wound VAC sponge to right thigh with placement of wound VAC.

3. Record review of the Operative Reports in Patient #1's medical record showed wound VAC dressing changes to the patient's right thigh on 03/19/14, 03/26/14, 03/29/14, 04/04/14, 04/09/14, and 04/14/14. Further review of the operative reports showed no indication that the number of sponges removed was reconciled with the number of sponges placed at the preceding dressing change.

4. Record review of the Trauma Mortality and Morbidity Committee Meeting and Multidisciplinary Trauma Case Conference minutes showed no surgeon discussion of ways to prevent the recurrence of retained wound VAC sponge until 04/22/14, five weeks after the retained wound VAC sponge was discovered.

5. During an interview on 04/22/14 at approximately 3:00 PM, Staff C, Vice President of Quality Assurance (VP-QA), stated that no policies and procedures had been developed to prevent wound VAC sponge retention.

6. Record review of the facility policy, "Surgical Attire" dated 04/14, showed these directives for staff:
- All persons entering semi-restricted (e.g., OR corridors) and restricted (e.g., ORs) areas of the surgical suite must wear surgical attire appropriate for use within the surgical environment.
- Hair/head covering will cover head and facial hair, including all side hair and hair at the nape of the neck.
- All persons entering the surgical environment where sterile supplies are opened will wear a single surgical mask that covers both nose and mouth.
- Masks are to be carefully removed and discarded after use.
- Masks are not to be saved by hanging around the neck.
- Shoe covers are to be removed before leaving the surgical area.
- Hands are to be washed after removing sterile and unsterile gloves.

7. Observation on 04/22/14 at 9:30 AM showed Staff D, OR Manager, and Staff E, OR Educator, wearing surgical shoe covers outside of the OR Department.

8. Observation on 04/22/14 at approximately 10:00 AM showed Staff GG, OR staff member, in the OR corridor wearing a surgical mask hanging at the front of her neck.

9. Observation on 04/22/14 at approximately Noon showed Staff HH, OR staff member, walking by the facility cafeteria wearing surgical shoe covers.

10. Observation on 04/22/14 at approximately Noon showed Staff II, OR staff member, standing at the facility lobby elevator wearing a surgical mask hanging at the front of her neck.

11. During an interview on 04/22/14 at 3:15 PM, Staff D and Staff E stated that they were unaware of the Surgical Services mask or shoe cover policies.

12. Observation on 04/23/14 at Noon showed Staff W, Labor and Delivery (L&D) OR Manager, wearing surgical shoe covers in a corridor outside the L&D Department.

13. Observation on 04/23/14 at approximately 12:15 PM showed Staff AA, Certified Registered Nurse Anesthetist (CRNA), in L&D OR #2 preparing Patient #16 for C-section:
- Staff AA's head covering did not cover all her hair, leaving some exposed.
- She put on sterile gloves and inserted an epidural catheter (a tube to deliver anesthesia medication) into Patient #16's back.
- She removed the soiled gloves and failed to wash her hands before touching the patient and objects in the room.

14. Observation on 04/23/14 at approximately 12:30 PM showed Staff Y, RN, in L&D OR #2 preparing Patient #16 for C-section: She put on sterile gloves and inserted an indwelling urinary catheter (a tube inserted in the bladder to drain urine) in the patient. She removed the soiled gloves and failed to wash her hands before touching the patient and objects in the room.

15. During an interview on 04/23/14 at approximately 3:15 PM, Staff W, L&D OR Manager, stated that she and her staff followed Lippincott (nursing reference manual) for OR policies and procedures. She stated that she was unaware of the facility's Surgical Services policies for her area of responsibility including the shoe cover policy. She stated that she did expect staff members in the OR to have all their hair covered and to wash their hands after removing gloves.

16. Record review of the 2014 AORN guideline titled, "Recommended Practice for Prevention of Retained Surgical Items," showed these recommendations for Nurses and Surgery Technicians (STs) when opening sterile instruments and supplies in the OR:
- The initial sponge count is performed to determine that all packages of radiopaque (apparent on x-ray) sponges contain the correct number.
- Packages containing an incorrect number of radiopaque sponges should be removed from the field.
- A count of the instruments at assembly of the instrument set (by sterilization department staff) provides a basic inventory reference for the instrument set but is not considered the initial count before the surgical procedure.

17. Record review of the facility policy titled, "Procedure for Surgical Hand Asepsis" dated 11/13, showed directive for staff to keep scrubbed hands and arms in view to avoid contamination.

18. Observation on 04/23/14 at approximately Noon showed Staff BB, RN, in L&D OR #2 preparing for Patient #16's C-section:
- Staff BB performed sponge and instrument counts with another RN.
- She opened several packages of sponges and placed all the sponges together.
- She counted the sponges one at a time for a total number of sponges without differentiating among the packages.
- She counted the instruments one at a time for a total number of instruments without differentiating among instrument types.
- After completing the preparation, she crossed her arms and placed her right sterile gloved hand in her left axilla (arm pit).

Observation on 04/23/14 at approximately 3:00 PM showed Staff BB, RN, in L&D OR #2 preparing for Patient #17's C-section:
- Staff BB performed sponge and instrument counts with another RN.
- She opened several packages of sponges and placed all the sponges together.
- She counted the sponges one at a time for a total number of sponges without differentiating among the packages.
- She counted the instruments one at a time for a total number of instruments without differentiating among instrument types.

19. During an interview on 04/23/14 at approximately 3:15 PM, Staff W, L&D OR Manager, stated that:
- Staff BB did not count the sponges by the package.
- Standard practice was that if the sponge package count did not match the expected count per the manufacturer, the package was taken off the sterile field.
- Staff BB did not differentiate between instrument types when counting the instruments.
- Standard practice was not to differentiate between instrument types when counting instruments.
- The instrument inventory sheet provided by the sterilization department would be used to determine the type of any missing instrument by the process of elimination.

20. During an interview on 04/24/14 at 9:25 AM, Staff X, OR RN, stated that there are times when staff performing instrument counts in the OR do not differentiate between instrument types. He also stated that the instrument inventory sheet provided by the sterilization department would be used to determine the type of any missing instrument.

21. During an interview on 04/24/14 at 9:50 AM, Staff MM, Surgical Technician (ST), stated that there are times when staff performing instrument counts in the OR do not differentiate between instrument types. She also stated that the instrument inventory sheet provided by the sterilization department would be used to determine the type of any missing instrument.

22. Record review of the 2014 AORN guideline titled, "Recommended Practice for Prevention of Retained Surgical Items," showed the recommendation that linen and waste containers should not be removed from the OR until all counts are completed and reconciled and the patient has been transferred out of the room.

23. Observation on 04/22/14 at approximately 10:00 AM showed OR staff removing linen and waste containers from OR #10 while the patient was still in the room.

24. Record review of the facility's 2014 Medical Equipment Management Plan showed the directive that each employee should know clinical interventions in the event of a medical equipment failure.

25. Record review of the facility policy titled, "Warming Cabinets with Blankets and Fluids" dated 01/12, showed these directives for staff:
- Temperature of warming cabinets will be checked and recorded daily by the perioperative staff.
- If the temperature is out of range, the staff member will adjust the temperature, document that the adjustment was made and notify clinical engineering if the temperature is above acceptable temperature or range.
- Blanket warming cabinets are not to exceed 130 degrees Fahrenheit (F, a temperature measuring scale).
(Blanket warmers store blankets used to cover surgical patients. Blankets with temperatures higher than the accepted range could cause patient burns.)

26. Record review of the facility form titled, "Warmer (Fluid/Blanket) Temperature Document Chart," for the blanket warmer between OR #11 and OR #12 showed:
- The guideline for an appropriate temperature range for the blanket warmer was 100 to 130 degrees F.
- There were handwritten temperature entries from 04/01/14 through 04/22/14.
- The temperatures ranged from 135 to 200 degrees F for 20 of the 22 days monitored.

27. During an interview on 04/22/14 at approximately 2:00 PM, Staff D, OR Manager, stated that the temperature for the blanket warmer between OR #11 and OR #12 is checked by night shift staff members. She was unaware of the ongoing high temperature readings and the Biomed Department (clinical engineering that inspects and repairs biomedical equipment used for patient care) should have been notified about the problem when it first occurred.

28. During an interview on 04/23/14 at 10:50 AM, Staff U, Biomed Program Coordinator, stated that his department had not been notified about the high temperature readings for the blanket warmer between OR #11 and OR #12 until 04/22/14.

29. During an interview on 04/24/14 at approximately 2:00 PM, Staff C, VP-QA, stated that OR staff had notified the charge nurse of the high temperature readings for the blanket warmer between OR #11 and OR #12 but no further action was taken.

30. During an interview on 04/24/14 at 9:30 AM, Staff JJ, Director of Outpatient Surgery, stated that she had been in that role for four months and was unaware of the Surgical Services policies for her area of responsibility.

31. Record review of the index of Surgical Services policies showed no policy for outpatient surgery post-operative care planning and coordination, and provisions for follow-up care.

32. During an interview on 04/24/14 at approximately 2:00 PM, Staff C, VP-QA, stated that there was no policy for outpatient surgery post-operative care planning and coordination, and provisions for follow-up care.