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DETROIT RECEIVING HOSPITAL 4201 ST ANTOINE ST - 2C DETROIT, MI 48201 Oct. 18, 2018
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0173
Based on observation, interview and document review the facility failed to ensure that the physician order for the restriction of a patients freedom of movement for non-violent/non-self-destructive patient was renewed in writing at least every twenty four (24) hours, for three of four (patient #1,2, &3) patients in restraint/restriction of freedom records reviewed, resulting in the potential for unauthorized use of restraint/seclusion/restriction of rights for all patients treated at this facility. Findings include:

On 10/16/2018 at 1010 during the tour of the Surgical Intensive Care (SICU) unit the patient #1 was observed to be in 2 soft wrist restraints.
On 10/16/2018 at 1025 during review of the electronic medical record for patient #1 the Initial order for soft wrist restraint for a non-violent/non-self-destructive patient was dated 10/15/2018 at 0816, the renewal order had not yet been written.

On 10/16/2018 at 1040 during the tour of the Neurological Intensive Care (NICU) unit the patients #2 and #3 were both observed to be in 2 soft wrist restraints.

On 10/16/2018 at 1045 during review of the electronic medical record for patient #2 the Initial order for soft wrist restraint for a non-violent/non-self-destructive patient was dated 10/15/2018 at 0700, the renewal order had not yet been written.

On 10/16/2018 at 1055 during review of the electronic medical record for patient #3 the order for soft wrist restraint for a non-violent/non-self-destructive patient was dated 10/15/2018 at 0015 the renewal order had not yet been written.

On 10/16/2018 at 1100 staff #1 was asked when is the renewal to be written. Staff #1 stated "every 24 hours, we try to have then all renewed at midnight so that the order is not missed."

On 10/17/2018 at 1600 the policy titled "Restraint in the Non-Psychiatric Healthcare Setting" #1 CLN 008 dated effective 04/30/2018 was reviewed. On page 7 of 19 under W. Non-Violent/Medical Support Restraint... 6. it states "Continued use of restraint beyond the first day requires an order by the physician/Midlevel provider designee no less than once every calendar day based on his/her face-to-face assessment of the patient."
VIOLATION: INFECTION CONTROL Tag No: A0747
The facility failed to maintain an ongoing infection control program designed to prevent, control and investigate infections and communicable diseases for 12 of 12 months reviewed, resulting in the potential for transmission of infectious agents for all patients served by the facility. See specific tags:

-- A 0749 - 1. The facility failed to follow infection control policy and procedure for donning and removal of gloves and hand hygiene. 2. The facility failed to ensure that the Infection Control Plan and surveillance policies followed nationally recognized guidelines and their 2018 Infection Control Program Plan.

-A 0756 -1. The facility failed to ensure that the hospital -wide Quality Assessment and Performance Improvement program addressed problems identified by the Infection Control Department for six (#19, #21,#22 #25, #26, and #27) of seven patients with surgical site infections reviewed, out of a total of 15 reported on 2018 surveillance logs, resulting in the potential for missed opportunities for corrective action and quality improvement. 2. failed to ensure that breaches in sterile processing of surgical instruments were documented, investigated and corrective measures implemented in coordination with the Infection Control Department for two (#35 and one unidentified) of five patients reviewed for problems with sterile instrument processing out of a total of six contaminated instrument events documented by the facility for 9/15/18 through 10/5/18, resulting in the potential for Surgical Site Infections.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

This citation has two Deficient Practice Statements.

Deficient Practice Statement #1

The facility failed to ensure that the Infection Control Plan and surveillance policies followed nationally recognized guidelines and their 2018 Infection Control Program Plan resulting in failure to report, investigate and implement corrective measures for those surgical site infections not under mandatory government reporting requirements for 12 of 12 months reviewed, resulting in missed opportunities to prevent post operative infections and improve quality of care with the potential to effect all patients receiving surgeries at the facility. Findings include:

On 10/17/18 at 1000 the Infection Control Program was reviewed with the Infection Control Lead, Staff QQ. Review of the 2018 IC Program Risk Analysis revealed that neurological (neuro) surgeries were assessed as high risk for surgical site infections (SSI) with a score of 30 (Score of 12-23 requires surveillance for trends, scores > 24 requires intervention). There was no risk analysis done for any other type of surgery that didn't require mandatory reporting to the Center for Disease control (CDC)'s National Healthcare Safety Network (NHSN). There was no surveillance documented for any other SSI except Neuro-Surgery and Open Reduction of Fractures (ORIF) without mandatory NHSN reporting requirements. There was no SSI surveillance documented for surgeries where contaminated instruments were entered on Adverse Event Reports.

Review of facility Infection Control (IC) Reports from 08/2017 through 09/2018 at this time revealed no infection rates were calculated for Neuro-Surgeries since 01/10/18.

On 10/17/18 at approximately 1100 Staff QQ was asked about this and stated that administration made structural changes in the hospital network resulting in staff lay offs, so administration instructed the Infection Control (IC) Department to only do surveillance for the healthcare acquired infections (HAI) that the hospital was required to report to NHSN (mandatory reporting requirement).

On 10/17/18 at approximately 1115, the Infection Control (IC) Program Committee meeting minutes and agendas from 01/17 through 10/18 were reviewed with Staff QQ and revealed hospital acquired infection (HAI) rates were only discussed and noted for HAI that the hospital was required to report to NHSN. No rates of Neuro Surgery Surgical Site Infections (SSI) were reported to the Infection Control Committee during 2018.

Review of the "Adult Central Campus HAI Reports" from January 2018 through August 2018 at this time with Staff QQ revealed months where the SSI rate was reported as "none" when SSI surveillance logs reviewed at this time noted SSI occurred. The February report given to the Central IC Program Committee meeting on 3/14/18 noted only discussion of one Hysterectomy SSI (mandated reporting to NHSN). Review of IC logs at this time revealed two patients with lumbar-spinal surgeries had developed SSI during February 2018. Review of the March IC report (MDS) dated [DATE] revealed the notation, "SSI: None to report". Review of IC surveillance logs at this time revealed documentation that one patient who had Neuro-surgery and three patients who had ORIF had developed SSI.

On 10/18/18 at approximately 1330, the Director of Quality, Staff GGG was interviewed regarding the IC Program and stated that administration informed her when she was hired that they did surveillance for HAI infections with NHSN mandatory reporting requirements. Staff GGG stated that Administration was currently working on the 2019 Infection Control Plan and that the decision was already made that surveillance would be limited to those HAI's with mandatory reporting requirements. Staff GGG expressed surprise when told that their 2018 risk analysis had identified neurological surgeries as high risk for SSI and the 2018 IC Plan required tracking, trending (surveillance and reporting of rates) and interventions for Neuro-Surgery SSI. Staff GGG stated that she did not realize that it was a national standard for Infection Control programs to identify high risk/high volume surgeries and do tracking and trending of SSI for these surgeries. Staff GGG was unable to explain why SSI surveillance was not periodically audited for surgeries with the types of instrument sets most frequently identified as having sterile processing problems.





Deficient Practice Statement #2
Based on observation, interview and policy review the facility failed to follow infection control policy and procedure for donning and removal of gloves and hand hygiene following removal of gloves, during three of five observations of staff (TT, VV, and WW) in the operating room (OR), and for one of one observations of staff (Y) in the surgical soiled utility room, resulting in the potential for transmission of infectious agents for all patients undergoing surgery by the facility. Findings include.

On 10/16/18 at 1035 in OR #4, two medical staff (VV and WW) were observed assisting with patient placement on the OR table. Medical staff VV and WW were observed to don and remove non-sterile gloves 2 times with no hand hygiene between and following glove removal. Medical staff WW was observed to remove non-sterile gloves and open a supply cabinet and remove packages of sterile gloves and place them on a side table in the OR. Both medical staff VV and WW were observed to exit the OR without performing hand hygiene prior to exit. At 1045 Circulating Registered Nurse (RN) staff N was informed of the above noted observation and shook her head side to side and stated the two staff were a medical resident and a medical student.

On 10/17/18 at 1142 in OR #3, physician (TT) was observed to enter the OR following the surgical procedure he had performed. Physician TT observed the closure of the incision by a medical Resident and the removal of the patient drapes. The Resident cleaned the incision area and placed a dressing over the surgical incision. Physician TT was observed to remove a roll of surgical tape from a common supply bin which contained multiple rolls of tape under a metal stand. Physician TT did not perform hand hygiene or don gloves and was observed to lay the roll of tape on the dressing and pull a strip off while pressing it onto the patient's incision dressing and skin. Physician TT repeated the application of the surgical tape to the dressing three times and then returned the roll of tape to the common bin under the metal stand. Physician TT was observed a few minutes later to again remove a roll of tape from the common bin and apply another strip of tape to the dressing in the same manner noted above and return the tape to the common bin. At 1155 the RN OR manager (staff Q) was informed of the above observation and made no comment, just shook her head side to side.

On 10/18/18 at 0930 the facility policy 2 IC 000 titled Hand Hygiene Policy, dated 1/2017 documented the following: "Objective/purpose: To prevent the transmission of microorganisms from person to person in all health care settings. . .Policy: Hand hygiene is the single most effective method to reduce the transmission of infection. . .All DMC department managers are responsible for enforcing hand hygiene. . .Procedure and.\provisions: . .B. Indications for hand hygiene are: 1. Upon patient room entry and exit. 2. Before having direct contact with patients. 3. Before donning sterile and exam gloves. 4. Prior to the insertion of invasive devices. . . 5. Before and after dressing changes. 6. Between clean and contaminated tasks on the same patient. 7. After care of the patient including contact with the patient's intact skin. 8. After contact with a source of microorganisms. . .9. After contact with equipment or surfaces likely to be contaminated. . .13. After removal of gloves. . .I. Other aspects of hand care and protection: 1. Glove use: a) Gloves are never a substitute for hand hygiene. b) Gloves are worn for anticipated contact with blood and body fluids. . .c) Gloves are worn when handling items or surfaces soiled with blood or body fluids. d) Hand hygiene must be performed every time gloves are removed. . ."




Additionally, on 10/16/18 at approximately 1400, Tech Staff Y was observed in the Surgical Area Soiled Utility Room spraying Pre-Klenz cleaner on instrument sets while ungloving and regloving without performing hand hygiene. Interview with the Surgical Manager Q, on 10/16/18 at approximately 1405, verified that Staff Y did not perform hand hygiene per policy/procedure, she stated, "She should have washed her hands after ungloving."