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Based on inspection of the restricted surgical staff areas and operating room suites, it was determined that the hospital did not provide adequate surveillance and monitoring of the environment of care to ensure compliance with procedures for a safe and sanitary environment in surgical areas.

Findings include:

Tours of the surgical staff restricted areas and suite on 6/5 and 6/7/12 identified instances of unsanitary environment, which represents risk for cross-contamination.

Examples include:

Staff put on surgical scrub attire in unclean locker rooms on the fourth floor restricted areas and then travel down the stairwell to the third floor surgical suite, where it is required that only clean surgical attire may be worn.

Staff were observed wearing surgical scrub attire outside of the OR without donning appropriate outer coverings as required.

Staff locker rooms were not maintained in a clean and sanitary manner. Items were not appropriately stored and large amounts of dirt and dust were noted.

One instance was observed on 6/7/12 where an employee held used surgical scrubs in one hand that made direct contact with newly obtained clean scrubs attire dispensed from scrub exchange machine.

Cross-refer to findings noted under Surgical Services, tag # A951.
These findings noted above also represent the failure to monitor the environment of care and ensure effective oversight of staff to ensure compliance with hospital procedures.
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Based on record review, review of documents, and interviews it was evident that the hospital did not ensure that surgical services were rendered in a manner the conforms to standards of practice.

Findings include:

Review of MR #1 on 6/9/12 shows documentation that on 5/23/ 2012, during the procedure for a laporoscopic nephrectomy the patient sustained a penetrating injury to the aorta and other vessels during the insertion of a bladed trocar.

Review of MR# 1 found documentation that the surgery began at 0819 hrs. The trocar insertion was made at 0821hrs, and bleeding was identified on the camera by the surgical staff immediately. There is documatation that the surgeon attempted to manage the bleeding vessel via the gelport (hand access laparoscopy) starting at 0822hrs.
At 0835hrs the patient's blood pressure was noted to be 60/30. The procedure was then converted to open laparotomy at 0853hrs. The patient received the first unit of packed red blood cells at 0900hrs. At 1047hrs the patient coded and CPR was initiated. At 1110hrs an open thoracotomy was performed with direct cardiac massage. The patient's thoracic aorta was not cross clamped until 1117hrs.

On interview with the fellow who inserted the trocar, he stated that he inserted the trocar against resistance.

Based on review of documents and staff interviews, it was determined that surgical services were not organized to ensure the availability of necessary equipment in advance.

Findings include:

Review of surgical documents for the Moses Division found that during the period ranging from 7/27/11 through 4/18/12, there were nine (9) cancellations for procedures that occurred on the date of surgery due to lack of equipment.

MR#17:
Case was cancelled for surgery due to lack of available tissue for corneal transplant. The patient did have the procedure on 2/7/12. The medical record was not available.

MR#18:
Scheduled surgery for 12/30/11 was canceled on the date of surgery since the equipment or instrument was not available. No further information was available to include further review. The medical record for this encounter was not available, according to interview with medical records staff on 6/8/12.

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Based on record review and interview it was evident that the surgical staff failed to incorporate all surgical staff into the " time out."


Findings include:

Review of MR #1 on 6/5/12 found that the transplant fellow who inserted a trocar was not noted to be listed on the time out form.

Review of the facility policy and procedure found that an additional time out is done when another practitioner joins the team.



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Based on observations, review of procedures, and staff interviews, it was determined that surgical services were not delivered in a manner to promote the health and safety of patients in a safe and sanitary environment.
Findings include:
The hospital did not implement effective procedures to ensure a safe and sanitary environment in the surgical service and operative suite. Specifically, the facility did not implement procedures for the provision of a clean and sanitary environment of care for patients undergoing surgery.
The following observations were made during tours conducted of the surgical areas and restricted access staff locations in the Moses Division on 6/5/12 and 6/7/12:
1. Hospital procedures for appropriate donning of surgical attire were not followed nor enforced by managerial personnel.
At least three instances were observed of staff walking in non-surgical public areas of the hospital in surgical costumes and head coverings with no donning of appropriate outer garments as required by hospital procedures for dress code.
For example, one observation was made on 6/5/12 at approximately 12:45 PM during which an unidentified male staff member was seen walking in non-surgical public corridors of the hospital in surgical scrubs with no evidence of wearing buttoned laboratory coat as required by procedures.
Another observation was made on 6/7/12 at 9:50 AM in the hospital lobby during which an unidentified male employee left the hospital building to walk on the street. This employee was dressed in green scrubs and was wearing a surgical mask tied around his neck and was not observed to be wearing a laboratory coat over the scrubs.
On 6/5/12 at lunch time, approximately 12:45 PM, staff were observed sitting outside of the facility wearing scrubs and sitting on outdoor benches. None wore outer garments over the scrub attire.
These staff did not don appropriate outer garments as required by hospital procedures. This observation did not conform to draft of hospital procedures for staff attire which clearly specify the need to don buttoned laboratory coat over scrubs when worn outside the surgical suite and restricted or semi restricted areas.

2. During an initial tour conducted on 6/5/12 at approximately 11:30 AM, unsanitary conditions were observed in the area of female staff locker room located on the fourth floor of a restricted access area. A follow up tour conducted of operative staff lounges and male physician and staff locker rooms on 6/7/12 at approximately 2PM also found similar unsanitary and unclean conditions.
Findings include:
a. The staff locker rooms located on a restricted section on the fourth floor of the Moses division were noted to be unsanitary. Staff change into scrubs and attire in these unclean locations, and then travel along a stairwell leading into the third floor sub-sterile operating room suite. From this corridor staff will travel as assigned into sterile operating rooms. This poses risk for cross-contamination.
b. On 6/5/12, at 11:40 AM a tour of the female locker room found presence of large amounts of dust in plastic shoe bins on the floor and throughout the entire locker room area. Spillage was observed on the floors along with pervasive dirt particles and debris scattered on the floor in the locker room and in the bathroom. Rust colored droplets and dust were seen on air vents.
c. Personal bags and belongings along with shoes were stored on top of lockers in the female locker room; these items were located close in proximity to the ceiling, contrary to regulatory requirements. The floors were dirty and grimy. The adjoining bathroom and shower were dirty, with green film in the female shower. Broken equipment, including a mirror mounted on the lockers and and a broken chair in the shower were observed. During re-visit on 6/7/12, it was noted the items stored on top of lockers had been removed and floors cleaned, however the damaged mirror had not been removed.
d. Containers labeled for soiled linen were instead utilized for garbage in the female staff locker room.
e. On 6/5/12, a live fly was observed in the female shower. Two gold cylinders were observed hanging from the ceiling, for which staff reported was placed to address flies.
f. Although no evidence of live bedbug insects were observed, four staff reported that there had been a problem with bedbugs sited in the operating room and in the staff locker rooms and staff lounges. Staff interviews conducted on 6/8/12 (staff #s 10 and #11) found there had been a bed bug identified on the surgical field during 2011, which had been treated.
Review of hospital extermination log documents and staff interviews on 6/7/12 corroborated the past presence of bedbugs in the locker rooms (9/21/11) and in the OR (10/3/11), which had been addressed by contracted extermination company and hospital management (prior to the survey). While this issue had been addressed, the presence of cluttered and unclean surroundings may present a continued risk factor for re-infestation.
Inspection of lockers in the female and male locker rooms on 6/5 and 6/7/12, respectively, found evidence of cluttered or dirty lockers. Staff did not conform to written hospital prevention procedures for bed bugs, which require that hoarding of excess items in staff lockers must be minimized.
g. Tour of the physician and male staff locker room on 6/7/12 at 2:15 PM found unsanitary conditions. In the male physician locker room, evidence of a large amount of accumulated dirt and dust in the corners was found between locker #s 50-51. Locker 252 found dried brown liquid residue of unknown etiology with an opened and spilled packet of powdered dietary sweetener on the floor of the locker.
In the male staff locker room on the fourth floor, an old intercom was mounted to the wall and contained a sharp metal edge. Beneath this was a chair where it is presumed staff may sit. The protrusion of a metal edge may present a hazard to staff entering this area. The shower area was dirty and contained broken tiles and ingrained and encrusted dirt throughout the area.
h. Staff were observed on 6/5/12 eating and drinking in fourth floor staff lounge, room# 11-4-044 in which the floors of this room were sticky and were covered in dirt and grime.
i. A metal unenclosed storage rack located on the 4th floor OR staff restricted corridor contained boxes of paper gowns, caps, and shoe covers stored in open boxes. This rack was located proximal to a stairwell leading from the fourth floor to the restricted sub-sterile OR suite on the third floor. The presence of these items near the stairwell suggests gowns are donned in an unsanitary area prior to entry to a restricted stairwell that requires wearing of surgical attire.
j. On 6/7/12 at 2:10 PM, a staff member (staff #9) was observed obtaining a clean set of scrubs from the surgical attire dispensing machine prior to disposing the used scrubs. Surveyors observed contact made between the clean and used surgical scrub attire. This represents risk for cross contamination.
k. Staff interview on 6/7/12 at approximately 2:30 PM found there are instances where staff may bring coffee to the operating room suite. While it is the practice of supervisory staff to intervene to prevent these events, it was stated at interview this does occur on occasion.
The above noted findings of an unsanitary environment of care in the semi restricted operative staff areas and the operating room suites represent a high risk potential for cross contamination, in that staff changed from dirty to clean attire in an unclean area and then travel to restricted sub sterile and sterile operative areas.

l. During tour of OR on 6/5/12 at approximately 11:30 AM it was observed that an employee walked into the semi sterile corridor with dangling earrings. The Director of Peri operative Services (staff #10) was present during tour. She informed the surveyor that the hospital policy states an employee can wear stud earrings however employees wear dangling earrings anyway. The Director of Perioperative Services informed the surveyor that she will be modifying her policy on jewelry to state no earrings are allowed. The current policy pertaining to jewelry is ineffective and still in effect.

m. During tour of OR on 6/5/12 at approximately 12:30 PM it was observed that an employee was walking from the semi sterile area to the non sterile area with scrubs and a messenger bag on his side. The employee was observed leaving the semi sterile area to the non sterile area with his scrubs and bag. It was observed that administrative staff present during the tour did not enforce the policy with the employee that personal belongings are to be left in lockers.

n. In addition, it was observed during the tour that most employees walking through the OR corridors did not wear hospital identification badges or identification badges worn were covered by their OR scrubs and /or paper gown.


These findings noted above also represent the failure to monitor the environment of care and ensure effective oversight of staff to ensure compliance with hospital procedures.

Based on review of medical records, it was determined that operative consent forms did not consistently include documentation of the specific risks of operative procedures. Specifically, operative consent forms did not consistently include documentation of the specific risks of operative procedures or explain risks of the types of anesthesia to be used.

Findings include:

13 of 21 applicable medical records reviewed on 6/8 and 6/11/12 did not include written and individualized discussion of the risks, benefits, or alternatives relative to the specific type of operative procedure being performed.
In addition, operative consents in medical records did not reflect discussion of the individualized risks of the specific types of anesthesia to be used.

The operative consent form contained pre-formatted typed language which certified " I have (the provider) explained the nature purpose, benefits, risks of, and reasonable alternatives to the proposed procedures/operations and sedation and/or blood products, where applicable". Template language includes" I have discussed potential problems related to recuperation, the likelihood of achieving treatment goals and the risks, benefits, and side effects of reasonable alternatives, including the possible consequences of receiving no treatment.

Review of informed consent and refusal policy on 6/11/12 requires that the discussion notes may be included in section II of the consent form or progress notes.

Examples include:

Review of MR #1 on 6/5/12 found inadequate documentation on the operative consent explaining the risks of laparoscopic donor nephrectomy, including risk of death.

The patient signed a form titled "Information for potential live donors-permission to proceed with evaluation" form as an outpatient on 2/24/12. This document discussed "the risk of death from this procedure in the US is between 3 to 6 out of 10,000".

In addition, the facility failed to explore the possible conflict of interest due to the finding that the patient also worked for her brother, who was the purported recipient. The patient also had no active health insurance until the end of the month and reported that the job would pay her one month salary following donor surgery. The need to rule out possible financial or emotional coercion given this factor was unexplored.

The review of the operative consent for laparoscopic donor nephrectomy found the patient signed on 5/16/12 and again on 5/23/12 (date of surgery) for "laparoscopic left donor nephrectomy; possible open".

The section titled informed consent discussion included predetermined typed language that noted the risks, benefits, alternatives, and consequences of having no treatment were discussed. The section for remarks listed "' risk of bleeding, infection, damage to other organs". This section also contained an illegible word written next to the word "operation".

There was no evidence written of the discussion of the possible risk of death.
This patient expired intraoperatively during performance of the donor nephrectomy procedure on 5/23/12.

MR # 9:
Patient underwent surgical repair of umbilical hernia with mesh placement on 2/10/12.
The patient's operative consent did not include documentation of the individualized risks associated with this type of procedure in the remarks section. In addition, while the pre-operative anesthesia assessment includes a preformatted statement that notes the risks benefits and alternatives to anesthesia plan were discussed, the individualized risks for the type of anesthesia were not documented on the operative consent.

Similar findings were identified in the following records for informed surgical consents which lacked documentation of individualized discussion of the specific risks, benefits, or alternatives to the operative procedure being performed or the anesthesia plan.

Refer to MR #s:
(MR #1, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
















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Based on record review and interview it was evident that the anesthesia department failed to formulate and implement policies and procedures to ensure that there is an effective escalation policy in effect for anesthesia to intervene where there is an unsafe situation in the O.R.

Findings include:

Review of MR#1 on 6/9/12 shows documentation that the patient sustained a perforation of the aorta during the insertion of a trocar for laparoscopic surgery.

At interview with the anesthesia resident on 6/6/12 it was stated by the resident that she and her attending were of the opinion that the patient was so unstable after a trocar perforated the aorta that emergent intervention was required and that the patient was not responding to multiple blood transfusions and pressors. She stated that the patient's hands were cyanotic and cold to touch. The anesthesia resident stated that she wanted the patient to be placed in a supine position in order to insert a central line into the patient's neck. However, the surgeons did not have the patient placed in a supine position.

At interview, the anesthesia resident stated that the anesthesia attending was not in the operating room when the patient became unstable.

At interview with the anesthesia attending, she stated that she was not in the operating room when the patient became unstable.

Review of MR#1 on 6/9/12 shows documentaion that the anesthesia resident administered Vasopressen IV, Levophed IV and Pheneylphrene IV at a "wide open rate". There is no documentation that Vasopressen was administered at a rate that was titrated to the patient's blood presuure.

Based on review of concurrent records and staff interviews, documentation of post-anesthesia assessment was not present in medical records.

Findings include:

Review of 2 of 6 applicable concurrent medical records on 6/11/12 found no evidence of documented post-anesthesia assessments following surgery as required.

Example:
MR #15: Patient underwent exploratory laparatomy surgery for perforated gastric ulcer on 6/2/12. During concurrent review on 6/11/12, no evidence of anesthesia assessment was included in the medical record.

In addition, the pre-anesthesia consent was not countersigned by an attending physician. Review of the pre-operative anesthesia assessment document dated 6/2/12 found evidence of CRNA resident signature but this document contained no written signature of the concurring anesthesiologist.

Refer to MR # 15, MR #16.

Staff interview on the unit confirmed these documents were missing from applicable records.









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