The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

LENOX HILL HOSPITAL 100 EAST 77TH STREET NEW YORK, NY 10021 Dec. 6, 2017
VIOLATION: INFORMED CONSENT Tag No: A0955
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

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Based on Medical Record review, document review and interview, the Surgical Services Staff did not implement the facility's Policy when obtaining consent to have a company representative or visitor present in the Operating Room (OR) during a patient's surgical procedure, in three (3) of three (3) Medical Records.

This lack of documentation makes it difficult to determine the identity of all nonsurgical staff in the OR.

Findings include:

The facility's Policy and Procedure titled "Company Representative and/or Visitors in the Patient Care Areas" last revised 7/8/16 stated the following: the Director of the Patient Care Area will - ensure that the physician has documented in the patient medical record an informed consent discussion ... on the [above] consent form ... the presence, role and responsibility of the company representative" the policy furthered stated, "the requesting physician shall engage in a detailed ... discussion with the patient ... including but not limited to: the name of the vendor, name of the visitor, the name of the company representative" and documents the informed discussion on the "Consent for the Presence of a Company Representative and/or Visitor" form.

The facility Consent Form titled "Consent for the Presence of a Company Representative and/or Visitor" stated; "I hereby acknowledge that a Company Representative and/or Visitors from [blank space for a company name] will be present during the above ... procedure" but does not provide a place to document the Representative and/or visitors' name.

Review of Patient #8's Medical Record identified the following information: the patient (MDS) dated [DATE] for a Right Total Knee Replacement. The Medical Record contained a signed and dated "Consent for the Presence of a Company Representative and/or Visitor" which listed that a "Stryker" Representative would be present during the procedure. The patient underwent surgery from 8:30AM until 11:43AM. There is no documentation of the name of the Representative anywhere in the Medical Record.

The "Rep Trax" Security Log dated 12/04/17 revealed that there were four (4) different Stryker Representatives signed in between 7:22AM and 10:01AM. All four (4) Representatives are listed as going to the Operating Room but there is no indication of which OR Suite or OR case they were involved in.

The same lack of documentation regarding the Company Representative's name was found in the Medical Records for Patients #9 and #7.

Per interview with Staff AA (Nurse Manager), on 12/02/17 at 1:30PM, the Nurse stated that the "Operating Room Staff books the case and she then calls the company which will be used to get a Representative. They do not always send the same person."

Per interview with Staff S (Director of Quality Management) on 12/02/17 at 2:30PM, the Director stated that the Vendor is not entered in the OR Log ... the Vendors all wear red hats (to identify them as a Company Representative), but there is still is no way to know which Vendor Rep (Representative) it was.
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VIOLATION: OPERATING ROOM REGISTER Tag No: A0958
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Based on document review and interview, the Surgical Services Department's OR (Operating Room) Register was not complete.

Findings include:

The facility's OR Register titled, "OR Report Log," dated 11/6/17 to 11/17/17, did not include patients' names, ages, pre-op (preoperative) and post-op (postoperative) diagnoses and the names of the person(s) administering anesthesia.

This was confirmed with Staff S.

Per interview with Staff S (Administrator) on 12/06/17 at 1:47PM, the facility did not have an OR Register listed by Surgery Service, which included patients' names, ages, hospital identification number, date of surgery, total surgery time, names of surgeons and assistants, names of nursing personnel, types of anesthesia used, names of person(s) administering anesthesia, the surgeries performed and the pre and post op diagnoses within one (1) document.

Staff S stated that when this information is needed, the OR Schedule, OR Report Log and the [individual patient's] OR Record is utilized, but that not all components are located on one (1) register, listed by Surgical Service.

The facility's OR Schedules, dated 12/04, 12/05 and 12/06/17, did not include the Surgical Assistants' names, Nursing Personnel, pre-op and post-op diagnoses and the type of anesthesia given.

OR Reports were electronically filed within the individual Patient Record and would have to be accessed by Patient Name, Medical Record Number or Hospital Encounter Number.

No single Register, with all the required information, was available.
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VIOLATION: OPERATIVE REPORT Tag No: A0959
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

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Based on observations, document review, Medical Record reviews and interviews, the Surgeon failed to document a complete Post-Operative Note. Specifically, the Operative Report does not document participation by other Practitioners in the patient's surgical procedure.

This lack of documentation makes it difficult to determine the identity of persons who are active participants in surgical procedures.

Findings include:

Review of Patient #4's Medical Record identified the following information: Patient #4 (MDS) dated [DATE] for a Left Knee Arthroscopy, Partial Medial Meniscectomy, Partial Debridement and Chondroplasty with Synovectomy. The "Operating Room Record" documents that the surgery began at 8:13AM and was completed at 8:30AM. The Record further documents that the Surgeon, an Orthopedic fell ow, an Anesthesiologist, a Circulating Nurse and a Surgical Technician were in attendance. The immediate Post-Operative Note and the dictated Operative Report documented by the Surgeon on 12/05/17, does not include any participation by the Orthopedic fell ow during the surgical procedure.

Observations in the facility's Operating Room on 12/05/17 at 8:26AM, during the surgical procedure identified that Staff K (Surgical fell ow) was suturing the patient after Staff C (Primary Surgeon) had left the Operating Room. This was confirmed by Staff P (Assistant Director).

Per interview with Staff K on 12/05/17 at 11:45AM, Staff K confirmed that he was left stitching Patient #4's skin closed when Staff C exited the Operating Room.

Per interview with Staff C on 12/05/17 at 12:00PM, Staff C confirmed that he had left the Operating Room as Staff K was suturing Patient #4's skin closed.

The facility's current Bylaws contain the following statements in Article XI- Medical Records: an accurate, clear, and comprehensive medical record shall be maintained for every patient ... the record shall include ... surgical treatment and related reports such as record of operations, record of anesthesia ... [and] when residents are involved ... sufficient evidence shall be documented in the medical record to substantiate the active participation ... in the patient's care".

However, the Bylaws lack guidance for documenting a description of the specific significant surgical tasks that were conducted by Practitioners other than the Primary Surgeon.