HospitalInspections.org

Based on document review, medical record (MR) review and interview, (1) in 1 of 1 MRs reviewed (Patient #1), the hospital did not ensure the required passage of 72 hours between consent and surgery for sterilization performed as part of emergency surgery. Also, the MR lacked the correct sterilization informed consent form as required by the New York State (NYS) Medicaid Program. (2) Additionally, in 2 of 15 (Patient #2 and Patient #3) MRs reviewed, both lacked the physician's signature under the "Physician's Statement" on Form LDSS-3134 as required by the NYS Medicaid Program. This could affect a patient's right to make informed decisions regarding their care.

Findings related to (1) include:

-- Review of the facility's policy and procedure (P&P) titled, "Sterilization Procedure for Medicaid and Medicaid-Eligible Patients (Male or Female) Hysterectomies Covered by Medicaid Program," last reviewed 12/2017, indicated all Medicaid and Medicaid eligible patients who request a sterilization procedure ... will have the required Medicaid forms completed. Sterilization consent forms must be completed 30 days prior to the date of surgery for tubal ligation (TL) or vasectomy. Only in cases of premature delivery or emergency abdominal surgery may sterilization be performed in less than 30 days but must be more than 72 hours after the date of the individual's signature on the consent form.

-- Review of the NYS Medicaid form titled "Sterilization Consent Form (LDSS-3134)," dated 2/2001, indicated the physician must attest that: 1) 30 days have passed between the date of the signature on the consent form and the date the sterilization was performed or 2) The sterilization was performed less than 30 days but more than 72 hours after the date of the individuals signature on the consent because of the following circumstances, i.e., premature delivery or emergency abdominal surgery.

-- Review of Patient #1's MR, revealed she presented to the Emergency Department (ED) on 7/27/18 at 5:50 pm with complaints of abdominal pain, nausea, vomiting and diarrhea starting that day with an episode of syncope. She had a positive pregnancy test 3 weeks prior but was told her quantitative Human Chorionic Gonadotropin (HCG) (a blood test for a hormone produced during pregnancy) levels were not rising appropriately. An obstetrical transvaginal ultrasound was done and revealed possible ectopic pregnancy. An informed consent (surgical consent) form for "laparoscopy, possible salpingectomy, possible laparotomy, look in abdomen, possibly open abdomen, remove tubes" was signed by Patient #1 at 9:20 pm. Staff A, Hospitalist, documented "likely ruptured ectopic pregnancy. I reviewed the clinical situation with the patient and her family. I recommended that she have procedure of laparoscopy, possible laparotomy. Options, benefits, risks and potential complications were explained, including the option of doing nothing. Possibility of bleeding, infection and injury to other organs were discussed. All questions were answered to their satisfaction. Informed consent was obtained."

Staff B, Attending Surgeon, documented in his/her assessment "likely ectopic pregnancy, plan laparoscopy, possible laparotomy, patient requests sterilization and removal of both tubes." Staff B performed a "laparoscopy, laparoscopic left salpingectomy and a right tubal cauterization" on 7/27/18 at 10:14 pm (approximately one hour after the consent was signed.) The operative note revealed " ...The right fallopian tube, at the patient's request for sterilization purposes, was cauterized over."

Patient #1 was discharged to home on 7/28/18 at 3:07 pm in good condition.

The MR indicated Patient #1 had medical insurance through a NYS Medicaid Managed Care program. The MR lacked NYS "Sterilization Consent Form (LDSS-3134)".

-- Per interview of Staff A on 10/9/19 at 9:30 am, he/she recalled Patient #1 had an emergency ectopic pregnancy. The patient was seen in the ED and went directly to the operating room (OR). Patient #1 asked about getting her tubes tied (sterilization) but had a state sponsored medical insurance coverage requiring a consent for sterilization be signed 30 days in advance of the procedure. There is a clause in the consent, if a patient has signed the sterilization consent and it hasn't been 30 days and the patient is having emergency surgery a surgeon can perform the sterilization 72 hours later. It was not Staff A's intent to mean sterilization on the Informed Consent form when listing the surgical procedure to include "remove tubes." Patient #1 was disappointed she couldn't have her tubes tied at the time of the emergency surgery.

-- Per interview of Staff C, Medical/Surgical Charge Registered Nurse (RN) on 10/8/19 at 11:20 am, patients may present to the emergency department (ED) then go directly to the OR then to an inpatient unit or present to the ED, go to an inpatient unit then to the OR. Providers obtained informed consents, he/she acts as a witness on the consent form. He/she is not familiar with the consent process for patient's having (reproductive) sterilization in NYS.

-- During interview of Staff D, OR RN on 10/9/19 at 2:45 pm, he/she asks patients preoperatively "what are you here for" and looks at the consent. His/her focus is on the emergency components for an ectopic pregnancy, a TL is not emergent. He/she does not look at the type of insurance a patient has and is not familiar with a special NYS Medicaid sterilization form.

-- Per interview of Staff E, RN, Obstetrical (OB) Charge Nurse on 10/8/19 at 9:30 am, patients requesting a TL need paperwork signed 30 days prior to delivery and TL is not offered to the patient if not planned at least 30-days prior to delivery. He/she does not know if the 30-day requirement is related to the type of insurance the patient has. He/she does not recall receiving education about this topic.

-- Per interview of Staff F, OB RN on 10/8/19 at 11:00 am, he/she thinks a specific consent form in needed for TL with certain insurances but doesn't know if specific timeframes for acquiring the consent form is required.

-- Per interview of Staff I, Nurse Manager Surgery Center on 10/9/19 at 3:40 pm, he/she is aware of the NYS Medicare consent form for TL. As nurses we don't ask about a patient's insurance, the paperwork usually comes from the physician's office prior to elective/planned sterilization surgery.

Findings related to (2) include:

-- Review of the facility's P&P titled, "Sterilization Procedure for Medicaid and Medicaid - Eligible Patients (Male or Female) Hysterectomies Covered by Medicaid Program," last reviewed 12/2017, indicated the staff in the OR will obtain the signature from the "Physician's Statement" portion of the sterilization consent.

-- Review of the NYS Medicaid form titled "Sterilization Consent Form (LDSS-3134)," dated 2/2001, indicated the "Physician's Statement" (the final box/statement) is to be completed on the day of the procedure.

-- Review of Patient #2's MR, dated 6/17/19, revealed a Sterilization Consent Form lacking the physician's signature in the "Physician Statement" section.

-- Review of Patient #3's MR, dated 7/5/19, revealed a Sterilization Consent Form lacking the physician's signature in the "Physician Statement" section.

-- During interview of Staff G, Director of Quality Improvement on 10/21/19 at 10:00 am, he/she acknowledged the above findings.