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Based on interview and record review, facility registration staff failed to follow the hospital's policy and procedure related to obtaining patient signatures and initials on the Conditions of Admission (COA) form for 2 of 34 sampled patients (5,6). As a result, it was unclear if patients received and understood information regarding the conditions of admission to the hospital.

Findings:

1. The hospital admitted Patient 5 to the Forensic Unit on 3/4/15 with a diagnosis of Chest Pain, according to the face sheet.

During a review of Patient 5's medical record on 3/10/15, the COA form was reviewed. The COA had hospital information for patients that included consent to hospital procedures, nursing care, medications, patient rights and responsibilities, release of information, financial agreement, and assignment of benefits.

The COA found in Patient 5's record had a hospital registration staff's signature and a date of 3/9/15 on the "Witness" signature section of the form. There was no time noted in this section to indicate when the registration staff signed the form. There was no patient signature, date, or time on the "patient/parent/conservator/guardian" signature section of the form. In addition, there were no patient initials in the various sections of the form to indicate that the patient received and understood the COA information.

When interviewed on 3/10/15 at 11:25 A.M., Registrar 1 stated that in order to expedite the registration process, he signed and dated multiple blank COA forms, brought the form to the patients, and then had the nurse fax the copy to the Registration Office once the patient signed the form. Registrar 1 said he did not know that he was to enter a time on the "Date/Time" section of the form.

During an interview on 3/10/15 at 1:45 P.M., the Medical Records Director stated that the COA should be completed upon admission and that the registration staff should only "affix a witness signature while the patient is present." She also said that the "date and time section should be completed."

The Medial Records Director stated that if a patient was unable to sign the COA on admission, a team of registration staff used an "Unsigned COA List" to follow-up with patients on a daily basis to obtain a signed, dated, and timed copy of the COA form once the patient received the appropriate information. If the registration staff was unable to obtain a signed COA on a follow-up visit, a notation was made in the Patient Accounting Notes. There were no Patient Accounting Notes in Patient 5's medical record for 4 days (3/5/15 - 3/8/15) to indicate that registration staff followed up with the patient to obtain the signed COA. Per the Medical Records Director, they were "short-staffed."

According to the facility's policy and procedure entitled Condition of Admission, revised on 10/24/14, Section 2.0 directed facility registration staff to ... "Collect accurate information, provide all required forms to the patient, and obtain necessary signatures for all patients being registered for inpatient and outpatient services." Section 3.0 directed the registration staff to "explain the required form (Condition of Admission) to the patient/patient representative and obtain required signature. The Registration representative will sign the Consent form in the space indicated as Witness... Continuation of follow-up for obtaining signature on any unsigned document is required... Daily rounding to patient units to obtain the patient/patients signature... All attempts to obtain signature on the COA will be documented by the team member initiating the patient follow-up."

2. The hospital admitted Patient 6 to the Forensic Unit on 3/5/15 with a diagnosis of Hematoma (a localized collection of blood outside the blood vessels), according to the face sheet.

During a review of Patient 6's medical record on 3/10/15, the COA form was reviewed. The COA had hospital information for patients that included consent to hospital procedures, nursing care, medications, patient rights and responsibilities, release of information, financial agreement, and assignment of benefits.

The COA found in Patient 6's record had a hospital registration staff's signature and a date of 3/9/15 on the "Witness" signature section of the form. There was no time noted in this section to indicate when the registration staff signed the form. In addition, there was no patient signature, date, or time on the "patient/parent/conservator/guardian" signature section of the form. Nor were there any patient initials in the various sections of the form to indicate that the patient received and understood the COA information.

When interviewed on 3/10/15 at 11:25 A.M., Registrar 1 stated that in order to expedite the registration process, he signed and dated multiple blank COA forms, brought the form to the patient, and then had the nurse fax the copy to the Registration Office once the patient signed the form. Registrar 1 said he did not know that he was to enter a time on the "Date/Time" section of the form.

During an interview on 3/10/15 at 1:45 P.M., the Medical Records Director stated that the COA should be completed upon admission and that the registration staff should only "affix a witness signature while the patient is present." She also said that the "date and time section should be completed."

The Medial Records Director stated that if a patient was unable to sign the COA on admission, a team of registration staff used an "Unsigned COA List" to follow-up with patients on a daily basis to obtain a signed, dated, and timed copy of the COA form once the patient received the appropriate information. If the registration staff was unable to obtain a signed COA on a follow-up visit, a notation was made in the Patient Accounting Notes. There were no Patient Accounting Notes in Patient 6's medical record for 3 days (3/6/15 - 3/8/15) to indicate that registration staff followed up with the patient to obtain the signed COA. Per the Medical Records Director, they were "short-staffed."

According to the facility's policy and procedure entitled Condition of Admission, revised on 10/24/14, Section 2.0 directed facility registration staff to ... "Collect accurate information, provide all required forms to the patient, and obtain necessary signatures for all patients being registered for inpatient and outpatient services." Section 3.0 directed the registration staff to "explain the required form (Condition of Admission) to the patient/patient representative and obtain required signature. The Registration representative will sign the Consent form in the space indicated as Witness... Continuation of follow-up for obtaining signature on any unsigned document is required... Daily rounding to patient units to obtain the patient/patients signature... All attempts to obtain signature on the COA will be documented by the team member initiating the patient follow-up."

Based on interview and record review the facility failed to follow its procedure for the prevention of retained surgical objects for 1 of 34 sampled patients (Patient 1) having abdominal surgery resulting in a second surgery and admission to the intensive care unit in critical condition.

Findings:

Patient 1 was admitted to the facility on 12/23/14 via the Emergency Department (ED) for acute abdominal pain and ectopic pregnancy requiring surgery, per the clinical record.

On 1/6/15 the clinical record was reviewed with the Director of Regulatory Compliance (DRC). The DRC acknowledged that the ED Report, dated 12/23/14, indicated Patient 1 presented to the ED complaining of severe abdominal pain and was diagnosed with a ruptured ectopic pregnancy (a pregnancy growing outside of the uterus). Patient 1 was scheduled for immediate surgery.

On 1/6/15 the facility Procedure: Sponge, Sharps and Instrument Count, Prevention of Retained Surgical Objects, dated 11/14, was reviewed with the DRC and the Director of Surgical Services (DSS). The DRC and the DSS acknowledged that the procedure indicated that countable items include lap sponges (large surgical sponge commonly used in abdominal surgeries). The procedure also indicated that sponge counts shall be performed as follows; a Baseline count at the beginning of the case, a New Item count if anything new is added to the case, a Relief count if the operating room tech or nurse are relieved during the case, a Cavity count before the closure of an internal cavity (as in abdominal surgeries), a Closing count when wound closure begins, and a Final count at the end when the skin has been closed.

On 1/6/15 at 11:30 A.M., during an interview, Operating Room Nurse 1 (ORN 1) stated, "I've been an O.R. Nurse for 26 years. Counts are done before the surgery begins, during, and afterwards any time the incision is big enough for anything to get into the wound. Lap sponges are counted at the beginning, if you add any to the case, when you close each cavity and the skin, and at the end of the case. It's done for patient safety; you don't want to leave any foreign object in the body after surgery because it could cause an infection." ORN 1 continued, "At the end of this case [Patient 1], the surgeon was done closing the cavity and skin before the cavity count was done." ORN 1 further stated, "The surgeon finished closing the wound before we had the cavity count done and he left the room. The patient started to wake up, people were starting to come in to turn-over [clean up] the room, and the Charge Nurse phone rang, so I left the room to answer it; I felt rushed. The scrub tech [ORT 1] was still looking for all the sponges when anesthesia moved the patient out to PACU (recovery room). I assumed the counts were completed." ORN 1 then stated, "The skin count and the final count had not been done when the patient left the O.R."

On 1/6/15 at 12:30 P.M. during an interview, Operating Room Tech 1 (ORT 1) stated, "I've been a scrub tech for 4 years. Counts are done to ensure that nothing is left behind inside a patient that could hamper recovery, cause damage and an infection. We count sponges at the initial count, if we add any during the procedure, when we close the cavity, when we close the skin, and at the end of the case. The final count needs to be complete before the patient leaves the O.R." ORT 1 further stated, "After the cavity count was done, I was still missing two lap sponges. I began looking for them and said out loud that I was missing two sponges while the patient [Patient 1] was still in the O.R. I was still searching for the two sponges when that patient [Patient 1] was moved to the PACU." ORT 1 continued and stated, "At the end of the case nobody stopped as I looked for the laps [sponges] and voiced multiple times and loud enough for everyone to hear 'I'm missing two laps."

On 1/5/14 at 2 P.M., during an interview, ORT 2 stated, "I've been an O.R. Tech for 15 years. I saw her [ORT 1] searching the room and trash after the case was done. She said she had lost 2 sponges. She said the count was correct but the sponge holder had two empty places in it. The count was 'incorrectly correct'. The count could not have been correct and the patient [Patient 1] should not have left the O.R. room if the count was not correct. The team should stay until the count is confirmed."

On 1/6/15 at 2 P.M., during an interview, the DSS stated, "The patient is not to leave the O.R. room until the counts are complete and correct. Unfortunately, that didn't happen in this case."

On 1/6/15 at 2:15 P.M. during an interview, Patient 1's Anesthesiologist (ANA) stated, "I listen for the count and then start the transition to move the patient. I only listen for one count then I concentrate on the patient and moving them. No one ever told me to stop."

On 1/6/15 at 2:30 P.M. during an interview, Patient 1's Surgeon (MD 1) stated, "I packed the bowel with two lap sponges early in the case. I examined everything, the uterus and fallopian tubes; everything looked okay except for the ectopic. It was a very routine case; she should've gone home after a couple of days."

On 1/6/15 at 3 P.M. during an interview, the second surgeon (MD 2) stated, "I was the surgeon for [Patient 1] on the second case. The nurse on the floor called me to report that the patient was complaining of acute increased abdominal pain. I ordered a CT of the abdomen (a specialized x-ray of the abdomen) and some lab work. She [Patient 1] was very sick, she had a severe infection and the CT revealed that there were likely two foreign bodies in her abdomen. I took her straight to surgery." MD 2 further stated, "In surgery I removed what appeared to be two lap sponges, and during an inspection of her abdominal cavity determined that the inflammatory process as a result of the foreign objects had done significant damage to nearby organs. I had to remove her ovaries, remaining fallopian tube, and uterus, a total hysterectomy."

During a Quality Assurance group interview on 3/11/15 at 2 P.M., the incident was reviewed with administrative staff, including the DSS, DRC, Chief Nurse Executive, and the Chief of Staff. According to administrative staff, the facility implemented a plan on 1/8/15, which included additional measures in the O.R. for sponge count verification.