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Based on interview and record review, the facility failed to inform the governing body about two contracted services. This deficient practice had the potential for the governing body to be unaware of how the contractors performed.

Findings:

A review of the "Performance Improvement and Patient Safety Program" approved 10/22/19, revealed the Performance Improvement and Patient Safety (PIPS) Committee is a joint hospital leadership and medical staff committee. The document indicated the PIPS Committee "...Annually reviews and approves hospital-wide performance measures, including the evaluation of performance by patient care services provided through contractual agreement...". The document also indicated the PIPS Committee "...Reports and forwards recommendations monthly to the Medical Executive Committee, Joint Conference Committee and the Health Commission (Governing Body) through the Chief Medical Officer and Chief Quality Officer...".

A review of the "Bylaws of the Governing Body," signed 3/20/18, revealed the Governing Body delegated authority to oversee quality assurance and the Performance Improvement and Patient Safety Program to the Joint Conference Committee for Quality Assurance (JCC).

A review of the PIPS Committee meeting minutes from 4/24/19 revealed there were no contracts discussed during the Respiratory Care Services department presentation. A review of the PIPS Committee meeting minutes from 8/28/19 revealed one of three van transport contracts was not discussed during the Care Coordination department presentation.

A review of one non-emergency van transportation contract, expiring 6/30/21, revealed performance measures were to be reported annually to the hospital's performance improvement committees. The contract indicated the performance measures were on-time performance rate and maintaining up-to-date insurance coverage. A review of a second non-emergency van transportation contract, expiring 6/30/21, revealed the performance measures were on-time performance and maintaining up-to-date insurance coverage.

During an interview on 3/3/20 at 2:12 p.m. with Risk Manager 1 (RM1), RM1 stated the hospital department that is responsible for a contract must report to the PIPS Committee on how the contract is doing.

During an interview on 3/3/20 at 2:51 p.m. with RM1, RM1 stated the expectation is the hospital department will include all contracts for which the department is responsible in its report to the PIPS Committee.

During an interview on 3/5/20 at 12:58 p.m. with the Manager of Quality Data Center (MQDC), Respiratory Therapy Director, and Director of Hospital Operations (DHO), the MQDC stated each hospital department that holds department-level contracts is responsible for tracking performance metrics for those contracts. The DHO stated the respiratory therapy department is not responsible for the industrial and medical gas contract, but was unable to state which department is responsible.

During an interview on 3/5/20 at 1:26 p.m. with the Critical Care Nursing Director (CCND), MQDC, and DHO, the CCND stated she and the Respiratory Therapy Director were both responsible for the industrial and medical gas contract. The MQDC and CCND confirmed there was no report to the PIPS Committee about the industrial and medical gas contract. The MQDC also stated there was no report to the PIPS Committee about one of three van transportation contracts.

During an interview on 3/5/20 at 2:13 p.m. with the Director of Social Services (DSS), MQDC, and DHO, the DSS confirmed one of three van transportation contracts was not discussed during the Care Coordination department presentation to the PIPS Committee. The DSS stated "it was my oversight." When asked if contractor metrics are reported to the PIPS Committee, the DSS stated the department only reports cost metrics. The DSS said on-time performance for van transportation contractors was not discussed with the PIPS Committee.

A review of the "Contracting: Patient Care Services" policy, approved 2/27/19, revealed "...All contracts performance measures will be monitored and evaluated annually by the [hospital] Performance Improvement and Patient Safety Committee...".

Based on interview and record review, the facility failed to maintain a complete and accurate list of contracted services. This deficient practice had the potential for the facility to be unaware of which contracted services were in effect.

Findings:

A review of a sample of eleven written contracts revealed one contract for industrial and medical gas, and three contracts for van transportation.

A review of the "2019 PIPS Contracts" revealed the industrial and medical gas contract, and one of three van transportation contracts were missing from the contracts list.

During an interview on 3/5/20 at 1:26 p.m. with the Manager of Quality Data Center (MQDC) and Director of Hospital Operations (DHO), the MQDC confirmed the industrial and medical gas contract was not on the 2019 PIPS Contracts List. The DHO confirmed the 2019 PIPS Contracts List was not complete.

Based on interview and record review, the facility failed to ensure patients were informed of their rights for four out of 31 sampled patients (Patients 3, 27, 4 and 31) when:
1. For Patient 23, the Terms and Conditions of Agreement (TCOA) for Emergency Services was not signed upon admission to the Emergency Department (ED) on 3/1/20.
2. (a) For Patient 27, there was no evidence the TCOA was obtained upon admission to the ED on 2/29/20.
(b) For Patients 4 and 31, there was no evidence of completion of TCOAs.
3. Patients 1 and 2, had a "Verbal Consent" handwritten entry and an eligibility staff signature in the TCOA form. Facility policy did not have any guidance for verbal consent signed by hospital staff as witness.
These deficient practices violated patient's rights to medical and financial information.


Definition:
Terms and Conditions of Admission, (TCOA) as define in the hospital's Policy and Procedures: is "a form to obtain and document each patient's consent to hospitalization and routine services and to document the patient's assumption of financial responsibility for payment of charges for services rendered."

Findings:

1. Review of the Patient Demographics document indicated Patient 23 presented to the Emergency Department (ED) on 3/1/20 at 12:25 PM. The ED Provider Notes (PNs) dated 3/1/20 for Patient 23 indicated the Neurologic examination showed "alert and oriented to person, place, and time exhibits normal muscle tone." The mental status examination indicated, "attentive", and "briskly interactive". Motor examination indicated, "normal tone, normal strength in both upper and lower extremities." The Clinical Impression section of the Provider Notes indicated, "dysarthria (difficulty in articulating words)" and headache, electronically signed and dated by the Physician on 3/1/20 at 12:45 PM.

During a concurrent interview and record review on 3/3/20, at 11:20 AM, with the Registered Nurse (RN) 1, the Terms and Conditions of Admission (TCOA) for Emergency Services dated 3/1/20, was reviewed. The TCOA indicated missing signature on the line that read: "Signature: Patient or Legal Representative". RN 1 acknowledged patient's signature was missing and stated the box was marked for "physically unable to sign".

During an interview on 3/3/20, at 2:30 PM, with the Eligibility Manager (EM) 1, EM 1 verified the TCOA was not signed by patient on 3/1/20, and explained that initially upon admission to the ED, patient may not be able to sign any forms. However, EM 1 stated staff should have followed up with the patient when his condition stabilized, to check if he could, and would be able to sign the TCOA. EM 1 stated staff were not documenting when they approached patient for signature(s) and acknowledged it was an "area for improvement."

Review of the facility Policy and Procedure titled Terms and Conditions for Admission with the last revised date of 1/19, indicated: "Purpose:... Procedure: 1. ... A. Obtaining Patient's Consent: 1. The Eligibility Worker will obtain the appropriate signature on the "Terms and Conditions of Admissions" form. When this is not possible... the Eligibility Worker will conduct the needed follow-up and obtain proper signature..."

2. Review of the Patient Demographics document indicated Patient 27 presented to the ED on 2/29/20 at 9:27 PM. ED Provider Notes dated 2/29/20, indicated a Neurological Examination as "alert oriented to person, place, and time".the Musculoskeletal Examination indicated, "normal range of motion" and the "Clinical Impression" section of the Provider Notes indicated "shortness of breath", electronically signed and dated by the Physician on 3/1/20 at 12:45 PM.

During a concurrent interview and record review on 3/4/20 at 3:45 PM, with the Risk Management Nurse (RMN) 1, RMN 1 searched the Electronic Health Record (EHR) and verified there was no evidence the TCOA was obtained for Patient 27 on her admission to the ED on 2/29/20.

During an interview on 3/5/20, at 9:10 AM, with EM, EM acknowledged the TCOA for Patient 27 was not obtained on 2/29/20. When asked why TCOA should be obtained for each patient encounter, EM stated the TCOA would give patients hospital information. It would let the patients know their "medical coverage" and would give information that was consistent with their care.

Review of the facility Policy and Procedure titled Terms and Conditions for Admission with the last revised date of 1/19, indicated: "Purpose: ... Procedure: 1. ... Length of Time "Terms and Conditions of Admission" Form is valid. 1...3. For Emergency Department visits... A new "Terms of Conditions of Admission" form must be signed for each Emergency Department visit..."








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2b. No evidence of completion of COAs for Patients 4 and Patient 31.
3. Patient 1 and Patient 2, had a "Verbal Consent" handwritten entry and an eligibility staff signature in the TCOA form. Facility policy did not have any guidance for verbal consent signed by hospital staff as witness.

Findings:

2b. Review of the "Patient Demographics" document indicated Patient 4 presented to the Emergency Department on 11/26/19 at 10:37 am with altered mental status after missing dialysis treatment for one week. Patient 4 was admitted and discharged home five days later on 12/1/19.

During a review on 3/4/20 at 9 am, of Patient 4's electronic medical record with the Registered Nurse Quality Management (RNQ), she could not find evidence the TCOA form had been scanned or completed.

2c. Review of the "Patient Demographics" document indicated Patient 31 presented to the Emergency Department on 11/26/19 at 11:45 PM with eye pain and possibly after having assaulted someone on the streets. Patient 31 was discharged from the ED at 6:02 am on 11/27/19.

During a 3/4/20 9:40 am review of Patient 31's electronic record with the RNQ, she could not find evidence the TCOA form had been scanned or completed.

3a. Review of the "Patient Demographics" document indicated Patient 1 presented to the Emergency Department on 11/26/19 at 12:44 PM transferred from another general acute care hospital, due to unknown trauma when he fell after drinking alcohol. A physician's entry on 11/26/19 at 15:49 indicated Patient 1 was interviewed and provided information. Patient 1 was admitted and discharged on 12/2/19.

During a 3/5/20 9:10 am review of the electronic record with the RNQ, the scanned TCOA form contained a handwritten "verbal consent" in the signature space for "Patient or Legal Representative". In the "Date Time Witness" space a signature from a hospital staff had been entered on "11/26/19 13:45" (1:45 PM).

3b. Review of the "Patient Demographics" document indicated Patient 2 presented to the Emergency Department on 11/26/19 at 1:21 PM due to elevated heart rate, pneumonia, sepsis. A physician's entry on 11/26/19 3:45 PM indicated Patient 2 was interviewed and provided information. Patient 2 was admitted and discharged on 11/30/19.

During a review on 3/5/20 at 9:10 am of the electronic record with the RNQ, the scanned TCOA from contained a handwritten "verbal consent" in the signature space for "Patient or Legal Representative". In the "Date Time Witness" space a signature from a hospital staff had been entered on "11/26/19 " with no time.


During an interview with the Eligibility Manager (EM) on 3/5/20 at 10:20 am, he stated that staff of his department has the responsibility to complete the TCOA form as part of the registration duties and "...Yes, it is important we complete the form because it provides the patient with information about rights and responsibilities...". When shown the missing evidence of completion of TCOAs for Patient 4 and Patient 31, EM acknowledged and stated "Yes, we need to improve this process...". When asked about policy and procedure for completion through "Verbal Consent" and of eligibility staff signing as witnesses, as in the case of Patient 1 and Patient 2, EM stated "Our policy does not describe a process...for entering verbal consent...I understand it is a problem of potential conflict of interest my staff is signing as witnesses...We should now look at our policy for improving...I agree with you one hundred percent..."


Record review of a facility policy titled, "Terms and Conditions of Admission" last revised in 1/19, indicated "Purpose:...to set forth a process for establishing the contractual relationship between [facility name] and its patients...I. General Guidelines A. Obtaining the Patient's Consent 1. The Eligibility Worker will obtain the appropriate signature on the [TCOA] form. When this is not possible due to the patient having an emergent condition and /or being unable to sign due to a lack of decision making capacity, the Eligibility Worker will conduct the needed follow-up and obtain proper signature...B. Timing of Signature. 1. the signature of the patient...should be obtained at the earliest possible opportunity...2. The date and time on the form should always be the date and time the form was actually signed..." The document did not make references to a patient's verbal consent and to eligibility worker/staff signing as a witness.

Based on interview and record review, the facility failed to track ongoing data for one quality assessment project. This deficient practice resulted in the facility being unaware of its current performance.

Findings:

During a concurrent interview and record review on 3/5/20 at 10 a.m. with the Associate Chief Medical Officer (ACMO), Patient Safety Officer (PSO) and the Director of Regulatory Affairs (DRA), the PSO presented a document "Hospital Wide Patient Safety Dashboard" for December 2019. On the document was a box containing metrics for the Central Line Insertion Practices (CLIP) form. The PSO stated the facility obtains data monthly to track provider compliance with filling out the CLIP form after placement of a central line (a plastic tube placed in a large vein in the body in order to provide treatment). The ACMO stated the facility chose the CLIP form project because it is a required quality improvement project. The ACMO stated the goal was 25% compliance with filling out the CLIP form. The document did not provide data beyond August 2019. The PSO stated the infection control department is responsible for collecting the CLIP form data. When asked for the CLIP form data from September 2019 and on, the PSO stated they would have to find it.

During an interview on 3/5/20 at 2:37 p.m. with the Director of Regulatory Affairs (DRA), the DRA stated the facility is not currently collecting data on the CLIP form project. The DRA stated the facility cannot collect all of the data electronically through the electronic health record system, so the infection control department is only collecting data for patients with suspected or confirmed central line infections. The DRA confirmed there was no data for the CLIP form project beyond August 2019.

Based on interview and record review, the facility failed to complete a root cause analysis (RCA, a method used to analyze adverse events, which focuses on identifying the underlying problems that increase the likelihood of errors) within the timeframe specified by its policy. This deficient practice resulted in a delay in creating a corrective action plan.

Findings:

During an interview on 3/4/20 at 11:32 a.m. with the Director of Risk Management (DRM), the DRM stated the RCA process involves reviewing facts, analyzing the adverse event, creating an action plan, and monitoring to see if the action plan works. For an adverse patient event in the Emergency Department from 1/9/20, the DRM stated staff has not completed the RCA yet.

A review of the "Sentinel Event Review Policy," approved 3/27/19, revealed "...The RCA and corrective action plan for a sentinel event shall be complete within 45 calendar days from the date [hospital] became aware of the event."

During an interview on 3/5/20 at 11:53 a.m. with the DRM, the DRM confirmed staff was still in the process of analyzing the Emergency Department patient adverse event from 1/9/20. The DRM confirmed the facility is beyond the 45 calendar days discussed in its policy.

Based on observation, interview, and record review, the facility failed to limit the duties of one category of staff members (Medical Evaluation Assistant) to the scope of practice allowed by the state of California. This deficient practice had the potential for staff to be performing activities not permitted by the state of California.

Findings:

During a concurrent observation and interview on 3/2/20 at 12:31 p.m. with the ED Nurse Director, the medical evaluation assistants were sitting at a desk near the entrance to the Emergency Department (ED). The ED Nurse Director stated medical evaluation assistants greet patients, create patient charts in the electronic medical record, and take vital signs (measurements of bodily function).

During an interview on 3/2/20 at 12:52 p.m. with the ED Nurse Director, the ED Nurse Director stated medical evaluation assistant duties include performing electrocardiograms (EKG, a test that records the electrical signals of the heart), taking vital signs, watching patients over ED video monitors, placing splints, and drawing blood.

During an interview on 3/3/20 at 9:52 a.m. with Medical Evaluation Assistant (MEA), the MEA stated her current job description includes performing blood draws and EKG's, obtaining vital signs, assisting patients with dressing and using the bathroom, and transporting patients and lab tests. The MEA stated medical evaluation assistants are allowed to place splints, and the hospital provides classes for them on how to place splints. The MEA stated the last time she placed a splint was several years ago because they are short-staffed. The MEA stated she completed schooling to be a medical assistant and has a Certified Phlebotomy I certificate. When asked if any other educational background or degree is required for the medical evaluation assistant position, the MEA stated no.

During an interview on 3/3/20 at 10:02 a.m. with ED Nurse Manager 1 and ED Nurse Manager 2, ED Nurse Manager 1 stated the medical evaluation assistants are allowed to place splints with appropriate training. ED Nurse Manager 2 stated a medical assistant license allows the medical evaluation assistants to place splints.

A review of "City and County of San Francisco - Medical Evaluations Assistant," revised 1/12/2017, revealed under "Minimum Qualifications" that staff are required to possess a recognized medical assistant degree or certificate and a valid Certified Phlebotomy Technician I Certificate from the state of California.

A review of "Frequently Asked Questions - Medical Assistants" from the Medical Board of California, undated, revealed "...Medical assistants are legally authorized only to remove casts, splints and other external devices. Placement of these devices does not fall within the medical assistant's scope of practice...".

A review of "California Certified Phlebotomy Technician I (CPT I) Certificate" from the California Department of Public Health, updated 2/6/20, revealed the certificate authorizes holders "...to do skin puncture and venipuncture [puncturing veins] blood collection" only.

During an interview on 3/4/20 at 9:20 a.m. with Risk Manager 1 (RM1), RM1 confirmed that it is not within the medical evaluation assistants' scope of practice to place splints.

During an interview on 3/4/20 at 1:16 p.m. with RM1, RM1 stated there was no facility policy on staff performing within their scope of practice.