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Based on interview and record review, the hospital failed to submit a detailed three year capital plan to the surveyors during the survey. The deficient practice eliminated accountability that such a plan existed, and had the potential to cause inadequate resources to be available for necessary capital expenses.

Findings:

Review of the documents provided by the hospital regarding budget and capital plan indicated they included revenues and expenses for the current year to date; an income statement, balance sheet, cash flow statement, and financial statistics and ratios for 2020-2022; a listing of total capital expenses for the hospital by year for 2019-2028 which did not include detailed line items; and a detailed listing of capital expenses for 2019. None of the documents detailed proposed capital expenditures for 2020 or 2021.

In an interview on 3/22/19 at 1:58 p.m., the Vice President of Quality and Safety (VPQS) stated he would work on locating a detailed plan of capital expenses. In an interview on 3/22/19 at approximately 2:20 p.m. the VPQS stated more detail regarding capital expenses was still pending. In an interview on 3/22/19 at 2:51 p.m., the VPQS stated he was not able to produce a detailed capital plan for 2020 and 2021 in the time remaining for the survey.

Based on interview and record review, the hospital failed to maintain a policy regarding emergencies at off-campus departments that both reflected a recent relocation to a new main hospital building and provided for assessment, initial treatment, and referral consistent with the resources available at the off-campus location in addition to calling 911. The deficient practices had the potential to create ambiguity surrounding the hospital's obligations in emergencies, and sidestepped regulatory expectations that off-campus hospital departments participate in the initial phases of emergency care as their resources allow.

Findings:

Review of the hospital's state license (effective 3/2/19) indicated it permitted operation of a hospital at "Van Ness Campus". The approved services for the Van Ness Campus hospital included outpatient services at 25 other locations in San Francisco.

Review of the hospital's "Policy - Medical Emergencies on the Pacific, Davies, St. Luke's and California Campuses and in Outpatient Clinics and Departments Not Contiguous with the Main Campus (EMTALA) [Emergency Medical Treatment and Active Labor Act]" (revised 4/26/16) indicated the policy did not include the Van Ness campus in its listing of "Hospital and Off-Site Locations". Review of the policy indicated individual requests for treatment of an emergency medical condition that were not life threatening emergencies would be handled by calling 911 at the outpatient clinics located at 2100 Webster Street, 3698 California Street, 3838 California Street, 1625 Van Ness Avenue, and 1375 Sutter Street. Comparison of the policy to the hospital license indicated each of these locations hosted licensed hospital departments.

In an interview on 3/21/19 at 1:10 p.m., the Accreditation Consultant acknowledged the EMTALA policy was out of date when the surveyor asked about the Van Ness Campus. She stated the staff at outpatient clinics would assess registered patients, and would call 911 for anyone else.

Based on interview and record review, the facility failed to implement its policy and procedure on patient registration and admitting, informing patient's representatives regarding patients' rights and consent for treatment, for two of three sampled pediatric patients Patient 26 and Patient 2 when:

The signatures in the "Conditions of Admission and /or Registration" form for Patient 26 and Patient 2, did not identify names and relationship to the patients.

Failure to complete a legal agreement that affects patient's rights and provides information about the facility could impact the exercise of those rights.


Definitions:


Conditions of Admission (COA) Form is a document required by facilities for patients or patient's representatives to sign that constitutes a contract between the hospital and the patient. COAs typically outline the patient's obligations with respect to the hospital services they receive, consent for treatment, patient's rights and responsibilities, etc.

Patient's/Personal Representative: According to HHS.org, a website for the US Department of Health and Human Services at https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/personal-representatives/index.html; last checked on 3/26/19, indicated " ...For unemacipated minors, a parent, guardian, or other person acting in loco parentis (collectively, "parent") is the personal representative of the minor child and can exercise the minor's rights with respect to protected health information, because the parent usually has the authority to make health care decisions about his or her minor child ..."

Findings:

1.Patient 26, a two-month old patient, was admitted on 3/12/19, with diagnosis of acute bronchitis (An inflammation of the bronchial tubes, the airways that carry air to the lungs. It causes a cough that often brings up mucus. It can also cause shortness of breath, wheezing, a low fever, and chest tightness. In children, acute bronchitis usually occurs in association with a respiratory tract infection caused by virus).


During an observation on 3/18/19 1:06 PM in the 7th floor pediatric unit, Patient 26's room door was closed and had a sign on the door frame indicating "Contact Precautions- Droplet Precautions ..." The Nurse Manager, (NM 1) stated "Yes, our rooms are single rooms and parents are allowed to stay as they are the legal patient representatives ..."


During a review of the electronic record for Patient 26, the "Conditions of Admissions and /or Registration", a six pages scanned form, indicated " ...Upload on 3/13/2019 at 9:35 AM". The form included a statement on page 1 "Please review these Conditions of Admission/Registration carefully. This is a legal agreement that affects your rights and provides important information about [Facility name-location GACH]." Other information included: "Consent for Treatment ...Legal Relationship between Hospital and Physicians ...Patient Rights and Responsibilities ...Patient's Personal Property ..."


Page 2 of the COA, indicated "I have read the foregoing and I consent to treatment as described in the above Conditions of Admission/ Registration". An unreadable scribble like signature was dated "3/13/2019 09:35 AM". A box for "Name of Legal Representative" had no entries. A box for "If signed by someone other than the patient, please indicate your relationship to the patient", had no entries.


Review of a facility policy with last revision date of 1/31/19 and titled "Admitting", indicated "Conditions of Admission/ Registration: The registrar obtains the patient's signature on the consent form also known as the Conditions ...Registrars will visit the patient's room each day in order to obtain a signature ...". The document did not refer to a procedure in the case of pediatric patients.


2. Patient 2, a 4-year-old patient, was admitted on 3/19/19 with a diagnosis of bilateral strabismus (a condition in which the eyes do not properly align with each other when looking at an object). Surgical procedure - Bilateral Strabismus Repair (a surgery on the extraocular muscles to correct the misalignment of the eyes) was recommended and performed on 3/19/19.


During review of the electronic medical record of Patient 2 on 3/20/19 at 2:00 PM, the "Conditions of Admission and/or Registration" indicated on page 2 of 6, an unreadable black ink scribble was dated, "3/19/2019 06:33 AM". The box allocated for the "Name of Legal Representative:" was left blank. The box for "If signed by someone other than the patient, please indicate your relationship to the patient" was also left blank.
In concurrent interview with CNS 2, there was no answer given why the form was not complete.


During an interview with the Admissions Regional Manager (ARM) on 3/21/19 9:30 AM, she stated "Yes, the COA is a legal document that informs patients or their legal representative about patient's rights, financial responsibilities, etc ...And in the case of pediatric unemancipated minors we have the parent sign the form ..." After reviewing a printed copy of the COAs for Patient 26, ARM added "I don't know what happened, but yes, it is not completed, it should have the name of the person that signed it and state the relationship with the patient ..." When shown a copy of the facility policy "Admitting", ARM stated "You are right, it does not describe our procedure for pediatric patients ..."

Based on observation, interview, and record review, the facility did not ensure privacy for one of the 47 sampled residents while doing a procedure inside the patient's room.

The deficient practice had the potential for unnecessary exposure of the patient's body parts which can negatively affect patient's dignity and self-esteem.

Findings:

During an observation on the unit on 3/19/19 at 10:30 AM, in the hallway, Patient 47's door was open, no curtain drawn, he was lying on his bed with head elevated and his chest exposed while Staff 1 was looking at the monitor of the cardiac equipment.

During an interview with Staff 1 on 3/19/19 at 11:10 AM, she stated that before starting the procedure the patient should have been provided privacy by drawing the curtain. She further stated that if the patients are exposed they will feel vulnerable.

A review of the hospital's policy and procedure titled "Policy-Echocardiography (a test to visualize the heart's structure) Operational Guidelines" dated 6/1/2015, indicated " ...1. Examinations shall be performed in a setting providing reasonable patient comfort and privacy ...B. Patient privacy should be assured with the use of either appropriate curtains or doors...."

Based on observation, interview and document review, the facility failed to safeguard the contents of a hospitalized patient's electronic medical record from unauthorized disclosure for one of 47 sampled patients (Patient 41). This failure resulted in public exposure of the patient's confidential protected health information which was viewed by individuals whose access was not required for this patient's treatment, payment for care, or hospital operations in support of treatment or payment for care.

Findings:

On 3/18/19 at 11:20 a.m. while conducting rounds of the hospital's floors for health information privacy and security compliance, staff RN4 was found to have left her workstation on the Transplant Unit (10 West) without badging out. This failure left an electronic medical record screen containing Patient 41's protected health information visible in a public access corridor for at least two minutes. Patient 41's confidential information was viewed by three individuals with no connection to this patient and potentially additional such individuals prior to the arrival of the group conducting rounds.

This terminal and the other outfacing terminals observed during rounds of the hospital's care units did not have computer privacy screens (accessory used to reduce the viewing angle of a computer monitor).

At 11:22 a.m. when staff RN4 returned to her workstation, she was asked how long her screen remains up prior to activation of automatic log off. She responded "Oh, I don't know, 15 seconds?"

Staff RN4's manager (RNM) was then informed of this finding. He responded "She left her screen up?!"

On 3/19/19 at 11:30 a.m. in a one-to-one interview with this Transplant Unit nurse manager (RNM) he reported that the terminals on his unit require the user to badge in for access and badge out when leaving the workstation. RNM further stated that he does have sufficient access to badge out an absent staff member should he discover a screen display of protected health information left up. RNM's understanding is that an abandoned workstation screen can remain active for up to 15 minutes before timing out.

In a telephone interview on 3/20/19 at 9:15 a.m. with the facility's Information Security Officer (ISO) who works remotely, he reported that in areas of the hospital with thin client terminals (network computers without a hard disk drive) the user is required to badge in and out, as opposed to locking the screen when leaving the terminal. When asked about the total number of outfacing terminals at the main facility, the ISO responded there are a total of 128.

The hospital's "Confidentiality" policy and procedure last revised 1/1/2004 requires all employees complete a "Confidentiality Agreement." Signing this agreement is a condition of continued employment. "Failure to adhere to this policy and/or violation of the Confidentiality Agreement, including, but not limited to, violation of patient privacy and confidentiality...may result in severe disciplinary action, up to and including termination."

A Course Completion Report off the facility's learning management system showed that staff RN4 completed her "Workforce Confidentiality and Privacy Acknowledgement" on 1/23/18.

The hospital's "Workstation and End Point Device Security" policy and procedure states that idle timeouts on Workstations and End Point Devices (thin clients) are implemented to automatically log staff off after 15 minutes of inactivity.

Based on record review and interview with a staff, the facility failed to ensure current order is in place for one of 47 sampled patients (Patient 14) when restraints (measures to limit an individual's movement) were implemented without a physician's order.

This deficient practice posed a risk of carrying out inappropriate restrictions of patient's movement.

Findings:

During a concurrent record review and interview with CNS (Clinical Nurse Specialist) 2 on 3/21/19 at 1:52 PM, Patient 14 had a bilateral soft restraints applied on his left and right wrists for pulling his lines and tubes on 2/26/19 at 8 AM. The restraints were discontinued on 2/27/19 at 8 AM. There was no physician's order in place within those hours restraints were implemented. CNS 2 stated she did not find a physician's order for the restraints.

During a review on Patient 14's flowsheets dated 2/26/19 at 8AM, Patient 14 had a soft restraint in place until 2/27/19.

A review of hospital's policy and procedure titled "Policy- Restraint Management: Non Violent Restraints (Non-Behavioral), Violent Restraints (Behavioral), & Seclusion" dated 11/15/18, indicated " ... the staff member has no authority to reinstitute the intervention without a new order ...."

Based on interview and record review, the hospital's quality program failed to separately track drug incompatibilities in its routine pharmacy quality reports and tracked drug incompatibilities in ad hoc reports instead. The deficient practice had the potential to cause problem-prone practices related to drug incompatibilities to go unrecognized and unchanged for future patients.

Findings:

Review of the hospital's "Quarterly Medication Errors Report" and "Quarterly ADR [adverse drug reactions] Report" (both dated 4th quarter 2018) indicated neither report mentioned drug incompatibilities.

In an interview on 3/21/19 at 9:26 a.m., the Vice President of Quality and Safety (VPQS) stated the pharmacist tracked medication errors, but he had not seen a report regarding drug incompatibility. In an interview on 3/21/19 at 12:55 p.m., the VPQS stated he had created a report listing drug-drug interactions and could provide follow-up to any of the listed events.

Review of the undated report provided by the VPQS indicated there had been eleven incidents of drug-drug interactions with dates ranging from 7/16/17 to 3/20/19.

Based on observation, interview, and record review, the hospital failed to ensure 2 of 10 sampled credentials files (Providers 3 and 10) had accurate data regarding the quality of the providers' work at the time of reappointment. The deficient practice had the potential to cause decisions regarding medical staff and allied health practitioner competence to be made based on inaccurate information , thereby creating the potential for poor quality care to go unnoticed and unchanged for future patients.

Findings:

1. Review of Provider 3's credentials file indicated he was reappointed to the hospital's medical staff for a two-year term on 8/1/18. A quality profile dated 5/16/18 indicated Provider 3 had 0.01% minor discrepancies identified on peer review (when another doctor reviews a doctor's work) during the period July 2017 to December 2017. The profile indicated 609 "Peer Reviews Performed Last 6 Months", but did not specify whether those 609 reviews were reviews of Provider 3 or reviews by Provider 3.

Review of a "RADPEER [brand name of a peer review system offered by American College of Radiology] Individual Physician Report" dated 2/8/18 indicated during the time period 7/6/17 to 1/2/18, Provider 3 had performed peer review on 609 cases, 262 of Provider 3's cases had been reviewed, and Provider 3 had 0.76% minor discrepancies (2 cases out of 262).

In an interview on 3/19/19 at 1:56 p.m., the Statit (a brand of software used for performance data) Coordinator (SC) confirmed the RADPEER report for 7/6/17 to 1/2/18 was the source of the data on Provider 3's quality profile. When the surveyor asked why the minor discrepancy rate on the RADPEER report (0.76%) was higher than the minor discrepancy rate on the quality profile (0.01%), the SC replied that the surveyor had found a technical flaw in the quality profile.

2. Review of Provider 10's credentials file indicated she was a certified nurse midwife reappointed to the hospital's allied health professional staff for a two-year term on 8/1/17. Provider 10's file contained a quality profile dated 6/8/17 which indicated there had been no practice based learning conferences regarding Provider 10 from June 2015 through June 2017. No other documentation was present in the file indicating there had been any peer review activity regarding Provider 10.

In an interview on 3/19/19 at 9:52 a.m., the SC stated the practice based learning performance indicator on the quality profile was no longer being used. When the surveyor asked how the hospital knew whether there had been any peer review activity and what the results of the peer reviews were, the Director of Medical Staff Services (DMSS) stated peer review activity was tracked in the MIDAS system (a brand of database used to track health care quality data). The DMSS stated at the time of reappointment, the credentialers ran MIDAS reports; if there was peer review activity, the report was placed in the credentials file; if there was no peer review activity, the report was not filed. The DMSS stated the absence of a MIDAS report in the credentials file meant there had been no peer review activity.

In an observation and interview on 3/20/19 at 11:10 a.m., the SC queried the MIDAS system regarding Provider 10 for the dates 8/1/15 through 7/31/17 and found reports of peer review activity. The Manager of Medical Staff Services acknowledged the reports found by the SC were not in Provider 10's file.

Review of a "PHYSICIAN REAPPOINTMENT REPORT" dated 3/20/19 provided by the SC indicated Provider 10 had cases peer reviewed with dates of service 11/29/15, 8/7/16, and 3/21/17. The report indicated a committee determined on 5/17/17 that there was an opportunity for improvement in the care provided for date of service 3/21/17.

Based on interview and record review, in 1 of 10 sampled credentials files (Provider 7), the hospital failed to check the medical board database for the presence of adverse peer review reports ("805 reports", named after the section number of the law that requires them) at the time of reappointment as required by state law. The deficient practice had the potential to cause reappointment decisions to be made with incomplete information regarding the provider's competence.

Findings:

Review of the California Business and Professions Code, section 805.5(a) indicated, "Prior to granting or renewing staff privileges for any physician and surgeon, psychologist, podiatrist, or dentist, any health facility licensed pursuant to Division 2 (commencing with Section 1200) of the Health and Safety Code, any health care service plan or medical care foundation, the medical staff of the institution, a facility certified to participate in the federal Medicare Program as an ambulatory surgical center, or an outpatient setting accredited pursuant to Section 1248.1 of the Health and Safety Code shall request a report from the Medical Board of California, the Board of Psychology, the California Board of Podiatric Medicine, the Osteopathic Medical Board of California, or the Dental Board of California to determine if any report has been made pursuant to Section 805 indicating that the applying physician and surgeon, psychologist, podiatrist, or dentist has been denied staff privileges, been removed from a medical staff, or had his or her staff privileges restricted as provided in Section 805."

Review of Provider 7's credentials file indicated he was reappointed to the hospitals's medical staff on 8/1/17 for a two-year term. No information was present in the paper credentials file indicating that the facility had checked the medical board database for 805 reports regarding Provider 7. Review of an undated screen printout from the hospital's credentialing database indicated Provider 7's medical license was verified on 5/11/15 and again on 3/21/17. No more recent license verification was present. The details of the 3/21/17 license verification did not include any notation that staff had checked for the presence or absence of 805 reports regarding Provider 7.

In an interview on 3/20/19 at 9:35 a.m., the Manager of Medical Staff Services stated there had not been an 805 check regarding Provider 7 in 2017.

Based on interview and record review, the hospital failed to include provisions in its medical staff bylaws regarding voting by the medical staff whether to accept or reject a unified medical staff across separately certified hospitals. The deficient practice eliminated clearly defined mechanisms for the medical staff to exercise rights afforded to them by federal regulations.

Findings:

Review of hospital listings in ASPEN Central Office, a database used by CMS (Centers for Medicare & Medicaid Services) to track regulatory activity at CMS certified facilities, indicated there were separate CMS certifications for "California Pacific Medical Center [CPMC] - Van Ness Campus", "California Pacific Medical Center - Davies Campus Hosp[ital]", and "California Pacific Medical Center - Mission Bernal". Review of the "CPMC Medical Staff Bylaws" (5/16/18) indicated the bylaws did not differentiate between the three hospitals, and did not address mechanisms by which the medical staff could vote to accept or reject a unified medical staff across the separately certified hospitals. "ARTICLE XII - Amendments to the Bylaws" indicated amendments had to be approved by the Bylaws Committee and the Medical Executive Committee before being voted on by the medical staff. The bylaws indicated amendments were not effective unless approved by the governing body, but the governing body could not "unreasonably" withhold its approval, and would therefore have to state its reasons for withholding approval. Article XII did not specifically address voting to opt in or opt out of a unified medical staff structure.

In an interview on 3/18/19 at 12:42 p.m., the Chief Medical Executive (CME) stated CPMC consisted of three campuses: Van Ness, Davies, and Mission Bernal. He stated the three campuses each had separate Medicare certifications, but had one unified medical staff. The CME stated the Van Ness campus had recently located from the previous Pacific Campus. He stated the medical staffs of the California and Pacific campuses had merged in the mid 1990's, the Davies medical staff had merged with California/Pacific in the early 2000's, and the Mission Bernal (previously known as Saint Luke's) medical staff had merged in January, 2018. The CME stated the medical staffs of Saint Luke's and "Cal/Pac/Davies" had each voted to approve the merger with Saint Luke's, but he did not know how the medical staff would opt out of the unified medical staff structure in the future. The CME stated it would be difficult at this point to define what constituted the medical staff of each separately certified hospital for purposes of voting since there were very few medical staff who only practiced at one of them.

Review of an e-mail from the Deputy General Counsel (DGC) to the Director of Accreditation & Licensure dated 3/18/19 indicated the DGC had interpreted the option to opt out of the unified medical staff structure as "at the time of election and not an ongoing obligation". The e-mail also indicated, however, that the DGC felt the right to opt out was addressed in the bylaws provisions regarding amendments in general.

Based on interview and record review, the hospital failed to have a mechanism of notifying members of its medical staff, both at initial appointment and at reappointment, of their right to opt out of a unified medical staff structure across separately certified hospitals. The deficient practice had the potential to cause medical staff members to be unaware of their rights.

Findings:

Review of hospital listings in ASPEN Central Office, a database used by CMS (Centers for Medicare & Medicaid Services) to track regulatory activity at CMS certified facilities, indicated there were separate CMS certifications for "California Pacific Medical Center [CPMC] - Van Ness Campus", "California Pacific Medical Center - Davies Campus Hosp[ital]", and "California Pacific Medical Center - Mission Bernal". Review of the "CPMC Medical Staff Bylaws" (5/16/18) and the "Medical Staff Rules & Regulations" (5/16/18) indicated neither document addressed periodic notification to individual members of the medical staff of their right to vote to accept or reject a unified medical staff across the separately certified hospitals.

In an interview on 3/18/19 at 12:42 p.m., the Chief Medical Executive (CME) stated CPMC consisted of three campuses: Van Ness, Davies, and Mission Bernal. He stated the three campuses each had separate Medicare certifications, but had one unified medical staff. The CME stated the medical staffs had voted to merge at different times for each campus, but he did not think there had been a statement to the medical staff regarding their right to opt out of the unified medical staff structure in the future.

Review of an e-mail from the Deputy General Counsel (DGC) to the Director of Accreditation & Licensure dated 3/18/19 indicated the DGC had interpreted the option to opt out of the unified medical staff structure as "at the time of election and not an ongoing obligation". The e-mail also indicated, however, that the DGC felt the right to opt out was addressed in the bylaws provisions regarding amendments in general.

Based on interview and record review, the hospital failed to maintain policies addressing the process by which members of its unified medical staff could raise concerns specific to each separately certified hospital, and how such concerns would be considered. The deficient practice had the potential to cause local concerns to receive inadequate attention.

Findings:

Review of hospital listings in ASPEN Central Office, a database used by CMS (Centers for Medicare & Medicaid Services) to track regulatory activity at CMS certified facilities, indicated there were separate CMS certifications for "California Pacific Medical Center [CPMC] - Van Ness Campus", "California Pacific Medical Center - Davies Campus Hosp[ital]", and "California Pacific Medical Center - Mission Bernal".

Review of the "CPMC Medical Staff Bylaws" (5/16/18) and the "Medical Staff Rules & Regulations" (5/16/18) indicated neither document addressed either a process by which medical staff from separately certified hospitals within the unified medical staff could raise concerns or the mechanism by which such concerns would be addressed.

In an interview on 3/18/19 at 12:42 p.m., the Chief Medical Executive (CME) stated CPMC consisted of three campuses: Van Ness, Davies, and Mission Bernal. He stated the three campuses each had separate Medicare certifications, but had one unified medical staff. The CME stated the hospital had the same policies in effect at each campus and there were no unique needs at the different campuses.

Based on record review and interview, the facility failed to develop a care plan for two of 47 sampled patients (Patient 11, Patient 15) that reflected the current patient needs assessment when:

1. there was no care plan for anticoagulant therapy for Patient 11 who was on Heparin (a blood thinner drug that can cause bleeding) injection and

2.Norco (a controlled drug containing narcotic) was administered to Patient 15 with undocumented pain location.

The deficient practice had a potential to pose a risk of not providing appropriate, consistent and individualized care to the patients.

Findings:

1. During a concurrent record review and interview with RN (Registered Nurse) 9 on 3/20/19 at 1:10 PM, Patient 11 has an electronic physicians order dated 3/16/19 for heparin injection 5,000 units. The hospital staff stated that there was no care plan initiated for the anticoagulant (drugs that prevents blood clot) use for Patient 11.

During a review of Patient's 11's medication administration record dated 3/16 /19, indicated "Heparin Inj.(injection) 5,000 Units Dose: 5,000 Freq (frequency): Q12H (every 12 hours) Route: SC (subcutaneous-under the skin) Start: 03/16/19 1145."

A review of the hospital's policy and procedure titled "Policy- High Risk Medications" dated 1/30/2017, indicated the CPMC (California Pacific Medical Center) high risk medication list includes: Heparin (excluding flushes) ...."

A review of hospital's policy and procedure titled "Policy- Patient Plan of Care" dated 4/26/2016, indicated " ...Each patient will have a plan of care that is appropriate to his/her specific assessed needs ... It is the patient's plan-the centralized plan that drives the priorities and professional processes of care for the inter-professional team to prevent/manage/minimize potential problems and outcomes."

2. During a concurrent record review and interview with CNS (Clinical Nurse Specialist) 2 on 3/22/2019 at 9:45 AM, Patient 15's electronic physician's record dated 3/14/2019 at 4:11 PM, indicated hydrocodone/acetaminophen (Norco 5) 5 mg/325 1 tab every 8 hours by mouth as needed for pain. She also has a medication ordered on 3/14/2019 for tramadol (ultram) 50 mg 1 tab every 6 hours
by mouth as needed for breakthrough pain.

During an interview with Patient 15 on 3/19/19 at 9:15 AM, she stated that she has pain on her leg that does not go away. She stated that there were no other interventions being done except for the pain pills. She added that a massage would help to relieve the pain.

During a review of Patient 15's electronic medication administration dated 3/20/19 at 9:23 AM, patient was given Norco 5 for undocumented pain location. Patient 15 complained of pain at 1:45 PM and she was given a tramadol for undocumented pain location. She was given again Norco 5 at 7:37 PM for documented right leg pain.

A review of hospital's policy and procedure titled "Policy- Pain Management" dated 2/21/19, indicated " ...Planning 1. The patient experiencing pain should have pain treatment plan developed and based on: 1. Clinical condition, b. History (including a history of chronic pain and chronic analgesic use); and c. Pain management goals. The pain management treatment plan should be a stepwise approach and include: a. Non-pharmacologic pain treatment strategies as a firs line approach or in combination with pharmacologic treatment ...."

Based on observation, interview, and record review, the hospital failed to administer medications in accordance to professional standards of practice and hospital policy and procedures when:

1. The hospital nurses did not rotate the site for injection for 2 of 2 patients (Patient 16, Patient 17) on subcutaneous (SC-injection given under the skin) Heparin (blood thinner). This failure increases the risk for an adverse reaction to Heparin;

2. Three out of seven as-needed pain medication administrations for Patient 21 did not have documented pain assessment at or around the time of administration and subsequent pain re-assessment. This failure may result in inadequate pain assessment for the patient;

3. The hospital nursing staff deviated from the insulin (medication to treat high blood glucose) infusion protocol (formal set of rules and procedures to be followed during a particular course of treatment) during the administration for two of three patients (Patients 34 and 35) receiving insulin infusion. This had the potential for medication errors that could result in hypo/hyperglycemia (too low or high blood glucose) for patients;

4. The hospital nursing staff did not titrate (increase or decrease medication dose in response to the patient's clinical status) the infusion of propofol (medication for induction and maintenance of anesthesia or sedation) as ordered by the physician for one of three patients (Patient 37) receiving propofol infusion. This had the potential for patients to be overly sedated from the effects of the medication.

5. The hospital failed to ensure that a medication was prepared in accordance with accepted standards of practice when an unlabeled syringe containing a white-colored liquid was found inside the drawer of the anesthesia cart in Operating Room (OR 3) located at the Pacific Campus on 3/19/19.

Findings:

1. A review on 03/19/19 of the online Lippincott Procedures for subcutaneous injections indicated, "Subcutaneous injections...For subcutaneous injections administered repeatedly...rotate sites. Choose one injection site in one area, move to a corresponding injection site in the next area, and so on. When returning to an area, choose a new site in that area..."

A review on 03/19/19 of the Heparin manufacture's insert indicated, "Deep Subcutaneous Injection...A different site should be used for each injection to prevent the development of massive hematoma ... "

During an observation on 3/19/19 at 9:30 AM, Registered Nurse 1 (RN 1) injected Heparin subcutaneously into Patient 16's left arm. Before the injection RN 1 did not check where the previous injection was administered. After the injection, she did not document that she had injected Patient 16's left arm.

A review on 3/19/19 of Patient 16's clinical record indicated that Patient 16 had physician's orders on 3/8/19 for Heparin 5,000 units every 12 hours to prevent blood clots. The record also indicated the nurses had injected the Heparin in the following location and the following dates and times:
*3/19/19 morning Heparin dose-No documented site
*3/18/19 evening Heparin dose-No documented site
*3/18/19 morning Heparin dose-No documented site
*3/17/19 evening Heparin dose-No documented site
*3/17/19 morning Heparin dose-No documented site
*3/16/19 evening Heparin dose-No documented site
*3/16/19 morning Heparin dose-Abdominal Tissue
*3/15/19 evening Heparin dose-No documented site
*3/15/19 morning Heparin dose-injected Abdomen Left Lower Quadrant

The above indicated that there were multiple examples of undocumented area of injection site for Heparin. When the nurses do not check the prior area of injection before administering Heparin it would be unknown if they were rotating the injection site.

A review on 3/20/19 of Patient 17's clinical record indicated that Patient 17 had physician's orders on 3/16/19 for Heparin 5,000 units every 12 hours to prevent blood clots. The record also indicated the nurses had injected the Heparin in the following location and the following dates and times:
*3/19/19 morning Heparin dose-injected Abdomen Left Lower Quadrant
*3/18/19 evening Heparin dose-injected Arm Left Upper
*3/18/19 morning Heparin dose-No documented site
*3/17/19 evening Heparin dose-No documented site
*3/17/19 morning Heparin dose-No documented site
*3/16/19 evening Heparin dose-No documented site
*3/16/19 morning Heparin dose-No documented site

The above indicated that further clinical record review of Heparin indicated that Patient 17's nurses did not consistently document the site of injection when administering subcutaneous Heparin.

During an interview on 3/20/19 at 9:13 AM, the Pharmacy Manager 1 stated that he was not aware that the nurses may not be rotating the subcutaneous injection site because of the missing documentation. He also stated that he would educate and take necessary action to ensure that subcutaneous injections were rotated.



27000

2. During a medication observation on 3/19/19 at 8:44 a.m. with Registered Nurse 6 (RN 6) and the assistant Chief Nursing Executive (CNE), Patient 21 complained she had a pain level of 8 out of 10 (scoring range, 0-10; 0 = no pain, 10 = worst pain possible).

On 3/19/19 at 10:36 a.m., a review of Patient 21's clinical record with CNE and RN 7 revealed she was admitted to the hospital for a cardiac arrest (abrupt loss of heart function, breathing, and consciousness).

Patient 21's clinical record showed two pain medication orders: Tramadol 50 mg 1 tablet every 6 hours as needed for breakthrough pain, dated 3/14/19; and Norco 5/325 mg 1 tablet every 8 hours as needed for pain, dated 3/18/19.

The medication administration record showed the following administrations:

- Tramadol: 3/17/19 at 4:09 a.m., 10:48 a.m.; and 9:08 p.m.; 3/18/19 at 3:52 a.m. and 9:12 p.m.

- Norco: 3/18/19 at 6:49 p.m., and 3/19/19 at 5:47 a.m.

The above showed seven as-needed pain medication administrations, but three did not have documented reason (such as pain assessment or pain level); and they did not have the subsequent pain re-assessment. These were the administration on 3/17/19 at 9:08 a.m.; and 3/18/19 at 3:52 a.m. and 6:49 p.m. RN 7 said there should be documented pain assessment at around the time of administration and re-assessment within 1 hour of oral medication administration. Both RN 7 and CNE confirmed the finding.

The hospital's "Pain Management" policy, revised 2/21/19, indicated, "Pain is treated in accordance with the plan based on an assessment.... Reassessment of pain... should be documented within 1 hour of intervention."

3a. The hospital identified insulin as one of the high risk medications (drugs that bear a heightened risk of causing significant patient harm when they are used in error).

On 3/20/19 at 9:17 a.m., a review of Patient 34's clinical record with Clinical Nurse Specialist 3 (CNS 3), Pharmacist 1, and the Director of Pharmacy (DOP) revealed he was admitted to the hospital for low oxygen in the blood and acute respiratory (breathing) failure.

On 3/10/19 at 11:58 a.m., the patient had a physician order for insulin infusion (drip) per the DKA (diabetic ketoacidosis) protocol. The order indicated to start the infusion at a certain prescribed rate, then titrate (go up or down) the rate based on the patient's hourly blood glucose (BG) reading.

The insulin administration record showed insulin infusion was started on 3/10/19 at 2:11 p.m. at the prescribed drip rate of 7.71 milliliters (ml) per hour; the BG was 441 mg/dL (milligrams per deciliter, unit of measurement). The goal BG was 150 - 250 mg/dL. Approximately 4 hours later, at 6:38 p.m., the patient's BG went down to 224 mg/dL, the protocol indicated to decrease the drip rate by 50%. The administration record showed the staff reduced by 55% instead of 50% as indicated by protocol. The resultant drip rate was 3.5 ml/hour, instead of 3.85 ml/hour (50% of 7.71 ml/hour). CNS 3 and the pharmacists could not find any documented reason why the drip was administered different from the prescribed protocol. There was no additional physician order to decrease more than that indicated by the protocol.

3b. On 3/20/19 at 9:50 a.m., a review of Patient 35's clinical record with CNS 3, Pharmacist 1, and DOP revealed the patient was admitted for a heart surgical procedure. On 3/15/19 at 11:55 a.m., she had a physician order for insulin infusion via the General Medicine Insulin Regular IV Drip Protocol. The goal BG was 120 to 180 mg/dL.

The administration record showed the Operating Room started the insulin drip during the procedure, and it was continued when the patient arrived in the Intensive Care Unit (ICU) on 3/15/19 at 12 p.m., with the insulin drip rate at 2 units/hour. The protocol was carried out for several hours, and the drip rate was titrated up to 8 units/hour per protocol. At 4 p.m. (on 3/15/19), the patient's BG was at 201 mg/dL; the protocol indicated to give 7.5 units/hour, but the administration record showed the nursing staff maintained it at 8 units/hour.

There was no physician order to give different from the prescribed protocol. CNS 3 said she could not find the reason why the protocol was deviated.

During a follow up interview on 3/21/19 at 10:40 a.m., CNS 3 said she discussed the findings with the involved nurses. Patient 34's nurse said she made a calculating error; and Patient 35's nurse said she saw the patient's BG level kept going up, so she decided to give 8 units/hour instead of 7.5 units/hour as per protocol. CNS 3 acknowledged the insulin drip for Patients 34 and 35 was not completely given as per prescribed protocol.

The hospital's "Medication Administration and Safe Practices" policy and procedures, revised 1/18/19, indicated the hospital established the standardized Medication Administration Process (MAP) to ensure safe and accurate medication administration, that "variability in the process results in medication errors."

4. On 3/20/19 at 11:40 a.m., a review of Patient 37's clinical record with RN 8, Pharmacist 3, and DOP revealed he was admitted to the hospital for diagnoses including heart failure and coronary artery disease (a condition where the major blood vessels supplying the heart are narrowed).

The clinical record showed the patient was intubated (placement of flexible plastic tube into the windpipe to maintain an open airway) and had a physician order for propofol via intravenous infusion to maintain sedation on 3/11/19 at 6:53 p.m., as follows:

Propofol Drip
- Starting dose: 5 mcg/kg/min (micrograms per kilogram per minute)
- Titrate by 5 mcg/kg/min every 5 minutes
- Goal: Maintain RASS Scale Score 0 to minus 1 (-1)
- Maximum dose: 50 mcg/kg/min

RASS: Richmond Agitation Sedation Score is a validated tool that aids in assessing a patient's level of consciousness/sedation on a scale of integers ranging from positive 4 to minus 5 (+4 to -5). A score of +4 means combative; +3 means very agitated; +2 means agitated, +1 means restless, 0 means alert and calm; -1 means drowsy, -2 means light sedation, -3 means moderate sedation; -4 means deep.

The propofol administration record showed the ICU nursing staff received Patient 37 on 3/11/19 around 6 p.m. with propofol infusion running at the maximum dose of 50 mcg/kg/min. The patient's RASS was -4 (deep sedation). The administration record showed the following:

Date & Time Rate (mcg/kg/min) RASS
3/11 6 - 7 p.m. 50 -4
7 - 8 p.m. 50 -3
8 - 9 p.m. 50 -3
9-10 p.m. 50 -3
10 -11 p.m. 50 -3
11-12 a.m. 50 -3
3/12 12 - 1 a.m. 50 -3
1 - 2 a.m. 50 not documented
2 - 3 a.m. 50 -3
3- 4 a.m. 50 not documented
4 - 5 a.m. 50 -3
5 - 6 a.m. 30 not documented
6 - 7 a.m. 25 not documented
7 - 8 a.m. 30 not documented
8 - 9 a.m. 30 -3
9 -10 a.m. 30 -3
10-11 a.m. 30 -3
11-12 p.m. 15 -1
12 p.m. off

Thus, for the next 10 hours after receiving the patient, the ICU nursing staff maintained the propofol rate at 50 mcg/kg/min, despite the hourly RASS scores at constant -3. The rate was finally decreased to 30 mcg/kg/min, then 25 mcg/kg/min between 5 a.m. and 7 a.m. with no documented RASS. One hour later, at around 8 a.m., the nursing staff ran the propofol rate at 30 mcg/kg/min, the RASS at this time was -3. It was maintained at 30 mcg/kg/min despite the hourly RASS of -3 for the next few hours until it was turned off at around noon on 3/12/19.

During the review, Pharmacist 3 said the propofol rate should have been titrated down when the patient's RASS was -3, to keep goal RASS from 0 to -1. He said considering the patient's clinical condition, the goal RASS should have been from -1 to -2. He said the order should have been clarified; regardless, he acknowledged the propofol infusion was not administered as ordered for Patient 37.

The hospital's "Medication Administration and Safe Practices" policy and procedures, revised 1/18/19, indicated the hospital established the standardized Medication Administration Process (MAP) to ensure safe and accurate medication administration, that "variability in the process results in medication errors," and "the Prescriber or his/her designee will be called to clarify orders when they are incomplete or unclear."



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5. During an observation on 3/19/19 at 10:03 AM, OR (Operating Room) 3 was being set up for a surgical procedure. During an inspection of the anesthesia cart, with the Director of Surgical Services (DSS) present, an unlabeled syringe containing 5 ml of white-colored liquid was found inside the bottom drawer. The syringe was placed in a gray, plastic emesis basin alongside an opened vial of Diprivan, (an intravenous medication used before and during surgery or other medical procedures that causes relaxation and sleepiness.) and a normal saline IV flush syringe. During a concurrent interview, the Director of Surgical Services (DSS) acknowledged the syringe was unlabeled, and she had to verify who had prepared it.

During an interview on 3/19/19 at 10:06 AM, the anesthesiologist stated that she had drawn up the Diprivan into the unlabeled syringe. When asked about when she would draw up the medication, the anesthesiologist said, "At the start of the case, when they're [patient] in the room." The anesthesiologist stated that she should've labeled the syringe with the name of the medication, her initials, time, and date.

Record review of hospital policy and procedure titled, "Medication Administration and Safe Practices," latest revision dated 1/18/2019, indicated, "Purpose: 1. To ensure safe, accurate, and timely medication administration based on a standardized Medication Administration Process (MAP) ... Policy: ... Appendix A: Adult Care Medication Administration Process Steps: ... Preparation ...Medication must be labeled with name of drug and dose throughout medication process from preparation through administration ..."

Record review of hospital policy and procedure titled, "Medication Dispensing/Labeling Outside of Pharmacy," latest revision dated 4/26/16, indicated, " ... Policy: All solutions/medications, as designated by the FDA, should be properly labeled by the end user when transferred from the manufacturers' or pharmacy labeled container, to identify its content ... Procedure: ... Relabeling is required when any solution/medication is transferred from the original packaging to another container ... Each solution/medication shall be relabeled with the following information: 1. Required: Name and Concentration of Drug 2. IF medication could expire prior to conclusion of procedure 3. IF amount is not apparent from container, include amount ...F. Any unlabeled solution/medication, on or off the sterile field, is to be immediately discarded ..."

Review of clinical information on Diprivan (propofol) injectable emulsion, USP 10 mg per mL for Intravenous Administration, revised April 2017, from FDA.gov indicated, " ...Guidelines for Aseptic Technique for General Anesthesia/MAC Sedation: DIPRIVAN must be prepared for use just prior to initiation of each individual anesthetic/sedative procedure ...DIPRIVAN should be drawn into a sterile syringe immediately after a vial is opened ...The syringe should be labeled with appropriate information including the date and time the vial was opened. Administration should commence promptly and be completed within 12 hours after the vial has been opened ..." (Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019627s066lbl.pdf)

Based on interview and document review, the hospital failed to administer medications as ordered when the hospital nurses failed to document the verbal orders into clinical record for one of 47 sampled patients (Patient 18) in accordance to policy and did not implement the physician's orders as intended by the physician. This failure in communication resulted in a medication error that may have caused serious harm.

Findings:

A review on 3/19/19 of Patient 18's clinical record indicated that Patient 18 had physician's orders dated 3/18/19 for Norepinephrine IV start at 5 mcg/min and increase dose by 1 mcg/min every minute to reach a goal mean arterial pressure (MAP-measure of arterial blood pressure) of greater than 65 mmHG for hypotension and hemodynamic instability due to septic shock.

During an interview on 3/19/19 at 11:00 AM, the Medical Doctor 1 (MD 1) stated that Patient 18 had a very low MAP on 3/18/19 at around 8:00 AM. He then gave verbal orders to the nursing staff that was present. He verbalized various titrations that exceeded the 1 mcg/min (3-5 mcg/min titrations). A review of the clinical record did not have documented evidence of these verbal orders. He also said Patient 18 eventually stabilized and that after giving the verbal orders he intended the original orders to restart which would mean to titrate by 1 mcg/min.

A review on 3/19/19 of Patient 18's clinical record indicated the following titrations that exceeded 1 mcg/min after MD 1 gave the verbal orders to restart titrations at 1 mcg/min:
*3/18/19 10:07 AM increase by 5 mcg/min
*3/18/19 10:43 AM decrease by 5 mcg/min
*3/18/19 12:05 PM increase by 10 mcg/min
*3/18/19 12:55 PM decrease by 5 mcg/min
*3/18/19 1:11 PM decrease by 5 mcg/min
*3/18/19 1:22 PM decrease by 2 mcg/min
*3/18/19 1:48 PM decrease by 2 mcg/min
*3/18/19 4:00 PM increase by 2 mcg/min
*3/18/19 5:57 PM decrease by 2 mcg/min
*3/19/19 12:03 AM decrease by 2 mcg/min
*3/19/19 12:18 AM decrease by 2 mcg/min
*3/19/19 12:53 AM decrease by 2 mcg/min
*3/19/19 2:28 AM decrease by 2 mcg/min

A review on 3/19/19 of the hospital policy dated 12/15/17 and entitled Policy-Orders, Nurse Entry indicated "The nurse receiving the verbal/telephone order shall write it down and then read back the order, obtaining verification of accuracy...The RN/LVN will enter the verbal/telephone order into Sutter EHR [electronic health record] as a verbal/telephone order..."
A review on 3/19/19 of Patient 18's clinical record did not have any documented verbal orders for Norepinephrine. The only Norepinephrine physician's orders were the original orders which indicated Norepinephrine titrate by 1 mcg/min every minute to reach a goal MAP of 65 mmHG.

During an interview on 3/20/19 at 1:07 PM, the Pharmacy Manager 1 stated that he was not aware that the verbal orders were not documented as required by hospital policy. He acknowledged that it was important that the nurses and physicians need to effectively communicate to ensure the accurate and safe administration of medications.

Based on interview and record review, the hospital failed to ensure that orders were dated, timed, and authenticated in a timely manner by the ordering practitioner according to medical staff rules and regulations when:

1. A Breath Hydrogen Test (BHT) procedure was performed on Patient 7 without a signed physician's order on 3/20/17.
Breath Hydrogen Test (BHT) - a procedure to help diagnose small bowel bacterial overgrowth wherein breath samples are taken from the patient for a specified period of time.

2. Lactulose powder was administered on Patient 7 without a signed physician's order on 3/20/19.

These failures had the potential to result in inappropriate treatment and/or care of patients.

Findings:

1. Review of clinical record for Patient 7 indicated, that she was admitted on 3/20/19, for a BHT procedure in the Outpatient GI Unit located at the California Campus.

Further review of Patient 7's clinical record included a "Pre-Procedure Order- Gastroenterology ..." form that indicated, " ...Schedule Date: 3/20/19 ...Scheduled Procedure ...BHT ... Signature MD, blank, Date, blank, Time, blank ..."

During an interview with Gastroenterology Nurse (RN 11) on 3/22/19 at 9:30 AM, she confirmed that she performed the BHT procedure on Patient 7. She stated that she looked at the Patient 7's "Pre-Procedure Order - Gastroenterology (GI)" form, but was not able to check if the order was signed by the physician. RN 11 said, "I missed that part..."

Record review of hospital policy and procedure titled, "Medical Staff Rules & Regulations, dated 5/16/18, indicated, " ... g. Orders ... ii. In accordance with regulatory standards and Hospital policy, all treatment orders shall be dated, noting the time ordered, and signed by the responsible physician ..."

2. Review of clinical record for Patient 7 indicated, that she was admitted on 3/20/19, for a BHT procedure in the Outpatient Gastrointestinal (GI)Unit located at the California Campus.

Further review of Patient 7's clinical record, indicated, "lactulose ... Powder 10 g (grams) ...Ordered Dose 10 g ...Verbal Order Info: ... Order Mode: Transcribed Orders, Entered by: registered nurse [name], Responsible Provider: blank, Signed by: blank, and Signed on: blank..."

Review of Patient 7's medication record, indicated, " ...Hospital Medication Detail ...Lactulose ... Powder 10g ..." was given on "3/20/19 ..., recorded time 0848 ..."

During an interview with RN 11 on 3/22/19 at 9:40 AM, she confirmed that she administered the lactulose on Patient 7 without a signed physician's order.

During an interview with the Informatics Coordinator Registered Nurse (RN 10) on 3/22/19 at 9:49 AM, she stated that the physician had not signed the medication order for Lactulose.

Record review of hospital policy and procedure titled, "Medical Staff Rules & Regulations, dated 5/16/18, indicated, " ... g. Orders ... ii ... All medication related verbal orders shall be transmitted only to a registered nurse, ... All orders must be countersigned as soon as possible but within forty-eight (48) hours by the prescribing physician ..."

Based on interview and document review, the facility failed to resolve medical record deficiencies in a timely manner, as defined by more stringent California state law, Title 22 California Code of Regulations Section 70751(g), requiring completion of medical records within two weeks following the patient's discharge. This failure resulted in noncompliance with both facility policies and medical staff rules regarding medical record completion with the potential to cause inaccurate quality and care information, poor patient care by other healthcare team members, compromise in safe patient care, and interference with patient-related studies.

Findings:

The facility's Medical Staff Bylaws, Rules and Regulations with regard to medical records completion reflect the required 14-day time frame under California state law, and for teaching cases, state that the Attending Physician, not the Resident, is ultimately responsible for record completion.

A report printed on 3/19/19 at 6:38 a.m. entitled "Delinquencies by provider with Patient Detail" with the sub-header "Finding episodes with deficiencies delinquent greater than 14 days as of 3/18/2019" contains 21 pages of delinquent records. While most of the delinquencies listed involve Verbal Orders, other delinquencies on the list include: Pending Notes, Progress Notes, ED (Emergency Department) Provider Note, History and Physical, Immediate Post Op (Postoperative) Note, Discharge Summary, Coding Query, Consultation Report, and Procedure Note.

The most common reasons for the delinquency are either "Cosign Needed" or "Review Needed." A co-signature is needed for orders given verbally by Residents or for other documentation types initiated by Residents, awaiting the Attending Physician's review and signature. Delinquencies assigned to individual providers in the report represent a cross section of medical staff departments/services. Delinquencies assigned to department work pools for validation and re-assignment as appropriate include: Pharmacy, Physical/Occupational/Speech Therapies, Respiratory Therapy, Health Information Management Administration, Interventional Radiology, Nutrition, Perioperative, and Nursing.

Aging of the delinquent records shows the most current are from first quarter 2019. The oldest delinquencies listed extend as far back as 9/27/16.

The most recent weekly suspension lists issued 3/7/19 and 3/14/19 were designated for a sister facility and represent multiple departments/services. Responsible providers include not only Attending Physicians, but Dentists, Residents, Physician Assistants and Nurse Practitioners. The Medical Staff's policy and procedure "Medical Records Suspension Notification Procedure" last revised 5/16/18 states "This Procedure applies to physicians...."

Time frames for completion are further restricted in the hospital's policy and procedure "Content and Documentation Policy for the Medical Record" last revised 3/29/18. For example, all acute hospital verbal orders must be signed, dated and timed within 48 hours, skilled nursing verbal orders within 5 days, verbal "Do Not Resuscitate" and restraint orders within 24 hours.

The hospital's policy and procedure "Administrative Completion of Deficiencies Policy" last revised 1/30/19 states that assigned staff with responsibility for working their deferred Verbal Orders pool, need to do so daily, "...ideally at least once per shift. No order should remain in the deferred Verbal Order pool longer than 24 hours." It further states "No Order should remain in the Nursing Admin (Administration) Deferred Verbal Order pool longer than 72 hours." Also "No Order should remain in the MD Admin (Physician Administration) Deferred Orders pool longer than 72 hours." The process to close the record administratively using an HIM (Health Information Management) log in is to be completed within 7 days of notification.

In an interview on 3/20/19 at 10:00 a.m. with the local Health Information Management Director (HIMD), she was asked whether Residents are suspended, fined or have paychecks withheld. She responded no, but that the Resident appears on the Suspension List rather than the Attending Physician because 1) that is the order of routing for deficient record completion in the electronic system, and 2) listing the Resident serves as an incentive for them to complete their work. The HIMD also explained that their location is serving as a pilot for the entire health system for administrative review and completion of records. Resources are being added to establish additional work pools to resolve the deficient and delinquent medical records until they are completed or administratively closed as appropriate.

Based on observation, interview, and document review, the hospital staff failed to:

1. Store, "protect from light" medications when Lidocaine with Epinephrine, Bupivacaine with Epinephrine (medications used for local anesthesia), and Cytarabine (Chemotherapy medication) were stored under direct light. This failure increased the potential for administering compromised medications;

2. Ensure the temperature for a medication freezer was maintained at a range specified by the manufacturer for storing frozen premixed vancomycin (intravenous antibiotic to treat various infections) injection bags. Storing medications outside of the specified temperature range may affect the product's potency and efficacy, and therefore would affect the patient's therapeutic outcome.

Findings:

1. A review on 3/18/19 of a hospital policy dated 10/30/18 entitled Procedure-Inventory Control indicated "Drugs which require protection from light shall be stored appropriately".

A review on 3/18/19 of the manufacturer inserts indicated protect from light for Bupivacaine with Epinephrine, Lidocaine with Epinephrine, and Cytarabine. According to the manufacturer the Bupivacaine with Epinephrine, Lidocaine with Epinephrine, and Cytarabine were to be stored away from light.

During an observation on 3/18/19 at 10:15 AM, there were twenty-two 10 ml Bupivacaine/Epinephrine vials and twenty-five 10 ml Lidocaine/Epinephrine vials that were stored under direct light in the main inpatient pharmacy. During an observation on 3/18/19 at 11:06 AM, there were eight vials of 5 ml Cytarabine were found in the satellite pharmacy and were stored under direct light.

The above mentioned medications were found under direct light, were uncovered, and inappropriately stored. Medication that require protect from light deteriorate under direct light. The labels of each of these medications indicated "protect from light".

During an interview on 3/18/19 at 11:15 AM, the Pharmacy Manager 1 stated he did not know the Bupivicaine with Epinephrine, Lidocaine with Epinephrine, and Cytarabine were not protected from direct light. He said he would cover these medications and place amber bags.




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2. On 3/18/19 at 10:55 a.m., a review of the temperature setting in the electronic temperature monitoring system (ETMS) was conducted with the director of pharmacy and Pharmacist 2. It reflected the pharmacy set the temperature range for one medication freezer from -40ºF (negative degrees Fahrenheit) to 4ºF. He said the ETMS would trigger an audible alert to notify the pharmacy staff when temperature went out of range.

The said pharmacy freezer was observed to contain multiple medications including three boxes, each box contained six frozen premixed vancomycin injection bags. The manufacturer's label outside the vancomycin carton box indicated to "store at or below -20ºC (or -4ºF)." In other words, the upper limit of the temperature setting could not go above -4ºF. Thus the set temperature range maintained in the ETMS exceeded that specified by the manufacturer for storing frozen vancomycin product.

A review of the medication freezer's electronic temperature log from 3/4/19 to 3/18/19 showed the temperature readings did not go above -4ºF during this period. However, Pharmacist 2 acknowledged the upper limit was set above that required for storing frozen vancomycin product; the pharmacy would not have been alerted when the temperature reached above -4ºF because it was within the set range.

The hospital's "Drug Storage and Inspections" policy and procedures, revised 7/12/18, indicated, "Medication freezer temperature shall be maintained between -13 to 14ºF or at a range otherwise specified by the pharmaceutical manufacturer(s) for that product."

Based on observation, interview, and document review, the facility failed to ensure a discharged patient's medication, unlabeled medication, and expired medications were not available in the patient care areas. The failure had the potential for expired medications given to patients. Expired medications can have decreased potency and affect the therapeutic outcome for patients.

Findings:

1. On 3/18/19 at 11:31 a.m., inspection of the medication refrigerator in the Intensive Care Unit (6 East) with Pharmacist 1 and the director of pharmacy (DOP) identified a compounded (mixed) sterile preparation (CSP) for a patient. The pharmacy label on the CSP indicated it was prepared on 3/12/19, and had the instruction to not use after 3/13/19. The pharmacy staff members said the patient was no longer in the ICU; and the CSP was no longer usable and should have been returned to the pharmacy.

2. On 3/18/19 at 1:10 p.m. in the presence of multiple hospital staff members including the DOP and Pharmacist 1, random inspection of medications in the 10-West Unit identified nine (9) lorazepam injection vials in the Pyxis, stored at room temperature. The manufacturer's label on the vials indicated to keep the medication in the refrigerator. Pharmacist 1 said the pharmacy had stability data from the manufacturer indicating lorazepam vials could be stored at room temperature for 28 days from the date removed from the refrigerator. Five of the nine lorazepam vials did not have a new labeled expiration. Pharmacist 1 said they should have been short-dated with the 28-day expiration date from the date removed from the refrigerator.

On 3/21/19, the DOP provided an undated drug information from the manufacturer for the lorazepam injection vials. It indicated the stability data showed lorazepam injection vials could be stored at room temperature for 30 days, and "after storage at room temperature for up to 30 (thirty) days the product should be destroyed."

3. On 3/18/19 at 2:35 p.m. accompanied by DOP and Pharmacist 1, inspection of medications in the PACU identified 15 lorazepam injection vials in the Pyxis. Five of 15 vials had the labeled expiration date of 3/15/19. The pharmacists acknowledged those vials had expired and should have been removed from the Pyxis.

The hospital's "Drug Storage and Inspections" policy and procedures, revised 7/12/18, indicated, "Outdated, recalled, and discontinued medications, discharged patient medications, illegibly labeled medications or otherwise unusable products are removed and returned to pharmacy for destruction in a timely fashion" and "Pharmacy will label all medications with proper storage, use and safety information as appropriate."

Based on interview and record review, the hospital's quality program failed to separately track drug incompatibilities in its routine pharmacy quality reports and tracked drug incompatibilities in ad hoc reports instead. The deficient practice had the potential to cause problem-prone practices related to drug incompatibilities to go unrecognized and unchanged for future patients.

Findings:

Review of the hospital's "Quarterly Medication Errors Report" and "Quarterly ADR [adverse drug reactions] Report" (both dated 4th quarter 2018) indicated neither report mentioned drug incompatibilities.

In an interview on 3/21/19 at 9:26 a.m., the Vice President of Quality and Safety (VPQS) stated the pharmacist tracked medication errors, but he had not seen a report regarding drug incompatibility. In an interview on 3/21/19 at 12:55 p.m., the VPQS stated he had created a report listing drug-drug interactions and could provide follow-up to any of the listed events.

Review of the undated report provided by the VPQS indicated there had been eleven incidents of drug-drug interactions with dates ranging from 7/16/17 to 3/20/19.

Based on observation, staff interview and review of facility documents, the hospital failed to ensure Food and Nutrition Services was organized in a manner appropriate to the scope and complexity of the operations when:

1. a system was developed that delegated authority to the Registered Dietitian (RD) to order medical nutritional supplements. Delegation of the authority was not within the Scope of Practice of a RD in accordance with State law (Cross Reference A630).
2. the facility failed to provide organized dietetic services as evidenced by findings of unsafe food handling practices and inadequate oversight of foodservice operations (Cross Reference A620, A630 and A749).
3. the facility failed to ensure meals were portioned in accordance with menu (Cross Reference A630); and
4. the facility failed to ensure effective sanitation of patient related foodservice equipment and utensils (Cross Reference A749).

The cumulative effect of these systematic problems resulted in the inability of the hospitals' food and nutrition services to direct and staff in such a manner to ensure the nutritional needs of patients were met in accordance with practitioners' orders and acceptable standards of practice.

Based on observation, dietary staff interview and departmental document review, the hospital failed to ensure effective monitoring of food safety for foods capable of supporting bacterial growth associated with foodborne illness. Failure to ensure effective oversight may r result in foodborne illness resulting in nausea and vomiting, further compromising medical status of patients. This had the potential to affect the census of all patients receiving food from dietetic services.

Findings:

During initial tour observations on 3/18/19 beginning at 11 a.m., in the kitchen lack of a comprehensive system for monitoring the cool down of foods capable of supporting bacterial growth associated with foodborne illness was identified (Cross Reference A749).

In an interview on 3/19/19 beginning at 2:35 p.m., and concurrent review, with Dietary Supervisor(DS) 1, of the departmental document titled "Cooling Temperature Log" dated 3/9-3/19/19 revealed there were entries missing in the cooling log. DS 1 acknowledged his position responsibilities included day to day supervision of food production staff. In a concurrent interview the Director of Food Services (DFS) stated that food safety was conducted through a monthly audit which included an infection control component. The DFS also stated that this audit has not yet been conducted as the department recently moved to a new location.

In an interview on 3/19/19 beginning at 2:10 p.m., the surveyor asked Registered Dietitian (RD) 1 to describe her oversight in food and nutrition services. RD 1 described dietetic oversight as weekly test trays, menu product review, temperature checks in kitchen and patient test trays. RD 1 stated she does not evaluate food production activities, specifically in relationship to food safety. RD 1 stated she had not identified any systematic inconsistencies.

Review of departmental documents titled, "Food Safety QA (Quality Assurance)" dated 11/27 and 12/17/18 respectively evaluated operations within the department such as hand washing, cleanliness of the department, availability of sanitizing solutions, hot and cold holding temperatures of foods and food storage practices. Additionally, the audit included review of the cooling log to identify whether or not foods were properly cooled. It was noted the log dated 12/27/18 had incomplete logs that was listed as a repeat finding and identified as an opportunity for improvement however, there was no documented plan to ensure all foods were properly monitored.

Review of position description titled "Supervisor" dated 12/28/2000 for Food and Nutrition Services noted one of the essential functions of the position is to maintain a clean and sanitary safe food service environment. It was also noted the minimal educational requirements was a high school diploma with a thorough knowledge of clinical nutrition. A position whose primary purpose is to manage food production services does not have the education or expertise to provide guidance on clinical nutrition.

Review of undated departmental organizational chart titled "California Pacific Medical Center Van Ness" listed RD 1 as the dietitian responsible to provide guidance and oversight to the DFS. Review of position description dated 8/5/18 titled "Lead Dietitian" listed one of the purposes of the position to provide guidance and support for the managers/supervisors and staff of Food and Nutrition service. Specifically, the duties listed the approval of patient service menus, revision of policies and procedures and conducting in-services education programs. The position description did not list any responsibilities in relationship to food production activities. Similarly, there were no essential functions listed in relationship to technical skills related to food production activities. Critical and analytical functions were limited to medical nutrition therapy and technical skills in relationship to food services was limited to the review of patient menus.

Review of hospital document titled "Clinical Competency Validation" for RD 1 dated 2/5/19 was limited to competency evaluation related to medical nutrition therapy. RD 1's undated resume listed the possessing of food safety certification intended for food service workers, however, the certificate expired in 2017.

Based on medical record review, Registered Dietitian (RD) interview and departmental document review, the hospital failed to ensure that the attending physician or professional responsible for the care of patients ordered nutritional supplements in accordance with State law. These failures occurred when:

1. Registered Dietitians ordered medical nutrition supplements for patients on physician ordered regular diets as well as therapeutic diets such as cardiac, carbohydrate consistent and fluid restricted diets.

According to the California Business and Professions code, RDs may not prescribe dietary treatments. The registered dietitian ordered nutritional supplements without a physician's order. With the exception of regular diets, the remaining diets have specific nutrition parameters. The policy of the hospital indicated that it established means to delegate authority to the qualified RD for o
ordering oral nutrition supplements as part of all diet orders.

2. Dietary staff did not plate meals in accordance with physicians orders when portions for 4 random residents were not correct.

Failure to ensure all medical interventions, including the implementation of nutritional supplements, are ordered by the practitioner responsible for the care, may result in further compromising the medical status of patients. This affected 34 patients.

Findings:

1. According to the California Business and Professions Code 2586(a) (1) Notwithstanding any other law, a registered dietitian, or other nutritional professional meeting the qualifications set forth in subdivision (e) of Section 2585 may, upon referral by a health care provider authorized to prescribe dietary treatments, provide nutritional and dietary counseling, conduct nutritional and dietary assessments, and develop and recommend nutritional and dietary treatments, including therapeutic diets, for individuals or groups of patients in licensed institutional facilities or in private office settings. The registered dietitian, or other nutritional professional meeting the qualifications set forth in subdivision (e) of Section 2585, may perform nutritional assessments and initiate nutritional interventions within the parameters of the prescribed diet order pursuant to a licensed health care facility's approved nutrition screening policy and procedure. The registered dietitian, or other nutritional professional meeting the qualifications set forth in subdivision (e) of Section 2585, shall collaborate with a multidisciplinary team, which shall include the treating physician and the registered nurse, in developing the patient's nutrition care plan. Unless otherwise stated in the diet order by a patient's provider, the registered dietitian, or other nutritional professional meeting the qualifications set forth in subdivision (e) of Section 2585, may individualize the patient's nutritional or dietary treatment when necessary, by modifying the distribution, type, or quantity of food and nutrients within the parameters of the diet order. Any modification, and the rationale for the modification, shall be documented in the patient's record for review by the practitioner, or other licensed health care professional, who is legally authorized to prescribe and is responsible for the care of the patient. This state law does not allow registered dietitians to prescribe or order dietary treatments.

Medical record reviews were conducted on 3/19/19 beginning at 10 a.m.

Patient 5 was admitted with diagnosis including cirrhosis (inflammation of the liver) and evaluation of altered consciousness (not able to understand). A comprehensive nursing assessment completed on 2/25/19 documented a height of 5 feet 6 inches and a weight of 181 pounds.

A comprehensive nutrition assessment conducted on 2/27/19 completed by the Registered Dietitian noted Patient 5's estimated needs were 1700-2040 calories and 80 to 102 grams of protein. He was classified at moderate nutritional risk.

Diet order dated 2/28/19 was for tube feeding (feeding through a tube in the nose) of Nepro® (a tube feeding formula) at a rate of 10 cc's (cubic centimeter - a metric unit of measure) per hour. On 3/2/19 the tube feeding rate was advanced to a goal rate of 30 cc's four times per day. On 3/4/19 the physician initiated oral feeding with a dysphasia diet with thickened liquids (a mechanically altered diet used for patients with swallowing difficulty). A nutrition assessment on 3/4/19 indicated the tube feeding was removed, however Patient 5 had inadequate oral intake related to confusion and lethargy (tiredness). Estimated dietary intake was less than 40 percent of required needs. The RD also implemented a nutritional supplement (Nepro®) three times per day. Additional nutrition assessments dated 3/18 and 3/20/19 continued with the nutritional supplements.

In a concurrent interview RD 2 stated it was the usual practice for RD's to order nutritional supplements, as needed, after a nutrition assessment. Once the supplement was entered into the system it was considered an order by nursing staff and the order would be implemented. RD 2 also stated there was a protocol that was approved by medical staff for this process.

Review of hospital supplement order 1022331213 dated 3/14/19 revealed on 3/14/19 at 1413 hours the RD ordered and released the nutritional supplement. On 3/14/19 at 1416 a Registered Nurse acknowledged the order as a new order.
Additional medical record review on 3/19/20 beginning at 1 p.m., revealed Patients 5 and 7 also received a nutritional supplement without a physicians' order. In a concurrent interview RD 3 stated the protocol order was implemented so the physician would not need to sign off on the nutritional supplements.

Hospital document titled "Policy-Clinical-Oral Nutrition Supplement Ordering using Protocol Order Mode" dated 1/30/17 showed "All diet orders include the option of an Oral Nutrition Supplement" A registered dietitian upon further assessment, may add, change, or discontinue an ONS by following the approved Supplement Matrix of the facility's Diet Manual". It was noted this policy was reviewed and granted final approval by the hospitals Accreditation Manager on 1/30/17.

A review of the undated hospital document titled " CPMC Medical Staff Bylaws" does not indicate Registered Dietitian responsibilities in ordering diets for patients. A review of the California Nursing Practice Act does not confer to a licensed nurse the ability to implement treatment or medical nutrition therapy to patients without a physician's order. Review of hospital document titled "Diet List" dated 3/20/19 revealed there were 34 patients receiving nutritional supplements.

2. During meal plating observation on 3/18/19 beginning at 11:30 a.m., Patient 8's physician ordered diet was a 2-gram sodium restricted diet. Instructions for meal plating, printed on the tray ticket, included a ½ portion serving of vegetarian lasagna. Dietary staff was observed plating a full dish of lasagna. Similarly, Patient 9, 10 and 11's diet guided staff to plate 1/3 cup of potato-cauliflower mash. Dietary staff plated a ½ cup portion. Follow up observation on 3/19/19 beginning at 11:45 a.m., noted that dietary staff continued to plate ½ cup potato-cauliflower mash for 3 random patients with ½ cup portions rather than the 1/3 cup portions as printed on the individual tray tickets.

In an interview on 3/18/19 beginning at 1:30 p.m., with Dietary Staff (DS) 2 he acknowledged he prepares the vegetarian lasagna. He stated that once the item was prepared and baked it would be cut into 24 equal servings and placed in smaller dishes and reheated as needed for patient meal trays. He did not prepare and ½ portion servings. In a concurrent interview the Director of Food Services stated the department had daily production sheets. Items would be produced based on the inventory on hand as well as anticipated demand for a particular item.

Review of undated document titled "Food Production Worksheet" noted the document listed specific food items, the recipe number as well as desired portion size. The production sheet called for one size of vegetable lasagna, an 8.75-ounce portion. There was no guidance to prepare ½ portions of this item. Similarly, the production sheet guided staff to prepare the item for ½ cup portions.

In an interview on 3/19/19 beginning at 2:10 p.m., the surveyor asked Registered Dietitian (RD) 1 to describe her oversight in food and nutrition services. RD 1 described oversight to include weekly test trays focusing on accuracy of the trays. RD 1 stated she had not identified any systematic inconsistencies.

Departmental document titled "Tray Accuracy Check Sheet" dated 3/14/19 failed to note any issues with correct portion sizes.

Based on observation, interview and record review, the facility failed to implement its infection control program when:

1. the medical records of two of 47 sampled patients (Patient 26 and 30) did not include documentation of parents and visitor's education regarding transmission based precautions. Patient 26 was a pediatric patient, who was on droplet precautions and Patient 30 was an elderly patient who was on contact precautions.

2. the facility failed to follow national infection control guidelines when 1 of 10 sampled medical staff (Provider 6) did not have results of his most recent tuberculosis (TB, an infection that usually attacks the lungs) skin test (TST), 1 of 10 sampled medical staff (Provider 2) did not have documentation of a TST, and 1 of 10 sampled medical staff (Provider 1) did not have documentation regarding immunization against hepatitis B virus (HBV, and infection that attacks the liver).

3. the hospital failed to ensure effective infection control practices in dietetic services when:

3a. Dietary staff did not fully monitor cool down for foods capable of supporting bacterial growth associated with foodborne illness;
3b. The dishwasher did not sanitize dishes in accordance with standards of practice and manufacturers' guidelines;
3c. The hospital installed cart washing system did not effectively sanitize patient meal carts; and
3d. Hospital employees with facial hair did not wear beard restraints in accordance with the current standard of practice.

Failure to ensure effective systems to mitigate bacterial growth or potential cross contamination may result in exposing all hospitalized patients to foodborne infections, further compromising medical status of patients.

4. the facility failed to ensure staff implemented infection control prevention for two of the 47 sampled patients (Patient 47, Patient 14) when:

4a. a licensed nurse (RN 9) was wearing the same pair of gloves on the hallway after a routine patient care, and

4b. a PICC (Peripherally Inserted Central Catheters) line dressing of Patient 14 was changed only after two weeks.

The deficient practices increased the risk of health care associated infections for patients and staff.

Findings:

1a. Patient 26, a two-month old patient, was admitted on 3/12/19, with diagnosis of acute bronchitis. The record indicated a physician order for "Droplet Precautions" date 3/13/19 at 11:21 AM.

During an observation on 3/18/19 at 1:06 PM while touring the 7th floor pediatric unit, escorted by a Registered Nurse (RN 5), the Nursing Supervisor (RNS) and the Clinical Nurse Specialist (CNS 1); Patient 26's room door was closed and had a pink color sign on the door frame indicating "Contact Precautions- Droplet Precautions ...". RNS described what droplet precautions meant " ...the required use of gloves, gown; and also a mask when close to the patient ...". When asked about education of parents, CNS 1 stated "We educate the parents within 12 to 24 hours of admission, including droplet precautions, since they are in the room with the child ...". Documentation of parent's education in the medical records was requested.

During an interview on 3/20/19 11: 10 AM RN 5 stated "We could not find records of Patient's 26 parents education regarding droplet precautions..."

1b. Patient 30 was admitted on 3/16/19 with diagnoses of aspiration pneumonia, difficulty swallowing, fever, diabetes (abnormal elevated blood sugar level). The record indicated a physician order for "Contact Precautions" dated 3/17/19.

During an observation on 3/20/19 at 10:55 AM, while touring the 7th floor adult unit, Patient 30's room had a green color sign at the door indicating "Contact Precautions". Patient 30 was not visible as the curtains were drawn. A visitor not wearing gloves or gown was seen coming from behind the curtains, grabbed a cup and went back to the patient side behind the curtains.

During an interview on 3/20/19 at 11:05 AM, with Registered Nurse 1 (RN 1), when asked about Patient 30's visitor not wearing personal protective equipment (PPE) as per contact precautions, RN 1 stated, "We have done the visitors education but they refused to wear PPE ...Yes, there should be documentation of that in the medical record ..."

During a review of Patient 30's electronic record with the shift assigned Registered Nurse (RN 2) on 3/20/19 at 11:15 AM, she stated, "I cannot find documentation of the education of family and visitors regarding contact precautions, or of their refusal ...it should be there ..."

Review of a facility policy titled "Infection Control Strategies - Guidelines for Use of Transmission Based Precautions ..." indicated under "Policy ...appropriate precautions are taken whenever diseases are known to spread by ...in order to protect patients, staff and visitors ...".

Review of a facility policy titled "Infection Control Program Education: Infection Control and Prevention" indicated under "Policy: To provide infection control and prevention education to ... to provide specific infection control and prevention to our patients, families, and visitors."

Review of a facility policy titled "Patient and Family Education" indicated under "Policy ...The education will be directed at what the patient and family need to know in order to understand their needs, cooperate with the diagnostic process ...C. The following components are included ...5. Information about the disease process and treatment ...H. Evaluation and response to teaching ...I. Documentation of the teaching process is done in the patient education ...should reflect written, video or audio materials used ..."



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2a. Review of Provider 6's credentials file indicated he was reappointed to the hospital's medical staff on 2/1/18 for a two-year term. Review of Provider 6's health records indicated Provider 6 had a TST placed on 10/2/18 and read on 10/4/18. The document did not specify the results of the TST. No other records regarding TB screening of Provider 6 were provided to the surveyor.

2b. Review of Provider 2's credentials file indicated he was reappointed to the hospital's medical staff on 6/1/18 for a two-year term. Review of Provider 2's health records indicated Provider 2 completed a questionnaire on 10/12/18 and marked a box next to the statement, "I have had a positive TB test in the past". No documentation was present regarding when, where, or by what method Provider 2 had tested positive. Documentation of a normal chest x-ray on 2/17/05 was present.

In an interview on 3/20/19 at 9:28 a.m., the Manager of Medical Staff Services (MMSS) acknowledged there was no TST result for Provider 6. The MMSS stated the hospital did not ask medical staff for documentation of their previous positive TB screening test. The MMSS stated she did not know what national guideline the hospital followed for TB screening of medical staff.

Review of the hospital's "Policy- Influenza Immunization and Tuberculosis Screening Requirements for non-employee Licensed Independent Practitioners" (revised 11/4/16) indicated the policy did not specify on which national guideline it was based. The policy indicated, "Tuberculosis screening is provided at EHS [employee health services] clinics held annually at every campus... If screened elsewhere, the LIP [licensed independent practitioner] will provide written documentation of tuberculin skin test or... blood test for tuberculosis... History of Positive TST - A baseline chest x-ray and yearly symptom review are required."

Review of the CDC (Centers for Disease Control and Prevention) "Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005" indicated, "HCWs [health care workers] who perform any of the following activities should also be included in the TB screening program. - entering patient rooms or treatment rooms whether or not a patient is present... If uncertainty exists whether to classify a setting as low risk or medium risk, the setting typically should be classified as medium risk... TB Screening Procedures for Settings (or HCWs) Classified as Medium Risk ·All HCWs should receive baseline TB screening upon hire, using two-step TST or a single BAMT [TB blood test] to test for infection with M. [mycobacterium] tuberculosis. ·After baseline testing for infection with M. tuberculosis, HCWs should receive TB screening annually (i.e., symptom screen for all HCWs and testing for infection with M. tuberculosis for HCWs with baseline negative test results). ·HCWs with a baseline positive or newly positive test result for M. tuberculosis infection or documentation of previous treatment for LTBI [latent TB infection, when a person is infected with TB but not yet contagious] or TB disease should receive one chest radiograph result to exclude TB disease. Instead of participating in serial testing, HCWs should receive a symptom screen annually... Additional tests for M. tuberculosis infection do not need to be performed for HCWs with a documented history of TB disease, documented previously positive test result for M. tuberculosis infection, or documented completion of treatment for LTBI or TB disease. Documentation of a previously positive test result for M. tuberculosis infection can be substituted for a baseline test result if the documentation includes a recorded TST result in millimeters (or BAMT result)... All other HCWs should undergo baseline testing for M. tuberculosis infection to ensure that the test result on record in the setting has been performed and measured using the recommended diagnostic the recommended procedures... All recordings of TST results should also document the size of the induration in millimeters, not simply as negative or positive."

2c. Review of Provider 1's credentials file indicated he was reappointed to the hospital's medical staff for a two-year term on 4/1/17. Review of Provider 1's health records indicated there was no documentation regarding immunization against HBV. A lab report dated 8/18/14 addressed Provider 1's immunity against four vaccine preventable diseases, but did not address HBV.

In an interview on 3/20/19 at 9:28 a.m., the MMSS acknowledged there was no documentation regarding Provider 1's HBV vaccination, declination, or immunity.

Review of the hospital's "Policy- Immunization Requirements for non-employee Licensed Independent Practitioners: Measles (Rubeola), Mumps, Rubella, Varicella, Pertussis and Hepatitis B" (revised 7/21/17) indicated the policy did not specify on what national guideline it was based. The policy indicated, "All LIPs with clinical privileges (except physicians practicing exclusively in telemedicine) are required to provide proof of immunity to the communicable infectious diseases as described below. Declination for good cause will be considered... Hepatitis B 1. Hepatitis B vaccine will be offered. 2. Documentation of [greater than or equal to] 3 dose hepatitis B vaccination series AND post vaccination serologic testing 1-2 months after the last dose of the vaccine series is recommended."

Review of the CDC guideline "Immunization of Health-Care Personnel [HCP]" (11/25/11) indicated, "All unvaccinated persons whose work- and training-related activities involve reasonably anticipated risk for exposure to blood or other infectious body fluids (e.g., HCP, long-term-care facility staff, and public safety workers) should be vaccinated with the complete, [greater than or equal to] 3-dose hepatitis B vaccine series."



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3a. Potentially Hazardous Foods (PHF's) are those capable of supporting bacterial growth associated with foodborne illness. These foods require time/temperature control for food safety. Protein based foods such as meat and cooked starches such as pasta, rice, lasagna and heat treated vegetables require time/temperature control to mitigate bacterial growth associated with foodborne illness (Food Code, 2019).

During initial tour on 3/18/19 beginning at 11 a.m., in the kitchen the following was noted:
In the retail refrigerator there were four pieces of meat, each weighing approximately two pounds. Two were labeled baked pork and the remaining two were labeled as citrus pork all with a preparation date of 3/16/19. Additionally, there was jook (a rice porridge) with a preparation date of 3/16; pasta with a preparation date of 3/17 and confetti rice with a preparation date of 3/18/19.

In a concurrent interview the Food Service Director (FSD) he stated the hospital utilized a cook chill method of food production. He further stated many of the items on the patient and café menus were prepared up to several days in advance. Once the item was cooked and cooled it was divided into individual portions reheated as needed over the next several days. The FSD stated the items would be cooled in the blast chiller (equipment that circulates cold air) and temperatures recorded on the cool down log.

An observation on 3/18/19 beginning at 1:15 p.m., Cook 2 was observed preparing a pan of lasagna. He stated once the lasagna was complete it would be baked, cooled then divided into individual portions for the patient menu.

Observation on 3/18/19 at 2:10 p.m., in the café refrigerator there were two pieces of cooked pork, each weighing approximately two pounds with a preparation date of 3/18/19.

Concurrent interview and document review on 3/19/19 with Supervisor 1 revealed 6 of 7 cooled items were not recorded on the cool down log. The unrecorded items were vegetarian lasagna (3/19), citrus pork (3/16), baked pork (3/16), confetti rice (3/18) and jook (3/16). Supervisor 1 acknowledged the missing items and stated the supervision of food production staff fell within his position description.

Departmental policy titled "Cooling Standards and Procedures" dated 9/27/17 guided staff to cool all hot foods from 140 degrees Fahrenheit (F) to 70 degrees F within 2 hours then from 70 degrees F to 41 degrees F or below within an additional 4 hours ...Monitor the temperatures of cooling foods and record on the cooling log. The policy also guided staff to check the temperatures of all cooling foods at least every 2 hours to ensure proper cooling.

3b. According to the US Department of Agriculture dish machines that sanitize using hot water ensure mechanical operations by being cycled through equipment that is set up to achieve a utensil surface temperature of 160 degrees F as measured by an irreversible registering temperature indicator (Food Code, 2017).

On 3/18/19 beginning at 2:45 p.m., in an observation dishwashing procedures were reviewed. It was noted that the temperature indicator on the dish machine read 154 degrees F for two cycles. A third cycle had a maximum temperature of 156 degrees F. In a concurrent interview the DFS stated prior to washing dishes staff ran through an irreversible temperature indicator. The temperature indicator was a had a grey colored square on the right hand side. Manufacturers' instructions printed on the strip "when indicator turns black stated temperature has been achieved" the temperature listed on the strip was 160 degrees F. The DFS ran two strips through the machine, neither of the strips turned black. The DFS of also ran through a second strip that had the capability to measure temperatures of 160, 170 and 180 degrees F respectively. Neither strip turned black after being affixed to a plate and being cycled through the dish machine.

3c. Quaternary ammonium (quat) sanitizes dishes by using its positively charged cations to link with the negatively charged particles of unwanted pathogens. Quats' frequently don't work well in hot water, making testing a necessary part of any quat sanitation process. Quat test paper measures the concentration of the quat sanitizer in the water, applying a color scale ranging from 0 to 500 ppm. Most quat sanitizers need solutions of 200 400 ppm (parts per million-Chemark).

In an observation on 3/18/19 beginning at 2:35 p.m., sanitation of patient meal carts was reviewed with Dietary Staff (DS) 2. DS 2 described the use of a power washing unit that washed the carts with detergent, rinsed and sanitized them. The surveyor asked DS 2 describe how he ensured the sanitizer strength was adequate. DS 2 demonstrated the strength of the sanitizer by spraying some of the sanitizing rinse water into a red bucket after which he dipped an orange colored strip into the solution. The strip did not react rather remained orange. Concurrent review of the manufacturers' guidance printed on the side of the strips revealed if the concentration of the solution was between 200-400 ppm the strip would have turned green.

In a concurrent interview the Director of Food and Nutrition Services (DFNS) stated the cart washing system was installed by the facility. In a follow up interview on 3/19/19 at 1:25 p.m., the DFNS stated there was no daily testing of sanitizer or evaluation of operational effectiveness of the system after installation.

3d. According to the United States Department of Agriculture Food Code, 2017 it is the standard of practice to ensure food employees wear hair restraints such as hats, hair coverings or nets, beard restraints, and clothing that covers body hair, that are designed and worn to effectively keep their hair from contacting exposed food clean equipment, utensils, and linens; and unwrapped single service and single use articles.

In an observation on 3/18/19 beginning at 2:45 p.m., two staff members were handling cleaned/sanitized dishes. It was noted that both staff members had facial hair, however neither staff member was wearing a beard restraint. In an interview om 3/19/19 at 2:45 p.m., the DFNS stated dietary staff were not required to cover facial hair if it was closely cropped.

Departmental policy titled "Policy-Training-Dress Guidelines for Food Service Management and Clinical Nutrition Staff" dated 3/28/18 noted that the departmental policy was not consistent with the standard of practice rather the policy did not require beard restraints if facial hair was trimmed, neat and clean.



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4a. During an initial tour of 10 East on 3/18/19 at 2 PM, RN (Registered Nurse) 9 was administering medication to Patient 47 inside his room wearing a pair of gloves. She brought out patient's lunch tray and a French fries basket from his room carrying these items outside into the hallway wearing the same gloves. She opened the utility room door with the same gloves on. She came out of the utility room wearing the same gloves and walked towards the nurse's station and opened the medication room's door.

During an interview with RN 9 on 3/19/19 at 10:45 AM, she stated that she was supposed to remove the gloves before leaving the patient's room when she was done with patient care.

The facility policy and procedure titled "Policy-Infection Control Strategies- Guidelines for Use of Transmission Based Precautions: Airborne, Droplet, Contact Precautions, and Enhanced Contact Precautions" dated 1/18/19, indicated " ... Staff should not wear PPE (Personal Protective Equipment) including gloves outside the patient's room ...."

4b. During a concurrent observation and interview with NM (Nurse Manager) 2 on 3/19/19 at 8:30 AM, in the patient's room, Patient 14 had a PICC line on his left upper arm with an undated Tegaderm dressing (a transparent film dressing use to protect catheter sites from microorganism). NM 2 stated that it should have been changed and dated a week ago.

During a concurrent review of Patient 14's electronic chart record and CNS (Clinical Nurse Specialist) 2 on 3/21/19 at 2:30 PM, the PICC line is inserted on 3/2/19. The dressing was changed on 3/6/19 at 5 AM. CNS 2 stated that there is no dressing changed done between 3/6/19 to 3/20/19.

A review of hospital's policy and procedure titled "Procedure-Central Venous Catheter Management-Adult" dated 7/21/17 indicated, " ... Dressing Change ... Change site dressing once a week, on Wednesday and/or damp, loosened or soiled ...."

Based on observation, interview and record review, the hospital failed to ensure that surgical services were provided in accordance with acceptable standards of practice when:

1.There was no evidence the vaporizer plate for one Sterrad 100S sterilizer in the Sterile Processing Department (SPD) at the Pacific Campus location was replaced according to manufacturer's maintenance guidelines between January to December 2018, and January to February 2019.

2.There was no evidence temperature and humidity in the PACU at the Pacific Campus were monitored according to Association of PeriOperative Registered Nurses (AORN) guidelines.

3.The temperature in six of 10 Operating Rooms (OR) located at the Pacific Campus was not maintained according to facility policy and procedures on 3/4/19, 3/7/19, 3/8/19, 3/12/19, 3/14/19, 3/15/19 and 3/18/19.

4. The hospital failed to ensure that the code cart in the Operating Room (OR) Sterile Core located at the Pacific Campus was checked on 3/11/19, 3/12/19, 3/13/19 and 3/15/19 (refer to A956)

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality health care in a safe environment.

Definitions:

Association of PeriOperative Registered Nurses (AORN) - a nationally recognized organization that provides registered nurses in the Operating Room (OR) and related services with perioperative nursing principles and guidelines.

Heating, ventilation and air conditioning (HVAC) - refers to the system to regulate environmental controls such as air change, temperature, humidity and pressure relationship in certain areas of the health care facility for safety and comfort.

Operating room (OR) - a room in the health care facility where surgical procedures are performed.

Post Anesthesia Care Unit (PACU) - a unit where patients recover after a procedure or surgery.

Sterile processing department (SPD) - a department in the health care facility where cleaning, decontamination, disinfection, sterilization and preparation of medical devices and equipment are performed.

Sterrad 100S Sterilizer - a low temperature sterilizer uses in the sterile processing departments and ORs of hospitals and other medical facilities

Vaporizer Plate - a part of the Sterrad 100S Sterilizer that minimizes the risk of liquid hydrogen peroxide coming into contact with the load in the chamber. It also helps keep the load and the chamber clean.

Code Cart - an emergency supply cart designed to provide emergency medications, supplies and equipment needed to respond to cardiopulmonary arrests and severe medical emergencies.

Defibrillator - a device designed to detect and restore abnormal heart rhythms.

Operating room (OR) - a room in the health care facility where surgical procedures are performed.

Sterile Core - an area by the OR used for sterile supply storage.

Findings:

1. On 3/19/19 at 11:15 AM, a tour of the Sterile Storage Area of the SPD located at the hospital's Pacific campus was conducted with the SPD Interim Manager (SPDIM) and SPD Supervisor (SPDS).

During an interview with the SPDS on 3/19/19 at 11:20 AM, when asked about the preventive maintenance on the Sterrad 100S sterilizer, he stated that the vapor plate on the equipment had to be changed every thirty days. When the surveyor requested for the maintenance log, the SPDS was unable to provide any record, and said, "my paper was missing ..."

During an interview with the SPDM on 3/19/19 at 11:50 AM, when asked which standard of practice or nationally recognized professional guidelines were followed in the SPD, she stated the "manufacturer's IFUs (Instructions for Use)..."

Record review of hospital document titled, "Sterrad Vapor Plate Log ...Machine 100S," for the Year "2019," indicated, there was no record the vapor plate was changed for the months of January and February 2019.

During a follow-up interview with the SPDS on 3/21/19 at 10:00 AM, he confirmed that there were no records of the vapor plate replacement on the Sterrad 100S sterilizer from January to December 2018, and January to February 2019.

Record review of the manufacturer's "Sterrad 100S System Vaporizer Plate Replacement Log Sheet," dated 2016, provided by the hospital, indicated, "Instructions: Replace the vaporizer plate every 30 days or 145 cycles, whichever comes first ..."

Review of the manufacturer's "Sterrad 100S Sterilization System Routine Maintenance Guide", dated, 2005, indicated, " ...Vaporizer Plate/Vaporizer Maintenance: The injector valve vaporizer plate is normally replaced by the customer when the cassette collection box is replaced ... Replacing the Vaporizer Plate: ... This vaporizer plate minimizes the risk of liquid hydrogen peroxide coming into contact with the load in the chamber. It also helps keep the load and the chamber clean ...PROCEDURE: 1. Replace the vaporizer plate every 30 days or 145 cycles, whichever comes first ..."

Record review of hospital policy and procedure titled, "Sterrad Sterilization Equipment, Quality Control," latest revision dated 10/12/16, indicated, "Purpose: To establish policies and procedures regarding quality control practices associated with sterilization of instruments using the Sterrad sterilizer ... Policy: ... 8. Preventive maintenance of Sterrad devices is performed by CPMC's Biomed Department per the manufacturer's instructions for use (IFU) ...."

2.During an interview with the Interim Director of Surgical Services (IDSS) on 3/19/19 at 12:20 PM, when asked which standard of practice or nationally recognized professional guidelines were followed in the Preop, OR and PACU. She stated, "AORN for all 3 areas ..."

During an interview with the Director of Nursing (DON) on 3/21/19 at 9:30 AM to follow up on temperature and humidity records requested on 3/20/19 for the PACU located in the Pacific Campus, she stated there were no records available because the hospital does not monitor and track the readings.

Record review of AORN's Guidelines for "Perioperative Practice: Design and Maintenance," online publish date revised 08/2018, indicated, " ...XII. The health care organization should create and implement a systematic process for monitoring and maintaining structural surfaces and HVAC system performance. Heating, ventilation, and air conditioning systems control room air quality, temperature, humidity, and air pressure of the room in comparison to the surrounding areas. The HVAC system reduces the amount of environmental contaminants (eg, microbial-laden skin squames, dust, lint) in the surgical suite by carrying airborne contaminants away from the sterile field and removing them through the return duct vents located at the periphery of the room. The restricted areas are intended to be the cleanest; therefore, the HVAC requirements for the restricted areas are the most stringent ...XII.b.
Operational values for HVAC settings should be either the settings described in Recommendation II.e.1. or the settings that applied at the time of design or the most recent renovation of the HVAC system and as stated in the state or local regulations ...II.e. The HVAC system should be designed to meet the requirements associated with the intended use of the space. II.e.1. The HVAC design parameters for each area, as described in Table 3, should be used for the design of a new or remodeled system, unless other parameters are required by state or local regulations ...Table 3 Heating, Ventilating, and Air Conditioning Design Parameters: ...Area Postanesthesia care unit ... Design Temperature F 70-75 ...Design Relative Humidity ...20%-60% ..."

3. Record review of the Pacific Campus OR temperature log from 3/4/19 to 3/19/19 indicated that the readings were not within the parameters the hospital followed for the ORs below.

In the OR, the temperature range is 68 to 75 F (Fahrenheit).

On 3/4/19, the temperatures were: OR 2 62.8 F, OR 4 66 F, OR 7 66 F.
On 3/7/19, the temperatures were: OR 2 63.3 F, OR 4 64.9 F, OR 5 66.9, OR 7 65.3 F.
On 3/8/19, the temperatures were: OR 2 63.1 F, OR 4 63.9 F, OR 5 66 F, OR 6 67.5 F, OR 7 64 F.
On 3/12/19, the temperatures were: OR 2 62.6 F, OR 4 65.3 F, OR 5 67.5 F, OR 7 65.8 F.
On 3/14/19, the temperatures were: OR 1 67.8 F, OR 2 67.3 F, OR 4 65.3 F, OR 7 65.8 F.
On 3/15/19, the temperatures were: OR 2 66.9 F, OR 4 65.3 F, OR 7 65.8 F
On 3/18/19, the temperatures were: OR 2 67.5 F, OR 4 66.7 F, OR 7 66.6 F.
On 3/19/19, the temperatures were: OR 4 67.5 F, OR 7 66.6 F.


During a concurrent interview and record review of the OR temperature log and work order documents, with the Director for Environment of Care (EOC) and Safety on 3/22/19 at 10:10 AM, she acknowledged that the temperature readings were outside the identified parameters. She said, "We need to tighten up the policy ..." She explained that corrective actions weren't done and stated, " ...we're not able to adjust, and to make sure everything is within acceptable range...we did not follow the policy ..."

Record review of hospital policy and procedure titled, "Temperature & Humidity," latest revision dated 3/21/19, indicated, " ... Policy: Any area of a facility that has been designated to be used for the administration of nonflammable inhalation anesthetic agents in the course of examination or treatment. To include: Surgery Operating Room, ... In the above referenced areas, in the absence of a request made by a Physician, the space temperature boundaries are between 68-75F ... Procedure: Responsibility: The Department Manager is responsible for ensuring the temperature and humidity readings will be taken and recorded daily in each procedural room ... Readings are documented on the Temperature and Humidity Log maintained by the department ...All actions will be recorded in the work order system and reported back to the department when action is completed ...Reporting and Corrective Action: Temperature/Humidity Readings Department Responsibilities: Daily temperature/humidity readings must be documented. If the temperature/humidity reading is out of the identified parameters, report the variance to the department manager/designee ...Department staff need to take immediate action to try to restore the temperature or humidity within the designated parameters before contacting the Pharmacy or Engineering even when temperature/humidity is monitored electronically. Repeat the reading in one hour. If the temperature/humidity remains outside the designated parameters, staff need to take the following steps: Report the variance to the department director/manager/designee who will contact the Service Center and place a work order ...Documentation: Department staff must document all actions taken including: The initial out of range reading, the specific action taken and whether the corrective action restored temperature/humidity within designated parameters, the one hour repeat reading if temperature/humidity remains out of range, the work order number obtained from the service center, documentation should be recorded on the manual log or in the temperature/humidity monitoring system for areas/equipment monitored electronically. Engineering: Engineering will take action to resolve the variance. Engineering will document the corrective action taken and whether it was successful on the work order system work request and on the department's temperature/humidity log, initialing their entry. Documentation will be maintained in the work order System Database. Consult with the department Lead if the temperature/humidity cannot be timely rectified ..."

Based on observation, interview and record review, the hospital failed to ensure that the code cart in the Operating Room (OR) Sterile Core located at the Pacific Campus was checked on 3/11/19, 3/12/19, 3/13/19 and 3/15/19.

Failure to check the code cart to ensure availability and readiness for use had the potential to place patients at risk during care and initial treatment of a medical emergency.

Findings:

During a tour on 3/19/19 at 9:12 AM, in the OR Sterile Core Area located at the Pacific Campus, with the Interim Director of Surgical Services (IDSS) present, the code cart was inspected. During a concurrent record review of the code cart binder, the daily checklist for March 2019 indicated, "Instructions: Check the contents on the top of the cart and the defibrillator function once a day. Check off contents; note the lock (s), ...Equipment To Be Checked ...Test Defibrillator ..." The daily item checklist for March 11, 12, 13 and 15 were blank.

During an interview on 3/19/19 at 9:13 AM, the IDDS stated that the code cart was not checked on the dates indicated above. She also stated the charge nurse should have checked the code cart or assigned the duty. The IDDS confirmed there were cases in the OR on those dates.

Record review of an undated, hospital policy and procedure titled, "Crash Cart Maintenance and Module Exchange," indicated, "Policy: All crash carts will be inspected routinely for intact locks, presence of designated equipment stored outside of the locked areas of the cart, and for outdated or unusable drugs and/or supplies ... Procedure: I. Cart checks: Performed by designated Department/Unit staff A. The Crash cart is checked on a daily basis (tops, sides, and numbered locks) on units/departments that are open daily; for units that are not open daily, code cart is checked on days when the department is open. B. Daily checks include: 1. Functionality of all equipment located on the outside of the cart such as the defibrillator/monitor, suction, and oxygen tank/gauge ...2. The medication list ... 3. The supply list ...4. Numbered Security lock(s) on the cart ..."