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Based on interview and record review, the facility failed to follow its criteria for granting medical staff privileges and failed to include relevant medical staff privileges when

1. Physician 1 (PHY1) was granted privileges to admit and manage patients in Intensive Care Unit (ICU) without meeting training or certification requirements.

2. Physician 2 (PHY2) was granted privileges to perform procedures potentially requiring fluoroscopy (a type of medical imaging that shows continuous X-ray images for examinations or procedures), without applying for or being granted fluoroscopy privileges and without having fluoroscopy certificate on file.

This deficient practice had the potential for physicians to be caring for patients without appropriate training and to be performing procedures without appropriate certification, potentially placing patients at risk.

Findings:

1. During a concurrent interview and record review on 5/12/21 at 10:43 a.m. with the Director of Medical Staff (DMS), the credentialing file of PHY1 was reviewed. The approved privilege list for PHY1 from February 2021 included "... Critical Care-Level II -*(May admit patients to ICU, manage patients in ICU, and provide consultation for patients in ICU) ...". PHY1's Urology Privilege Delineation Form, signed in June 2020, indicated that board certification or completion of an approved residency program in Internal Medicine, Cardiology, Pulmonology, or Critical Care plus the management of ten patients in the past two years was required for initial appointment with Critical Care-Level II privileges. A review of PHY1's American Medical Association (AMA) Physician Profile revealed no board certification or completed residency program in Internal Medicine, Cardiology, Pulmonology, or Critical Care.

During an interview on 5/12/21 at 4:52 p.m. with the DMS, the DMS stated the Critical Care-Level II privilege should not be on the Urology Privilege Delineation Form, and that it was a clerical error.

During an interview on 5/13/21 at 8:23 a.m. with the Chair of the Department of Surgery (ChDS), when asked how the privilege to admit and manage patients in the ICU was granted to a physician who did not meet facility requirements, the ChDS stated the Critical Care-Level II privilege was inadvertently added to the Urology Privilege Delineation Form. When asked how it was not noticed despite PHY1's application passing through multiple departments during the approval process, the ChDS stated he pays more attention to evaluating privilege requests for procedures.

During a review of the facility's Medical Staff Bylaws, approved 2/20/2020, Article 4.5-1 revealed "... Medical staff application forms ... For initial applicants, these forms shall require detailed information which shall include ... The applicant's qualifications, including ... professional training and experience ... related to the clinical privileges to be exercised by the applicant ...".

During a review of the facility's Medical Staff Bylaws, approved 2/20/2020, Article 5.2-2 revealed "... Requests for clinical privileges shall be evaluated on the basis of the member's education, training, experience, demonstrated professional competence and judgment ...".

2. During a concurrent interview and record review on 5/12/21 at 10:43 a.m. with the Director of Medical Staff (DMS), the credentialing file of PHY2 was reviewed. The approved privilege list for PHY2 from March 2020 included repair of aneurysms (localized ballooning in an artery wall), treatment of peripheral blood vessel (blood vessels outside of the heart and brain) obstructions, and treatment of intra-abdominal blood vessel (blood vessels within the abdominal cavity) obstructions but did not include fluoroscopy privileges. The DMS stated PHY2 had no fluoroscopy certificate on file at the facility, and that fluoroscopy privileges were not an option on the Vascular Surgery Privilege Delineation Form.

A review of the Food and Drug Administration (FDA) webpage titled Fluoroscopy, dated 09/28/2020, indicated fluoroscopy can be used for "... placement of devices within the body, such as stents (to open narrowed or blocked blood vessels) ...".

A review of the Society for Vascular Surgery webpage titled Definition of Vascular Surgery, undated, indicated "... The vascular surgeon must have advanced knowledge and experience with the management of vascular (related to blood vessels) problems including ... Indications and techniques relating to open and endovascular treatment (minimally invasive procedure using catheters and medical imaging such as fluoroscopy) of vascular disorders ...".

A review of the California Department of Public Health Radiologic Health Branch (RHB) website, updated May 4, 2021, indicated the Radiologic Health Branch "... Certifies physicians ... who use X-ray machines on human beings, and administers exams to physicians ... for X-ray certification & permitting ...". The RHB Permits and Certificates on the Web website, undated, indicated "... A person who holds a valid and current certificate or permit must provide ... a copy of the individual's certificate or permit. It is the possession of a valid authorization, certificate, or permit that allows a person to use x-rays in the healing arts ...".

During an interview on 5/13/21 at 9:40 a.m. with the Director of Surgical Services (DSS), the DSS confirmed that vascular surgery procedures are performed at the facility. The DSS confirmed fluoroscopy is performed at the facility. The DSS stated an operating room technologist positions the fluoroscopy machine but that a physician operates it. The DSS stated it was not in the operating room technologist's scope of practice to run the fluoroscopy machine. The DSS stated she would expect a physician performing procedures requiring fluoroscopy to have fluoroscopy privileges.

During an interview on 5/13/21 at 8:23 a.m. with the Chair of the Department of Surgery (ChDS), the ChDS stated fluoroscopy is restricted to those providers with fluoroscopy certificates. The ChDS confirmed that an operating room technologist cannot run the fluoroscopy machine, that a physician in the operating room is required to possess a fluoroscopy certificate. When asked if he would expect to see a fluoroscopy certificate requirement listed on the Vascular Surgery Privilege Delineation Form, the ChDS stated it should be added to all privilege delineation forms.

During an interview on 5/13/21 at 8:53 a.m. with the ChDS, the ChDS stated the facility would add fluoroscopy certificate requirement to the Vascular Surgery Privilege Delineation Form.

During a review of the facility's Medical Staff Bylaws, approved 2/20/2020, Article 4.5-1 revealed "... Medical staff application forms ... For initial applicants, these forms shall require detailed information which shall include ... The applicant's qualifications, including ... special certification(s) ... related to the clinical privileges to be exercised by the applicant ...".

During a review of the facility's Medical Staff Bylaws, approved 2/20/2020, Article 5.2-2 revealed "Requests for clinical privileges shall be evaluated on the basis of the member's education, training, experience, demonstrated professional competence and judgment ...".

Based on interview and record review the hospital failed to ensure documentation in their medical records to flag (mark an item for attention), identify and evidence isolation ( help prevent air spread of germs) precaution cases of patients with positive COVID-19 (highly contagious respiratory virus disease caused by a Coronavirus) lab tests. The Face Sheet (a one-page medical record form of important patient information for identification and health status) used to identify isolation patients were not correctly documented to indicate isolation status for 5 of 14 medical records reviewed (Pt 14, Pt 15, Pt 16, Pt 17, and Pt 18). This failure had the potential in delayed or lack of isolation precautions being ensured in the hospital and created lack of exposure risk awareness for care providers and staff for patients diagnosed with COVID-19, particularly when the hybrid (paper and digital) electronic medical record (EMR) system was viewed remotely by medical staff not in the hospital or when the printed medical records were sent with the patient at or after discharge.

FINDINGS:

During a concurrent interview and record review with the Director of Health Information Management (DHIM) and Registered Nurse Informatics (RNI) on 5/11/21 at 8:53 am, Patient 14's electronic medical record (EMR) of a 61 year old female admitted on 12/31/20 and discharged on 1/5/21 was reviewed. Pt 14 was an inmate from the nearby state women's prison facility and admitted via the Emergency Department for weakness. Pt 14 had a history of Congestive Heart Failure (CHF, a chronic condition in which the heart does not pump blood as it should), diabetes (a disease in which the body's ability to produce the hormone insulin is impaired resulting in too much sugar in the blood) and hypertension (conditions of high or raised blood pressure). Pt 14 was admitted with symptoms of nausea (feeling of sickness in the stomach), vomiting, generalized abdominal pain and hypotension (low blood pressure) with a systolic blood pressure in the 70's (blood pressure lower than the norm of 90 when the heart is beating). Pt 14 had a confirmed COVID-19 positive lab test result on 12/31/20. A detailed review of the medical record showed a two lab tests for COVID-19. On 12/31/20 at 0329 the SARS@-COVIGG lab result showed "Non-Reactive". There was also a COVID-19 Antigen test collected on 12/31/20 at 1504 with Positive results, with a medical record notation that the results were called to the ED at 1539 on 12/31/20. Both COVID-19 lab tests were printed as lab reports with a Print Date of 1/7/21 which indicated the forms became part of the patient's medical record on or after that date. The ED Addendum report for Pt 14 on 12/31/20 stated a Primary Impression Diagnosis of COVID-19 yet contained conflicting information that stated "Communicable Disease/Condition: No" noted by the ED staff. The discharge summary for Pt 14 on 1/5/20 stated a primary Discharge Diagnosis of Pneumonia due to COVID-19 virus, Status: Acute. The Face Sheet for the medical record of Pt 14 did not have an entry comment that indicated ISOLATION status for COVID-19.

On 5/11/21, the hospital's Policy and Procedure for staff notification of reportable infectious diseases was requested of the DHIM but not provided, and the DHIM stated that the Quality Assurance and Infection Control staff would provide the policy but was not received.

During a concurrent interview and record review with the DHIM and RNI on 5/11/21, at 9:23 am, Patient 15's EMR of a 41-year-old female admitted on 3/28/21 and discharged on 4/3/21 was reviewed and discussed. Pt 15 was admitted via the ED for fever and a 5-day duration of worsening shortness of breath and cough. Pt 15 had a COVID-19 rapid test in the ED as well as a PCR (polymerase chain reaction test considered more accurate) test on 3/28/21 that showed "Detected" on 3/28/21, with results that showed received at 3/29/21 at 0649 and verified by the external lab at 1610. This information was contradicted on the ED Assessment of Pt 15 for 3/28/21 under "Reportable Conditions, Communicable Disease/Condition: No", although the medical record had the primary impression diagnosis that stated, "Acute hypoxemic respiratory failure due to COVID-19". This information conflicted with an earlier COVID-19 rapid test found to be negative for Pt 15, as documented in the admission history and physical on 3/28/21 at 2142. The Face Sheet for the medical record of Pt 15 did not have an entry comment for ISOLATION status for COVID-19 during the inpatient stay.

During a concurrent interview and record review with the DHIM and RNI on 5/11/21, at 9:53 am, Patient 16's EMR was of a 31-year-old male admitted on 1/30/21, who left the hospital against medical advice on 2/2/21 at an undocumented time between 0050 and 1320. Pt 16 had a history of gallstones (a concentration of minerals forming stones in the gallbladder), schizophrenia (a long-term mental disorder involving breakdown in thought, emotion, and behavior leading to inappropriate actions and feelings), and alcohol use who was admitted via the ED. Pt 16 had an endoscopic retrograde cholangiopancreatography (ERCP, a procedure to diagnose and treat problems in the liver, gallbladder, bile ducts and pancreas) operation performed on 1/31/21. Pt 16 had a COVID-19 rapid test on 1/30/21 and PCR test on 2/1/21 which were non-reactive. On 1/31/21 Pt 16 had a COVID-19 PCR test result that was positive, collected on 1/30/21, and verified as a result on 1/31/21 at 9:44 pm from the regional lab. The documented result was faxed as a paper lab test result on 1/31/21 at 10:02 p.m. The discharge summary for Pt 16 was dated 2/2/21 at 12:50 am documented Discharge Diagnoses of choledocholithiasis (gall stones), cholelithiasis, schizophrenia, alcohol abuse, and hypokalemia (low potassium), and did not include the positive COVID-19 result among the diagnoses. The Face Sheet for the medical record of Pt 16 did not have an entry of COVID-19 under ISOLATION.


During a concurrent interview and record review with the DHIM and RNI on 5/11/21 at 10:23 am, Patient 17's EMR was of a 72-year-old female admitted on 2/8/21 and discharged on 2/19/21. Pt 17 was seen in the ED with a chief complaint of cough and prior medical history of CHF, diabetes mellitus, hypertension, and obesity (excessive amount of body fat). Pt 17 was "worried that she had COVID-19" in the ED and a COVID-19 PCR test was done on 2/8/21 which confirmed positive at 1752. The Face Sheet for the medical record of Pt 17 did not have an entry comment for COVID-19 under ISOLATION. The patient was discharged to a skilled nursing facility, which was required to be advised of a positive COVID-19 diagnosis.

During a concurrent interview and record review with the DHIM and RNI on 5/11/21 at 10:53 am, Patient 18's EMR was of a 60-year-old male admitted on 5/5/21 and was an inpatient being treated in the Intensive Care Unit. Pt 18 had tested positive for COVID-19 when admitted via the ED on 5/5/21, with test results reported at 1:08 pm. The COVID-19 lab test report for Pt 5 was marked as faxed to the hospital on 5/6/21 at 10:02 pm. The ED Assessment for Pt 18 on 5/5/21 documented that the patient presented to the ED after traveling from India on the day before admission, with conflicting information the "Reportable Conditions, Communicable Disease/ Condition: No". There was an Infectious Disease consultation report for Pt 18 on 5/6/21 that documented the diagnosis of Bilateral Pneumonia due to COVID-19 and had been reported to the local public health authority. The Face Sheet for the medical record of Pt 18 did not have an entry comment for COVID-19 under ISOLATION.

During a concurrent interview and record review with the DHIM and RNI on 5/13/21, at 8:34 am, Patient 24's EMR was of a 58-year-old male who was admitted via the ED on 11/3/20 and expired in the hospital on 12/15/20. Pt 24 was admitted with left lower quadrant abdominal pain and was an inmate from a nearby prison. Pt 24 had a history of Gastro-intestinal bleeding (GI, internal stomach and intestine bleeding), irritable bowel syndrome (IBS, chronic inflammation of the colon). Detailed record review showed documentation of surgery performed on Pt 24 on 11/3/20 which involved an exploration of the abdomen and colon resection (excision of diseased large intestine) and colostomy (surgical operation to divert the large intestine to an artificial opening in the abdominal wall to bypass damaged colon). Additional surgeries for Pt 24 were done on 11/25/20 and 12/7/20 for rectal bleeding and infection of the abdominal wound. The Face Sheet for the medical record of Pt 24 did have an entry comment for CMRSA (community associated Methicillin Resistant Staphylococcus aureus, a germ that is highly resistant to antibiotics and found in skin infections that are often spread in hospitals) under the ISOLATION space of the face sheet.

During an interview on 5/13/21, at 8:45 am, the DHIM was asked about the multiple versions of the face sheets in the patient EMRs. DHIM stated that there may be multiple versions of the face sheet when information was added to the medical record after patient admission and was updated. The face sheet was a document scanned to the EMR in the HIM department after discharge of a patient and was sent as a printed document with the medical records that accompanied discharged patients. DHIM was asked about the uses of medical record face sheets and how healthcare providers used the copies of the face sheet. DHIM stated that physicians who had access to the EMR from a remote location such as their office, had access and viewed the face sheet for identification and health status purposes. DHIM stated that local ambulatory clinics associated with the hospital also referred to discharged patient EMRs from remote locations and utilized the medical record face sheet for identification of patient and health status.

On 5/13/21, the policy and procedure for documentation and notification of infection diseases for inpatient medical records was requested but not provided.

Based on interview, and record review, the hospital failed to implement its policy and procedures when a hospital staff who had not received sterile (germ free) IV (intravenous- inject into the vein) compounding (making of drug products) training, compounded a sterile IV product for Patient 5.

This failure put Patient 5 at risk for developing medication related adverse events and risk of infections due to receipt of contaminated IV medications.

Findings:

During a concurrent interview and record review, on 5/11/21, at 12:07 p.m., with Director of Pharmacy (DP), the hospital's "Night Locker Pulls", dated 1/1/21-3/31/21, was reviewed. The "Night Locker Pulls" document indicated, on 2/20/21 at 7:29 a.m., Registered Nurse (RN) 4 removed vasopressin (drug that can be used in increase blood pressure) injection 20 units/ml (milliliter-unit of measure) vial from the night locker Pyxis (a device that dispenses automatically) for Patient 5.

A review of Patient 5's "Medication Administration Record(MAR)', dated 2/20/21 at 7:34 a.m., RN 4 administered vasopressin 20 units in 250 ml IV solution bag to Patient 5.

A review of sterile compounding competency training for all hospital staff indicated, there was no documentation of competency training for RN 4. DP stated RN 4 did not complete sterile compounding for immediate use and should not have been compounding vasopressin for Patient 5.

Staff pharmacist (RPH) 2 stated there was no documentation in the pharmacy-compounding log that pharmacy staff compounded vasopressin.

DP stated it was potentially unsafe for a hospital staff who had not received competency training to compound a sterile product because a patient could be administered an unsafe or incorrect dose. DP acknowledged it was not consistent with hospital policy.

During a review of the hospital's policy and procedure (P&P) titled, "Sterile Compounding for Immediate Use", dated 2/21, indicated, "Any staff completing sterile compounding for immediate use shall successfully complete training and competency assessment on CSP [compounded sterile product] for immediate use initially and annually."

Based on interview and facility document review, the facility failed to follow procedures to ensure Time Temperature Control for Safety (TCS) food (food that has a high probability of growing harmful bacteria) was stored safely in 7 of 7 patient food refrigerators located on nursing units. This failure had the for food to grow harmful bacteria leading to food borne illness.

Findings:

A high temperature for a patient food refrigerator located on a nursing unit resulted unsafe food temperatures above 41 degrees Fahrenheit (F) on the last CMS Full Validation Survey on December 23, 2020. The Plan of Correction Version 3, dated 3/30/2021, for this finding indicated the Maintenance Department staff would check the temperature of each patient food refrigerator in person 3 times per day during their rounds. When the Maintenance Department staff observed a temperature that was not within the acceptable temperature range for refrigerators (32-40 degrees F), either during in person rounds or due to a notification from the Trane Tracer system (a system that tracks refrigerator temperatures with a thermometer probe connected to the refrigerator and an alarm sounds if the temperature goes above a set temperature), Maintenance staff would notify Nutrition Resources Staff to measure the temperature of the food within the refrigerator to ensure the food was still within the acceptable temperature range. If the Nutrition Resources Staff were unavailable at the time the out of range temperature was noted, then the House Supervisor (the Registered Nurse in charge of hospital operations in the absence of the hospital's administrative team) would be notified, who would measure the temperature of the food within the refrigerator to ensure the food was still within the acceptable temperature range. If the food was at an acceptable range, the food would be transferred to a different food refrigerator. If the food was found to be at an unacceptable range, then all perishable food would be discarded. RNs who were assigned as the House Supervisor would be trained on this process by 4/9/2021. Maintenance staff would then attempt to adjust the temperature of the refrigerator to return it to acceptable range. If a temperature within the acceptable range was unable to be achieved within 30 minutes, the refrigerator would be tagged as out of service until it was able to be returned to the acceptable temperature range.

Review of the Daily Rounds Log from 4/1/21 - 5/10/21 (40 days) showed 7 patient food refrigerator temperatures located on the units were logged 3 times a day (Shift 1, 2, and 3) by maintenance staff. The log showed the acceptable range for the patient food refrigerators was 32 - 40 degrees F. During this date range, temperatures were documented above 40 degrees F nine (9) times for the West Med/Surg (Medical/Surgical) unit patient food refrigerator. These temperatures ranged from 41 to 48 degrees F. Temperatures were documented above 40 degrees F ten (10) times for the OB (Obstetrics) unit patient food refrigerator. These temperatures ranged from 41 to 43 degrees F. The temperature for the Central Med/Surg unit patient food refrigerator was documented above 40 Degrees F one (1) time at 41 degrees F. In total, the number of times a refrigerator was documented above 40 degrees F by maintenance staff during this time period was 20 times. Out of these 20 times, 5 comments were written to say the temperature of the refrigerator was adjusted. However, there were no comments to indicate the Nutrition Resources Department or a House Supervisor was contacted to measure perishable food temperatures, the food was moved to a different refrigerator, or the refrigerator was brought back to an acceptable range within 30 minutes.

In an interview on 5/11/21 at 10:30 a.m., Clinical Coordinator 1 (CC1), stated she was a House Supervisor every other weekend. She said she was not trained on taking food temperatures for food located in the patient food refrigerators on the units. She said she knew nothing about appropriate food temperatures.

In an interview on 5/12/21 at 9:40 a.m., when the Clinical Nutrition Resources Director (CNRD) who was in charge of the overall and day-to-day operation of the Nutrition Resources Department (Food and Nutrition Services) was asked to describe the process for checking the patient food refrigerator temperatures, she stated she had to ask The Director of Facilities and Safety Officer (DFSO) what the process was when refrigerator temperatures went above 40 degrees Fahrenheit (F), because it was his department. She also stated she did not recall that maintenance staff notified her about high temperatures for patient food refrigerators located on the nursing units since the CMS Full Validation Survey on December 23, 2020. Then she stated, if the food refrigerator temperatures were found to be high by maintenance staff, they should notify her or the unit supervisor.

In an interview on 5/12/21 at 10 a.m., the DFSO stated if there was an issue with the temperature of a patient food refrigerator, the Nutrition Resources Department or the House Supervisor would be contacted. He said if they were contacted, this would not be documented. He confirmed there was no documentation the Nutrition Resources Department or the House Supervisor were contacted due to high temperatures for patient food refrigerators since the last CMS Full Validation Survey on December 23, 2020. Then he stated he did not expect his staff to contact the Nutrition Resources Department every time a refrigerator temperature was found above 40 degrees F during their daily rounds. Referring to the temperatures on the Daily Rounds Log from 4/1/21 - 5/10/21, he stated the only times he expected his staff to notify the Nutrition Resources department was when the temperature was 44 degrees or above and when the temperature was documented above 41 degrees for all three shifts. He also stated, if maintenance staff discovered the patient food refrigerator was above 40, they should document if they adjusted the refrigerator temperature and recheck within 20 minutes, but not necessarily contact the Nutrition resources department.