Bringing transparency to federal inspections
Tag No.: A0749
Based on policy review, hospital documents review, employee health record review, observations, personnel file review, and staff interviews facility staff failed to 1. follow their protocols on investigating a positive COVID tested employee for 1 of 2 surgical staff reviewed (Employee #1), 2. follow Employee Health screening guidelines for 6 of 12 COVID positive employees (Employee #1, #2, #4, #5, #6, and #8), 3. wear appropriate personal protective equipment (PPE) in the surgical services restricted areas for 2 of 2 observations, 4. wear the correct PPE during aerosolizing generating procedures for 1 of 1 anesthesia personnel interview 5. ensure respiratory fit testing upon hire for 2 of 2 new personnel (Registered Nurse #12 and Environmental Services #1).
The findings include:
1. Review on 11/17/2020 of a policy titled, "Non-bloodborne Communicable Diseases Exposure Plan", effective 09/11/2020 revealed, "PURPOSE: ...provide guidelines for the prevention and control of selected communicable diseases that spread among patients, staff and visitors...DEFINITIONS: ...D. Exposure Workup...The collection of information about and investigation of exposure events...A...1. Infection Prevention Responsibilities a. After notification of a suspected exposure, verify the infectious source (patient, HCW [healthcare worker], volunteer, visitor, etc.) and determine if an exposure has occurred...e. Identify and notify areas where exposures may have occurred...3. Employee Health Responsibilities a. When the infectious source is a HCW...b. Determine if the HCW or volunteer worked during the infectious period and identify the areas where they may have worked during the infectious period...4.b. Determine the immune status of the potentially exposed patient. c. Determine the necessity for patient notification...C. Employee and Volunteer Exposures 1. a. After notification of suspected exposure, verify the infectious source...and determine if exposures have occurred...Employee Health Responsibilities j. Investigate, report and follow-up with HCWs and volunteers on potential exposures...ATTACHMENTS...EXHIBIT 1: Definition of Exposure for Non-bloodborne Communicable Diseases...COVID 19 - Within 6 feet for greater than 15 minutes."
Review on 11/19/2020 of an Employee Health (EH) form titled "Positive Employee" no date revealed 7 questions that EH asked employees positive with COVID. Review of the questions revealed "COVID-19 results, Date resulted, Where tested, Symptoms, First day symptoms, EE (employee) masked/PPE at all times while working, Last day worked."
Review of the EH record for EE #1 revealed a "Brief Note Visit" written by the Employee Health Physician Assistant (EHPA) dated 10/22/2020 at 0923 that stated, "Informed by Infection Prevention that (EE #1) has a positive Covid result. We have no info concerning illness. Attempted to call; no answer. LMOM (left message on machine). I will enter Covid monitoring based on report from Infection Prevention. I have not yet spoken to employee." Review of a "Confirmed Positive Employee Note" by EHPA dated 10/22/2020 at 0931 revealed, "EE (Employee) complains of sore throat 10/18. Developed fatigue, decreased taste/smell since yesterday. Was seen at ER (emergency room) at (facility) and Covid test Positive 10/21/20. No fever, not much cough. Advised OOW (out of work) through 10/28." Review failed to reveal EH asking about EE #1's last day of work and if EE #1 wore a mask at all times while working.
Review on 11/19/2020 of EE #1's work schedule from 10/19/2020 through 10/21/2020 revealed EE #1 worked in the clinic at the hospital on 10/19/2020 and saw 22 patients. Review revealed EE #1 performed surgery on 10/20/2020 for 12 patients and saw 38 patients in the clinic on 10/21/2020.
Interview on 11/18/2020 at 1224 with EE #1 revealed after feeling fatigued and having a post nasal drip with a scratchy throat days prior (10/18/2020), EE #1 tested positive for COVID-19 on 10/21/2020 "around 1530" in the facility's ED (Emergency Department). EE #1 stated "I thought it was allergies". EE #1 further revealed that he had lasagna for lunch on 10/21/2020 and remembered that it had a metallic taste and no smell. Interview revealed EE #1 went to the Employee Health website to review the most common COVID symptoms and became concerned, so EE #1 called EH on 10/21/2020, but had to leave a voicemail. EE #1 stated, "Employee Health called me back when I was actually in the ER to tell me I should get tested...I was already home when the ER called me back with the positive result. Once I found out, I called Employee Health back and left another message." Interview revealed that EH returned EE #1's call on the morning of 10/22/2020 to advise him of the need to stay home for 10 days and drink plenty of fluids. Interview further revealed, EE #1 did not receive a call from Infectious Disease. Interview revealed EH did not ask EE #1 about wearing a mask or who else he was in contact with. EE #1 stated, "I did have my fellow and scribe get tested because I work closely with them. They were both negative. I'm never around the circulating nurse or scrub tech that long, we're always 6 ft apart. None of the other staff tested positive as far as I know." Interview revealed EE #1 was unsure about the patient notification process but didn't think patients had any reason to be concerned because, "The CDC (Centers for Disease Control) definition of an exposure or close contact is more than 15 minutes face-to-face, less than 6 feet apart." EE #1 further revealed, "I know there are several people in our department who tested positive and as far as I know they didn't contact their patients...no changes in retrospect. I think I acted appropriately. I feel like it stopped with me."
Interview on 11/18/2020 at 1342 with the Infection Preventionist revealed, "It's always been an expectation that if an employee is sick, they're not supposed to come to work." Interview revealed the Infection Preventionist reviewed every positive COVID test that came from the facility's ED and reported it to the local health department. Interview revealed the Infection Preventionist reviewed EE #1's chart as a positive COVID test and when she realized EE #1 was a staff member she reached out to EH to let them know. Interview revealed if an employee did not wear a mask and the employee was less than 6ft away from a patient or co-worker for greater than 15 minutes it was considered an exposure. If an employee had on a mask and were closer, than 6ft for greater than 15 minutes to a patient or co-worker it would not be considered an exposure because the employee had a mask on. Interview revealed when there was an exposure infection prevention completed the patient contact tracing and EH completed the employee contact tracing. Interview revealed the "Non-Bloodborne Communicable Diseases" policy needed to be updated to include that an exposure for COVID was without a mask, less than 6ft apart for greater than 15 minutes not just "Within 6 feet for greater than 15 minutes."
Interview on 11/19/2020 at 0915 with the Director of Employee Health revealed the process for when employees tested positive for COVID was employees were supposed to notify employee health. Interview revealed when EH was called about an employee's positive COVID test they were supposed to ask the employee seven questions about the result including: the COVID 19 result, date resulted, where the employee was tested, symptoms, the first day of symptoms, if the employee was masked and used PPE at all times while working, and the last day they worked. Interview revealed the expectation was for the answers to these questions to be documented in the EH system. Interview revealed that contact tracing was only done if the employee tested positive and the employee stated they did not wear a mask at all times while at work. Interview revealed the Director monitored the positive COVID employees in the entire hospital system. Interview revealed it was possible to pull out the positive employees from a specific hospital in the hospital system, but it would take time.
Interview on 11/18/2020 at 1519 with MD #3, an Infectious Disease physician revealed "....most of the time a medical grade mask on the patient and employee is not considered an exposure or a very low risk." MD #3 revealed, "For low risk exposures, we would notify patients and other healthcare workers would get notified as well. For healthcare workers involved, we let them keep working with self-monitoring..." Interview revealed in EE #1's case MD #3 was not notified of his positive test. Interview revealed MD #3, the Employee Health Director and Infection Prevention talk on a daily basis about positive COVID employees and exposure risk. Interview revealed most of the time employees exposure was none or low risk as long as the employee was wearing the correct PPE. Interview revealed "there is always an opportunity to enhance our process." Interview revealed for EE #1, MD #3 had been notified of the case this morning and was still investigating the case but considered it a low risk exposure. Interview revealed "I think what we need to do is to shore up our process...there was a communication hiccup between employee health infection prevention and myself..."
2. Review on 11/17/2020 of a policy titled, "Non-bloodborne Communicable Diseases Exposure Plan", effective 09/11/2020 revealed, "PURPOSE: ...provide guidelines for the prevention and control of selected communicable diseases that spread among patients, staff and visitors...DEFINITIONS: ...D. Exposure Workup...The collection of information about and investigation of exposure events...Employee Health Responsibilities j. Investigate, report and follow-up with HCWs and volunteers on potential exposures...ATTACHMENTS...EXHIBIT 1: Definition of Exposure for Non-bloodborne Communicable Diseases...COVID 19 - Within 6 feet for greater than 15 minutes."
Review on 11/19/2020 of an Employee Health form titled "Positive Employee", no date, revealed 7 questions that EH asked employees positive with COVID. Review of the questions revealed "COVID-19 results, Date resulted, Where tested, Symptoms, First day symptoms, EE masked/PPE at all times while working, Last day worked."
a. Review of the EH record for EE #1 revealed a "Brief Note Visit" written by the Employee Health Physician Assistant (EHPA) dated 10/22/2020 at 0923 that stated, "Informed by Infection Prevention that (EE #1) has a positive Covid result. We have no info concerning illness. Attempted to call; no answer. LMOM (left message on machine). I will enter Covid monitoring based on report from Infection Prevention. I have not yet spoken to employee." Review of a "Confirmed Positive Employee Note" by EHPA dated 10/22/2020 at 0931 revealed, "EE (Employee) complains of sore throat 10/18. Developed fatigue, decreased taste/smell since yesterday. Was seen at ER (emergency room) at (facility) and Covid test Positive 10/21/20. No fever, not much cough. Advised OOW (out of work) through 10/28." Review failed to reveal EH asking about EE #1's last day of work and if EE #1 wore a mask at all times while working.
Interview on 11/19/2020 at 0915 with the Director of Employee Health revealed the process for when employees tested positive for COVID was employees were supposed to notify EH. Interview revealed when EH was called about an employee's positive COVID test they were supposed to ask the employee seven questions about the result including: the COVID 19 result, date resulted, where the employee was tested, symptoms, the first day of symptoms, if the employee was masked and used PPE at all times while working, and the last day they worked. Interview revealed the expectation was for the answers to these questions to be documented in the EH system.
b. Review of the employee health record for EE #2 revealed a Brief Note Visit dated 10/29/2020 at 1441 that stated, "EE left VM (voicemail) stating no taste or smell 10/28. EE states HA (headache), cough, chill, congestion since 10/25. COVID test 10/29. EE denies known COVID exposure but works in the ER. (Emergency Room) EE will notify EH of result and manager of OOW status." Review of a Confirmed Positive Employee Note written on 10/30/2020 at 1648 revealed, "EE with Confirmed POS COVID via (facility)...EE wore mask AD (all day) at work and ate alone. Advised OOW x 10 d (days) from 10/28 monitoring/quarantine. ER if any symptom increases." Review failed to reveal EH asking EE #2 the result date for the COVID test, and the last day worked.
Interview on 11/19/2020 at 0915 with the Director of Employee Health revealed the process for when employees tested positive for COVID was employees were supposed to notify EH. Interview revealed when EH was called about an employee's positive COVID test they were supposed to ask the employee seven questions about the result including: the COVID 19 result, date resulted, where the employee was tested, symptoms, the first day of symptoms, if the employee was masked and used PPE at all times while working, and the last day they worked. Interview revealed the expectation was for the answers to these questions to be documented in the EH system.
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c. Review of the employee health record for EE #4 revealed "10/19/2020 1134...EE (employee) reports that her COVID test resulted as positive, she was tested on 10/19. Her last day of work was 10/19, but she wore a mask at all times and left work after 1 hour. She is aware that she will need to quarantine for 10 days from 10/19 and be cleared by EH (employee health) prior to RTW (return to work)..." Review failed to reveal EH asking about EE #4's symptoms, first day of symptoms, where EE #4 was tested and the date of their COVID-19 result.
Interview on 11/19/2020 at 0915 with the Director of Employee Health revealed the process for when employees tested positive for COVID was employees were supposed to notify EH. Interview revealed when EH was called about an employee's positive COVID test they were supposed to ask the employee seven questions about the result including: the COVID 19 result, date resulted, where the employee was tested, symptoms, the first day of symptoms, if the employee was masked and used PPE at all times while working, and the last day they worked. Interview revealed the expectation was for the answers to these questions to be documented in the EH system.
d. Review of the employee health record for EE #5 revealed "...10/15/2020 0926...EE reports that she is experiencing HA, fatigue, cough and BA's (body aches). She will get tested for COVID today. she is aware that she will need to be OOW until cleared by EH...10/16/2020 1545...EE reports that she became symptomatic and was tested for COVID on 10/15 which resulted as positive. She reports that she always wears her mask and isn't within 6ft of people on breaks. EE aware that she will need to quarantine for 10 days from 10/15 and cleared by EH prior to RTW..." Review failed to reveal EH asking about EE #5's last day of work, first day of symptoms or where she was tested.
Interview on 11/19/2020 at 0915 with the Director of Employee Health revealed the process for when employees tested positive for COVID was employees were supposed to notify EH. Interview revealed when EH was called about an employee's positive COVID test they were supposed to ask the employee seven questions about the result including: the COVID 19 result, date resulted, where the employee was tested, symptoms, the first day of symptoms, if the employee was masked and used PPE at all times while working, and the last day they worked. Interview revealed the expectation was for the answers to these questions to be documented in the EH system.
e. Review of the employee health record for EE #6 revealed "...10-09-2020 1510...EE's supervisor called to say that EE reported that he was tested for COVID on 10/07 and it was positive. Called EE to verify, no answer LMOM to call back...10-16-2020 1426 -10/16: Several attempts to contact EE unsuccessfully with mailbox full and unable to LMOM. EE was not entered into COVID POS monitoring correctly and therefore has not received any monitoring questionnaires but was placed on 10d OOW monitoring for COVID spreadsheet. Will send email to EE and supervisor advising needs to contact Employee Health for further discussion...10-16-2020 1437 10/16 EE is PRN (works as needed) and notes test was 10/9 and POS. EE advised OOW x 10d from 10/9 will update and correct chart..." Review failed to reveal any other documentation about further contact to EE #6 asking about where tested, symptoms, first day of symptoms, the last day worked and if EE #6 was masked or had PPE on at all time.
Interview on 11/19/2020 at 0915 with the Director of Employee Health revealed the process for when employees tested positive for COVID was employees were supposed to notify EH. Interview revealed when EH was called about an employee's positive COVID test they were supposed to ask the employee seven questions about the result including: the COVID 19 result, date resulted, where the employee was tested, symptoms, the first day of symptoms, if the employee was masked and used PPE at all times while working, and the last day they worked. Interview revealed the expectation was for the answers to these questions to be documented in the EH system.
f. Review of the employee health record for EE #8 revealed "...10-12-2020 1238...EE states + COVID. Symptoms started 10/9. EE states always masked while at work with patients and co-workers. Advised OOW x 10 days. States understanding...10-19-2020 1543 Attempted to call patient to discuss RTW. No answer and mailbox full. will send email to call us and will email supervisor...10-20-2020 0007...EE LM (left message) stating last fever last week. Cleared to RTW..." Review failed to reveal documentation of when EE #8's COVID test came back, results from her COVID test came back, where she was tested, what her symptoms were, and the last day she worked.
Interview on 11/19/2020 at 0915 with the Director of Employee Health revealed the process for when employees tested positive for COVID was employees were supposed to notify EH. Interview revealed when EH was called about an employee's positive COVID test they were supposed to ask the employee seven questions about the result including: the COVID 19 result, date resulted, where the employee was tested, symptoms, the first day of symptoms, if the employee was masked and used PPE at all times while working, and the last day they worked. Interview revealed the expectation was for the answers to these questions to be documented in the EH system.
3. Review on 11/19/2020 of a policy titled "Infection Control, Surgical Services" last revised 06/2019 revealed " ...1. Restricted Area a. All personnel entering the restricted area will wear freshly laundered scrub attire, mask, hair covering and shoe covers if appropriate ...The restricted areas are marked with red lines. Restricted areas include: ...3) Sterile supply areas. 4) Decontamination - shoe covers, fluid-resistant masks, eye protection and a fluid-resistant gown are required to be worn in this area ..."
a. Observation on 11/17/2020 at 1145 in the sterile processing area a restricted area revealed the Manager of Sterile Processing wearing a cloth mask.
Interview on 11/19/2020 at 1130 with the Director of the Operating Room revealed staff were not supposed to wear cloth masks "behind the red line" or in patient areas. Interview revealed staff should be wearing a surgical mask. Interview revealed the Director spoke with the Manager of Sterile Processing about not wearing a cloth masks in the sterile processing area.
b. Observation on 11/18/2020 at 1100 in the sterile processing area, a restricted area revealed the Manager of Sterile Processing wearing a cloth mask while cleaning surgical instruments and a Sterile Processing Tech cleaning endoscopes wearing a cloth mask.
Interview on 11/19/2020 at 1130 with the Director of the Operating Room revealed staff were not supposed to wear cloth masks "behind the red line" or in patient areas. Interview revealed staff should be wearing a surgical mask. Interview revealed the Director spoke with the Manager of Sterile Processing about not wearing a cloth masks in the sterile processing area.
4. Review of a PPE guidance titled "Updated August 25: Follow Guidance on Masks and Appropriate Use of PPE" last updated 08/25/2020 revealed " ...This affects all physicians, APPs, (Advanced Practice Providers) house staff, nurses and clinical staff at all (Healthcare System Name) locations. Clinical leaders: Please share this message with appropriate staff ...Personnel Performing Aerosol-Generating Procedures Please wear gowns, gloves, N95 respirators and goggles for ALL patient encounters requiring the performance of aerosol-generating procedures (AGPs). These include, but are not limited to intubation, extubation ...and any other cough-inducing procedures ..."
Interview on 11/19/2020 at 1110 with the Director of the OR (Operating Room) revealed she was not sure if they used N95s during intubation in surgery, she would have to ask the lead CRNA (Certified Registered Nurse Anesthetist). Interview revealed patients were tested for COVID within 7 days of their scheduled surgery.
Interview on 11/19/2020 at 1115 with CRNA #1, the lead CRNA revealed N95 masks were not worn during intubation in surgery. Interview revealed patients had to screen negative for COVID-19 within 7 days of having surgery at the hospital and the hospital did not accept COVID-19 positive patients for surgery. Interview revealed staff in the OR during intubation wore surgical masks.
Interview on 11/19/2020 at 1515 with the Director of Clinical Compliance revealed the OR staff should be following the guidance from 08/25/2020 for aerosol generating procedures and should be wearing full PPE, including N95 respirators for intubation procedures.
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5. Review on 11/17/2020 of the facility policy "Communicable Diseases, Employee Health" last revised 10/2016 revealed, "All HCWs (Healthcare Worker) must have a pre-placement health evaluation prior to their start date. The following is to be completed as part of the evaluation ... 3. Respiratory Protection Screening: Must be completed for individuals whose job activities may place them at 'reasonable risk' for exposure to infectious airborne diseases or hazardous airborne materials ... During the pre-placement screening and on an annual basis, designated HCWs are required by OSHA to complete respirator fit testing and a questionnaire ..."
Review on 11/19/2020 of the facility communication "Annual Respirator Fit Testing Temporarily Suspended" dated 2/26/2020 revealed, "Effective today, February 26, 2020, Employee Health will no longer conduct annual respirator fit testing (N95) until further notice. Note: New employees and students who have direct patient care will continue to be tested during their new employment visit with Employee Health."
a. Personnel file review on 11/19/2020 failed to reveal fit testing documentation during pre-placement (on-hire) for RN #12.
Interview on 11/19/2020 at 1400 with the Infection Preventionist, revealed direct patient care staff should be fit tested on hire.
b. Personnel file review on 11/19/2020 failed to reveal fit testing documentation during pre-placement (on-hire) for EVS #1 (Environmental Services).
Interview on 11/19/2020 at 1400 with the Infection Preventionist, revealed direct patient care staff should be fit tested on hire.
NC00171236