DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER
(X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY COMPLETED
450702 A. BUILDING __________
B. WING ______________
01/15/2022
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP
LONGVIEW REGIONAL MEDICAL CENTER 2901 N FOURTH ST, LONGVIEW, TX, 75605
For information on the provider's plan to correct this deficiency, please contact the provider or the state survey agency.
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY SHOULD BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A0043 Governing Body
482.12
Corrected On:
19159 Based upon observation, record review, and interview, the Governing Body failed to A. ensure the Quality Improvement Program was organized and effectively coordinated, implemented, and monitored Performance improvements (PI). The facility failed to have an effective manner for clinical and non-clinical departments to report Quality information to administrative staff. B. ensure PIs that were currently in place were being tracked, trended and analyzed. C. ensure that high risk and problem-prone areas were focused on, identified, data collected, PI's developed and PI's reported timely in clinical and non-clinical services. Refer to Tag A0283 for additional information. D. ensure that 2 (NP # 1, and # 31) of 3 Nurse Practitioners (NPs) were granted privileges for prescriptive authority specifically Moderate Sedation. NPs were routinely ordering moderate sedation in the Interventional Radiology Department and the Emergency Department without the proper credentialing and delineation of privileges approved by the Medical Staff. The NPs placed all patients receiving moderate sedation at great risk for patient harm and possible subsequent death. Refer to Tag A0341 for additional information E. ensure a hospital-wide program was in place to prevent and control infections in 9 of 9 areas reviewed for infection control (front entrance of hospital, Coronavirus disease (COVID) unit, Emergency department (ED), Laundry, Main central supply, Lab, Wound care center, Progressive care unit, and Intensive care unit). The facility failed to: 1. ensure there was an effective infection control program which included an infection control committee and staff to assist with surveillance, infection control rounding and identifying infection control problems in the facility. 2. ensure visitor screening for COVID was performed per their internal policy. 3. ensure sterile and non-sterile supplies were stored in a manner to prevent cross contamination. They failed to ensure clean and soiled equipment were separated. 4. ensure lab supplies were transported under specified temperatures per the manufacturer. The facility failed to ensure lab and surgical supplies were transported in a manner to prevent cross contamination. 5. ensure physicians, nurses, and housekeeping staff used proper personal protective equipment (PPE) while working on the COVID unit. 6. ensure expired supplies were discarded and multi-dose vials were dated when opened. 7. ensure the lab was kept in clean and sanitary conditions. 8. ensure patient equipment and rooms were kept clean and sanitary Refer to tag A0749 for additional information. F. ensure there was a qualified individual who was appointed by the Governing body to be over the antibiotic stewardship. This was found in 1 of 1 physicians who was identified as being over the program (Physician #7). Refer to tag A0760 for additional information. G. ensure a clean and sanitary environment in 10 (Surgical Hallways X3, Operating Rooms (OR's) #2, #3, #5, #6, Central Supply Room, Cardiac Cath Lab #3, and OR #2 in Labor and Delivery) of 10 areas observed. H. ensure the temperature and humidity was monitored in the C-section room to inhibit microbial growth, reduce the risk of infection, promote patient comfort, and assure the physical safety of all patients. Refer to Tag A0940 for additional information.
A0117 Patient Rights: Notice Of Rights
482.13(a)(1)
Corrected On:
36827 Based on observation, review of records, and interview, the facility failed to develop a process that ensured patients were provided with the original copy of the Important Message from Medicare (IM Letter) and/or Medicare Outpatient Observation Notice (MOON Letter) within the required time-frame for 3 patients (Patient #33, #34, and #35) out of 5 patients reviewed for completed notices. Findings included: On 1-10-2022, interviews were conducted with Registration Staff, Non-Physician Staff #30, #31, and #33 located in the Emergency Department, Outpatient Radiology Registration, and Day Surgery Registration. Each confirmed that the IM Letter and/or Moon letter was signed during the admission registration process. During the Admission Registration process, patients sign multiple forms such as consent to treat, privacy policies information, patient rights information, as well as the IM and/or Moon letters. All staff interviewed stated that the patient was asked if they wanted a copy of all of the paperwork they had signed. If the patient stated no, copies of all signed paperwork were not provided. This included the IM Letters and Moon Letters. The information on the IM Letters and Moon Letters contained important information about the patient's rights that was not found to available to the patient elsewhere. General patient rights information was found in the patient handbook located in a package in patient rooms. The handbook did not contain information about Medicare patients' rights as contained on the Moon Letter and IM Letter. These rights would not be in a general public handbook as they are specific to Medicare patients and the patients' admission status as an inpatient or an outpatient under observation. Review of the Medicare Claims Processing Manual Chapter 30 provided requirements for the delivery of the IM and MOON letters, along with time frames for delivery, as follows: "200.3.1 - Delivery of the Important Message from Medicare Hospitals must follow the procedures listed below in delivering the Important Message from Medicare (IM). ... Hospitals must deliver the original copy of the IM at or near admission, but no later than 2 calendar days following the date of the beneficiary's admission to the hospital. Hospitals may deliver the initial copy of the notice if the beneficiary is seen during a preadmission visit, but not more than 7 calendar days in advance of admission. If a beneficiary receives and signs the initial copy of the IM as part of the preadmission process, the follow-up copy of the notice must be delivered if delivery of the initial copy occurred more than 2 calendar days prior. In-Person Delivery. The IM must be delivered to the beneficiary in person. However, if the beneficiary is not able to comprehend the notice, it must be delivered to and signed by the beneficiary's representative. ... Notice Delivery and Retention. Hospitals must give the original copy of the signed or annotated notice to the patient. Hospitals must retain a copy of the signed notice and may determine the method of storage that works within their existing processes, for example, storing a copy in the medical record or electronically ... 400.3.3 - Hospital Delivery of the MOON Hospitals and CAHs must deliver the MOON to beneficiaries in accordance with section 400.2 above. Hospitals and CAHs must provide both the standardized written MOON, as well as oral notification. Oral notification must consist of an explanation of the standardized written MOON. The format of such oral notification is at the discretion of the hospital or CAH, and may include, but is not limited to, a video format. However, a staff person must always be available to answer questions related to the MOON, both in its written and oral delivery formats. The hospital or CAH must ensure that the beneficiary or representative signs and dates the MOON to demonstrate that the beneficiary or representative received the notice and understands its contents. Use of assistive devices may be used to obtain a signature. Electronic issuance of the MOON is permitted. If a hospital or CAH elects to issue a MOON viewed on an electronic screen before signing, the beneficiary must be given the option of requesting paper issuance over electronic issuance if that is what the beneficiary prefers. Regardless of whether a paper or electronic version is issued and regardless of whether the signature is digitally captured or manually penned, the beneficiary must be given a paper copy of the MOON, as specified in 400.3.9, and the required beneficiary specific information inserted, at the time of notice delivery 400.3.4 - Required Delivery Timeframes The MOON must be delivered to a beneficiary who receives observation services as an outpatient for more than 24 hours, and must be delivered not later than 36 hours after observation services begin. The MOON must be delivered before 36 hours following initiation of observation services if the beneficiary is transferred, discharged, or admitted. The MOON may be delivered before a beneficiary receives 24 hours of observation services as an outpatient. The start time of observation services, for purposes of determining when more than 24 hours of observation services have been received, is the clock time observation services are initiated (furnished to the patient), as documented in the patient's medical record, in accordance with a physician's order. This follows the elapsed clock time, rather than the billed time, associated with the observation services." Review of Patient #33's chart was made on the afternoon of 1-10-2022 with RN Staff #27 and #28. Patient #33 was a Medicare patient and had been admitted as an inpatient on 1-3-2022. The patient was anticipated to be discharged on 1-11-2022, the next morning. RN Staff #27 was not able to find evidence of the initial delivery of the IM Letter in the electronic chart. RN Staff #28 was unable to find the physical copy of the letter. An interview was conducted with Patient #33 who confirmed that he had not been given a copy of the IM Letter at admission. On the morning of 1-11-2022, Patient #34's chart was reviewed with RN Staff #21. Patient #34 was a Medicare eligible patient who was required to receive the IM Letter upon admission. He was admitted on 12-9-2021. No record was found of the patient receiving the initial delivery of the IM letter within 2 days of admission. He had been anticipated to be discharged and given an IM letter on 12-13-2021. His discharged had been delayed and the discharge delivery was made again on 12-17-2021, prior to discharge as required. On the morning of 1-11-2022, Patient #35's chart was reviewed with RN Staff #21. An order was place on 8-1-2020 at 2050 (8:50 PM), and again on 8-2-2020 at 0014 (12:14 AM). An order for inpatient was placed on 8-4-2020, over 36 hours after the initial order for inpatient and original observation admission date of 8-1-2020 listed on the medical record. No record of a MOON letter was found in the patient chart. An interview was conducted with Staff #21 who was going to check with registration to see if the MOON Letter was elsewhere. Staff #21 confirmed that registration had no record of providing the patient with a MOON Letter. The facility was unable to provide information or data on the tracking of this process to ensure patients received their notice of rights.
A0131 Patient Rights: Informed Consent
482.13(b)(2)
Corrected On:
36827 Based on review of records and interview, the facility failed to ensure that patient consents were properly completed in 9 patients (Patient #8, #9, #13, #34, #37, #73, #77, #78, and #80 ) out of 17 patients charts reviewed for consents. Findings included: Patient #13 A chart review was conducted on 1-10-2022 for dialysis Patient #13. A consent was found to be signed by the patient and witnessed by a registered nurse. It had been signed on 1-3-2022 at 6:15 AM. The patients name was printed on the line where the attending physician's name was to be filled in. The form read as follows: "I authorize (Patient #13's printed name), my attending physician, to treat (line left blank instead of the full name of the patient) with the artificial kidney machine." The last section of the form contained the following statement: "TO BE COMPLETED BY PHYSICIAN: I hereby certify that I have explained the nature, purpose, benefits, risks, side effects, likelihood of achieving goals, potential problems that might occur during recuperation, risks for not receiving the proposed care, treatment, and services, and alternatives of the proposed operation/procedure. I have offered to answer any questions and have fully answered all such questions. I believe that the patient/their representative fully understands what I have explained and agrees to proceed." The required physician signature, date, and time had been left blank. On 1-10-2-22 at 10:00 AM, an interview was conducted with RN Staff #7 about the consent for hemodialysis. During the interview, RN Staff #7 failed to notice the discrepancies in the consent (Patient name in the physician blank and patient name was blank. No signature by the physician.) Patient #34 Patient #34 was admitted on 12-9-2021. A consent for blood products was found in the chart that had been signed on 12-10-2021 by the patient and witnessed by a registered nurse. Block #6 of the form was titled, "Additional Risks or Risk Factors Specific to this Patient." The block had been left blank and did not identify if there were no other specific risk factors (not applicable) or if this block had been overlooked. Page 3 of 3 contained the following statement: "TO BE COMPLETED BY PHYSICIAN/PROVIDER (PA, CRNP, HOSPITALIST): I hereby certify that I have explained the nature, purpose, benefit, risks, side effects, likelihood of achieving goals, and potential problems that might occur during the blood/blood product transfusion procedure; also explained the risks for not receiving the care, treatment, services, and alternatives of the proposed blood/blood product transfusion procedure. I have offered to answer any questions and have fully answered all such questions. I believe the patient/their representative fully understands what I have explained and agrees to proceed." This section was not signed by the physician or a verbal attestation documented by a nurse's signature. A consent for General Anesthesia was found in the chart. The section for Additional comments/risks had check boxes to indicate the type of anesthesia specific to the patient with additional comments and risks. This section did not have the specific type of anesthesia that patient was to receive identified. The block for Other was a fill in the blank entry that other types of risks could be entered. This block was left blank did not identify if there were no other specific risk factors (not applicable) or if this block had been overlooked. Patient #37 Patient #37 was admitted on 12-5-2021 with a right femur fracture. A consent for the surgical procedure was found in the file. The name of the physician performing the procedure was not listed on the consent. The patient signed the consent on both pages, but the signature had no date listed. A physician signature of 12-6-2021 was on the form, but a patient identification sticker covered the block for time so the time of physician signature could not be verified. A separate blood consent was found on the chart. A telephone consent was completed by two nurses on 12-8-2021 0024 (12:24 AM) with the patient's daughter. . Page 3 of 3 contained the following statement: "TO BE COMPLETED BY PHYSICIAN/PROVIDER (PA, CRNP, HOSPITALIST): I hereby certify that I have explained the nature, purpose, benefit, risks, side effects, likelihood of achieving goals, and potential problems that might occur during the blood/blood product transfusion procedure; also explained the risks for not receiving the care, treatment, services, and alternatives of the proposed blood/blood product transfusion procedure. I have offered to answer any questions and have fully answered all such questions. I believe the patient/their representative fully understands what I have explained and agrees to proceed." This section was not signed by the physician or a verbal attestation documented by a nurse's signature. Patient #73 Patient #73 was admitted on 1-10-2022. An Admission Consent to Treat was found on the chart. Section 8 contained the Notice of Privacy Practices and required the patient to initial either consent to give the facility permission to release the patient's name, room number, and general condition to anyone who inquires during the patient stay; or to withhold consent to release this information. This section was not completed. A review of the Longview Regional Medical Center Policy titled, "Functional Manual - Consent Policy was made as follows: "SUBJECT: To establish general guidelines for obtaining patient consent. ... PROCEDURE: Consent to Hospital Admission and Treatment This general consent form is designed to cover all routine procedures in the hospital for which a surgical or special consent form is not required. Procedures include routine medical, diagnostic, radiology and laboratory testing as well as most outpatient testing. This consent is valid for the length of the patient's current hospitalization. Disclosure and Consent for Medical and Surgical Procedures. The consent for Medical and Surgical procedures OR- 1701 should be used for the following procedures. 1. Major and minor surgery involving entry into the body, either through an incision or through a natural body opening. 2. Procedures in which general, regional block or spinal anesthesia is used, regardless of whether an entry into the body is involved. 3. The administration of medicine, dye and other material that involves mor than slight risk of harm to the patient or that may cause a change in the patient's body structure. 4. Experimental procedures. 5. Blood/transfusions, blood products ... RESPONSIBILITY FOR OBTAINING CONENT Consent to Hospital Admission and Treatment The admitting employee responsible for coordinating the patient's admission into the hospital is responsible for obtaining and witnessing the patient's signature on the medical consent form (conditions of admission). ... Surgical/Procedural Consent The attending physician and/or surgeon are responsible for informing the patient of all alternative options, all potential complications and risks, and benefits or (sic) surgery. The physician, or designee, is also responsible for obtaining the proper signature indicating consent. Disclosure of Risks It is the physician's or surgeon's responsibility to give the patient sufficient information regarding the planned procedure so that the patient gives an informed consent. Every consent for a procedure listed on - Texas Medical Disclosure Panel - must have the list of risks defined by the panel written on the consent form. ... CONSENT OR REFUSAL FOR BLOOD AND/OR BLOOD PRODUCTS The nurse may obtain the patient's consent or refusal for blood and/or blood products on the Blood and/or Blood Product consent form (1740), following the physician's informing the patient all of the alternative options, of all potential risks, and benefits. Regardless of the number of transfusions per hospital stay, only one consent for blood transfusion is necessary." 32143 Review of Patient #8's blood consent revealed the physician signed the consent on 1/6/22 at 1600 (4:00PM) but the patient's son did not sign the blood consent until 1/7/22 at 11:25AM. There was no documentation found that the physician had talked to the son previously concerning the risk and benefits. Review of Patient #9's chart revealed the blood consent was signed by the patient's daughter and the nurse on 1/9/22 at 1656. The physician signed the consent but there was no date or time documented. Review of Patient #78's chart revealed the physician did not sign or date the blood consent. Review of Patient #77's chart revealed the nurse recieved a telephone consent at 1700 (5:00PM) but only wrote 12/22. There was no complete date for day or year. The physician did not sign or date the blood consent. Review of Patient #80's chart revealed the physician did not sign or date the blood consent.
A0144 Patient Rights: Care In Safe Setting
482.13(c)(2)
Corrected On:
29191 Based on observation, record review, and interview, the facility failed to ensure the chlorine checks were conducted and performed every 4 hours per the manufacture guideline "RPC Ultra-low Total Chlorine Test Strips" and the facility's dialysis policy. This deficient practice has the likelihood to cause dialysis patients to have severe injury or death. Findings included: Observed Staff #3 on 01/10/2022 at 10:30 AM perform chlorine checks on the "Tablo" dialysis machine. Staff #3 collected 30 cc of water from the "Tablo" dialysis machine and using the "RPC Ultra-low Total Chlorine Test Strips" to perform the chlorine check. Staff #3 swished the chlorine test for about 10 seconds and held it up to the light. Staff #3 stated, "I know its good when the water turns yellow in the cup." The "RPC Ultra-low Total Chlorine Test Strips" instructions for use were not followed per the manufacture's guideline. A review of the medical record revealed the chlorine checks were not documented in the medical record. The documentation on the "Tablo" dialysis machine only had a pass or fail of the chlorine check test and was documented by the staff member. There was no documentation of the actual chlorine test results. The facility dialysis staff failed to follow the facility dialysis policy "Water Cultures and AAMI Quality Sample Collection." A review of the of the "RPC Ultra-Low Total Chlorine Test Strips" instructions for use revealed the following: "Introduction: Testing to determine levels of chloramines and/or free chlorine in water used for dialysis and the rinse water of dialysis machines is required by the Centers for Medicare and Medicaid Services (CMS), water treatment system manufacturers, and dialysis machine manufacturers. CMS has adopted the Association for the Advancement of Medical Instrumentation (AAMI) recommendations. The AAMI/ANSI National Standard for Hemodialysis Systems (RD62 - 2006) lists the maximum allowable level for these contaminants. RPC's Kl00-0 106 E-Z Chek® Sensitive and K 100-0118 (includes optional "F" color chart version) UltraLowTM Total Chlorine Test Strips are FDA 510k cleared for testing dialysis water for low levels of total chlorine and are widely used for this purpose. WARNING: Levels of chloramines and free chlorine in dialysis water greater than the AAMI/ANSI maximum allowable levels (0.1 ppm chloramines and 0.5 ppm free chlorine) may cause severe injury or death to dialysis patients. Failure to follow instructions for use for the K100-0106 E-Z Chek® Sensitive, K100-0118 (IF) Ultralow Test Strips, or other analytical tests (e.g. DPD based tests) for chlorine may result in inaccurate test results. Test Procedure: 1) Collect a fresh 100 ml sample of water in a clean plastic sample cup (such as RPC # K100-l 100). A. The sample cup should be known to be free of chlorine or, prior to collecting the sample, rinse the clean sample cup with the water to be tested. B. Be sure to collect the sample just prior to performing the test as Chlorine tends to volatilize out of the sample quickly. 2) Remove one test strip from its foil package and swish it in the sample for the amount of time indicated according to the following temperature ranges: Water sample temperature from 42° F to 61° F (6° C to 16° C), swish time = 60 seconds. Water sample temperature from 62° F to 74° F (17° C to 23° C), swish time = 32 seconds. Water sample temperature from 75° F to 88° F (24° C to 31° C), swish time = 20 seconds. Water sample temperature from 89° F to 93° F (32° C to 34° C), swish time = 15 seconds. A. Move the strip back and forth at a constant gentle rate of approximately two, 1-2-inch-wide strokes (one forward - one backward) per second as shown in Figure 1. 3) Remove the strip and shake once, briskly, to remove excess water. 4) Wait 20 seconds for the test strip color to develop. While waiting, fold the white plastic handle of the test strip under the reagent area aperture so that it provides a consistent viewing background (Figure 2) 5) Alter the 20 second wait period, immediately compare the strip color to the K] 00-0118 or K 100-011 8F color chart to determine the Total Chlorine level in the sample. NOTE: The strip should yield a uniform color across the entire viewing window. If the window is not a uniform color (e.g., part green and part 'yellow) repeat the test. A valid result is one in which the viewing window has a uniform color ONLY. Storage and handling: Store at temperatures between 59°-86°F (150 C to 300 C). Do not use a test strip after the expiration date. The lot number and expiration date are printed on each foil wrapper. Do not touch the indicator pad. Do not allow the test strip to come in contact with liquids or with work surfaces that may be contaminated with potentially interfering substances. Do not leave test strips in areas exposed to chlorine vapors or other oxidizing vapors." A review of the facility's dialysis policy titled, "Policy Water Cultures and AAMI Quality Sample Collection" dated 9/20/2020 revealed the following: "PURPOSE: To provide unit standard procedure for testing of water to be used for hemodialysis treatments. This will ensure safe and effective treatments for hemodialysis patients and proper care of hemodialysis equipment. B. Compliance with maximum level of chemical contaminants in water 2. Prior to each hemodialysis treatment water will be tested for the presence of total chlorine (baseline test). In addition, every 4 hours from the beginning of a hemodialysis treatment, should the treatment last beyond four hours' time, the machine will be tested for presence of Total Chlorine. 3. Document results on flow sheet. Total Chlorine results should be documented in the patient medical record. 4. Water to be used in hemodialysis treatments cannot exceed 0.1 mg/L chloramines. 5. If the baseline water chlorine test exceeds these values, the dialysis coordinator is notified, and any hemodialysis treatments are postponed. A positive test for chlorine/chloramines require changing of the carbon tanks, which must be done within 24 hours. 6. IF a chlorine check performed while patients are being dialyzed turns positive. a. Stop the treatment and notify the Nephrologist. b. Contact "Tablo" maintenance personnel to have filters replaced within 24 hours. Use a backup machine to perform treatments until the filters are replaced." An interview with Staff #6 and #7 on 01/10/2022 at 3:00 PM confirmed that chlorine checks were not being performed by the dialysis staff per the "RPC Ultra-low Total Chlorine Test Strips" manufacture's guidelines and the facility's policy "Water Cultures and AAMI Quality Sample Collection" was not being followed.
A0263 QAPI
482.21
Corrected On:
10135 Based on interview, and record review, the facility failed to implement and maintain an effective data-driven quality assessment and performance program. The facility failed to track, measure, and analyze success on performance improvement projects for the timeframe of January 2021 to December 2021. The facility failed to: A. ensure the Quality Improvement Program was organized and effectively coordinated, implemented, and monitored Performance improvements (PI). The facility failed to have an effective manner for clinical and non-clinical departments to report Quality information to administrative staff. B. ensure PIs that were currently in place were being tracked, trended and analyzed. C. ensure that high risk and problem-prone areas were focused on, identified, data collected, PI's developed and PI's reported timely in clinical and non-clinical services. Refer to A tag 0283 for additional information.
A0283 Quality Improvement Activities
482.21(b)(2)(ii), (c)(1), (c)(3)
Corrected On:
10135 Based on interview, and record review, the facility failed to ensure data collected was used to identify opportunities for improvement. The facility failed to track, measure, and analyze success on performance improvement projects for the timeframe of January 2021 to December 2021. The facility failed to: A. ensure the Quality Improvement Program was organized and effectively coordinated, implemented, and monitored Performance improvements (PI). The facility failed to have an effective manner for clinical and non-clinical departments to report Quality information to administrative staff. B. ensure PI's that were currently in place were being tracked, trended and analyzed. C. ensure that high risk and problem-prone areas were focused on, identified, data collected, PI's developed and PI's reported timely in clinical and non-clinical services. This deficient practice had the likelihood to cause harm to all patients. Findings include: QUALITY ORGANIZATION Review of an undated facility's quality organization chart revealed the following: According to the organization chart the regulatory compliance branch reported to the Medical Quality and Resource Committee (MQRC) which reported directly to the Medical executive committee (MEC). The regulatory compliance branch had the responsibility of approval of performance improvement indicators for departmental committees. The Medical Quality and Resource Committee had a responsibility of reviewing the quality reports and the top ten performance improvements for the hospital. Trauma, clinical specialties, Pharmacy and therapeutics, Emergency department/ Critical care, Obstetrics/gynecology/Pediatrics/Neonatal intensive care, Surgery, Medicine and COVID branched off as reporting to the Medical executive committee. Bypassing the Quality branch on the organization chart. The majority of the medical committees were segmented and not being funneled into the branch which had the responsibility to review their information prior to going to the Medical executive committee. The Medical Quality and Resource Committee (MQRC) and the regulatory compliance branch could not effectively review and analyze this information. During an interview on 01/11/2022 after 1:35 p.m., with Registered nurse #40 (Chief quality officer) confirmed the organization chart did not reflect the correct way to report. Registered nurse #40 said they had come up with another organization chart, but it had not been approved yet. INFECTION CONTROL During an interview on 01/10/2022 after 9:30 a.m., Registered nurse #13 (Infection control preventionist) said the facility was without an infection control preventionist from January to May 2021. Registered nurse #13 said he had started the position in May 2021 and was reestablishing the infection control committee in February 2022. Since there was no committee he was taking his infection control information to the Clinical outcome meetings, but that stopped in October 2021 because of Coronavirus disease (COVID). Staff #13 provided documentation showing the last formal infection control committee meeting was 08/29/2019. Registered nurse #13 said he was developing a rounding schedule, but it had not been implemented yet. The units that he had not rounded on was dietary, radiology, pharmacy, and wound care. Registered nurse #13 said the employees who had taken the COVID vaccine being tested every 2 weeks. When asked to see the information on the testing and staff that were off work with COVID. Registered nurse #13 said Employee health kept the information and that it was not being sent to him. Without an infection control committee and incomplete rounding there was no way to address infection control improvement projects for the hospital units. Without having the staff's COVID vaccine information, there was no way Staff #13 could track, trend and analyze the information. LINEN/LAUNDRY During an interview on 01/10/2022 after 10:48 a.m., Staff # 26 (Director of Laundry) said she had some performance improvements that were being taken to the linen committee. Staff #26 said she also had some performance improvements which came from her corporate office and had been started, but they were not being taken through the hospital's Quality department. WOUND CARE CENTER During an interview on 01/12/2022 after 2:44 p.m., Staff #49 (Director of Wound Care) said they did not have any performance improvements that they were working on. PHARMACY During an interview on 01/13/2022 after 10:22 a.m., Staff #50 (Interim Director of Pharmacy) said she had been in her position since 11/01/2021. Staff #50 said the facility had only 2 of 4 pharmacy and therapeutic (P&T) meetings for 2021. During the last P & T meeting they did not go into depth on adverse events or medication errors. Staff #50 said they were tracking problems in pharmacy and showed the surveyor the computerized system they were using. Staff #50 said the information was not being analyzed and sent to the Quality department. PERFORMANCE IMPROVEMENT PROJECTS AND PROGRAM During an interview on 01/11/2022 after 1:35 p.m., with Registered nurse #40 (Chief quality officer) said she had been in her position since June 2021. The facility's reporting quarters for Quality were as follows: First Quarter January- March 2021 Second Quarter April- June 2021 Third Quarter July-September 2021 Fourth Quarter October- December 2021 All of the individual department committees met monthly and were supposed to report to the Medical Quality and Resource Committee (MQRC) quarterly. Registered nurse #40 showed meeting minutes for the MQRC with the following meetings dates: 02/25/21, 05/27/21, 08/26/21 and 12/30/21. She said the 12/30/21 was canceled because they did not have a doctor available. During an interview and record view on 01/12/2022 after 8:49 a.m., the following was found: Registered nurse #40 said their Quality department noticed in September 2021 that not all departments had project improvements that were tracked. Registered nurse #40 said she talked to the departments and told them they had to put at least one project improvement into place. Registered nurse #40 said that wound care put into place handwashing. When asked where was the monthly tracking to show how they were doing or the data that had been collected. Staff #40 said she had not gotten that information yet. The information was due by 12/30/21, but since they were not having that meeting the information would due before the January meeting. When questioned about when the departments were supposed to have their information into to her to analyze, she said there was no schedule yet. When asked if she was able to analyze the information before taking it to the Medical executive committee she said "no". Registered nurse #40 said nursing and pharmacy were entering medication errors into the system. The system was tracking the information, but the information was not being reported to Quality. Adverse events were being tracked, but not trended and sent to Quality. Registered nurse #40 said the only way Quality got an adverse event was if it reached a certain severity. The patient advocate was rounding and taking complaints and grievances, but the information was not being analyzed and brought through Quality. Registered nurse #40 said that would normally be the job of the risk manager, but they did not have one. The corporate Risk manager had been helping out by looking over "ERS and legal cases." The only project improvement she had from surgery was on immediate use. Same day surgery, post anesthesia and central supply did not have their own specific project improvements. Dialysis had one project improvement which was obtaining physician orders before treatments. When asked where the raw data was she reported not having it. Registered nurse #40 said that high risk discharge screening for resources was started while she was in case management around January 2021, but she did not take it through the Quality process. Review of a list of contracted services revealed there was 31 services which included anesthesia, blood supplier, hospice, lithotripsy, Neonatal intensive care unit eye exam, housekeeping, surgery monitoring, tele intensivist, tele neurology, staffing services, and wound care. The contracted linen service was not listed. Each one of the services on the list had one improvement project listed, but there was no documentation in the monthly slots of how the services were doing for 2021 with the listed improvement project. Staff #40 said contracted services did not have any project improvements that were being reported and that linen services was not even on the list. Staff #40 said linen service had improvement projects, but they were not being reported to Quality. Review of the facility's policy named "QUALITY IMPROVEMENT PLAN" dated 08/2021 which revealed the following: ". The Quality Improvement Program is designed to provide a systematic and organized mechanism to promote safe and quality patient care and services. Through an integrated, interdisciplinary process, patient care services shall be continuously monitored and evaluated to promote optimum outcomes. The organization has the responsibility to design, measure, assess, and improve performance and patient safety. Ultimate authority and accountability for the quality and safety of patient care and services lies with the Governing Board and is delegated through the Quality Improvement Program to the Medical Staff, Administration and staff of the hospital ..." " ...Quality improvement activities will address both clinical and organizational functions. These activities are designed to assess key functions of patient care and to identify, study, and correct problems and improvement opportunities found in the processes of care delivery ..." " ...Quality Improvement and Risk Management programs must be integrated to assure the ongoing improvement of quality and safety of patient care and services provided by the organization. To achieve this integration: The Risk Manager if a member of the Quality Improvement Council and provides reports as specified by the Council ..." " ...Occurrence reports involving potential or actual quality issues will be referred too and evaluated by the Risk Manager and referred to the Medical Staff Review Committees as appropriate. Identified opportunities to improve will be reported to the Quality Improvement Council for prioritization."
A0338 Medical Staff
482.22
Corrected On:
41831 Based on observation, document review, and interview, the Medical Staff failed to ensure that 2 (NP # 1, and # 31) of 3 Nurse Practitioners (NPs) were granted privileges for prescriptive authority specifically Moderate Sedation. NPs were routinely ordering moderate sedation in the Interventional Radiology Department and the Emergency Department without the proper credentialing and delineation of privileges approved by the Medical Staff. The NPs placed all patients receiving moderate sedation at great risk for patient harm and possible subsequent death. Cross Refer to Tag A0341
A0341 Medical Staff Credentialing
482.22(a)(2)
Corrected On:
41831 Based on observation, document review, and interview the Medical Staff failed to ensure that 2 (NP # 1, and # 31) of 3 Nurse Practitioners (NPs) were granted privileges for prescriptive authority specifically Moderate Sedation. NPs were routinely ordering moderate sedation in the Interventional Radiology Department and also in the Emergency Department. Without the proper credentialing and delineation of privileges approved by the Medical Staff, the NPs placed all patients receiving moderate sedation at great risk for patient harm and possible subsequent death. Findings Include: A review of the Medical Credential Files for the Nurse Practitioner in the Interventional Radiology Department as well as in the Emergency Department revealed the following: Nurse Practitioner # 1 A review of the credentialing file for Physician Assistant (NP #1) was as follows: No prescriptive authority was requested or recommended. No Moderate Sedation Privileges were requested or recommended. The Delineation of Privleges was signed by NP # 1, Physician # 5, and Physician # 6 on 04/12/2021. Nurse Practitioner # 31 A review of the credentialing file for Nurse Practitioner # 31 (NP) #31 was as follows: No prescriptive authority was requested or recommended. No Moderate Sedation Privileges were requested or recommended. The Delineation of Privleges was signed on 06/07/2021 by the medical director. An interview was conducted with Registered Nurse (RN) # 2 on 01/12/2022 at 8:15 AM. RN #2 was asked if NP # 1 ever ordered moderate sedation. RN # 2 stated, "Yes, NP # 1 usually orders the medications and performs the procedures." RN # 2 was then asked if the physician was in the room at any time during the procedures, RN # 2 stated "not usually." An interview was conducted with Physician # 5, on 01/12/2022 at 8:20 AM, regarding NP # 1 ordering moderate sedation. Physician # 5 reported being unaware NP # 1 could not order moderate sedation. Patient #70 A review of the medical record revealed the patient was admitted for a same day surgery procedure on 12/07/2021 at 11:05 AM. Further review of the "Intra Procedure" documentation revealed the patient was cleared for the procedure by NP# 1 at 12:34 PM. Further review of the nurse note revealed, "sedation started at 12:58 PM, NP# 1 started procedure at 13:02." Patient # 55 A review of the emergency room record revealed the patient arrived at the emergency room with an injury to the wrist requiring sedation for closed reduction. The review revealed an entry on 09/08/2021 at 12:14 PM where NP# 31 entered the order for moderate sedation. Further review of the documentation revealed the medications fentanyl and versed were used during the procedure Patient #57 A review of the emergency room record revealed an entry on 07/04/2021 at 8:25 PM where NP# 31 documented repair of a superficial laceration on a pediatric patient under the use of the drug Ketamine. Further review of the document revealed NP # 31 entered the order for moderate sedation. A review of the facility policy titled "Moderate Sedation Policy," revealed the following: QUALIFICATIONS: Physicians responsible for the oversight of the patient receiving moderate sedation must meet the hospital's credentialing requirements for administration of moderate sedation. *Must select #1 or #2 below and all must have #3 1. If a physician has completed a residency program in which moderate sedation was a specific clinical training in management of patients whom required moderate sedation during a procedure, then the physician would be approved with moderate sedation as a core privilege. A. Emergency Physicians B. Interventional Radiologists C. Interventional Cardiologists D. Interventional Gastroenterologists E. Interventional Pulmonologists F. Others with Credentialing Committee approval 2. If a physician has not completed a residency program as described in number 1 above, then he/she must: a. Complete an ACLS course or b. Score 90 or greater on LRMC Moderate Sedation Test as approved by Anesthesia physician group and Credentialing Committee. 3. Each physician requesting Moderate Sedation must also submit a written attestation of the receipts of the LRMC Moderate Sedation Policy stating that they have reviewed and will abide by the policy. Physicians responsible for the oversight of the patient receiving moderate sedation must meet the hospital's credentialing requirements for administration of moderate sedation. Credentialing requirements are ACLS or a score of 90 or greater on the Moderate Sedation test as approved by the Anesthesia group and the Credentialing Committee. Each physician requesting Moderate Sedation must also submit a written attestation of the receipt of the LRMC Moderate Sedation Policy stating that they have reviewed and will abide by the policy." A review of the Texas Board of Nursing position statement 15.8 "Role of the Nurse in Moderate Sedation," revealed the following regarding non-CRNA advanced practice nurses with regards to moderate sedation: "Therefore, it is the position of the Board that the administration of anesthetic agents (e.g. propofol, methohexital, ketamine, and etomidate) is outside the scope of practice for RNs and non-CRNA advanced practice registered nurses except in the following situations:" A review of rule Texas Administrative Code 222.5 ""Advanced Practice Registered Nurses with Prescriptive Authority-Prescriptive Authority Agreement" revealed the following: "(b) An APRN with full licensure and a valid prescriptive authorization number and a physician are eligible to enter into or be parties to a prescriptive authority agreement only if the APRN: (c) A prescriptive authority agreement must, at a minimum: (1) be in writing and signed and dated by the parties to the agreement; (2) state the name, address, and all professional license numbers of the parties to the agreement; (3) state the nature of the practice, practice locations, or practice settings; (4) identify either: (A) the types or categories of drugs or devices that may be ordered or prescribed; or (B) the types of categories of drugs or devices that may not be ordered or prescribed; (5) provide a general plan for addressing consultation and referral; (6) provide a plan for addressing patient emergencies; (7) state the general process for communication and the sharing of information between the APRN and the physician related to the care and treatment of patients; (8) if alternate physician supervision is to be utilized, designate one or more alternate physicians who may: (A) provide appropriate supervision on a temporary basis in accordance with the requirements established by the prescriptive authority agreement and the requirements of Chapter 157, Subchapter B, Occupations Code; and (B) participate in the prescriptive authority quality assurance and improvement plan meetings required under §157.0512, Occupations Code: (9) describe a prescriptive authority quality assurance and improvement plan and specify methods for documenting the implementation of the plan that includes the following: (A) chart review, with the number of charts to be reviewed determined by the APRN and physician; and (B) periodic meetings between the APRN and the physician ... ... ... ..... (g) The prescriptive authority agreement is not required to describe the exact steps that an APRN must take with respect to each specific condition, disease, or symptom ... ..... (k) The prescriptive authority agreement and any amendments must be reviewed at least annually, dated, and signed by the parties to the agreement. The prescriptive authority agreement shall be made available to the Board, the Texas Medical Board, or the Texas Physician Assistant Board not later than the third business day after the date of receipt of the request from the respective licensing board. (l) The prescriptive authority agreement should promote the exercise of professional judgment by the APRN commensurate with the APRN's education and experience and the relationship between the APRN and the physician."
A0410 Blood Transfusions And Iv Medications
Corrected On:
32143 Based on record review and interview the facility failed to ensure blood consents were dated and timed, ensure physicians signed and dated the blood consents acknowledging they explained the benefits and risks, ensure the nurses were verifying the blood products per policy with dates and times, and failed to ensure the transfusion records were filled out per policy. One or more of these deficient practices were found in the medical records of 7 of 7 (#8, #9, #15, #77, #78, #79, #80) patients. Review of Patient #8's blood consent revealed the physician signed the consent on 1/6/22 at 1600 (4:00PM) but the patient's son did not sign the blood consent until 1/7/22 at 11:25AM. There was no documentation found that the physician had called and talked to the son previously concerning the risk and benefits. Review of Patient #9's chart revealed the blood consent was signed by the patient's daughter and the nurse on 1/9/22 at 1656. The physician signed the consent but there was no date or time documented. Review of Patient #15's chart revealed the transfusion record was altered. The nurses must check and verify the blood before transfusion. The first nurse verifier documented the time and date as 12/31/21 at 0220(2:20AM). The second nurse verifier had originally written the time as 0300 (3:00PM) but marked over the time as 0220. The date was also marked over from a different date. Review of Patient #77's chart revealed the physician did not sign or date the blood consent. Review of Patient #78's chart revealed the physician did not sign or date the blood consent. Review of Patient #79's chart revealed the transfusion record was incomplete. The nurses must check and verify the blood before transfusion. The first nurse verifier failed to document the time and the second nurse verifier failed to date or time the blood verification process . Review of Patient #80's chart revealed the physician did not sign or date the blood consent. Review of the Blood Transfusion form revealed that the nurse failed to answer if the blood consent had been signed. The first nurse verifier failed to document the date and time of the nurse to nurse verification process. Review of the policy and procedure "Policy Title: Nursing-Blood and Blood Products Transfusion Protocol Policy" stated, "Validate physician (or licensed healthcare provider) order for transfusion. Order to specify type and amount of blood product to be transfused ... d. Verify that consent is obtained by the physician from patient (or authorized significant other if patient is a minor or unable to sign). The Consent for Blood Transfusion should be signed and placed under consents tab of chart .... m. At the bedside, the RN responsible for administering the blood and a second RN or provider must perform a final clerical check just prior to transfusion. The following items must be checked: i. Verify that the patient Consent/Refusal form is signed. Verify the written order and that the unit obtained is the unit ordered by the healthcare provider (check the appropriate boxes on Transfusion Slip under Pre-transfusion Documentation). ii. Appearance of the unit: check for discoloration, abnormal cloudiness, presence of clots or clumps, air bubbles, or loss of bag integrity. iii. Compare patient's name, and date of birth and hospital number on the patient's hospital wristband and the Blood Bank ID wristband number with those on the Transfusion Slip and the patient demographic label affixed to the product bag. iv. Verify blood bag identification number, ABO blood group, Rh compatibility, expiration date on the Transfusion Slip with the same information on the UNIT itself. Also verify that the patient's Blood Bank wristband identification number on the Transfusion Slip and patient demographic label matches the blood bag identification number. v. Once this final clerical check is completed and all information is verified, the two RNs (or RN and MD) must sign, date and time the appropriate boxes on the Transfusion Slip under the Pre-Transfusion Documentation section."
A0501 Pharmacist Supervision Of Services
482.25(b)(1)
Corrected On:
36827 Based on review of records and interview, the Director of Pharmacy failed to: A) ensure that corrective action was taken/documented and failed areas were retested until passed in 2 areas (Longview-6:Ante Room air sample and Longview-12:Ante Room surface samples) out of 12 sterile compounding areas checked on a semi-annual basis. B) develop and/or keep current policy and procedures for correcting and documenting corrections of negative findings resulting from the required semi-annual testing conducted by the qualified contractor. Findings included: During interview on the morning of 1-12-2022, Interim Director of Pharmacy, Non-Physician Staff #50 confirmed that the sterile compounding rooms had been built to comply with USP (United States Pharmacopeia) 797 Pharmaceutical Compounding-Sterile Preparations and USP 800 Hazardous Drugs - Handling in the Health Care Setting. On 1-14-2022, a review of documents relating to sterile compounding was made with the Staff #50. The required semi-annual testing of the sterile compounding rooms was last completed by a qualified contractor on 7-30-2021 with a report date of 8-6-2021. Review of the report was as follows: Page 2 of 7 "USP 797 - Summary of Sample Analysis Results The summary information for each sample includes a Pass/Fail result with respect to the USP 797 action level guidelines for concentration of colony forming units (see Table 1) and actionable microorganisms (United States Pharmacopeia, 2014). Actionable microorganisms are defined here as Gram-negative bacteria, coagulase-positive Staphylococcus, molds, and yeasts." Six areas were listed with two tests in each area, air and surface. The report indicated that areas Longview-6:Ante Room Air sample failed due to actionable microorganism/s detected (other fungi), and Longview-12:Ante Room Surface sample failed due to Total CFU (colony forming unit) result exceeds action level concentration and actionable microorganism/s detected (other fungi). When asked for evidence of follow-up action and evidence that the problem had been corrected, Staff #50 was unable to find any. Staff #50 contacted the qualified contractor who confirmed that follow-up testing to ensure the original finding were corrected had not been completed by them. No other certified contractor report was provided. Staff #50 provided the Environmental Monitoring Log for the sterile compounding rooms for 2021 as evidence that the areas were clean. The log only showed results for "Air Sample" and "Surface Sample" for two areas identified as Chemo and IV. When asked, Staff #50 confirmed that she was unable to provide evidence that the areas identified by the qualified contractor as Longview-6:Ante Room Air and Longview-12:Ante Room Surface were checked as part of the monthly monitoring. Additionally, monitoring for 7-30-2021, the same date as the monitoring completed by the qualified contractor, indicated that the areas monitored passed. The qualified contractor monitoring failed results for Longview-6:Ante Room Air and Longview-12:Ante Room Surface. Review of USP 797, 2008 edition in current use, was as follows: " ENVIRONMENTAL QUALITY AND CONTROL Achieving and maintaining sterility and overall freedom from contamination of a CSP (compounded sterile preparations) is dependent on the quality status of the components incorporated, the process utilized, personnel performance, and the environmental conditions under which the process is performed. ... ENVIRONMENTAL VIABLE AIRBORNE PARTICLE TESTING PROGRAM The risk of contaminating a CSP prepared under low-risk level and medium-risk level conditions is highly dependent on proper hand hygiene and garbing practices, compounding personnel aseptic technique, and the presence of contamination, assuming that all work is performed in a certified and properly functioning ISO (international organization for standardization) Class 5 (see Table 1) PEC (primary engineering control) and secondary engineer controls, ISO Class 7 (see Table 1) buffer area, and ISO Class 8 (see Table 1) ante-area. ... Action Levels, Documentation, and Data Evaluation--The value of viable microbial sampling of the air in the compounding environment is realized when the data are used to identify and correct an unacceptable situation. ... Any cfu count that exceeds its respective action level (see Table 2) should prompt a re-evaluation of the adequacy of personnel work practices, cleaning procedures, operational procedures, and air filtration efficiency with the aseptic compounding location. An investigation into the source of the contamination shall be conducted. Sources should include HVAC (heating, ventilation, and air conditioning) systems, damaged HEPA (high efficiency particulate air) filters, and changes in personnel garbing or work practices. The source of the problem shall be eliminated, the affected area cleaned, and resampling performed. Counts of cfu (colony forming units) are to be used as an approximate measure of the environmental microbial bioburden. Action levels are determined on the basis of cfu data gathered at each sampling location and trended over time. The numbers in Table 2 should be used only as guidelines. Regardless of the number of cfu identified in the pharmacy, further corrective actions will be dictated by the identification of microorganisms recovered (at least the genus level) by and appropriate credentialed laboratory of any microbial bioburden captured as a cfu using an impaction air sampler. Highly pathogenic microorganisms (e.g., Gram-negative rods, coagulase positive staphylococcus, molds and yeasts) can be potentially fatal to patients receiving CSPs and must be immediately remedied, regardless of cfu count, with the assistance of a competent microbiologist, infection control professional, or industrial hygienist. ... QUALITY ASSURANCE (QA) PROGRAM A provider of CSPs shall have in place a formal QA program intended to provide a mechanism for monitoring, evaluating, correcting, and improving the activities and processes described in the chapter. Emphasis in the QA program is placed on maintaining and improving the quality of systems and the provision of patient care. In addition, the QA program ensures that any plan aimed at correcting identified problems also includes appropriate follow-up to make certain that effective corrective actions were performed. Characteristics of a QA program include the following: 1. Formalization in writing; 2. Consideration of all aspects of the preparations and dispensing of products as described in this chapter, including environmental testing and verification results; 3. Description of specific monitoring and evaluation activities; 4. Specification of how results are to be reported and evaluated; 5. Identification of appropriate follow-up mechanisms when action limits or thresholds are exceeded; and 6. Delineation of the individuals responsible for each aspect of the QA program. In developing a specific plan, focus is on establishing objectives, measurable indicators for monitoring activities and processes that are deemed high risk, high volume, or problem prone. In general, the selection of indicators and effectiveness of the overall QA program is reassessed on an annual basis." A review of Longview Regional Medical Center Policy Title: Pharmacy- Sterile Compounding Policies and Quality Assurance Policy was made as follows: The most recent Policy Approvals date was 6/21/2017. The policy References listed the outdated USP General Chapter 797, Pharmaceutical Compounding: Sterile Preparations, 2004. (2008 was the current official version approved for use by USP) Page 4-5 of the policy stated: "Procedures: Preparation & Dispensing Policies and Procedures It shall be the ultimate responsibility of all personnel who prepare compounded sterile products to understand fundamental practices and precautions. Up-to-date policies and procedures for compounding sterile products will be written to reflect current standards of practice and quality. Up-to-date policies and procedures, as well as additions, revisions, and deletions, will be available to all personnel involved in these activities. All personnel involved in these activities must read the policies and procedures before compounding sterile products. Page 9-10 of the policy stated: "A qualified contractor will certify the laminar airflow and barrier isolator workbench every six months. A qualified contractor will recertify the laminar airflow workbench or barrior (sic) isolator whenever the hood is relocated or moved. Prefilters in the laminar airflow hood will be changed every 90 days. Air and surface samples shall be tested at leas monthly to monitor for airborne microbial contamination in controlled critical areas. Settle plates or wipe samples will be used for testing. If an airborne microbial contamination results, the entire cleanroom, equipment, and hard surfaces will be cleaned and disinfected. Ceiling filters will be changed or cleaned. The laminar airflow hood will be recertified, if appropriate. Remodeling of the controlled area may be necessary, if the problem persists." Page 24 of the policy identified air quality testing of the direct compounding environment as a quality indicator. It did not identify semi-annual surface testing as a quality indicator. Page 25 of the policy stated: "Reporting & Evaluation of Results: All quality assurance indicators listed above shall be evaluated and results will be reported at least annually to the P&T (pharmacy and therapeutics) Committee and/or other Committee deemed responsible by the hospital (e.g., Performance Improvement, Infection Control). Results of quality assurance indicators will be evaluated. If an indicator is not adequately met, the activity will be continuously monitored. Proper steps will be taken and procedures and/or equipment changed in order to meet quality assurance indicators. Unmet quality indicators will be reported to P&T Committee, and/or other hospital Committees, quarterly until met. ... P&T Committee or other Committees will annually review the sterile product compounding policies and procedures along with the quality assurance indicators for appropriateness to prevent morbidity and mortality in patients who are treated with CSPs."
A0582 Adequacy Of Laboratory Services
482.27(a)
Corrected On:
29191 Based on observation, record review, and interview, the facility failed to ensure patients that had been tested for Hepatitis B with a reactive/positive result had been confirmed by the reference lab. This deficient practice had the likelihood to cause Hepatitis B exposure to all patients and staff. Findings included: A review of the medical record for Patient #13 revealed a positive Hepatitis B that was drawn on 01/03/2022. The Hepatitis B test was flagged with # C which means that test was sent for confirmation to the reference lab. On 01/11/2022 surveyor went to the lab and asked for the confirmation on the Hepatitis B test. Surveyor waited for results and Lab Manager #13 was unable to obtain the results from the reference lab. Further discussion with Lab Manager #13 revealed there was a system failure with the Lab computer interface and the facility's computer was not responding. Surveyor asked how many Hepatitis B test had not been confirmed by the reference lab. The Lab Manager #13 ran the Hepatitis B for the past year. There were 3731 patients tested for Hepatitis B and 9 had reactive/positive. The Lab Manager was able to pull the 9 reactive/positive and review the results and the history of the patients. Four of the 9 patients were outpatient lab test from a sister facility. Two of the 9 patients were known as Hepatitis B positive patients. One of the patients had been confirmed on 9/9/2021 by the lab technician manually sending the specimen to the reference lab. One of the patients was a Labor and Delivery patient that had not been confirmed. One was Patient #13 that had not had a Hepatitis B test confirmed. Patient had been discharged to a long-term care facility and was a dialysis patient. The long-term facility had not been notified nor had the dialysis unit. There was a high risk for potential exposure. An interview with the Lab Manager #13 reported that the lab staff were not following the procedure/process for HBSAG (Hepatitis B Surface Antigen) confirmatory testing. A review of the lab guideline record titled, "ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT Systems" revealed the followed: "Calculation of Results For detailed information about how the system calculates results, refer to the system operating instructions. The system reports HB5A9 results in Index Values and as reactive or nonreactive. Interpretation of Results The initial cutoff value was determined by testing 1500 HBsAg-negative samples and commercially available HB5Ag sensitivity and seroconversion panels. The cutoff for the ADVIA Centaur HB5AgII assay was verified based on results generated from the clinical studies and the seroconversion sensitivity. The cutoff value (50.00 Index Value) for not performing confirmatory testing was determined by testing initially reactive HB5Ag samples from known positive and negative sample populations in the ADVIA Centaur HBsAg Confirmatory method. The 50.00 cutoff for the ADVIA Centaur HB5Ag Confirmatory assay was verified based on results generated from the clinical studies where 100% (95% CI 97.5-100%) of 145 available positive specimens with ADVIA Centaur HB5AgII Index values greater than 50.00 were confirmed positive for the presence of HBsAg. *Samples with an Index Value of less than 1 .0 are considered nonreactive (negative) for HBsAg. *Samples with an Index VaIue of 1 .0 but 50 are considered reactive (positive) for HB5Ag. The test must be repeated in duplicate. If 2 of the 3 results are nonreactive, the sample is considered negative for HB5Ag. If at least 2 of the 3 results are reactive, the sample is repeatedly reactive, and the presence of HB5Ag should be confirmed with the ADVIA Centaur HBsAg Confirmatory assay, additional HBV marker assays, or another approved confirmatory method." During an interview on 01/11/2022 after 3:00 PM, Staff #13 confirmed that the confirmation was not indexing to the reference lab. Staff #13 reported that all reactive/positive patients and outpatient facility services will be notified.
A0747 Infection Prevention Control Abx Stewardship
482.42
Corrected On:
10135 Based on observation, interview and record review, the facility failed to ensure a hospital-wide program was in place to prevent and control infections in 9 of 9 areas reviewed for infection control (front entrance of hospital, Coronavirus disease (COVID) unit, Emergency department (ED), Laundry, Main central supply, Lab, Wound care center, Progressive care unit, and Intensive care unit). The facility failed to: A. ensure there was an effective infection control program which included an infection control committee and staff to assist with surveillance, infection control rounding and identifying infection control problems in the facility. B. ensure visitor screening for COVID was performed per their internal policy. C. ensure sterile and non-sterile supplies were stored in a manner to prevent cross contamination. They failed to ensure clean and soiled equipment were separated. D. ensure lab supplies were transported under specified temperatures per the manufacturer. The facility failed to ensure lab and surgical supplies were transported in a manner to prevent cross contamination. E. ensure physicians, nurses, and housekeeping staff used proper personal protective equipment (PPE) while working on the COVID unit. F. ensure expired supplies were discarded and multi-dose vials were dated when opened. G. ensure the lab was kept in clean and sanitary conditions. H. ensure patient equipment and rooms were kept clean and sanitary Refer to tag A0749 for additional information. I. ensure there was a qualified individual who was appointed by the Governing body to be over the antibiotic stewardship. This was found in 1 of 1 physicians who was identified as being over the program (Physician #7). Refer to tag A0760 for additional information.
A0749 Infection Control Program
482.42(a)(1)
Corrected On:
10135 Based on observation, interview and record review, the facility failed to ensure practices were in place to prevent and control infections in 10 of 10 areas reviewed for infection control (front entrance of hospital, Coronavirus disease (COVID) unit, Emergency department (ED), Laundry, Main central supply, Lab, Wound care center, Progressive care unit, women's care and Intensive care unit). The facility failed to: A. ensure there was an effective infection control program which included an infection control committee and staff to assist with surveillance, infection control rounding and identifying infection control problems in the facility. B. ensure visitor screening for COVID was performed per their internal policy. C. ensure sterile and non-sterile supplies were stored in a manner to prevent cross contamination. They failed to ensure clean and soiled equipment were separated. D. ensure lab supplies were transported under specified temperatures per the manufacturer. The facility failed to ensure lab and surgical supplies were transported in a manner to prevent cross contamination. E. ensure physicians, nurses, and housekeeping staff used proper personal protective equipment (PPE) while working on the COVID unit. F. ensure expired supplies were discarded and multi-dose vials were dated when opened. G. ensure the lab was kept clean and sanitary condition. H. ensure patient equipment and rooms were kept clean and sanitary This deficient practice had the likelihood to affect all patients. Findings include: INFECTION CONTROL PROGRAM During an interview on 01/10/2022 after 9:30 a.m., Registered nurse #13 (Infection control preventionist) said the facility was without an infection control preventionist from January to May 2021. Registered nurse #13 said he had started the position in May 2021 and was reestablishing the infection control committee in February 2022. Since there was no committee he was taking his infection control information to the Clinical outcome meetings, but that stopped in October 2021 because of COVID. Staff #13 provided documentation showing the last formal infection control committee meeting was 08/29/2019. Registered nurse #13 said he was developing a rounding schedule, but it had not been implemented yet. The units that he had not rounded on was dietary, radiology, pharmacy, and wound care. Registered nurse #13 said the employees who had taken the COVID vaccine being tested every 2 weeks. When asked to see the information on the testing and staff that were off work with COVID. Registered nurse #13 said Employee health kept the information and that it was not being sent to him. Registered nurse #13 said he was the only staff working in the infection control program and that they had hired one more person for the program. Registered nurse #13 said when he was hired on he had to focus on the main issues first and that the COVID tracker could take up to two hours out of his day. Review of the 2021 "Infection Prevention and Control Annual Plan.." revealed the following: " ...Scope of Service Infection Prevention and Control is a facility-wide patient safety component involving all departments. The infection Preventionist along with the Infection Control Committee determines the specific focus of surveillance, education, and consultation efforts on an ongoing basis, dependent on hospital epidemiology, community disease surveillance and real or perceived local or world threats.." COVID SCREENING During observations on 01/10/2022 after 8:30 a.m., unidentified facility staff were at a desk at the front entrance of the facility. People were observed walking up to the desk and staff were not screening for COVID. During an observation on 01/10/2022 after 11:58 a.m., Staff #27 was sitting at a desk at the front entrance of the facility. Staff #27 and an unidentified volunteer were handing out mask to people who entered the hospital. No one was questioned about COVID symptoms. Staff #27 said they stopped asking the questions about 1 month ago because of the way the people were acting. Staff #27 said no one told them to stop asking about the symptoms. Registered nurse #13 (Infection control preventionist confirmed the 11:58 a.m. observation and said that were still suppose to be screening. A sign on the wall behind the staff read: "Upon arrival, anyone entering Longview Regional Medical Center must be screened for COVID-19 under these guidelines answering the following screening questions: **Have you had any of the following symptoms? *Fever of 100.0 & signs/symptoms of *Body Aches *Illness *Muscle pain *Cough *Headache *Flu-like symptoms *Diarrhea *Shortness of breath or difficulty breathing *Vomiting *Fever *New loss of taste or smell *Chills *Sore throat **Have you been in close contact in the last 14 days with someone who has or is under investigation for COVID-19 or who is ill with a respiratory illness without wearing the proper protective equipment? **Are you currently being tested for COVID-19? If the answer is "yes" to any of the above, visitors will not be allowed access to the facility unless seeking emergency medical assistance." LAUNDRY (soiled linen area) During an observation on 01/10/2022 after 11:22 a.m., the following was found: The negative air flow vent located in the ceiling above the washers was coated with a layer of dust. A staff member who was fully donned in her PPE was rolling a bin of soiled linen down the hallway and put it on a scale to weigh it. Afterwards she rolled the bin of soiled linen back down the hallway. A shelf was in the hallway which had air filters stored on it and they were not contained in anything. There were also boxes of plastic bags stored on the shelf also. There was an open shelf in front of the scale where cleaning supplies such as disinfectant sprays and wipes were stored. Another cart in the same area had staff drink and containers of food stored on it and a cloth facemask. Registered nurse #13 and Staff #26 confirmed the observations. Staff #26 said the bags were used for the linen hampers on units which did not have a soiled utility room. The cleaning supplies were used to clean both sides of the laundry room. EMERGENCY DEPARTMENT During an observation on 01/10/2022 after 12:04 p.m., the following was found: A Sequential depression device (SCD) was hanging on a shelf over next to respiratory supplies in the supply storage room. There was identification on the device to indicate if it was clean or not. Registered nurse #14 said their system was to tag or bag the equipment after cleansing. Registered nurse #14 said she had just cleaned the device, but failed to tag it. Clean equipment room - there were intravenous poles stored in the room which had bases and wheels that were soiled with debris. One intravenous pole had wheel caster that were rusted. The rusted equipment could not be sanitized with rust on it. A pink step ladder was stored in the room and it was soiled with brown stains. A monitor was stored in the room and the base of the equipment was soiled with debris. Oxygen gauges, oxygen flow meters and multiple different cords were stored in open plastic bins on the wall which were not contained within a bag or tagged to indicate they were clean Inside the "EMS Equipment Storage" room crutches were stored where they were touching the floor. Clean braces were stored on shelves on the other side of the room. On one of the shelves was a brace which had been removed from the package and there a soiled wheelchair leg on the shelf with the brace. Registered nurses #'s 13 and 14 confirmed the observations. MAIN CENTRAL SUPPLY AREA AND LAB During an observation on 01/10/2022 after 1:20 p.m., the following was found: In the main receiving area microscopic slides had been removed from their shipping boxes and placed on the shelf. There were shipping boxes of supplies beside and above the slides. A plastic bin was packed over the rim with bags of dialysate. The container was so packed that the container lid could not be secured. There were shipping boxes of supplies store all around the plastic bin. Sterile supply area shelves of sterile supplies were touching up against the walls in the room. While in the supply an unidentified staff was removing sterile supplies from the shelves and placing them in a plastic container. Staff #28 (Director of supply chain) said the staff were getting supplies ready to take over to the hospital. Staff #28 said when the bins were taken over to the hospital they are unpacked by staff there. Staff #28 said they cleansed the bins once per week. Staff #28 said the staff at the hospital had 30 minutes to get the supplies unpacked. During observations on 01/10/2022 after 2:29 p.m., central supply staff were observed delivering lab supplies which were in shipping boxes. The boxes were taken through the lab and placed on floor behind lab equipment. The following directives were on some of the boxes: Medical Laboratory Supplies Refrigerate Upon Arrival (2-8 (degrees) C) Do Not Freeze * Perishable* Expedite Review of the Delivery forms revealed some receipt dates and times of 01/10/2022 at 11:14 a.m., 11:20 a.m. and 11:33 a.m. Registered nurse #13 confirmed the observations and that the transportation truck was not temperature regulated. During an interview on 01/10/2022 after 2:37 p.m., Staff #14 (blood bank lead) checked the boxes and said some were chemical reagents used for lab test. Staff #14(blood bank lead) said the supplies would be put in within the hour or as soon as possible. Then said she really did not have a clue of when they were supposed to be put up. During an observation on 01/10/2022 after 2:40 p.m., sterile surgical supplies that were brought from central supply were being unpacked by nursing staff in a busy hallway. During an interview on 01/10/2022 after 2:47 p.m., Staff #28 (Director of supply chain) confirmed the receipt times for the lab supplies and said the supplies were brought over like that because there was no place in central supply to refrigerate the supplies. Staff #28 said the surgery supplies were being unpacked in the busy hallway because central supply did not have the manpower to unbox them. The supplies should be unboxed in central supply. COVID UNIT Patient #29 During an observation on 01/10/2022 after 3:14 p.m., Registered nurse #16 was in full PPE and rolled Patient #29 in his room. Registered nurse #16 came out of the patient's room with her PPE still on. She came up the hallway and talked to a nurse in the hallway. After noticing that she was being observed she went back to Patient #29's room and removed her PPE. During an interview at this time, Registered nurse #16 said she had brought Patient #29 up from the Emergency room and the patient was COVID positive. Patient #30 During an observation on 01/11/2022 after 8:37 a.m., Staff #51 (housekeeping) was standing in Patient #30's room mopping. The door to the room was open and Staff #15 (housekeeping) did not have on a face shield. Registered nurse #13 (Infection control preventionist) asked Staff #15 (housekeeping) where was her face shield. Staff #15 (housekeeping) said she did not have one. Patient #31 During an observation on 01/11/2022 after 9:25 a.m., Physician #14 was observed to enter Patient #31's room with only a mask on. Review of the clinical record of Patient #31 revealed a positive COVID lab test dated 01/08/2022 (3 days ago). Registered nurse #13 (Infection control preventionist) confirmed the observations. Registered nurses #13 (Infection control preventionist) said Physician #14 should also have on a gown and face shield. Review of a facility's policy named "IC-3.130 COVID-19 Transmission Based Precautions Policy" updated 02/23/2021 revealed the following: "...II. Use of Personal Protective Equipment HCP (healthcare personnel) who enter the room of a patient with suspected or confirmed SARS-CoV-2 infection should adhere to Standard Precautions and use a NIOSH-approved N95 or equivalent or higher-level respirator, gown, gloves, and eye protection ..." WOUND CARE CENTER During an observation on 01/12/2022 after 2:44 p.m., the following was found: A storage cabinet was found with expired casting supplies that were used for training, containers of paint, boxes of surgical hand scrubs, patient boots and splints, a wheelchair and crutches stored touching the floor. A multidose vial of the anesthetic agent Xylocaine was stored in a cabinet with other unopened medications. The vial had been used and was not dated. Registered nurse #41 confirmed the observation and said that the medication was good for 30 days after opening. Oxygen storage room There were portable oxygen tanks, a refrigerator with snacks, Styrofoam cups, a Dynamap, and sterile wound supplies all stored in the same room. There was no separation of sterile and non-sterile. The following expired dressings were also found in the room: Two packets of Renasys soft ports expired 06/11/2021 Eight packets of Renasys soft dressing kits with soft ports expired 01/07/2022. V.A.V. Granufoam wound dressings expired 06/30/2021 and 07/31/2021. One bag of the V.A.V. Granufoam wound dressing was stored underneath the cabinet and it was open. Registered nurse's 13 and #41 confirmed the observations. Review of a facility policy named "Pharmacy-Sterility Guideline for Single and Multi-Dose Vials and Other Solutions with Medications Policy" reviewed 01/2017 revealed the following: "...Use of multiple-dose vials should be avoided to the extent possible. However, when these are used, the expiration date for multiple-dose (containing preservatives) vials will be 28 days or less ..." Review of a facility's policy named "Material Management-Warehouse Storeroom Par Level Area Setup and Storage Policy' revised 10/09/2019 revealed the following: "Ensure that inventory is not too close to the ceiling, floor or walls ..." "All supplies must be contained in plastic bins; no unsealed cardboard boxes are allowed in the warehouse area. No supplies stored on the floor in are of the hospital or storeroom. Segregate open sterile product from outer shipping cartons; use dual locations or bulk storage when area does not allow for all products to be removed from cartons. Supplies in corrugated cardboard boxes may well be delivered by the storeroom to clinical area, but the supplies should be immediately removed from the corrugated cardboard boxes and the corrugated cardboard boxes should be removed from the area within 30 minutes of delivery and disposed. Outside shipping containers and corrugated cartons should not be used as containers in sterile storage areas..." Review of a facility's policy named "IC-Supplies: Event Related Shelf Life and Storage Policy "reviewed 02/11/2019 revealed the following: "...Storage Sterile and clean supplies should be stored and maintained in a manner that will reduce the risk of contamination. Patient care supplies should be stored separately from the supplies..." 32143 Laboratory During a tour of the Laboratory was conducted on 1/10/22 at 9:40AM. The tour was conducted with Staff #13 Lab Director and Staff #42 Director of Nursing (DON). The following items were found: Laboratory blood samples were placed in a red plastic container that was visibly soiled. A piece of paper was taped on the inside of the container that was torn and splattered with blood. The note stated not to leave the samples without notifying a tech. Blood tubes were inside the lab techs carts to be used for patient sampling. The blood tubes were found to be expired since 3/17/20. The tubes were 13 months expired. Staff #13 stated, "I was not aware they were expired." Staff #13 stated that the staff were using the tubes. Cardboard boxes filled with computer paper was stacked in the lab next to the blood bank refrigerator. The boxes had shipping labels and were visibly soiled. The floor of the lab was visibly soiled with dried spilled substances, heavy dirt, dust, and hair. Computers and analyzing equipment were sitting on the floor. The floor around and under the equipment had a heavy buildup of dirt, dust, and hair. Under a desk was a black plastic grate sitting on the floor. On top of the grate, was shipping boxes and unopened chemicals. A staff member was resting her feet on top of the grate. Under the grate was a heavy accumulation of dirt, pieces of paper, heavy dust, and hair. Biohazard containers were half filled with the tops open. The container and the container dolly were splattered with blood. A two-tiered metal cart was holding equipment and chemicals. The cart was sitting next to biohazard trash. The cart was rusted and heavily soiled with dirt, dust, and hair. A table was holding a computer monitor and tubing going down to a pump that pumps contaminated chemicals out of the building. The computer cables were intertwined with the chemical line with no security to avoid pulling the pump tubing off causing a potential spill. The pump was heavily soiled with a brown gooey substance and dust. A double-sided cooler/refrigerator was found holding clean reagents for testing, next to dirty/contaminated patient samples. The samples were in an open plastic bag. The plastic bag was hanging out of the refrigerator keeping the door from sealing and cooling properly. The outside of the cooler was soiled with splattered dried substances, dirt, dust, and hair. A machine used for lab testing had tubing going down to the floor and into a jug of a purple chemical substance. The chemical was spilled all over the floor, the back of the machine and on the table holding it. A beige colored "cryo fridge" was found to be heavily soiled on the outside with dirt, and grime. The handle was excessively soiled with a sticky dirt substance. The inside of the beige colored "cryo fridge" was found to have mold growing around the seal and on the fridge itself. Inside the bottom of the fridge was dried spills, dust, hair, and trash. Inside the fridge was reagents and testing materials. The beige colored "cryo fridge" was found to have a piece of paper with writing stuck to the bottom of the fridge and into the fridge preventing it from sealing. The paper was touching the floor that was heavily soiled with spilled dried liquids, dirt, and the bottom of the door hinge was severely rusted. Staff #42 was taking pictures and validated the findings. The inside of a white refrigerator next to the #1 beige colored "cryo fridge" was found to have mold growing around the seal and on the fridge itself. The refrigerator was holding reagents and testing supplies. A second beige colored "cryo fridge" was found to have mold growing around the seal and the inside was found to be rusted, missing paint and soiled. A fourth refrigerator was holding patient blood samples. The refrigerator was found rusted, and heavily soiled on the bottom with dried unknown substances, dust, dirt, hair allowing for contamination. Underneath the sink and eye wash station was found to be heavily soiled with dirt, mold, and trash. In a cabinet marked "DANGER CAUSTIC" a yellow plastic container was found with two other different containers, signs, and a bottle of liquids. The yellow container was used to carry caustic materials. The box was heavily soiled with dirt, dust, and dried unknown spilled substances. A sliding two door refrigerator was found holding reagents and supplies. The bottom of the refrigerator was soiled with a person's ink pen, paper, plastic trash, dust, and a spilled white powdery substance in the tracks. A tour of the ICU and Patient care areas were conducted on 1/10/22 at 11:00AM. Staff #42 toured with the surveyors. Room 414 ICU (Terminally clean) Terminal cleaning is a thorough, deep-cleaning of a patient room between occupants. Its purpose is to rid the room of infectious agents and provide the new occupant a sanitary space for recovery and healing. The room had trash in the trash can. Pillows for patient use was found sitting in the cabinet. The pillows were removed and found to be heavily soiled with blood. Staff #42 took pictures and confirmed the findings. The computer monitor was soiled with dust and spilled liquids. The previous patients name sticker with her information was found stuck to the monitor. The toilet area was soiled. The toilet paper holder had not been wiped out and was soiled. The floor around the toilet was soiled with paper, plastic pieces from syringe caps, dirt, dust, and hair. The wall behind the toilets were splattered with unknown dried substances. The floor of the room was soiled with dust and hair. There was a buildup of dirt around the furniture and toilet. There was also a blue fall mat found stored between the commode and closet. The mat was sitting on the dirty soiled floor. The mat was found to be heavily soiled with dust, dirt and hair. In the medication room of ICU a mini refrigerator was found sitting on the floor under a cabinet. The refrigerator held medication and IV bags. The floor around the refrigerator was heavily soiled with dirt, dust, plastic syringe caps and trash. The trash can in the ICU medication room was soiled with dried spilled liquids, and old stickers, dust, and hair. Inside the ICU medication room was a basket of alcohol pads. The outside packaging was soiled with a dried brown liquid substance. OB OR #1 and #2 C-Section Surgical Suite tour was conducted with Staff #22 RN Labor and Delivery and Staff #18 RN Director of Obstetrics. OB OR Room #1 OB OR Room #1 was terminally cleaned and ready for another case. An IV pole was found to have old sticker stuck to it, was soiled, and rusted. A wooden chair was found in the room with no sealant and was unable to be cleaned properly. A blue supply cart was found in the room. The cart was soiled with dirt, dust, and hair. Hanging on a blue supply cart was a trashcan. The trashcan was heavily soiled with spilled betadine. A bair hugger machine was found to be rusted and soiled with dust. The air exchange vent was soiled with dust. The floor was soiled with dust, hair and plastic caps, trash. The suction machine was soiled with unknown substance, dust, and hair. OB OR #2 C-section Room The surgical table was broken down and pooled blood was found on the table. A chair was found in the room and the vinyl was split. The chair was unable to be cleaned properly. A wooden computer stand was found in the OR suite. The wood was exposed. There was no way to clean this exposed wood to prevent infection. The blue supply cart was found to be rusted and soiled with dust and hair. An angiocath 14guage needle was found expired since June of 2021. Staff #22 and 18 confirmed the findings and stated that they would make sure the OR rooms were recleaned before and further surgeries. Room 308 Labor and Delivery 308 Labor and delivery room was found to have a vinyl chair that was split all over the seat area and was not able to be cleaned properly. 36827 Progressive Care Unit (PCU) On the morning of 1-12-2022, the pharmacy and medication rooms were toured with Non Physician Staff #50. Upon entering the medication room for PCU West, it was observed that dirty equipment was being stored in the medication room. RN Staff #43 joined the tour at that time. There were three racks for portable oxygen cylinders. One rack was for full oxygen cylinders from the oxygen supplier with nine cylinders in it. One rack was for portable oxygen cylinders that were in use (used for patients but still had more than 500 pounds per square inch of oxygen in them) with two cylinders in it. A third rack was for portable oxygen cylinders that had been used by patients and were empty and did not have any cylinders in it. There were also two cylinder single-tank carts used to wheel the oxygen cylinders throughout the hospital when the cylinder was in use by a patient. An interview was conducted with RN Staff #43 and Staff #50 during the tour. RN Staff #43 confirmed that there was not a process for cleaning cylinders, storage carts or cylinder single tank carts prior to putting them into the medication room. Staff #50 confirmed that medication storage and dirty equipment storage in the same medication room did not conform to United States Pharmacopeia (USP) guidelines for safe medication storage which was one of the guidelines followed by the hospital's pharmacy.
A0760 Antibiotic Stewardship Program
Corrected On:
10135 Based on interview and record review, the facility failed to ensure there was a qualified individual who was appointed by the Governing body to be over the antibiotic stewardship. This was found in 1 of 1 physicians who was identified as being over the program (Physician #7). This deficient practice had the likelihood to cause harm to all patients. Findings include: During an interview on 01/13/2022 after 10:22 a.m., Staff #50 (Interim Director of Pharmacy) said she had been in her position since 11/01/2021. Staff #50 said that the facility had only 2 of 4 pharmacy and therapeutic (P&T) meetings for 2021. Staff #50 said that Physician #7 was over the antibiotic stewardship program, but when staff had a question they called Physician #15. Review of "NOMINATING COMMITTEE "minutes dated 09/20/2019 revealed Physician #7 was over the Pharmacy and Therapeutic committee. There was no mention of Physician #7 being over the antibiotic stewardship program. Review of Physician #7's credentialing file dated 09/2021 revealed no documented training or education in infectious disease or antibiotic stewardship. During an interview on 01/14/2022 after 8:10 a.m., Registered nurse #40 (Chief quality officer) confirmed the information in the credentialing file and committee minutes. Registered nurse #40 said she had already talked to Physician #7 and told him that they needed to get training on his file.
A0800 Discharge Planning - Early Identification
482.43(a)
Corrected On:
29191 Based on record review and interview, the facility failed to identify patients who tested reactive/positive to Hepatitis B and were high risk for exposing other patients upon discharging to a long-term care facility and a dialysis unit. Also, the facility failed to follow the facility policy on discharge planning. This deficient practice had the likelihood to expose Hepatitis B to all patients who were discharged from the facility to a long-term care facility or dialysis unit. Findings Included: PATIENT #13 Review of the patient's History and Physical revealed the following: Patient #13 was an 86-year-old male who was admitted to the hospital on 12/31/2021 with the diagnosis of Pneumonia. Patient #13 had a history of Atelectasis, Dyspnea, Pleural Effusion, Right pneumothorax, Cardiac overload, Influenza, Cardiomyopathy, End Stage Renal Disease, Systolic Heart Failure, Paroxysmal atrial Fibrillation, anticoagulation therapy, Essential hypertension, and malignant tumor of prostate. Patient #13 had tested reactive/positive to Hepatitis B on 01/03/2022. The dialysis staff dialyzed Patient #13 in his room and considered the patient positive until the confirmatory test results for Hepatitis B came back. Patient is a DNR (Do Not resuscitate.) Review of the Case Management discharge planning notes revealed the following: The note was written by Staff #30 on 01/05/2022 at 12:44 PM Tentative Discharge Destination: Long-term Care Facility Comments: "SW spoke with patient's spouse to complete initial assessment. Educated on SW role. Patient lives at home with spouse and required some assistance in ADLs prior to admission. Uses Elite HH for skilled services. DME: walker. PCP: Dr. McDaniel. No MPOA. Pt is a DNR. Choice letter completed. IMM completed. SW will remain available." The note was written by Staff #30 on 01/06/2022 at 14:56 PM Comments: "CM to arrange SNF at discharge. Spoke to son because patient is confused at this time. Verbal phone choice by Lyle Potter for Haven Care SNF. Referral faxed. Pending approval." The note was written by Staff #30 on 01/07/2022 at 15:19 PM Comments: "Faxed "Pasrr" [sic] and negative covid test to the long-term care facility. Patient is approved. Plan for discharge today." All case management notes were reviewed, and the above documents were all that were provided to the surveyor. There was no documentation of the positive Hepatitis B results to the Long-term care facility or the dialysis unit. Review of the discharge summary report dated 01/07/2022 revealed the following: The discharged summary consisted of 19 pages which included discharge medication, Discharge instructions, special instructions, allergies, patient problems, Lab results (13 pages), wellness, and vital signs. There was no physician discharge summary documentation with the discharge summary or available in the chart. The Hepatitis B test result was written as positive with the flag #C. The Hepatitis B test was never confirmed. The Hepatitis B test results was embedded in the 13 pages of lab results. A facility would have to be alerted to find the Hepatitis B reactive test results. An interview on 01/12/2022 at 2:00 PM with Staff #30 revealed the following: Surveyor asked Staff #30 to review the Case Management notes to see if the record contained any information about the patient being Hepatitis B reactive. Staff #30 stated, "I don't find anything in the case management notes." An interview with Staff #26, Interim Case Management Director, on 01/12/2022 at 2:30 PM revealed the following: Surveyor asked Staff #26 to review the Case Management notes to see if the record contained any information about the patient being Hepatitis B reactive. Staff #26 stated, "I agree with Staff #30 I don't find anything in the case management notes and I will discuss the case management department the importance of alerting the outpatient facilities about Hepatitis B reactive patients." An interview with Staff #7 on 01/12/2022 at 3:00 PM revealed the following: Staff #7 was asked if the dialysis staff had notified the dialysis unit where Patient #13 was to be dialyzed about the reactive Hepatitis B results. Staff #7 stated, "No." Patient #13 had the likelihood to expose other dialysis patients to Hepatitis B that were being dialyzed at the dialysis unit. Review of the facility policy titled, "Case Management-Discharge Planning Policy" dated with a revisions date of 10/2019 revealed the following: "Discharge Planning is a process used to determine what a patient needs for a smooth transition from one level of care to another within or outside the current setting. As a continuous process, discharge planning starts earlier and continues later and involves healthcare professionals, the patient and family caregivers along the continuum of a patient's care. IDENTIFICATION OF PATIENTS IN NEED OF DISCHARGE PLANNING A. All patients are screened by nursing services for potential discharge needs upon admission or placement in Observation. Nursing will communicate with the Case Manager/Social Worker those patients with special needs that could impact discharge planning process, i.e. language or communication barriers, visual impairments, etc. B. The Case Manager will screen all acute care patients, with the possible exception of maternity and normal newborn cases, preferably on the day of admission/observation placement but within no more than one working day, for potential discharge planning needs, utilizing a High- Risk Screening tool. This screen will take place during the initial clinical review for medical necessity and will be in conjunction with the initial screening completed by Nursing in the Admission Assessment process. C. Screening criteria will include but not be limited to the following: a. Age b. Prior hospitalization c. ED visit history d. Medications e. Principal diagnosis f. Comorbidities g. Functional impairment TRANSFER OR REFERRAL A. The hospital will facilitate the transfer or referral of patients when the discharge plan involves a need for continuity of care, along with necessary medical information, to appropriate facilities, agencies, or outpatient services, as needed, for follow-up or ancillary care." An interview with Staff #26 and #30 on 01/12/2022 at 2:30 PM confirmed case management department had failed to alert the long-term care facility and dialysis unit that Patient #13 had a Hepatitis B reactive result. Also, that the staff failed to follow the facility policy about alerting the facility of necessary medical information that could harm other patients.
A0940 Surgical Services
482.51
Corrected On:
40989 Based on observation, document review, and interview the facility failed to: A. ensure a clean and sanitary environment in 10 (Surgical Hallways X3, Operating Rooms (OR's) #2, #3, #5, #6, Central Supply Room, Cardiac Cath Lab #3, and OR #2 in Labor and Delivery) of 10 areas observed. B. ensure the temperature and humidity was monitored in the C-section room to inhibit microbial growth, reduce the risk of infection, promote patient comfort, and assure the physical safety of all patients. Findings Include: A. SURGERY DEPARTMENT An observation tour of the Surgery Department was conducted 1/11/2022 at 9:00 AM with Staff #9 and Staff #32. The following was observed: Surgical Spine Hallway Leading into the hallway where the spine surgeries are scheduled, there was a visible crack in the flooring about 3-4 feet in length. The floors were heavily marked with a black stain and appeared dirty. At the end of the hallway near Operating Room (OR) #8, two surgical beds used for spine surgeries were noted facing the window. There was no identifying label or indication that the beds were clean or dirty. Along the hallway there was a protective rail creating a barrier to ensure the wall was not damaged. This rail was noted to be dirty, multiple black marks from equipment, and the top layer was noted to be peeling away from the surface. A metal cabinet door next to the rail was missing paint and exposing the metal surface beneath. The metal surface cannot be properly sanitized and could possibly harbor bacteria that could lead to a hospital acquired infection and placed surgical patients at great risk. The floor along the hallway was split at the bend of the laminate where the floor meets the wall. The small metal strip that creates a division between the floor and the walls was peeling away from the sheetrock and creating an opening between the sheetrock and the laminate. Above the baseboard in the hallway there was a red electrical plug labeled "ECLOR-40". The wall surrounding the plug was noted to be dirty and missing paint and exposing the sheetrock. At the bottom of the electrical outlet, on both sides, there was separation between the wall and the baseboard. At the top of the baseboard was a black colored stain. Further down the hallway, below the medical gas control board panel and directly above the chair rail there was a hole in the wall exposing the sheetrock. A small refrigerator that was used to store supplies was in an alcove in the hallway. Inside the refrigerator was Vistaseal (a coagulant device used to control mild to moderate bleeding) and Transdermal eye masks (cold eye masks that can be used to reduce the swelling postoperatively). The bottom of the refrigerator was soiled with dirt, dust, debris, and human hair. Surgical Hallway for OR #11 and #12 Leading into the hallway of OR #11 and #12, right at the opening of the double doors, was a large crack in the floor that went from wall to wall. Again, along the hallway the metal strip that creates the division between the laminate and the sheetrock wall was visibly noted to be pulling away and leaving an opening exposing the bare, unpainted sheetrock beneath. The floors were stained with multiple black marks throughout. Multiple cracks in the hallway laminate floor were noted and a previous repair was also noted. Surgical Hallway for OR #4 and #5 Outside OR #5 was a patient stretcher. The hard-plastic covering at the base of the stretcher covering the manufacturing name was peeling away from the side creating an environment for bacteria to grow. Beneath the plastic peeling away, it was noted that paint was missing from the stretcher. Under the stretcher was noted to be heavily soiled with dirt, dust, and debris. Next to the medical gas control panel on the wall, in the hallway for OR #4, the wall was missing paint and exposing the sheetrock. Sheetrock cannot be properly sanitized and therefore places all surgical patients at risk for acquiring a hospital acquired infection. OR#2 The floors in OR#2 were noted to have large chips and/or holes in the laminate. This would allow for body fluids, blood, or irrigations fluids to pool creating an environment for bacteria growth. The large tears in the laminate were not sealed. Again, along the wall where the laminate meets the sheetrock, the metal strip creating a division between the wall and the laminate was pulling away from the wall and causing the paint to peel. OR #3 The floors in OR#3 were noted to have large chips and/or holes in the laminate. This would allow for body fluids or blood to pool creating an environment for bacteria growth. The large tears in the laminate were not sealed. The floors were heavily stained with scuff marks from the stretchers and the OR beds. The anesthesia machine was noted to have a cracked surface on the top tray. This tray was where the intubation equipment (equipment that is used to secure the airway during surgery) was placed when a patient arrives in the OR for a surgical procedure. This creates an environment for bacteria growth and placing all patients at a great risk for a hospital acquired infection. A rolling chair used by the anesthesia providers was noted to have a tear in the seat cover exposing the soft foam under the protective covering. The bottom of the chair had peeling paint on all four of the legs. This surveyor was able to pick the peeling paint from the surface which exposed the metal surface beneath. The peeling paint on the legs cannot be sanitized due to the flaking of the paint. The operating table appeared to be rusted along the sides, in the connectors on the metal frame. When wiped with a caviwipe the area could not be cleaned. The Velcro on the bed frame was noted to be heavily covered with white lint and a brown colored stain. Staff #32 could not confirm nor deny if the brown color stain was old dried blood or betadine that was used for a surgical prep on a patient prior to surgery. The Velcro was used to secure the mattress to the frame of the operating table. The operating table was raised to ensure cleanliness. When the table was raised, the metal frame surrounding the electrical components of the operating table came apart in two separate places. The metal surrounding the electrical part of the bed came apart exposing the electrical compartment inside the bed. The metal base of the bed lifted simultaneously when raising the bed. Underneath the metal base was a heavy white lint. The operating table can be raised and lowered during surgical procedures depending on the procedure and the surgeon's preference. This poses an infection control issue as well as a safety issue for all patients during a surgical procedure if the electrical components are contaminated with body fluids or water used for irrigation. OR#5 The floors in OR#5 were noted to have large chips and/or holes in the laminate. This would allow for body fluids or blood to pool creating an environment for bacteria growth. The large tears in the laminate were not sealed. The floors were heavily stained with scuff marks and dust from the wheels of the stretchers and the OR beds. OR #6 The Velcro on the operating table was noted to be heavily covered with white lint and a brown colored stain. Staff #32 could not confirm nor deny if this brown colored stain was old dried blood or betadine that was used for a surgical prep on a patient prior to surgery. The velcro was used to secure the mattress to the frame of the operating table. Without a secure connection between the mattress and the surgical bed frame, the patient was at risk of injuries due to the mattress sliding off the bed frame during a surgical procedure. The mattress pad was noted to have tears in the leather covering. Central Supply The floor in central supply was noted to have missing laminate and exposing the concrete beneath. The floor could not be properly sanitized to prevent contamination of sterile instruments stored in the room. Cardiac Cath Lab #3 An observation tour of the Cardiac Cath Lab was conducted on 1/12/2022 at 1:30 PM with Staff #38. The following was observed: A led lined drape on the side of the Cath Lab table was noted to have a torn piece of leather covering the led. The led lined drape is used to protect the staff from radiation during a procedure. The base of the bed had chipped and missing paint exposing the metal surface. The metal surface could not be properly sanitized to prevent a patient from getting hospital acquired infection. An interview was conducted on 1/12/2022 at 1:45 PM with Staff #38. Staff #38 was asked if a work order had been placed repair the drape or the base of the table. Staff #38 replied, "A couple years ago in 2019, when you all were here, they came in and repainted the base of the bed, but it gets wet from mopping all the time and it just keeps happening." Staff #36, #37, and #38 confirmed the findings. Labor and Delivery OR #2 A tour of the OB department was conducted on 1/12/22 at 1:35 PM. Staff #18 confirmed that OR #2 had been used earlier for a cesarean section procedure but had been terminally cleaned and was ready for another procedure. The operating table in OR #2 was found to have pooled blood under the mattress cushion located at the center of the operating table. Staff #18 confirmed the finding. A review of the document titled, "Corrective Maintenance Work Orders" was as follows: " ...WO# 064869 Expansion Joint Uneven, Surgery/OR 7/7/2020 3:26 PM, Expansion joint in hallway by OR 10 and OR 7 heavy carts travel; over expansion joint and are tipped over during transport causing an employee safety issue. WO# 73059 Central Sterile has holes in the floors, please repair, 12/27/2021 4:44 PM, with a handwritten note that read add to floor list on the document ..." A review of the document titled, "LRMC Operating Room Infection Prevention Rounding" by Staff #13 dated 12/07/2021 at 10:43 AM was as follows: " ...Many areas of floors have open cracks or pulled away from wall. These need to be repaired and sealed. Several OR tables have rust spots as well as some equipment like Domocos (sic). Cleaned/Soiled areas: It is impossible to determine clean from dirty with equipment stored in the halls and note identified as clean ..." A review of the facility policy titled, "Operating Room Infection Control" Surgical Services, Original Effective Date: 05/03/1997 and reviewed on 2/2020 was as follows: " ...Environmental Sanitation: 1. Every case shall be treated as potentially contaminated; therefore, the sanitation routine will be consistent in each Operating Room suite following each case. 2. Patients shall be provided with a safe, clean environment, free from dust and organic debris. 3. During the surgical procedure, efforts shall be directed at confining contamination. 4. After the procedure, all items that have come in contact with the patient and/or the sterile field shall be considered contaminated, and their disposition into appropriate containers or receptacles. 5. At the conclusion of the days schedule, Operating Room suites, scrub/utility areas, furnishings, and equipment shall be cleaned. Operating Room Infection Control 1. Before the first case of the day, all lights, beds, tables and carts are wiped down with a damp cloth. 2. All floors are mopped at the end of the surgery day daily. 3. Rooms are terminally cleaned each day ..." An interview was conducted with Staff #9 and Staff #32 on 1/11/2022 at 11:00 AM. Staff #9 was asked if the floors were repaired on a regular basis. Staff #9 stated, "We have been sending work orders and complaining about the floors for a long time. They will come and patch something but leave the rest of it. The holes in the OR's are getting really bad and in great need of repair. We had an expansion many years ago and the area where the new and old floors were joined, the floors always crack there. You can't clean the floors as required with all the cracks and we have been saying that for a while now and its even been reported." Staff #32 was asked if the spine tables in the hallway, facing the window were dirty or clean. Staff #32 stated, "They should be clean, but we have no place to store them except for here." Staff #32 was asked how she ensured that the beds were clean if there was no label or indicating mark that the equipment had been cleaned. Staff #32 stated, "I cannot guarantee that they are cleaned but the staff do know to clean the equipment before placing it in the hallway." Staff #32 confirmed that The National Guidelines the Surgical Services Department follows was AORN (Association of Operating Room Nurses). Staff #9, #13, and #32 confirmed the findings. B. A review of the document titled, "Temperature, Humidity, and Pressure Logs" for January 2022 in the Labor and Delivery Department was as follows: OR#1 (C-Section Room) The temperature was out of range for 3 of 12 days documented. There was no documentation that the Engineering Department was notified and no recheck of temperature after adjustments were made. 1 out of 12 days the Temperature or Humidity was not documented. OR#2 (C-Section Room) The temperature was out of range for 3 of 12 days documented. There was no documentation that the Engineering Department was notified and no recheck of temperature after adjustments were made. 2 out of 12 days the Temperature or Humidity was not documented. Further review of the document was as follows: " ... Notify Engineering for readings outside the shaded areas. VARIANCE TRACKING: Document any out of range readings below and indicate corrective action taken. Notify Engineering immediately for inappropriate pressures or temperature & humidity out of the following ranges: Temperature 68-73 degrees, Humidity 35-60%..." A review of the AORN Perioperative Standards and Recommended Practices, " ...Temperature should be maintained between 68 degrees F to 75 degrees Fahrenheit (20 degrees to 23 C) within the operating room suite. General work areas in sterile processing should be maintained between 68 degrees to 73 degrees F. Relative humidity should be maintained between 20% and 60% within the perioperative suite, including operating rooms, recovery area, cardiac catheterization rooms, endoscopy rooms, instrument processing areas, and sterilizing areas and should be maintained below 60% in sterile storage areas. Low humidity increases the risk of electrostatic charges, which pose a fire hazard in an oxygen-enriched environment or when flammable agents are in use and increases the potential for dust. High humidity increases the risk of microbial growth in areas where sterile supplies are stored, or procedures are performed. Temperature should be monitored and recorded daily using a log format or documentation provided by the HVAC (heating, ventilation, and air conditioning) system..." Staff #18 confirmed the above findings.