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The facility failed to maintain an ongoing infection control program designed to prevent, control and investigate infections, and failed to ensure that infection control surveillance for surgical site infections was documented, comprehensive and accurate, reviewed, evaluated and used to identify areas of improvement, for nine of nine months (January 2017-October 2017) reviewed, resulting in the potential for transmission of infectious agents for all patients served by the facility. See citation - A 749

Based on interview and record review, the facility failed to ensure that the Infection Control Program had a documented system for identifying, investigating and controlling infections in the facility, performed comprehensive and accurate surveillance for Surgical site infections (SSI), and reported accurate Surgical site infection (SSI) rates to the Infection Control and Quality Assurance Performance Improvement (QAPI) committees for nine of nine months (January 2017-October 2017) reviewed, resulting in missed opportunities for quality improvement initiatives and decreasing healthcare associated infections. Findings include:

On 12/12/17 at 1400, the facility infection Control Program was reviewed with the facility Infection Control Coordinator, Staff J, and Staff S, who were also interviewed at this time.

Staff J reported that Staff S "helped (her) with the infection control surveillance." Staff J reported that she was also the facility diabetic educator and the chemotherapy nurse.

When asked, Staff J stated that she did "comprehensive whole house" surveillance (looked at every infection), as the facility was small. When asked to see logs or documentation of infections in the facility, Staff J stated that she did not use a log, and did not document surveillance data, but reported numbers of Healthcare Acquired Infections (HAI) by type and numbers, and also reported numbers and rates of Surgical Site Infections (SSI) per physician to the Infection Control Committee each month. These were reviewed with Staff J and Staff S at this time. When asked to provide documentation of microorganisms cultured from the sites, antibiotics used to treat the infections, dates of onset, locations and dates of admission/surgery, patient names or other data, Staff J stated that she did not document this. When asked for the source of data to calculate her infection numbers, Staff J was unable to provide this for six of nine patients (#11-16) reviewed, and was unable to state how the data was analyzed for trends, or areas for improvement. When asked about this, Staff J stated, "I don't see where it's a requirement to have a log of HAI or other infections."

When asked whether nationally recognized infection control organizations considered it a standard of practice for line listings or logs of HAI be kept, with dates of onset, patient identifiers, patient location, laboratory results, signs and symptoms, and antibiotics prescribed, Staff J stated, "(The main Hospital Corporation) sent me this spread sheet to use, but I haven't gotten around to using it yet." Review of this blank (uncompleted) spreadsheet, entitled "2017 Surgical Site Infection Line List" revealed standard fields for infection control logs. When asked, Staff J and Staff S were unable to provide this information for nine of nine patients selected for review (Patients #1, #9, #10, #11, #12, #13, #14, #15, and #16).

When asked, Staff J stated that the annual infection control plan for 2017's goal for SSI was zero HAI SSI. Review of the Annual Infection Control Plan and monthly Infection Control Committee meeting minutes from January 2017 - October 2017 confirmed this, and included documentation that this goal was not met. When asked what action plan was put in place to reach this unmet goal for SSI, Staff J stated, "Our SSI rates are very low."

When asked how facility Joint Replacement (Arthroplasty) surgery SSI rates compared to national benchmarks, Staff J stated that no comparisons were done because facility SSI rates for hip replacement surgery and implanted devices were not reported to the Center for Disease Control (CDC)'s National Healthcare Safety Network (NHSN), as reporting was optional and not mandatory.

When asked how surveillance for HAI SSI rates was done, Staff J stated that the Surgical (OR) Unit manager, Staff M "lets me know if any patient reports their surgical site is infected. She collects the data from patients when she does their follow up phone calls 48 hours after surgery." When asked to state how long after surgery with an implanted device (such as a joint replacement) would an infection still be counted as healthcare acquired (HAI), Staff J stated, "nine days". When asked to provide facility definitions for HAI, Staff J provided a facility Infection Control policy that stated that the facility used CDC definitions for SSI. When asked to provide this, Staff J was unable. After a delay of approximately 20 minutes of searching on the office computer, Staff S provided the online CDC NHSN manual which defined an SSI occurring after insertion of hip or knee prosthesis (joint replacement) as an HAI if it occurred within 90 days of surgery.

Nine Patients (#1, #9, #10, #11, #12, #13, #14, #15, and #16) who had joint prosthesis incision and drainage (I & D), surgical revision of implanted hardware, or a diagnosis of surgical wound infection were selected for review from discharged patient lists and surgical logs from 6/1/17 through 12/1/17. Seven of the nine patients reviewed were determined upon review at this time to have infections at the site of the implanted device (#1, #9, #12, #13, #14, #15, and #16). There was no documentation of record review or HAI decision making on six of nine charts reviewed. Staff J and Staff S reported that only two of these infections was counted as an SSI HAI on the infection control report, but were unable to provide documentation that these were the patient counted. When asked, Staff J and Staff S were unable to state who had done the initial arthroplasty or hardware insertion on five of nine patients reviewed. When asked, Staff J and Staff S stated that they did not review admissions or surgery logs for diagnoses indicative of surgical site infection, such as "Incision and Drainage ( I & D) of joint prosthesis", or "Infected Surgical Wound" as part of their surveillance for infections. When queried, Staff S and Staff J were unable to provide documentation that they reviewed microbiology laboratory reports as part of their surveillance for HAI.

Patient #1:

At this time, Review of Patient #1's clinical record revealed that Patient #1 was a 59 year old female who had a left knee total arthroplasty (joint replacement) on 7/5/17 by Orthopedic Surgeon, Staff I. Patient #1 had an Incision and Drainage ( I & D) of the left total knee arthroplasty done by Staff I on 9/6/17 (61 days later), with an admission diagnosis of "infected surgical wound." The surgeon's pre admission History and Physical (H & P ) dated 9/1/17 documented the patient was treated with only one antibiotic, levofloxacin 750 milligrams (mg) daily (QD) (a flouroquinolone antibiotic). A Microbiology report dated 8/2/17 documented that the microorganism that grew from the patient's leg drainage was resistant to Levofloxacin and Ciprofloxacin. On 10/26/17, Patient #1 had a second I & D of the left total knee arthroplasty by Staff I. The diagnoses was noted as left knee infection post total arthroplasty. The Surgeon's preoperative H & P, dated 10/23/17 documented that the antibiotic used to treat the infection was Levofloxacin 750 mg qd, with the last dose on 10/23/17. An Occurrence (Adverse Event) Report was documented on 10/26/17 for this patient during the patient's third surgery on the left knee. The Occurrence Report documented that the Surgeon, Staff I had performed an unusual surgical wound dressing tecnique. The surgeon packed the surgical site with sterile gauze and sutured the wound closed, despite Operating Room (OR) staff concerns. The Hospital Administrative team and Chief of Surgery immediately met with the OR team and Staff I and the patient immediately returned to surgery and the gauze packing removed. There was no documentation of additional complications for Patient #1.

Review of the Infection Control report of infections for 2017 revealed that Staff I had a documented SSI rate of zero (0) for July and for September. When asked if Patient #1's infected surgical wound was counted as a Healthcare Acquired Infection (HAI SSI), Staff J and Staff S stated, "No." When asked what made them decide that Patient #1's infection was not an HAI SSI, Staff J stated, "The patient had a lot of risk factors, and was non compliant." When asked whether she was aware that Patient was treated with an antibiotic which the laboratory reported that her infection was resistant to, Staff J stated that she did not review antibiotics used in the facility. When asked if the facility had an antibiotic utilization review program, Staff J stated, "The pharmacist we had before handled that. Our antibiotic utilization program kind of fell by the wayside since we got the new pharmacist."

Patient #9

Patient #9 was a 70 year old female who had an I &D of her right total knee replacement on 2/8/17 by Staff I. Patient #9 had a second I & D of the right knee arthroplasty at the facility performed by Staff I on 3/13/17, and a surgical debridement (removal of diseased and dead tissue) and curettage of the right knee surgical site by Staff I on 5/2/17. There was no documentation in the clinical record of who had done the original right knee arthroplasty, or when it was done. When asked about this, Staff J and Staff S reported that they did not know where or when the original arthroplasty was done, or whether Staff I had done the initial arthroplasty. When queried, Both Staff J and Staff S stated they had not reviewed this patient's record for possible HAI.

Patient #12

Patient #12 was a 70 year old male who had a left shoulder I & D with drain insertion on 8/9/17 by Staff I for a diagnosis of left shoulder cellulitis. Patient #12 had a second left shoulder I & D by Staff I on 9/21/17. Staff J and Staff S were not able to provide additional information, and stated they had not reviewed this.

Patient #13

Patient #13 was a 77 year old male who had a left knee total arthroplasty on 7/13/17 by Staff I. Patient #13 had a repeat arthroscopy with left quadricepts repair on 9/11/17 by Staff I following a fall. Patient # 13 had a I & D of the left knee arthroplasty on 10/12/17 (31 days later) for a diagnosis of "Infection Left Total Knee." When queried, Staff S stated that Patient #13's SSI had been counted as an SSI for Staff S for October. Review of the 2017 Infection summaries for Staff S revealed documentation that Staff S had one SSI in October. When asked, neither Staff J nor Staff S was able to provide documentation that this SSI was the one documented, not another one that was not reviewed at this time, and were unable to provide any additional information about that counted SSI, or decisionmaking on whether the SSI met the definition for an HAI or not.

Patient #14

Patient #14 was a 56 year old male who had surgery on 2/20/17 by Staff I for "Distal Left Fibula Fracture" (broken ankle) with insertion of tubular plate, locking screws and ancillary screw. Patient #14 had an I & D of the left ankle on 5/8/17 (<90 days) by Staff I for a diagnosis of Left ankle wound not healing after surgery. Microbiology cultures were positive for group B beta Hemolytic Streptococcus and other microorganisms on 5/8/17. When asked, Staff J and Staff S reported that they had not reviewed this case to rule out an HAI, as they were not aware of it.

Patient #15

Patient #15 was a 57 year old female who had an I & D with Wound Closure of left knee by Staff I on 2/20/17. Her diagnosis was documented as surgical wound dehiscence (incision opening back up). A Microbiology lab report dated 1/28/17, ordered by Staff I, documented an infection of the left knee with Corynebacterium. When asked, Staff J and Staff S reported that they had not reviewed this case to rule out an HAI as they were not aware of it, and were unable to provide documentation or state who had performed the initial surgery and when.

Patient #16

Patient #16 was a 44 year old male who had an I&D of the left shoulder on 8/17/17 by Staff I for a diagnosis of Methicillin Resistant Staphylococcus aureus (MRSA) infection, and a second I & D on the left shoulder on 9/18/17 by Staff I for a diagnosis of MRSA. When queried, Staff S stated that she had a file on this case, and reported that the initial surgery was done in March of 2017 by Staff S for a shoulder tear. Review of microbiology reports for Patient #16 revealed a positive microbial culture (infection) from a sample of drainage from the left shoulder on 6/9/17 (<90 days). When asked, Staff J and Staff S stated that this was not counted as an SSI, and could not explain why. Review of the 217 Infection Control SSI Numbers for June 2017 revealed Staff S was documented as having one SSI that month. Staff J and Staff S were unable to provide any additional information about that counted SSI, or decisionmaking on whether the SSI met the definition for an HAI or not.


On 12/12/17 at approximately 1500, the facility Chief Operating Officer Staff A was interviewed and the facility Infection Control Program surveillance for SSI discussed. Staff A stated that the facility QAPI program received statistics on HAI including provider specific SSI, and provided documentation of the facility's action plans to reduce HAI including SSI for review. Staff A stated that the QAPI committee had discussed Staff I's SSI rates, but peer review and surgeon interviews had revealed that Staff I's patients had multiple risk factors that placed them at higher risk than average for a post operative infection. When queried, Staff A stated that the QAPI committee would address the fact that SSI rates were not accurate both because comprehensive surveillance methods were not done, and because of a lack of documentation in the clinical record of the initial surgery. Staff A stated that an action plan would be put in place at the next QAPI committee, which had been postponed due to survey. Staff A stated that Staff I did all his surgeries in the facility.

Review of the Infection Control Program Policies and Procedures provided on 12/12/17 at approximately 1430 revealed no instructions or direction on surveillance methodology or documentation.

On 12/14/17 at approximately 1230, Staff I was interviewed. StafF I stated that he had trouble with documenting in the electronic Medical Record (EMR), and that is why the date of the initial surgery was often missing. Staff I reported that he did the initial surgeries on all the patients reviewed, (#1, #9, #10, #11, #12, #13, #14, #15 and #16). Staff I stated that he did not do I & D or treat surgical site infections on other surgeon's patients. Staff I stated that the procedure he had used to pack Patient #1's wound was one used, "in the old days." Staff I stated that he planned to remove the gauze the day following surgery when the patient came in for a post operative check-up. Staff I stated that he was told by Administration, "to never do that again."