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Based on record reviews, and interviews, the hospital failed to meet the requirements of 42 CFR 482.1 as evidenced by failing to be primarily engaged in providing inpatient services. The regulation at 42 CFR 482.1 implements the statutory requirement at Section 1861(e) of the Social Security Act (Act). The regulation requires that: (i) Hospitals participating in Medicare must meet certain specified requirements and (ii) The Secretary may impose additional requirements if they are found necessary in the interest of the health and safety of the individuals who are furnished services in hospitals.

The Act defines hospital as: an institution that ". . . is primarily engaged in providing, by or under the supervision of physicians, to inpatients (A) diagnostic services and therapeutic services for medical diagnosis, treatment, and care of injured, disabled, or sick persons, or (B) rehabilitation services for the rehabilitation of injured, disabled, or sick persons..."


Findings:

The hospital's Average Length of Stay (ALOS) was 1.67, the Average Daily Census ( ADC) was 0.65. There were no inpatients at midnight on Monday, 11/27/17 (day the survey began), and there had not been any inpatients since Monday, 11/20/2017. The hospital's physicians routinely scheduled procedures at the beginning of the week.

Lafayette General Surgical Hospital is essentially a 10-bed acute care hospital with 4 operating rooms, 5 pre-op beds and 5 post-op beds, that primarily provides surgical services to inpatients and outpatients. There are no patients admitted for acute care services that are not post-op surgical patients of the hospital.

The hospital data provided for the period of 11/27/16 to 11/26/17 revealed that the hospital provided services to 142 inpatients and 3427 outpatients. Of the 3427 outpatients, 3015 patients were day surgery patients (had a surgical procedure and were discharged after recovery) and 412 were "outpatient bedded" patients (post-operative patients with extended recovery period that lasted beyond 24 hours but were not admitted as inpatients). The records provided showed that the total volume of services provided by Lafayette General Surgical Hospital were primarily for outpatient surgical services. The ADC for that time period was 0.65, and the ALOS was 1.67 days.

Review of the "ADC & ALOS 11/27/16 - 11/26/17" log revealed from 09/01/2017 to 09/19/17 (19 days) there were no inpatients in the hospital.

Review of schedules provided by S1ADM on 11/27/17 at 3:00 p.m. and interview with S1ADM on 11/27/17 at 3:20 p.m. revealed the following:

Services- the hospital has a service agreement with Hospital A (50% owner of this hospital) to provide dietary, pharmacy, radiology, respiratory, medical records, laboratory services, and surgical equipment decontamination and materials management. Anesthesia services are provided by contract with a local anesthesiology group. The surgical services provided by the hospital are for Orthopedics, General Surgery, Neuro-Spine, Urology, Plastics, and EENT (Eye, Ear, Nose and Throat).

Staffing- the staffing for the hospital when there are no inpatients (such as Thanksgiving and the Friday after), were a RN and security guard. When the hospital has inpatients, there are 2 nurses, one of whom is a RN, on the inpatient unit. Pharmacy is onsite Monday through Friday during the day, and available through the on-call pharmacist at Hospital A on evenings, nights, weekends, and holidays. There is no surgeon on-call, because the surgeons cover their own inpatient(s) if admitted to the hospital for inpatient services. An internal medicine doctor is on-call (through a group practice) for the hospital.

Surgery staffing- each OR surgical case is staffed with one RN, one OR Tech and a CRNA. The pre-op and post-op units are staffed by RNs.

Review of the patient list of patients having surgical procedures, provided by S4PADM, for 11/13/17 through 11/26/17, revealed the following:

11/13/17 (Monday) - 14 outpatient day surgery patients; 1 outpatient bedded patient; no inpatient;

11/14/17 (Tuesday) - 15 outpatient day surgery patients; 3 outpatient bedded patients; 2 inpatients - post-op patients who had extended recovery period (both had a stay > 48 hours);

11/15/17 (Wednesday) - 12 outpatient day surgery patients; 3 outpatient bedded patients; 3 inpatients - post-op patients who had extended recovery period (one with a 29 hour 25 minute stay; one with a 25 hour 14 minute stay; one with a 46 hour stay);

11/16/17 (Thursday) - 23 outpatient day surgery patients; 2 outpatient bedded patients; no inpatient;

11/17/17 (Friday_ - 21 outpatient day surgery patients; 3 outpatient bedded patients; 1 inpatient - post-op patients who had extended recovery period (discharged within < 24 hours);

No patients 11/18/17 (Saturday) and 11/19/17 (Sunday);

11/20/17 (Monday) - 15 outpatient day surgery patients; 4 outpatient bedded patients; 2 inpatients - post-op patients who had extended recovery period (one with a 33 hour 16 minute stay; one with a > 48 hour stay);

11/21/17 (Tuesday) - 17 outpatient day surgery patients; 3 outpatient bedded patients; no inpatients;

No patients 11/23/17 (Wednesday), 11/24/17 (Thursday), 11/25/17 (Friday), 11/26/17 (Saturday), and 11/27/17 (Sunday).


Review of admissions on 11/27/2017 revealed the following:

Review of Patient #1's medical record revealed she was admitted on Monday, 11/27/17 at 8:42 a.m. for a Right Knee Arthroplasty. Patient #1 was discharged on 11/29/17.

Review of Patient #2's medical record revealed he was admitted on 11/27/17 at 7:06 a.m. for a Right Knee Arthroplasty. He was discharged on 11/29/17.


In an interview on 11/27/17 at 10:25 a.m., S4PADM indicated the ALOS was computed as follows: the discharge date and time minus the admit date and time and the sum of all inpatient encounters divided by the number of inpatients for the past 12 months. He further indicated the ADC was computed as follows by dividing the total number of midnights/encounter by 365. He confirmed the above-listed ALOS and ADC were the results of this computation. S4PADM indicated there were 142 inpatients and 412 outpatients from 11/27/16 to 11/26/17 time period.


In an interview on 11/27/17 at 3:20 p.m., S1ADM indicated the surgeons schedule their inpatient procedures at the beginning of the week, usually Monday through Thursday.

Based on policy review, record review, and interview, the hospital failed to ensure in its resolution of a grievance, the hospital provided the patient with a written notice of its decision that contained the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of the completion for 1(R1) of 2 (R1, R2) patients reviewed with a grievance from a total of 4 (R1 - R4) patients with complaints/grievances.


Findings:

Review of the hospital's policy titled, "Patient Complaint and Grievance Policy" revealed in part:

I. To provide patients or patient's representative with a timely and efficient process for managing complaints and grievances regarding patient care ....

III. Definition of Terms:

D. Verbal Complaint - A grievance if it cannot be resolved at the time of the complaint by staff present, if it is postponed for later resolution, if it is referred to other staff for later resolution, if it requires investigation, and/or if it requires further actions for resolution.

V. Procedure

D. Grievance Resolution Process

4. Regardless of the nature of the grievance, the substance of each grievance must be addressed while identifying, investigating, and resolving any deeper, systemic problems indicated by the grievance.

5. In resolution of the grievance, a written notice of the decision must be provided to the complainant that contains the name of the facility contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance investigation, and the date of completion.


Review of a Compliance/HIPAA Concern Event Report with a date of event of 08/23/17 that indicated Patient R1 initiated a grievance on 08/18/17 regarding numbness to the tongue. Further review of the report revealed the grievance was investigated and resolved on 10/19/17.


In an interview on 11/28/17 at 3:30 p.m. with S3QC, she stated she was responsible for patient grievances. After review of the hospital's Patient Complaint and Grievance Policy, S3QC verified she had not sent written communication to Patient R1 in response to their grievance.

Based on record reviews and interview, the hospital failed to ensure its QAPI program developed quality indicators to measure, analyze, and track aspects of performance that assess processes of care and hospital services and operations as evidenced by failure to have quality indicators developed for the contracted services of biohazardous waste, organ and tissue services, and nerve monitoring done by Companies A and B.


Findings:

Review of the "Reporting Calendar" for fiscal year 2017, presented by S3QC as the current dashboard of quality indicators developed for measurement, analysis, and tracking, revealed no documented evidence that quality indicators had been developed to measure, analyze, and track the contracted services of biohazardous waste, organ and tissue services, and nerve monitoring done by Companies A and B.


In an interview on 11/29/17 at 2:45 p.m. with S2DON and S3QC present, S3QC confirmed she was responsible for the QAPI program for the hospital. She confirmed that no quality indicators had been developed for the above-listed contracted services.

Based on record reviews and interviews, the hospital failed to maintain an ongoing program for quality assurance that shows measureable improvement in indicators for which there is evidence identified to reduce medication errors. This deficient practice is evidenced by the hospital failing to identify medication errors for 2 (#25, #30) of 8 (#10, #24, #25, #26, #27, #28, #29, #30) patients' medical records reviewed for medication administration from a total sample of 30 patients.


Findings:

A review of the hospital's "Medication Variance" policy revealed in part:

II. Definition of Terms:

A. Medication Variance - any error in drug, time, dosage, route of administration or identification. This includes any error in procedure by those involved in the administration of medications, e.g., ...nurse .... The following are types of variances:

2. Time

a. Drug given too frequently
b. Drug not given often enough

III. General Information:

A. It is the responsibility of every licensed nurse to identify and report any drug variance ....


Patient #25

A review of the Physician's Orders dated 6/12/17 for Patient #25 revealed in part:

Cefazolin (Ancef) 2 grams IV Piggyback ...Infuse over 1 hours ...first dose

Cefazolin (Ancef 2 grams 50 ml D5W (Premix) ...Infusion IV Piggyback q 8 hours, Infuse over 30 minutes.


Review of the eMAR dated 06/12/17 indicated the first dose of Ancef 2 grams was administered to Patient #25 on 06/12/17 at 8:25 a.m. Further review of the eMar revealed the second dose of Ancef 2 grams was administered at 2:33 p.m.


Patient #30

A review of the Physician's Orders dated 07/19/17 for Patient #30 revealed in part:

Cefazolin (Ancef) 2 grams IV Piggyback ...Infuse over 1 hours ...first dose

Cefazolin (Ancef 1 gram 50 ml D5W (Premix) ...Infusion IV Piggyback q 6 hours, Infuse over 30 minutes.


Review of the eMAR dated 07/19/17 indicated the first dose of Ancef 2 grams was administered to Patient #30 on 07/19/17 at 10:17 a.m. Further review of the eMar revealed the second dose of Ancef 1 gram was administered at 7:55 p.m.


On 11/28/17 at 1:12 p.m., an interview was held with S23RPH and S3QC. S23RPH stated she had been the pharmacist at the surgical hospital for the last two weeks. S23RPH stated she presented quality concerns to the medical executive committee that included missing drugs on the formulary, medication variances, and adverse reactions. During the interview, the quality data for the last year presented by S3QC was reviewed. S3QC explained out of approximately 60,000 medication doses given, there was only one medication error identified. S3QC was asked how she was able to determine medication errors. S3QC stated the nursing staff self-reported by sending an electronic medication variance report to S23RPH. When asked, S23RPH stated she was able to run a report to review medication errors. However, S23RPH stated she was not reviewing patient's medical records for medication errors. S23RPH added "We need to figure out a way to determine near misses and detailed review of tracking medication errors. Self-reporting was the only way."


On 11/29/17 at 10:47 a.m., an interview was conducted with S5RNMgr. After reviewing the eMAR for Patient #25, she explained Patient #25 was to receive Ancef 2 grams every 8 hours after the first dose. S5RNMgr verified the second scheduled dose of Ancef 2 grams was due at 4:00 p.m. and should have been given in the appropriate time frame. After reviewing Patient #30's eMAR, S5RNMgr also verified the second dose of Ancef 1 gram was due to be given at 4:17 p.m. and should have been administered in the appropriate time frame according to hospital policy. S5RNMgr acknowledged both occurrences were considered medication errors. S5RNMgr stated the nursing staff administering the medication should have self-reported by completing a medication incident report. She explained that S3QC, who monitored medication variances, would have received the reports and then, would inform the S5RNMgr. S5RNMgr confirmed there was no incident report completed for the two medication errors listed above.


On 11/29/17 at 4:00 p.m., an interview was conducted with S2DON. She stated S24RN randomly reviewed patients' charts for accuracy of antibiotic administration and correct timing. She explained S24RN reported findings to S3QC, who then reported to Patient Safety. After review of the findings, S2DON verified the medical records of Patients #25 and #30 were not reviewed and identified as having a medication error.

Based on record reviews and interview, the hospital failed to ensure the selected distinct improvement projects included the reason for conducting the project as evidenced by failure to document the reason for conducting the distinct improvement project for 1 of 3 distinct improvement projects reviewed.


Findings:

Review of the distinct improvement project begun on 05/25/17 related to immediate use steam sterilization, presented as a completed project by S3QC, revealed no documented evidence that the reason the project was selected was documented.

In an interview on 11/29/17 at 2:45 p.m. with S2DON and S3QC present, S3QC confirmed the documentation of the completed distinct improvement project related to immediate use steam sterilization did not include the reason the project was selected.

Based on record reviews, policy review, and interview, the hospital failed to ensure drugs and biologicals were administered in accordance with the orders of qualified practitioners responsible for the patient's care and in accordance with hospital policy. This deficient practice is evidenced by 2 medication errors that had not been identified by the hospital for 2 (#25, #30) of 8 (#10, #24, #25, #26, #27, #28, #29, #30) patients' records reviewed for medication administration from a total sample of 30 patients.


Findings:

A review of the hospital's "Medication Administration" policy revealed in part:

I. Statement of Purpose:

To safely administer prescribed medications.

IV. General Information:

C. The five (5) rights of medication administration ensure safety:

5. Right Time - Ensure adherence to the prescribed frequency and time of administration.

R. Medication should be administered according to standard medication administration times specified in the eMAR. Unless, delayed for diagnostic testing, medications should be given no earlier than 1 hour before the scheduled time or no later than 1 hour after the scheduled time ....


Patient #25

A review of the Physician's Orders dated 06/12/17 for Patient #25 revealed in part:

Cefazolin (Ancef) 2 grams IV Piggyback ...Infuse over 1 hour ...first dose

Cefazolin (Ancef 2 grams 50ml D5W (Premix) ...Infusion IV Piggyback q 8 hours, Infuse over 30 minutes.


Review of the eMAR dated 06/12/17 indicated the first dose of Ancef 2 grams was administered to Patient #25 on 06/12/17 at 8:25 a.m. Further review of the eMar revealed the second dose of Ancef 2 grams was administered at 2:33 p.m.


Patient #30

A review of the Physician's Orders dated 07/19/17 for Patient #30 revealed in part:

Cefazolin (Ancef) 2 grams IV Piggyback ...Infuse over 1 hour ...first dose

Cefazolin (Ancef 1 gram 50ml D5W (Premix) ...Infusion IV Piggyback q 6 hours, Infuse over 30 minutes.


Review of the eMAR dated 07/19/17 revealed the first dose of Ancef 2 grams was administered to Patient #30 on 07/17/17 at 10:17 a.m. Further review of the eMar revealed the second dose of Ancef 1 grams was administered at 7:55 p.m.


On 11/29/17 at 10:47 a.m., an interview was conducted with S5RNMgr. After reviewing the eMAR for Patient #25, she explained that Patient #25 was to receive Ancef 2 grams every 8 hours after the first dose. S5RNMgr verified the second scheduled dose of Ancef 2 grams was due at 4:00 p.m. and should have been given in the appropriate time frame. After reviewing Patient #30's eMAR, S5RNMgr also verified the second dose of Ancef 1 gram was due to be given at 4:17 p.m. and should have been administered in the appropriate time frame according to hospital policy.

Based on record reviews and interviews, the hospital failed to ensure all medical records were completed no later than 30 days after discharge as evidenced by having 46 medical records not completed within 30 days after discharge for 2 (S16MD, S20MD) of 2 physicians with delinquent medical records.

Findings:

Review of the hospital's Medical Staff Bylaws, Rules and Regulations revealed the following:

B. Medical Records

18. The patient's medical record shall be complete at the time of discharge. Any records incomplete at the time of discharge must be completed within 30 days.

a. Records not completed by the 30th day following discharge are considered delinquent and the practitioner shall be notified that his privileges outlined in this regulation have been suspended. The suspension shall remain in effect until all records have been completed. During the time the physician's privileges are suspended, he will not be able to admit or consult on patients.

b. Failure to complete all records by the 15th day of suspension will result in voluntary relinquishment of all clinical privileges and medical staff membership


Review of a list of delinquent medical records provided by the hospital revealed S16MD had 17 medical records delinquent greater than 30 days, 14 medical records greater than 60 days, and 1 medical record greater than 90 days. Further review revealed S20MD had 6 medical records delinquent greater than 30 days, 3 medical records greater than 60 days, and 5 medical records greater than 90 days.


In an interview on 11/28/17 at 1:45 p.m. with S21HIMMgr, she stated that medical records that were 30 days delinquent or greater were considered delinquent. At 15 days delinquent, the physician would receive a letter informing them of their medical records approaching 30 days delinquency. At 30 days delinquent, the physician will receive a letter and a pending suspension notification. After 30 days delinquent, a final letter of suspension was sent to the physician. She stated after 45 days they were suspended from admissions of patients or elective procedures. When asked, S21HIMMgr stated missing H & Ps, dictated reports, discharge summaries, and missing signatures would constitute a delinquent medical record.


In an interview on 11/28/17 at 2:07 p.m. with S1ADM, she stated S16MD and S20MD had received their 15, 30 and 45 day letters. She verified S16MD and S20MD had not been suspended as per the hospital's Medical Staff Bylaws.


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Based on record reviews and interviews, the hospital failed to ensure all patient records included documentation of outcomes of hospitalization, disposition of care, and provisions for follow-up care. This deficient practice was evidenced by failure of the hospital to ensure the treating licensed practitioner completed a discharge summary for 3 (#3, #4, #14) of 8 (#3, #4, #12, #13, #14, #15, #16, #17) patient records reviewed for discharge summaries from a total sample of 30 patients.


Findings:

Review of the Medical Staff's Rules and Regulations, presented as current Rules and regulations by S1ADM, revealed that a medical record must be established for each patient entering the hospital. This record shall include the patient's condition on discharge and a summary or discharge note.


Patient #3

Review of Patient #3's medical record revealed she was admitted on 07/19/17 and was discharged on 07/20/17. Further review revealed no documented evidence that a discharge summary was documented by her physician/

In an interview on 11/28/17 at 1:00 p.m., S7RN confirmed the electronic medical record had no evidence that a discharge summary had been completed by the physician.


Patient #4

Review of Patient #4's medical record revealed she was admitted on 03/07/17 at 5:22 a.m. and transferred on 03/07/17 at 10:53 a.m. Further review revealed no documented evidence that a discharge summary had been documented by her physician.

In an interview on 11/28/17 at 3:10 p.m., S7RN confirmed the electronic medical record had no evidence that a discharge summary had been completed by the physician.


Patient #14

Review of Patient #14's EMR revealed an admission date of 11/09/17 with an admission diagnosis of Dysphagia. Further review revealed Patient #14 had an EGD and balloon dilitation, was admitted as an inpatient, and was discharged on 11/11/17. Additional review revealed no documented evidence of a discharge summary for Patient #14.

In an interview on 11/28/17 at 2:36 p.m. with S5RNMgr, she confirmed, after review of Patient #14's EMR, that there was no discharge summary in the patient's record.

Based on observations, record reviews, and interviews, the infection control officer failed to ensure the hospital's system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel was implemented in accordance with hospital policy and acceptable standards of practice as evidenced by:


1) Failing to ensure IC practices were implemented in accordance with acceptable standards of practice for contact precautions for 1 (#2) of 1 patient observed on contact precautions on 11/27/17 at 1:50 p.m. and during the in and out catheter procedure performed for 1 (#2) of 1 patient observed during an in and out catheter procedure on 12/28/17 at 12:25 p.m.


2) Failing to ensure IC practices were implemented in accordance with standards of practice during an observation of cleaning and processing of an endoscope on 11/29/17 at 9:25 a.m.


3) Failing to ensure surgical attire was donned in accordance with acceptable standards of practice during observations on 11/29/17 from 7:35 a.m. to 9:30 a.m. Staff had hair protruding from surgical hats, skull caps were used which prevented hair from being contained, surgical masks were worn hanging from the neck when outside the surgical suite, and beards were not covered with a hood.


4) Failing to ensure IV fluids and irrigation solutions were not warmed at a temperature greater than that allowed by the manufacturer as observed on 11/29/17 at 7:35 a.m.


5) Failing to ensure expired surgical supplies were not available for use as evidenced by observation of 2 syringe/gauze assembly products on the shelf available for use in the materials room on 11/29/17 at 9:15 a.m.


6) Failing to ensure an action plan had been developed when the infections had increased from 4 infections in 2016 to 4 infections in the first quarter of 2017.


7) Failing to ensure the contracted housekeeping staff (who performed terminal cleaning of the OR daily) and the contracted sterile processing department staff were evaluated for competency by the qualified IC officer.


Findings:

1) Failing to ensure IC practices were implemented in accordance with acceptable standards of practice for contact precautions and during the in and out catheter procedure performed:

Observation on 11/27/17 at 1:50 p.m. with S5RNMgr present revealed a sign on the room of Patient #2 for contact precautions that revealed the door was to be kept closed. Further observation revealed the door had a crack large enough that Patient #2 could be seen lying in bed when the surveyor was standing outside his door.

Observation on 11/28/17 at 12:25 p.m. revealed S8RN performed an in and out catheter procedure for Patient #2. Continuous observation revealed that S8RN was gowned and gloved. prior to starting the procedure. S8RN removed the foam cushion used to elevate Patient #1's foot and placed it on the floor. She removed her gloves. While wearing her gown used as personal protective equipment, S8RN left the room and stepped into the hall to get more gloves. She did not remove her gown before exiting the room. S8RN performed hand hygiene upon re-entering the room and donned gloves. After completing the catheterization, S8RN removed her gloves and performed hand hygiene. With ungloved hands, she took the foam cushion off the floor, lifted Patient #2's right leg, and placed the cushion under his foot. She then touched the handle of the walker with ungloved hands.

Review of the policy titled "Contact Precautions", presented as a current policy by S2DON, revealed that contact precautions are used for a current infection or history of MRSA infection/colonization. Further review revealed in addition to standard precautions, the door should be kept closed. A protective gown should be worn whenever direct contact with the patient, environmental surfaces , or items in the patient's room is likely. During the course of providing care to any patient, gloves should be changed after contact with infective material before touching any other part of the patient's body or anything else in the patient's environment.

Review of Patient #2's medical record revealed he was admitted on 11/27/17 and had an order for contact precautions BID.

In an interview on 11/27/17 at 1:50 p.m., S5RNMgr indicated Patient #2 had a history of MRSA, and his door should be closed.

In an interview on 11/28/17 at 12:40 p.m., S8RN confirmed the above-listed breaches in infection control.


2) Failing to ensure IC practices were implemented in accordance with standards of practice during an observation of cleaning and processing of an endoscope:

Observation on 11/29/17 at 9:25 a.m. revealed S18SPDT, a contracted employee from Hospital A, was cleaning a contaminated endoscope. Continuous observation during the procedure revealed she filled 2 sinks with water. The sinks had markings for gallon levels but no marks for 1/2 gallon levels. Observation revealed a sign posted above the sink of "6.5 gal H2O to 3.25 oz. detergent." Further observation revealed S18SPDT wore the same gloves for performing the leak test on the contaminated scope, cleaning the contaminated scope, and placing the cleaned scope in the Medivator for processing.

Review of the hospital policy titled "Cleaning Procedure For Fiberoptic Bronchoscopes/Endoscopes", presented as a current policy by S2DON, revealed no documented evidence that the policy included information related to the amount of water to be used for cleaning and the use of gloves and when to change gloves during the procedure.

Review of SGNA's "Standards of infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes" revealed instructions to dilute and use detergent in accordance with the manufacturer's instructions.

Review of CDC's "Guidelines for Hand Hygiene in Health-Care Settings" revealed that hands should be decontaminated when moving from a contaminated body site to a clean body site.

In an interview on 11/29/17 at 9:25 a.m. at the conclusion of the procedure, S18SPDT confirmed she didn't change her gloves when she went from a contaminated scope to a clean scope. She confirmed she should have changed her gloves before she placed the clean scope in the Medivator. She confirmed that she estimated the 1/2 gallon to make 6.5 gallons, since there was no 1/2 gallon marking in the sink.


3) Failing to ensure surgical attire was donned in accordance with acceptable standards of practice:

Observations in the semi-restricted and restricted areas of the OR on 11/29/17 from 7:35 a.m. to 9:30 a.m. revealed the following breaches in surgical attire:

S9ORS had hair loose and protruding from her surgical hat at the nape of the neck.

S10RN was in the hall with her surgical mask hanging around her neck and hair exposed at the side of her surgical hat.

S11ORT had hair loose extending outside the surgical hat at the side of the hat.

S12SPDT had his beard uncovered.

S13ST had a skull cap with his hair exposed at the sideburns and nape of the neck.

S14CRNA had a skull cap with his hair exposed at the sideburns and nape of the neck, and his beard was uncovered.

S15SCE has his personal T-shirt exposed at the neck of his scrub top.

S16MD had a skull cap with his sideburns and hair at the nape of his neck exposed.

S17MD entered the surgical suite from the physician's lounge with his surgical mask hanging around his neck and entered OR 3.


Review of AORN's "Guidelines for Perioperative Practice, 2015 edition, Guideline for Surgical Attire" revealed surgical masks should not be worn hanging down from the neck. Further review revealed all personnel should cover head and facial hair, including the sideburns and the ears and nape of the neck when in semi-restricted and restricted areas. Skull caps fail to contain the side hair above and in front of the ears and the hair at the nape of the neck and the ears and should not be worn.

In an interview during the above observations on 11/29/17 from 7:35 a.m. to 9:30 a.m., S9ORS confirmed the breaches in surgical attire listed above.


4) Failing to ensure IV fluids and irrigation solutions were not warmed at a temperature greater than that allowed by the manufacturer:

Observation of the warmer used to heat IV solutions and plastic containers of Sterile Water for Irrigation on 11/29/17 at 7:35 a.m. revealed the temperature was 130 degrees F. Observation of the label on the plastic container of Sterile Water for irrigation revealed the solution could be warmed to not more than 50 degrees C. for a maximum of 60 days, after which time the solution has to be discarded.

Review of documentation by Baxter International, presented by S2DON, revealed that irrigation solutions in arthromatic or uromatic plastic containers could be warmed up to 122 degrees F. for a period of no longer than 72 hours. Further review revealed solutions for irrigation in pour bottles could be warmed to not more than 122 degrees F. for a maximum of 60 days.

Review of the "Fluid warmer Log 1 & (and) 2 Not to exceed 130 degrees F. and fluids must be rotated every 72 hours", presented by S2DON, revealed the temperature each day that the temperature was documented in September, October, and November 2017 was either 130 degrees F. or 131 degrees F.

In an interview on 11/29/17 at 7:35 a.m., S2DON confirmed the registered temperature on the warmer was currently 130 degrees F., and the documented temperatures on the logs for September, October, and November 2017 had either been 130 degrees F. or 131 degrees F. She confirmed these temperatures were above the manufacturer's recommendations for warming temperatures.


5) Failing to ensure expired surgical supplies were not available for use:

Observation on 11/29/17 at 9:15 a.m. in the materials room with S19SPDS present revealed 2 expired Alliance Single-Use Syringe/Gauze Assemble on the shelf available for use. One had expired on 12/11/16, and one had expired on 09/06/17.

In an interview on 11/29/17 at 9:15 a.m., S19SPDS indicated the expired supplies should not be on the shelf and available for use.


6) Failing to ensure an action plan had been developed when the infections had increased from 4 infections in 2016 to 4 infections in the first quarter of 2017:

Review of the policy titled "Infection Prevention & (and) Control Plan", presented as the current plan by S3QC, revealed the surveillance system of the infection prevention program includes data collection, data collation, data evaluation and analysis, comparing data with internal and external benchmarks, and developing and implementing interventions and improvement plans using a team approach.

Review of the IC data presented by S3QC, the IC Officer for the hospital, revealed there were 4 infections logged and investigated for 2016. Review of the "Infection Prevention Meeting Minutes" for 03/23/17 revealed there were 4 infections since the start of the fiscal year (the first quarter of 2017). Review of the "Infection Prevention Meeting Minutes" for 07/11/17 revealed there was an additional 2 infections in the second quarter. Review of the "Infection Prevention Meeting Minutes" for 10/12/17 revealed there was an additional 3 infections in the third quarter. There was no documented evidence that an action plan was developed and implemented to address the increase in infections until an infection prevention task force was begun 08/03/17.

In an interview on 11/29/17 at at 1:30 p.m. with S3QC and S2DON present, S3QC confirmed that an action plan to address the increase in infections that was identified in the first quarter of 2017 was not developed until the third quarter of the year.


7) Failing to ensure the contracted housekeeping staff (who performed terminal cleaning of the OR daily) and the contracted sterile processing department staff were evaluated for competency by the qualified IC officer:
Review of the policy titled "OR Sanitation", presented as a current policy by S2DON, revealed that terminal cleaning at the completion of the day was done by the OR attendants/housekeeping staff.

Review of the competency evaluation for S18SPDT, who was contracted from Hospital A, revealed the evaluation was conducted in 2015 by S19SPDS.

Review of the competency evaluation for S19SPDS, who was contracted from Hospital A, revealed the evaluation was conducted in 2015 by S18SPDT.

No documented evidence was provided of an evaluation of competency conducted by a hospital staff member competent in current infection control practices for S18SPDT, S19SPDS, and the contracted housekeeping staff who performed daily terminal cleaning of the OR.

In an interview on 11/29/17 at 1:30 p.m. with S2DON and S3QC present, S3QC and S2DON confirmed S18SPDT and S19SPDS, contracted sterile processing staff, had not been evaluated for competency by a hospital-employed staff person competent in the hospital's infection control practices and acceptable standards of practice. They both confirmed that the contracted housekeeping staff who performed daily terminal cleaning of the OR had also not been evaluated for competency by a hospital-employed staff person competent in the hospital's infection control practices and acceptable standards of practice.

Based on record reviews and interview, the hospital failed to ensure patient safety policies/procedures utilized to protect patients from potential fire risk (when using alcohol-based skin preparations) were documented in the patient record. This deficient practice was evidenced by failure of hospital staff to document visualization of the surgical site for dryness and the drying time interval for the surgical site for 4 (#2, #12, #13, #15) of 5 (#2, #12, #13, #14, #15) patient records reviewed for documentation of drying of alcohol-based skin preparation solutions from a total sample of 30 patients.


Findings:

Review of the Hospital's policy titled, "Fire Prevention in the Operating Room", revealed the following, in part: I. Purpose: To provide and maintain a safe environment to patients undergoing operative procedures. To delineate responsibilities for department employees in order to decrease the chance of patient and employee injuries. VI. Special Considerations: Table 1- Fire Risk Ignition: Ignition Sources: Electrosurgical Unit; Strategies to manage: After prepping, allow prep to dry and fumes to dissipate. Wet prep and fumes trapped beneath drapes can ignite.
Table II. Fire Risk Fuel: Fuel Sources: Patient and staff linens, drapes, gowns, towels, lap pads, sponges, Alcohol- based skin preparations. Strategies to manage: Do not trap volatile chemicals or chemical fumes beneath drapes. Prep solutions: Use flammable prep solutions with caution. After prepping, allow prep to dry and fumes to dissipate. Wet preps and fumes trapped beneath drapes can ignite.


Patient #2

Review of Patient #2's electronic medical record (EMR) revealed an admission date of 11/27/17 with an admission diagnosis of primary Osteoarthritis. Further review revealed Patient # 2 was scheduled for right total knee replacement surgery.

Review of Patient #2's intraoperative record, dated 11/27/17, revealed the skin of the surgical area was prepped with Chloraprep (an alcohol-based surgical skin prep). Additional review revealed no documentation of skin prep drying time and no documentation of visualization of the site for dryness.


Patient #12
Review of Patient #12's EMR revealed an admission date of 10/27/17 with an admission diagnosis of meniscus tear. Further review revealed Patient # 12 was scheduled for left knee arthroscopy.

Review of Patient #12's intraoperative record, dated 10/27/17, revealed the skin of the surgical area was prepped with Chloraprep. Additional review revealed no documentation of skin prep drying time and no documentation of visualization of the site for dryness.


Patient #13
Review of Patient #13's EMR revealed an admission date of 11/08/17 with an admission diagnosis of Osteoarthritis of the left knee. Further review revealed Patient #13 was scheduled for total knee arthroscopy.

Review of Patient #13's intraoperative record, dated 11/08/17, revealed the skin of the surgical area was prepped with Chloraprep. Additional review revealed no documentation of skin prep drying time and no documentation of visualization of the site for dryness.


Patient #15
Review of Patient #15's EMR revealed an admission date of 11/14/17 with an admission diagnosis of Osteoarthritis of the left knee. Further review revealed Patient #15 was scheduled for left total knee arthroscopy.

Review of Patient #15's intraoperative record, dated 11/14/17, revealed the skin of the surgical area was prepped with Chloraprep. Additional review revealed no documentation of skin prep drying time and no documentation of visualization of the site for dryness.

In an interview on 11/28/17 at 1:40 p.m. with S5RNMgr, she confirmed alcohol-based skin prep drying time and direct visualization of the prepped site for dryness was not documented in the above-referenced patients' intraoperative surgical records. She reported S2DON had also confirmed alcohol-based skin prep drying time and direct visualization of the prepped site for dryness was not routinely documented in the patients' surgical records.

Based on record reviews and interview, the hospital failed to ensure that a H&P and/or an updated physical examination was completed and documented in the patient's medical record prior to the patient's surgical procedure and/or procedure requiring anesthesia services for 5 (#2,#3, #4, #8, #12) of 13 (#1, #2, #3, #4, #7, #8, #9, #10, #11, #12, #13, #14, #16) surgical patient records reviewed for H&Ps and updated H&Ps out of a total sample of 30 patients.


Findings:

Review of the hospital's Medical Staff Rules and Regulations revealed in part:

B. Medical Records. 2. A history and physical examination must be recorded within 24 hours of admission and before surgery, and must be signed, dated, and timed within 30 days of patient discharge. This report, which documents the medical necessity of the admission, should include all pertinent findings resulting from an assessment of all the systems of the body. If a history has been recorded and a physical examination has been performed within 30 days prior to patient admission to the hospital, a reasonably legible copy of these reports on forms approved by the hospital may be used in the patient's medical record in lieu of the admission history and report of the physical examination, provided it includes an update to the patient's condition since it was last assessed, within 24 hours of admission or prior to surgery and is recorded by a member of the Medical/Dental staff. In the event a history and physical has been performed within 30 days, a copy of the History and Physical and an Interval note, which includes all additions to the history and physical findings is acceptable, provided it includes an update to the patient's condition since it was last assessed, within 14 hours of admission or prior to surgery. This updated History and Physical must be signed, dated, and timed or the physician may indicate with an attestation that it is signed, dated and timed a that the update to the history and physical was performed.


Review of the stamp applied to the H&P when an H&P update was required revealed the box read as follows: "Updates to patient's condition _____ ___ No changes to patient's condition ____________________ Physician's Signature Date and Time."



Patient #2

Review of Patient #2's electronic medical record (EMR) revealed an admission date of 11/27/17 with an admission diagnosis of primary Osteoarthritis. Further review revealed Patient # 2 was scheduled for right total knee replacement surgery.

Review of Patient #2's original History and Physical revealed the examination was dated 11/21/17. Further review revealed a stamped addendum, dated 11/27/17 at 7:50 a.m., signed by the patient's physician. The addendum indicated there was no change in the patient's condition since the original History and Physical on 11/21/17. Additional review revealed no documented evidence that a physical assessment had been conducted at the time the addendum had been documented.


Patient #3

Review of Patient #3's medical record revealed she was admitted on 07/19/17 for a surgical procedure of Fleur-de-lis Pannulectomy. Further review revealed her H&P on the chart was signed by the physician on 07/17/17. Further review revealed the the H&P had the stamped box with the space in front of "No changes to patient's condition" with a check mark, and the physician signed the entry on 07/19/17 at 9:15 a.m. There was no documented evidence whether a physical exam was conducted to determine if there were changes to Patient #3's condition since her last H&P.



Patient #4

Review of Patient #4's medical record revealed she was admitted as an inpatient on 03/07/17 for a Thoracic Lamination for Implantation of a Spinal Cord Stimulator Paddle. Further review revealed her H&P was done on 03/07/17 at 7:15 a.m. by S22MD with no documented evidence of documentation of a complete physical exam. There was no documented evidence of the results of an examination of the head, ears, eyes, nose, and throat, the cardiovascular system, the respiratory system, the gastrointestinal system, the genitourinary system, and current medications and dosage, allergies, and anesthesia problems.



Patient #8

Review of Patient #8's medical record revealed revealed he was admitted as an outpatient on 06/15/17 for surgery for a Left Inguinal Hernia Repair. Further review revealed a copy of his H&P signed by S20MD on 05/31/17 had the stamped box with the space in front of "No changes to patient's condition" with a check mark, and S20MD signed the entry on 06/15/17 at 7:20 a.m. There was no documented evidence whether a physical exam was conducted to determine if there were changes to Patient #8's condition since his last H&P.



Patient #12

Review of Patient #12's EMR revealed an admission date of 10/27/17 with an admission diagnosis of meniscus tear. Further review revealed Patient # 12 was scheduled for left knee arthroscopy.

Review of Patient #12's original History and Physical revealed the examination was dated 10/23/17. Further review revealed a stamped addendum, dated 10/27/17 at 7:10 a.m., signed by the patient's physician. The addendum indicated there was no change in the patient's condition since the original History and Physical on 10/23/17. Additional review revealed no documented evidence that a physical assessment had been conducted at the time the addendum had been documented.

In an interview on 11/28/17 at 2:10 p.m., S2DON indicated the H&P should include a review of all systems. She further indicated the H&P update should have documentation that a physical exam was conducted by the physician. S2DON confirmed the stamp used to document the H&P update did not include that a physical exam was conducted to determine whether there were changes in the patient's condition since the patient's most recent H&P had been done.













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