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NEEDHAM, MA 02494

FORM AND RETENTION OF RECORDS

Tag No.: A0438

Based on medical record review and staff interview, the Hospital failed to ensure that all medical records were accurate for 1 (#27) of 30 Active Patients.

For Active Patient #27, review of the pre-operative History and Physical (H&P) in the medical record on 10/9/14, indicated that the Patient had a fractured right wrist. The medical record also indicated that Patient #27 was admitted to the Hospital on 10/8/14, with a diagnosis of complex distal radius fracture of the left wrist.

Active Patient #27 had surgery on 10/8/14 for a left open reduction internal fixation (ORIF) on the left wrist, on 10/8/14.

Further record review indicated that the pre-operative H & P dated 10/6/14, documented that Patient #27 had a Right Distal Radius Fracture and that the Surgical Plan was an "ORIF (of the) Right Distal Radius Fracture."

During an interview on 10/9/14 at 9:00 A.M., the Nursing Director of Surgical Services said that the H&P was not accurate.

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on observations, review of Hospital policy and procedures, and staff interview the Hospital failed to consistently adhere to the their policies and procedures for hand hygiene, isolation precautions, use of personal protective equipment (PPE), for 3 Active Patients (#17, #22 and #23) from a sample of 30 Active Patients and 1 Outpatient (#1) from a total sample of 6 Outpatients.

Findings include:

The Hospital policy titled "Seasonal and H1N1 Flu Infection Control Precautions" indicated the PPE required to be worn by the Health Care Provider for a patient on droplet plus precautions, was a facemask with a visor. If an aerosol-generating procedure (i.e. suctioning or a nebulizer treatment) was needed for a patient on droplet plus precautions, an N95 particulate respirator was required.

1. The Surveyor observed Active Patient #23 in the Intensive Care Unit (ICU) at 10:00 A.M. on 10/7/14. Patient #23 was in a private room with a precaution sign at the door. The Precaution sign indicated Active Patient #23 was on Droplet Plus Precautions and required staff wear a surgical mask for close contact and eye protection when direct contamination with respiratory droplets was likely.

The Precaution Sign and the Hospital Policy had different requirements for the required PPE. The policy required a facemask and visor, while the Precaution Sign only required a surgical mask.

Observations again in the ICU, at 10:10 A.M. on 10/7/14, indicated that a Dietary Associate donned a N95 particulate respirator and entered Active Patient #23's room. The Surveyor interviewed the Dietary Associate when she exited the Patient's room. The Dietary Associate said that she wore the mask like the one pictured on the Precaution Sign.

The Surveyor observed Active Patient #23 in the Intensive Care Unit again at 10:15 A.M., on 10/7/14. The Surveyor observed a Registration Clerk don a N95 particulate respirator and enter Active Patient #23's room.

Both staff, the Dietary Associate and Registration Clerk, failed to adhere to Hospital policy as they donned a N95 particulate respirator and not a facemask with a visor. Neither staff were required to don a N95 respirator as neither staff were going to perform suctioning or a nebulizer treatment.

2. Review of the personnel records and N95 respirator fit testing information on 10/7/14, indicated the Dietary Associate was last fit tested on 7/22/13 and the Registration Clerk had never been medically cleared or fit tested for use of the particulate respirator.
According to the Occupational Safety and Health Administration's (OSHA), 29 CFR 1910.134, "General Industry Standard for Respiratory Protection Devices," a Hospital is required to medically evaluate and fit test (a procedure to ensure correct fit of an employees particulate respirator/mask) any employee who wears an N95 particulate respirator. Thereafter, an annual fit test is required.

3. The Surveyor observed Registered Nurse (RN) #6 caring for Active Patient #22. Active Patient #22 was on Contact Precautions for a multi-drug resistant organism. RN #6 donned her gown and gloves according to Hospital policy. After RN #6 cared for Patient #22 she removed her gloves and failed to perform hand hygiene prior to retrieving supplies from the clean supply cart in the patient's room, potentially contaminating the clean supplies in the cart.


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4. Observation in the Post Operative Care Unit (PACU) at 9:25 A.M. on 10/6/14, indicated that the alarm for the Airborne Infection Isolation Room (AIIR) failed to sound when tested by the Surveyor and Nursing Director of Surgical Services. Visualization of the AIIR keypad indicated that the alarm had been silenced. The alarm was reset and the door to the AIIR closed. When the alarm was re-tested, the keypad again indicated that the alarm was silenced. Neither the Surveyor or the Nursing Director of Surgical Services had silenced the alarm.

[According to the Centers for Disease Control and Prevention (CDC), an AIIR is a single-occupancy patient-care room used to isolate persons with a suspected or confirmed airborne infectious disease. Environmental factors are controlled in AIIR's to minimize the transmission of infectious agents that are usually transmitted from person to person by respiratory droplets associated with coughing or sneezing.]

The Nursing Director of Surgical Services immediately contacted the Director of Facilities to report the problem. The Nursing Director of Surgical Services said that there was a problem in the AIIR monitoring system. The Nursing Director of Surgical Services also said that the AIIR was tested monthly by the Facilities Staff. The Surveyor requested documentation of the monthly testing during the observation on 10/6/14 and again on 10/7/14. The documentation was not provided to the Surveyor.

5. For Outpatient #1, observations of the insertion of an intravenous (IV) line in the Pre-operative Holding Area on 10/6/14 at 10:25 A.M., indicated that Physician #1 failed to follow manufacturer's directions for use (MDFU) for the ChloraPrep skin disinfectant as follows:

MDFU for the use of the ChloraPrep Frepp 1.5 milliliter (ml) applicator for a dry arm, indicated to use gentle back-and-forth strokes for 30 seconds and allow to dry for 30 seconds.

Physician #1 only used back-and-forth strokes with the ChloraPrep Frepp applicator, on the IV site for seven seconds before administering a local anesthetic and inserting the IV.

6. For Active Patient #17, observations in operating room (OR) #3 from 11:50 A.M. to 12:20 P.M. on 10/6/14, indicated the following:

a. RN#2 failed to perform hand hygiene after removal of her contaminated gloves and before donning clean gloves on three occasions.

b. Physician #3 failed to perform hand washing after removing his bloodied gloves. After glove removal, Physician #3 then immediately began using the control to the computerized medical record and typing on the computer keyboard.

c. RN #2 failed to perform hand hygiene after removal of her contaminated right glove and before touching the handle on the clean supply cabinet to open the cabinet and retrieve a roll of tape, creating a risk for cross-contamination.

7. Review of MDFU of the Steris Coverage Plus disinfectant on 10/6/14, indicated
"Thoroughly wet surface with a wipe, keep wet for two minutes and allow to air dry. Use as many wipes as needed for the surface to remain wet for the entire contact time."

Observations in OR #3, at 12:10 P.M. on 10/6/14, indicated that after the surgery of Inpatient #17 was completed, Anesthesia Technician #1, disinfected the following: anesthesia machine; blood pressure cuff and tubing; the monitor and tubing that monitored patients' heart rhythms, respirations and oxygen levels; the medication storage and administration machine; the anesthesia staff's chair; the medication administration pump; and the pole that held intravenous (IV) fluids.

Continued observation and use of the Surveyor's watch indicated the Anesthesia Technician failed to follow MDFU for the disinfectant wipes and ensure that all surfaces were visibly wet for two minutes. The surfaces remained visibly wet for only 40 to 60 seconds.

8. For Outpatient #1, observation in OR #3, when the surgical procedure was completed, at 2:00 P.M. on 10/6/14, indicated that RN #3 failed to perform hand hygiene after removal of her contaminated gloves. Additionally, RN #3 provided a risk for cross-contamination when she picked up Outpatient #1's clinical record, with now-contaminated hands, and accompanied the Patient to the PACU, while holding the clinical record.

SURGICAL PRIVILEGES

Tag No.: A0945

Based on observation and staff interview, the Hospital failed to ensure that a roster of practitioners, that specified the surgical privileges of each practitioner, was available to Surgical Staff. Findings include:

1. Observation of the surgical scheduling procedure, in the scheduling office on 10/6/14 at 9:40 A.M., indicated the following:

While accessing the surgical scheduling system to review the privileges (surgical procedures approved by the Governing Body), of Physician #6, Scheduler #1 was unable to access the list of Physician #6's privileges (approved surgical procedures), in the computer.

During the observation, Scheduler #1 said she was unable to get past Physician #6's name. She couldn't retrieve the Physician's list of approved surgical procedures. After about 20 minutes, Scheduler #1 said she was able to access the procedure list.

Simultaneously, the Nursing Director of Surgical Services attempted to access Physician #6's privileges. It took 15 minutes before the Nursing Director of Surgical Services was able to retrieve the privileges.

The Nursing Director of Surgical Services said that she was having trouble finding Physician #6's privilege list in the computer. The Nursing Director of Surgical Services said that there was a problem with the computer system.

Additionally, in the event that surgery staff needed to verify a surgeon's procedure list, the Nursing Director of Surgical Services said that the computerized list was the only list available to the surgical staff. The Nursing Director of Surgical Services said that during off-shift hours, holidays and weekends, the Nursing Supervisor would retrieve surgeons' privileges for the surgery staff. This was possible only if the computer was functioning properly. The Nursing Director of Surgical Services also said that no paper copy of all surgeons' lists of approved surgical procedures was available to surgical staff in the event the scheduling system was not functioning.

2. During interview on 10/7/14 at 11:00 A.M. the Chief Executive Officer (CEO) said that surgeons must only perform the specific surgical procedures for which they were approved by the Governing Body. The CEO said that the problem with the surgery scheduling system would be fixed.

HISTORY AND PHYSICAL

Tag No.: A0952

Based on review of Hospital protocols, review of Medical Staff Bylaws, patient and staff interviews, and review of medical records, the Hospital failed to ensure that a History and Physical (H&P) Examination was completed and documented no more than 30 days before or 24 hours after admission or prior to surgery, or that an updated examination of the patient, including any changes in the patient's condition, was documented prior to surgery or a procedure requiring anesthesia services, for 2 Active Patients (#17 and #25) from a total of 30 Active Patients, and 2 Outpatients (#1, #2) from a total of 6 Outpatient records. Findings include:

1. Review of the Hospital's Medical Staff Bylaws on 10/7/14, indicated the following:

"A complete H&P shall be completed and recorded within 24 hours after admission of the patient. This report shall include all pertinent findings resulting from an assessment of all systems of the body....No patient may be operated upon or given a procedure requiring anesthesia services without such documentation. For a H&P completed within 30 days, an update documenting any changes in the patient's condition is completed prior to surgery or a procedure requiring anesthesia services."

2. Review of the Hospital policy titled "Preoperative Preparation of Surgical Patients" on 10/6/14, indicated to "Provide a H&P, done within 30 days prior to surgery on ALL patients regardless of age or type of surgery."

3. For Active Patient #17, medical record review on 10/6/14, indicated that the Hospital document titled "Immediate Pre-Procedure H&P Interval Note" was checked-off by Physician #2 to attest "I have examined the patient and I confirm that there has been no change in patient condition since the H&P was documented." Further review of the medical record indicated that although Physician #2 attested that he examined Patient #17, on 10/6/14, prior to surgery there was no documentation of an updated examination for Patient #17.

Physician #2 failed to document an updated examination of Active Patient #17, for a H&P completed 9/30/14, within 30 days prior to surgery, as required.

4. For Outpatient #1, medical record review on 10/6/14, indicated that the "Immediate Pre-Procedure H&P Interval Note" was checked-off by Physician #2 to attest that he had examined the patient and that there were no changes in Outpatient #1's condition since the H&P, completed on 9/29/14. Further review of the medical record indicated that although Physician #2 attested that he examined Outpatient #1, on 10/6/14, prior to surgery there was no documentation of an updated examination for Outpatient #1.

During interview in the Post Anesthesia Care Unit (PACU), on 10/6/14 at 3:30 P.M., Outpatient #1 said that Physician #2 did not perform any physical examination on 10/6/14, prior to surgery.

5. For Outpatient #2, medical record review on 10/6/14, indicated that the record lacked a complete H&P completed within 30 days of surgery. The H&P was dated 9/4/14, 32 days prior to surgery. At the time of the record review, the Nursing Director of Surgical Services accessed Outpatient #2's electronic medical record and found that Physician #4 had not completed a H&P prior to surgery.

During interview on 10/6/14/at 4:00 P.M., the Nursing Director of Surgical Services said that Physician #4 was supposed to re-examine the Patient and perform a complete H&P.

6. For Active Patient #25, medical record review on 10/7/14, indicated that the "Immediate Pre-Procedure H&P Interval Note" was checked-off by Physician #2 to attest that he had examined the patient and that there were no changes in Active Patient #25's condition since the H&P, completed on 9/9/14. Further review of the medical record indicated that although Physician #2 attested that he examined Active Patient #25 on 10/6/14, prior to surgery, there was no documentation of an updated Patient examination.

OPERATIVE REPORT

Tag No.: A0959

Based on medical record review, staff interviews, and review of Medical Staff Bylaws, indicated that the Hospital failed to ensure that an operative report was documented or dictated immediately after surgery for 3 (#17, #25, and #26) of 30 Active Patients and 1 (#1) of 6 Outpatients. Findings include:

Review of the Medical Staff Bylaws on 10/6/14, indicated the following:

"The completed operative report must be authenticated and filed in the medical record as soon as possible after surgery. A hand written operative note or procedure note detailing the names of surgeons, assistants, technical procedures, findings and outcomes (e.g., blood loss, complications, specimens removed, post-operative diagnosis) should be written in the progress note immediately after surgery or procedure. The operative report must be dictated within 48 hours of surgery."

1. For Active Patient #17, a patient who had surgery on the morning of 10/6/14, review of the dictated operative report at 2:00 P.M. on 10/6/14, indicated that it lacked documentation of the name of the anesthetist, the type of anesthesia administered, and the parts of the surgery performed by the assistant practitioner, although required by Hospital Medical Staff Bylaws.

2. For Outpatient #1, review of the Brief Operative Note in the Post Anesthesia Care Unit (PACU), after the Patient's 10/6/14 surgery, indicated that it lacked documentation of the findings of the procedure, tissue removed or altered, name of assistant, name of anesthetist, the type of anesthesia administered, complications (if any), and the post-operative condition of Outpatient #1, as required by Hospital policy.

3. For Active Patient #25, medical record review on 10/7/14, indicated that although Physician #2 completed a hand written Brief Operative Note after the Patient's 10/6/14 surgery, the note lacked the name of the anesthetist, the type of anesthesia administered, complications (if any) and the post-operative condition of the Patient.

During the record review, the Inpatient Director of Nursing said that Physician #2 should have written a complete operative note that included the above parameters. According to the Medical Staff Bylaws, a complete hand written operative note should have been written immediately after surgery.

4. For Active Patient #26, medical record review on 10/7/14, indicated that the record lacked an operative note. Active Patient #26 had surgery on 10/6/14. During the record review, the Inpatient Director of Nursing said that Physician #7 should have written an operative note. According to the Medical Staff Bylaws, a hand written operative note should have been written immediately after surgery.

During the medical record review on 10/7/14 at 2:30 P.M., the Inpatient Director of Nursing reviewed the electronic medical record (EMR) and said that the EMR also lacked a dictated operative note.

Physician #7 failed to document a written operative note or dictate an operative note immediately after surgery, although required.

POST-ANESTHESIA EVALUATION

Tag No.: A1005

Based on medical record review and staff interview, the Hospital failed to ensure that a complete post-anesthesia evaluation was completed and documented by an individual qualified to administer anesthesia for 4 (#7, #17, #25, #26 ) of 30 Active Patients and 1 (#2) of 6 Outpatients. Findings include:

1. For Active Patients #17, #25 and #26, and Outpatient #2, medical record reviews, indicated that although the medical records contained the Hospital document entitled "Post Anesthesia Progress Note" the document was incomplete. Six important physiological functions were assessed; vital signs, respiratory function, cardiovascular function and hydration status, patient alertness (level of consciousness), pain, and nausea and vomiting (N/V).

According to 482.52(b)(3), the elements of an adequate post-anesthesia evaluation should be clearly documented and conform to current standards of anesthesia care, and include the following documentation:

Respiratory function, including respiratory rate, airway patency, and oxygen saturation;
Cardiovascular function, including pulse rate and blood pressure;
Mental status; Temperature; Pain; N/V; and Postoperative hydration.

Each of the above elements were documented on the form in the format as follows:

Vital signs appropriate; Respiratory function appropriate; Cardiovascular function and hydration status appropriate; Patient alertness; Pain control satisfactory; and N/V control satisfactory.

Each of these elements were only checked "Yes." There were no specific assessments or findings documented for each of the above elements. Only satisfactory or appropriate was documented.

During interview on 10/7/14 at 11:15 A.M., the Chief of Anesthesia said that by documenting appropriate or satisfactory for the above listed elements, indicated that they met the Post Anesthesia Care Unit Nursing criteria and the American Society of Anesthesiologists criteria.
However, there were no criteria listed on the Post Anesthesia Progress Note that identified what was meant by satisfactory or appropriate.



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2. For Patient #7, medical record review conducted on 10/7/14, indicated that the record lacked a complete post-anesthesia evaluation.

Review of the medical record indicated that Patient #7 was admitted to the facility on 10/3/14, with a diagnosis of a dislocation of the left hip. Patient #7 had surgery on 10/3/14, and had a closed reduction completed on the left hip. Further record review indicated that the postoperative anesthesia progress note form dated 10/3/14, was blank and lacked an assessment of the patient's vital signs, respiratory function, cardiovascular function, mental status, pain, and nausea and vomiting control, as required by Hospital policy.

On 10/7/14 at 11:32 A.M., the Nursing Director of Surgical Services said that the anesthesiologist failed to document on the postoperative anesthesia progress note form as per Hospital policy. (The Hospital's Post Anesthesia Progress Note form included the assessment of a patient's vital signs, respiratory function, cardiovascular function, mental status, pain control and nausea and vomiting control). According to the Nursing Director of Surgical Services, the anesthesiologist should have documented on the post anesthesia progress note form and if a form was not available, the anesthesiologist should have written a progress note in the medical record.