The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

MARTHA'S VINEYARD HOSPITAL INC ONE HOSPITAL ROAD, FIRST FL, WING 5, PO BOX 1477 OAK BLUFFS, MA 02557 Nov. 2, 2017
VIOLATION: PATIENT CARE POLICIES Tag No: C0273
Based on records reviewed the Critical Access Hospital (CAH) failed to ensure it furnished health care pharmacy services through an agreement between the CAH and the Pharmacy services contractor.

Findings included:

The document titled Pharmacy Services Agreement, dated 2/22/12, indicated a contract agreement between the Health Care System and a Pharmacy Service. The Pharmacy Services Agreement indicated a signature to indicate representation of the Health Care System.

The Pharmacy Services Agreement did not indicate an agreement between the CAH and the Pharmacy Service. The Pharmacy Service Agreement did not indicate a signature to indicate representation of the CAH.
VIOLATION: QA - QUALITY OF PATIENT CARE Tag No: C0336
Based on records reviewed and interviews the Critical Access Hospital (CAH) failed to ensure an effective and adequate quality assurance program. The CAH failed to analyze, identify appropriate corrective actions, implement corrective actions and monitor identified corrective actions in a timely manner.

Findings included:

The Surveyor interviewed the Pharmacy Director, at 10:30 A.M. on 10/30/17. The Pharmacy Director said that the CAH did not investigate compounding practices in other areas of the CAH as part of the CAH internal investigation regarding Patient #1 (to ensure compliance with CAH policy).

The report titled, Medication Occurrences, dated 1/1/17-10/30/17, indicated 30 of 67 medication occurrences involving administration or wasting (discarding) of narcotics or benzodiazepines (tranquilizers). The report indicated the following themes: the patient's medical records did not indicate a physician ordered for the medication, the medications were withdrawn from the automated medication dispensing machine and the patient's medical record did not indicate the medication as administered to the patient or the medications were not wasted (discarding) according to CAH policy.
VIOLATION: QUALITY ASSURANCE Tag No: C0337
Based on records reviewed and interviews the Critical Access Hospital (CAH) failed to ensure:

1.) Patient care services were evaluated,
2.) That quality assurance data was provided to the Governing Body (Board of Trustees) and
3.) The CAH failed to evaluate the Pharmacy Services agreement.

Findings included:

The document titled Quality Improvement and Patient Safety, Medical Error Reduction Program, dated 6/2011, indicated the Quality Improvement Patient Care Assessment Committee sent minutes of their meetings to the CAH President and the Board of Trustees (Governing Body).

The Surveyor interviewed the CAH Board of Trustees Chairman at 11:00 A.M. on 11/2/17. The Board of Trustees Chairman Trustees said the Board of Trustees reviewed information about the quality of patient care of cases that were Board of Registration in Medicine mandated as reportable. The Board of Trustees Chairman said that the Chief Medical Officer attended the Board of Trustees meetings. The Board of Trustees Chairman said the Board of Trustees did not know of Patient #1's adverse patient event.

The Board of Trustees Meeting Minutes, dated 2/ 8/2017, indicated no documentation to indicate quality assurance program reporting. The Board of Trustees Meeting Minutes indicated no documentation to indicate the Board of Trustees received patient quality data and no documentation to indicate the Board of Trustees analysis or directives to the Medial Staff or CAH administrators regarding quality of patient care.

The document titled Quality of Service Review, dated 1/1/16-12/31/16, indicated quality information that was generated by the contracted pharmacy service.

The CAH provided no documentation to indicate that the CAH evaluated the Pharmacy Services Agreement for pharmacy services provided.
VIOLATION: ORGANIZATIONAL STRUCTURE Tag No: C0240
The Organizational Structure Condition of Participation was found out of compliance.

Findings included:

1.) The Governing Body failed to ensure the Critical Access Hospital (CAH)
Governing Body assumed full legal responsibility for determining, implementing and monitoring policies governing the CAH's total operation and for ensuring that those policies were administered so as to provide quality health care in a safe environment.

Refer to TAG: C-0241.

2.) The Governing Body failed to ensure that the Provision of Services Condition of Participation was in compliance.

Refer to TAG: C-0270.

3.) The Governing Body failed to ensure that the Periodic Evaluation & Quality Assurance Review Condition of Participation was in compliance.

Refer to TAG: C-0330.
VIOLATION: GOVERNING BODY Tag No: C0241
Based on observations, records reviewed and interviews the Governing Body failed, for six patients (Patients #1, #2, #3, #5, #11 & #12) of 11 medical records reviewed, to ensure the Critical Access Hospital (CAH) Governing Body assumed full legal responsibility for determining, implementing and monitoring policies governing the CAH's total operation and for ensuring that those policies were administered so as to provide quality health care in a safe environment.

Findings included:

The Surveyor interviewed the Chief Executive Officer (CEO) at 10:05 A.M. on 11/2/17. The CEO said that the Hospitalist Program was disorganized (Physicians that care for CAH inpatients), the Hospitalist physicians were dissatisfied and the issues with the Hospitalist Program were not resolved.

The document titled Quality Improvement and Patient Safety, Medical Error Reduction Program, dated 6/2011, indicated the Quality Improvement Patient Care Assessment Committee sent minutes of their meetings to the CAH President and the Board of Trustees (Governing Body).

The Board of Trustees Meeting Minutes, dated 1/2017-8/2017, indicated no documentation to indicate quality assurance program reporting.

The Surveyor interviewed the CAH Board of Trustees Chairman at 11:00 A.M. on 11/2/17. The Board of Trustees Chairman said the Board of Trustees did not know of Patient #1's adverse patient event.

The document titled Root Cause Analysis (RCA), dated 3/21/17, indicated the CAH's internal investigation of Patient #1's adverse patient event and corrective actions.

The CAH provided no documentation to indicate the implementation and completion of the identified corrective actions and the CAH provided no documentation to indicate monitoring for compliance.

The CAH written policy titled Occurrence Screen Reporting, dated 8/2014, indicated all employees of the facility and Medical Staff were responsible for submitting Occurrence Screens (occurrence reports for adverse patient events).

The Surveyor interviewed the Vice President & Quality Chair, Chief Nurse Executive, Quality Director and Quality Analyst at 2:30 P.M. on 11/1/17. The Quality Analyst said Patient #11's esophagus was perforated on 8/25/17, the adverse patient event was discovered on 8/26/17 and was not notified of the adverse patient event prior to the discovery on 8/26/17.

The CAH provided no documentation or internal investigation information to indicate the CAH identified potential needed corrective actions for CAH employees of the facility and Medical Staff responsible for submitting Occurrence Screening Worksheets for adverse patient events in accordance with CAH written policy.

The CAH written policy titled Medication Use Automated Dispensing Systems, dated 10/2017, indicated partial doses of administered controlled substances (drugs that Federal Regulations classified for potential abuse, narcotics) must be wasted (disposed) in both the automated dispensing system and on the medication administration record.

The report titled, Medication Occurrences, dated 1/1/17-10/30/17, indicated 30 of 67 mediation occurrences involving administration or wasting (discarding) of narcotics or benzodiazepines (tranquilizers). The report indicated the following four themes regarding physician orders, administration and wasting:

a.) Patients' medical records did not indicate a physician ordered the medication,
b.) Medications were withdrawn from the automated medication dispensing machine,
c.) Patients' medical records did not indicate the medication as administered to the patient,
d.) Medications were not wasted (discarding) according to CAH policy.

The Vice President & Quality Chair, Chief Nurse Executive, Quality Director and Quality Analyst said they did not know about the Medication Occurrence report that indicated the Emergency Department medication occurrences.

The CAH provided no documentation or immediate corrective actions to indicate that the CAH identified their quality program for reporting occurrences and adverse patient events was ineffective and inadequate.

Two of eight medical records reviewed for hip surgery patients (Patients #3 & #5) indicated documentation of peri-articular medication mixtures were not administered and or documented according to CAH written policy.

The CAH provided no documentation to indicate that the CAH conducted an evaluation of the Pharmacy Services Agreement for quality pharmacy services provided.

The CAH written policy titled Employee Performance Evaluation, dated 3/15/13, indicated that the CAH performed employee performance evaluations prior to the completion of the initial introductory employment period and one (1) year from the date of hire and annually thereafter.

The CAH provided no documentation to indicate that the CAH evaluated the Pharmacy Services Director according to CAH policy.
VIOLATION: PROVISION OF SERVICES Tag No: C0270
The Provision of Services Condition of Participation was found out of compliance.

Findings included:

1.) The Critical Access Hospital (CAH) failed to ensure CAH staff furnished health care services in accordance with its written policy regarding wasting of controlled drugs (drugs that Federal Regulations classified for potential abuse, narcotics). The CAH failed to ensure CAH Managers performed employee performance evaluations according to CAH policy.

Refer to TAG: C-0271

2.) The CAH failed to ensure it furnished health care pharmacy services through an agreement between the CAH and the Pharmacy Services contractor.

Refer to TAG: C-0273

3.) The CAH failed to ensure accurate record keeping for the disposition (wasting) of morphine, a controlled drug; therefore, the CAH failed to ensure the reconciliation of the disposition of morphine (a narcotic) impeding the identification or loss or diversion of a narcotic.

Refer to TAG: C-0276

4.) The CAH failed to ensure health care services provided through the Pharmacy Services Agreement was a Medicare participating provider and the CAH failed to ensure that the Governing Body was responsible for (signed-off, made official) the pharmacy services provided under the Pharmacy Services Agreement.

Refer to TAG: C-0285

5.) The CAH failed to ensure a registered nurse, doctor of medicine or osteopathy or physician assistant administered drugs in accordance with CAH written policy, Federal law and Massachusetts State law.

Refer to TAG: C-0296
VIOLATION: PATIENT CARE POLICIES Tag No: C0271
Based on records reviewed and interviews the Critical Access Hospital (CAH) failed for two patients (Patients #2 & #5) to ensure CAH staff furnished health care services in accordance with its written policy regarding wasting of controlled drugs (drugs that Federal Regulations classified for potential abuse, narcotics). The CAH failed to ensure CAH Managers performed employee performance evaluations according to CAH policy.

Findings included:

The CAH written policy titled Medication Use Automated Dispensing Systems, dated 10/2017, indicated partial doses of administered controlled substances (drugs that Federal Regulations classified for potential abuse, narcotics) must be wasted (disposed) in both the automated dispensing system and on the medication administration record.

The report titled, Medication Occurrences, dated 1/1/17-10/30/17, indicated 30 of 67 mediation occurrences involving administration or wasting (discarding) of narcotics or benzodiazepines (tranquilizers). The report indicated the following four themes:

a.) Patients' medical records did not indicate a physician ordered the medication,
b.) Medications were withdrawn from the automated medication dispensing machine,
c.) Patients' medical records did not indicate the medication as administered to the patient,
d.) Medications were not wasted (discarding) according to CAH policy.

Two of eight medical records indicated documentation of peri-articular medication mixtures were not administered and or documented according to CAH written policy.

The document titled Intra-Operative Medications, dated 6/5/17 for Patient # 2, indicated a physician administered the peri-articular medication mixture that included morphine. The Intra-Operative Medications document did not indicate the dose of the peri-articular medication mixture the physician administered.

The document titled Intra-Operative Medications, dated 7/11/17 for Patient # 5, indicated a physician administered 18 milliliters, a partial mixture of the peri-articular medication mixture that included morphine.

The Surveyor interviewed Registered Nurse (RN) #2 at 10:30 A.M. on 11/1/17 and RN #1 at 2:30 P.M. on 11/2/17. RN #1 and #2 said we (the nurses) do not document waste of the peri-particular injection.

The CAH written policy titled Employee Performance Evaluation, dated 3/15/13, indicated that the CAH performed employee performance evaluations prior to the completion of the initial introductory employment period and one year from the date of hire and annually thereafter.

The Pharmacy Director's employee record indicated the CAH hired the Pharmacy Director on 8/1/16. The Pharmacy Director's employee record did not indicate any performance evaluations or competence evaluations.

The Surveyor interviewed the Human Resources Representative at 2:15 P.M. on 11/2/17. The Human Resources Representative said that the CAH performed employee performance evaluations at the 90-day initial introductory employment period and every two years. The Human Resources Representative said the CAH did not perform an initial introductory period performance evaluation because the CAH knew the Pharmacy director for eight years prior to hiring him from work performed with the Pharmacy contracted services.
VIOLATION: POLICIES - DRUG MANAGEMENT Tag No: C0276
Based on records reviewed and interviews the Critical Access Hospital (CAH) failed to ensure accurate record keeping for the disposition (wasting) of morphine, a controlled drug; therefore, the CAH failed to ensure the reconciliation of the disposition of morphine (a narcotic) impeding the identification or loss or diversion of a narcotic.

Findings included:

The CAH written policy titled Medication Use Automated Dispensing Systems, dated 10/2017, indicated partial doses of administered controlled substances (drugs that Federal Regulations classified for potential abuse, narcotics) must be wasted (disposed) in both the automated dispensing system and on the medication administration record.

The document titled Compounding Formula, undated, indicated a mix of medications that included bupivacaine, (anesthetic, causes pain insensitivity, ketorolac (non-steroidal anti-inflammatory drug) and morphine (a narcotic). The volume of the medication mixture was 77 milliliters.

The document titled Intra-Operative Medications, dated 7/11/17 for Patient # 5, indicated a physician administered 18 milliliters, a partial mixture of the peri-articular medication mixture that included morphine.

The CAH provided no documentation to indicate wasting of 59 milliliters of the peri-articular medication mixture.

The Surveyor interviewed Registered Nurse (RN) #2 at 10:30 P.M. on 11/1/17. RN #2 said the nurses did not document waste of the peri-articular mix (mix of medications used in orthopedic surgery injected around a joint) and she did not know if the doctor documented the waste of the peri-articular mix of medications that included morphine.

The CAH written policy titled Medication Use Automated Dispensing Systems, indicated the Pharmacy was responsible for signed records of all controlled drugs (morphine) delivered. The policy indicated a nurse accepting the delivery of the controlled drug must verify the drug (peri-articular medication mixture containing morphine) must verify the drug was correct at the time of delivery. The policy indicated the Pharmacy was responsible for reconciliation of discrepancies.

The Surveyor interviewed RN #1 at 2:30 on 11/2/17. RN #1 said the Pharmacy delivered the peri-articular medication mixture to an RN working in the Post Anesthesia Care Unit (PACU). RN #1 said no indication of a verification process between the Pharmacy and PACU nurse to ensure the correct drug in accordance with CAH policy.

The CAH provided no documentation to indicate the peri-articular medication mixture was verified as correct at delivery of the peri-articular medication mixture from the Pharmacy to the PACU.

The CAH written policy titled Medication Use Automated Dispensing Systems, dated 10/2017, indicated all controlled drug discrepancies must be recorded and reported to the Pharmacy Department on a hospital Occurrence Screen. Refer to Condition of Participation Periodic Evaluation and Quality Assurance Review: TAG: C-0330
VIOLATION: SERVICES PROVIDED THRU AGREEMENT/ARRANGEMENT Tag No: C0285
Based on records reviewed and interviews the Critical Access Hospital (CAH) failed to ensure health care services provided through the Pharmacy Services Agreement was a Medicare participating provider and the CAH failed to ensure that the Governing Body was responsible for (signed-off, made official) the pharmacy services provided under the Pharmacy Services Agreement.

Findings included:

The document titled Pharmacy Services Agreement, dated 2/22/12, indicated a contract agreement between the Health Care System and a Pharmacy Service. The Pharmacy Services Agreement indicated a signature to indicate representation of the Health Care System. The Pharmacy Services Agreement did not indicate an agreement between the CAH and the Pharmacy Service. The Pharmacy Service Agreement did not indicate a signature to indicate representation of the CAH.

The Surveyor interviewed the Chief Nurse Executive at 1:15 P.M. on 11/6/17. The Chief Executive Nurse said she did not know if the Pharmacy Service was a Medicare provider. The Chief Nurse Executive said she did not know how the CAH monitored the Pharmacy Services Agreement for Quality Assurance. The Chief Nurse Executive said she needed to ask the Pharmacy Director. Refer to the Condition of Participation Periodic Evaluation and Quality Assurance Review: TAG: C-0330.

The CAH provided no documentation to indicate the CAH evaluated the Pharmacy Services Agreement for quality. The CAH provided no documentation to indicate the Pharmacy Services was a Medicare provider.
VIOLATION: NURSING SERVICES - SUPERVISION OF CARE Tag No: C0296
Based on records reviewed and interviews the Critical Access Hospital (CAH) failed for two patients (Patients #3 & #5) to ensure a registered nurse (RN), doctor of medicine or osteopathy or physician assistant administered drugs in accordance with CAH written policy, Federal law and Massachusetts State law.

Findings included:

The CAH written policy titled Medication Use Automated Dispensing Systems, dated 10/2017, indicated partial doses of administered controlled substances (drugs that Federal Regulations classified for potential abuse, narcotics) must be wasted (disposed) in both the automated dispensing system and on the medication administration record.

Two of eight medical records reviewed (for Patients #3 and #5) indicated documentation of peri-articular medication mixtures were not administered and or documented by an RN, doctor of medicine or osteopathy or physician assistant administered drugs in accordance with CAH written policy.

The Surveyor interviewed Registered Nurse (RN) #2 at 10:30 A.M. on 11/1/17 and RN #1 at 2:30 P.M. on 11/2/17. RN #1 and #2 said we (the nurses) do not document waste of the peri-particular injection.

The CAH provided no documentation to indicate that an RN, doctor of medicine or osteopathy or physician assistant wasted the peri-articular mix of drugs that included morphine, a narcotic and controlled drug, in accordance with CAH written policy.
VIOLATION: PERIODIC EVALUATION & QA REVIEW Tag No: C0330
The Periodic Evaluation & Quality Assurance Review Condition of Participation was found out of compliance.

Findings included:

1.) The Critical Access Hospital (CAH) failed to ensure for five patients (Patients #1, #3, #5, #11 & #12) that they identified CAH quality processes that evaluated their total quality program, including that their collection and analysis of quality information was not effective and was inadequate.

Refer to TAG: C-0331.

2.) The CAH failed to ensure that CAH employees and Medical Staff followed established policies and the CAH failed to implement changes needed.

Refer to TAG: C-0335.

3.) The CAH failed to ensure an effective and adequate quality assurance program. The CAH failed to analyze, identify appropriate corrective actions, implement corrective actions and monitor identified corrective actions in a timely manner.

Refer to TAG: C-0336.

4.) The CAH failed to ensure patient care services were evaluated, that quality assurance data was provided to the Governing Body (Board of Trustees) and the CAH failed to evaluate the Pharmacy Services agreement.

Refer to TAG: C-0337.

5.) The CAH failed to ensure implementation of corrective action(s) to address deficiencies found through the quality assurance program.

Refer to TAG: C-0342.

6.) The CAH failed to ensure documentation of corrective action outcomes (monitoring).

Refer to TAG: C-0343.
VIOLATION: ANNUAL PROGRAM EVALUATION Tag No: C0331
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observations, records reviewed and interviews the Critical Access Hospital (CAH) failed to ensure that they identified CAH quality processes that evaluated their total quality program, including that their collection and analysis of quality information was not effective and was inadequate.

Findings included:

The Physician Note, dated 2/21/17, indicated the Physician admitted Patient #1 to the CAH for hip surgery. The Physician note, dated 2/22/17, indicated Patient #1 was hypotensive (low blood pressure), bradycardic (low heartbeat) and tachycardic (fast heartbeat) with increased oxygen requirements during the hip surgery. The Physician Note indicated Patient #1 was transferred to the Intensive Care Unit and then to a major medical center.

The Anesthesia Note, dated at 9:37 A.M. on 2/21/17, indicated the surgeon injected local anesthetic medications (the peri-articular medication mixture), that included ropivicaine, toradol, epinephrine and morphine (a narcotic), into Patient #1's joint space. The Anesthesia Note, dated at 9:40 A.M. on 2/21/17, indicated Patient #1 had immediate significant hypotension with bradycardia.

The CAH written policy titled Occurrence Screen Reporting, dated 8/2014, indicated all employees of the facility and medical staff were responsible for submitting Occurrence Screens (occurrence reports for adverse patient events). The policy did not indicate when (time-period) staff must submit the Occurrence Screen.

The document titled Quality Improvement and Patient Safety, Medical Error Reduction Program [Quality Improvement and Process Improvement (QAPI) Plan], dated 6/2011, indicated the Chief Quality Officer as responsible for the occurrence reporting system, investigation and analysis of occurrences with resolution and follow-up. The document indicated the agent or employee who witnessed, discovered, or had direct knowledge of the occurrence was responsible for completing the Occurrence Screen. The document indicated the agent or employee submitted an Occurrence Screen to the Patient Care Assessment Coordinator within 24 hours; the agent or employee was responsible for submitting an Occurrence Screen for undesirable occurrences that were inconsistent with normal patient care before the end of the shift or before leaving the CAH.

The Surveyor interviewed the Medical Staff Vice President & Quality Chair, Chief Nurse Executive, Quality Director and Quality Analyst at 2:30 P.M. on 11/1/17. The Medical Staff Vice President & Quality Chair, Chief Nurse Executive said all CAH staff were expected to report patient events. The Chief Nurse Executive, Quality Director and Quality Analyst said the CAH patient event reporting included staff completing the Occurrence Screen and sending it through the interoffice mail to the Patient Advocate, and the Patient Advocate informed the appropriate manager of the event by e-mail and the Manager was responsible to investigate the event. They said that the Patient Advocate also informed the Quality Director and Quality Analyst of the event by e-mail and followed-up with the manager in a week for no manager response to the event.

The document titled Occurrence Screening Worksheet, dated 3/1/17 (eight days after Patient #1's adverse patient event), indicated a medication error that occurred during Patient #1's hip surgery. The Occurrence Screening Worksheet indicated a signature to indicate that RN #1 signed the Occurrence Screening Worksheet. The Occurrence Screening Worksheet indicated RN #1 immediately reported a medication error to the surgeon and the surgeon was not concerned. The Occurrence Screening Worksheet indicated the surgeon would not fill out an Occurrence Screening Worksheet for this medication error.

The CAH provided no additional Occurrence Screening Worksheets to indicate that RN #1, the covering circulating RN, the anesthesiologist or any other CAH employee of the facility or member of the Medical Staff submitted an Occurrence Screening Worksheet in accordance with the CAH policy or the document titled Quality Improvement and Patient Safety, Medical Error Reduction Program.

The document titled Root Cause Analysis (RCA), dated 3/21/17, indicated the CAH internal investigation of Patient #1's adverse patient event. The RCA included the following corrective actions:

a.) The written Preference Cards (procedure instructions that included medications) in an Operating Room Manual no longer included medications.
b.) Re-education of the entire Operating Room Team regarding attention and detail required during the surgery time-out procedure.
c.) Create a pathway for a smoother transfer process to the major medical center for patients with intra-operative complications and communicate the transfer process to all providers.

The document titled Preference Cards, dated at 12:15 P.M. on 11/2/17, indicated that the Operating Room did not use typed Preference Cards.

The Surveyor observed, on 11/2/17, that written Preference Cards in two Operating Room Manuals included medications.

The Preference Cards titled:

a.) Carpal Tunnel Release contained the medications bupivacaine, epinephrine, and normal saline;
b.) Endometrial ablation contained the medications lidocaine and ropivicaine;
c.) Hysteroscopy contained the medication lidocaine;
d.) Knee arthroscopy contained the medications sensorcain and epinephrine;
e.) Knee soft tissue contained the medications kefzol, bupivacaine, and sodium chloride;
f.) Leep procedure contained the medications lidocaine, ascetic acid, and monsels solution;
g.) Post-Partum tubal ligation contained the medication ropivicaine;
h.) Quad repair contained the medications kefzol, bupivacaine, and sodium chloride;
i.) Total hip arthroplasy contained the medication tobramycin;
j.) Total knee arthroplasty contained the medications TXA and gentamycin;
k.) Total laparoscopic hysterectomy contained the medications ropivicaine, floseal hemostatic agent, and
l.) Trigger finger contained the medications lidocaine and epinephrine.

The CAH provided no documentation to indicate compliance with their written policy on Occurrence Reporting as identified in their RCA corrective actions that all employees of the facility and Medical Staff were responsible for submitting Occurrence Screens.

The CAH provided no documentation to indicate the CAH implementation and completion of identified corrective actions and the CAH provided no documentation to indicate the CAH monitored for compliance.

The Surveyor interviewed the Medical Staff Vice President & Quality Chair, Chief Nurse Executive, Quality Director and Quality Analyst at 12:30 P.M. on 11/2/17. The Quality Analyst said the CAH had another case of concern regarding a patient with an esophageal (tube that connects the throat to the stomach) perforation (puncture), Patient #11.

The Physician Note, dated 8/30/17, indicated Patient #11 (MDS) dated [DATE] with a foreign body (food) in the esophagus. The Physician Note indicated Patient #11 underwent surgery for removal of the food from the esophagus and the esophagus perforated. The Physician Note indicated the CAH transferred Patient #11 to the Intensive Care Unit, was treated with comfort measures and died on [DATE].

The Quality Analyst said she became aware of Patient #11's perforated esophagus, occurrence event, while conducting routine patient medical record reviews. The Quality Analyst said Patient #11's esophagus perforated on 8/25/17 and she discovered the occurrence event on 8/26/17. The Quality Analyst said she was not notified of Patient #11's esophageal perforation prior to conducting the routine medical reviews on 8/26/17.

The document titled Occurrence Screening Worksheet, dated 9/1/17, indicated Patient #11's patient adverse event as submitted by the Patient Safety Manager seven days after Patient #11's adverse patient event.

The Quality Analyst said the Patient Safety Manager completed the Occurrence Screening Worksheet on 9/1/17 because an Occurrence Screening Worksheet was not completed.

The Quality Analysist said the CAH reviewed the Occurrence Screen Log this morning (11/2/17) and that the CAH had an additional two cases of quality concerns: 1.) regarding a pressure ulcer case and 2.) a case regarding a patient (Patient #12) who was evaluated in the ED for depression and ingesting 80 tablets of a medication on 10/18/17.

The Emergency Department (ED) Report, dated 10/18/17-10/21/17, indicated Patient #12 presented to the ED physician for a psychiatric evaluation on 10/18/17. The ED Report indicated Patient #12 reported to have ingested 80 tablets of ibuprofen (pain medication) on 10/19/17 and he/she did not want to live. The ED Report indicated the ED discharged Patient #12 to an inpatient psychiatric hospital.

The document titled Occurrence Log, dated 1/5/17-11/2/17, indicated no indication of corrective actions regarding Occurrence Screening Reporting according to CAH policy.

The CAH provided no documentation or internal investigation information to indicate the CAH identified potential needed corrective actions for CAH employees of the facility and Medical Staff responsible for submitting Occurrence Screening Worksheets for adverse patient events in accordance with CAH written policy.

The Occurrence Screen Log, dated 1/5/17-11/2/17, indicated 22 of 154 occurrences with a theme regarding patient identification and two occurrences with a theme regarding the Pharmacy Agreement.

The CAH provided no thorough analysis regarding the patient identification occurrences indicated in the Occurrence Screen Log.

The CAH written policy titled Medication Use Automated Dispensing Systems, dated 10/2017, indicated partial doses of administered controlled substances (drugs that Federal Regulations classified for potential abuse, narcotics) must be wasted (disposed) in both the automated dispensing system and on the medication administration record.

The report titled, Medication Occurrences, dated 1/1/17-10/30/17, indicated 30 of 67 mediation occurrences involving administration or wasting (discarding) of narcotics or benzodiazepines (tranquilizers). The report indicated the following four (4) themes: the

a.) Patients' medical records did not indicate a physician ordered the medication,
b.) Medications were withdrawn from the automated medication dispensing machine,
c.) Patients' medical record did not indicate the medication as administered to the patient or
d.) Medications were not wasted (discarding) according to CAH policy.

The Vice President & Quality Chair, Chief Nurse Executive, Quality Director and Quality Analyst said they did not know about the Medication Occurrence report that indicated the Emergency Department medication occurrences.

The Surveyor interviewed the Chief Nurse Executive at 2:00 P.M. on 11/2/17. The Chief Nurse Executive Nurse said she discovered the Emergency Department medication occurrences on 9/8/17, the events dated from June, July and August 2017 and no Occurrence Screen Worksheets were completed.

The document titled Controlled Substance Review Timeline, dated 11/2/17, indicated the Chief Executive Nurse discovered the Emergency Department medication occurrences on 9/8/17 at a Quality Team Meeting. The document indicated the pharmacist notified the Emergency Department Nurse Manager and the pharmacy had not completed Occurrence Screen Worksheets (according to CAH policy). The document indicated the Emergency Department Nurse Manager reviewed the medication occurrences with the Emergency Department nurses (involved with the occurrences) and the Emergency Department Nurse Manager did not document the reviews.

The CAH provided no documentation or immediate corrective actions to indicate that the CAH identified their quality program for reporting occurrences and adverse patient events was not effective and was inadequate.

The CAH written policy titled Medication Use Automated Dispensing Systems, dated 10/2017, indicated partial doses of administered controlled substances (drugs that Federal Regulations classified for potential abuse, narcotics) must be wasted (disposed) in both the automated dispensing system and on the medication administration record.

Two of eight medical records indicated documentation of peri-articular medication mixtures were not administered and or documented according to CAH written policy.

The document titled Operative Note, dated 6/5/17 for Patient #2, indicated the surgeon infiltrated the local anesthetic mixture into the superficial and deep tissues for postoperative pain management. The document titled Intra-Operative Medications, dated 6/5/17 for Patient # 2, indicated a physician administered the peri-articular medication mixture that included morphine. The Intra-Operative Medications document did not indicate the dose of the peri-articular medication mixture the physician administered.

The document titled Operative Note, dated 7/11/17 for Patient #5, indicated the surgeon infiltrated the peri-articular medication mixture into the superficial and deep tissues for postoperative pain management. The document titled Intra-Operative Medications, dated 7/11/17 for Patient # 5, indicated a physician administered 18 milliliters, a partial mixture of the peri-articular medication mixture that included morphine.

The Surveyor interviewed RN #2 at 10:30 A.M. on 11/1/17. RN #2 said we (the nurses) do not document waste of the peri-particular injection.

The Surveyor interviewed the RN #1 at 2:30 P.M. on 11/2/17. RN #1 said that the peri-articular medication mixture was not wasted because the peri-articular medication mixture was not retrieved from the automated dispensing system and therefore there was not a place to document waste. RN #2 said that the pharmacy delivered the peri-articular medication mixture to a nurse working in the Post Anesthesia Care Unit who delivered the peri-articular medication mixture to a nurse in the Operating Room on the morning of the patient's surgery.

The CAH provided no documentation to indicate that the transferring of the peri-articular medication mixture from the pharmacy to the PACU nurse. The CAH provided no documentation to indicate the CAH implemented needed corrective actions to confirm that CAH employees and Medical Staff wasted controlled drugs according to CAH policy. The CAH provided no documentation or immediate corrective actions to indicate that the CAH identified their quality program for implementing immediate corrective actions and monitoring activities were not effective and or were inadequate regarding narcotic wastage.
VIOLATION: PERIODIC EVALUATION Tag No: C0335
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on records reviewed and interviews the Critical Access Hospital (CAH) failed to ensure that CAH employees and Medical Staff followed established policies and the CAH failed to implement changes needed.

Findings included:

The CAH written policy titled Occurrence Screen Reporting, dated 8/2014, indicated all employees of the facility and Medical Staff were responsible for submitting Occurrence Screens (occurrence reports for adverse patient events).

The document titled Quality Improvement and Patient Safety, Medical Error Reduction Program [Quality Improvement and Process Improvement (QAPI) Plan], dated 6/2011, indicated the agent or employee who witnessed, discovered, or had direct knowledge of the occurrence was responsible for submitting the Occurrence Screen within 24 hours. The document indicated that for undesirable occurrences inconsistent with normal patient care the agent or employee submitted the Occurrence Screen before the end of the shift or before leaving the CAH.

The Physician Note, dated 2/21/17-2/22/17 indicated the Physician admitted Patient #1 to the CAH for hip replacement surgery, transferred to the Intensive Care Unit and then to a major medical center.

The Anesthesia Note, dated at 9:37 A.M. and 9:40 A.M. on 2/21/17, indicated the Patient #1 had immediate significant hypotension (low blood pressure) with bradycardia (low heartbeat) within three (3) minutes of a local injection of anesthetic medications, that included ropivicaine, toradol, epinephrine and morphine (a narcotic), into Patient #1's joint space.

The Surveyor interviewed the Medical Staff Vice President & Quality Chair, Chief Nurse Executive, Quality Director and Quality Analyst at 2:30 P.M. on 11/1/17. The Medical Staff Vice President & Quality Chair, Chief Nurse Executive said the CAH expected all CAH staff to report patient events.

The document titled Occurrence Screening Worksheet, dated 3/1/17, indicated the Occurrence Screening Worksheet as submitted eight days after Patient #1's adverse patient event where a medication error occurred during Patient #1's hip replacement surgery. The Occurrence Screening Worksheet did not indicate a signature representing an employee of the facility or Medical Staff who witnessed, discovered, or had direct knowledge of the occurrence in accordance with CAH written policy.

The Physician Note, dated 8/30/17, indicated Patient #11 (MDS) dated [DATE], underwent surgery for removal of food from the esophagus, was diagnosed with an esophageal (tube that connects the throat to the stomach) perforation (puncture), was transferred to the Intensive Care Unit, treated with comfort measures and died on [DATE].

The Quality Analyst said she became aware of Patient #11's perforated esophagus on 8/26/17, and was not notified of Patient #11's esophageal perforation prior 8/26/17.

The document titled Occurrence Screening Worksheet, dated 9/1/17, indicated Patient #11's patient adverse event as submitted by the Patient Safety Manager (7 days after Patient #11's adverse patient event).

The Quality Analyst said the Patient Safety Manager completed the Occurrence Screening worksheet on 9/1/17 because an Occurrence Screening Worksheet was not completed.

The CAH provided no documentation or internal investigation information to indicate the CAH identified potential needed corrective actions for CAH employees of the facility and Medical Staff responsible for submitting Occurrence Screens for adverse patient events in accordance with CAH written policy.

The CAH written policy titled Medication Use Automated Dispensing Systems, dated 10/2017, indicated partial doses of administered controlled substances (drugs that Federal Regulations classified for potential abuse, narcotics) must be wasted (disposed) in both the automated dispensing system and on the medication administration record.

The report titled, Medication Occurrences, dated 1/1/17-10/30/17, indicated medication occurrences involving administration or wasting of narcotics or benzodiazepines (tranquilizers).

The Surveyor interviewed the Chief Nurse Executive at 2:00 P.M. on 11/2/17. The Chief Nurse Executive Nurse said no Occurrence Worksheets were completed.

The CAH written policy titled Medication Use Automated Dispensing Systems, dated 10/2017, indicated partial doses of administered controlled substances (drugs that Federal Regulations classified for potential abuse, narcotics) must be wasted (disposed) in both the automated dispensing system and on the medication administration record.

The documents titled Operative Notes, dated 6/5/17 for Patient #2, and dated 7/11/17 for Patient #5, indicated the surgeon administered the peri-articular injection medication mixture (that included morphine, a narcotic) into the superficial and deep tissues for postoperative pain management.

The documents titled Intra-Operative Medications, dated 6/5/17 for Patient # 2 and dated 7/11/17 for Patient #5, did not indicate the amount or dose of the peri-articular medication mixture administered according to CAH policy.

The Surveyor interviewed Registered Nurse (RN) #1 at 10:30 A.M. on 11/1/17 and R.R. #2 at 2:30 P.M. on 11/2/17. RN #1 and #2 said that the Operating Room did not document waste of peri-particular medication mixtures.

The CAH provided no documentation to indicate that the CAH implemented needed corrective actions to confirm that CAH employees and Medical Staff wasted controlled drugs according to CAH policy.
VIOLATION: QA - PERFORMANCE IMPROVEMENT Tag No: C0342
Based on records reviewed and interviews the Critical Access Hospital (CAH) failed to ensure implementation of corrective action(s) to address deficiencies found through the quality assurance program.

Findings included:

The document titled Root Cause Analysis (RCA, dated 3/21/17, indicated the CAH internal investigation. The RCA included the following corrective actions:

a.) The written Preference Cards in an Operating Room Manual no longer included medications.
b.) Re-education of the entire Operating Room Team regarding attention and detail required during the surgery time-out procedure.
c.) Create a pathway for a smoother transfer process to the major medical center for patients with intra-operative complications and communicate the transfer process to all providers. Refer to TAG: C343.

The Surveyor interviewed the Chief Nurse Executive, Quality Director and Quality Analyst at 12:30 P.M. on 10/31/17. The Chief Nurse Executive, Quality Director and Quality Analyst said the Preference Cards (pages in a notebook binder that contained medications compounded, mixed, by Operating Room nurses for peri-articular (around the joint) injections and other Preference Cards that contained medications) were removed from the Operating Room. They said that the Preference Cards were no longer in use in the Operating Rooms and that interventions were corrective actions after patient #1's adverse patient occurrence on 2/21/17.

The Surveyor interviewed the Chief Nurse Executive at 9:30 A.M. on 11/2/17. The Chief Nurse Executive said that the Preference Cards were not in use in the Operating Rooms.

The document titled, dated 11/2/17, indicated the CAH removed the Preference Cards from use in the Operating Rooms.

The Surveyor observed, on 11/2/17, a notebook binder that contained Preference Cards with directions for medications preferred by the surgeon for the patient's surgery.

The CAH provided no documentation to indicate that the CAH re-educated all providers that administer intra-operative medications of intra-operative medication documentation requirements of the CAH.

The Surveyor interviewed the Medical Staff Vice President, Quality Chair at 2:30 P.M. on 11/1/17. The Medical Staff Vice President, Quality Chair said not all of the medical Staff that transferred patients attended medical Staff Meetings regarding CAH transfer process.

The CAH provided no documentation to indicate that the CAH re-educated all providers that transfer patients from the CAH to the major medical center of CAH transfer procedures.

The policy titled Time-Out, dated 4/2017, indicated the purpose of this procedure was to confirm that the surgical team reviewed with their full attention that everything was correct.

The CAH provided no documentation to indicate that the CAH re-educated the entire Operating Room team regarding attention and detail required during the World Health Organization (WHO) Universal Protocol for Safety Surgery (Time-Out policy) to enhance communication in accordance with the identified corrective measures (actions).

The CAH provided no documentation to indicate that the CAH analyzed other areas of the CAH that compounded medication for practices and compliance with CAH policy.
VIOLATION: QA - DOCUMENTATION Tag No: C0343
Based on records reviewed and interviews the Critical Access Hospital (CAH) failed to ensure documentation of corrective action outcomes (monitoring).

Findings included:

The document titled Root Cause Analysis (RCA), dated 3/21/17, indicated the CAH internal investigation of Patient #1's adverse patient event. The RCA included the following corrective actions:

a.) The written Preference Cards (procedure instructions that included medications) in an Operating Room Manual no longer included medications.
b.) Re-education of the entire Operating Room Team regarding attention and detail required during the surgery time-out procedure.
c.) Create a pathway for a smoother transfer process to the major medical center for patients with intra-operative complications and communicate the transfer process to all providers.

The Surveyor interviewed the Chief Nurse Executive, Quality Director and Quality Analyst at 12:30 P.M. on 10/30/17. The Quality Analyst said that the CAH did not monitor or audit their identified corrective actions.

The Surveyor observed at 2:30 P.M. on 11/2/17, ten months after Patient #1's adverse event, that two (2) Operating Room Manuals were accessible in the Operating Room with Preference Cards that contained medications.

The Surveyor interviewed the Chief Nurse Executive at 10:30 A.M. on 11/1/17. The Chief Nurse Executive said that the Pharmacy Director monitored narcotic waste.

The report titled Analyzer Report, dated 8/3/17-10/27/17, indicated monitoring of narcotic waste. The Report indicated no indication of controlled medication wastage generated from the Operating Rooms.