Stephens Memorial Hospital

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Centers for Medicare and Medicaid Services) national database and verified with the proficiency testing company, American Proficiency Institute (API). The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 Successful participation in a proficiency testing program 493.1403 Laboratory Director, Moderate Complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Based on a desk review of proficiency testing records, it was determined the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of Routine Chemistry for the pH Blood Gas, PO2 Blood Gas, and PCO2 Blood Gas analytes. Refer to D2096. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS form 0155 and American Proficiency Institute (API) records, the laboratory failed to attain a satisfactory score of at least 80% acceptable responses for each analyte in the subspecialty of Routine Chemistry for the pH Blood Gas, PO2 Blood Gas, and PCO2 Blood Gas analytes. Findings included: 1. Review of the CMS 0155 report revealed the following results: API 2019 - 2nd Event laboratory received an unsatisfactory score for: pH Blood Gas 40% PO2 Blood Gas 40 % PCO2 Blood Gas 20% API 2020 - 1st Event laboratory received an unsatisfactory score for: pH Blood Gas 60% PO2 Blood Gas 40 % PCO2 Blood Gas 40% 2. Review of the laboratory's API proficiency testing records revealed the following results: API 2019 - 2nd Event laboratory received an unsatisfactory score for: pH Blood Gas 40% PO2 Blood Gas 40 % PCO2 Blood Gas 20% API 2020 - 1st Event laboratory received an unsatisfactory score for: pH Blood Gas 60% PO2 Blood Gas 40 % PCO2 Blood Gas 40% D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records from 2019 (2nd and 3rd Events) and 2020 (1st Event), it was revealed that the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two consecutive testing events or two out of three consecutive testing events in the specialty of Routine Chemistry for the pH Blood Gas, PO2 Blood Gas, and PCO2 Blood Gas analytes.. Two out of three unsatisfactory scores result in unsuccessful PT performance. Findings included: 1. Review of the CMS 0155 report revealed the following results: API 2019 - 2nd Event laboratory received an unsatisfactory score for: pH Blood Gas 40% PO2 Blood Gas 40 % PCO2 Blood Gas 20% API 2020 - 1st Event laboratory received an unsatisfactory score for: pH Blood Gas 60% PO2 Blood Gas 40 % PCO2 Blood Gas 40% 2. Review of the laboratory's API proficiency testing records revealed the following results: API 2019 - 2nd Event laboratory received an unsatisfactory score for: pH Blood Gas 40% PO2 Blood Gas 40 % PCO2 Blood Gas 20% API 2020 - 1st Event laboratory received an unsatisfactory score for: pH Blood Gas 60% PO2 Blood Gas 40 % PCO2 Blood Gas 40% -- 2 of 3 -- D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of laboratory proficiency testing performance it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An entrance conference was held 10/14/2019 with the Testing Person. The survey process was discussed. An opportunity for questions and comments was given. Based upon the onsite survey conducted 10/14/2019 through 10/17/2019, this facility was found NOT to be in compliance with CLIA regulations found at 42 CFR for the specialties/subspecialties in which it was surveyed. 493.1240 Preanalytic Systems 493.1250 Anayltic Systems 493.1403 Laboratory Director Moderate Complexity 493.1409 Technical Consultant 493.1421 Testing Personnel 493.1441 Laboratory Director High Complexity 493.1447 Laboratory Technical Supervisor An exit conference was held on 10/17/2019 with the CEO and the CFO. The exit conference attendees were advised the laboratory was out of compliance and advised of conditions and deficiencies found during the survey. An opportunity for questions and comments was provided. D3025 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(d) Investigation of transfusion reactions. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as appropriate, to Federal and State authorities. This STANDARD is not met as evidenced by: Based on review of the facility's policies/procedures, blood bank's policies /procedures, transfusion records, patient charts and in interview with staff, the facility failed to promptly identify, investigate and report blood transfusion reactions to the laboratory for 2 of 67 transfused blood products in 2019 (04/18/2019 and 07/29 /2019). Findings included: 1. Review of the facility's policy (last effective date of 08 /31/2018) provided by the Chief Nursing Officer (CNO) on 10/24/2019 stated, "4.3 Acute Hemolytic Transfusion Reaction...Symptoms of acute hemolytic reactions include: Chills, Fever (change of 1 degree celcius [sic] with no known cause) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 39 -- Increased pulse rate (tachycardia - heart rate >100, heart rate should decrease as transfusion progresses. If increases by >10 points, should report to MD) Decreased blood pressure (Decrease of 10 mm Hg since start of transfusion for either systolic or diastolic); chest tightness or pain; Shock; Dyspnea or tachypnea (Respirations should be 12-20 per minute unless patient has other known issues causing compromise [sic]); pulmonary rales; nausea and vomiting; flank or back pain; urticaria; hemoglobinuria... The transfusion must be stopped immediately and supportive measures instituted as ordered by physician." Review of the blood bank's policy (last effective date of 11/2 /2018) stated, "4.3 Acute Hemolytic Transfusion Reaction...Symptoms of acute hemolytic reactions include: Chills, Fever (change of 1 degree celcius [sic] with no known cause), Increased pulse rate (tachycardia), Decreased blood pressure (Acute Hypotension); Increased Blood Pressure (Acute Hypertension); chest tightness or pain; Shock; Dyspnea or tachypnea; pulmonary rales; nausea and vomiting; flank or back pain; urticaria; hemoglobinuria...The transfusion must be stopped immediately and supportive measures instituted as ordered by physician." The policies were not consistent with one another. During a telephone interview on 10/21/2019 at 10:00 am, the laboratory manager stated him, and a prior nurse worked on the blood bank policy (effective date 11/2/18) together and it was intended to also serve as the facility policy for consistency. 2. During an interview on 10/24/2019 at 2:24 pm, the CNO was asked about the inconsistencies in the facility and blood bank's transfusion policies, she stated the facility policy (last effective date of 08/31/2018) is the one she had worked on and was unaware of the blood bank's policy. 3. Review of patient transfusion records and patient charts from 04/2019 through 10//2019 revealed the following two patients who had acute hypertension/hypotension and were not promptly identified, investigated and reported to the laboratory: 04/18/2019 - Patient #43697 was transfused 1 unit of packed red blood cells beginning at 4:37 pm. Within 30 minutes of transfusion, the documented blood pressure was 169/72 mm Hg with a respiratory rate of 16 breaths per minute; within 1 hour of transfusion, the documented blood pressure was 140/83 mm Hg and a respiratory rate of 71 breaths per minute; and within 2 hours of transfusion the blood pressure was 113/73 mm Hg with a respiratory rate of 18 breaths per minute. A second unit was transfused beginning at 10:10 pm. Within 30 minutes of transfusion, the documented blood pressure was 152/74 mm Hg; within 1 hour of transfusion, the documented blood pressure was 128/74 mm Hg; and within 2 hours of transfusion the blood pressure was 116/67 mm Hg. The transfusion records included a checked off "NO" to the question "Was there a reaction to transfusion?" The patient chart did not include documentation of reporting to the blood bank of an acute drop of blood pressure or acute increase in breaths per minute. 07/29/2019 - Patient #389 was transfused 1 unit of packed red blood cells beginning at 5:50 pm. At 7:35 pm, the documented blood pressure was 137/56 mm Hg; and at 8:35 pm, the blood pressure was 163/62 mm Hg and a manual blood pressure was documented of 160/70 mm Hg. The transfusion records included a checked off "NO" to the question "Was there a reaction to transfusion?" The patient chart stated, "20:35, 07-29-2019. B/P 163/72. Manual B/P 160/70. No complaints. Color improved. Lips & skin tone pink. Called Dr [name] with update Advised him that she is on Metoprolol 25 mg BID with first dose to be given @ 9am. He ordered a dose to be given now" and "20:36, 07-29-2019. Dr [name] is aware that patient is asymptomatic with her elevated B/P." During an interview on 10/15/2019 at 2:24 pm, the CNO reviewed the above findings and confirmed the transfusions should have been reported to the blood bank. 4. Review of transfusion records from 10/2018 through 10/2019 included a total of 128 blood products transfused and no documented/investigated transfusion reactions. The laboratory had not had a transfusion reaction reported and investigated since 2010. The facility failed to promptly identify, investigate and report blood transfusion reactions to the laboratory. -- 2 of 39 -- D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory policy, Sysmex CA-600 quality control records, Daily QC Error Log, and confirmed in interview, the laboratory failed to retain all quality control records for at least two years for 4 of 4 QC runs in 2019 (random review August-September). Findings: 1. Review of the laboratory's "Analytic Processes" policy revealed: "Quality Control ... Quality control logs will be maintained. The log will include the date tested, initials of the individual that performed, the result obtained, an indication of whether the result was acceptable or not, and if not acceptable-

Summary Statement of Deficiencies No Tags No deficiency details available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --