Hamilton County Hospital

Summary Statement of Deficiencies 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: Based on the review of proficiency testing (PT) records from American Proficiency Institute (API) and interview with the Chief Operations Officer (COO), the laboratory failed to successfully participate in PT for the analytes: Hematology, Cell I.D. or WBC Diff, RBC (Erythorocyte Count), Hematocrit (Non-Waived), Hemoglobin (Non- Waived), WBC (Leukocyte Count), Platelet Count, Partial Thromboplastin Time (PTT) and Prothrombin Time (PT) for two out of three consecutive proficiency testing events: 2022 Event 1 and 2022 Event 2 (refer to D2131). D2131 HEMATOLOGY Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: A PT desk review and phone interview with the A PT desk review and phone interview with the Chief Operations Officer (COO) on 10/3/22 revealed the laboratory failed to successfully particiate in PT from API for the analytes: 0760 Hematology, 0765 Cell I.D. or WBC Diff, 0775 RBC (Erythrocyte Count), 0785 Hematocrit (Non- Waived), 0795 Hemoglobin (Non-Waived), 0805 WBC (Leukocyte Count), 0815 Platelet Count, 0835 Partial Thromboplastin (PTT) and 0845 Prothrombin Time (PT). Findings: 1. Review of the 2022 API 1st Event and 2nd Event revealed a score of 0% for 0760 Hematology. 2. Review of the 2022 API 1st Event and 2nd Event revealed a score of 0% for 0765 Cell I.D. or WBC Differential. 3. Review of the 2022 API 1st Event and 2nd Event revealed a score of 0% for 0775 RBC (Erythrocyte Count). 4. Review of the 2022 API 1st Event and 2nd Event revealed a score of 0% for 0785 Hematocrit (Non-Waived). 5. Review of the 2022 API 1st Event and 2nd Event revealed a score of 0% for 0795 Hemoglobin (Non-Waived). 6. Review of the 2022 API 1st Event and 2nd Event revealed a score of 0% for 0805 WBC (Leukocyte Count). 7. Review of the 2022 API 1st Event and 2nd Event revealed a score of 0% for 0815 Platelet Count. 8. Review of the 2022 API 1st Event and 2nd Event revealed a score of 0% for 0835 Partial Thromboplastin (PTT). 9. Review of the 2022 API 1st Event and 2nd Event revealed a score of 0% for 0845 Prothrombin Time (PT). 10. Phone interview 10/3/22 at 9:30 a.m. with the Chief Operations Officer (COO) confirmed, the laboratory failed to successfully particiate in PT from API for the analytes: 0760 Hematology, 0765 Cell I.D. or WBC Diff, 0775 RBC (Erythrocyte Count), 0785 Hematocrit (Non-Waived), 0795 Hemoglobin (Non-Waived), 0805 WBC (Leukocyte Count), 0815 Platelet Count, 0835 Partial Thromboplastin (PTT) and 0845 Prothrombin Time (PT). -- 2 of 2 --

Summary Statement of Deficiencies D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on a review of competency assessment records, and interview, the technical supervisor failed to evaluate the competency for one of two testing personnel (TP). Findings: 1. No competency assessment records (including both 6 month and annual) for TP #1 were made availible at the time of survey. 2. Interview with General Supervisor on December 1, 2020 at 3:15 p.m. confirmed, the technical supervisor failed to evaluate the competency for one of two testing personnel (TP). 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 --

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of Quality Assurance (QA) procedures, the lack of available (QA) documents, and interview with staff reveals that the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the general laboratory systems. Findings: 1. The laboratory failed to follow their Quality Assurance Plan ,written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the general laboratory systems. On March 20, 2019 at 1130 an interview with the Technical Consultant #1 confirmed that the laboratory had not performed the monitors outlined in the current Quality Assurance Plan. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test 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 -- system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: A review of calibration verification records for the Sysmex XS-1000i, and interview with staff revealed that the laboratory failed to perform calibration verification once every six months. Finding were as follows 1. Review of the Sysmex XS-1000i calibration verification documentation revealed the laboratory failed to perform calibration verification at least once every six months. The laboratory performed a calibration verification on January 12, 2018 but failed to perform the calibration verification that was due in July 2018. This was confirmed in interview with Testing person #2 on March 20, 2019 at 11:00 hrs. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Review of quality control (QC) records from 2018 and interview with the Technical Consultant #1 and General Supervisor #2 at 12:30 PM on March 20, 2019 revealed that the laboratory failed to perform QC as required. The laboratory failed to perform quality control at least once a day of patient testing for quantitative procedures, include two control materials of different concentrations. The findings: 1) The Troponin cartridges for the ISTAT require quality control at least once a day of patient testing with two control materials of different concentrations. 2) QC records indicate that external, liquid controls are tested monthly and with each new shipment and lot number of cartridges. 3) No Individualized Quality Control Plan has been performed to allow the laboratory to reduce the frequency of QC performance. D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this section. -- 2 of 3 -- This STANDARD is not met as evidenced by: 1. A review of manufacturer's instructions for Innovin , quality control and quality assessment records for coagulation, observation of the laboratory's equipment, and interview with staff on March 20, 2019 revealed that the laboratory did not follow manufacturer's instructions for International Normalized Ratio (INR) . Findings were as follows: a. Manufacturer's instructions from CA 600 for the determination of INR state: "The normal PT is defined as the mean of the normal range and must be specifically determined for each lot of Innovin, with the specific instrument/technique used for patient testing".At the time of the survey the laboratory failed to produce a normal patient mean for the calculation of the INR b. Quality control and quality assessment records for Sysmex CA600 coagulation analyzer on March 20, 2019 did not include determination of the Prothrombin Time (PT) for patient normal range for the current lot of Innovin in use. Therefore the accuracy or reliability can not be verified. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Review of 2018 blood bank function check records and interview with staff reveals that laboratory failed to regularly inspect the alarm system(s) according to its established policy. Findings: 1. According to the current policy for "GEM BB Refrigerator Operation and Maintenance" and the policy in place for 2018 named "Blood Bank Refrigerator Alarm Testing". Quarterly checks of the alarm system should be verified to ensure the system is functioning properly. 2. The laboratory provided documentation of one alarm check on December 7, 2018 but failed to provide documentation of the other three alarm checks for 2018. Interview on March 20, 2019 at 1145 with the technical consultant #1 confirmed that there were no records of the three missing alarm checks. -- 3 of 3 --

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: A review of manufacture ' s package H Pylori Test revealed this assay has not been established for patients under 18 years of age revealed the laboratory failed to follow manufactures instructions. Findings were as follows a. Based upon a review of the H Pylori Test revealed the laboratory performed 1 patient under the age of 18 November 14, 2017 .Patient was 11 years old Therefore, the accuracy of the testing cannot be verified. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Based on a review of lab policies and procedures, proficiency testing (PT) records during calendar years 2017 through the PT provider, American Proficiiency Institute API and staff interview, the laboratory failed to document each step in the testing and reporting of results for all proficiency test samples. Findings were: a. A review of the laboratory's Proficiency API for 2017 all three events the Laboratory Director and Testing Person"s failed to sign the Attestion Statement D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of laboratory and personnel policies/procedures, competency records and staff interview, the laboratory director failed to define by policy /procedure the manner in which competency was assessed for technical consultant . Findings were as follows: a. The laboratory must have policies and procedures to assess competency based on the position responsibilities listed on Form CMS 209. Technical Consultant failed to have a competency documented at the time of the survey 01/11/2018. . D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: A review of American Proficiency Institute (API) proficiency, Quality Control, Quality Assessment, and Interview with staff revealed the laboratory failed to verify the accuracy for the analyte Ammonia for the 1 st and 2nd events of 2017. Finding were as follows: 1. Based upon a review of API 1 st event Ammonia received a 33% grade 2 nd event 67%. The laboratory failed to produce