Warren Community Hospital

Summary Statement of Deficiencies 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 observation, document review, and interview with laboratory personnel, the laboratory failed to retain Endocrinology quality control records for at least two years for one of four Endocrinology test results obtained between June and December 2022. Findings are as follows: 1. The laboratory performed Endocrinology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:10 a.m. on 03/29/23. 2. A Tosoh AIA 360 Automated Immunoassay analyzer was observed as present and available for use during the tour of the laboratory. The laboratory performed quantitative hCG testing using this analyzer. 3. Quality Control (QC) testing was required each day of patient testing as established in the Tosoh AIA 360 BHCG procedure found in the Procedure Manual - Chemistry, Coagulation, Hematology, Microscopy, Rapid tests, Urinalysis. 4. Manual documentation of quantitative hCG QC performance on 08/01/22 was not found on the HCG Total Beta Control Log for a quantitative hCG test result from 08/01/22. 5. The Tosoh Patient Test Result Log indicated four specimens received quantitative hCG testing between June and December 2022. Manual documentation of QC performance was found for three of the four testing dates. 6. In an interview at 3:05 p.m. on 03/29/23, the GS confirmed the above finding. The GS indicated records were no longer available in the Tosoh analyzer data to verify quantitative hCG QC performance on 08/01/22. . D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- (b) The technical consultant is responsible for-- (b)(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 document review and interview with laboratory personnel, the Technical Consultant failed to ensure comprehensive semi-annual and annual competency assessments were performed for six of six testing personnel in 2021 and 2022. Findings are as follows: 1. The laboratory performed Endocrinology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:10 a.m. on 03/29/23. 2. Quidel Corporation QuickVue hCG Combo test kits were observed as present and available for use during the tour. 3. Personnel competency evaluations encompassing all duties performed were required as established in the Competence Testing procedure found in the Procedure Manual - General, Safety, Phlebotomy. 4. The QuickVue serum hCG test was not included on the Annual Competency Checklist forms completed between April 2021 and December 2022. Testing personnel (TP) were not assessed for competency on this test. See below. 2021 - 5 of 5 tenured TP were not assessed annually 2021 - 1 of 1 new TP was not assessed semi-annually 2022 - 6 of 6 TP were not assessed initially 5. The laboratory was unable to provide documentation of serum hCG competency assessments upon request. 6. In an interview at 11:20 a.m. on 03/29/23, the GS confirmed the above finding. . D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: . Based on review of personnel documents and interview with laboratory personnel, the laboratory failed to ensure staff performing high complexity testing meet the qualification requirements of 493.1489 to perform the functions specified in 493.1495 for the complexity of testing performed. Findings are as follows: The laboratory failed to obtain an equivalency evaluation of foreign credentials for one testing personnel performing high complexity testing in 2021 and 2022. See D6171. . D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) -- 2 of 4 -- (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to obtain a foreign credential equivalency evaluation for one of three testing personnel with foreign credentials who were performing high complexity testing between April 2021 and March 2023. Findings are as follows: 1. The laboratory performed testing under the following Specialties - Subspecialties as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:10 a.m. on 03/29/23: Microbiology - Bacteriology, Mycology, Parasitology Diagnostic Immunology - General Immunology Chemistry - Routine, Urinalysis, Endocrinology, Toxicology Hematology Immunohematology - ABO/Rh, Antibody Detection, Compatibility 2. Testing Personnel 3 (TP3) was listed on the Laboratory Personnel Report (CLIA) -- 3 of 4 -- Form CMS-209 as an employee performing high complexity testing. Competency Assessment records from 2021 and 2022 indicated TP3 was trained and competent to perform testing in all areas of the laboratory. 3. TP3 completed education in the Philippines as indicated in education credentials provided by the laboratory. 4. Appropriate education was required for all testing personnel as established in the Competence Testing procedure found in the Procedure Manual - General, Safety, Phlebotomy 5. An equivalency evaluation of TP3's foreign credentials was not found in personnel records. The laboratory was unable to provide the equivalency evaluation upon request. 6. In an interview at 11:15 a.m. on 03/29/23, the GS confirmed the above finding. 7. The laboratory was given an opportunity to provide the missing documentation within five days of the survey date. 8. In an email received at 4:20 p. m. on 03/30/23, the GS indicated a foreign credential evaluation had not been completed for TP3. . -- 4 of 4 --

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of six 2020 proficiency testing (PT) results when the PT program did not obtain the agreement required for scoring. Findings are as follows: 1. The laboratory performed Hematology and Immunohematology testing as confirmed by General Supervisor 1 (GS1) during a tour of the laboratory at 8:05 a.m. on 04/22 /21. 2. The laboratory performed PT using the American Proficiency Institute (API) provider. 3. Six results were not graded by API due to lack of consensus. See below. Survey Event: Hematology / Coagulation - 1st Sample ID: HCA-04, HCA-05 Analyte: activated Partial Thromboplastin Time Survey Event: Hematology / Coagulation - 2nd Sample ID: HCA-07, HCA-09, HCA-10 Analyte: activated Partial Thromboplastin Time Survey Event: Immunology / Immunohematology - 3rd Sample ID: SER-11 Analyte: Antibody Screening for Transfusion 4. The API report referred the laboratory to the expected result data summary for evaluation of the non-graded test results. The data summary for the above analytes were not present in laboratory records. Evaluations of the non-graded results were not found in laboratory records. 5. Investigation of non-graded PT results was required as established in the Proficiency Testing Procedure located in the North Valley Health Center - Laboratory Manual. The laboratory was unable to provide evaluations of the non-graded results upon request. 6. In an interview at 10:15 a.m., on 04/22/21, GS1 confirmed the above finding. . Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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: . Based on document review and interview with laboratory personnel, the laboratory failed to verify the accuracy at least twice annually of 1 test performed in 2019 and 2020. Findings are as follows: 1. The laboratory performed Urine Drug Sceening testing under the specialty of Chemistry as confirmed by General Supervisor 1 (GS1) during a tour of the laboratory at 8:05 a.m. on 04/22/21. 2. The laboratory performed proficiency testing (PT) using the American Proficiency Institute (API) provider. 3. Documentation of twice annual accuracy verification of Urine Drug Sceening was not found in laboratory records from 2019 and 2020. The laboratory was unable to provide verification documents for calendar year 2019 and 2020 upon request. 4. In an interview at 10:15 a.m., on 04/22/21, GS1 confirmed the above finding. . D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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 document review and interview with laboratory personnel, the technical supervisor failed to ensure 2 of 4 testing personnel (TP) received competency assessments for all test procedures performed in 2017 and 2018. Findings are as follows: 1. The laboratory performed Urine Sediment (US), Manual Differential (Diff), Wet Preparation (WP) and KOH* microscopic examinations as confirmed by the General Supervisor (GS) during a tour of the laboratory on 04/02/19 at 8:05 a.m. 2. Competency assessment documents for 1 of 3 fully trained TP in 2017 and 1 of 4 fully trained TP in 2018 did not include an evaluation of the following microscopic examinations: Year TP Missing assessments 2017 TP1 US, WP, KOH 2018 TP3 US, Diff, WP, KOH 3. The laboratory was unable to provide the missing competency assessments upon request. 4. In an interview on 04/02/19 at 9:20 a.m., the GS confirmed evaluations of the above items were not included in the 2017 and 2018 competency assessments. *Note KOH - Potassium Hydroxide 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 --