Evergreen Sheridan Lab

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 review the laboratory's procedures manual; patients test records; quality control records; and interview with the laboratory director, the laboratory failed to retain all analytic systems activities and quality control records for at least 2 years as specified for its Prothrombin Time and International Normalized Ratio (PT INR) testing. Findings: 1. The laboratory did not have a comprehensive procedures manual that included all required information for its PT INR tests. 2. On March 31, 2021 at 3: 00 PM, the surveyor requested the following documents: a. Patients Test Reports results for 21 patients tested from January 7, 2019 through March 31, 2021. b. Corresponding Quality Control Records for the dates of patients' testing. c. Manufacturers' assay information sheets for Lots of thromboplastin used. d. Established normal patient Prothrombin time mean with for each new thromboplastin lot number. e. Documentation of each thromboplastin lot number along with the International Sensitivity Index (ISI). f. Verification of Abnormal low or abnormal high prothrombin time testing INR calculation using ISI value. 3. There was no documentation presented to the surveyor for the following requested documents: a. Manufacturers' assay information sheets for Lots of thromboplastin used from January 7, 2019 through March 31, 2021. d. Established normal patient Prothrombin time mean for each new thromboplastin lot number used from January 7, 2019 through March 31, 2021. e. Documentation of each thromboplastin lot number along with the International Sensitivity Index (ISI) from January 2019 through March 31, 2021. f. Verification of Abnormal low or abnormal high prothrombin time testing PT INR calculation using ISI value from each lot used from January 2019 through March 31, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- 2021. 4. On March 31, 2021 at 3:30 PM, the surveyor asked the laboratory director where is the documentation? The laboratory director, in turn, asked the testing person. Testing personnel told both the laboratory director that she had discarded all records from 2018. The surveyor noted that one of the lots of thromboplastin was still being used in 2019. 5. Review of QC records for the labs current lot of thromboplastin reagent revealed that there was no documentation to show that the laboratory tracked the lot number and expiration date and established normal patient Prothrombin time mean for each new thromboplastin lot testing from January 7, 2019 through March 31, 2021 for 20 of 20 patients test reports reviewed for the following dates: a. 01/07/2019 b. 02/12/2019 c. 03/26/2019 d. 04/05/2019 e. 05/21/2019 f. 06/18/2019 g. 07/05/2019 h. 08/21/2019 i. 10/29/2019 j. 01/28/2020 k. 02/26/2020 l. 03/10/2020 m. 04/06/2020 n. 05/05/2020 o. 06/25/2020 p. 08/20/2020 q. 11/17/2020 r. 12/22/2020 s. 01/15/2021 t. 03/22/2021 6. On March 31, 2021 at 4:00 PM, the laboratory director confirmed the surveyor's findings. 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 review of laboratory's procedures manuals; Laboratory Personnel Report - CLIA (Form 209); personnel records; and interview with the laboratory director, the laboratory failed to establish and follow written policies and procedures to assess consultant competency. Findings: 1. Review of the laboratory's procedures manual revealed that there were no procedures that describes the laboratory's process for performing competency assessments on the Clinical Consultant of the laboratory. 2. Review of form 209 revealed that the laboratory listed the name of its Clinical Consultant. 3. Review of personnel records revealed that there was no competency assessment performed on the Clinical Consultant. 4. On March 31, 2021 at 10:30 AM, the laboratory director confirmed the surveyor's findings. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the laboratory's procedures manual; quality control (QC) records; and interview with the laboratory director, the laboratory failed to monitor and evaluate the overall quality of the analytic systems and correct problems as specified for it Hematology procedures that include Complete Blood Counts (CBCs) and Coagulation (PT INR) tests. Findings include: 1. The laboratory lacked a complete comprehensive procedure manual that includes instruction for the test order, specimen -- 2 of 7 -- receipt, specimen processing, specimen testing, and result reporting. See tag D5400 2. Review of quality conrod records revealed the following: a. The laboratory used expired QC reagents when it tested and reported CBC results for patients' tested specimens. See tag D5417. b. The laboratory did not show all required steps in the performance of QC for PT INR testing. And the lab did not retain all QC documentation when it performed and report patient's PT INR test results. See tag D5545. 3. On March 31, 2021 at 4:00 PM, the laboratory director confirmed the surveyor's findings. 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 D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of laboratory records, direct observations, and interview with testing personnel (TP) #2; the laboratory failed to enroll in proficiency testing challenges gram stain testing in the sub-specialty of bacteriology. Findings Include: 1. Direct observation of testing supplies during a tour of the laboratory on 10-2-2018, at 12: 00pm, identified gram stain reagents. 2. Interview with TP#2, at 1:10 pm, confirmed that gram stain testing is performed by the laboratory. 3. Review of American Association of Bioanalysts (AAB) proficiency testing (PT) documentation found no record of PT for gram stain testing. 4. Test volume data provided by TP#2 at 1:45 pm, on 10-2-2018 documented in 2017 through 10-2-2018 that 161 gram stain test had been performed by the laboratory. 5. Interview with TP#2 confirmed on 10-2-2018, at 6:00 pm, the laboratory had not performed PT for gram stain testing. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of laboratory records, direct observations, and interview with laboratory testing personnel (TP) #2; the laboratory failed to meet the applicable analytic systems requirements in 493.1251 through 493.1283 in Appendix C of the State Operations Manual. Findings Include: 1. The laboratory failed to have procedures in place for microbiology testing. See D5401. 2. The laboratory procedure for prothrombin time testing failed to include all the required components of a test procedure. See D5403. 3. The laboratory failed to accurately monitor room temperature and incubator temperatures in 2018 and failed to have preventative maintenance records for temperature monitoring in 2017. See D5413. 4. The laboratory failed to verify the performance of the Siemens Microscan 4 after the laboratory moved to the new location into a new location in May of 2018. See D5421. 5. The laboratory failed to conduct calibration verifications for electrolytes (Sodium, Potassium, and Chloride) on the Dimension EXL 200. See D5439. 6. The laboratory failed to perform quality control testing on each lot and shipment of Tryptic Soy Agar 5% / EMB Bi-plates used for urine culture testing. See D5477. 7. The laboratory failed to perform quality controls each day tests are performed for antimicrobial susceptibility. See D5507. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with testing personnel (TP) #2; the laboratory failed to have a procedure manual for all tests performed in the specialty of microbiology. Findings Include: 1. Review of laboratory's policy and procedure manual found the laboratory failed to have procedures in place for urine culture identification, susceptibility, and gram stain testing. 2. On survey date 10-2- 2018, at 2:20 pm, TP#2 confirmed no microbiology procedures were available for review. 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 -- 2 of 7 -- 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 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 surveyor review of CASPER Report 155 Proficiency Testing (PT) records and communication with the PT vendor American Association of Bioanalysts (AAB); this laboratory failed to successfully participate in the testing of Bacteriology PT samples. Findings include: 1. Review of the CASPER Report 155 on September 04, 2018 and communication with the PT provider at 10:22 AM, confirmed the initial unsuccessful PT performance under the subspecialty of Bacteriology for PT event 2 of 2017, and event 1 of 2018. See D-2028. D2028 BACTERIOLOGY 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): 493.823(e) 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: Based on surveyor review of CASPER Report 155, Proficiency Testing (PT) records and communication with the PT vendor American Association of Bioanalysts (AAB); this laboratory failed to successfully participate in the testing of Bacteriology PT samples. Findings include: 1. Review of the CASPER Report 155 on September 04, 2018 revealed that the the initial unsuccessful PT performance occurred under the subspecialty of Bacteriology for PT event 2 of 2017, and event 1 of 2018 as listed below: BACTERIOLOGY EVENT - 2, 2017 = 0% Unsatisfactory EVENT - 1, 2018 = 0% Unsatisfactory 2. During a phone communication with the PT vendor AAB on September 04, 2018 at 10:22 AM, the Bacteriology PT failing scores for events 2 of 2017 and event 1 of 2018 were confirmed. -- 2 of 2 --