Mercy Waldron

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies 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 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 review of 2022 CMS Casper reports 0155D, 153D, and American Proficiency Institue (API) proficiency testing results, it was determined the laboratory failed to have initial successful participation in proficiency testing in the sub- speciality of Immunohematology and the test Compatibility testing as evidence by: 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 as cited at D2173. D2181 COMPATIBILITY TESTING 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): 493.863(e) Failure to achieve an overall testing event score of satisfactory 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 review of 2022 CMS CASPER Reports 155D, 153D and the American Proficiency Institute(API) proficiency testing results, the laboratory failed to achieve satisfactory performance in two consecutive proficiency testing events for the analyte compatibility testing as evidenced by: A. The Laboratory received a score of 80% for compatibility testing in the third proficiency testing event of 2022. B. The Laboratory received a score of 80% for compatibility testing in the second proficiency testing event of 2022. 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 review of 2022 proficiency testing results the laboratory director failed to provide overall management and direction to the lab for successful participation in proficiency testing. 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 review of the 2022 proficiency testing events, it was determined the laboratory director failed to ensure the laboratory successfully participated in proficiency testing for the analytes Compatibility Testing. Refer to D2173 -- 2 of 2 --

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 review of the 2021 CMS Casper Reports 0155D, 0153D, and the American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to have initial successful participation in proficiency testing for the analyte Total Bilirubin (TBILI). 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 as cited at D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- 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 review of the 2021 CMS Casper Reports 0155D and 0153D and American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to have satisfactory participation in proficiency testing for the analyte Total Bilirubin (TBILI) Survey Findings follow: A. A review of the proficiency testing results revealed the laboratory received a sore of 0% for the analyte TBILI in the first proficiency testing event of 2021. B. A review of the proficiency testing results revealed the laboratory received a score of 40% for the analyte TBILI in the third proficiency testing event of 2021. 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 review of the 2021 proficiency testing results, it was determined the laboratory director failed to ensure that the proficiency testing samples are tested as required under Subpart H of this part. 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 review of the 2021 proficiency testing event, it was determined the laboratory director failed to ensure the laboratory successfully participated in proficiency testing for the analytes Total Bilirubin. Refer to D2096 -- 2 of 2 --

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Through observation, review of manufacturer's package inserts, and interview with laboratory staff it was determined that the laboratory failed to amend expiration dates of three of three hematology controls, three of three chemistry controls as required by the manufacturer and failed to label one of one bottles of saline solution. Findings follow: 1. Failure to amend expiration dates of control material as required by the manufacturer. A) Review of the manufacturer's package insert for Biorad Multiqual chemistry controls states "when thawed and opened the product is stable for all analytes for 14 days"; review of the manufacturer's package insert for e-check hematology controls states when opened and placed into use the product is stable for 14 days. B) During a tour of the laboratory on 7/23/21 at 09:45a.m., three of three bottles of Biorad Multiqual chemistry controls lot # 56671 levels 1,2 and 3 with an expiration date 2023-06-30 were observed thawed and opened in the laboratory refrigerator and three of three bottles of e-check hematology controls lot# 11520804, 11520805, 11520806 with an expiration date 2021-02-22 were observed opened in the laboratory refrigerator. C) In an interview at 10:00 a.m. the laboratory staff member, identified as number two on the CMS 209 form confirmed that the materials, identified above, were opened and in use and were not labeled with an amended expiration date as required by the manufacturer. 2. Failure to label one of one bottle of saline soution. A) During a tour of the laboratory on 7/23/21 at 09:45 a.m., one of one plastic bottle half filled with a clear liquid was observed on the laboratory counter in 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 -- the blood bank area with no label of contents. B) When asked what the bottle, identified above, contained, on 7/23/21 at 09:45 a.m. the laboratory staff member, identified as number two on the CMS 209 form, said the bottle contained "blood bank saline" and confirmed that it was in use and was not labeled. D5781

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 review of the 2020 and 2021 CMS Casper Reports 0155D, 0153D, and the American Proficiency Institute(API) proficiency testing results, it was determined the laboratory failed to have initial successful participation in proficiency testing for the Sub-Specialty of Endocrinology and the analytes Thyroid Stimulating Hormone (TSH), Free Thyroxine(FT4), Free Triiodothyronine (FT3), Chloride (CL) and N- terminal pro-brain natriuretic peptide (NT-proBNP). Survey Findings Follow: 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 as cited at D2108. Failure to achieve satisfactory 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 -- performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance as cited at D2107 and D2096. . 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 review of 2020 and 2021 CMS Casper Reports 0155D and 0153D and American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to have satisfactory participation in proficiency testing for the analyte of Chloride (CL) and N-terminal pro-brain natriuretic peptide (NT-proBNP). Survey Findings follow: A. A review of the proficiency testing results revealed the laboratory received a sore of 60% for the analyte CL and 20% for the analyte NT- proBNP in the third proficiency testing event of 2020. B. A review of the proficiency testing results revealed the laboratory received a score of 0% for the analytes of CL and NT-proBNP in the first proficiency testing event of 2021. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 review of 2020 and 2021 CMS Casper Reports 0153D, 0155D and American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to achieve satisfactory performance for Thyroid Stimulating Hormone (TSH), Free Triiodothyronine (FT3) and Free Thyroxine (FT4) in two consecutive proficiency testing events which is unsuccessful performance. Survey Findings follow: A. A review of the proficiency testing results revealed the laboratory received a score of 20% for the analytes FT3, FT4 and TSH in the third proficiency testing event of 2020. B. A review of the proficiency testing results revealed the laboratory received a score of 0% for the analytes FT3, FT4 and TSH in the first proficiency testing event of 2021. D2108 ENDOCRINOLOGY CFR(s): 493.843(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: . Based on review of 2020 and 2021 CMS Casper Reports 0155D and 0153D and -- 2 of 3 -- American Proficiency Institute proficiency testing results, it was determined the laboratory failed to have satisfactory participation in proficiency testing for the Sub- specialty of Endocrinology. Survey Findings follow: A. A review of the proficiency testing results revealed the laboratory received an overall score of 46% in third proficiency testing event of 2020 for the Sub-Specialty of Endocrinology. B. A review of the proficiency testing results revealed the laboratory received an overall score of 0% in first proficiency testing event of 2021 for the Sub-Specialty of Endocrinology. 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 review of 2020 and 2021 proficiency testing results, it was determined the laboratory director failed to ensure that the proficiency testing samples are tested as required under Subpart H of this part. As cited at 6016 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 review of 2020 and 2021 proficiency testing event , it was determined the laboratory director failed to ensure the laboratory successfully participated in proficiency testing for the Sub-Specialty Endocrinology and the following analytes TSH, FT4, FT3, CL and NT-proBNP. As cited at D2096, D2107 and 2108. -- 3 of 3 --

Summary Statement of Deficiencies D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Through a review of the laboratory policy and procedure manual, monthly Levey- Jennings graphs for Protime, APTT (activated partial thromboplastin time), and D- dimer, and quality control package inserts, and through interviews with laboratory staff, it was determined the laboratory failed to determine statistical ranges for the establishment of control ranges. Survey findings include: 1. The laboratory used package insert ranges instead of establishing it's own ranges for the Protime and APTT which used STA-COAG CONTROL (N + ABN) PLUS as the control material. A. The package insert for the STA-COAG CONTROL (N + ABN) PLUS states that the control ranges given in the package insert are intended only as a guideline and it is recommended that each laboratory establish its own target values and acceptance ranges. The ranges listed in the package insert as guidelines are as follows: Normal Protime 12.5 to 15.5; Normal APTT 30 - 41; Abnormal Protime 20 - 32; and Abnormal APTT 79 - 103. B. Instrument quality control printouts for QC lot 252679, 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 -- which the laboratory began using as a control on 11/1/2018, list the following current (2/6/2019) control ranges used as acceptance ranges: Normal Protime 12.5 to 15.5; Normal APTT 30 - 41; Abnormal Protime 20 - 32; and Abnormal APTT 79 - 103. These ranges are the exact ranges listed in the package insert which are intended only as guidelines. C. In an interview on 2/5/2019 at 3:18/2019, laboratory employee #2 (as listed on the form CMS-209) confirmed the ranges programmed into the instrument as acceptable ranges were taken from the package insert of the control material. 2. The laboratory failed to use calculated standard deviation in setting acceptable ranges for quality control for the D-dimer assay. A. The laboratory policy and procedure manual includes a policy for quality control daily review that states the laboratory uses quality control failure rules, 1-3s; 2-2s; and R-4s where "s" is standard deviation. The 1-3s rule is defined as a failure of one control level outside of three standard deviations from the mean. The 2-2s rule is defined as a failure of two controls outside of the same two standard deviations from the mean. The R-4s rule is defined as two controls in the same run being separated by four standard deviations (one control outside of plus two standard deviations and another control outside of minus two standard deviations in the same run). In order to use these control rules the laboratory must calculate standard deviations. B. A review of the current Levey-Jennings graph for D- dimer dated 2/6/2019 revealed the calculated standard deviation for D-dimer Level 1 Control (Lot # 35669700) at the time of the survey was documented as 0.056 (rounded 0.06). The plus or minus two standard deviation range for D-dimer Level 1 Control, listed on quality control daily printouts, is -.408 to 2.052. This is calculated from an approximate 0.6 standard deviation instead of the 0.06 calculated by the quality control software. The standard deviation in use for calculation of the range is ten times the actual standard deviation that the test system is experiencing. C. In an interview on 2/5/2019 at 3:18/2019, laboratory employee #2 (as listed on the form CMS-209) confirmed the current ranges in use for the D-dimer Level 1 Control (Lot # 35669700) are not the appropriate and do not correlate with the instrument calculations. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Through a review of Individual QC Charts for September 2018, November 2018, and January 2019, a review of patient test reports, and an interview with laboratory staff, it was determined the laboratory reported AST (aspartate aminotransferase) before quality control was within the laboratory's acceptable range. Survey findings include: A. The Individual QC Chart for September 2018 shows that on 9/30/2018 Level 1 quality control Lot #47983 (acceptable range for the control was 38.1 to 42.9) results for AST were unacceptable when initially performed at 2:20 a.m. (result listed as 33) and was repeated thirteen times before the control was acceptable on the 14th repeat at 12:08 p.m. (acceptable result 39). B. A review of patient chemistry test reports for 9/30 /2018 revealed that one of four patients with AST reported on 9/30/2018 was reported before the quality control was acceptable at 12:08 p.m.. Patient #31966785 had an AST result reported on 9/30/2018 at 11:14 (54 minutes before the acceptable control). -- 2 of 3 -- C. In an interview at 10:12 on 2/6/2019, laboratory employee #2 (as listed on the form CMS-209) confirmed an AST result was reported on Patient #31966785 before the quality control was acceptable. D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Through a review of immunohematology quality control records for 2018 through January 2019 and Blood Bank Worksheets for 2018 through the date of the survey, as well as interviews with laboratory staff it was determined the laboratory failed to perform and document quality control for immunohematology testing on one day of patient testing. Survey findings follow: a. A review of quality control records for January 2018 through January 2019 revealed the laboratory failed to document immunohematology (blood bank) quality control on 1/18/2019. b. A review of the Blood Bank Worksheet for 1/18/2019 showed a blood type and Rh and a crossmatch for two units of blood was performed on Patient #E1402198693. c. At 12:46 p.m. on 2 /6/2019 laboratory employee #2, from the Form CMS-209, reviewed quality control records and confirmed the lack of documented quality control on a day of blood bank patient testing. -- 3 of 3 --