Saint Francis Laboratory Poplar Bluff

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 chemistry proficiency testing (PT) results reported to the CLIA database by the PT provider for 2022/2023 and interview with the technical consultant (TC) on March 27, 2023 at 1:00 PM , the laboratory failed to successfully participate in PT. Refer to D-tag 2096, unsatisfactory performance in two consecutive urea nitrogen (BUN) PT challenges. 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 chemistry proficiency testing (PT) results reported to the CLIA database by the PT provider for 2022/2023 and interview with the technical consultant (TC), the laboratory failed to achieve satisfactory performance for urea nitrogen (BUN) in two consecutive testing events. Findings: 1. Review of the chemistry- core PT results for the third event of 2022 showed the laboratory obtained an unsatisfactory score of 20 percent for the analyte BUN. 2. Review of the chemistry- core PT results for the first event of 2023 showed the laboratory obtained an unsatisfactory score of 40 percent for the analyte BUN. 3. Interview with the technical consultant (TC) on March 27, 2023 at 1:00 PM confirmed the laboratory failed to achieve satisfactory performance for BUN in two consecutive testing events. -- 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 endocrinology proficiency testing (PT) results for 2022 reported to the CLIA database by the PT provider and phone interview with the technical consultant on August 8, 2022 at 3:15 PM, the laboratory failed to successfully participate in PT. Refer to D-tag 2107, unsatisfactory performance for two consecutive Thyroid Stimulating Hormone (TSH) PT events. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 endocrinology proficiency testing (PT) results reported to the CLIA database by the PT provider and phone interview with the technical consultant, the laboratory failed to achieve satisfactory performance for Thyroid Stimulating Hormone (TSH) for two consecutive testing events in 2022. Findings: 1. Review of the endocrinology PT results for the first event of 2022 showed the laboratory obtained an unsatisfactory score of 40 percent for the analyte TSH. 2. Review of the endocrinology PT results for the second event of 2022 showed the laboratory obtained an unsatisfactory score of 0 percent for the analyte TSH. 3. Phone interview with the technical consultant on August 8, 2022 at 3:15 PM confirmed the laboratory failed to achieve satisfactory performance for the analyte TSH for two consecutive PT events in 2022. -- 2 of 2 --

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 assessment procedures, 2019, 2020 and to date August 11, 2021 quality control (QC) and interview with the laboratory manager, the laboratory failed to follow written procedures for review of QC for 31 of 31 months. Findings: 1. Review of quality assessment procedures revealed "Quality Control" procedure states "All quality control records should be reviewed and assessed at least monthly by the appropriate staff". 2. Review of Tosoh AIA 900 analyzer QC, Dimension EXL analyzer QC, Cobas 6000 analyzer QC, Stago Sta Compact Max analyzer QC, Sysmex X1000i analyzer QC and Biosite Alere Triage analyzer QC showed no review for 2019, 2020 and to date August 11, 2021. 3. Interview with the laboratory manager on August 11, 2021 at 11:30 AM confirmed the laboratory failed to follow written procedures for review of QC. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of urine centrifuge, microscopic procedures, hematology procedures, freezer temperature logs, manual differential stain, chemistry reagents, pipettes, protector hood, Tosoh AIA 900 chemistry analyzer quality control (QC) logs, package inserts, Sysmex X1000i and interviews, the laboratory failed to meet the condition of analytic systems. The laboratory failed to follow written procedures and ensure procedures were provided for all testing personnel (Refer to 5401); failed to ensure freezer was within acceptable criteria (Refer to D5413); failed to ensure stain was labeled with expiration date (Refer to D5415); failed to ensure chemistry reagents are not used when they have exceeded their expiration dates (Refer to D5417); failed to ensure pipettes and protector hood was maintained (Refer to D5435); failed to include two control materials of different concentrations each day of patient testing (Refer to D5447); failed to establish or verify the criteria for acceptability of chemistry QC (Refer to D5469); failed to document stain quality (Refer to D5473); and failed to define a relationship between automated differentials and manual differentials (Refer to 5775). 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 hematology procedures and interview with the laboratory manager the laboratory failed to have written procedures for fecal white blood cell, white blood cell (WBC) manual differential and use of an alternative anti-coagulant for hematology testing. Findings: 1. Review of hematology procedures showed no written procedure for fecal white blood cell, WBC manual differential and use of an alternative anti-coagulant for hematology testing. 2. Interview with the laboratory manager on August 11, 2021 at 11:30 AM confirmed the laboratory failed to have written procedures for fecal white blood cell, WBC manual differential and use of an alternative anti-coagulant for hematology testing. 44735 Based on review of urinalysis microscopic procedure, centrifuge maintenance, and interview with the technical consultant (TC) #2, the laboratory failed to follow written procedures for "Urinalysis Microscopic Guidelines". Findings: 1. Review of procedure "Urinalysis Microscopic Guidelines" states "Centrifuge at 1500 rpm for 5 minutes." 2. Review of centrifuge maintenance showed the Quest Diagnostics VanGuard V6500 centrifuge was checked at 3400 RPM's. 3. Interview with TC #2 on August 11, 2021 at 10:00 AM confirmed the laboratory failed to follow written procedures for "Urinalysis Microscopic Guidelines". D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and -- 2 of 10 -- test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, documentation of freezer temperatures, observation of quality control (QC) material stored in the freezer, and interview with the laboratory manager, the laboratory failed to follow the manufacturer's instructions for storage of control materials for 211 of 214 testing days from January 1, 2021 through August 11, 2021. Findings: 1. Review of the manufacturer's instructions for Bio-Rad liquichek cardiac markers control, Bio-Rad specialty immunoassay liquichek control, and Bio-Rad liquid assayed multiqual control showed controls must be stored at minus 20 degrees Celsius (C) to minus 70 degrees C. 2. Review of the laboratory's temperature chart showed a defined acceptable range of minus 15 degrees C to minus 20 degrees C. For 211 of 214 testing days the laboratory failed to meet the manufacturer's required minus 20 degrees C to minus 70 degree C temperature range. 3. Observation of the laboratory freezer showed 1 box of Bio-Rad liquichek cardiac markers control level 1, 1 box of Bio-Rad specialty immunoassay liquichek control level 2, and 2 boxes of Bio-Rad liquid assayed multiqual level 3 controls currently in use. 4. Interview with the laboratory manager on August 11, 2021 at 11:30 AM confirmed the laboratory failed to properly monitor the freezer and store QC materials and supplies per manufacturer's instructions. 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: Based on observation of fecal white blood cell stain, white blood cell (WBC) manual differential stain and interview with the laboratory manager, the laboratory failed to label stain with expiration dates. Findings: 1. Observation of Quicklink III fixative, Quicklink III solution 1 and Quicklink III solution II used for staining fecal white blood cells and WBC manual differentials showed no expiration date. 2. Interview with the laboratory manager on August 11, 2021 at 11:30 AM confirmed the laboratory failed to label stain with expiration dates. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. -- 3 of 10 -- This STANDARD is not met as evidenced by: Based on review of chemistry reagents and interview with the laboratory manager, the laboratory failed to ensure chemistry reagents are not used when they have exceeded their expiration date. Findings: 1. Review of chemistry reagents still in use showed: 3 cobas e multi lot #267636-01 expiration 5/20. 1 cobas e multi lot #360917-01 expiration 6/30/20. 2 cobas e multi lot #233508-01 expiration 12/19. 1 cobas e multi lot #292350-01 expiration 8/31/20. 4 traige cardiac lot #101020 expiration 6/22/21. 2. Interview with the laboratory manager on August 11, 2021 at 11:30 AM confirmed the laboratory failed to ensure chemistry reagents are not used when they have exceeded their expiration date. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of maintenance documentation and interview with the technical consultant (TC) #2, the laboratory failed to perform and document function checks for one Fisherbrand Elite pipette, one DiamondPro pipette and the Labconco Protector Laboratory Hood for 2019, 2020 and to date August 11, 2021. Findings: 1. Review of pipette calibration documentation showed the last calibration for the Fisherbrand Elite 100-1000 microliter multichannel pipette serial number LU08908 was November 20, 2018 and the last pipette calibration for the DiamondPro 10-100 microliter multichannel pipette serial number LD623321 was November 20, 2018. 2. Review of the Labconco Protector Laboratory Hood serial number 110947689 showed the last inspection was completed in July 2018. 3. Interview with the TC #2 on August 11, 2021 at 9:30 AM confirmed, the laboratory failed to perform and document function checks for one Fisherbrand Elite pipette, one DiamondPro pipette and the Labconco Protector Laboratory Hood for 2019, 2020 and to date August 11, 2021. 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: Based on review of 2021 Tosoh AIA- 900 chemistry analyzer quality control (QC) logs for vitamin B12, and interview with the technical consultant (TC) #2, the -- 4 of 10 -- laboratory failed to include two control materials of different concentrations each day of patient testing for 15 of 114 patient testing days. Findings: 1. Review of 2021 vitamin B12 chemistry QC logs showed no documentation of acceptable level 1 QC for April 20, April 21, April 23, April 26, April 27, May 4, May 24, May 27, June 7, June 8, July 8, July 12, July 13, July 19, and August 10. 2. The laboratory reported 277 vitamin B12 patient results during the timeframe that there was no acceptable vitamin B12 QC. 3. Interview with the TC #2 on August 11, 2021 at 10:30 AM confirmed the laboratory failed to include two control materials of different concentrations each day of patient testing. 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: Based on review of the Liquichek Immunoassay Plus Control package insert, LIS Total Quality Control (QC) module for the Tosoh AIA- 900 chemistry analyzer and interview with the technical consultant (TC) #2, the laboratory failed to ensure the established criteria for acceptability of controls was followed by the laboratory personnel for 15 of 114 patient testing days. Findings: 1. Review of the Liquichek Immunoassay Plus Control package insert showed QC ranges for vitamin B12 level one, lot number 85331 as 163 - 303 pg/mL. 2. Interview with testing personnel #1 confirmed that the laboratory uses Liquichek Immunoassay Plus Control package insert QC ranges for vitamin B12. 3. Review of the LIS Total QC module for the Tosoh AIA- 900 chemistry analyzer showed QC ranges for vitamin B12 level one, lot number 85331 as 153.2 - 376.4 pg/mL. 4. Interview with the TC #2 on August 11, 2021 at 10:30 AM confirmed the laboratory failed to ensure the established criteria for acceptability of controls was followed by the laboratory personnel. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: -- 5 of 10 -- Based on lack of hematology records and interview with the technical consultant (TC) #2, the laboratory failed to document the quality of staining materials each day of use for manual differentials for 2019, 2020 and to date August 11, 2021. Findings: 1. Lack of hematology records showed the laboratory failed to document the quality of staining materials each day of use for manual differentials. 2. Interview with TC #2 on August 11, 2021 at 9:00 AM confirmed the laboratory failed to document the quality of the manual differential stain each day of use. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on observation of laboratory procedures, review of laboratory records and interview with the laboratory manager, the laboratory failed to develop a procedure to monitor, evaluate and define acceptable limits for white blood cell counts (WBC) using two different methodologies two times a year. Findings: 1. Observation of the laboratory revealed a Sysmex X1000i for performing automatic WBC differentials and an area for staining, counting and performing WBC manual differentials. 2. Review of the proficiency results showed a lack of enrollment for the secondary method for WBC manual differentials. Review of the laboratory records revealed a lack of documentation to define and evaluate the relationship between automatic and manual WBC differentials two times a year. 3. Interview with the laboratory manager on August 11, 2021 at 11:30 AM, confirmed testing personnel perform manual differentials. Interview also confirmed the laboratory is not enrolled in proficiency testing for manual WBC differentials and failed to define a relationship between the primary method of automatic differentials and the secondary method of manual WBC differential counts two times a year. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of personnel records, the laboratory's policy "Responsibilities of Laboratory Medical Director", competency evaluations, quality control (QC) records and interview with the laboratory manager, the laboratory director (LD) failed to -- 6 of 10 -- delegate the responsibilities of the technical consultant to personnel meeting the qualifications of technical consultant from April 2019 to May 2021. Findings: 1. Review of personnel records showed that the laboratory did not have a qualified technical consultant on staff from April 2019 to May 2021. 2. Review of the policy "Responsibilities of Laboratory Medical Director" states "Personnel- Ensure that there are sufficient qualified personnel with adequate documented training and experience to meet the needs of the laboratory." 3. Review of competency evaluations showed the laboratory failed to have a qualified technical consultant perform competency evaluations for nine of eleven testing personnel in 2019, 2020 and to May 2021. 4. Review of QC records showed the the laboratory failed to have a qualified technical consultant to review, monitor, and address QC problems from April 2019 to May 2021. 5. Interview with the laboratory manager on August 11, 2021 at 10:30 AM confirmed the laboratory director (LD) failed to delegate the responsibilities of the technical consultant to personnel meeting the qualifications of technical consultant from April 2019 to May 2021. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy "Responsibilities of Laboratory Medical Director", and interview with the laboratory manager, the laboratory director failed to specify, in writing, the responsibilities and duties of the technical consultant engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing and failed to specifically delegate to qualified staff the competency evaluation responsibility. Findings: 1. Review of the laboratory's policy "Responsibilities of Laboratory Medical Director" showed that there was no delegation of competency evaluation to the technical consultants. 2. Interview with the laboratory manager on August 11, 2021 at 10:00 A.M. confirmed that the laboratory director failed to specifically delegate to qualified staff the competency evaluation responsibility. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on review of personnel records and interview with the laboratory manager, the -- 7 of 10 -- laboratory did not have academic credentials required to qualify one of two technical consultants that provides technical oversight for moderate complexity testing. (Refer to D6035) D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) 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; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on review of personnel records and interview with the laboratory manager, the laboratory failed to have documentation of academic credentials to qualify one of two technical consultants that provide technical oversight for moderate complexity testing from April 2019 to date August 11, 2021. Findings: 1. Review of the personnel records for technical consultant #1 showed no academic credentials to qualify the technical consultant. 2. Interview with the laboratory manager on August 11, 2021 at 10:30 AM confirmed, the laboratory failed to have the required documentation to qualify technical consultant #1. D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 -- 8 of 10 -- The technical consultant is responsible for the technical and scientific oversight of the laboratory. This STANDARD is not met as evidenced by: Based on review of the "Form CMS-209" and interview with the laboratory manager, the laboratory failed to ensure a technical consultant (TC) was responsible for technical and scientific oversight of the laboratory for 21 of 26 months. Findings: 1. Review of the "CMS-209" showed no qualified TC from April 2019 to May 2021. 2. Interview with the laboratory manager on August 11, 2021 at 11:30 AM confirmed the laboratory failed to ensure a TC was responsible for the technical and scientific oversight of the laboratory. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on review of "Quality Control" procedure, Tosoh AIA 900 quality control (QC), Tosoh AIA 900 Unity peer review, Dimension EXL Unity peer review, and interview with the laboratory manager, the technical consultant (TC) failed to ensure acceptable levels of analytic performance were maintained. Findings: 1. Review of "Quality Control" procedure states "All quality control records should be reviewed and assessed at least monthly by the appropriate personnel". 2. Review of Tosoh AIA 900 QC showed vitamin B12 QC level 1 was not within acceptable limits for 14 days in 2021, 277 patient test results were reported with no documentation of TC review. 3. Review of Tosoh AIA 900 Unity peer review showed no documentation of TC review for: November 2020 Unity report stated ferritin level 1 and level 3 "Warning: Acceptable values are above -2 below 2". December 2020 Unity report stated ferritin level 1 and level 3 "Warning : Acceptable values are above -2 below 2". December 2020 Unity report stated vitamin B12 level 3 "Data exclusion lab CV=65.46%. Acceptable values are 0-23%". 4. Review of Siemens Dimension EXL Unity peer review showed no documentation of TC review for: November 2020 Unity report stated creatinine level 3 "Warning: Acceptable values are above -2 and below 2". June 2021 Unity report stated "ALT level 3 Data exclusion: Lab CV=18.55%. Acceptable values are 0 to 18%". 5. Interview with the laboratory manager on August 11, 2021 at 11:30 AM confirmed the TC failed to ensure acceptable levels of analytic performance were maintained. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. -- 9 of 10 -- This CONDITION is not met as evidenced by: Based on review of personnel records, and interview with the laboratory manager, the laboratory failed to provide academic qualifications required to perform moderate complexity testing for two of eleven testing personnel. (Refer to D6065) D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy 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; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of academic credentials and interview with the laboratory manager, the laboratory failed to provide academic credentials to qualify two of eleven testing personnel (TP). Findings: 1. The laboratory could not provide academic credentials to show TP #6 and TP #9 were qualified to perform moderate complexity testing. 2. Interview with the laboratory manager on August 11, 2021 at 10:00 AM confirmed the laboratory failed to provide academic credentials for two TP. -- 10 of 10 --

Summary Statement of Deficiencies 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 Alere D-dimer procedure, D-dimer quality control (QC) logs and interview with the technical supervisor the laboratory failed to follow procedure and perform D-dimer QC one month in the last twelve months. Findings: 1. Review of Alere D-dimer procedure states "external QC is ran once every 30 days or with each new lot". 2. Review of D-dimer QC showed no QC was performed in the month of October 2018. 3. Interview with the technical supervisor on November 7, 2018 at 10: 30 AM confirms the laboratory failed to follow D-dimer procedure. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. 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 -- This STANDARD is not met as evidenced by: Based on observation of the blood bank multi-setting pipettor, lack of function check documentation and interview with the technical supervisor, the laboratory failed to define a function check protocol to ensure accurate performance of the pipettor. Findings: 1. Observation of the multi-setting blood bank pipettor showed it delivers 12.5, 25 and 50 microliters of fluid volume. The laboratory did not have documentation to show the laboratory verified the pipettor delivered the appropriate volumes. The laboratory did not have a written function check protocol to verify acceptable performance of the multi-setting blood bank pipettor. 2. Interview with the technical supervisor on November 7, 2018 at 11:30 AM confirmed the laboratory failed to verify accurate performance of the blood bank pipettor. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control (QC) documents for bacteriology and interview with the technical supervisor the laboratory failed to check each batch of blood agar, MacConkey agar, chocolate agar and blood culture media for its ability to support growth and as appropriate, select or inhibit specific organisms for 2017 to date. Findings: 1. Review of QC logs showed the laboratory failed to check each batch of blood agar, MacConkey agar, chocolate agar and blood culture media for its ability to support growth and as appropriate, select or inhibit specific organisms. 2. Interview with the technical supervisor on November 7, 2018 at 10:30 AM confirmed the laboratory failed to check each batch of blood agar, MacConkey agar, chocolate agar and blood culture media for its ability to support growth and as appropriate, select or inhibit specific organisms. 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: Based on review of quality control (QC) and patient records for 2018, QC procedures and interview with the technical supervisor, the laboratory failed to ensure results of control materials meet the laboratory's limits of acceptability before reporting patient results. QC records for the ALT analyte showed level three QC material failed to meet acceptable criteria for 35 of 39 test runs during October / November 2018. Findings: 1. Review of QC records showed the laboratory established acceptable limits for ALT -- 2 of 3 -- of 192-251 U/L for lot number 45773 and entered the acceptable limits into the chemistry analyzer QC files. Instrument printouts from the chemistry analyzer revealed the QC for ALT level three, lot number 45773 failed to meet the laboratory's criteria for acceptability for 35 QC runs from October 2, 2018 through November 7, 2018. The printouts revealed the failed QC results obtained were less than 192 U/L (minimal acceptable value) and flagged as out of range for the 35 QC runs. 2. Review of QC procedures revealed the laboratory did not review, accept or reject QC results directly from the analyzer. The QC data is transmitted from the analyzer to the laboratory information system (LIS) for review by testing personnel and periodic review by the technical supervisor. The laboratory accepts or rejects all QC results from the LIS. Review of the QC graphs from the LIS showed acceptable limits stated in the LIS for QC level three lot number 45773 differed from those established by the laboratory. The QC limits (164-280 U/L) stated in the LIS exceeded those established by the laboratory and did not flag the QC results as unacceptable or "out of range." 3. Patient records retrieved by the technical supervisor showed the laboratory reported 1720 patient ALT results from October 2, 2018 through November 7, 2018. 4. Interview on November 4, 2018 at 11:30 AM, the technical supervisor said the QC ALT limits for lot number 45773 stated in the LIS differed from those established by the laboratory and were incorrect. Interview confirmed the results of QC level three for the ALT analyte failed to meet the laboratory's criteria for acceptability before reporting patient results D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of patient test reports, approved laboratory procedure manual and interview with the technical supervisor, the laboratory failed to ensure pertinent patient normal were available for interpretation. Findings: 1. The differences between normal values on patient test reports and those included in the approved procedure manual are as follows: Normal values included on patient test reports: Triglyceride (0- 150 mg/dl) Iron (50-170 ug/dl) Ferritin (15-200 ng/ml) Creatine Kinase (26-192 U/L) CK-MB (0.-3.6 ng/ml) Troponin I (0.00-0.06 ng/ml) Vitamin D (10.8-54.7 ng/ml) Normal values included in the procedure manuals approved by the laboratory director: Triglyceride (0.0-200.0 mg/dl) Iron (65.0-175 ug/dl) Ferritin (22.0-415.0 ng/dl) Creatine Kinase (39-308 U/L) CK-MB (0.5-3.6 ng/ml) Troponin I (0.02-0.10 ) Vitamin D (10.8-54.8 ng/ml) 2. Interview with the technical supervisor on November 7, 2018 at 11:30 AM confirmed the normal values stated in the approved laboratory procedure manual differed from those included on the test reports. -- 3 of 3 --