Marshfield Medical Center-Neillsville

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 D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) records and interview with the general supervisor, the laboratory did not retain immunohematology PT records for the second event in 2020. Findings include: 1. Review of WSLH PT records for 2020 showed no evidence of testing records, signed attestation statements, PT result scores from the provider, documentation of result review and investigation for all immunohematology scores of 80% for the second event in 2020. 2. Interview with the general supervisor on February 23, 2022 at 11:45 AM confirmed the laboratory did not have immunohematology PT testing records, documentation of results review and investigation for scores of 80% for the second event in 2020. D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. This STANDARD is not met as evidenced by: Based on surveyor review of blood culture reports and interview with the general supervisor, the laboratory did not retain any preliminary test results from the culture, including the gram stain result. Findings include: 1. Review of the test report for 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 -- patient 1 showed the laboratory referred an isolate from a positive blood culture, collected on February 11, 2022 at this facility, to a reference laboratory for identification and susceptibility testing on February 13, 2022. The report showed testing personnel, staff A, called a critical test result on February 13, 2022 at 3:58 AM but the report did not identify the test performed at this laboratory or the reported result. 2. Interview with the general supervisor on February 23, 2022 at 1:35 PM revealed testing personnel perform and report a gram stain when a blood culture is positive. Further interview confirmed the report for patient 1 did not identify the test or the results called by staff A on February 13, 2022 at 3:58 AM and the system does not retain preliminary reports. This is a repeat deficiency from January 30, 2020. 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 surveyor observation of laboratory equipment, review of laboratory procedures and training and competency evaluations and interview with the general supervisor, the laboratory did not follow their written policies for training and competency evaluation for two analyzers on four of four current staff members. Findings include: 1. Observation of laboratory equipment on February 23, 2022 at 8: 40 AM revealed two new analyzers: a. Beckman Coulter DxH520 back up hematology analyzer b. Werfen GEM Premier 4000 blood gas analyzer 2. Review of the "Competency Assessment of Testing Personnel" procedure stated "Newly hired personnel or current staff member who is learning a procedure for the first time must demonstrate competency in accordance to the following schedule": a. "Initial training and competency must be documented prior to reporting of any patient results." b. "Six months following the initial competency assessment." 3. Review of training and competency evaluation records showed no evidence of initial training and competency for the DxH 520 backup hematology analyzer for four of four current staff members. Further review showed no evidence of six month competency for the GEM Premier 4000 blood gas analyzer for four of four current staff members. 4. Interview with the general supervisor on February 23, 2022 at 11:00 AM confirmed the laboratory did not follow their written policies for training and competency evaluation for two analyzers on four of four current staff members. This is a repeat deficiency from January 9, 2014 and January 30, 2020. 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 surveyor review of Wisconsin State Laboratory of Hygiene (WSLH) -- 2 of 7 -- proficiency testing (PT) records and interview with the general supervisor, the laboratory did not evaluate the accuracy for "Not scored-insufficient peer group" for twenty-five of thirty mean platelet volume (MPV) results and twenty-five of thirty nucleated red blood cell (NRBC) results in 2020 and 2021. Findings include: 1. Review of WSLH PT records showed the laboratory did not evaluate the accuracy of the following PT results in 2020 and 2021. a. 2020-HemeReg1: Five of five "Not scored-insufficient peer group" "MPV" results and five of five "Not scored- insufficient peer group" "NRBC" results. b. 2020-HemeReg2: Five of five "Not scored-insufficient peer group" "MPV" results and five of five "Not scored- insufficient peer group" "NRBC" results. c. 2020-HemeReg3: Five of five "Not scored-insufficient peer group" "MPV" results and five of five "Not scored- insufficient peer group" "NRBC" results. d. 2021-HemeReg1: Five of five "Not scored-insufficient peer group" "MPV" results and five of five "Not scored- insufficient peer group" "NRBC" results. e. 2021-HemeReg3: Five of five "Not scored-insufficient peer group" "MPV" results and five of five "Not scored- insufficient peer group" "NRBC" results. Further review showed the laboratory did evaluate the accuracy for five of five "Not scored-insufficient peer group" "MPV" results and five of five "Not scored-insufficient peer group" "NRBC" results for 2021- HemeReg2. 2. Interview with the general supervisor on February 23, 2022 at 10:10 AM confirmed the laboratory did not evaluate the accuracy for "Not scored- insufficient peer group" for twenty-five of thirty mean platelet volume (MPV) results and twenty-five of thirty nucleated red blood cell (NRBC) results in 2020 and 2021. 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 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 surveyor observation of the chemistry freezer, review of the manufacturer's requirements and chemistry freezer temperature log, and interview with the general supervisor, the laboratory did not define an acceptable temperature range that was consistent with the manufacturer's acceptable range for the MAS Diabetes quality control material stored in the freezer. Findings include: 1. Review of the manufacturer's package reqrirements for the MAS Diabetes quality control showed the manufacturer's required storage at -15 to -25 Celsius (C). 2. Observation of MAS Diabetes quality control in the chemistry freezer on February 23, 2022 at 3:22 PM showed the manufacturer required storage at -15 to -25 Celsius (C). 3. Review of the temperature logs for December 2021 and January 2022 showed the defined acceptable temperature range for the chemistry freezer was -20 to -35 C. Forty-four of forty-nine days showed recorded temperatures were colder than -25 C. 4. Interview with the general supervisor on February 23, 2022 at 3:27 PM confirmed the laboratory's acceptable range for the chemistry freezer was not consistent with the manufacturer's acceptable range for the MAS Diabetes quality control material stored. This is a repeat deficiency from January 30, 2020. -- 3 of 7 -- 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. This STANDARD is not met as evidenced by: Based on surveyor observation of microbiology culture media and interview with the general supervisor, the laboratory had sixteen of sixteen expired macconkey agar plates available for use for patient testing in the laboratory. Findings include: 1. Observation of the microbiology culture set up area on February 23, 2022 at 1:50 PM revealed five of five macconkey agar plates had expired on February 16, 2022. Further observation in the microbiology refrigerator revealed ten of ten macconkey agar plates had expired on February 16, 2022. There were no unexpired macconkey agar plates in the laboratory. 2. Observation of the microbiology incubator on February 23, 2022 at 1:52 PM revealed a blood culture proficiency test culture set up on a macconkey agar plate which expired on February 16, 2022. 3. Interview with the general supervisor on February 23, 2022 at 1:52 PM confirmed sixteen of sixteen macconkey agar plates expired on February 16, 2022 and were available for patient testing in the laboratory. This is a repeat deficiency from February 24, 2010. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on surveyor review of calibration verification records and interview with the general supervisor, the laboratory did not perform calibration verification every six months for two analytes on the Siemens Dimension EXL chemistry analyzer in 2021. Finding include: 1. Review of calibration verification records showed calibration verification performed on the following analytes: a. Calcium: October 2020 and June -- 4 of 7 -- 2021. Further review showed no additional documentation of calibration verification between those dates. b. Triglyceride: October 2020 and March 2021. Further review showed no additional documentation of calibration verification between those dates. 2. Interview with the general supervisor on February 24, 2022 at 9:00 AM confirmed the laboratory did not perform calibration verification every six month for two analytes on the Siemens Dimension EXL chemistry analyzer in 2021. This is a repeat deficiency from November 4, 2011 and January 30, 2022. 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 surveyor review of laboratory records and interview with the general supervisor, the laboratory had not evaluated and defined the relationship between test systems from three of three primary and backup analyzers on a twice a year basis. Findings include: 1. Review of laboratory records showed no evidence of evaluation of the relationship between test systems for the following: a. Coagulation analyzers: Siemens CA660 and CA620 both perform protime and partial thromboplastin time (PTT) testing. b. Hematology analyzers: Beckman Coulter DxH600 and DxH520 both perform complete blood count (CBC) testing. c. Blood gas analyzers: Werfen GEM Premier 4000 and Abbott I-Stat analyzers both perform arterial blood gas (ABG) testing. 2. Interview with the general supervisor on February 24, 2022 at 10:35 AM confirmed the laboratory had not evaluated and defined the relationship between the test systems from three of three primary and backup analyzers on a twice a year basis. 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 surveyor review of quality control (QC) procedures and interview with the general supervisor, the technical consultant did not review and evaluate the microbiology QC program to ensure the program was maintained to assure acceptable levels of test performance. Findings include: 1. Review of gram stain QC records showed no evidence of technical consultant review of the weekly gram stain QC from May 25, 2021 through February 22, 2022. Further review showed QC was not performed for nine of forty weeks during that timeframe. 2. Review of blood culture media QC records showed no evidence of technical consultant review of the new lot blood culture media QC from March 4, 2021 through January 22, 2022. 3. Interview with the general supervisor on February 23, 2022 at 1:38 PM confirmed the technical -- 5 of 7 -- consultant did not review and evaluate the microbiology QC program to ensure the program was maintained to assure acceptable levels of test performance. D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Item 1: Based on surveyor review of laboratory procedures, quality control (QC) records and interview with the general supervisor, testing personnel did not perform and document quality control for the gram stain test weekly according to the procedure for nine of forty weeks between May 25, 2021 and February 22, 2022. Findings include: 1. Review of the "Gram Stain-Regional Center Labs" procedure revealed "QC is performed weekly and on each new lot or shipment in accordance with the current CLSI standards". 2. Review of the "Weekly Gram Stain Quality Control-Regional Center" log from May 25, 2021 through February 22, 2022 showed no documentation of gram stain QC for nine of forty weeks. 3. Interview with the general supervisor on February 23, 2022 at 1:38 PM confirmed testing personnel did not perform and document quality control for the gram stain test weekly according to the procedure for nine of forty weeks between May 25, 2021 and February 22, 2022. Item 2: Based on surveyor review of the Cepheid Gene Xpert Individualized Quality Control Plan (IQCP), quality control (QC) logs and patient records and interview with the general supervisor, testing personnel did not perform and document quality control per the IQCP plan for two analytes performed on the Cepheid Gene Xpert analyzer. Findings include: 1. Review of the Cepheid Gene Xpert IQCP for Streptococcus A (Strep A) and Chlamydia trachomatis/Neisseria gonorrhea (CT/NG) tests QC is to be performed every 30 days and with each new lot or shipment. 2. Review of the Cepheid Gene Xpert QC logs showed: a. Strep A QC performed June 11, 2021 and July 26, 2021 with no documentation of additional QC run between those dates. b. CT /NG QC performed July 28, 2021 and September 9, 2021 with no documentation of additional QC run between those dates. c. CT/NG QC performed November 10, 2021 and December 31, 2021 with no documentation of additional QC run between those dates. 3. Review of patient records showed: a. Strep A testing on fourteen patients was performed between July 11, 2021 and July 26, 2021. b. CT/NG testing on two patients was performed between August 28, 2021 and September 9, 2021. c. CT/NG testing on two patients was performed between December 10, 2021 and December 31, 2021. 4. Interview with the general supervisor on February 23, 2022 at 3:05 PM confirmed testing personnel did not perform and document quality control per the IQCP plan for two analytes performed on the Cepheid Gene Xpert analyzer. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: -- 6 of 7 -- Based on surveyor review of previous cited deficiencies and plans of correction, the laboratory director has not provided overall management and direction in accordance with 143.1455 of this subpart. Findings include: 1.

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on surveyor review of proficiency test (PT) records and interview with the general supervisor, the laboratory director or a qualified designee did not attest to the routine integration of the immunohematology PT samples into the patient workload using the laboratory's routine methods for six of six immunohematology events in 2018 and 2019. Findings include: 1. Review of American Proficiency Institute (API) immunohematology PT records showed the laboratory director, who is the immunohematology technical supervisor, did not sign six of six immunohematology attestation statements in 2018 and 2019. 2. Interview with the general supervisor on January 29, 2020 at 3:39 PM confirmed the laboratory director or a qualified designee did not sign the immunohematology attestation statements in 2018 and 2019. This is a repeat deficiency previously cited on November 11, 2015 and February 24, 2010. 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 surveyor observation of the microbiology refrigerator, review of quality Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- control (QC) records and interview with the general supervisor, the laboratory did not retain quality control and expiration date of the Optochin (P) discs used for patient testing since February 14, 2019. Findings include: 1. Observation of the microbiology refrigerator on January 29, 2020 at 2:00 PM revealed a vial of P discs used for patient testing, Lot# 6309912, opened February 14, 2019. Further observation revealed the expiration date was not readable on the vial. 2. Review of quality control records revealed no documentation of QC retained on the current vial, Lot 6309912, opened February 14, 2019. 3. Interview with the general supervisor on January 29, 2020 at 2: 10 PM confirmed the laboratory had no documentation of the expiration date for the vial of P discs. Further interview confirmed documentation of QC was not available. This is a repeat deficiency previous cited on January 23, 2008. D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. This STANDARD is not met as evidenced by: Based on surveyor review of a blood culture report and interview with the general supervisor, the laboratory did not retain any preliminary test results from the culture, including a reported gram stain result. Findings include: 1. Review of the test report for patient one showed the laboratory referred an isolate from a positive blood culture, collected on November 19, 2019 at this facility, to another laboratory for identification and susceptibility testing on November 20, 2019 at 8:58 AM. The report showed testing personnel staff A called a critical test result on November 20, 2019 at 9:11 AM but the report did not identify the test performed at his laboratory or the reported result. 2. Interview with the general supervisor on January 29, 2020 at 12:15 PM revealed testing personnel perform and report a gram stain when a blood culture is positive. Further interview confirmed the report for patient one did not identify the test or the result called by staff A on November 20, 2019 at 9:11 AM. The general supervisor also stated the information system does not retain preliminary reports. 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 surveyor review of laboratory procedures and competence evaluation records and interview with the general supervisor, the laboratory did not follow their written policies for training and competence evaluation for one of one new testing personnel. Findings include: 1. The laboratory's procedure "Competency Assessment of Testing Personnel" stated, "Initial training and competency must be documented prior to the reporting of any patient results" and "Whenever a new test method is added or an existing procedure is modified substantially, all testing personnel must demonstrate competency in performing the new (or altered) test procedure." 2. -- 2 of 8 -- Review of training and competence evaluation records for testing personnel staff B showed no evidence of initial training and competency for the hematology analyzer (UniCel DxH 600), or three chemistry analyzers (Dimension EXL 200, MedtoxScan Profile-V, and STAT-Site M Beta-Hydroxybutyrate Analyzer). 3. Interview with the general supervisor on January 29, 2020 at 8:45 AM confirmed records were not available to show the laboratory trained and evaluated competence of staff B for the MedtoxScan Profile-V or for the new UniCel DxH 600, Dimension EXL, or the STAT-Site M Beta-Hydroxybutyrate Analyzer. This is a repeat deficiency previously cited on January 9, 2014. 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)