Gifford Medical Center

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 record review, the laboratory (lab) failed to achieve satisfactory performance for Prothrombin Time in two out of the three proficiency testing events in 2025 resulting in unsuccessful participation. Findings include: 1. The lab failed to attain satisfactory scores for Prothrombin time in Events 1 and 3 of 2025. Refer to D2121. 2. The lab's unsatisfactory Prothrombin Time proficiency scores in two of the last three events in 2025 resulted in unsuccessful participation. Refer to D2130. D2121 HEMATOLOGY CFR(s): 493.851(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review, the laboratory (lab) failed to obtain at least an 80% score for Prothrombin Time proficiency testing in 2025 events 1 and 3 resulting in unsatisfactory analyte performance. Findings include: 1. Review on 11/3/2025 of CASPER Report 0155D revealed the lab attained the following proficiency testing scores through the College of American Pathologist (CAP) for Prothrombin Time: 2025 Event 1 = 60% 2025 Event 3 = 60% 2. Review on 11/3/2025 of lab's proficiency testing evaluations for CAP events CGL-A 2025 (2025 Event 1) and CAP CGL-C 2025 (2025 Event 3) confirmed the lab attained a 60% score for Prothrombin Time in both 2025 Events 1 and 3. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on record review, the laboratory (lab) failed to achieve satisfactory performance for Prothrombin Time in two out of the last three proficiency testing events in 2025, resulting in unsuccessful performance. Findings include: 1. Review on 11/3/2025 of CASPER Report 0155D revealed the lab achieved unsatisfactory proficiency testing performance for Prothrombin Time in 2025 Events 1 and 3. Refer to D2121. 2. Review on 11/3/2025 of lab's proficiency testing evaluations for CAP events CGL-A 2025 (2025 Event 1) and CAP CGL-C 2025 (2025 Event 3) confirmed the lab's unsatisfactory proficiency testing scores for Prothrombin Time in 2025 Events 1 and 3. Refer to D2121. -- 2 of 2 --

Summary Statement of Deficiencies D5425 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(3) (b)(3) The laboratory must determine the test system's calibration procedures and control procedures based upon the performance specifications verified or established under paragraph (b)(1) or (b)(2) of this section. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory (lab) failed to demonstrate test systems used for bacteriology, mycology, parasitology, and virology testing are stabile and support the quality control plan (QCP) to perform quality control (QC) monthly. Findings include: 1. Review on 7/3/2025 of the lab's QCPs, signed by the Lab Director on 7/1/2025, for Chlamydia trachomatis and Neisseria gonorrhoeae (CT /NG) and for multiplex vaginal panel (MVP; includes bacterial vaginosis, Candida group, Candida glabrata, Candida krusei, and Trichomonas vaginalis) revealed instruction to perform QC using two levels of controls for each new lot number and shipment and monthly. 2. Review on 7/3/2025 of the lab's individualized quality control plan (IQCP) risk assessments for CT/NG and MVP revealed the lab performed in house quality control (QC) testing over the course of 32 days (4/16/2025 through 5 /17/2025) using two different lot numbers (lots 43312 and 43605) of test cartridges for CT/NG and two different lot numbers (lots 03801 and 03807) of test cartridges for MVP. Further review revealed the lab demonstrated CT/NG lot 43312 was stabile for 13 days, and CT/NG lot 43605 was stabile for 18 days through it's in-house QC testing. No CT/NG QC data was provided for 4/29/2025. The lab's in-house QC testing for MVP revealed the lab demonstrated both lots 03801 and 03807 was stabile for 16 days each. There was no data to demonstrate a lot number of CT/NG or MVP test cartridges can be stabile for 31 days. 3. Interview by electronic mail on 7/3/2025 with the Technical Supervisor confirmed the lab used two different lot numbers 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 2 -- both CT/NG and MVP risk assessment QC studies and did not obtain in-house QC data that demonstrates a single lot number of CT/NG and MVP test cartridges were tested for 31 days to support the QCP to perform QC monthly. -- 2 of 2 --

Summary Statement of Deficiencies D5309 TEST REQUEST CFR(s): 493.1241(e) (e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory (lab) failed to ensure the collection time is transcribed accurately for 3 of 3 test requisitions reviewed from 2025. Findings include: 1. Review on 3/26/2025 of 3 paper test requisitions for specimens revealed 3 of 3 collection times documented on the test requisitions had been entered incorrectly by lab personnel during order entry and receipt into the lab information system. Patient #1's collection date and time on the test requisition was 3 /20/25 at 10:30 a.m. and had been entered by the lab as 3/20/25 at 12:27 p.m.; Patient #2's collection date and time on the test requisition was 3/25/25 at 06:15 a.m. and had been entered by the lab as 3/25/25 at 07:44 a.m.; and Patient #3's collection date and time on the test requisition was 3/25/25 at 07:00 a.m. and had been entered by the lab as 3/25/25 at 07:46 a.m. 2. Interview on 3/26/2025 at 9:20 a.m. with the Technical Supervisor confirmed the correct collection times listed above had been entered by lab personnel incorrectly. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) 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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493. 1261 through 493.1278. (d)(2) For each test system, perform control procedures using 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 -- the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory (lab) failed to develop an individualized quality control plan (IQCP) to bacteriology, mycology, parasitology and virology conduct control testing less frequent than 2 levels each day of patient testing in 2024 and 2025. Findings include: 1. Review on 3/25/2025 of verification of performance specifications revealed new test systems for Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) and for multiplex vaginal panel (MVP; includes bacterial vaginosis, Candida group, Candida glabrata, Candida krusei, and Trichomonas vaginalis) was both completed in August 2024. 2. Interview on 3/25 /2025 at 2:10 p.m. with the Technical Supervisor revealed control testing was performed for each new lot or shipment and monthly and the lab did not develop an IQCP for the CT/NG and MVP for alternative control test frequency. 3. Review on 3 /26/2025 of control records for CT/NG and MVP confirmed control testing had been performed for each new lot or shipment and every month. 4. Review on 3/26/2025 of the lab's test list revealed the test volumes for analytes in CT/NG and MVP are 1,100 and 1,500 respectively. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review and staff interview, the Technical Supervisors failed to ensure competency assessments were performed semiannually in the first year for 3 of 3 new testing personnel in 2023 and 2024. Findings include: 1. Review on 3/25/2025 of personnel form CMS-209 revealed 6 new testing personnel performing high complexity testing. 2. Review on 3/25/2025 of personnel records for revealed 3 (TP1, TP2, TP3) of the 6 new testing personnel had performed testing for at least 1 year. Review of the competency assessments for these 3 testing personnel revealed the following: TP1 started in April 2023 and had no documentation of any competency assessments in 2023 and 2024; TP2 was employed from August 2023 to December 2024 and had 1 competency assessment done in December 2024; TP3 started 11/6 /2023 and had no semi annual competency assessment. 3. Interview on 3/25/2025 at 11:10 a.m. with the Technical Consultants confirmed the above findings. -- 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 record review and staff interview, the laboratory failed to successfully participate in a proficiency testing program for blood gas hydrogen concentration (pH), partial pressure of carbon dioxide (pCO2) and partial pressure of oxygen (pO2) analytes for events 2 and 3 in 2023. Refer to D2093 and D2096. D2093 ROUTINE CHEMISTRY CFR(s): 493.841(d) Failure to return proficiency testing results to the proficiency testing program within 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 -- the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory (lab) failed to return blood gas hydrogen concentration (pH), partial pressure of carbon dioxide (pCO2) and partial pressure of oxygen (pO2) proficiency testing results to the Wisconsin State Laboratory for Hygiene (WSLH) before the due date for events 2 and 3 in 2023 resulting in unsatisfactory performance for both events. Findings include: 1. Review on 1/5/2024 of CASPER Report 0155D for the lab revealed it obtained 0% scores for pH, pCO2, and pO2 for WSLH events 2 and 3 in 2023. 2. Interview on 1/5/2024 at 8: 45 a.m. with the Technical Supervisor confirmed the above scores and revealed the lab did not submit results to WSLH before the due date for each of those events. 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 record review and staff interview, the laboratory (lab) failed to achieve satisfactory performance for blood gas hydrogen concentration (pH), partial pressure of carbon dioxide (pCO2) and partial pressure of oxygen (pO2) in two out of three proficiency testing events in 2023 resulting in unsuccessful performance. Findings include: 1. The laboratory obtained 0% scores for blood gas pH, pCO2 and pO2 in proficiency testing events 2 and 3 of 2023 resulting in two consecutive events with unsuccessful participation for these analytes. Refer to D2093. 2. Interview on 1/5 /2024 at 8:45 a.m. with the Technical Supervisor confirmed the above finding. -- 2 of 2 --

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 record review, observation, and staff interview, the laboratory (lab) failed to perform quality control (QC) testing following written procedures for Bacteriology, Virology, Hematology, and Routine Chemistry testing in 2023. Findings include: 1. Review on 3/16/2023 of the lab's Quality Control Plan for the Biofire Filmarray System (Biofire) revealed QC was to be performed on each new lot/shipment of test panel kits and monthly. Test panel kits used on the Biofire include blood culture identification panel (BCID2), gastrointestinal (GI) panel, and a respiratory panel. 2. Observation on 3/16/2023 at approximately 3:00 p.m. of the lab's Biofire instrument and testing area revealed two opened lots of BCID2 panels, lot# 2GZE22 and lot# 2M1222. 3. Review on 3/16/2023 of BCID2 QC records from January 2023 to March 2023 revealed monthly QC had been performed for lot# 2GZE22 on January 21, 2023 and monthly QC had been performed for lot# 2M1222 on February 21, 2023. There were no records that QC was performed for lot# 2M1222 prior to being put into use. Review of GI QC records on 3/16/2023 from January 2023 to March 2023 revealed monthly QC had been performed for three lots, lot# 2MUY22, lot# 2KSR22, and lot# 2QTT23. QC had been performed for lot# 2MUY22 on January 23, 2023 and was labeled as monthly and lot QC. Monthly QC had been performed for lot# SKSR22 on February 12, 2023, and for lot# 2QTTT23 on March 10, 2023. The lab could not provide documentation that QC was performed for lot# 2KSR22, and lot# 2QTT23 before being put into use. 4. Interview with the Technical Supervisor on 3/16/2023 at 3:20 p.m. confirmed the above findings. 5. Review on 3/17/2023 of the lab's 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 2 -- Control Plan for the Cepheid GeneXpert Test System (Cepheid) revealed instruction to perform external QC for each new lot or shipment and monthly. The Cepheid is used to perform testing to identify Sars-CoV-2, Influenza A and B, and Respiratory Syncitial Virus (collectively referred to as the multiplex respiratory panel by the manufacturer when included in the same test cartridge). 6. Review on 3/16/2023 of QC records from January 2023 to March 2023 revealed QC for the current multiplex respiratory panel lot# 1000613575 was performed on January 13, 2023. There was no record of monthly QC for lot# 1000613575 after January 13, 2023 and the lot was still in use. There was no documentation of monthly QC for Sars-CoV-2 test lot# 10005455146 currently in use. 7. Interview with the Technical Supervisor on 3/16 /2023 at 2:30 p.m. confirmed QC had not been performed monthly on the Cepheid instrument. 8. Review on 3/16/2023 of the lab's policy titled "Quality Control - General" revealed the lab's acceptable QC ranges for Prothrombin Time (PT), activated Partial Thromboplastin Time (aPTT), Fibrinogen (Fib), and Troponin were the manufacturer's assayed ranges. 9. Review on 3/16/2023 of the manufacturer's package inserts for PT, aPTT and Fibrinogen QC material revealed the manufacturer's ranges for Level 1 normal control (lot# N0925618) was PT = 9.8 - 13.8 seconds, aPTT = 24.1 - 32.1 seconds, Fib = 238 - 358 mg/dL. The manufacturer's ranges for Level 3 abnormal control (lot# N0925458) was: PT = 30.6 to 45.8 seconds, and aPTT = 49.3 - 66.7 seconds (Fib not tested with Level 3). 10. Review on 3/16/2023 of the lab's Coagulation QC revealed the acceptable ranges for Level 1 normal control (lot# N0925618) was: PT = 9.6 - 13.6 seconds, aPTT = 25.5 - 33.5 seconds, and Fib = 237 - 357 mg/dL and the ranges entered for Level 3 abnormal control (lot# N0925458) was: PT = 31 - 45.4 seconds, and aPTT = 49.0 - 67.0 seconds. Further review revealed the target values (means) entered into the instrument did not match the manufacturer's state target values which resulted in the ranges not matching the manufacturer's. 11. Interview with the Technical Supervisor on 3/16/2023 at 1:45 p.m. confirmed the manufacturer's stated values for the coagulation QC specified above had not been entered correctly. 12. Review on 3/16/2023 of the manufacturer's package insert for the current Troponin QC lot# 67680 revealed the following acceptable ranges: Level 2 = 3,974 - 7,671 pg/mL, and Level 3 = 11,844 - 22, 894 pg/mL. 13. Review on 3/16 /2023 of the Troponin QC ranges set for 1 of 2 chemistry instruments (serial# ending in 616) revealed Level 2 set to 4,503 - 7,202 pg/mL and Level 3 set to 16,316 - 20,081 pg/mL. 14. Review on 3/16/2023 of the lab's QC lot change log revealed the current QC lot# 67680 was changed on 1/4/2023. 15. Interview with the Technical Supervisor on 3/16/2023 at 2:00 p.m. confirmed the manufacturer's ranges for the current Troponin QC had not been entered correctly on 1 of 2 chemistry instruments. -- 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 record review and staff interview, the laboratory failed to successully participate in proficiency testing for blood gas hydrogen concentration (pH) in 2021 and 2022. Refer to tags D2087 and D2096. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. 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 -- This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory (lab) failed to attain a proficiency testing (PT) score of at least 80% for blood gas hydrogen concentration (pH) in event 3 of 2021 and event 2 of 2022. Findings include: 1) Review on 10/4 /2022 of PT scores revealed the lab's pH score was 60% for WSLH PT event 3 in 2021 and 0% for WSLH PT event 2 in 2022. 2) Interview on 10/4/2022 at 12:40 p.m. via telephone with the Technical Supervisor confirmed the scores listed above. 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 record review and staff interview, the laboratory (lab) failed to achieve satisfactory performance in two out of three WSLH proficiency testing (PT) events for blood gas hydrogen concentration (pH) in 2021 and 2022, resulting in unsuccessful PT performance. Refer to D2089. -- 2 of 2 --

Summary Statement of Deficiencies D6117 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(4) The technical supervisor is responsible for 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 record review and staff interview, the Chemistry Technical Supervisor (TS) failed to ensure the established acceptable parameters of the quality control procedure are followed for testing performed on two Dimension EXL 200 analyzers in 2021. Findings include: 1) Review on 4/27/2021 of the laboratory's procedure titled "Quality Control General Chemistry and Special Chemistry" revealed on page 1 that assayed control materials are used for all analytes on the Dimension EXL 200. Further review on page 1 revealed acceptable criteria includes "Instructions for Technologist: ...2. One control reads within +/- 2 SD of established mean and the other control between 2-3 SD (only once, check previous QC records.)" 2) Interview on 4/27/2021 at approximately 12:30 p.m. with the Chemistry TS confirmed the laboratory uses the manufacturer's assayed control ranges and does not establish their own ranges to use the Westgard rule referenced in the control procedure when one control material is within 2 SD and the other is between 2-3 SD. 3) The laboratory could not provide literature references to support the control procedure or their current practices at the time of the survey. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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 record review and staff interview, the laboratory failed to establish and follow written policies and procedures to assess the competency of the Technical Supervisor (TS)/General Supervisor (GS) in 2017 and 2018. Findings include: 1) Review on 4/11/2019 of the laboratory's "Competency Assessment Program" procedure signed and dated by the laboratory director on 5/1/2017 revealed no policies and procedures to assess the TS/GS to ensure delegated and assigned responsibilities are met. 2) Interview on 4/11/2019 at 8:15 a.m. with the TS/GS confirmed the laboratory did not have policy and procedure in place to assess the competency of the TS/GS. D5543 HEMATOLOGY CFR(s): 493.1269(a)(d) (a) For manual cell counts performed using a hemocytometer-- (a)(1) One control material must be tested each 8 hours of operation; and (a)(2) Patient specimens and control materials must be tested in duplicate. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to perform testing using at least one control material every 8 hours for high complexity manual cell Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- counts in 2017, 2018, and 2019. Findings include: 1) Review on 4/11/2019 of two cerebral spinal fluid (CSF) manual cell counts performed February 2019 revealed no control testing documentation. 2) Review on 4/11/2019 of the laboratory's procedures "Cell Count on Body Fluids" dated 4/3/2013 and "Semen Analysis - Fertility" dated 12 /21/2017 revealed the laboratory used a hemocytometer for CSF and semen cell counts. The procedures failed to include instruction to perform manual cell counts using a control material. 3) Interview on 4/11/2019 at 11:25 a.m. with the Technical Supervisor and Staff A (testing personnel) confirmed the laboratory did not perform manual cell counts with a control material when performing manual cell counts on patient semen and CSF specimens. 4) The laboratory performed 5 semen analysis and approximately 10 CSF cell counts in 2018. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on record review and staff interview, the Technical Supervisor (TS) failed to ensure all staff performing blood gas and co-oximetry analysis were included in procedures for evaluation of competency in 2017 and 2018. Findings include: 1) Review on 4/11/2019 of personnel records revealed 5 of 5 testing personnel from the respiratory department failed to be evaluated for competency of blood gases (hydrogen concentration, partial pressure of oxygen and partial pressure of carbon dioxide) and co-oximetry (carboxyhemoglobin) analysis. 2) Interview on 4/11/2019 at 8:15 a.m. with the TS confirmed the 5 respiratory department personnel performed blood gas and co-oximetry analysis and these 5 testing personnel were not evaluated for competency for these test procedures. D6125 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on record review and staff interview, the Technical Supervisors (TS) failed to ensure competency assessments of testing personnel conducted in 2018 included assessment of test performance. Findings include: 1) Review on 4/10/2019 of proficiency testing (PT) records from 2018 revealed all PT specimens from each PT event was performed by one testing personnel. Assignments for each PT event were rotated amongst testing personnel. 2) Review on 4/10/2019 of personnel records and PT records revealed PT was the only method used for competency assessment of test performance for testing personnel in 2018. The following were not assessed for test performance of specific test systems/specialties: 10 of 13 testing personnel for -- 2 of 5 -- complete blood counts, 11 of 13 testing personnel for sperm counts, 10 of 13 testing personnel for immunohematology, 11 of 13 testing personnel for fetal fibronectin, 10 of 13 testing personnel for coagulation (protime, prothrombin time, and fibrinogen), 11 of 13 testing personnel for d-dimer, 11 of 13 testing personnel for mononucleosis, 10 of 13 for serum pregnancy, and 15 of 18 for blood gases and co-oximetry. Testing personnel who did not participate in a PT even for a given test system/specialty were not assessed for test performance through alternate methods (testing previously analyzed specimens or internal blind testing). 3) Interview on 4/10/2019 at 10:00 a.m. with the TS confirmed PT was the sole source for assessment of test performance and not all testing personnel participated in PT in 2018. 4) This is a repeat deficiency from the recertification survey completed on 4/4/2017. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review and staff interview, the Technical Supervisor (TS) failed to evaluate the competency of one of one new testing personnel performing hematology, chemistry and microbiology testing semiannually within the first year in 2018. Findings include: 1) Review on 4/10/2019 of personnel records revealed one new testing personnel (Staff B) hired in January of 2018 and completed training for hematology, chemistry and microbiology by April 2018. There was no documentation that Staff B was evaluated for competency for test procedures in hematology, chemistry or microbiology semiannually from April 2018 to April 2019. 2) Review on 4/10/2019 of the laboratory's "Competency Assessment Program" procedure signed and dated by the laboratory director on 5/1/2017 revealed new employees will complete competency assessments within the first six months from the first day of employment. 3) Interview on 4/10/2019 at 10:00 a.m. with the TS confirmed a semiannual competency assessment had not been performed within the first year for Staff B. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on record review and staff interview, the laboratory failed to ensure one of one new testing personnel performing high complexity testing in 2018 and 2019 met qualification requirements. Findings include: 1) Review on 4/10/19 of personnel records revealed one of one new testing personnel hired in January 2018 failed to include documentation of qualifications for high complexity testing. Refer to D6171. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) -- 3 of 5 -- (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. -- 4 of 5 -- This STANDARD is not met as evidenced by: Based on record review and staff interview, one of one new testing personnel failed to meet qualification requirements for performing high complexity testing in 2018 and 2019. Findings include: 1) Review on 4/10/2019 of personnel records revealed one of one new testing personnel (Staff B) hired in January 2018 obtained a Bachelor of Arts in "Communications Disorders." Further review of personnel records revealed Staff B was trained in all specialties of the laboratory including high complexity hematology, immunohematology and microbiology (gram stains and planting only). The laboratory failed to provide, at the time of survey, documentation of Staff B's qualifications for performing high complexity testing. Staff B completed training and began patient testing for hematology and microbiology by April 2018 and immunohematology by August 2018. 2) Interview on 4/10/2019 at 9:30 a.m. with the Technical Supervisor (TS) revealed Staff B had completed courses to sit for a medical technologist certification exam and was certified as a medical technologist through a nationally recognized organization. TS confirmed the laboratory did not obtain documentation of qualifications for Staff B to perform high complexity testing. -- 5 of 5 --