Trace Regional Hospital

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation (proficiency testing) D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records 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 -- (graded copies from the American Proficiency Institute (API) and the CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 12/6/2024, the laboratory failed to achieve satisfactory performance in two of two testing events (2024-Event 2, and 2024-Event 3) resulting in unsuccessful participation in routine chemistry for IRON, TOTAL (0425). Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute (API) and CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 12/6/2024, the laboratory has not successfully performed proficiency testing for IRON, TOTAL (0425) in two of two testing events. Findings include: A review of the laboratory records from the American Proficiency Institute (API) and the CMS CASPER reports 0153D/0155D revealed the laboratory scored the following for IRON, TOTAL: IRON, TOTAL: Year 2024-2nd Event 60% Year 2024-3rd Event 60% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing records (graded copies from the American Proficiency Institute (API) and CASPER reports 0153D /0155D from the Centers for Medicare and Medicaid Services data system) on 12/6 /2024, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing records (graded -- 2 of 3 -- copies from the American Proficiency Institute and CASPER report 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 12/6/2024, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the Beckman Coulter DxH 690 T quality control (QC) records from 10/16/2021 through 4/30/2023 and confirmation with TP #3 at 2:30 p.m. on 5/19 /2023, the laboratory failed to retain the QC assay sheets for each lot used to perform daily QC on the Beckman Coulter DxH 690 T. Assay sheets which include acceptable ranges/standard deviations, storage requirements, and lot numbers/expiration dates were not retained for ten of eleven lot numbers of QC. Findings include: 1. Review of the Beckman Coulter DxH 690 T QC records from 10/16/2021 until 5/18/2023, revealed eleven lot numbers of hematology QC lots had been used. No assay sheets were retained for the following lots: a. DxH 690 T QC lot # 123173780 low, 133173780 normal, 143173780 high b. DxH 690 T QC lot # 123173730 low, 133173730 normal, 143173730 high c. DxH 690 T QC lot # 123173790 low, 133173790 normal, 143173790 high d. DxH 690 T QC lot # 123184060 low, 133184060 normal, 143184060 high e. DxH 690 T QC lot # 123174120 low, 133184120 normal, 143194120 high f. DxH 690 T QC lot # 123174160 low, 133184160 normal, 143194160 high g. DxH 690 T QC lot # 123174230 low, 133184230 normal, 143194230 high h. DxH 690 T QC lot # 123174660 low, 133184660 normal, 143194660 high i. DxH 690 T QC lot # 123174710 low, 133184710 normal, 143194710 high j. DxH 690 T QC lot # 123174800 low, 133184800 normal, 143194800 high 2. TP #3 confirmed in an interview at 2:30 p.m. on 5/19/2023 the lab did not retain QC assay sheets with each change of lot number for the QC material for the DxH 690 T hematology analyzer. Ten of eleven QC assay sheets were not retained during the period surveyed. 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 review of laboratory personnel records and interview with the laboratory manager/technical consultant #2, listed on the Centers of Medicare & Medicaid Services (CMS) 209 form at 4:00 p.m. on 10/12/15, the Laboratory Director failed to follow written policies to assess competency of the technical consultant (TC) at least annually. There was no evaluation for the Technical Consultants on the day of survey for the years 2019, 2020 or 2021. Findings include: 1. Interview with TC#2 confirmed there were no competency evaluations documented by the laboratory director for the TC since the last survey on 5/30/19. 2. Based on review of the personnel records on 10 /15/21, the laboratory director failed to follow policies and evaluate the technical consultant at least annually for the years 2019, 2020 and 2021. THIS IS A REPEAT DEFICIENCY 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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 review of chemistry laboratory records from 5/30/19 through 10/15/21 and confirmation with the laboratory manager at 4:00 p.m. on 10/15/21, the laboratory failed to perform calibration verification on the Siemens Dimension EXL-LM chemistry analyzer every 6 months for sodium, potassium and chloride and a seven (7) drugs of abuse panel (including cocaine, THC, barbiturates, benzodiazapine, opiates, PCP and amphetamines). Findings include: 1. Review of Siemens Dimension EXL LM calibration verification records revealed no records of calibration verification on Sodium (NA), Potassium (K), and Chloride (CL) or the 7 drugs of abuse panel for 2019, 2020 or 2021. These chemistry tests have only 1 or 2 calibration points. Calibration verification is required every 6 months. 2. The laboratory manager in an interview at 4:00 p.m. on 10/15/21 confirmed that calibration verifications for NA, K, CL and the drugs of abuse panel were not performed in 2019, 2020, and 2021. THIS IS A REPEAT DEFICIENCIY D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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 qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control (QC) logs, patient testing logs and interview with both technical consultants as listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form on 10/15/21 at 2:00 p.m., the laboratory failed to include a positive and negative control on each day of patient testing for the Quidel Quick Vue Combo hCG Pregnancy test when performed using serum between 11/24 /19 and 9/18/21. Findings Include: 1. Interview with the technical consultants on 10/15 /21 at 2:00 p.m. confirmed that testing personnel (TP) were not performing two levels of QC (positive and negative) each day of patient testing with serum with the Quick Vue Combo hCG test kit. Use of serum as a sample on the Quick Vue Combo hCG kit makes it a moderate complexity test which requires QC on each day of use. 2. There was no IQCP (Individualized Quality Control Plan) available for review on the day of survey. An IQCP is required after 1/1/16 if two levels of quality control (QC) are not performed each day of use for moderate/high complexity testing. 3. Review of the -- 2 of 4 -- Quick Vue Combo hCG patient test log and QC log from 11/24/19 through 9/18/21, revealed that on the 6 days listed below, pregnancy tests were performed on serum samples. No QC was performed on these days: 11/24/19- 1 patient tested 1/1/20 - 1 patient tested 7/20/20 - 1 patient tested 10/13/20 - 1 patient tested 1/13/21 - 5 proficiency testing samples 9/18/21 - 5 proficiency testing samples D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of immunohematology (blood bank) records and Jewett temperature graphs from 6/1/19 through 10/15/21, the laboratory failed to follow the manufacturer's instructions for equipment operation. Review of the Jewett recorder graphs revealed the laboratory failed to change the temperature recorder graphs every seven days (according to manufacturer's instructions) as follows: 5/19/20 through 6/1 /20 6/23/21 through 7/1/20 8/22/20 through 9/1/20 10/3/21 through 10/13/20 10/13/20 through 10/25/20 11/17/20 through 11/25/20 11/25/20 through 12/3/20 12/19/20 through 12/28/20 1/12/21 through 1/21/21 1/28/21 through 2/5/21 2/12/21 through 2 /20/21 2/20/21 through 3/1/21 3/1/21 through 3/9/21 3/16/21 through 3/24/21 4/15/21 through 4/24/21 4/24/21 through 5/3/21 5/3/21 through 5/11/21 5/24/21 through 6/3 /21 6/3/21 through 6/11/21 6/11/21 through 6/22/21 6/22/21 through 7/2/21 8/3/21 through 8/11/21 8/19/21 through 8/28/21 8/28/21 through 9/6/21 9/15/21 through 9/23 /21 9/6/21 through 9/15/21 9/30/21 through 10/8/21 D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of laboratory personnel records including the Centers of Medicare and Medicaid Services (CMS) 209 personnel form and interview with the both technical consultants (TC) listed on the CMS 209 form, on the day of survey (10/15 /21), the TC failed to evaluate annually and document the performance of testing personnel (TP) #2 for the years 2019 and 2020. Findings include: 1. Based on laboratory personnel records available for review on 10/15/21, there were no annual evaluations/competencies performed by the technical consultant on TP #2 for 2019 and 2020. 2. Interview with the TC on 10/15/21 at 4:00 p.m. confirmed that annual evaluation/competencies had not been documented as performed for TP #2 for 2019 or 2020. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES -- 3 of 4 -- 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 annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of laboratory personnel records including the Centers of Medicare and Medicaid Services (CMS) 209 personnel form and interviews with the technical consultants (TC) on 10/15/21, the technical supervisor failed to evaluate annually and document the performance of the TP #1, #2 and #3 who are responsible for immunohematology (blood bank) testing. Findings include: 1. Based on the laboratory personnel records available for review on 10/15/21, there were no annual evaluations /competencies on high complexity testing performed by the technical supervisor for TP #1, #2 and #3 since the last survey on 5/30/19. 2. Interview with both TC/TP on 10 /15/21 at 4:00 p.m. confirmed the annual evaluation/competencies for immunohematology had not been documented as performed by the technical supervisor for TP #1, #2 and #3 for 2020 and 2021. -- 4 of 4 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of Sysmex CA-500 coagulation system manufacturer operator's manual, coagulation quality control (QC) records from 9/1/17 through day of survey, 5 /30/19, and confirmation with staff at 11:00 am on 5/30/19 the laboratory did not establish a normal patient mean (NPM) nor enter the correct ISI (International Sensitivity Index) when changing to a new lot of Prothrombin reagent (Innovin) as required by the manufacturer's instructions. Both NPM and ISI are used to calculate the INR (international normalized ratio) which is reported as part of the Prothrombin Test results. Findings include: 1. According to the CA-560 manufacturer's instructions, the NPM has to be entered into the analyzer along with the appropriate ISI value in order for the analyzer to calculate an accurate patient INR (international normalized ratio) which is reported with the Prothrombin result. 2. Based on review of the Coagulation QC records from 9/1/17 through 5/30/19 there was no documentation of when the Innovin reagent (lot # 539394 expiration date 8/18/19) in use on the day of survey, was started. 3. Based on observation of the coagulation instrument, the ISI value entered in the Sysmex CA-500 on the day of survey was 0.96. The ISI value of Innovin Lot #539394, in use on the day of survey, is 1.02. 4. There was no documentation available the day of survey to indicate the laboratory had established a NPM (normal patient mean) with the new lot number of Innovin per manufacturer's instructions. 5. Interview with the laboratory manager confirmed that when Innovin Lot # 539394 was put into use, the NPM was not established nor was the ISI value changed in the CA-560. 6. According to the volume form and QC records, 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 -- approximately 496 patients' PT results had been tested and resulted during this time period. 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 review of chemistry laboratory records from last survey 6/7/19 through the day of this survey, 5/30/19, and confirmation with laboratory manager at 5:00 pm on 5 /29/19, the laboratory failed to perform calibration verification on the Siemens Dimension EXL-LM chemistry analyzer every 6 months for sodium, potassium, chloride and the drugs of abuse panel (cocaine, THC, barbiturates, benzodiazepine, opiates, PCP and amphetamines). Findings include: 1. Review of Siemens Dimension EXL-LM calibration verification records revealed that a calibration verification was not performed on Sodium (NA), Potassium (K), and Chloride (CL) or the drugs of abuse panel every 6 months. The laboratory did not perform the calibration verifications on the NA, K and CL analytes due for 2017. The laboratory did not perform the 2nd calibration verification due in December 2017 for the drugs of abuse panel (cocaine, THC, barbiturates, benzodiazepine, opiates, PCP and amphetamines). These chemistry tests have only 1 or 2 calibration points and therefore require calibration verification to be performed every 6 months to verify the laboratory's reportable range. 2. During an interview at 5:00 pm on 5/29/19, the laboratory manager confirmed that semiannual NA, K and CL calibration verifications due in 2017 were not performed. The laboratory manager also confirmed that calibration verification due in 12/17 for the drugs of abuse panel was not performed by the laboratory. -- 2 of 2 --