North Sunflower Medical Center

Summary Statement of Deficiencies 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 Gem Premier 3500 blood gas records, and interview with Respiratory Supervisor, testing personnel (TP) #13, as listed on the Centers for Medicare and Medicaid Services (CMS) 209 form, the blood gas testing personnel failed to perform the calibration verification on the Gem Premier blood gas analyzer at least once every 6 months for pH, PCO2 and CO2 for two of four sixth-month calibration verification procedures due. Findings include: 1. Review of the Gem 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 -- Premier records for pH, pCO2 and CO2 from last survey on 2/23/2023 through 10/31 /2024, revealed that a calibration verification using performance verification product (PVP) was not performed on the blood gas tests every 6 months as required by the manufacturer. The Gem Premier records revealed the PVP was performed on 2/24 /2023 and 7/18/2024. Two of the four sixth-month calibration verifications were not performed. 2. Interview with the Respiratory Supervisor (TP #13) on 10/31/2024 at 2: 00 p.m., confirmed the (PVP) calibration verification on pH, PCO2, and CO2 tests had not been performed every 6 months. D6053 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of Respiratory testing personnel (TP) records, including the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and interview with the Laboratory Manager and Respiratory Supervisor, the Laboratory Director /Technical Consultant (LD/TC) failed to evaluate and document the performance of six of fourteen Respiratory testing personnel at least semiannually during the first year of moderate complexity testing. Findings include: 1. Review of the Respiratory (blood gas) personnel records since the last survey on 2/23/2023 revealed no semiannual evaluation available for the performance of six of fourteen testing personnel. a. TP #11 initial training - 4/24/2023, semiannual evaluation due - 10/2023 b. TP #12 initial training - 4/11/2023, semiannual evaluation due - 10/2023 c. TP #14 initial training - 6 /08/2023, semiannual evaluation due - 12/2023 d. TP #15 initial training - 6/20/2023, semiannual evaluation due - 12/2023 e. TP #17 initial training - 7/26/2023, semiannual evaluation due - 01/2024 f. TP #19 initial training - 6/01/2023, semiannual evaluation due - 12/2023 2. The Respiratory Supervisor confirmed in an interview on 10/31/2023 at 3:00 p.m., there was no semiannual evaluation/competency performed TP #11, TP #12, TP #14, TP #15, TP #17 and TP #19. 3. The LD/TC failed to document semiannual competency evaluations on six of fourteen new blood gas testing personnel. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The following condition level deficiencies were cited: D2016 - 42 C.F.R. 493.803 Condition: Successful participation, proficiency testing 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 (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 7/19/2023, the laboratory failed to maintain satisfactory performance in two of two testing events (2023-Event 1, and 2023-Event 2) resulting in unsuccessful participation in routine chemistry for the analyte Total Protein. Refer to D2096. 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 -- D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. 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 7 /19/2023, the laboratory failed to participate in proficiency testing for Total Protein in one of one 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 Total Protein: Total Protein: Year 2023-1st Event 0% 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 7 /19/2023, the laboratory has not successfully performed proficiency testing for Total Protein 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 Total Protein: Total Protein: Year 2023-1st Event 0% Year 2023-2nd Event 0% -- 2 of 2 --

Summary Statement of Deficiencies D0000 The following condition level deficiencies were cited: D2016 - 42 C.F.R. 493.803 Condition: Successful participation, proficiency testing 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 (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 4/7/2023, the laboratory failed to maintain satisfactory performance in two 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 -- of two testing events (2022-Event 3, and 2023-Event 1) resulting in unsuccessful participation in routine chemistry for the analytes Iron and Blood Urea Nitrogen (BUN). 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 4 /7/2023, the laboratory has not successfully performed proficiency testing for Iron and Blood Urea Nitrogen (BUN) 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 and Blood Urea Nitrogen (BUN): Iron: Year 2022-3rd Event 60% Year 2023-1st Event: 0% Blood Urea Nitrogen (BUN): Year 2022-3rd Event: 40% Year 2023- 1st Event: 0% -- 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute and the CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 2 /14/2023, the laboratory failed to maintain satisfactory performance in two of two testing events (2022 - Events 2 & 3) resulting in unsuccessful performance in Immunohematology for Compatibility Testing. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) 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 an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute and CASPER reports 0153D /0155D from the Centers for Medicare and Medicaid Services data system) on 2/14 /2023, the laboratory has not successfully performed proficiency testing for Compatibility Testing in two of two testing events. Findings include: A review of the laboratory records from the American Proficiency Institute and the CMS CASPER reports 0153D/0155D revealed the laboratory scored the following for Compatibility Testing: Year 2022 - 2nd Event: 80% Year 2022 - 3rd Event: 60% -- 2 of 2 --

Summary Statement of Deficiencies 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 Gem Premier 3500 blood gas records from 1/11/19 through 6/22 /21 and confirmation with testing personnel (TP) #13 (respiratory supervisor) as listed on the CMS (Centers for Medicare & Medicaid Services) 209 form at 3:00 pm on 6/24 /21, the laboratory failed to perform the calibration verification on the Gem Premier blood gas analyzer every 6 months for pH, pCO2 and pO2. Findings include: 1. Review of the respiratory Gem Premier records for pH, pCO2 and pO2 from 10/25/18 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 -- until 6/22/21 revealed that calibration verification using PVP (performance verification product) was performed on 1/24/19, 10/29/20, and 6/22/21. 2. The manufacturer requires calibration verification every 6 months. The time frame of calibration verifications exceeds the manufacturer's requirement. 2. During an interview at 3:00 pm on 6/24/21, TP #13 (respiratory supervisor) confirmed that the (PVP) calibration verification on pH, pCO2, and pO2 tests had not been performed every 6 months. -- 2 of 2 --

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of hematology proficiency testing (PT) records since the last survey on 1-26-17 and confirmation by Technical Consultant #2 listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, the laboratory tested all five hematology PT samples of Event 1, Event 2, and Event 3 of 2017 and Event 1 of 2018 twice prior to submitting the results to the PT provider. Technical Consultant #2 confirmed the laboratory routinely tests patient hematology samples only once prior to reporting results. 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 observation of the patient and Quality Control (QC) logs for the Sure-Vue RF (Rheumatoid Factor) test from 5/10/17 to 9/26/18 and the Sure-Vue RF manufacturer's procedure, the laboratory failed to follow the manufacturer's instructions for the rotator speed when testing patient specimens. Findings include: The manufacturer's instructions for the Sure-Vue RF test system state the rpm's 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 -- (rotations per minute) on the rotator should be between 80-100 rpm (20-25 rpm per 15 seconds) for 2 minutes when testing patients. The laboratory was using the range of 24-27 rpm for 15 seconds to verify the rpm's prior to patient testing. This range includes rpm's that are higher than the manufacturer's requirement . Approximately one hundred and fifty three patients were tested when the rotator speed was verified using the incorrect range from 5/10/17 through 9/26/18. 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 bacteriology microbiological culture media (MacConkey II agar) in use by the laboratory on 10-24-18, the media had exceeded the expiration date as established by the manufacturer when patient microbiological cultures were performed and results reported. Findings include: Surveyor observation of the MacConkey II microbiological culture media in use by the laboratory on 10-24- 18 revealed the laboratory performed patient microbiological culture testing procedures using expired MacConkey II agar as follows: MacConkey agar (lot # 8194728) observed under the biological safety hood, in the bacteriology refrigerator and in the bacteriology incubator had expired on 10-12-18. Seven urine cultures on expired media were observed as testing was in progress on 10-24-18. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: 1. Based on the Respiratory Department personnel and training documentation available the day of survey, the laboratory director had not ensured that testing personnel listed on the CMS 209 personnel form as testing personnel #20 and #21 had received the appropriate initial training for testing blood gases prior to testing patients. Testing personnel #20 and #21 both began employment in the Respiratory Department in 2018 according to staff (Hire date unavailable on day of survey). 2. Based on the laboratory personnel and training documentation available the day of survey, the laboratory director had not ensured that testing personnel listed on the CMS 209 personnel form as tesing personnel #4, #5 and #7 had received the appropriate initial training for moderate complexity testing (endocrinology, chemistry, hematology, urinalysis, etc.) prior to testing patients. Testing personnel #4 began employment in June 2017, #5 began in May 2017 and #7 began August 2018. -- 2 of 4 -- D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) 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; This STANDARD is not met as evidenced by: Based on observation of quality control (QC) records, microbiological media (stored and in use), review of proficiency testing records since the last survey on 1-26-17 through 10-25-18 and interview with staff at 3:00 pm on the day of survey, the technical consultant did not identify training needs for performing quality control, using media prior to expiration, and failure to perform proficiency testing samples in the same manner as patients. Findings include: The technical consultant did not recognize the following testing personnel training needs: 1. Quality control material for Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and D- dimer were tested numerous times without troubleshooting or retraining of testing personnel (repeated until values were in range). 2. MacConkey II media was used beyond its expiration date for patient testing of urine cultures. (Refer to D5417) 3. Proficiency Testing specimens were not tested in the same manner as patient specimens. (Refer to D2010) D6053 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of laboratory personnel records from last survey (1/26/17) through the current survey (10/25/18) and the CMS 209 personnel form, the technical supervisor failed to evaluate and document the performance of testing personnel # 8 responsible for performing high complexity testing at least semiannually during the first year of employment. The hire date for testing personnel #8 was 5/17/17. An annual competency evaluation was performed on 5/23/18. A semiannual evaluation must be performed during the first year of employment by the laboratory. 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 since last survey and confirmation with staff, the technical consultant failed to evaluate annually and document the performance of testing personnel/respiratory supervisor (listed on the Centers for -- 3 of 4 -- Medicare & Medicaid 209 form) as testing personnel #22 for the years 2017 and 2018. 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 review of laboratory personnel records from last survey (1/26/17) through day of survey (10/25/18) and the CMS 209 personnel form, the technical supervisor failed to evaluate and document the performance of testing personnel # 8 responsible for performing moderate and high complexity testing at least semiannually during the first year of employment. The hire date for testing personnel #8 was 5/17/17. An annual competency evaluation was performed on 5/23/18. A semiannual evaluation must be performed during the first year of employment by the laboratory. -- 4 of 4 --