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Summary Statement of Deficiencies 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 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 a review of the serum Human Chorionic Gonadotropin (hCG) QC (Quality Control) records, the serum hCG IQCP (Individualized Quality Control Plan), and an interview with Testing Personnel #1, the Laboratory failed to document the serum hCG QC every month as per the IQCP. The surveyor noted 1 out of 22 months of QC not documented reviewed from 2023 through 2025. The findings include: 1. A review of the serum hCG records revealed the laboratory exceeded the monthly requirements for external serum hCG QC for the period between 1/11/2024 to 3/27/2024; 44 days overdue. 2. A review of the serum hCG IQCP revealed, "Three levels of control must be ran each month..." 3. During an interview on October 7, 2025, at 3:47 PM, Testing Personnel #1 confirmed the above findings. 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 D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of Policies and Procedures and an interview with Testing Personnel #1, the Laboratory Director failed to approve the procedure for Emerald Cell Dyn Hematology analyzer prior to patient testing. This was noted from the time patient testing began in March 2023 to the date of the current survey, November 15, 2023. The findings include: 1. A review of the Policies and Procedures revealed no evidence of a written procedure for the newly implemented Emerald Cell Dyn Hematology analyzer. 2. During an interview on 11/14/2023 at 1:00 PM, Testing Personnel #1 confirmed the procedure was available online, however, it was not reviewed or approved by the Laboratory Director before patient testing began. 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 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 -- 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 a review of Policies and Procedures, the calibration verification records for the Vitros 5600, and an interview with Testing Personnel #1, the laboratory failed to perform calibration verifications at least every six months for the Chemistry analytes with less than three routine calibrators. This was noted for one out of three calibration verifications performed from April 2022 to July 2023. The findings include: 1. A review of Policies and Procedure revealed the following text listed under "Calibration Verification, Linearity, and Instrument Validations": "...Calibration Verification is to be made every 6 months on all instruments of Moderate to High Complexity..." 2. A review of the calibration verification records for Vitros 5600 revealed the following: a) Total Iron Binding Capacity (TIBC), Total Cholesterol, and Low-density Lipoprotein (LDL) had a calibration verification performed on 4/14/2022. The next calibration verification was not recorded until 1/23/2023. b) Vitamin D had a calibration verification performed on 4/15/2022. The next calibration verification was not recorded until 1/30/2023. 3. During an interview on 11/15/2023 at 12:15 PM, Testing Personnel #1 confirmed the above findings. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of Emerald Cell Dyn Hematology Quality Control (QC) records and an interview with Testing Personnel #1, the laboratory failed to have a procedure in place that monitors the accuracy and precision of test performance over time. The findings include: 1. A review of Emerald Cell Dyn QC records revealed only raw data from the instrument. No evidence of Levy Jennings charts or peer group data was available for review at the time of survey. 2. During an interview on 11/14/2023 at 2: 00 PM, the Surveyor inquired about the review of Levy Jennings charts for the Hematology analyzer. Testing Personnel #1 confirmed that the laboratory was not monitoring Levy Jennings charts for shifts or trends for that testing system. -- 2 of 3 -- 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 a review of Personnel records and an interview with Testing Personnel #1, the Technical Consultant failed to assess competency for the Emerald Cell Dyn Hematology analyzer at least semi annually during the first year of patient testing. This was noted for two out of eleven Testing Personnel documented on the Laboratory Personnel Report (CMS-116). The findings include: 1. A review of Personal records revealed the following: a) Testing Personnel #5 had an initial training for the Cell Dyn Hematology analyzer documented on 3/2/2023. No evidence of a six month competency assessment was available for review. b) Testing Personnel #6 had an initial training for the Cell Dyn Hematology analyzer documented on 3/1 /2023. No evidence of a six month competency assessment was available for review. 2. During an interview on 11/15/2023 at 12:00 PM, Testing Personnel #1 confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of the Vitros 5600 Procedure Manual and an interview with Testing Personnel #1, the Laboratory Director failed to approve the Vitros 5600 Procedures, before patient testing began in November 2019. This was noted on one of three new instruments installed since the previous survey. The findings include: 1. A review of the Vitros 5600 Procedure Manual revealed it was online and there was no evidence that the Laboratory Director reviewed the procedures, prior to patient testing starting in November 2019. 2. During an interview on 10/27/2021 at 11:22 AM, Testing Personnel #1 confirmed the procedures online were not reviewed by the Laboratory Director. 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 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 -- 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 a review of calibration verification records for the Vitros 5600 and Tosoh G8, and an interview with Testing Personnel (TP) #1, the laboratory failed to perform calibration verifications at least every six months for the Chemistry analytes with less than three routine calibrators. This affected two opportunities in 2020 and one opportunity in 2021 for the Vitros 5600 and Tosoh G8. This is a repeat deficiency. The findings include: 1. A review of the calibration verification records for the Vitros 5600 revealed calibration verification had not been performed since patient testing started in November 2019. The following analytes have less than three calibrations: a) Direct Low-Density Lipoprotein Cholesterol (dLDL) b) Estradiol c) Total Iron- Binding Capacity (TIBC) d) Follicle-Stimulating Hormone (FSH) e) Luteinizing Hormone (LH) f) Prolactin g) Vitamin B12 h) Vitamin D 2. A review of the calibration verification records for Tosoh G8 revealed the last calibration verification for Hemoglobin A1c was performed on 12/03/2019. 3. During an interview on 10/27 /2021 at 12:10 PM, Testing Personnel #1 confirmed calibration verifications had not been performed every 6 months for the tests listed above. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (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 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. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the IQCP (Individualized Quality Control Plan), the Quality Control (QC) records for the Luminex Verigene - Respiratory Panel and Luminex Aries - Clostridium difficile (C. Difficile) and an interview with Testing Personnel #1, the laboratory failed to ensure two levels of quality control (QC) were performed and documented every 31 days of patient testing as per the IQCP. This was noted one time since patient testing started in November 2020 for Respiratory Panel and March 2021 for C. Difficile. The findings include: 1. A review of the IQCP for the Luminex Verigene - Respiratory Panel and Luminex Aries - Clostridium difficile (C. Difficile) revealed a QC Plan which specified two levels of QC should be performed and documented every 31 days of patient testing. 2. A review of the November 2020 to September 2021 Luminex Verigene - Respiratory Panel QC revealed QC was -- 2 of 5 -- performed on 07/08/2021 and not performed again till 08/23/2021 (more than 31 days). From 08/09/2021 to 08/22/2021, 128 patient tests were performed. 3. A review of the March 2021 to October 2021 Luminex Aries - Clostridium difficile (C. Difficile) QC revealed QC was performed on 07/08/2021 and not performed again till 08/23/2021. From 08/09/2021 to 08/22/2021, 2 patient tests were performed. 4. During an interview on 10/27/2021 at 3:00 PM, Testing Personnel #1 confirmed the laboratory failed to follow their IQCP and perform QC every 31 days. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control records for Chemistry testing and an interview with Testing Personnel #1 (TP #1), the laboratory failed to provide documentation of at least two acceptable levels of Quality Control (QC) for TIBC (Total Iron-Binding Capacity), Total Bilirubin, Phosphorus, Estradiol, Folate, and Free triiodothyonine (FT3) for days in May of 2021. This was noted for one month out the following three months reviewed by the surveyor, December 2019, July 2020 , and May 2021. This is a repeat deficiency. The findings include: 1. A review of the quality control records for Chemistry and Endocrinology testing, performed on the Vitros 5600, revealed several days in May 2021 when documentation indicated that not at least two levels of QC were within acceptable ranges. The following was revealed: a) TIBC acceptable range in the Laboratory Information System (LIS) was 8.21 to 757.56 for Level 1, according to the 10 data runs when the ranges were established by the laboratory the acceptable range should have been 239.47 to 255.895. For the month of May 2021 the observation range was 215.56 to 225.74, meaning Level 1 for TIBC was unacceptable for each day of patient testing. b) Total Bilirubin Level 1 was unacceptable 05/04 /2021, 05/05/2021, and 05/06/2021 according to the acceptable range in the LIS. c) Phosphorus Level 1 was unacceptable 05/20/2021, 05/21/2021, and 05/24/2021 according to the acceptable range in the LIS. d) Estradiol Level 1 was unacceptable 05 /11/2021 according to the acceptable range in the LIS. e) Folate Level 1 was unacceptable 05/25/2021 according to the acceptable range in the LIS. f) FT3 Level 1 was unacceptable 05/03/2021 according to the acceptable range in the LIS. 2. During an interview on 10/27/2021 at 1:20 PM, the surveyor and Testing Personnel #1 reviewed the Chemistry QC reports from May 2021. TP #1 explained the QC values must have shifted when the ranges were changed, but could not provide documentation of the QC being within range. TP #1 explained they were using unassayed controls and would change the baseline every 30 days, but could not provide documentation of changes in baselines, only the original 10 day control evaluation where the means and standard deviations were determined. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. -- 3 of 5 -- This CONDITION is not met as evidenced by: Based on a review of quality control records, a review of personnel records, a review of the procedure manual, and interviews with Testing Personnel #1, the Technical Consultant failed to fulfil her responsibilities. The findings include: 1. Refer to D6042. 2. Refer to D6046. 3. Refer to D5481. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on review of quality control records for Chemistry testing, Chemistry Quality Control Procedure, and an interview with Testing Personnel #1 (TP #1), the Technical Consultant failed to establish a quality control program for Chemistry testing. This was noted for one month out the following three months reviewed by the surveyor, December 2019, July 2020 , and May 2021. The findings include: 1. Refer to D5481. A review of the Chemistry Quality Control revealed the Technical Consultant reviewed the QC, but failed to document the outliers. 2. A review of the Chemistry Quality Control Procedure revealed no information on using unassayed controls for the Vitros 5600 and how ranges would be determined or changed when needed. 3. During an interview on 10/27/2021 at 2:20 PM, TP #1 confirmed the laboratory was using unassayed controls and did not have a procedure for this process. QC reviewed in May 2021 revealed QC being out of range according to the Laboratory Information System (LIS) printouts and Instrument printouts reviewed by the surveyor. No documentation could be provided to show the controls being within range on dates listed in D5481. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(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 a review of personnel records, proficiency testing records, and an interview with Testing Personnel #1, the Technical Consultant failed to assure Testing Personnel (TP) #1 maintain competency to perform Complete Blood Count (CBC), serum human Chorionic Gonadotropin (hCG), and Cardiac Panel (Triage Meter). This was noted on one of twelve testing personnel. The findings include: 1. A review of personnel records revealed Testing Personnel #1 had competency evaluated for Vitros 5600, Tosoh G8, Luminex Verigene, and Luminex Aries annually. TP #1 did not have records of competency evaluation on Horiba ABX Micros 60 (CBC), Triage Meter (Cardiac and D-Dimer Panel), and Serum hCG. 2. A review of proficiency testing records revealed Testing Personnel #1 performed the following testing events: a) 2020 -- 4 of 5 -- Chemistry - Core 1st Event Triage Meter (Cardiac and D-Dimer Panel) and Serum hCG b) 2021 Chemistry - Core 2nd Event Triage Meter (Cardiac and D-Dimer Panel) and Serum hCG c) 2021 Chemistry - Core 3rd Event Triage Meter (Cardiac and D- Dimer Panel) and Serum hCG e) 2019 Hematology 2nd Event Horiba ABX Micros 60 (CBC) f) 2020 Hematology 3rd Event Horiba ABX Micros 60 (CBC) g) 2021 Hematology 2nd Event Horiba ABX Micros 60 (CBC) 3. During an interview on 10 /26/2021 at 3:00 PM, Testing Personnel #1 confirmed competency evaluations for Horiba ABX Micros 60 (CBC), Triage Meter (Cardiac and D-Dimer Panel), and Serum hCG had not been performed. TP #1 also confirmed she periodically would run patient testing on these tests and performed training/competency evaluations on urgent care staff, who also performed these tests. -- 5 of 5 --

Summary Statement of Deficiencies 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 a review of API (American Proficiency Institute) proficiency testing records and an interview with the General Supervisor (Testing Personnel #1), the surveyor determined the laboratory failed to self-evaluate (grade) proficiency testing scores returned ungraded from API. This affected Event #1, 2019 and Event #1, 2018, two of seven testing events reviewed by the surveyor. The findings include: 1. A review of API proficiency testing records revealed the following: a) The KOH (Potassium Hydroxide Preparation) and the Urine Sediment Examination were not graded by API on Hematology, Event #1, 2019. The laboratory did not document a review and evaluation of the results to determine the laboratory's accuracy of interpretation. The staff documented no action was taken. b) For Event #1, 2018, specimen CHO2 for Cholesterol (Chemistry) was not graded by API. The result report included a question mark (?) next to the value, however no documentation was provided of a review and evaluation to determine the laboratory's accuracy of testing. 2. In an interview at 2:19 PM on May 22, 2019, the surveyor inquired of what action was taken for ungraded proficiency testing results. Testing Personnel (TP) #1 stated she was not sure what "no consensus" meant. The surveyor discussed the laboratory's responsibility to evaluate scores returned from the proficiency testing provider as not graded. TP #1 confirmed the above noted findings. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of the 2017-2019 American Proficiency Institute (API) proficiency testing records, and an interview with the General Supervisor [Testing Personnel (TP) #1, the only personnel interpreting the microscopics and Chemistry testing], the surveyor determined the laboratory failed to implement and document