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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 observation of the laboratory, review of laboratory records, and staff interview, the laboratory failed to maintain analytic records of complete blood count test kits in 2021 and 2022. The findings include: 1. Observation of the laboratory on January 25, 2022 at approximately 8:30 am revealed the Sight OLO instrument (serial number q303) on the counter in use for patient testing for CBC. Observation included demonstration of test performance including the use of individually wrapped test kits used for performing patient or quality control tests. 2. Review of laboratory records revealed the following: No records were maintained documenting CBC test kit lot numbers, expiration dates or dates in use. The first patient was tested on November 16, 2021 (patient #313). 3. Interview with the laboratory liaison on January 25, 2022 at approximately 1pm confirmed the laboratory does not maintain records of CBC test kit lot numbers, expiration dates, or dates in use since testing began on November 16, 2021. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. 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 -- This CONDITION is not met as evidenced by: The laboratory procedure failed to define how to handle complete blood count (CBC) results outside the verified reportable range (Refer to D5403) and failed to verify the reportable range of the Sight OLO CBC instrument (Refer to D5421). D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies 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: The laboratory failed to maintain satisfactory participation in three out of four proficiency testing (PT) events for the hematology specialty, two consecutive PT events for the white blood cell, hemoglobin, platelet and wbc differential, three of four PT events for the hematocrit analyte and four out of four PT events for the red blood cell analyte. (Refer to D2123, D2130, and D2131) D2123 HEMATOLOGY CFR(s): 493.851(c) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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 review of the Centers for Medicare and Medicaid Services Casper report 155 (CMS 155), the laboratory's proficiency testing (PT) records and Quality Assessment records, interview with a PT program representative, the proficiency testing program's calendar for PT ship dates and submission due dates, and the laboratory's patient data logs and patient test reports, the laboratory failed to participate in PT events 2019 event three and 2020 event one. The findings include: 1) Review of the CMS 155 revealed a score of 100% for proficiency testing events 2019 event three and 2020 event one. 2) Review of the laboratory's PT and Quality Assessment records revealed the following: 2019 Event Three PT program evaluation report- not graded and scored as 100% for "Instrument Out of Service." 2019 Event Three PT tracking form revealed documentation that the lab "Forgot to run samples." 2020 Event One PT program evaluation report-not graded and scored as 100% for "Lab Reported Test Problem." 2020 Event One PT tracking form revealed documentation of "Shipment Not Received." 2020 Event one PT submission form revealed the laboratory submitted to the PT program documentation of "Unable to locate sample", "No patient samples are being run." Quality Assessment document dated 4-25-2020 revealed the following: "1st PT event was not received, clinic unaware of shipment." 3) Interview with a representative of the PT program via phone on 12-1-2020 at 10am revealed that the shipment for 2020 event one was signed for by a representative of the physician office on 03-10-2020. 4) Review of the proficiency testing program calendar for ship dates and submission due dates revealed the following: 2019 event three--ship dates = November 11, 12; submission due date=December 2. 2020 event one-- ship dates = March 9,10; submission due date = March 27. 5) Review of patient data logs and patient test reports for the periods the proficiency testing events were open revealed the following: 2019 event three--patient testing performed and reported from 11-26-2019 through 12-2-2019 during the time the PT event was open (patient number 1 reported on 11.26.19, patient numbers 2,3, and 4 reported on 11.27.19, patient number 5 reported on 12.2.19). 2020 event one-- patient testing performed and reported from 3-11-2020 through 3-23-2020 during the time the PT event was open (patient number 6 reported on 3.11.20, patient number 7 reported on 3.13.20, patient number 8 reported on 03.23.20). The laboratory failed to participate in 2019 event three and 2020 event one with patient testing performed and reported during the periods the PT events were open. D2130 HEMATOLOGY CFR(s): 493.851(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. -- 2 of 6 -- This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services Casper report 155 (CMS 155), the laboratory's proficiency testing (PT) evaluation reports and Quality Assessment records, interview with a PT program representative, the proficiency testing (PT) program's calendar for PT ship dates and submission due dates, the laboratory's patient data logs and patient test reports, the 2019 event three PT tracking form, the laboratory failed to participate in PT events 2019 event three and 2020 event one, with patient testing performed, resulting in the first unsuccessful PT occurrence for the white blood cell (WBC), platelet (PLT), hemoglobin (HGB), WBC differential (WBC Diff), red blood cell (RBC), and Hematocrit (HCT) analytes and subsequent unsatisfactory performance for the red blood cell and hematocrit analytes resulting in the second and third unsuccessful PT occurrence for the RBC analyte and the second unsuccessful occurrence for the HCT analyte. The findings include: 1) Review of the CMS 155 revealed the following scores: WBC analyte: 2019 event three=100%, 2020 event one=100%. PLT analyte: 2019 event three=100%, 2020 event one=100%. HGB analyte: 2019 event three =100%, 2020 event one=100%. WBC Diff analyte: 2019 event three=100%, 2020 event one=100%. RBC analyte: 2019 event three=100%, 2020 event one=100%, 2020 event two=40%, 2020 event three=0%. HCT analyte: 2019 event three=100%, 2020 event one=100%, 2020 event three=60%. 2) Review of the laboratory's PT and Quality Assessment records revealed the following: 2019 Event Three PT program evaluation report graded as 100% for "Instrument Out of Service." 2019 Event Three PT tracking form revealed documentation that the lab "Forgot to run samples." 2020 Event One graded as 100% for "Lab Reported Test Problem." 2020 Event One PT tracking form revealed documentation of "Shipment Not Received." Quality Assessment document dated 4-25-2020 revealed the following: "1st PT event was not received, clinic unaware of shipment." 3) Interview with a representative of the PT program via phone on 12-1-2020 at 10am revealed that the shipment for 2020 event one was signed for by a representative of the physician office on 03-10-2020. 4) Review of the proficiency testing program calendar for ship dates and submission due dates revealed the following: 2019 event three--ship dates = November 11, 12; submission due date=December 2. 2020 event one-- ship dates = March 9,10; submission due date = March 27. 5) Review of patient data logs and patient test reports for the periods of proficiency testing events revealed the following: 2019 event three--patient testing performed and reported from 11-26-2019 through 12-2-2019 during the time the PT event was open (patient number 1 reported on 11.26.19, patient numbers 2,3, and 4 reported on 11.27.19, patient number 5 reported on 12.2.19). 2020 event one--patient testing performed and reported from 3-11-2020 through 3-23-2020 during the time the PT event was open (patient number 6 reported on 3.11.20, patient number 7 reported on 3.13.20, patient number 8 reported on 03.23.20). The laboratory failed to participate in 2019 event three and 2020 event one with patient testing performed during the periods the PT events were open, resulting in the first unsuccessful PT occurrence for the WBC, PLT, HGB, WBC Diff, RBC, and HCT analytes. 6) Review of the laboratory's 2020 PT evaluation reports revealed the following: Red Blood Cell analyte: 2020 Event two: Sample numbers HEM-06, HEM-07, HEM-08 scored as unacceptable, resulting in an overall score of 40% for the RBC analyte and the second unsuccessful performance for the RBC analyte. 2020 Event three: Sample numbers HEM-10, HEM-11, HEM-12, HEM-13, HEM-14 and HEM-15 scored as unacceptable, resulting in overall score of 0% for the RBC analyte, and the third unsuccessful PT performance for the RBC analyte. Hematocrit Analyte: 2020 Event three: Sample numbers HEM-12 and HEM-15 scored as unacceptable, resulting in an overall score of 60% for the hematocrit analyte and the second unsuccessful PT performance for the HCT analyte. -- 3 of 6 -- D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance 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 review of the Centers for Medicare and Medicaid Services Casper report 155 (CMS 155), the laboratory's proficiency testing (PT) and Quality Assessment records, interview with a PT program representative, the proficiency testing (PT) program's calendar for PT ship dates and submission due dates, the laboratory's patient data logs and patient test reports, the 2019 event three PT tracking form, the laboratory failed to participate in PT events 2019 event three and 2020 event one, with patient testing performed, and failed to maintain satisfactory performance for 2020 event three, resulting in the second unsuccessful PT occurrence for the hematology specialty. The findings include: 1) Review of the CMS 155 revealed the following: 2019 event three=100% 2020 event one=100% 2020 event three=73% 2) Review of the laboratory's PT and Quality Assessment records revealed the following: 2019 event three PT program evaluation report graded as 100% for "Instrument Out of Service." 2019 event three PT tracking form revealed documentation that the lab "Forgot to run samples." 2020 event one graded as 100% for "Lab Reported Test Problem." 2020 event one PT tracking form revealed documentation of "Shipment Not Received." 2020 event one PT submission form revealed documentation to the PT program of "Samples not found" and "No patient testing." Quality Assessment document dated 4-25-2020 revealed the following: "1st PT event was not received, clinic unaware of shipment." 2020 event three PT evaluation report revealed the following: RBC=0%, HCT=60%, HGB=100%, WBC=100%, PLT=80%, WBC Diff=100%, resulting in an overall score of 73% for the hematology specialty. 3) Interview with a representative of the PT program via phone on 12-1-2020 at 10am revealed that the shipment for 2020 event one was signed for by a representative of the physician office on 03-10-2020. 4) Review of the proficiency testing program calendar for ship dates and submission due dates revealed the following: 2019 event three--ship dates = November 11, 12; submission due date=December 2. 2020 event one-- ship dates = March 9,10; submission due date = March 27. 5. Review of patient data logs for the periods of proficiency testing events revealed the following: 2019 event three--patient testing performed and reported from 11-26-2019 through 12-2- 2019 during the time the PT event was open (patient number 1 reported on 11.26.19, patient numbers 2,3, and 4 reported on 11.27.19, patient number 5 reported on 12.2.19). 2020 event one--patient testing performed and reported from 3-11-2020 through 3-23-2020 during the time the PT event was open (patient number 6 reported on 3.11.20, patient number 7 reported on 3.13.20, patient number 8 reported on 03.23.20). The laboratory failed to participate in 2019 event three and 2020 event one with patient testing performed during the periods the PT events were open, and failed to maintain satisfactory performance for 2020 event three resulting in the second unsuccessful PT occurrence for the Hematology specialty. 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 -- 4 of 6 -- with 493.1407 of this subpart. This CONDITION is not met as evidenced by: The laboratory director failed to maintain compliance with successful proficiency testing for the specialty of hematology, the white blood cell, platelet, white blood cell differential, hemoglobin, red blood cell and hematocrit analytes. (Refer to D6004) D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Service Report 155 (CMS 155), the laboratory's proficiency testing (PT) records, interview with a PT provider representative, patient data logs and patient test reports, and PT evaluation reports, the laboratory director failed to ensure successful PT performance for the specialty of hematology, the white blood cell, platelet, white blood cell differential, hemoglobin, red blood cell and hematocrit analytes. The findings include: 1) Review of the CMS 155 report revealed the following scores: Hematology specialty: 2019 event three = 100%, 2020 event one = 100%, 2020 event three = 73%. White Blood Cell analyte: 2019 event three = 100%, 2020 event one = 100% Platelet analyte: 2019 event three=100%, 2020 event one=100% White Blood Cell Differential: 2019 event three=100%, 2020 event one = 100% Hemoglobin: 2019 event three=100%, 2020 event one = 100% Red Blood Cell analyte: 2019 event three = 100%, 2020 event one = 100%, 2020 event two = 40%, 2020 event three = 0%. Hematocrit analyte: 2019 event three = 100%, 2020 event one = 100%, 2020 event three = 60%. 2) Review of the laboratory's hematology proficiency testing PT evaluation and PT submission reports revealed the following: 2019 event three not graded-scored as 100%- Laboratory reported to the PT program that "Instrument Out of Service." 2020 event one not graded-scored as 100%. Laboratory reported to the PT program "Unable to locate sample, No patient samples being run, test problem." 2020 event two- red blood cell overall score of 40%. 2020 event three-red blood cell overall score of 0%, hematocrit overall score of 60%. 3) Phone interview on December 10, 2020 at 10am with the laboratory's PT provider revealed that the PT samples for 2020 event one were signed for by a representative of the physician's office on 03.10.2020. 4) Review of patient data logs and patient test reports during the PT submission timeframe for 2019 event three and 2020 event one revealed patient testing was performed and reported during the PT submission period for both events. The laboratory director failed to ensure satisfactory PT performance when the laboratory failed to participate in 2019 event three and 2020 event one with patient testing performed and reported during the PT submission period, resulting in the first unsuccessful occurrence for the hematology specialty, white blood cell, platelet, white blood cell differential, -- 5 of 6 -- hemoglobin, red blood cell and hematocrit analytes. 5) Review of the laboratory's subsequent PT evaluation evaluation reports revealed the following: The laboratory failed to maintain satisfactory overall performance for 2020 event three for hematology with a score of 73% resulting in the second unsuccessful PT occurrence for the hematology specialty. The laboratory failed to maintain satisfactory PT performance for the red blood cell analyte for 2020 event two and 2020 event three resulting in the second and third subsequent unsuccessful PT occurrence. The laboratory failed to maintain satisfactory PT performance for the hematocrit analyte for 2020 event three resulting in the second unsuccessful PT occurrence for the hematocrit analyte. The laboratory director failed to ensure successful PT performance for the specialty of hematology, the white blood cell, platelet, white blood cell differential, hemoglobin, red blood cell and hematocrit analytes. -- 6 of 6 --