Roundup Memorial Healthcare

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on record review and interview with Technical Supervisor (TS) #1, the laboratory failed to ensure the laboratory was enrolled in an HHS-approved proficiency testing program for Hematology (Complete Blood Counts (CBC) with differential: Cell Identification, WBC Differential, Erythrocyte Count, Hematocrit, Hemoglobin, Leukocyte Count, Platelet Count), Chemistry (Blood Gas: PH, pCO2, pO2) and (Alcohol), Immunology (Infectious Mononucleosis), Mycology (KOH Preps), Parasitology (Wet Preps), and Urinalysis (Microscopic Urinalysis) from January 1, 2021 to May 06, 2022. See D6088 and D6116 Findings: 1. A review of Test Volume Report revealed 3972 Complete Blood Counts with automated differentials (CBC), 55 manual White Cell differentials, 102 Blood Gas, 108 Ethyl Alcohol, 18 Infectious Mononucleosis, 2 KOH, 8 Wet Preps, 2 Stool prep for WBC were performed from November 1, 2021 to November 1, 2022 (12 months). 2. A review of 2021 and 2022 American Proficiency Institute (API), testing program records lacked documentation of proficiency testing for all of year 2021 and the 1st Event of 2022. 3. An interview on November 1, 2022, at 10:30 AM with the TS #1 confirmed the laboratory failed to enroll in an HHS-approved proficiency testing program for Complete Blood Counts (CBC) with differential: Cell Identification, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- WBC Differential, Erythrocyte Count, Hematocrit, Hemoglobin, Leukocyte Count, Platelet Count, PH, pCO2, pO2, Alcohol, Infectious Mononucleosis, KOH Preps, Wet Preps, Stool prep for WBC and Microscopic Urinalysis from January 1, 2021 to May 06, 2022 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 record review, and interview with the Technical Supervisor (TS) #1, the laboratory failed to retain the quality control (QC) documentation for D-Dimer performed on the Triage Analyzer for the year 2021. Findings: 1. No QC documentation for D-Dimer performed in 2021 on the Triage Analyzer were available for review. 2. Interview on November 01. 2022 at 2:00 PM with TS #1 confirmed the QC documentation for D-Dimer performed on the Triage Analyzer was not retained for the year 2021. 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 a record review and an interview with the Technical Supervisor (TS) #1, the laboratory failed to follow their procedures and perform competency assessment for two out of three Technical Supervisors and one out of one General Supervisor (GS) listed on the CLIA CMS-209 Personnel Report form. Findings: 1. A record review of the CMS-209 Personnel Report Form revealed two out of three TS and one out of one GS listed failed to have either an initial and six-month competency review for new personnel or an annual competency assessment performed for the year 2022. 2. A review of Competency Assessment Plan revealed the laboratory failed to follow their policy and procedure as stated, "The following staff will need to complete an annual competency (as applicable): A. Technical Staff; B. General Supervisor; C. Technical Supervisor". 3. An interview on November 01, 2022, at 11:00 AM, confirmed the laboratory failed to follow their policy and procedure and perform competency assessments for the positions of technical supervisors and general supervisor listed on the CMS-209 Personnel Report Form from January 1, 2022 to November 1, 2022 D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. -- 2 of 9 -- This STANDARD is not met as evidenced by: Based on a review of testing and proficiency testing records for 2021 and 2022, and interview with the Technical Supervisor (TS) #1, the laboratory failed to perform twice annually accuracy verification or proficiency testing for two of two analytes (PSA and ESR) during January 1, 2021 to May 6, 2022 and for seven of seven new analytes (glycated hemoglobin (A1c), ammonia, C-Reactive Protein (CRP), Ferritin, N-terminal pro b-type natriuretic peptide (NT-proBNP), Vitamin B12 and Vitamin D) from November 1, 2021 to May 6, 2022. Findings: 1. A review of proficiency testing records for 2021 and 2022 lacked documentation of American Proficiency Institute (API) testing records or twice annually accuracy verification studies as follows: ESR and PSA from January 1, 2021 to May 6, 2022; and new analytes (A1c, ammonia, CRP, Ferritin, NT-proBNP, Vitamin B12 and Vitamin D) from November 1, 2021 to May 6, 2022. 2. A review of Test Volume Report revealed 451 A1c, 35 Ammonia, 220 CRP, 131 Ferritin, 246 NT-proBNP, 286 PSA, 54 Vitamin B12, and 278 Vitamin D were performed from November 1, 2021 to November 1, 2022 (12 months). 3. A review of Proficiency Testing policy and procedures revealed the laboratory failed to follow their procedure as stated, "4. Any analytes for which compatible proficiency testing specimens are not available will undergo and alternative performance assessment approved by the laboratory medical director and performed twice per year." 4. An interview with the TS #1 on November 1, 2022, at 10:40 AM confirmed the laboratory failed to follow their procedure and perform either a proficiency testing program or a twice-yearly accuracy verification for the analytes listed above. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D3021 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(1) Blood and blood products storage and distribution. If a facility stores or maintains blood or blood products for transfusion outside of a monitored refrigerator, the facility must ensure the storage conditions, including temperature, are appropriate to prevent deterioration of the blood or blood product. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with Technical Supervisor (TS) #2, the laboratory failed to ensure the appropriate temperature is maintained during the time blood and blood products are shipped for years 2019 and 2020. Findings: 1. Review of Immunohematology records lacked documentation of visual inspection and temperature of blood and blood products upon receipt of new shipments for years 2019 and 2020. 2. Observation of shipping containers revealed the lack of thermometers to monitor blood or blood components temperatures during shipment and upon receipt. 3. Review of Vitalant website revealed, "The receiving hospital must inspect the packing configuration and document acceptability, measure and record the receipt temperature of the shipment, verify shipper contents and sign the "Received By" section of the form, recording the date and time of receipt. Send a completed copy of the form to the local Vitalant center and retain a copy at the facility." 4. Interview with TS#2 on April 28, 2021 at 12:30 PM, confirmed the laboratory failed to ensure appropriate monitoring of blood and blood products during shipment and document acceptability, measure and record the receipt temperature of the shipment for years 2019 and 2020. . D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (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 3 -- (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of policy and procedure manual, laboratory records and interview with the Technical Supervisor (TS)#2, the laboratory failed to document the intended staining characteristics for each day manual differentials slides were stained. Findings include: 1. Review of hematology records revealed the laboratory failed to document the staining quality of manual differential slides each day of staining for years 2019 and 2020. 2. Review of policy # LAB 07.74, lacked how the laboratory would document staining quality control checks on manual differentials slides. 3. Interview on April 26, 2020 at 10:30 AM with TS #2, confirmed the laboratory failed to document staining quality of manual differential slides for years 2019 and 2020. . D5553 IMMUNOHEMATOLOGY CFR(s): 493.1271(b)(f) (b) Immunohematological testing and distribution of blood and blood products. Blood and blood product testing and distribution must comply with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); and 640.11(b). (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 records, policy and procedure manual, and interview with the Testing Personnel (TP)#3; (3 of 4), the laboratory failed to document visual inspection and record temperature upon receipt of new shipments of blood and blood products for 2019 and 2020 Findings: 1. No documentation of visual inspection and temperature of blood and blood products upon receipt of new shipments for years 2019 and 2020 were available for review. 2. Review of policy, Lab 11.30 Storage of Biologicals-Blood Products states "1. Inspect blood products/blood units prior to storage" 3. Review of policy, Shipping/Distribution (121A) states "Blood Component receipt temperature must be documented." 4. Interview with TP#3 on April 28, 2021 at 11:30 AM, stated the laboratory does not document visual inspection and temperature upon receipt of new shipments of blood and blood products upon arrival. . D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on record review and interview with the Technical Supervisor (TS)#2, the laboratory failed to include the normal reference ranges in the patient results report for Microscopic Urine Analysis (UA): white blood cells (WBC), red blood cells (RBC), -- 2 of 3 -- and epithelial cells. Findings: 1. Review of Microscopic Urine Analysis results for patient results report: Accession #19-245-1011 lacked a normal reference range for UA Micro Exam: WBS, RBC, and Epithelial Cells. 2. Interview on April 28, 2021 9: 17 AM with (TS)#2 confirmed the lack of normal reference ranges on the Microscopic Urine analysis patient results report. . -- 3 of 3 --