Complete Care Camp Bowie

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. . D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on the review of the manufacturer's instructions, the laboratory maintenance logs from 1/1/2022 to 8/31/2022, patient records, and confirmed in interview revealed the laboratory failed to document five of 36 weekly, two of eight monthly, and one of three quarterly scheduled maintenance following the manufacturer's instructions on one of one Sysmex XP-300 hematology instrument. The findings were: 1. Review of the manufacturer's instructions titled Sysmex Automated Hematology Analyzer XP- 300 Instructions for Use (North American Edition) (Code No. AU553517. Date of Last Revision: June 2013. Software Version: 00-12 and onwards.) in Chapter 12. Cleaning and Maintenance revealed the following for the XP-300 Hematology analyzer (SN#:A5293). "To ensure proper functioning of the instrument, it is necessary to periodically clean an service the instrument. Perform maintenance according to the schedule below. And record the results in the Maintenance checklist." 2. Further review of the manufacturer's instructions titled Sysmex Automated Hematology Analyzer XP-300 Instructions for Use (North American Edition) in Chapter 12.1 Maintenance schedule revealed: "Weekly Clean SRV tray (see 12.5) Every month (or every 1,500 samples Clean TD (see 12.6) Clean waste chamber (see 12.7) Every 3 month (or every 4,500 samples) Clean SRV (see 12.8)" 3. Review of 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's maintenance logs titled SYSMEX XP 300 MAINTENANCE revealed the following scheduled maintenance's: Weekly Clean SRV tray Monthly Clean RBC and WBC Transducer Clean Waste Chamber Quarterly Clean Sample Rotor Valve (SRV) 4. Further review of the laboratory's maintenance logs from 1/1/22 to 8/31/22 revealed no documentation of the following maintenance. Five of 36 weekly maintenance reviewed 5/8/22-5/14/22 5/22/22-5/28/22 6/12/22-6/18/22 7/24/22-7/30 /22 8/21/22-8/27/22 Two of eight monthly maintenance reviewed June, 2022 July, 2022 One of three quarterly maintenance reviewed June, 2022 5. Review of the laboratory's patient records for the above timeframe revealed 15 patients had CBC testing performed. 5/8/2022 Patient ACCT: 39527 5/8/2022 Patient ACCT: 39530 5/14 /2022 Patient ACCT: 39602 5/27/2022 Patient ACCT: 39778 5/27/2022 Patient ACCT: 39780 5/27/2022 Patient ACCT: 39782 5/27/2022 Patient ACCT: 39783 6/13 /2022 Patient ACCT: 40077 6/14/2022 Patient ACCT: 40085 6/14/2022 Patient ACCT: 40087 7/28/2022 Patient ACCT: 40688 7/29/2022 Patient ACCT: 40696 7/29 /2022 Patient ACCT: 40698 8/21/2022 Patient ACCT: 40991 8/22/2022 Patient ACCT: 40997 6. An interview with the technical consultant on 9/13/2022 at 1:10 pm in the breakroom confirmed the above findings. Key: CBC=Complete Blood Count D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on the review of the manufacturer's product insert, the laboratory's policy, the simulator QC run logs from January 2022 to August 2022, patient records, and confirmed in an interview found the laboratory failed to document a simulator QC run for one of 25 days reviewed following the manufacturer's instructions on cardiac panel test on one of one Alere Triage Meter Pro instrument. The findings were: 1. Review of the manufacturer's product insert titled Triage Cardiac Panel Product Insert (Catalog#: 97000HS. 2014 Alere.) under Testing Patient Specimens Procedural Notes revealed "For each day of patient testing, perform QC Device testing." 2. Further review of the manufacturer's product insert titled Triage Cardiac Panel Product Insert under Quality Control Consideration Performing Alere Triage System revealed "Use the QC Device to ensure proper function of the meter. Perform QC Device testing for the following conditions:...Each day of patient testing...." 3. Review of the laboratory's policy titled Laboratory Procedure Cardiac Panel Triage signed by the LD on 3/3/2020 under C. QC Simulator for Triage Meter revealed "2. QC Simulator Frequency Testing with the QC Simulator is performed: Each day patient tests are performed...." 4. An interview with the technical consultant on 9/13/2022 at 3:00 pm in the lab confirmed QC Device named in the product insert was as the same as QC simulator named by the laboratory. 5. Random review of the Triage simulator QC run logs from 1/1/2022 to 8/31/2022 revealed one of 25 days reviewed did not have documentation of QC simulator run on the day of patient testing on Triage Meter Pro (SN: 77123). 1/30/2022 6. Review the laboratory's patient records for the above date revealed the laboratory performed one patient Cardiac panel testing. 1/30/2022 Patient ACCT: 38164. 7. An interview with the technical consultant on 9/13/2022 at 3:11 pm in the breakroom confirmed the above findings. Key: QC=Quality Control LD=Laboratory Director -- 2 of 3 -- D5461 CONTROL PROCEDURES CFR(s): 493.1256(d)(6)(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-- Perform control material testing as specified in this paragraph before resuming patient testing when a complete change of reagents is introduced; major preventive maintenance is performed; or any critical part that may influence test performance is replaced. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the review of the manufacturer's instructions, the laboratory's reagent replace logs from 3/2/2022 to 8/18/2022, QC logs, patient records, and confirmed in an interview found the laboratory failed to document a quality control run after a change in a reagent for two of four days reviewed on one of one Sysmex XP-300 hematology instrument. The findings were: 1. Review of the manufacturer's instructions titled Sysmex Automated Hematology Analyzer XP-300 Instructions for Use (North American Edition) (Code No. AU553517. Date of Last Revision: June 2013. Software Version: 00-12 and onwards.) in Chapter 4. Reagents revealed two reagents were used in the XP-300 Hematology analyzer (SN#:A5293). Cellpack Stromatolyser-WH 2. Random review of the reagent replace logs from 3/2/2022 to 8 /18/2022 revealed two of four days reviewed had no documentation of a quality control run after the following reagent change on the Sysmex XP-300 hematology analyzer. 3/2/2022 at 1:47 pm Stromatolyser-WH Lot#Y1006 Exp 11/17/2022 8/18 /2022 at 1:19 pm Cellpack Lot#Y2027 Exp 03/20/2023 3. Review of the laboratory's QC logs for the above dates revealed the next QC was performed on the following date and time after reagent changes: Reagent change 3/2/2022 at 1:47 pm Stromatolyser-WH Next QC 3/3/2022 at 00:12 am. Reagent change 8/18/2022 at 1:19 pm Cellpack Next QC 8/19/2022 at 00:06am 4. Review of the patient records for the above dates revealed the laboratory performed nine patient CBC testing after the reagent change with no documentation of a quality control run before next QC runs. 3 /2/2022 at 3:50 pm Patient ACCT: 38586 3/2/2022 at 6:46 pm Patient ACCT: 38588 3 /2/2022 at 10:10 pm Patient ACCT: 38586 8/18/2022 at 2:04 pm Patient ACCT: 40946 8/18/2022 at 3:26 pm Patient ACCT: 40947 8/18/2022 at 7:31 pm Patient ACCT: 40950 8/18/2022 at 8:01 pm Patient ACCT: 40951 8/18/2022 at 10:19 pm Patient ACCT: 40953 8/18/2022 at 10:36 pm Patient ACCT: 40954 5. An interview with the technical consultant on 9/13/2022 at 1:10 pm in the breakroom confirmed the above findings. Key: QC=Quality Control CBC=Complete Blood Count -- 3 of 3 --

Summary Statement of Deficiencies D0000 Laboratory representatives were present at the entrance conference conducted 03/09 /2021. The survey process was discussed. An opportunity for questions and comments was given. The exit conference was held with the laboratory representatives on 03/09 /2021. The laboratory was found to be in substantial compliance for the specialties /subspecialties for which it was surveyed. The standard level deficiencies cited were discussed. The process for submitting the corrections was explained. CMS form 2567 will be emailed from the Texas State Health and Human Services Commission, Health Facility Compliance Arlington Group. 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: I. Based on review of the laboratory's Individualized Quality Control Plan (IQCP), manufacturer's instructions, quality control (QC) records, patient records, and confirmed in interview, the laboratory's IQCP failed to support its reduction in frequency to every 30 days for the MetLac 12 cartridge on the Piccolo Xpress chemistry analyzer. Findings: 1. Review of the laboratory's "Piccolo IQCP (Individualized Quality Control Plan)" for the Metlac12 cartridge stated: "After performing a risk assessment (covering the specimen, the environment, the testing personnel, the reagents and the test system), quality control recommendations and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- verifying our QA plan was sufficient to assess the testing we perform on this meter, there is a manageable risk associated with running liquid QC on this test per the manufacturer's instructions (which is less stringent than what CLIA requires). The manufacturer recommends running external liquid control samples with each new lot /shipment, every 30 days, when training or retraining new operators, when patient results do not match the symptoms or clinical condition or when the laboratory conditions have changed significantly ... We will run external liquid control samples with each new lot/shipment, every 30 days, when training or retraining new operators, when patient results do not match the symptoms or clinical condition or when laboratory conditions have changed significantly" Review of the laboratory's risk assessment revealed: "Additional points QC is run per manufacturer's recommendation and less than the CLIA requirements for 2 levels of controls for each day of patient testing. We performed a 10 day external liquid QC study upon implementation of this analyzer. All values were within the expected ranges. In addition, we have been running waived tests on the Piccolo analyzer with the same QC requirements and have documented the stability of the analyzer through these results." The laboratory's IQCP failed to support its reduction in frequency to every 30 days. 2. Review of the Piccolo Metlac 12 Panel assay sheet revealed: "Quality Control ...Abaxis recommends control testing to follow federal, state, and local guidelines." 3. Review of QC records from December 2020 through February 2021 revealed the laboratory performed quality control on the following dates on the Piccolo Xpress chemistry analyzer Metlac 12 cartridge (random sampling): QC level 1 lot #2004021- 1, expiration date 09/30/21 QC level 2 lot #2004021-2, expiration date 09/30/21 QC level 1 and 2 was performed on 12/18/2020, 01/05/2021, 02/04/2021 4. Review of patient records revealed the laboratory failed to perform QC every day of patient testing. Refer to D5447, I. 5. During an interview on 03/09/2020 at 1:15 pm, technical consultant confirmed the laboratory's IQCP failed to support its reduction in frequency to every 30 days for the Metlac 12 chemistry cartridge. II. Based on review of the laboratory's Individualized Quality Control Plan (IQCP), manufacturer's instructions, quality control (QC) records, patient records, and confirmed in interview, the laboratory's IQCP failed to support its reduction in frequency to every 30 days for the cardiac panel cartridge on the Alere Triage analyzer. Findings: 1. Review of the laboratory's "Triage meter IQCP (Individualized Quality Control Plan)" for the cardiac panel cartridge stated: "After performing a risk assessment (covering the specimen, the environment, the testing personnel, the reagents and the test system), quality control recommendations and verifying our QA plan was sufficient to assess the testing we perform on this meter, there is a manageable risk associated with running liquid QC on this test per the manufacturer's instructions (which is less stringent than what CLIA requires). The manufacturer recommends running external liquid control samples with every 30 days with continued use of the same reagent lot number and with each new lot of reagents ... We will run an internal quality control device (QCD) daily on the Triage meter. We will run liquid external quality control material on new lots/shipments and every 30 days as applicable" Review of the laboratory's risk assessment revealed: "Additional points QC is run per manufacturer's recommendation and less than the CLIA requirements for 2 levels of controls for each day of patient testing. We performed a 10 day external liquid QC study upon implementation of this analyzer. All values were within the expected ranges." The laboratory's IQCP failed to support its reduction in frequency to every 30 days. 2. Review of the Alere Triage user's manual stated: "TOTAL QUALITY ASSURANCE ... QUALITY CONTROL SAMPLES It is still valuable to apply the traditional approach to quality control by testing quality control samples. These controls will check the total intergrety of the system. The interval for analyzing these controls, however, can be extended due to the many other Total Quality Assurance features -- 2 of 7 -- inherent in the Alere Triage tests. The Alere Triage tests have been designed to maximize Total Quality Assurance in any testing environment. The combination of the QC features of the Alere Triage tests reduce the impact of procedural errors, ensure reagent integrity, and assurance that patient results are accurate each and every time a test is performed. Based on CLIA guidelines and other regulating bodies, Alere makes the following QC recommendations: Run two levels of POS and NEG external liquid control samples as appropriate with each new lot of reagents and once every thirty days with continued use of the reagent lot number. Run the QC Device daily." 3. Review of QC records from December 2020 through February 2021 revealed the laboratory performed quality control on the following dates on the Alere Triage analyzer for the cardiac panel cartridge (random sampling): QC level 1 lot #03652, expiration date 05/21 QC level 2 lot #03665, expiration date 05/21 QC level 1 and 2 was performed on 12/07/2020 QC level 1 lot #03654, expiration date 06/04/21 QC level 2 lot #03668, expiration date 06/30/21 QC level 1 and 2 was performed on 01/06 /2021, 01/19/2021 QC level 1 lot #03657, expiration date 09/09/21 QC level 2 lot #03667, expiration date 09/14/21 QC level 1 and 2 was performed on 02/18/2021 4. Review of patient records revealed the laboratory failed to perform QC every day of patient testing. Refer to D5447, II. 5. During an interview on 03/09/2020 at 3:00 pm, technical consultant confirmed the laboratory's IQCP failed to support its reduction in frequency to every 30 days for the cardiac panel cartridge. III. Based on review of the laboratory's Individualized Quality Control Plan (IQCP), manufacturer's instructions, quality control (QC) records, patient records, and confirmed in interview, the laboratory's IQCP failed to support its reduction in frequency to every 30 days for the D-Dimer cartridge on the Alere Triage analyzer. Findings: 1. Review of the laboratory's "Triage meter IQCP (Individualized Quality Control Plan)" for the D- Dimer cartridge stated: "After performing a risk assessment (covering the specimen, the environment, the testing personnel, the reagents and the test system), quality control recommendations and verifying our QA plan was sufficient to assess the testing we perform on this meter, there is a manageable risk associated with running liquid QC on this test per the manufacturer's instructions (which is less stringent than what CLIA requires). The manufacturer recommends running external liquid control samples with every 30 days with continued use of the same reagent lot number and with each new lot of reagents ... We will run an internal quality control device (QCD) daily on the Triage meter. We will run liquid external quality control material on new lots/shipments and every 30 days as applicable" Review of the laboratory's risk assessment revealed: "Additional points QC is run per manufacturer's recommendation and less than the CLIA requirements for 2 levels of controls for each day of patient testing. We performed a 10 day external liquid QC study upon implementation of this analyzer. All values were within the expected ranges." Two levels of liquid QC were NOT performed every 8 hours of operation, as required for nonmanual coagulation test systems. The laboratory's IQCP failed to support its reduction in frequency to every 30 days. 2. Review of the Alere Triage user's manual stated: "TOTAL QUALITY ASSURANCE ... QUALITY CONTROL SAMPLES It is still valuable to apply the traditional approach to quality control by testing quality control samples. These controls will check the total intergrety of the system. The interval for analyzing these controls, however, can be extended due to the many other Total Quality Assurance features inherent in the Alere Triage tests. The Alere Triage tests have been designed to maximize Total Quality Assurance in any testing environment. The combination of the QC features of the Alere Triage tests reduce the impact of procedural errors, ensure reagent integrity, and assurance that patient results are accurate each and every time a test is performed. Based on CLIA guidelines and other regulating bodies, Alere makes the following QC recommendations: Run two levels of POS and NEG external liquid control samples as appropriate with each new -- 3 of 7 -- lot of reagents and once every thirty days with continued use of the reagent lot number. Run the QC Device daily." 3. Review of QC records from December 2020 through February 2021 revealed the laboratory performed quality control on the following dates on the Alere Triage analyzer for the D-Dimer cartridge (random sampling): QC level 1 lot #C3654, expiration date 06/04/21 QC level 2 lot #C3667, expiration date 06/17/21 QC level 1 and 2 was performed on 12/11/2020, 01/02/2021 QC level 1 lot #C3654, expiration date 06/04/21 QC level 2 lot #C3658, expiration date 06/30/21 QC level 1 and 2 was performed on 01/14/2021 QC level 1 lot #C3657, expiration date 07/09/21 QC level 2 lot #C3669, expiration date 07/14/21 QC level 1 and 2 was performed on 02/10/2021 4. Review of patient records revealed the laboratory failed to perform two levels of liquid QC every 8 hours of patient testing. Refer to D5545. 5. During an interview on 03/09/2020 at 3:00 pm, technical consultant confirmed the laboratory's IQCP failed to support its reduction in frequency to every 30 days and failed to test two samples of control material each 8 hours of testing for the D-Dimer cartridge. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: I. Based on review of manufacturer's instructions, laboratory policies, quality control (QC) records, patient records, and confirmed in interview, the laboratory failed to perform two levels of control each day of patient testing on the Piccolo Xpress analyzer for the Metlac 12 cartridge for 10 of 10 days in 2021 (random sampling 01 /2021-02/2021). Findings: 1. Review of the Piccolo Metlac 12 Panel assay sheet revealed: "Quality Control ...Abaxis recommends control testing to follow federal, state, and local guidelines." 2. Review of laboratory policies revealed the laboratory developed an Individualized Quality Control Plan (IQCP) to modify the quality control frequency for each day of patient testing to implement monthly quality control. The IQCP failed to support its reduction in frequency to every 30 days for the Metlac 12 cartridge on the Piccolo Xpress analyzer. Refer to D5445, I. 3. A random sampling of QC and patient records from January 2021 through February 2021, revealed the following dates QC was not performed and patients were tested on the Piccolo Xpress analyzer for the Metlac 12 cartridge: 02/01/2021- Patient ID:32113 02 /03/2021- Patient IDs: 32127, 32128, 32126 QC last performed on 01/05/2021 02/17 /2021- Patient IDs: 32268, 32266, 02/18/2021- Patient ID: 32288 02/19/2021- Patient ID: 32303 02/20/2021- Patient IDs: 32312, 32319 02/21/2021- Patient ID: 32326 02 /23/2021- Patient IDs: 32356, 32349 02/24/2021- Patient ID: 32366 02/25/2021- Patient IDs: 32378, 32370 QC last performed on 02/04/2021 Note: The Metlac 12 cartridge tested for the following chemistry analytes: glucose, blood urea nitrogen (BUN), creatinine, sodium, potassium, chloride, carbon dioxide, calcium, phosphorus, magnesium, albumin, and lactate. 4. During an interview on 03/09/2021 at 1:15 pm, the technical consultant confirmed the laboratory failed to perform QC every day of patient testing. II. Based on review of manufacturer's instructions, laboratory policies, quality control (QC) records, patient records, and confirmed in interview, the laboratory failed to perform two levels of control each day of patient testing on the -- 4 of 7 -- Alere Triage for the cardiac cartridge for 6 of 6 days in 2021 (random sampling 01 /2021-02/2021). Findings: 1. Review of the Alere Triage user's manual stated: "TOTAL QUALITY ASSURANCE ... QUALITY CONTROL SAMPLES It is still valuable to apply the traditional approach to quality control by testing quality control samples. These controls will check the total intergrety of the system. The interval for analyzing these controls, however, can be extended due to the many other Total Quality Assurance features inherent in the Alere Triage tests. The Alere Triage tests have been designed to maximize Total Quality Assurance in any testing environment. The combination of the QC features of the Alere Triage tests reduce the impact of procedural errors, ensure reagent integrity, and assurance that patient results are accurate each and every time a test is performed. Based on CLIA guidelines and other regulating bodies, Alere makes the following QC recommendations: Run two levels of POS and NEG external liquid control samples as appropriate with each new lot of reagents and once every thirty days with continued use of the reagent lot number. Run the QC Device daily." 2. Review of laboratory policies revealed the laboratory developed an Individualized Quality Control Plan (IQCP) to modify the quality control frequency for each day of patient testing to implement monthly quality control. The IQCP failed to support its reduction in frequency to every 30 days for the cardiac cartridge on the Alere Triage analyzer. Refer to D5445, II. 3. A random sampling of QC and patient records from January 2021 through February 2021, revealed the following dates QC was not performed and patients were tested on the Alere Triage analyzer for the cardiac cartridge: 02/11/2021- Patient ID: 32216 02/16 /2021- Patient IDs: 32255, 32254 QC last performed 01/19/2021 02/28/2021- Patient ID: 32402 03/04/2021- Patient ID: 32447 03/05/2021- Patient ID: 32458 03/08/2021- Patient ID: 32489 Note the cardiac cartridge tested for troponin, myoglobin and creatinine kinase-MB (CK-MB) analytes. 4. During an interview on 03/09/2021 at 3: 00 pm, the technical consultant confirmed the laboratory failed to perform QC every day of patient testing. D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) 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 manufacturer's instructions, laboratory policies, quality control (QC) records, patient records, and confirmed in interview, the laboratory failed to perform two levels of liquid QC material each 8 hours of operation for the D-Dimer analyte on the Alere Triage analyzer for 6 of 6 days in 2021 (random sampling). Findings: 1. Review of the Alere Triage user's manual stated: "TOTAL QUALITY ASSURANCE ... QUALITY CONTROL SAMPLES It is still valuable to apply the traditional approach to quality control by testing quality control samples. These controls will check the total intergrety of the system. The interval for analyzing these controls, however, can be extended due to the many other Total Quality Assurance features inherent in the Alere Triage tests. The Alere Triage tests have been designed to maximize Total Quality Assurance in any testing environment. The combination of the QC features of the Alere Triage tests reduce the impact of procedural errors, ensure reagent integrity, and assurance that patient results are accurate each and every time a test is performed. Based on CLIA guidelines and other regulating bodies, Alere -- 5 of 7 -- makes the following QC recommendations: Run two levels of POS and NEG external liquid control samples as appropriate with each new lot of reagents and once every thirty days with continued use of the reagent lot number. Run the QC Device daily." 2. Review of laboratory policies revealed the laboratory developed an Individualized Quality Control Plan (IQCP) to modify the quality control frequency for each day of patient testing to implement monthly quality control. The IQCP failed to support its reduction in frequency to every 30 days for D-Dimer on the Alere Triage analyzer. Refer to D5445, III. 3. A random sampling of QC and patient records from January through February 2021, revealed the following dates QC was not performed each 8 hours of testing using two levels of control materials on each day of patient testing and patients were analyzed for the D-Dimer analyte on the Alere Triage meter: 02/11 /2021- Patient ID: 32216 02/16/2021- Patient IDs: 32255, 32254 02/24/2021- Patient IDs: 32361, 32363 02/25/2021- Patient ID: 32371 03/05/2021- Patient ID: 32458 03 /08/2021- Patient ID: 32489 QC was last performed on 02/10/2021 at 8:43 am The laboratory failed to include two levels of liquid QC material and electronic QC each 8 hours of operation for the D-Dimer analyte on the Alere Triage analyzer. 4. During an interview on 03/09/2021 at 3:00 pm, the technical consultant confirmed the above findings. D5781

Summary Statement of Deficiencies D0000 The Complete Care Camp Bowie clinical laboratory is not in compliance with the 42 CFR Part 493, Requirements for Laboratories. Biennial certification survey was conducted 07/18/19. Standard level deficiencies were cited as follows: D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review of American Proficiency Institute (API) proficiency testing and interview with the Technical Consultant the laboratory failed to score at least 80% for White Blood Cell (WBC) differential for 1 (3rd testing event 2017) out of 6 (1st, 2nd testing event 2019, 1st, 2nd, 3rd testing event 2018, and 3rd testing event 2017) testing events reviewed. Findings Included: Review of API proficiency testing for WBC differential revealed a score of 0% in the 3rd testing event in 2017. Interview on 07/18/19 at 10:30 AM the Technical Consultant confirmed the proficiency testing failure in the 3rd testing event of 2017 in WBC differential. 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 --