Richardson Medical Center

Summary Statement of Deficiencies D0000 A Certification survey was performed on January 25, 2024 at Richardson Medical Center Respiratory, CLIA ID # 19D0713341. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 review of the laboratory's policy, CMS 209 form, personnel records and interview with personnel, the laboratory failed ot follow their established competency assessment policy for nine (9) of nine (9) testing personnel reviewed in 2022 and 2023. Findings: 1. Review of the laboratory's "Arterial Blood Gas Specimen Collection Competency and Checklist" policy revealed " Competency for each person to perform his/her duties must be assessed: Following training within 90 days; During the first year of employment that an individual tests specimens, competency must be assessed at least every six months; Annually thereafter (usually done in conjunction with employee annual performance evaluation); If an employee fails to demonstrate satisfactory performance on a competency assessment must be reassessed following

Summary Statement of Deficiencies D0000 A Recertification Survey was performed at Richardson Medical Center Respiratory- CLIA # 19D0713341 on April 29, 2022. Richardson Medical Center Respiratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803 CONDITION: Successful Participation 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing; Laboratory Director 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 observation during the laboratory tour, review of laboratory's policies and procedures and proficiency testing results as well as interview with personnel, the 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 -- laboratory failed to successfully participate in proficiency testing for two (2) of six (6) events reviewed. Findings: 1. The laboratory failed to achieve a score of at least 80% for pO2 in two (2) of six (6) consecutive events reviewed, resulting in an initial unsuccessful performance for 2020 and 2021: a) CAP AQ-B 2020 Crit Care/Aqueous Blood Gas: score received 60% b) CAP AQ-C 2020 Crit Care/Aqueous Blood Gas: score received 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 review of the proficiency testing results from the CASPER 155D report, laboratory's proficiency test records and interview with personnel, the laboratory failed to achieve a score of at least 80% for pO2 in two (2) of six (6) consecutive events reviewed, resulting in an initial unsuccessful performance for 2020 and 2021. Findings: 1. Review of the CASPER 155D report and the laboratory's College of American Pathologists (CAP) proficiency test records from 2020 and 2021 for pO2 revealed the laboratory received the following scores in two (2) of six (6) events reviewed: a) CAP AQ-B 2020 Crit Care/Aqueous Blood Gas: score received 60% b) CAP AQ-C 2020 Crit Care/Aqueous Blood Gas: score received 0% 2. Further review of the laboratory's proficiency test records revealed the laboratory did have remedial action documentation for each of the identified events. 3. In interview on April 29, 2022 at 2:34 pm, Personnel 10 stated the 2nd event failure in 2020 was due to personnel error in running the sample and the 3rd event failure in 2020 was due to clerical errors in the submitting of results. Personnel 10 confirmed the above identified events did not receive score of 80% or greater. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of manufacturer's instrument manual and temperature logs as well as interview with personnel, the laboratory failed to monitor the room humidity where the Roche Cobas b 221 Blood Gas analyzer is utilized for twenty-seven (27) of twenty seven (27) months reviewed. Findings: 1. Observation by surveyor during the laboratory tour on April 29, 2022 at 2:00 pm revealed the laboratory utilizes the Roche Cobas b 221 Chemistry analyzer for Arterial Blood Gas (ABG) testing. 2. Review of the manufacturer's instrument manual under "Environmental parameters" revealed "Operating Conditions for Relative Humidity 20 -- 2 of 3 -- - 85%. 3. Review of the laboratory's Daily Temperature Log from January 2020 through March 2022 revealed the laboratory did not document humidity readings for each day of operation. 4. In interview on April 29, 2020 at 3:24 pm, Personnel 10 confirmed the laboratory did not document the humidity each day of patient testing. 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 with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on observation by surveyor, review of laboratory records, and interview with personnel, the Laboratory Director failed to provide overall management and direction for the laboratory. Findings: 1. The Laboratory Director failed to ensure the laboratory followed the

Summary Statement of Deficiencies D0000 A Certification Survey was performed at Richardson Medical Center-CLIA ID # 19D0713341 on January 31, 2018. Richardson Medical Center was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1210 CONDITION: Routine Chemistry 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing, Laboratory Director D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: ***REPEAT DEFICIENCY from survey May 23, 2016*** Based on record review and interview with personnel, the laboratory failed to ensure the Laboratory Director and Testing Personnel signed the attestation statement for one (1) of three (3) proficiency testing (PT) events reviewed. Findings: 1. Review of the laboratory's "Proficiency Log" revealed Personnel 5, Personnel 7, and Personnel 13 performed proficiency testing for the 2017 Blood Gas 3rd Event. 2. Review of the laboratory's WSLH Proficiency records for 2017 revealed the laboratory did not have documentation of the following: a) 2017 Blood Gas 3rd Event: Laboratory Director signature on the attestation statement b) 2017 Blood Gas 3rd Event: signature of all testing personnel who performed testing on the attestation statement 2. Further review of the laboratory's 2017 Blood Gas 3rd Event PT records revealed only Personnel 5 signed as an "analyst" on the attestation statement and Personnel 10 signed as Laboratory Director/Designee. 3. In interview on January 31, 2018, Personnel 10 confirmed the 2017 Blood Gas 3rd Event's attestation statement was not signed by the identified personnel. 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 -- D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observation, record review, and interview with personnel, the laboratory failed to ensure the quality of testing in the specialty of Routine Chemistry. Findings: 1. The laboratory failed to ensure the Laboratory Director and Testing Personnel signed the attestation statement for one (1) of three (3) proficiency testing (PT) events reviewed. Refer to D2009. 2. The laboratory failed to follow their established policy for competency assessment. Refer to D5401 I. 3. The laboratory failed to establish a policy for twice a year comparison testing for blood gas testing performed on the Opti CCA-TS. Refer to D5401 II. 4. The laboratory failed to label control material for the Cobas b 221 with expiration dates for proper use. Refer to D5415. 5. The laboratory failed to ensure reagents have not exceeded their expiration date. Refer to D5417. 6. The laboratory failed to have a complete Individualized Quality Control Plan (IQCP). Refer to D5445 I. 7. The laboratory failed to perform external controls monthly per the laboratory's Individualized Quality Control Plan (IQCP). Refer to D5445 II. 8. The laboratory failed to have a system in place for twice a year comparison testing for blood gas testing performed on the Opti CCA-TS. Refer to D5775. 9. The laboratory's Quality Assurance monitors failed to identify and correct quality issues. Refer to D5793. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: I. Based on record review and interview with personnel, the laboratory failed to follow their established policy for competency assessment. Findings: 1. Review of the laboratory's "Competency" policy revealed the following: "Laboratory testing employees will be assessed to be competent to fulfill their duties as laboratory personnel as required by federal regulation by the following methods: a) Direct observation of routine patient test performance, including patient preparation, specimen handling, processing and testing. b) Monitoring the recording and reporting of the test results c) Review of test results, quality control records, proficiency testing results, and preventive maintenance records d) Direct observation of performance of instrument maintenance and function checks e) Assessment of test performance through testing previously analyzed specimens, or external proficiency testing samples f) Assessment of problem solving skills" 2. Review of personnel records revealed the laboratory utilizes a checklist "ABG Skills Analysis" form and "Blood Gas Laboratory" form with "Patient Comparison Samples" and "Quality Controls: Manual" sections. 3. Review of the laboratory's forms for personnel competency revealed the forms did not include "Direct observation" of tasks as listed in policy. 4. -- 2 of 9 -- In interview on January 31, 2018 at 10:06 am, Personnel 10 stated the identified forms are what the laboratory utilizes to perform competency assessments. In further interview, Personnel 10 confirmed the competency assessment forms did not reflect the six (6) required procedures. II. Based on observation, record review and interview with personnel, the laboratory failed to establish a policy for twice a year comparison testing for blood gas testing performed on the Opti CCA-TS. Findings: 1. Observation by surveyor during laboratory tour on January 31, 2018 revealed the laboratory utilizes the Cobas b 221 and the Opti CCA-TS for blood gas analysis. 2. In interview on January 31, 2018 at 9:05 am, Personnel 10 stated the Opti CCA-TS is utilized as the back-up analyzer for blood gas testing. 3. Review of the laboratory's policy and procedure manual revealed the laboratory did not have a written policy for twice a year comparison testing for the Opti-CCA-TS. 4. In interview on January 31, 2018 at 11:38 am, Personnel 10 confirmed the laboratory did not have a written policy for comparison testing on the blood gas back-up analyzer . D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the laboratory failed to label control material for the Cobas b 221 with expiration dates for proper use. Findings: 1. Observation by surveyor during the laboratory tour on January 31, 2018 revealed the laboratory stored the following controls at room temperature without documentation of expiration dates: a) Cobas AUTO-TROL PLUS B Level 1, Lot # 21460753, Quantity 1 box, Shipment received November 13, 2017 b) Cobas AUTO-TROL PLUS B Level 1, Lot # 21460757, Quantity 1 box, Shipment received June 28, 2017 c) Cobas AUTO-TROL PLUS B Level 3, Lot # 21460946, Quantity 1 box, Shipment receive date not documented d) Cobas AUTO-TROL PLUS B Level 2, Lot # 21460850, Quantity 1 box, Shipment received November 13, 2017 e) Cobas AUTO-TROL PLUS B Level 2, Lot # 21460850,Quantity 1 box, Shipment received June 23, 2017 2. Review of the Cobas AUTO-TROL PLUS B package insert under the storage and stability section revealed the following requirements: "Unopened in the closed box: -Up to the stated expiration date at 2-8 degrees Celsius -Up to 3 months at room temperature -Up to 60 days on the AutoQC module Do not freeze. Roche Diagnostics cannot guarantee the performance of the quality control when stored outside of recommended range." 3. In interview on January 31, 2018 at 2:30 pm, Personnel 10 stated the identified controls stored at room temperature were not labeled with expiration dates. 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. -- 3 of 9 -- This STANDARD is not met as evidenced by: Based on observation and interview with personnel, the laboratory failed to ensure reagents have not exceeded their expiration date. Findings: 1. Observation by surveyor during the laboratory tour on January 31, 2018 revealed the following expired items: a) pCO2 Electrode, Lot # 21561850, Expiration date: 2016-11-04, Quantity: 1 electrode b) pCO2 Electrode, Lot # 21570549, Expiration date: 2017-08- 04, Quantity: 1 electrode 2. In interview on January 31, 2018 at 9:15 am, Personnel 10 stated the instrument will not allow you to install expired reagents. Personnel 10 confirmed the identified electrodes were expired. 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 observation, record review, and interview with personnel, the laboratory failed to have a complete Individualized Quality Control Plan (IQCP). Findings: 1. Observation by surveyor during the laboratory tour on January 31, 2018 revealed the laboratory utilizes the Cobas b 221 for blood gas testing. 2. Review of the laboratory's IQCP "Quality Control Plan" revealed the following sections: a) External QC Samples: "External QC samples (Levels 1, 2, 3) to be analyzed monthly." b) Internal Procedural control c) Proficiency Testing d) Maintenance/Function Checks e) Training f) Required Quality Assessment Plan Monitoring: "Quality Control Assessment Plan to be reviewed annually." 3. Further review of the laboratory's IQCP documents, effective January 1, 2016, revealed the following components were not included: a) In-house QC data to support the reduction of performing external controls as listed above b) Effective Quality Assessment Plan c) Signature/approval by Laboratory Director 4. In interview on January 31, 2018 at 12:45 pm, Personnel 10 stated he thought the laboratory had quality control data for thirty (30) days, but was unable to find it. 5. In further interview on January 31, 2018 at 2:10 pm, Personnel 10 confirmed the IQCP documents were signed by himself, not the Laboratory Director. 6. Review of the laboratory's Task 1 and 3 forms revealed the laboratory performs 1,600 blood gas tests annually. II. Based on observation, record review, and interview with personnel, the laboratory failed to perform external controls monthly per the laboratory's Individualized Quality Control Plan (IQCP). Findings: 1. Observation by surveyor during the laboratory tour on January 31, 2018 revealed the laboratory utilizes the Cobas b 221 for blood gas testing. 2. Review of the laboratory's Individualized Quality Control Plan (IQCP) documents revealed "External QC samples (Levels 1, 2, 3) to be analyzed monthly." 3. Review of the laboratory's QC records for September 2017 through December 2017 revealed the laboratory did not perform external QC monthly. 4. In interview on January 31, 2018 at 2:10 pm, Personnel 10 confirmed the laboratory did not perform external QC monthly. Personnel 10 stated he was unable to determine that the external QC was performed -- 4 of 9 -- each month. 5. Review of the laboratory's Task 1 and 3 forms revealed the laboratory performs 1,600 blood gas tests annually. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: ***REPEAT DEFICIENCY from survey May 23, 2016*** Based on observation, record review, and interview with personnel, the laboratory failed to have a system in place for twice a year comparison testing for blood gas testing performed on the Opti CCA-TS. Findings: 1. Observation by surveyor during laboratory tour on January 31, 2018 revealed the laboratory utilizes the Cobas b 221 and the Opti CCA-TS for blood gas analysis. 2. In interview on January 31, 2018 at 9:05 am, Personnel 10 stated the Opti CCA-TS is utilized as the back-up analyzer for blood gas testing. 3. In further interview on January 31, 2018 at 11:38 am, Personnel 10 stated three samples are run annually on the Cobas and Opti analyzers for a comparison. 4. Review of the laboratory's 2017 records revealed the laboratory did not have documentation of an annual comparison of three (3) samples on the Cobas and Opti analyzers. 5. In further interview on January 31, 2018 at 11:38 am, Personnel 10 stated he did not see where the comparison between the two analyzers was performed in 2017. 6. In interview on January 31, 2018 at 12:50 pm, Personnel 10 stated it had been years since the laboratory used the Opti for patient testing. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of