Burbank Rehabilitation Center

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on record review, proficiency testing (PT) reports, and interview, the laboratory failed to review and evaluate the results obtained on proficiency testing performed in Blood Gas Chemistry during 2021. Findings include: 1. The College of American Pathologists (CAP) PT programs' reports for the years 2019 through 2021 and procedures manual were reviewed. 2. CAP- PT reports revealed the laboratory received the following scores for Event #2, 2021: *PH BLOOD GAS = 100% *P02 BLOOD GAS = 100% *PCO2 BLOOD GAS = 80% 3. The laboratory failed to follow its PT policy and implement procedures to review and evaluate all PT results received. 4. On a Recertification survey 10/05/2021 at 1:20 PM, the laboratory director confirmed the above findings. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. 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 STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview, the laboratory failed to accurately and reliably enter test results into the patient's electronic medical records (EMR), for two out of six patients. Findings include: 1. The laboratory's procedure manual, six randomly selected patients' i-STAT test records from 12/2019 to 09/2021, and patients' electronic records were reviewed. 2. The patients' results and electronic medical records (EMR) reports revealed that two out of four patients' results were entered incorrectly into the patients chart. 3. The laboratory failed to ensure the information from test results were accurately and reliably entered into the patients' EMR. 4. On a Recertification survey 10/05/2021 at 1:20 PM, the laboratory director confirmed the above findings. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in transcribing patients' results, affecting two out six patients. Findings include: 1. The laboratory's procedures manual, patients' electronic records, and patients' test logs were reviewed. 2. Review of six patients' reports revealed two out of six patients test results were transcribed incorrectly into their electronic medical record (EMR). See D5801. 3. The procedures manual failed to establish a policy and procedure for monitoring and preventing transcription errors when reporting patient results into EMR. 4. On a Recertification survey 10/05/2021 at 1:20 PM, the laboratory director confirmed the above findings. 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 record review, the Laboratory Personnel Report (CMS 209), and interview, the technical consultant (TC) failed to evaluate the competency of all testing personnel and assure that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently for two out of two testing personnel (TP) performing Blood Gas Chemistry testing. Findings: 1. The CMS 209, personnel records, and the laboratory's Performance/Competency Testing policies were reviewed. 2. The Competency Assessment policy states the following TC responsibility: "Evaluate and document testing personnel performance at least semiannually for the first year and annually there after." 3. The personnel records and CMS 209 revealed from 7-8-20 to 7-7-2021 no annual competency assessments was performed for two of two TP as outlined in the laboratory procedure. 4. On a -- 2 of 3 -- Recertification survey 10/05/2021 at 1:20 PM, the laboratory director confirmed the above findings. D6056 CLINICAL CONSULTANT CFR(s): 493.1415 The laboratory must have a clinical consultant who meets the qualification requirements of 493.1417 of this part and provides clinical consultation in accordance with 493.1419 of this part. This CONDITION is not met as evidenced by: Based on record review, Clinical Laboratory Improvement Amendments (CLIA) application (CMS 116), the Laboratory Personnel Report (CMS 209), and interview, the laboratory failed to have an employee who meets the qualification requirements and provide clinical consultation (CC) for the Blood Gas testing performed (D6057), affecting 159 patients. D6057 CLINICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1417 The clinical consultant must be qualified to consult with and render opinions to the laboratory's clients concerning the diagnosis, treatment and management of patient care. The clinical consultant must-- (a) Be qualified as a laboratory director under 493. 1405(b)(1), (2), or (3)(i); or (b) Be a doctor of medicine, doctor of osteopathy or doctor of podiatric medicine and possess a license to practice medicine, osteopathy or podiatry in the State in which the laboratory is located. This STANDARD is not met as evidenced by: Based on record review, the Laboratory Personnel Report (CMS 209), Clinical Laboratory Improvement Amendments (CLIA) application (CMS 116), and interview, the laboratory failed to employ a clinical consultant (CC) for the Blood Gas testing performed in the laboratory. Findings: 1. The CMS 209, personnel files, and CMS 116 application signed by the laboratory director (LD) on 10/05/2021 were reviewed. 2. The CMS 209 was reviewed and found the laboratory director (LD) failed to designate and ensure employment of a qualified CC for the laboratory. 3. The personnel files revealed that since June 06, 2020, the laboratory failed to have a qualified CC. 4. Review of the CMS 116 showed the laboratory performed 159 patients' tests annually. 5. On a Recertification survey 10/05/2021 at 1:20 PM, the LD confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to perform proficiency testing (PT) using the laboratory's primary method of testing. Findings: 1. At 10:00 AM on August 13, 2019, the surveyor was escorted to the laboratory. 2. The surveyor observed that the following blood gas analyzers were in the laboratory: A. IRMA B. i-STAT 1 3. Review of PT records revealed that the laboratory tested PT samples using both analyzers. 4. The Technical Consultant stated that PT was performed on both the IRMA and i-STAT 1, because they wanted to ensure that both analyzers performed properly. She said the i-STAT 1 is their primary method of testing and that the IRMA would be their backup system. 5. The Technical Consultant confirmed the surveyor's findings. D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an 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 -- authorized person. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to have a written or electronic request for patient testing from an authorized person when it performed blood gas testing on patient specimens. Findings: 1. At 1:30 PM on August 13, 2019, the surveyor selected a patient tracer for review. The tracer included the following records: A. Patients' test result B. The Test Order C. Quality Control Records 2. The Test Order was not available for review. 3. In an interview with testing personnel, it was revealed that the laboratory did not keep the test orders in the laboratory. Testing Personnel told the surveyor that the orders are filed in the patients' physical charts, along with the test results. The test order could not be retreived from the patient's chart. She also stated that sometimes the laboratory is given verbal orders for blood gases. There was no documentation to show when verbal orders for blood gas testing are given. 4. At 1:40 on August 13, 2019, the Technical Consultant confirmed the surveyor's findings. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for blood gas testing performed. Findings: 1. The laboratory failed to have an all-inclusive comprehensive procedures manual. See D5403 2. The laboratory had 2 blood gas analyzers. The Technical Consultant recommended which analyzer the laboratory should use. However, the laboratory has not decided which analyzer is their primary instrument. See D5411 3. Before testing patients' specimens, the laboratory did not verify the performance characteristics established by the manufacturer for accuracy, precision, reportable range, and reference intervals. See 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 -- 2 of 5 -- 493.1253. (7) Control procedures. (8)