Cadia Rehabilitation Pike Creek

Summary Statement of Deficiencies D0000 A Recertification Survey was conducted on July 31, 2025 at approximately 2:30 PM. The laboratory was surveyed according to 42 CFR Part 493 Clinical Laboratory Improvement Amendments (CLIA) requirements. Deficiencies were identified as follows: D2014 TESTING OF PROFICIENCY TESTING SAMPLES (b)(6) 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. This STANDARD is not met as evidenced by: Based on record review, interview, laboratory policy review, and review of the laboratory's Clinical Laboratory Improvement Amendments (CLIA) Application and Survey Summary (CASPER Report 0096D), the laboratory failed to maintain documentation of the steps in the processing of proficiency testing (PT) for arterial blood gas (ABG) for 3 (2023 ABG PT Event 3, 2025 ABG Event 1, and 2025 ABG Event 2) of 8 PT events reviewed. In addition, the laboratory failed to maintain a signed attestation form and instrument printouts for 1 (2025 ABG PT Event 2) of 8 PT events reviewed. Findings included: A laboratory policy titled, "Blood Gas Testing using a Handheld System," revised 01/31/2019, revealed the section titled, "Proficiency Testing" specified, "- Print results and enter results on [PT program] website and submit. After submission, [PT program] will return results in 1 - 2 weeks. Results are maintained in the [PT program] Binder." The laboratory's "CLIA Application and Survey Summary" (CASPER Report 0096D), with a run date of 07/22 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- /2025, revealed no scores were found for the following PT events: 2023 ABG PT Event 3 and 2025 ABG PT Event 1. The laboratory was unable to provide documentation of the processing of 2023 ABG PT Event 3, 2025 ABG Event 1, or 2025 ABG Event 2. The laboratory was also unable to provide a signed attestation form and instrument printouts for 2025 ABG PT Event 2. During an interview on 07 /31/2025 at 4:10 PM, Technical Consultant (TC)/ Testing Personnel (TP) #2 stated he had been in the position for only a month, and he was unable to locate the missing PT documentation. 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 interview and laboratory document and policy review, the laboratory failed to provide evidence of annual competency assessments for 2 (2023 and 2024) of 3 years reviewed for 20 testing personnel (TP) of 21 TP employee files reviewed for competency assessments. Findings included: A laboratory policy titled, "Blood Gas Testing using a Handheld System," revised 01/31/2019, revealed the section titled, "Training & [and] Competency" specified, "Staff are trained and complete competencies on obtaining and testing arterial blood gases upon hire using the Abbott iSTAT 1 handheld manual. Employees will demonstrate competency annually thereafter." Employee files for 20 of 21 employees identified as TP per the laboratory's CMS-209 revealed no documented evidence that annual competency assessments were completed in 2023 and 2024. During an interview on 07/31/2025 at 3:00 PM, Technical Consultant (TC)/Testing Personnel (TP) #2 stated he had been in the position for only a month and could not locate records of previous employee competency assessments. 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 interview and facility document review, the laboratory failed to document the review and evaluation of proficiency testing (PT) results for arterial blood gas (ABG) for 3 (2023 ABG PT Event 2, 2024 ABG PT Event 1, and 2024 ABG PT Event 3) of 8 PT events reviewed. Findings included: Review of PT testing results documents for 2023 ABG PT Event 2, 2024 ABG PT Event 1, and 2024 ABG PT Event 3 revealed the Lab Director or designee had not signed off as having reviewed the results. During an interview on 07/31/2025 at 4:05 PM, Technical Consultant (TC) /Testing Personnel (TP) #2 stated he had been in the position for only a month, and he did not know why the review of PT results was not documented as required. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on March 7, 2023 at approximately 10:00 am at Cadia Rehabilitation Pike Creek. The laboratory was surveyed according to 42 CFR part 493 Clinical Laboratory Improvement Amendments (CLIA) requirements. Specific deficiencies are as follows: 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: document review and interview. The laboratory failed to review Proficiency Testing (PT), provide an attestation page, or have all testing personnel participate in the PTs as required. 1. At approximately 10:38 am on March 7, 2023 during document review it was noted that the laboratory failed to include attestation pages on 6 of 6 PTs; results were not reviewed by the Laboratory Director (LD), and the same TP completed all PTs that were performed. 2. During the interview, the RD confirmed that there were no attestation pages signed by the TP or LD as required, and only one TP of 20 participated in the PTs. 3. Also during the interview the RD confirmed that the LD failed to review 6 of 6 PT results. 4.. At the end of the interview at approximately 11:25 am, no attestation pages, evidence of any otherTP performing PTs, or evidence of LD review were provided. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- 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: documen review and interview. The laboratory failed to review temperature logs as required. 1. During document review at approximately 11:10 am on March 7, 2023 the laboratory could not provide evidence of LD review of 3 of 3 temperature logs. 2. However, during document reveiw, under "Quality Assessment and Assurance" in the "Individulized Quality Control Plan for iSTAT tesing system" the document states, "2. Inspection of refrigerator temperature records", but there was no evidence that it was performed. 2. The RD confirmed during interview that the LD did not review temperature logs for temperature excursions or to ensure temperatures were being taken where test reagents were being stored. 3. At the end of the survey at approximately 11:25 am no evidence of temperature log review was provided as required, or as stated. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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. (e) The laboratory director must-- (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: document reviewand interview. The laboratory failed to perform Competency Assessment (CA) that included the six required elements for Testing Personnel. 1. At approximately 10:05 am on March 7, 2023 during document review, it was noted that the laboratory failed to provide Competency Assessment for 20 of 20 TP. All twenty TPs received initial and annual documented training, but none of the personnel were assessed at six months as required. 2. Additionally CA included 0 of the 6 required elements. 3. During document review of the "I-Stat Testing Competency" revised form provided on March 8, 2023, by the Respiratory Director (RD) included the six required elements of CA. 4. During interview, the RD confirmed that CA was performed initially and annually, but not at six months after the initial assessment as required and the six required elements were not included. 5. At the end of the survey at approximately 11:25 am on March 7, 2023 no six month CA was provided for any of the 20 testing personnel. -- 2 of 2 --

Summary Statement of Deficiencies 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: Based on review of the documents provided and interview with testing personnel it was determined that the procedure manual was incomplete. Findings include; 1. Review of the document provided to the surveyor did not include a procedure for how Proficiency Testing would be performed. 2. Interview with testing personnel 1 confirmed that while PT testing was being performed as prescribed by CLIA there was not a procedure describing this. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) 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. (e) The laboratory director must-- (e)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on review of the documents provided and interview with testing personnel 1 it was determined that the procedure manual was not available to all personnel. Findings Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- include; 1. Review of the document provided proved to be incomplete. 2. Interview with testing personnel 1 confirmed that the procedure manual was maintained on line and not available to all testing personnel. A hard copy signed and dated was later provided. -- 2 of 2 --