Lake Taylor Transitional Care Hospital

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Lake Taylor Transitional Care Hospital on May 8, 2025 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows: D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (e)(1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records, lack of documentation, and interviews, the laboratory failed to document remedial action for an unacceptable Partial Pressure of Carbon Dioxide (PCO2) analyte score on one out of four (4) Critical Care Blood Gas PT events as reviewed on the date of the inspection, May 8, 2025. Findings include: 1. Review of the laboratory's College of American Pathologists (CAP) PT documentation (2024 Events 1-3, 2025 Event 1), a total of 4 events, revealed no evidence of remedial action for: 2024 Event 2 Critical Care Blood Gas -PCO2 challenge sample AQ-10 scored as "Unacceptable". 2. Review of the laboratory's PT results revealed no corrective/evaluation documentation for the unacceptable score outlined above. The inspector requested documentation of remedial action. No documentation was available for review. 3. An exit interview with the Director of Respiratory Services, Respiratory Therapist Supervisor, and Ventilator Program Manager on 5/8/25 at 2:00 PM, confirmed the above 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 -- D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) (b) The laboratory must verify the accuracy of the following: (b)(1) Any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records, lack of documentation, and interviews, the laboratory failed to verify the accuracy of five (5) of 5 non-graded total carbon dioxide (TCO2) analyte results on one of four (4) PT events reviewed and noted on the date of the inspection, May 8, 2025. Findings include: 1. Review of the laboratory's College of American Pathologists (CAP) PT result documentation (2024 Events 1-3, 2025 Event 1), a total of 4 events, revealed no evaluation (due to less than 10 participating laboratories) or verification of accuracy for the non-graded TCO2 responses for: 2024 Event 3: challenge samples AQ-11, AQ-12, AQ-13, AQ-14, AQ- 15 (no score provided)--a total of 5 of 5 non graded TCO2 responses on the Critical Care Blood Gas module. 2. The inspector requested to review evaluation documentation for the 5 non graded analytes listed above. No documentation was available for review. 3. An exit interview with the Director of Respiratory Services, Respiratory Therapist Supervisor, and Ventilator Program Manager on 5/8/25 at 2:00 PM, confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Lake Taylor Transitional Care Hospital on May 2, 2023 by the Virginia Department of Health's Office of Licensure and Certification. The inspector noted that the facility performs SARS-CoV- 2 (COVID-19) testing and was in compliance with the applicable COVID-19 reporting requirements. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows and include the Condition under 42 CFR part 493 CLIA Regulation: D5400 -42 CFR. 493.1250 Condition: Analytic Systems. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report Form (CMS 209), proficiency testing (PT) records, and interviews, the laboratory failed to rotate PT among personnel responsible for performing patient blood gas testing in 2022. Findings include: 1. Review of the CMS 209 form revealed that the laboratory director identified twenty-one (21) testing personnel (TP) as responsible for performing patient non waived blood gas chemistry testing. 2. Review of the laboratory's 2022 College of American Pathologists (CAP) Critical Care Blood Gas with Chemistry module PT documentation (AQ Events A-C) revealed TP #1 performed/signed attestations for: CAP AQ- A, CAP AQ- B. (See Personnel Code Sheet.) 3. During an interview with the Respiratory Therapy Director on 05/02/23 at approximately 11:30 AM, the inspector inquired regarding how the laboratory's proficiency testing is assigned noting that TP #1 signed and performed two (2) of three (3) events in 2022. The Respiratory Therapy Director stated, "Our protocol is for 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 PT samples to be rotated and tested among all staff members who perform testing". 4. An exit interview with the Respiratory Therapy Director, Program Manager, and Vice President on 05/02/23 at approximately 1:30 PM confirmed the above findings. 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 a review of proficiency testing (PT) documentation, lack of documentation, and an interview, the laboratory failed to retain attestation statements signed by the laboratory director (LD) and testing personnel (TP) for two (2) of five (5) events reviewed. Findings include: 1. Review of the laboratory's College of American Pathologists (CAP) Critical Care Blood Gas with Chemistry module PT documentation (2021 Event C, 2022 Events A-C, 2023 Event A) revealed no signed attestation statements for the following two events: 2022 CAP AQ Event A - no attestation signatures for LD and TP; 2022 CAP AQ Event C - no attestation signatures for TP. The inspector requested to review the attestation signature documentation for the blood gas chemistry module events outlined above. No documentation was available for review. 2. An exit interview with the Respiratory Therapy Director, Program Manager, and Vice President on 05/02/23 at approximately 1:30 PM confirmed the above 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 review of laboratory policies, quality control (QC) documentation, patient test logs, and interviews, the laboratory failed to follow their established policy for QC performance every eight hours on eight days while reporting eleven patient blood gas panel results in a sampled nineteen month review. See D5401 (repeat deficiency). D5401 PROCEDURE MANUAL -- 2 of 3 -- 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 a review of policies, quality control (QC) documentation, patient test logs, and interviews, the laboratory failed to follow the established policy for QC performance every eight hours for eleven (11) patient blood gas panel tests assayed /reported on eight (8) days of the nineteen (19) months reviewed (October 2021 to the date of the inspection on May 2, 2023). *REPEAT DEFICIENCY Findings include: 1. Review of the laboratory's procedure manual (title: Respiratory Care Department- Blood Gas Laboratory) revealed QC instructions "three times a day at 0700, 1500, 2300, the three standard QC reference cartridges are to assayed for the OPTI CCA - TS2 blood gas analyzer." 2. The inspector requested to review QC documentation and OPTI CCA blood gas patient logs from October 2021 to 05/02/23. The sampled records revealed missing QC for the following dates and number of patients analyzed: 10/10/21 -1 patient - Medical Record (MR) #15723 (one of three QC missed, 1500); 07/28/22- 1 patient - MR #30686 (one of three QC missed, 1500); 08/19/22- 1 patient - MR #30158 (one of three QC missed, 1500); 09/27/22- 2 patients- MR #26344, #30872 (one of three QC missed, 1500); 01/06/23- 1 patient - MR #31035 (one of three QC missed, 0700); 01/16/23- 1 patient - MR #31213 (one of three QC missed, 0700); 02/15/23- 1 patient - MR #30135 (one of three QC missed, 2300); 03/14/23- 3 patients- MR #31034, 31035, 31035 (one of three QC missed, 2300). A total of 8 days with 11 patient blood gas panel results reported while not following the laboratory's QC protocols as outlined above. 3. An exit interview with the Respiratory Therapy Director, Program Manager, and Vice President on 05/02/23 at approximately 1:30 PM confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Lake Taylor Transitional Care Hospital on June 22, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows and include the Condition under 42 CFR part 493 CLIA Regulation: D5400 -42 CFR. 493.1250 Condition Analytic Systems. 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 review of laboratory policies, quality control (QC) documentation, instrument calibration verification records, patient test logs, and interviews, the laboratory failed to: 1. follow their established policy for blood gas chemistry QC performance every eight hours on five days while reporting six patient results in a sampled fourteen month review; 2. perform calibration verification on the OPTI AVL and OPTI CCA-TS2 every six months during the twenty-four months reviewed. See D5401 (Part A is a repeat deficiency) D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by 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 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: A. Based on a review of policies, quality control (QC) documentation, patient test logs, and an interview, the laboratory failed to follow the established policy for blood gas chemistry QC performance every eight hours on five (5) days with six (6) patients tested in the fourteen month timeframe reviewed. **REPEAT DEFICIENCY Findings include: 1. Review of the laboratory's procedure manual (title: Respiratory Care Department-Blood Gas Laboratory) revealed QC instructions "three times a day at 0700, 1500, 2300, the three standard QC reference cartridges are to assayed for the OPTI CCA - TS2 blood gas analyzer." 2. The inspector requested to review QC documentation and OPTI CCA blood gas patient logs from April 2020 to 06/22/21. The sampled records revealed missing QC for the following dates and number of patients analyzed: 04/08/20 - 1 patient (one of three QC missed, 0700); 05/28/20 - 2 patient (one of three QC missed, 1500); 11/02/20 - 1 patient (one of three QC missed, 1500); 11/07/20 - 1 patient (one of three QC missed, 0700); 11/20/20 - 1 patient (one of three QC missed, 1500); A total of 5 days with 6 patients tested while not following the laboratory's QC protocols as outlined above. 3. In an exit interview with the Director of Respiratory Services, two Program Managers, and Vice President on 6/22 /21 at approximately 4:00 PM, the above findings were confirmed. B. Based on a review of procedures, instrument calibration verification records, patient test logs, and interviews, the laboratory failed to perform calibration verification for Hydrogen Ion Concentration (pH), Carbon Dioxide Partial Pressure (PCO2), Bicarbonate (HCO3), and Oxygen Partial Pressure (PO2) on the OPTI AVL and OPTI CCA-TS2 analyzers every six months while reporting three hundred eighteen (318) patient arterial blood gas (ABG) panels according to procedure during the twenty-four (24) months reviewed. Findings include: 1. Review of the laboratory's OPTI AVL and OPTI CCA- TS2 procedures revealed calibration verification protocols as: OPTI AVL: "Calibration verification or the analytical measurement range will be performed twice per year." OPTI CCA-TS2: "Calibration verification allows for the validation of the blood gas analyzer's ability to recover known values at various points within the reportable range of all parameters. Refer to your regulatory agency". 2. Review of the laboratory's calibration verification records during the timeframe of June 2019 to the date of the survey on 06/22/21, revealed no calibration verification or linearity studies for: OPTI AVL, Serial Number (SN) 6666-6666, OPTI CCA - TS2, SN 003487. The inspector requested to review documentation of calibration verification for the analyzers outlined above. An installation validation study was available for review for the OPTI CCA - TS2 (dated 08/18/20). No other records were available. 3. The inspector inquired regarding the manufacturer's user guidance and director's approved policy for calibration verification instructions. The Director of Respiratory Services, stated at approximately 2:30 PM: "I have spoken with our field service at OPTI and they informed us that the calibration verification needs to be done every 6 months. There is a kit we will have to purchase to be able to do this so as soon as I am able to purchase the kit and get it here, our protocol will be to run the calibration verification and continue to do so every 6 months going forward as our procedure outlines." 4. Review of the laboratory's blood gas patient test logs revealed the following number of patient ABG samples were reported during lapses in 6 month calibration verification: OPTI AVL from June 2019 to 09/18/20: two hundred forty (240); OPTI CCA - TS2 from 03/18/21 to 06/22/21: seventy-eight (78); A total of 318 ABG panels were assayed during a lapse in calibration verification during the review timeframe -- 2 of 3 -- outlined. 5. In an exit interview with the Director of Respiratory Services, two Program Managers, and Vice President on 6/22/21 at approximately 4:00 PM, the above findings were confirmed. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Lake Taylor Transitional Care Hospital on March 21, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: 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 a review of patient test logs, proficiency testing (PT) records, and interviews, the laboratory failed to enroll for Hemoglobin (Hgb) in calendar year 2017 and 2018 while reporting five hundred thirty-four (534) patient results. Findings include: 1. A review of the 2017 and 2018 OPTI CCA blood gas analyzer patient test logs revealed that the laboratory reported and trended 534 patient hemoglobin results as a component of the Blood Gas Panel. 2. A review of the laboratory's 2017 (Event A, B, C) , 2018 (Event A, B, C), and 2019 (Event A) College of American Pathologists (CAP) PT records (a total of seven Critical Care/Aqueous Blood Gas events) revealed no Hgb scored results. The inspector requested to review the results. The Director of Respiratory Services stated: "I am not sure if we are enrolled for that portion of the testing events'. 3. A telephone interview with a CAP technical specialist at approximately 2:00 PM revealed that the laboratory was not enrolled for 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 4 -- available Hemoglobin on the Critical Care/Aqueous Blood Gas module. 4. In an exit interview with the Director of Respiratory Services and Lab Supervisor hospital at approximately 3:00 PM the above findings were confirmed. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), proficiency testing (PT) records and an interview, the laboratory failed to rotate PT among personnel performing blood gas chemistry patient testing during the twenty-four (24) months reviewed. Findings include: 1. Review of the CMS Form 209 revealed forty-three (43) testing personnel (TP). The laboratory supervisor confirmed in an entrance interview that the 43 TP performed patient blood gas testing on the OPTI CCA blood gas analyzer in calendar years 2017 and 2018. 2. Review of the laboratory's scored College of American Pathologists (CAP) PT documentation, a total of six (6) events, revealed TP A performed three (3) of the 6 events reviewed: TP A signed PT attestation for: AQ-B 2017, AQ-C 2017, AQ-C 2018 (See Personnel Code Sheet). 3. In an exit interview with the Director of Respiratory Services and Lab Supervisor hospital at approximately 3:00 PM, the above findings were confirmed D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records, and interviews, the laboratory failed to document remedial action taken for one (1) unsatisfactory scored event out of three (3) blood gas chemistry PT events reviewed for calendar year 2018. Findings include: 1. Review of the 2018 College of American Pathologists (CAP) chemistry PT result documentation, a total of three (3) events, revealed no evidence of remedial action for the 2018 AQ-C Routine Chemistry event (scored as 47%) with the following analytes scored as unacceptable: AQ-11: Blood Gas PCO2 and TCO2, Sodium (Na), Potassium (K), Chloride (Cl); AQ-12: Na, K, Cl; AQ-13: Na, K, Cl; AQ-14: Na, K, Cl; AQ-15: Na, K, Cl. Review of the laboratory's PT results revealed no corrective or remedial action documentation for the unacceptable scores listed above. The inspector requested documentation of remedial action. The Director of -- 2 of 4 -- Respiratory Services stated, "We did not notice the unacceptable results." 2. In an exit interview with the Director of Respiratory Services and Lab Supervisor hospital at approximately 3:00 PM, the above findings were confirmed 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 review of the laboratory's procedures and policies, quality control (QC) documentation, patient test logs, and an interview, the laboratory failed to monitor the quality of the OPTI CCA blood gas analyzer's testing with QC documented every eight hours on four days while reporting six patient panel results during the fourteen months reviewed. See D 5401 (a repeat deficiency). 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 policies, quality control (QC) documentation, patient test logs, and an interview, the laboratory failed to follow the established policy for blood gas chemistry QC performance every eight hours on four (4) days with six (6) patients tested during the fourteen (14) months reviewed. **REPEAT DEFICIENCY Findings include: 1. Review of the laboratory's QC policy (title: Quality Control in the Blood Gas Laboratory) revealed instructions to perform at least two (2) levels of QC every 8 hours. The procedure stated: "Three times a day (at 0700, 1500, 2300) three standard QC reference cartridges are to assayed for the OPTI CCA blood gas analyzer." 2. Review of QC documentation and OPTI CCA blood gas patient logs, from January 2018 to 3/21/19, revealed no QC recorded for the following: 08/21/18 - 2 patients tested and reported; 11/08/18 - 2 patients tested and reported; 02/01/19 - 1 patients tested and reported; 02/21/19 - 1 patients tested and reported; a total of 4 days with 6 patients tested. 3. In an exit interview with the Director of Respiratory Services and Lab Supervisor hospital at approximately 3:00 PM the above findings were confirmed D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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 -- 3 of 4 -- and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on a review of patient test logs, proficiency testing (PT) records (a total of six events), and interviews, the laboratory director failed to ensure PT enrollment for Hemoglobin (Hgb) in calendar year 2017 and 2018 while reporting five hundred thirty-four (534) patient results. Findings include: 1. A review of the 2017 and 2018 OPTI CCA blood gas analyzer patient test logs revealed that the laboratory reported and trended 534 patient hemoglobin results as a component of the Blood Gas Panel. 2. A review of the laboratory's 2017, 2018, and 2019 College of American Pathologists (CAP) proficiency testing (PT) records (a total of seven events) revealed no Hgb scored results. The inspector requested to review the results. No records were available for review. 3. A telephone interview with a CAP representative at approximately 2:00 PM revealed that the laboratory was not enrolled for the available Hemoglobin on the Critical Care/Aqueous Blood Gas module. 4. In an exit interview with the Director of Respiratory Services and Lab Supervisor hospital at approximately 3:00 PM the above findings were confirmed. -- 4 of 4 --