Hospital For Extended Recovery

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at the Hospital for Extended Recovery on October 21, 2025 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The Hospital for Extended Recovery was not in compliance with the applicable Conditions and Standards under 42 CFR part 493 CLIA Regulations. Specific deficiency is as follows: D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on a review of Medical Director Review sheets, laboratory temperature logs, lack of documentation, and interviews, the laboratory director failed to identify and document

Summary Statement of Deficiencies D0000 An unannounced off-site CLIA proficiency test desk review was conducted for Hospital for Extended Recovery on May 1, 2020 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: 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 an off-site desk review of the laboratory's College of American Pathologists' proficiency testing (PT) records and interviews, the laboratory failed to attain a score of at least eighty percent of acceptable responses for Chloride, Potassium, Sodium, Hematocrit, and Hemoglobin in two consecutive Chemistry and Hematology testing 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 -- events resulting in unsuccessful PT performance (reviewed: 2019 Third Event, 2020 First Event). See D2097 and D2131. D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) Failure to achieve an overall testing event score of satisfactory performance for 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 an off-site desk review of proficiency testing (PT) results and interviews, the laboratory failed to attain a score of at least eighty percent (80%) of acceptable analyte responses for Chloride (Cl), Potassium (K), and Sodium (Na) on two (2) consecutive chemistry testing events reviewed (2019 Third Event, 2020 First Event). Findings include: 1. Review of the laboratory's College of American Pathologists (CAP) Chemistry Critical Care Aqueous PT module results, revealed analyte scores of less than 80% for the following consecutive events: CAP AQI 2019 Event 3: Chemistry specialty score 33% (unsatisfactory): analytes Cl, Creatine, Glucose, K, Na, and Urea Nitrogen all scored 0% for challenge samples AQI-11 through AQI-15 (with comment "identified by CAP as being tested and scored zero due to lack of response"); CAP AQI 2020 Event 1: Chemistry specialty score 50% (unsatisfactory): analytes Cl, K, and Na scored 0% for challenge samples AQI-01 through AQI-05 (with comment "identified by CAP as being tested and scored zero due to lack of response"); resulting in an unsuccessful Chemistry PT performance. 2. In email correspondence interviews with the technical consultant on 05/01/20 at approximately 3:00 and 3:45 PM, the above findings were confirmed. D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for 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 an off-site desk review of proficiency testing (PT) records (2019 Third Event, 2020 First Event) and interviews, the laboratory failed to attain a score of at least eighty percent (80%) of acceptable responses for Hemoglobin (HGB) and Hematocrit (HCT) on two (2) consecutive hematology events reviewed, resulting in unsuccessful PT performance. Findings include: 1. Review of the laboratory's College of American Pathologists (CAP) Hematology AQI module records revealed scores of less than 80% for the following consecutive events: CAP 2019 Event 3: Hematology specialty score 0% (unsatisfactory); HGB and HCT scored 0%; sample challenges AQI-C #11 through 15 reported with comment "identified by CAP as being tested and scored zero due to lack of response"; CAP 2020 Event 1: Hematology specialty score 0% (unsatisfactory); HGB and HCT scored 0%; sample challenges AQI-A #01 through 05 reported with comment "identified by CAP as being tested and scored zero due to lack of response"; resulting in an unsuccessful PT Hematology performance. 2. In email correspondence interviews with the technical consultant on 05/01/20 at approximately 3:00 and 3:45 PM, the above findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Hospital for Extended Recovery on September 26, 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 deficiency was cited as follows: D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a tour, review of policy and procedures, performance verification records, patient accession test logs, and interviews, the laboratory failed to evaluate and verify accuracy, precision, and reportable range for one (1) of three (3) iSTAT analyzers in use for patient blood gas panel testing prior to reporting patient results during the timeframe of September 13, 2019 to the date of the survey on September 26, 2019. Findings include: 1. During a tour of the laboratory at approximately 11:00 AM, the inspector noted 3 i-STAT analyzers in use for patient blood gas panels (using Abbott i- STAT G3+ test cartridges): Serial Numbers 300897, 355061, and 318930. 2. Review of the laboratory's procedure manual revealed a policy (titled i-STAT Meter Evaluation/POCT Instrumentation Approval) which stated "All i-STAT analyzers (new and replacement) will have performance characteristics including precision, accuracy, method comparison tested and verified to be within tolerance limits. Devices are not used for patient testing until the validation studies are completed 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 -- reviewed for acceptance". The POCT Instrument Approval policy also included an Extended Care Unit i-STAT Meter Evaluation Form to be completed for each new /replacement analyzer which required the following information recorded: CLEW Number, Site Location, Serial Number, Date Instrument Received, Cartridges Validated for Use, Date in Use, and Date Instrument Returned. 3. Review of the available analyzer performance verification documents revealed no evaluation form or method validation/verification study for: i-STAT SN 318930. The inspector requested to review verification documentation of the instrument outlined above. No documentation was available for review. The technical consultant, stated at approximately 12:30 PM, "We borrowed that i-STAT about two weeks ago because one of our three devices' scanner stopped working. We borrowed it on September 13 from our main lab. I do not think we have used it for testing. It is a back up". 4. Review of the laboratory's electronic RALS patient accessioning log (from 1/1/19 to 9 /26/19) revealed that the lab reported three (3) blood gas patient panels (pH, PCO2, PO2, TCO2, HCO3) on two dates using i-STAT instrument SN 318930: 09/21/19: patient number 8830 and 2031, 09/25/19: patient number 8839. 5. In an exit interview with the technical consultant and nurse manager at approximately 1:30 PM, the above findings were confirmed. -- 2 of 2 --