Moss Rehab Einstein At Elkins Park

Summary Statement of Deficiencies D0000 A validation survey was conducted by the Pennsylvania State Agency for Moss Rehab Einstein at Elkins Park on 5/21/2026. The laboratory was found out of compliance with the following conditions: 493.1250 Condition: Analytic Systems 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview with the Point of Care Coordinator (POCC), the laboratory failed to monitor and document temperature and humidity to ensure operating conditions were met when 1 of 1 chemistry test (Whole Blood Glucose) was performed using the Roche Inform II glucose meter from 5/21 /2024 to 5/21/2026. Findings include: 1. On the day of the survey, 5/21/2026 at 1:30 pm, review of the manufacturer's instruction for use stated, " Use the test strips at temperatures between 4 to 30 degrees Celsius. Use the test strips between 10 - 80% relative humidity." 2. The laboratory failed to provide documentation for temperature and humidity readings taken to ensure operating conditions were met for 1 of 1 chemistry test (Whole Blood Glucose) performed using the Roche Inform II glucose meter from 5/21/2024 to 5/21/2026. 3. The POCC confirmed the findings above on 5 /21/2026 at 2:00 pm. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on lack of documentation, and interview with the Point of Care Coordinator (POCC), the laboratory failed to retain analytic systems records for 2 of 2 years as required from 5/21/2024 to 5/21/2026. Findings include: 1. On the day of survey, 5/21 /2026 at 11:45 am, the laboratory failed to provide documentation of the following analytic system records for 2 of 2 years as required from 5/21/2024 to 5/21/2026: - 2024 and 2025 - Refrigerator, room temperature and room humidity logs - 5/21/2024 to 5/21/2026 - Maintenance logs for Siemens EPOC analyzers - 5/21/2024 to 5/21 /2026 - New lot of reagent validations - 5/21/2024 to 5/21/2026 - Quality Control audits to be performed per policy by the POCC 2. The laboratory performed 1526 examinations in 2025 (CMS 116 estimated annual volume, dated 5/21/2026 ). 3. The POCC confirmed the above findings on 5/21/2026 at 12:30 pm. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) (a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of College of American Pathologists (CAP) proficiency testing (PT) records and interview with the Point of Care Coordinator (POCC), the laboratory failed to retain the documentation for 1 of 6 CAP PT events performed from 5/21 /2024 to 12/31/2025. Findings include: 1. On the day of survey, 5/21/2026 at 10:25 am, the laboratory could not provide the documentation for the following 1 of 6 CAP PT events performed in 2024: - CAP AQHC 2024 2. The POCC confirmed the above findings on 5/21/2026 at 12:30 pm. D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on lack of documentation, and interview with the Point of Care Coordinator (POCC), the laboratory failed to establish and maintain a policy to ensure all complaints and problems reported to the laboratory were documented and investigated when needed for 2 of 2 years from 5/21/2024 to 5/21/2026. Findings include: 1. On the day of survey, 5/21/2026 at 11:30 am, the laboratory could not provide a policy to ensure all complaints and problems reported to the laboratory were documented and investigated as needed for 2 of 2 years from 5/21/2024 to 5/21/2026. 2. The POCC confirmed the above findings on 5/21/2026 at 11:45 am. -- 2 of 10 -- 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 lack of documentation and interview with the Point of Care Coordinator (POCC), the laboratory failed to establish and follow a competency assessment (CA) procedure to assess the competency of 1 of 1 Technical Consultant (TC) for their supervisory responsibilities performed from 5/21/2024 to 5/21/2026. Findings Include: 1. On the day of survey, 5/21/2026 at 11:30 am, the laboratory failed to provide a competency assessment procedure to assess the competency of 1 of 1 TC (CMS 209, TC # 1 dated 5/21/2026) for their supervisory responsibilities performed in the laboratory from 5/21/2024 to 5/21/2026. 2. The laboratory failed to provide CA records for TC #1 for their supervisory responsibilities performed from 5/21/2024 to 5 /21/2026. 3. The laboratory performed 1526 examinations in 2025 (CMS 116 estimated annual volume, dated 5/21/2026 ). 4. The POCC confirmed the findings above on 5/21 /2026 at 11:50 am. D5301 TEST REQUEST CFR(s): 493.1241(a) (a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on record review, lack of documentation and interview with the Point of Care Coordinator (POCC), the laboratory failed to have written or electronic requests from an authorized person for blood gas patient testing performed for 2 of 2 years from 5/21 /2024 to 5/21/2026. Findings include: 1. On the date of the survey, 5/21/2026 at 1:30 pm, the laboratory could not provide written or electronic test requisitions from an authorized person for blood gas testing performed for 2 of 2 years from 5/21/2024 to 5 /21/2026. 2. The laboratory performed 1526 examinations (CMS 116 estimated annual volume, dated 5/21/2026 ). 3. The POCC confirmed the above findings on 5/21/2026 at 1:45 pm. 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 observation of the laboratory, record review, lack of documentation, and -- 3 of 10 -- interview with the Point of Care Coordinator (POCC), the laboratory failed to meet applicable analytic systems requirements in 493.1251 through 493.1283 for 2 of 2 years from 5/21/2024 to 5/21/2026. Refer to 5429, 5439, 5445, 5775, and 5781. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation of the laboratory, lack of documentation, and interview with the Point of Care Coordinator (POCC), the laboratory failed to assess the maintenance and function checks as defined by the manufacturer for 1 of 1 thermometer used to record room temperature and humidity in the laboratory when blood gas testing was performed from 5/21/2024 to 5/21/2026. Findings Include: 1. On the day of the survey, 5/21/2026 at 1:45 pm, observation of the laboratory revealed 1 of 1 room temperature and humidity thermometer with no expiration date, serial number or identifying label on the instrument. 2. The laboratory could not provide maintenance /function check records for the 1 of 1 thermometer used to record room temperature and humidity in the laboratory when blood gas testing was performed from 5/21/2024 to 5/21/2026. 3. The POCC confirmed the above findings on 5/21/2026 at 2:00 pm. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3)-- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the Point of Care Coordinator (POCC), the laboratory failed to perform calibration verification at least once every six months for 2 of 2 Siemens Epoc Blood Gas analyzers from 5/21/2024 to 5/21 /2026. Findings include: 1. On the date of survey, 5/21/2026 at 12:00 pm, the laboratory failed to provide calibration verification records performed at least once every 6 months for the following analytes tested on 2 of 2 Siemens Epoc Blood Gas analyzers from 5/21/2024 to 5/21/2026. - pH - PCO2 - PO2 -Sodium -Potassium - -- 4 of 10 -- Chloride -Calcium -Creatinine -Blood Urea Nitrogen -Glucose -Hematocrit -Lactate 2. The laboratory performed 1526 chemistry examinations in 2025 (CMS 116, estimated annual volume dated 5/21/2026 ). 3. The POCC confirmed the findings above on 5/21/2026 at 01:30 pm. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) 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. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on review of quality control (QC) records and interview with the Point of Care Coordinator (POCC), the laboratory failed to perform QC procedures as required for blood gas testing performed on 2 of 2 Siemens EPOC analyzers at least once each day of patient testing from 5/21/2024 to 5/21/2026. Findings include: 1. On the day of survey, 5/21/2026 at 01:00 pm, review of the laboratory's QC records revealed the laboratory failed to ensure QC was performed on 2 of 2 Siemens EPOC analyzers at least once each day of patient testing from 5/21/2024 to 5/21/2026. 2. Further review of QC records revealed the laboratory performed external QC for blood gas testing monthly. The laboratory failed to provide an Individualized Quality Control Plan (IQCP). 3. The laboratory performed 1526 examinations in 2025 (CMS 116 estimated annual volume, dated 5/21/2026 ). 4. The POCC confirmed the findings above on 5/21 /2026 at 01:30 pm. 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. This STANDARD is not met as evidenced by: Based on lack of documentation, and interview with the Point of Care Coordinator (POCC), the laboratory failed to evaluate twice a year the relationship between test results using different instruments/methodologies for blood gas examinations performed on 2 of 2 EPOC blood gas analyzers from 5/21/2024 to 5/21/2026. Findings include: 1. On the day of the survey, 5/21/2026 at 1:10 pm, the laboratory failed to provide documentation for the evaluation performed twice a year to monitor and evaluate the relationship between test results using different instruments /methodologies for blood gas examinations performed on 2 of 2 EPOC blood gas -- 5 of 10 -- analyzers from 5/21/2024 to 5/21/2026. 2. The laboratory performed 1526 chemistry examinations in 2025 (CMS 116, estimated annual volume dated 5/21/2026 ). 3. The POCC confirmed the findings above on 5/21/2026 at 1:30 pm. D5781