York Hosp Pulm Physiology Lab

Summary Statement of Deficiencies D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) (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, lack of documentation, and interview with Technical Consultant (TC) #2 (CMS 209, dated 12/08/2025), the laboratory failed to establish and maintain written policies for an ongoing mechanism to monitor, assess and when indicated, correct problems identified in the postanalytic systems specified in 493.1291 for 2 of 2 years from 2/29/2024 to 12/10/2025. Findings include: 1. On the day of survey, 12/10/2025 at 11:59 am, the laboratory could not provide a procedure for the ongoing mechanism to monitor, assess, and correct problems found in the postanalytic system specified in 493.1291 for 2 of 2 years from 2/29/2024 to 12/10 /2025. 2. The laboratory failed to provide records for the following periodic checks performed to verify the accuracy of the Laboratory's Information System (LIS) from 2 /29/2024 to 12/10/2025: - Patient results transmitted between instruments and LIS (EPIC) - Patient Specific data. 3. The laboratory performed 224 Blood Gas examinations in 2024 (CMS 116, estimated annual volume, dated 12/08/2025). 4. TC #2 confirmed the findings above on 12/10/2025 at 1:45 pm. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document 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 Operations Manager (OM) and Technical Consultant #1 (CMS 209 personnel # 2), the laboratory failed to perform and document the maintenance/ function checks for 1 of 1 thermometer used to monitor room temperatures (RT) used for storage of chemistry reagents from 08/16/2022 to the day of survey. Findings Include: 1. On the day of survey, 02/29/2024 at 12:00 pm, the laboratory could not provide maintenance /function check records for the following 1 of 1 thermometer used to monitor room temperatures used for storage of chemistry reagents from 08/16/2022 to 02/29/2024: - S/N 200506836: exp: 08/16/2022 2. The following Chemistry Blood Gas reagents were found to be stored in the laboratory. - 8 of 8 I stat EG7+ Cartridge (Manufacturer's storage requirements - 2 - 8 Celsius). 3. The OM and TC confirmed the findings above on 02/29/2024 at 12:30 pm. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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 review of competency assessment records and interview with the Technical Consultant (TC)1, the laboratory failed to establish a procedure to assess the competency of 2 of 2 technical consultants for their supervisory responsibilities in 2020 and 2021. Findings include: 1. On the day of survey, 05/25/2022 at 10:11 am, the TC could not provide a procedure for the competency assessment for 2 of 2 technical consultants ( personnel #2 and #6 on CMS 209) for their supervisory responsibilities in 2020 and 2021. 2. No documentation was found that competency assessment was performed for 2 of 2 TC (personnel #2 and #6 on CMS 209) for their responsibilities from 02/13/2020 to 05/25/2022. 3. The TC 1 confirmed the findings above had not been documented on 05/25/2022 around 11:30 am. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on review of the Yorktown Medical Center Pulmonary Physiology Lab ISTAT Operator List and interview with the Technical Consultant (TC #1), the Technical 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 -- Consultant failed to ensure the competency of 2 of 17 testing personnel (TP) for blood gas testing performed in 2020 and 2021 that included testing previously analyzed samples, internal blind testing samples or external proficiency testing. Findings include: 1. At the time of the survey, 05/25/2022, review of the Yorktown Medical Center Pulmonary Physiology Lab ISTAT Operator List revealed the technical consultant failed to ensure that the following testing personnel performed internal blind sampling, external proficiency testing or previously analyzed samples for blood gases: - 1 of 17 TP (CMS 209 personnel # 16) in 2020. - 1 of 16 TP (CMS 209 personnel # 15) in 2021. 2. The TC #1 confirmed the finding above on 05/25/2022 around 11:30 am. -- 2 of 2 --

Summary Statement of Deficiencies 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 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: Based on observation and interview with the Technical Consultants, at the time of survey, the laboratory failed to document room temperature for I-Stat EG7 cartridges used for Blood Gas testing, from (11/14/2017 through 02/13/2020). Findings include: 1. At the time of the survey, the surveyor observed 8 of 8 I-Stat EG7 cartridges lot N19348, at room temperature. 2. The laboratory could not provide documentation of room temperature from (11/14/2017 through 02/13/2020). 3. Technical Consultant 2 confirmed the above findings during the survey on (02/13/2020) at 12:00 hours. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --