North Hills Surgery Center

Summary Statement of Deficiencies 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: Review of the proficiency test attestation records for five events in 2023 and 2024, lack of documentation, and interviews with laboratory staff, determined that required signatures to attest to the routine integration of proficiency test samples in the patient workload were not present on one of the five events reviewed. Survey findings follow: A) Review of the attestation forms for American Proficiency Testing Institue (API) Chemistry Core 2023 and 2024 revealed that no attestation form for the API Chemistry Core 2024 2nd event was presented. B) In an interview, at 11:40 a.m. on 9 /27/24, the laboratory staff member (# 3 as listed on the form CMS-209) confirmed the attestation form identified above was not present and could not be located. 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. 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 -- This STANDARD is not met as evidenced by: Observation, review of temperature records, lack of documentation and interview demonstrated that the laboratory failed to monitor the temperature on each day of operation in one of one room in which supplies with storage temperature requirements were stored. . Findings follow: A) During a tour of the laboratory on 9/27/24 at 10:34 a.m., the surveyor observed one rooms (Pre-Op ) containing laboratory items with a temperature storage requirement. B) A review of the laboratory's temperature records revealed that no room temperatures were recorded for the Pre-Op room for the period of April 2023 to the date of the survey. C) During a tour of the laboratory on 9/27/24 at 10:40 a.m. the surveyor observed 2 boxes of Medline HCg Combo Pregnancy Tests, lot # 0000841323, expiration date 2026-08-03 with a storage temperature requirement of 36 degrees to 86 degrees Fahrenheit (F) and one box of I-Stat CHEM 8+ test cartridges , lot # 24211A, expiration date 10/10/24, with a temperature storage requirement of 18 degrees Centigrade (C) to 30 degrees C. in the Pre-Op area. D) Upon request, the laboratory could not present the temperature records for the Pre-Op room in which the supplies identified above were stored. E) In an interview on 9/27 /24 at 10:37 a.m., the laboratory staff member (# 3 on form CMS 209) confirmed that temperature records for the Pre-Op were not recorded since April 2023. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) 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. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Review of the quality control (QC) records for the moderately complex serum HCg testing, the manuafacturer's package insert for moderately complex Medline HCg Combo+ testing system, the laboratory's Individualized Quality Control Plan (IQCP) for serum HCg testing, testing personnel competency determination records, and interview with laboratory staff, determined that the laboratory failed to follow manufacturer's test instructions and the laboratory's IQCP for quality control of serum HCg determinations. Findings follow: A) Review of the manufacturer's package insert for the Medline Combo HCg+ serum HCg test revealed that external QC is to be performed with each new lot or shipment of the tests, at least monthly, and with each new operator. B) Review of the laboratory's IQCP for serum HCg testing revealed that external QC is to be performed with each new lot and shipment, at least monthly and with each new operator. C) Review of the personnel records for the testing personnel (# 11 on the form CMS 209) revealed that the employee was hired in January 2024. D) Review of external QC records for serum HCg testing using the Medline HCg Combo+ system revealed that no external QC was recorded for testing personnel (# 11 on from CMS 209). E) In an interview on 9/27/24 at 10:05, the laboratory staff member (# 3 on form CMS 209) , confirmed that there is no documentation of performing external QC testing for the testing personnel identified above and the testing personnel has performed serum HCg testing. -- 2 of 2 --

Summary Statement of Deficiencies D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Through a review of the laboratory policies and procedures, and I-STAT Quality Control Reports for 2022, and through interviews with laboratory staff, it was determined the laboratory failed to monitor, over time, the accuracy of the hematology test results. Survey findings include: A. A review of the general policy and procedure manual revealed a quality control policy stating that acceptable quality control ranges for each control will be written on each I-STAT Quality Control Record sheet. B. A review of I-STAT Quality Control Reports for 2022 and Eurotrol Package inserts revealed incorrect Quality control ranges were used from 3/4/22 until 5/10/22, without

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Through a review of the laboratory procedure manual, lack of documentation, and interviews with staff, it was determined the laboratory procedure manual and the IQCP for moderately complex serum Hcg testing had not been approved, signed, and dated by the current laboratory director. Survey findings follow: A) Review of the laboratory procedure manual revealed that it did not include an approval signature or signed date by the current laboratory director. B) Review of the IQCP for the moderately complex serum Hcg test revealed that it did not include an approval signature or signed date by the current laboratory director. C) In an interview at 10:15 AM on 02/24/21, laboratory employee #23 (as listed on the form CMS-209) confirmed the procedure manual and IQCP for serum Hcg testing had not been approved, signed, and dated by the laboratory director. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Through a review of personnel records and an interview with laboratory staff, it was determined the technical consultant failed to evaluate the competency of ten of ten 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 -- testing personnel whose records were reviewed in the survey. Survey finding follow: A) Review of the competency assessment records of laboratory staff members, identified as numbers 1,2,3,7,12,13,14,15,16,and 19 on the CMS 209 form, revealed that none of the competencies were signed as performed by the technical consultant and all were signed as "Validator Signature" by other laboratory personnel lacking the qualifications of a technical consultant. B) In an interview on 2/24/21 at 10:15 AM the laboratory staff member, identified as number 1 on the CMS 209 form, stated that testing personnel in the laboratory validate the competency assessment for one another on a reciprocal basis. C) In an interview on 2/24/21 at 10:15 AM the technical consultant, identified as number 23 on the CMS 209 form, confirmed that the competencies were not performed or reviewed by the technical consultant and that the signatories as "validators" lacked the qualifications as technical consultants. -- 2 of 2 --