Valley Pediatric Assoc Pa

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on survey review of the Procedure Manual (PM), Test Reports and interview with Testing Personnel (TP), the laboratory did not establish written policies and procedures for specimen referral for Bacteriology tests performed from 6/28/23 to 3/19 /25. The findings include: 1. The PM lacked written procedures for specimen referral. 2. There was no established criteria to send specimens for identification and susceptibility testing based on Urine Colony Count results in the PM. 3. The TP #1 as listed on the CMS 209 form confirmed on 3/19/25 at 11:40 am, the laboratory did not establish written policies and procedures for specimen referral. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test 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 -- reports. This STANDARD is not met as evidenced by: Based on surveyor review of the Temperature Logs (TL) and interview with Testing Personnel (TP), the laboratory failed to have a defined range for the incubator on the TL from 10/26/23 to 3/19/25. The finding includes: 1. There was no defined range for the incubator on the TL logs. 2. The TL did not state if the temperature was recorded in degrees Fahrenheit or degrees Celsius. 3. The TP #1 as stated on the CMS 209 form confirmed on 3/19/25 at 11:05 am, the TL did not have a defined range or state if recorded in degrees Fahrenheit or Celsius. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on surveyor review of Test Reports (TR) and interview with the Testing Personnel (TP), the laboratory failed to ensure the TR included all required information for Urine Colony Count tests performed from 2/13/23 to 3/19/25. The findings include: 1. Specimen identification number 3990 performed on 12/13/23 was sent to a reference laboratory for identification and susceptibilities. 2. The TR did not state the name and address of the laboratory where the identification and susceptibilities were performed. 3. TP #1 as listed on the CMS confirmed on 3/19/25 at 11:30 am, the laboratory failed to ensure the TR included all the required information. -- 2 of 2 --

Summary Statement of Deficiencies D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the Testing Personnel (TP), the laboratory failed to record a discontinuance date on the procedure not performd in the laboratory on the date of survey. The finding includes: 1. There was no discontinuance date on the Throat culture procedures in the PM. 2. The TP #8 as listed on the CMS-209 form confirmed on 6/27/23 at 10:45 am that a discontinuance date was not documented. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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 and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the Procedure Manual and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to establish a Quality Assurance (QA) 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 -- program for verifying manually entered results into the Electronic Media Record (EMR) from 5/4/21 to the date of survey. The TP#8 as stated on CMS-209 form confirmed on 6/27/23 at 11:45 AM that a QA program was not established. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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 and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on surveyor review of the Personnel Files (PF) and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to have appropriate education documentation for Testing Personnel (TP) performing laboratory testing on the date of survey. The findings include: 1. The laboratory did not have education records for TP #11 and TP #12 listed on the CMS form 209. 2. The TP confirmed on 6/27/23 at 11: 00 am the above records were not on file. -- 2 of 2 --

Summary Statement of Deficiencies D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 surveyors review of the Accession Log (AL), Test Report (TR) and interview with the Testing Personnel (TP), the laboratory failed to follow procedures to correct problems identified on the TR for Throat Cultures (TC) tests in the calendar year 2021. The finding includes: 1. Six out of ten patients reviewed did not have the correct collection date for TC on the TR. 2. The TP #7 listed on CMS form 209 confirmed on 5/4/2021 at 2:00 pm the laboratory failed to identify problems on the TR. 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 D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor review of work records and interview with the Registered Nurse (RN), the laboratory used expired Throat Culture (TC) media when they have exceeded their expiration dates from 7/17/18 to the date of survey. The findings include: 1. TC media with lot # 8109605 Expired on 7/17/18 were used from 7/17/18 to 8/9/18. 2. Approximately 99 patients specimens were run and reported. 3. The RN confirmed on 8/9/16 at 1:00 pm that the laboratory used expired TC media. 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 --