Advanced Medical Sports And Spine

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Advanced Medical Sports and Spine on November 5, 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 specific deficiency cited is as follows: D5781

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Advanced Medical Sports and Spine on July 18, 2023 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiencies cited are as follows: D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) 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. This STANDARD is not met as evidenced by: Based on a review of the laboratory's quality control (QC) records, lack of documentation, and interview, the laboratory failed to retain the manufacturer's package inserts for two (2) of four (4) toxicology QC lot numbers utilized for evaluating the precision/accuracy of the Medica Easy RA analyzer in the twenty-two months reviewed (October 2021 to July 18, 2023). The findings include: 1. Review of the laboratory's Medica Easy RA analyzer's QC records revealed the following 4 Diagnostic Products International (dP) H-TROL QC lot numbers (#) placed in use to evaluate precision/accuracy for toxicology patient testing from October 2021 through the date of the survey on July 18, 2023: #1127 #1128 #1812 #1813 2. The surveyor requested to review the H-TROL QC package inserts for the 4 lot numbers listed above. The laboratory provided package inserts for QC lot numbers 1812 and 1813. The package inserts for lot numbers 1127 and 1128 were not available for review. 3. In an exit interview with the laboratory director on July 18, 2023, at approximately 11: 30 AM, the above listed findings were confirmed. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) 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 -- Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on tour of the laboratory, review of the manufacturer's package insert and interviews, the laboratory failed to label two (2) of 2 Diagnostic Product International H-trol Custom Liquid Control vials with date placed in service and revised expiration date according to the manufacturer's package insert on the date of the survey on July 18, 2023. The findings include: 1. A tour of the laboratory area on July 18, 2023 at approximately 9:00 AM revealed 2 H-trol Liquid Control vials (levels 1 & 2) on the shelf of the laboratory refrigerator and one vial of H-trol Liquid Control Level 1 QC in the freezer. The lot numbers and expiration dates for the toxicology QC vials were: H-trol level 1 lot number (#) 1812, expiration date 2/28/2025; and H-trol level 2 lot # 1813, expiration date 2/28/2025. The surveyor noted the 2 vials stored in the refrigerator lacked documentation of date placed in service and revised expiration date. There were no other QC vials found in the refrigerator. The surveyor inquired with the laboratory director (LD) where the QC vials were kept if they were in use. The LD stated the QC vials in use were kept in the refrigerator and the unopened vials were kept in the freezer. 2. Review of the Diagnostic Product International H-trol Custom Liquid Control package insert revealed the following statement, "Storage & Stability - Unopened: A. The controls are stable until the expiration date when stored at -20 to -80 C and protected from light. B. The controls are stable until the expiration date when stored at 2-8 C, however, no stability claims can be made for Oxazepam as it may deteriorate over time when stored refrigerated. After opening: A. The controls are stable for six months or until the expiration date, whichever comes first, when stored at -20 to -80 C (Controls can be aliquoted and frozen.) B. The controls are stable for 31 days or until the expiration date, whichever comes first, when stored tightly capped at 2-8 C. Thaw controls as needed; allow to come to room temperature followed by gentle swirling before use." 3. In an exit interview with the laboratory director on July 18, 2023, at approximately 11:30 AM, the above listed findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Advanced Medical Sports and Spine on September 22, 2021 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: D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of procedures, tour, and an interview, the laboratory failed to ensure that twenty-eight (28) of 28 frozen urine specimens were stored at -20 degrees Celsius (C) per their approved procedure on the date of the inspection, September 22, 2021. Findings include: 1. Review of the laboratory's policy manual revealed a Urine Drug Screen Testing Procedure that stated under Sample Stability and Storage: "If the sample cannot be run immediately, store up to 7 days at 2-8 C, for longer storage the urines are stable at -20 C up to 12 months". 2. During a tour of the laboratory, the inspector noted the freezer temperature recorded as -15 degree C (the FisherBrand Traceable digital thermometer reading displayed a daily minimum reading as captured at -18 C and maximum had been 1 C). A review of the freezer contents revealed 28 patient urine samples stored for future batch testing. The inspector inquired of the storage temperature -20 C requirement. The lab director (LD) stated at approximately 11:55 AM: "Since test volumes have decreased due to the pandemic, I am batching runs which requires freezing patient samples. I can get a freezer that maintains -20 or colder since this unit does not". 3. An interview with the LD on 9/22/21 at approximately 12:30 PM, the above findings were confirmed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a tour, review of manufacturer's package insert instructions, and an interview, the laboratory failed to follow manufacturer's enzyme immunoassay reagent storage requirements for 10 of 10 urine drug test kits and 2 of 2 analyzer cleaner kits on the date of the inspection, September 22, 2021. Findings include: 1. During a tour of the laboratory, the inspector noted the refrigerator temperature recorded by the FisherBrand Traceable thermometer as 1 degree C with the following lot numbered (#) reagents and analyzer cleaner kits stored in the refrigerator: LIN-ZHI enzyme immunoassay reagents: 2 boxes Oxycodone (# 2003060, # 2106108), Amphetamines (# 2108085), 2 boxes Opiate (# 2008045, # 2107059), 2 boxes Cocaine Metabolite (each # 2104060), 2 boxes Benzodiazepine (#2005014, # 2108059), Methadone (# 2107024); EasyRa Cleaner Kits: 2 boxes (each # 21225). 2. Review of the outer package of the urine drug screen reagents and cleaner kits outlined above revealed storage temperature instructions: LIN-ZHI : "Store at 2-8 C" EasyRa Cleaner: "Store at 4-25 C" 3. The inspector inquired of the lab director (LD) at approximately 11:55 AM, to describe the policy regarding the storage of the twelve chemistry reagents/kits outlined above. The LD stated: "They should be stored per the package instructions. I can turn the temperature control valve up to get it into range". 4. An interview with the LD on 9/22/21 at approximately 12:30 PM, the above findings were confirmed. D5785